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Stevenson, William G. Stevenson and Paul D. Varosy
Link, Joseph E. Marine, Mark H. Schoenfeld, Amit J. Shanker, Michael J. Silka, Lynne Warner
N.A. Mark Estes III, T. Bruce Ferguson, Jr, Stephen C. Hammill, Pamela E. Karasik, Mark S.
Cynthia M. Tracy, Andrew E. Epstein, Dawood Darbar, John P. DiMarco, Sandra B. Dunbar,
Rhythm Society
Foundation/American Heart Association Task Force on Practice Guidelines and the Heart
of Cardiac Rhythm Abnormalities : A Report of the American College of Cardiology
2012 ACCF/AHA/HRS Focused Update of the 2008 Guidelines for Device-Based Therapy
Print ISSN: 0009-7322. Online ISSN: 1524-4539
Copyright © 2012 American Heart Association, Inc. All rights reserved.
is published by the American Heart Association, 7272 Greenville Avenue, Dallas, TX 75231Circulation
doi: 10.1161/CIR.0b013e3182618569
2012;126:1784-1800; originally published online September 10, 2012;Circulation.
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Circulation is available at http://circ.ahajournals.org DOI: 10.1161/CIR.0b013e3182618569
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may apply; see Appendix 1 for recusal information. †ACCF/AHA Representative. ‡Heart Rhythm Society Representative. §ACCF/AHA Task Force on
Performance Measures Liaison. ‖American Association for Thoracic Surgery Representative. ¶Society of Thoracic Surgeons Representative. #Heart Failure
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3rd, Ferguson TB Jr, Hammill SC, Karasik PE, Link MS, Marine JE, Schoenfeld MH, Shanker AJ, Silka MJ, Stevenson LW, Stevenson WG, Varosy PD.
2012 ACCF/AHA/HRS focused update of the 2008 guidelines for device-based therapy of cardiac rhythm abnormalities: a report of the American College
of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines and the Heart Rhythm Society. Circulation. 2012;126:1784–1800.
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2012 ACCF/AHA/HRS Focused Update of the 2008
Guidelines for Device-Based Therapy of Cardiac
Rhythm Abnormalities
A Report of the American College of Cardiology Foundation/American
Heart Association Task Force on Practice Guidelines and the Heart
Rhythm Society
Developed in Collaboration With the American Association for Thoracic Surgery, Heart
Failure Society of America, and Society of Thoracic Surgeons
2012 WRITING GROUP MEMBERS*
Cynthia M. Tracy, MD, FACC, FAHA, Chair;
Andrew E. Epstein, MD, FACC, FAHA, FHRS, Vice Chair*; Dawood Darbar, MD, FACC, FHRS†;
John P. DiMarco, MD, PhD, FACC, FHRS*‡; Sandra B. Dunbar, RN, DSN, FAAN, FAHA†;
N.A. Mark Estes III, MD, FACC, FAHA, FHRS*§; T. Bruce Ferguson, Jr, MD, FACC, FAHA*‖¶;
Stephen C. Hammill, MD, FACC, FHRS‡; Pamela E. Karasik, MD, FACC, FHRS†;
Mark S. Link, MD, FACC, FHRS*†; Joseph E. Marine, MD, FACC, FHRS†;
Mark H. Schoenfeld, MD, FACC, FAHA, FHRS*†; Amit J. Shanker, MD, FACC, FHRS‡;
Michael J. Silka, MD, FACC†; Lynne Warner Stevenson, MD, FACC*#;
William G. Stevenson, MD, FACC, FAHA, FHRS***; Paul D. Varosy, MD, FACC, FHRS†
2008 WRITING COMMITTEE MEMBERS
Andrew E. Epstein, MD, FACC, FAHA, FHRS, Chair; John P. DiMarco, MD, PhD, FACC, FHRS;
Kenneth A. Ellenbogen, MD, FACC, FAHA, FHRS; N.A. Mark Estes III, MD, FACC, FAHA, FHRS;
Roger A. Freedman, MD, FACC, FHRS; Leonard S. Gettes, MD, FACC, FAHA;
A. Marc Gillinov, MD, FACC, FAHA; Gabriel Gregoratos, MD, FACC, FAHA;
Stephen C. Hammill, MD, FACC, FHRS; David L. Hayes, MD, FACC, FAHA, FHRS;
Mark A. Hlatky, MD, FACC, FAHA; L. Kristin Newby, MD, FACC, FAHA;
Richard L. Page, MD, FACC, FAHA, FHRS; Mark H. Schoenfeld, MD, FACC, FAHA, FHRS;
Michael J. Silka, MD, FACC; Lynne Warner Stevenson, MD, FACC; Michael O. Sweeney, MD, FACC
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Tracy et al    2012 Device-Based Therapy Guideline Focused Update   1785
ACCF/AHA TASK FORCE MEMBERS
Jeffrey L. Anderson, MD, FACC, FAHA, Chair;
Alice K. Jacobs, MD, FACC, FAHA, Immediate Past Chair;
Jonathan L. Halperin, MD, FACC, FAHA, Chair-Elect; Nancy M. Albert, PhD, CCNS, CCRN;
Mark A. Creager, MD, FACC, FAHA; David DeMets, PhD; Steven M. Ettinger, MD, FACC;
Robert A. Guyton, MD, FACC; Judith S. Hochman, MD, FACC, FAHA;
Frederick G. Kushner, MD, FACC, FAHA; E. Magnus Ohman, MD, FACC;
William Stevenson, MD, FACC, FAHA; Clyde W. Yancy, MD, FACC, FAHA
Table of Contents
Preambl����������������������������������������������������������������������������1785
1. Introduction������������������������������������������������������������������1787
1.1. Methodology and Evidence Review����������������������1787
1.2. Organization of the Writing Group������������������������1787
1.3. Document Review and Approval���������������������������1788
1.4. Scope of the Focused Update��������������������������������1788
2. Indications for Pacing��������������������������������������������������1789
2.4. Pacing for Hemodynamic Indications�������������������1789
2.4.1. Cardiac Resynchronization Therapy�����������1789
2.8. Pacemaker Follow-Up�������������������������������������������1792
2.8.3. Remote Follow-Up and Monitoring������������1792
References������������������������������������������������������������������������1793
Appendix 1. Author Relationships With Industry and
Other Entities (Relevant)�����������������������������1796
Appendix 2. Reviewer Relationships With Industry and
Other Entities (Relevant)�����������������������������1798
Appendix 3. Indications for CRT Therapy—Algorithm��1800
Preamble
Keeping pace with the stream of new data and evolving evidence
on which guideline recommendations are based is an ongoing
challenge to timely development of clinical practice guidelines.
In an effort to respond promptly to new evidence, the American
College of Cardiology Foundation (ACCF)/American Heart
Association (AHA) Task Force on Practice Guidelines (Task
Force) has created a “focused update” process to revise the
existingguidelinerecommendationsthatareaffectedbyevolving
data or opinion. New evidence is reviewed in an ongoing fashion
to more efficiently respond to important science and treatment
trends that could have a major impact on patient outcomes and
quality of care. Evidence is reviewed at least twice a year, and
updates are initiated on an as-needed basis and completed as
quickly as possible while maintaining the rigorous methodology
that theACCF andAHA have developed during their partnership
of 20 years.
These focused updates are prompted following a thorough
review of late-breaking clinical trials presented at national
and international meetings, in addition to other new published
data deemed to have an impact on patient care (Section 1.1,
“Methodology and Evidence Review”). Through a broad-
based vetting process, the studies included are identified
as being important to the relevant patient population. The
focused update is not intended to be based on a complete lit-
erature review from the date of the previous guideline publica-
tion but rather to include pivotal new evidence that may affect
changes to current recommendations.
Specific criteria or considerations for inclusion of new data
include the following:
• publication in a peer-reviewed journal;
• large, randomized, placebo-controlled trial(s);
• nonrandomized data deemed important on the basis of
results affecting current safety and efficacy assumptions,
including observational studies and meta-analyses;
• strength/weakness of research methodology and findings;
• likelihood of additional studies influencing current findings;
• impact on current and/or likelihood of need to develop new
performance measure(s);
• request(s) and requirement(s) for review and update from
the practice community, key stakeholders, and other sources
free of industry relationships or other potential bias;
• number of previous trials showing consistent results; and
• need for consistency with a new guideline or guideline
updates or revisions.
In analyzing the data and developing recommendations
and supporting text, the writing group uses evidence-based
methodologies developed by the Task Force.1
The Class of
Recommendation (COR) is an estimate of the size of the treat-
ment effect, with consideration given to risks versus benefits,
as well as evidence and/or agreement that a given treatment or
procedure is or is not useful/effective and in some situations
may cause harm. The Level of Evidence (LOE) is an estimate
of the certainty or precision of the treatment effect. The writ-
ing group reviews and ranks evidence supporting each recom-
mendation, with the weight of evidence ranked as LOE A,
B, or C, according to specific definitions that are included in
Table 1. Studies are identified as observational, retrospective,
prospective, or randomized, as appropriate. For certain condi-
tions for which inadequate data are available, recommenda-
tions are based on expert consensus and clinical experience
and are ranked as LOE C. When recommendations at LOE C
are supported by historical clinical data, appropriate references
(including clinical reviews) are cited if available. For issues
for which sparse data are available, a survey of current practice
among the clinicians on the writing group is the basis for LOE
C recommendations, and no references are cited. The schema
for COR and LOE is summarized in Table 1, which also pro-
vides suggested phrases for writing recommendations within
each COR. A new addition to this methodology is separation
of the Class III ­recommendations to delineate whether the
­recommendation is determined to be of “no benefit” or is asso-
ciated with “harm” to the patient. In addition, in view of the
increasing number of comparative effectiveness studies, com-
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1786  Circulation  October 2, 2012
parator verbs and suggested phrases for writing recommenda-
tionsforthecomparativeeffectivenessofonetreatmentorstrategy
versus another have been added for COR I and IIa, LOE A or
B only.
In view of the advances in medical therapy across the spec-
trum of cardiovascular diseases, the Task Force has desig-
nated the term guideline-directed medical therapy (GDMT)
to represent optimal medical therapy as defined by ACCF/
AHA guideline (primarily Class I)–recommended therapies.
This new term, GDMT, will be used herein and throughout all
future guidelines.
Because the ACCF/AHA practice guidelines address patient
populations (and healthcare providers) residing in North
America, drugs that are not currently available in North
America are discussed in the text without a specific COR. For
studies performed in large numbers of subjects outside North
America, each writing group reviews the potential impact of
different practice patterns and patient populations on the treat-
ment effect and relevance to the ACCF/AHA target population
to determine whether the findings should inform a specific
recommendation.
The ACCF/AHA practice guidelines are intended to assist
healthcare providers in clinical decision making by describ-
ing a range of generally acceptable approaches to the diag-
nosis, management, and prevention of specific diseases or
conditions. The guidelines attempt to define practices that
Table 1.  Applying Classification of Recommendations and Level of Evidence
A recommendation with Level of Evidence B or C does not imply that the recommendation is weak. Many important clinical questions addressed in the guidelines do
not lend themselves to clinical trials. Although randomized trials are unavailable, there may be a very clear clinical consensus that a particular test or therapy is useful
or effective.
*Data available from clinical trials or registries about the usefulness/efficacy in different subpopulations, such as sex, age, history of diabetes, history of prior
myocardial infarction, history of heart failure, and prior aspirin use.
†For comparative effectiveness recommendations (Class I and IIa; Level of Evidence A and B only), studies that support the use of comparator verbs should involve
direct comparisons of the treatments or strategies being evaluated.
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Tracy et al    2012 Device-Based Therapy Guideline Focused Update   1787
meet the needs of most patients in most circumstances. The
ultimate judgment about care of a particular patient must
be made by the healthcare provider and patient in light of
all the circumstances presented by that patient. As a result,
situations may arise in which deviations from these guide-
lines may be appropriate. Clinical decision making should
consider the quality and availability of expertise in the area
where care is provided. When these guidelines are used as
the basis for regulatory or payer decisions, the goal should
be improvement in quality of care. The Task Force rec-
ognizes that situations arise in which additional data are
needed to inform patient care more effectively; these areas
will be identified within each respective guideline when
appropriate.
Prescribed courses of treatment in accordance with these
recommendations are effective only if they are followed.
Because lack of patient understanding and adherence may
adversely affect outcomes, physicians and other healthcare
providers should make every effort to engage the patient’s
active participation in prescribed medical regimens and life-
styles. In addition, patients should be informed of the risks,
benefits, and alternatives to a particular treatment and should
be involved in shared decision making whenever feasible,
particularly for COR IIa and IIb, for which the benefit-to-risk
ratio may be lower.
The Task Force makes every effort to avoid actual,
potential, or perceived conflicts of interest that may arise
as a result of industry relationships or personal interests
among the members of the writing group. All writing group
members and peer reviewers of the guideline are required
to disclose all current healthcare-related relationships,
including those existing 12 months before initiation of the
writing effort. In December 2009, the ACCF and AHA
implemented a new policy for relationships with industry and
other entities (RWI) that requires the writing group chair plus
a minimum of 50% of the writing group to have no relevant
RWI (Appendix 1 includes the ACCF/AHA definition of
relevance). These statements are reviewed by the Task Force
and all members during each conference call and/or meeting
of the writing group and are updated as changes occur. All
guideline recommendations require a confidential vote by
the writing group and must be approved by a consensus
of the voting members. Members are not permitted to
draft or vote on any text or recommendations pertaining to
their RWI. Members who recused themselves from voting
are indicated in the list of writing group members, and
specific section recusals are noted in Appendix 1. Authors’
and peer reviewers’ RWI pertinent to this guideline are
disclosed in Appendixes 1 and 2, respectively. Additionally,
to ensure complete transparency, writing group members’
comprehensive disclosure information—including RWI
not pertinent to this document—is available as an online
supplement. Comprehensive disclosure information for the
Task Force is also available online at www.cardiosource.org/
ACC/About-ACC/Leadership/Guidelines-and-Documents-
Task-Forces.aspx. The work of the writing group is supported
exclusively by the ACCF, AHA, and the Heart Rhythm
Society (HRS) without commercial support. Writing group
members volunteered their time for this activity.
In an effort to maintain relevance at the point of care for prac-
ticing physicians, the Task Force continues to oversee an ongo-
ing process improvement initiative. As a result, in response to
pilot projects, several changes to these guidelines will be appar-
ent, including limited narrative text, a focus on summary and
evidence tables (with references linked to abstracts in PubMed),
and more liberal use of summary recommendation tables (with
references that support LOE) to serve as a quick reference.
In April 2011, the Institute of Medicine released 2 reports:
Finding What Works in Health Care: Standards for Systematic
Reviews and Clinical Practice Guidelines We Can Trust.2,3
It is
noteworthy that the ACCF/AHA practice guidelines were cited
as being compliant with many of the standards that were pro-
posed.A thorough review of these reports and our current meth-
odology is under way, with further enhancements anticipated.
The recommendations in this focused update are considered
current until they are superseded in another focused update or
the full-text guideline is revised. Guidelines are official policy
of both the ACCF and AHA.
Jeffrey L. Anderson, MD, FACC, FAHA
Chair, ACCF/AHA Task Force on Practice Guidelines
1. Introduction
1.1. Methodology and Evidence Review
Late-breaking clinical trials presented at the annual scientific
meetings of the ACC, AHA, HRS, and European Society of
Cardiology (2008 through 2010), as well as other selected
data reported through February 2012, were reviewed by the
guideline writing group along with the Task Force and other
experts to identify trials and other key data that might affect
guideline recommendations. On the basis of the criteria and
­considerations noted previously (Preamble), recently pub-
lished trial data and other clinical information were consid-
ered important enough to prompt a focused update of the
“ACC/AHA/HRS 2008 Guidelines for Device-Based Therapy
of Cardiac Rhythm Abnormalities.”4
To provide clinicians with a comprehensive set of data, the
absolute risk difference and number needed to treat or harm, if
they were published and their inclusion was deemed appropri-
ate, are provided in the guideline, along with confidence inter-
vals (CIs) and data related to the relative treatment effects,
such as odds ratio, relative risk (RR), hazard ratio (HR), or
incidence rate ratio.
Consult the full-text version of the “ACC/AHA/HRS 2008
Guidelines for Device-Based Therapy of Cardiac Rhythm
Abnormalities” for policy on clinical areas not covered by
the focused update.4
The individual recommendations in this
focused update will be incorporated into future revisions or
updates of the full-text guideline.
1.2. Organization of the Writing Group
For this focused update, selected members of the 2008
­Device-Based Therapy (DBT) Writing Committee were
invited to participate on the basis of areas of expertise,
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1788  Circulation  October 2, 2012
requirements for committee rotation, and the current RWI
policy; those who agreed are referred to as the 2012 Focused
Update Writing Group. The HRS was invited to be a partner
on this focused update and has provided representation. The
writing group also included representatives from the Ameri-
can Association for Thoracic Surgery, Heart Failure Society
of America, and Society of Thoracic Surgeons.
1.3. Document Review and Approval
This document was reviewed by 2 official reviewers each
nominated by the ACCF, AHA, and HRS, as well as 1
reviewer each from the American Association for Thoracic
Surgery, Heart Failure Society of America, and Society of
Thoracic Surgeons, and 21 individual content reviewers. All
information on reviewers’ RWI was collected and distrib-
uted to the writing group and is published in this document
(Appendix 2).
This document was approved for publication by the
governing bodies of the ACCF, AHA, and HRS and was
endorsed by the American Association for Thoracic Surgery,
Heart Failure Society of America, and Society of Thoracic
Surgeons.
1.4. Scope of the Focused Update
Studies relevant to the management of patients treated with
DBT for cardiac rhythm abnormalities were identified and
reviewedasdescribedpreviouslyinSection1.1,“Methodology
and Evidence Review.” On the basis of these data, the writing
group determined that updates to the 2008 guideline were
necessary for cardiac resynchronization therapy (CRT) and
device follow-up.
Many clinical circumstances come into question in daily
practice as to the appropriate use of implantable cardio-
verter-defibrillator (ICD)/CRT devices. Many of these clini-
cal scenarios are both common and of great importance but
have not or cannot be addressed by multicenter clinical trials,
so many of these will be addressed in the “Appropriate Use
Criteria (AUC) for Implantable Cardioverter-Defibrillators
and Cardiac Resynchronization Therapy” document that
is currently in development. Unlike comprehensive guide-
lines, AUC documents blend evidence-based information
and clinical experience that can help guide allocation of
healthcare resources, and they focus on the most common
patient scenarios for which procedures may be considered.
The AUC document will help define when it is reasonable
to perform a procedure and, importantly, when it is not rea-
sonable. Some of the scenarios included in the AUC may
be outside guideline indications. As such, AUC are comple-
mentary to guidelines and should be used in conjunction
with them for determining patient care. Furthermore, the
ACCF and AHA are currently undertaking a revision of the
guidelines for management of heart failure (HF). The DBT
and HF guideline writing committees have worked to main-
tain concordance on the recommendations with regard to
indications for CRT.
The writing group also thoroughly reviewed the following
sections from the 2008 DBT guideline4
and determined that
although some new information may be available, the recom-
mendations remain current.
1. Hypertrophic Cardiomyopathy—The management of
hypertrophic cardiomyopathy is addressed in the “2011
ACCF/AHA Guideline for the Diagnosis and Treatment
of Hypertrophic Cardiomyopathy.”5
In that document, the
indications for ICDs have been modified on the basis of
reassessment of significance of risk factors. The present
writing group did not analyze the source documents that
led to these changes and refer the reader to the ACCF/
AHA Guideline for full discussion of ICDs in hypertro-
phic cardiomyopathy.
2. Arrhythmogenic Right Ventricular Dysplasia/
Cardiomyopathy—The writing group reviewed all pub-
lished evidence since the publication of the 2008 DBT guide-
line related to arrhythmogenic right ventricular dysplasia/
cardiomyopathy and determined that no changes to the cur-
rent recommendations for ICD indications were warranted.
3. Genetic Arrhythmia Syndromes—The writing group
acknowledges that recent guidelines and data suggest that
there may be a limited role for primary-prevention ICDs
in individuals with a genetically confirmed diagnosis of
long QT but without symptoms.6–8
Nevertheless, it is the
consensus of this writing group that until more definitive
trials or studies are completed, further refinement of crite-
ria for ICD implantation in this patient group would not be
appropriate. Therefore, the class of recommendations for
ICD implantation in asymptomatic patients with a geneti-
cally confirmed mutation will remain unchanged.
4. Congenital Heart Disease—As with other forms of
structural heart disease, there has been increased use of
ICDs for primary prevention of sudden cardiac death in
patients with congenital heart disease.4,9
Although ran-
domized clinical trials have not been performed, multiple
observational studies have consistently reported that sys-
temic ventricular dysfunction in patients with congenital
heart disease is the risk factor most predictive of subse-
quent sudden cardiac death or appropriate ICD rescue.10–12
These studies support consideration of an expanded role
of ICDs in future revisions of the guideline, provided that
consistent benefit with the use of ICDs in patients with
congenital heart disease and advanced ventricular dys-
function is demonstrated. Nevertheless, the current rec-
ommendations are not changed at this time. There remain
insufficient data to make specific recommendations about
CRT in patients with congenital heart disease.13
5. Primary Electrical Disease—The writing group re-
viewed all published evidence since the publication of the
2008 DBT guideline related to primary electrical disease
and determined that no changes were warranted in the
current recommendations for ICD indications with regard
to idiopathic ventricular fibrillation, short-QT syndrome,
Brugada syndrome, and catecholaminergic polymorphic
ventricular tachycardia.
6. Terminal Care—Patients with cardiovascular implant-
able electronic devices (CIEDs) are living longer, with
more surviving to develop comorbid conditions such as
dementia or malignancy that may ultimately define their
clinical course. This was recognized in the terminal care
section of the 2008 DBT guideline. Recommendations
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Tracy et al    2012 Device-Based Therapy Guideline Focused Update   1789
on management of CIEDs in patients nearing end of life
or requesting withdrawal of therapy were expanded upon
in 2 subsequent HRS expert consensus statements in an
effort to provide guidance to caregivers dealing with this
increasingly prevalent and difficult issue.14,15
2. Indications for Pacing
2.4. Pacing for Hemodynamic Indications
Although most commonly used to treat or prevent abnor-
mal rhythms, pacing can alter the activation sequence in
the paced chambers, influencing regional contractility and
­hemodynamics. These changes are frequently insignificant
clinically but can be beneficial or harmful in some conditions.
Pacing to decrease symptoms for patients with obstructive
hypertrophic cardiomyopathy is discussed separately in the
full-text guideline, Section 2.4.2, “Obstructive Hypertrophic
Cardiomyopathy.”
2.4.1. Cardiac Resynchronization Therapy
(See Table 2 and the Online Data Supplement for additional
data on the trials that comprise the basis for the recommenda-
tions in this focused update.)
The present document proposes several changes in rec-
ommendations for CRT, compared with the 2008 document.
The most significant changes are 1) limitation of the Class
I indication to patients with QRS duration ≥150 ms; 2)
Table 2.  Recommendations for CRT in Patients With Systolic Heart Failure
2012 DBT Focused Update Recommendations Comments
Class I
  1. CRT is indicated for patients who have LVEF less than or equal to 35%,
sinus rhythm, LBBB with a QRS duration greater than or equal to 150 ms,
and NYHA class II, III, or ambulatory IV symptoms on GDMT. (Level of Evidence:
A for NYHA class III/IV16–19
; Level of Evidence: B for NYHA class II20,21
)
Modified recommendation (specifying CRT in patients with
LBBB of ≥150 ms; expanded to include those with NYHA class II
symptoms).
Class IIa
  1. CRT can be useful for patients who have LVEF less than or equal to 35%, sinus
rhythm, LBBB with a QRS duration 120 to 149 ms, and NYHA class II, III, or
ambulatory IV symptoms on GDMT.16–18,20–22
(Level of Evidence: B)
New recommendation
  2. CRT can be useful for patients who have LVEF less than or equal to 35%,
sinus rhythm, a non-LBBB pattern with a QRS duration greater than or equal
to 150 ms, and NYHA class III/ambulatory class IV symptoms on
GDMT.16–18,21
(Level of Evidence: A)
New recommendation
  3. CRT can be useful in patients with atrial fibrillation and LVEF less than or
equal to 35% on GDMT if a) the patient requires ventricular pacing or
otherwise meets CRT criteria and b) AV nodal ablation or pharmacologic rate
control will allow near 100% ventricular pacing with CRT.23–26,26a,48
(Level of Evidence: B)
Modified recommendation (wording changed to indicate benefit
based on ejection fraction rather than NYHA class; level of
evidence changed from C to B).
  4. CRT can be useful for patients on GDMT who have LVEF less than or equal
to 35% and are undergoing new or replacement device placement with
anticipated requirement for significant (_40%) ventricular pacing.25,27–29
(Level of Evidence: C)
Modified recommendation (wording changed to indicate benefit
based on ejection fraction and need for pacing rather than NYHA
class; class changed from IIb to IIa).
Class IIb
  1. CRT may be considered for patients who have LVEF less than or equal to
30%, ischemic etiology of heart failure, sinus rhythm, LBBB with a QRS
duration of greater than or equal to 150 ms, and NYHA class I
symptoms on GDMT.20,21
(Level of Evidence: C)
New recommendation
  2. CRT may be considered for patients who have LVEF less than or equal to
35%, sinus rhythm, a non-LBBB pattern with QRS duration 120 to 149 ms,
and NYHA class III/ambulatory class IV on GDMT.21,30
(Level of Evidence: B)
New recommendation
  3. CRT may be considered for patients who have LVEF less than or equal to
35%, sinus rhythm, a non-LBBB pattern with a QRS duration greater than or
equal to 150 ms, and NYHA class II symptoms on GDMT.20,21
(Level of
Evidence: B)
New recommendation
Class III: No Benefit
  1. CRT is not recommended for patients with NYHA class I or II symptoms
and non-LBBB pattern with QRS duration less than 150 ms.20,21,30
(Level of
Evidence: B)
New recommendation
  2. CRT is not indicated for patients whose comorbidities and/or frailty limit
survival with good functional capacity to less than 1 year.19
(Level of
Evidence: C)
Modified recommendation (wording changed to include cardiac
as well as noncardiac comorbidities).
See Appendix 3, “Indications for CRT Therapy—Algorithm.”
CRT indicates cardiac resynchronization therapy; DBT, device-based therapy; GDMT, guideline-directed medical therapy; LBBB, left bundle-branch block; LVEF, left
ventricular ejection fraction; and NYHA, New York Heart Association.
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1790  Circulation  October 2, 2012
limitation of the Class I indication to patients with left bun-
dle-branch block (LBBB) pattern; 3) expansion of Class I
indication to New York Heart Association (NYHA) class II
(and with LBBB with QRS duration ≥150 ms); and 4) the
addition of a Class IIb recommendation for patients who have
left ventricular ejection fraction (LVEF) ≤30%, ischemic eti-
ology of HF, sinus rhythm, LBBB with a QRS duration ≥150
ms, and NYHA class I symptoms. These changes may have
important implications for patient selection in clinical prac-
tice, and the justification for these changes is discussed in the
following paragraphs.
Progression of left ventricular (LV) systolic dysfunction
to clinical HF is frequently accompanied by impaired elec-
tromechanical coupling, which may further diminish effec-
tive ventricular contractility. The most common disruptions
are prolonged atrioventricular conduction (first-degree
atrioventricular block) and prolonged interventricular con-
duction, most commonly LBBB. Prolonged interventricular
and intraventricular conduction causes regional mechanical
delay within the left ventricle that can result in reduced ven-
tricular systolic function, altered myocardial metabolism,
functional mitral regurgitation, and adverse remodeling with
ventricular dilatation.31
Prolongation of the QRS duration
occurs in approximately one third of patients with advanced
HF32,33
and has been associated with ventricular electrome-
chanical delay (“dyssynchrony”), as identified by multiple
sophisticated echocardiographic indices. QRS duration and
dyssynchrony both have been identified as predictors of
worsening HF, sudden cardiac death, and total death.34
Modification of ventricular electromechanical delay
with multisite ventricular pacing (commonly called
“biventricular pacing” or CRT) can improve ventricular
systolic function, reduce metabolic costs, ameliorate
functional mitral regurgitation, and, in some patients,
induce favorable remodeling with reduction of cardiac
chamber dimensions.35–37 Functional improvement has
been demonstrated for exercise capacity, with peak oxygen
consumption in the range of 1 to 2 mL/kg/min and a 50- to
70-meter increase in 6-minute walking distance, as well as a
10-point or greater reduction of HF symptoms on the 105-
point Minnesota Living with Heart Failure scale.16,38,39
Meta-analysesofinitialclinicalexperiencesandlargersubse-
quent trials of CRT confirmed an approximately 30% decrease
in hospitalizations and a mortality rate benefit of 24% to 36%.40
In the COMPANION (Comparison of MedicalTherapy, Pacing,
and Defibrillation in Heart Failure) trial (NYHA class III/IV HF,
QRS duration 120 ms, and LVEF ≤35% on GDMT), GDMT
was compared to CRT pacing therapy without backup defibril-
lation (CRT-Pacemaker) and to CRT therapy with defibrillation
backup (CRT-D).17
Both CRT-Pacemaker and CRT-D reduced
the risk of the primary composite endpoint by approximately
20% as compared with GDMT alone. CRT-D reduced the mor-
tality rate by 36% compared with medical therapy, but there
was insufficient evidence to conclude that CRT-Pacemaker was
inferior to CRT-D. The CARE-HF (Cardiac Resynchronization
in Heart Failure) trial18
limited subjects to a QRS duration 150
ms (89% of patients) or QRS duration 120 to 150 ms with
echocardiographic evidence of dyssynchrony (11% of pa-
tients). It was the first study to show a significant (36%) reduc-
tion in death rate for resynchronization therapy unaccompa-
nied by backup defibrillation compared with GDMT.18
In the present document, we give a Class I recommenda-
tion for CRT in patients with QRS duration ≥150 ms. The dif-
ferential classification seen in this document related to QRS
duration is based on the results of multiple analyses of CRT
benefit. The prevalence of mechanical dyssynchrony has been
documented in 40% of patients with dilated cardiomyopathy
and QRS duration 120 ms, and is as high as 70% among
patients with QRS duration 150 ms and intraventricular
mechanical delay, as identified by several echocardiographic
techniques.34,41
However, the aggregate clinical experience has
consistently demonstrated that a significant clinical benefit
from CRT is greatest among patients with QRS duration 150
ms.42,43
In a meta-analysis of 5 trials involving 6501 patients,
CRT significantly decreased the primary endpoint of death or
hospitalization for HF in patients with QRS duration ≥150
ms (HR: 0.58; 95% CI: 0.50 to 0.68; P0.00001) but not in
patients with QRS duration 150 ms (HR: 0.95; 95% CI: 0.83
to 1.10; P=0.51).42
In addition, subgroup analyses from sev-
eral studies have suggested that a QRS duration 150 ms is
a risk factor for failure to respond to CRT therapy.43,44
The
observed differential benefit of CRT was seen across patients
in NYHA classes I through IV. It has not been possible to
reliably identify those with shorter QRS durations who may
benefit. Patients with shorter QRS durations who otherwise
qualify for CRT are afforded Class II recommendations in
these guidelines.
An additional difference in the present document com-
pared with the 2008 DBT guideline4
is the limitation of the
recommendation for Class I indication to patients with LBBB
pattern as compared to those with non-LBBB. For patients
with QRS duration ≥120 ms who do not have a complete
LBBB (non-LBBB patterns), evidence for benefit with CRT
is less compelling than in the presence of LBBB.45–47
The
impact of the specific QRS morphology on clinical event
reduction with CRT was evaluated in a meta-analysis of 4
clinical trials including 5356 patients.43a
In those with LBBB,
CRT significantly reduced composite adverse clinical events
(RR: 0.64; 95% CI: 0.52 to 0.77; P=0.00001). No benefit was
observed for patients with non-LBBB conduction abnormali-
ties (RR: 0.97; 95% CI: 0.82 to 1.15; P=0.75). Specifically,
there was no benefit in patients with right bundle-branch
block (RR: 0.91; 95% CI: 0.69 to 1.20; P=0.49) or nonspe-
cific intraventricular conduction delay (RR: 1.19; 95% CI:
0.87 to 1.63; P=0.28). Overall, the difference in effect of
CRT between LBBB versus non-LBBB patients was highly
statistically significant (P=0.0001).43a
Nevertheless, other
studies have shown that CRT is more likely to be effective in
patients with advanced HF and non-LBBB morphologies if
they have a markedly prolonged QRS duration21,30
(see RAFT
[Resynchronization-Defibrillation for Ambulatory Heart
Failure Trial]21
discussion below). Furthermore, patients with
QRS prolongation due to frequent right ventricular apical
pacing may benefit from CRT when other criteria for CRT are
met.23,25,48
No large trial has yet demonstrated clinical ­benefit
among patients without QRS prolongation, even when they
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have been selected with ­echocardiographic measures of
dyssynchrony.49
The observed heterogeneity of response even among those
who would appear to be excellent candidates for CRT also
may result from factors such as suboptimal lead location and
the location of conduction block from fibrosis in relation to
the pacing site. Several recent studies have emphasized the
importance of LV lead placement. For example, wider LV–
right ventricular lead separation has been shown to provide
better results.50
A subanalysis of MADIT-CRT (Multicenter
Automatic Defibrillator Implantation Trial with Cardiac
Resynchronization Therapy)20
showed that an apical LV lead
position, as compared with a basal or midventricular position,
resulted in a significant increased risk for HF or death.51
Clinical trials of resynchronization included mainly
patients in sinus rhythm. However, prospective experience
among patients with permanent atrial fibrillation and with
decreased LV systolic function suggests that benefit may
result from biventricular pacing when the QRS duration is
120 ms, although it may be most evident in patients in whom
atrioventricular nodal ablation has been performed, such that
right ventricular pacing is obligate.24,26,52
The benefit of CRT
in patients with atrial fibrillation is more pronounced in those
with depressed ejection fraction.25
Similarly, patients receiv-
ing prophylactic ICDs often evolve progressively to dominant
ventricular pacing, which may reflect both intrinsic chrono-
tropic incompetence and aggressive up-titration of beta-adren-
ergic–blocking agents.
When device implantation or reimplantation is being
considered for patients who require ventricular pacing, it is
prudent to recall the results of the DAVID (Dual Chamber
and VVI Implantable Defibrillator) trial.53
In this trial, dual-
chamber rate-responsive pacing increased HF admissions
and mortality rate as compared to sinus rhythm. A cutoff of
approximately 40% right ventricular pacing was seen as dele-
terious.54
Similarly, in a substudy from MADIT-II (Multicenter
Automatic Defibrillator Implantation Trial II), patients who
were right ventricular paced 50% of the time had a higher
rate of new or worsened HF than those right ventricular paced
≤50% of the time.55
The major experience with resynchronization derives from
patients with NYHA class III symptoms of HF and LVEF
≤35%. Patients with NYHA class IV symptoms of HF have
accounted for only 10% of all patients in clinical trials of
resynchronization therapy. These patients were highly selected
ambulatory outpatients who were taking oral medications and
had no history of recent hospitalization.56
Although a benefit
has occasionally been described in patients with more severe
acute decompensation that required brief positive intravenous
inotropic therapy to aid diuresis, CRT is not generally used as
a “rescue therapy” for such patients. Patients with dependence
on intravenous inotropic therapy, refractory fluid retention, or
advanced chronic kidney disease represent the highest-risk
population for complications of any procedure and for early
death after hospital discharge, and they are also unlikely to
receive a meaningful mortality risk benefit from concomitant
defibrillator therapy.19,57
Patients with NYHA class IV HF symptoms who derive
functional benefit from resynchronization therapy may return
to a better functional status, in which prevention of sudden
death becomes a relevant goal. Even among the selected
NYHA class IV patients identified within the COMPANION
trial,17
there was no difference in 2-year survival rate between
the CRT patients with and without backup defibrillation,
although more of the deaths in the CRT-Pacemaker group
were classified as sudden deaths.56
Perhaps the most significant changes in the present docu-
ment compared to the 2008 DBT Guideline4
are the expan-
sion of the Class I recommendation for CRT to include
patients with LBBB, QRS duration ≥150 ms, and NYHA
class II and the addition of a Class IIb recommendation
for patients who have LVEF ≤30%, ischemic etiology of
HF, sinus rhythm, LBBB with a QRS duration of ≥150 ms,
and NYHA class I symptoms. These recommendations are
based on 4 studies in which CRT was evaluated in patients
with minimal or mild symptoms of HF in the setting of
low LVEF. These include MADIT-CRT, RAFT, REVERSE
(Resynchronization Reverses Remodeling in Systolic Left
Ventricular Dysfunction), and MIRACLE ICD II (Multicenter
InSync ICD Randomized Clinical Evaluation II), all of which
are discussed in the following paragraphs.20-22,58
MADIT-CRT20
randomized patients with NYHA class I or
II ischemic and NYHA class II nonischemic cardiomyopa-
thy, LVEF ≤30%, and QRS duration ≥130 ms on GDMT to
CRT-D or ICD alone. Of note, only 15% of the total cohort of
patients were NYHA class I. The primary endpoint, a com-
posite of death or HF event, was reduced by 34% by CRT-D
(HR: 0.66), with comparable benefit for both ischemic and
nonischemic etiology of HF. HF events were reduced by
41%, without significant reduction in mortality rate. CRT-D
therapy was demonstrated to be of more benefit in women
than in men (HR: 0.37 and 0.76, respectively) and in patients
with QRS duration ≥150 ms than in patients with QRS dura-
tion 150 ms (HR: 0.48 and 1.06, respectively).20
Patients
with LBBB had a significant reduction in ventricular tachy-
cardia, ventricular fibrillation, and death compared to non-
LBBB patients, who derived no benefit (HR: 0.47 and 1.24,
respectively).10
RAFT21
reported the use of CRT-D in patients with NYHA
class II or class III ischemic or nonischemic cardiomyopa-
thy, LVEF ≤30%, and QRS duration ≥120 ms, as compared
to those treated with an ICD alone. The primary outcome of
death or hospitalization for HF occurred in 33% of patients
receiving CRT-D and in 40% of patients receiving ICD only.
RAFT not only showed a significant reduction in hospital-
ization for HF (HR: 0.68; 95% CI: 0.56 to 0.83; P0.001)
but also was the first study to show a statistically significant
reduction in death (HR: 0.75; 95% CI: 0.62 to 0.91; P=0.003)
in mildly symptomatic patients with NYHA class II symp-
toms. However, CRT-D was associated with a higher risk
of adverse device- or implantation-related complications
at 30 days after implantation (P0.001) compared with an
ICD and no CRT. Patients with LBBB had a better outcome
than did non-LBBB patients, but the statistical interaction
between benefit and QRS morphology was weak in this trial
(P=0.046). CRT-D therapy was effective in patients with
QRS duration ≥150 ms but of no benefit in patients with
QRS duration 150 ms (HR for QRS duration ≥150 ms:
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1792  Circulation  October 2, 2012
0.59; 95% CI: 0.48 to 0.73; HR for QRS duration 150 ms:
0.99; 95% CI: 0.77 to 1.27; P=0.002 for interaction). Thus,
both MADIT-CRT and RAFT showed benefit in NYHA class
II patients treated with CRT-D and demonstrated that the
benefit was primarily achieved in patients with QRS duration
≥150 ms and LBBB.20,21
The REVERSE trial consisted of 610 patients. This study
assessed CRT-D therapy in patients with NYHA class I or II
HF symptoms on maximum medical therapy, LVEF ≤40%,
and QRS duration ≥120 ms followed for 12 months and
showed that 16% of patients receiving CRT and 21% with-
out CRT worsened (P=0.10). The time to first HF hospital-
ization was delayed in patients receiving CRT therapy (HR:
0.47). The primary echocardiographic endpoint of ventricular
remodeling assessed by LV end-systolic volume index was sig-
nificantly improved (reduction in end-systolic volume index)
in patients treated with CRT therapy (P0.0001). REVERSE
did not report a mortality rate benefit of CRT-D therapy.22
The
lack of reported mortality rate benefit may be related to the
higher ejection fraction enrollment criterion (LVEF ≤40%)
and the relatively short-term follow-up (12 months).22
MIRACLE ICD II included patients with NYHA class II
HF on GDMT with LVEF ≤35% and QRS duration ≥130
ms who were undergoing implantation of an otherwise indi-
cated ICD.58
In these patients, CRT did not alter exercise
capacity but did result in significant improvement in cardiac
structure and function and composite clinical response over
6 months.
Analysis of the multiple clinical trials of CRT is compli-
cated because trials encompass a range of LVEFs in their
entry criteria, as well as a range of measured outcomes. For
mortality rate, the trials showing benefit in NYHA class III
and IV patients typically included those with LVEF ≤35%.22,58
For patients with NYHA class II, trials showing mortality
rate benefit included those with LVEF ≤30%.20,21
A mortal-
ity rate benefit with CRT has not been shown for patients
who are NYHA class I.21
In terms of demonstrating improve-
ment in cardiac function (eg, significant reduction in LV size
and improvement in ejection fraction), trials have included
patients with LVEF ≤35% who are NYHA class III and IV.58
Similarly, for patients with LVEF ≤40%, trials demonstrating
improvement in function have included those who are NYHA
class I and II.22
The congruence of results from the totality
of CRT trials with regard to remodeling and HF events pro-
vides evidence supporting a common threshold of 35% for
benefit from CRT in patients with NYHA class II through IV
HF symptoms. Although there is evidence for benefit in both
CRT-D and CRT-Pacemaker patients with NYHA class III
and IV symptoms, for NYHA class I and II HF, all of the tri-
als tested only CRT-D and not CRT-Pacemaker, and as such,
recommendations for these classes of patients can be made
only for CRT-D.20-22,58
Taken together, the evidence from the randomized trials of
CRT-D in patients with reduced LVEF and NYHA class I or
II shows that CRT can provide functional ­improvement and
decreasetheriskofHFeventsandcomposite­outcomes.20,22,58,59
Still, CRT-D also has been shown to decrease the mortal-
ity rate for patients with NYHA class II but not for those
who have NYHA class I HF.20,21
As a result, the data
support a Class I recommendation for CRT implantation in
patients with LBBB and QRS duration ≥150 ms and NYHA
class II. Because of the lack of mortality rate benefit and
smaller sample size, we believe CRT may be considered for
patients who have LVEF 30%, ischemic etiology of HF,
sinus rhythm, LBBB with a QRS duration ≥150 ms, and
NYHA class I symptoms on GDMT (Class IIb; LOE: B).
For all patients, optimal outcomes with CRT require effec-
tive placement of ventricular leads, ongoing HF management
with neurohormonal antagonists and diuretic therapy, and
in some cases, later optimization of device programming,
especially atrioventricular (A-V) and interventricular (V-V)
intervals.51,60
Consistent with entry criteria for studies upon which
these recommendations are based, CRT implantation should
be performed only when the LVEF meets guideline criteria
for patients with nonischemic cardiomyopathy who have
received 3 months of GDMT, or for patients with ischemic
cardiomyopathy 40 days after myocardial infarction receiv-
ing GDMT when there was no intervening revasculariza-
tion, or 3 months if revascularization was performed. It is
assumed that the final decision to recommend CRT will be
based on an assessment of LVEF made after any appropriate
waiting period has concluded, during which GDMT has been
applied. Finally, the pivotal trials demonstrating the efficacy
of CRT took place in centers that provided expertise in device
and HF therapy both at implantation and during long-term
follow-up.
Two other organizational guidelines by the Heart
Failure Society of America61
and the European Society of
Cardiology62
have recently been published that address
indications for CRT. For the patient categories in common
between the Heart Failure Society of America document
and the present focused update, there was a good deal of
concordance. Although there are many areas of agreement,
some differences exist between the present guideline and the
European Society of Cardiology document. One difference is
that in the present guideline, CRT is recommended in NYHA
class I patients who have LVEF ≤30%, have ischemic heart
disease, are in sinus rhythm, and have a LBBB with a QRS
duration ≥150 ms (Class IIb; LOE: C).20,21
There is no simi-
lar recommendation in the European Society of Cardiology
document. The European Society of Cardiology recom-
mendations include patients with QRS duration 120 ms.
We have not recommended CRT for any functional class or
ejection fraction with QRS durations 120 ms. We also have
elected to consider the presence of LBBB versus non-LBBB
in the class of recommendations, on the basis of perceived
differential benefit by functional class, QRS morphology,
and QRS duration.
2.8. Pacemaker Follow-Up
2.8.3. Remote Follow-Up and Monitoring
Since the publication of the 2008 DBT guideline, important
changes have occurred related to follow-up and remote mon-
itoring of CIEDs.4,15,63
CIEDs include pacemakers, ICDs,
CRTs, implantable loop recorders, and implantable cardio-
vascular monitors. The current technology for follow-up,
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Tracy et al    2012 Device-Based Therapy Guideline Focused Update   1793
evidence supporting its use, and clinical practice of CIED
monitoring have evolved. Routine in-person office follow-
up supplemented by transtelephonic monitoring with limited
remote follow-up for pacemakers was the standard approach
before 2008.4,15
Transtelephonic monitoring, with moni-
tors that transmit the patient’s heart rhythm by converting
electrocardiographic information to sound and transmit-
ting it via telephone lines to a decoding machine that
then converts the sound back into a rhythm strip, is now
a dated ­technique4,15,63
because it allows for limited moni-
toring of heart rate, rhythm, and battery status of only
pacemakers.63
Contemporary remote monitoring uses bidirectional
telemetry with encoded and encrypted radiofrequency sig-
nals, allowing transmission and receipt of information from
CIEDs (pacemakers, ICDs, CRTs, implantable loop record-
ers, and implantable hemodynamic monitors).63
All major
CIED manufacturers have developed proprietary systems to
allow patients to have their devices interrogated remotely,
and many use wireless cellular technology to extend the
bidirectional telemetry links into the patient’s location.15,63
The information is analyzed, formatted, and transmitted
to a central server, where it can be accessed by clinicians
through the Internet. Information provided through remote
follow-up includes virtually all of the stored information
that would be obtained in an in-office visit, including bat-
tery voltage, charge time in ICDs, percent pacing, sens-
ing thresholds, automatically measured pacing thresholds
when available, pacing and shock impedance, and stored
arrhythmia events with electrograms.15,63
CIEDs with wire-
less telemetry capability may be programmed at a face-to-
face evaluation to subsequently send automatic alerts for a
variety of issues that the clinician deems significant, such
as abnormal battery voltage, abnormal lead parameters, or
increased duration or frequency of arrhythmia episodes.15
Remote transmissions can be made at predetermined inter-
vals or at unscheduled times for prespecified alerts related
to device function or activated by the patient for clinical
reasons.63
A detailed description of techniques, indications,
personnel, and frequency has been published as a consensus
document.15
Several prospective randomized trials have been conducted
evaluating the effect of remote monitoring on clinical out-
comes64–67
since the publication of the 2008 DBT Guideline.4
Collectively, these trials have demonstrated that remote moni-
toring is a safe alternative to office visits to evaluate CIEDs.
Compared with in-person office visits to evaluate CIEDs,
remote monitoring leads to early discovery of clinically action-
able events, decreased time to clinical decision in response to
these events, and fewer office visits.64–67
Long-term survival
rates of patients monitored remotely with ICDs in a practice
setting compare favorably with survival rates of patients in
clinical trials.68
Current suggestions for the minimum frequency of in-office
and remote monitoring of patients with CIEDs are summa-
rized in Table 3.15
Issues such as lead malfunction, unreliable
battery life indicators, and other device or lead recalls influ-
ence clinical decisions, which may change the appropriate
minimum follow-up.
Presidents and Staff
American College of Cardiology Foundation
William A. Zoghbi, MD, FACC, President
Thomas E. Arend, Jr, Esq, CAE, Interim Chief Staff Officer
Charlene May, Senior Director, Science and Clinical Policy
American College of Cardiology
Foundation/American Heart Association
Lisa Bradfield, CAE, Director, Science and Clinical Policy
Debjani Mukherjee, MPH, Associate Director, Evidence-
Based Medicine
Ezaldeen Ramadhan III, Specialist, Science and Clinical
Policy
American Heart Association
Gordon F. Tomaselli, MD, FAHA, President
Nancy Brown, Chief Executive Officer
Rose Marie Robertson, MD, FAHA, Chief Science Officer
Gayle R. Whitman, PhD, RN, FAHA, FAAN, Senior Vice
President, Office of Science Operations
Judy L. Bezanson, DSN, RN, CNS-MS, FAHA, Science and
Medicine Advisor, Office of Science Operations
Jody Hundley, Production Manager, Scientific Publications,
Office of Science Operations
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Table 3.  Minimum Frequency of CIED In-Person or
Remote Monitoring*
Type and Frequency Method
Pacemaker/ICD/CRT
Within 72 h of CIED implantation In person
2–12 wk postimplantation In person
Every 3–12 mo for pacemaker/CRT-
Pacemaker
In person or remote
Every 3–6 mo for ICD/CRT-D In person or remote
Annually until battery depletion In person
Every 1–3 mo at signs of battery depletion In person or remote
Implantable loop recorder
Every 1–6 mo depending on patient In person or remote
symptoms and indication
Implantable hemodynamic monitor
Every 1–6 mo depending on indication In person or remote
More frequent assessment as clinically In person or remote
Indicated
*More frequent in-person or remote monitoring may be required for all the
above devices as clinically indicated.
CIED indicates cardiovascular implantable electronic device; CRT, cardiac
resynchronization therapy; CRT-D, cardiac resynchronization therapy defibril-
lator; CRT-Pacemaker, cardiac resynchronization therapy pacemaker; and ICD,
implantable cardioverter-defibrillator.
Modified from Wilkoff et al.15
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ventricular tachyarrhythmias in the MADIT-CRT (Multicenter Automatic
Defibrillator Implantation Trial–Cardiac Resynchronization Therapy). J
Am Coll Cardiol. 2011;57:2416–23.
11. Silka MJ, Bar-Cohen Y. Should patients with congenital heart disease and
a systemic ventricular ejection fraction less than 30% undergo prophylac-
tic implantation of an ICD? Patients with congenital heart disease and a
systemic ventricular ejection fraction less than 30% should undergo pro-
phylactic implantation of an implantable cardioverter defibrillator. Circ
Arrhythm Electrophysiol. 2008;1:298–306.
12. Khairy P, Harris L, Landzberg MJ, et al. Implantable cardioverter-defibril-
lators in tetralogy of Fallot. Circulation. 2008;117:363–70.
13. van der Hulst AE, Delgado V, Blom NA, et al. Cardiac resynchronization
therapy in paediatric and congenital heart disease patients. Eur Heart J.
2011;32:2236–46.
14. Lampert R, Hayes DL, Annas GJ, et al. HRS expert consensus statement
on the management of cardiovascular implantable electronic devices
(CIEDs) in patients nearing end of life or requesting withdrawal of thera-
py. Heart Rhythm. 2010;7:1008–26.
15. Wilkoff BL, Auricchio A, Brugada J, et al. HRS/EHRA expert consen-
sus on the monitoring of cardiovascular implantable electronic devices
(CIEDs): description of techniques, indications, personnel, frequency and
ethical considerations. Heart Rhythm. 2008;5:907–25.
16. Abraham WT, Fisher WG, Smith AL, et al. Cardiac resynchronization in
chronic heart failure. N Engl J Med. 2002;346:1845–53.
17. Bristow MR, Saxon LA, Boehmer J, et al. Cardiac-resynchronization ther-
apy with or without an implantable defibrillator in advanced chronic heart
failure. N Engl J Med. 2004;350:2140–50.
18. Cleland JGF, Daubert J-C, Erdmann E, et al. The effect of cardiac resyn-
chronization on morbidity and mortality in heart failure. N Engl J Med.
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19. Hunt SA, Abraham WT, Chin MH, et al. 2009 Focused update incorporat-
ed into the ACC/AHA 2005 guidelines for the diagnosis and management
of heart failure in adults: a report of the American College of Cardiology
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lines. Circulation. 2009;119:e391-479.
20. Moss AJ, Hall WJ, Cannom DS, et al. Cardiac-resynchronization
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21. Tang ASL, Wells GA, Talajic M, et al. Cardiac-resynchronization therapy
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synchronization in mildly symptomatic heart failure patients and in as-
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23. Brignole M, Gammage M, Puggioni E, et al. Comparative assessment of
right, left, and biventricular pacing in patients with permanent atrial fibril-
lation. Eur Heart J. 2005;26:712–22.
24. Brignole M, Botto G, Mont L, et al. Cardiac resynchronization therapy in
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25. Doshi RN, Daoud EG, Fellows C, et al. Left ventricular–based cardiac
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26. Gasparini M, Auricchio A, Regoli F, et al. Four-year efficacy of cardiac
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the importance of performing atrioventricular junction ablation in patients
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26a.Wilton SB, Leung AA, Ghali WA, et al. Outcomes of cardiac resynchro-
nization therapy in patients with versus those without atrial fibrillation:
a systematic review and meta-analysis. Heart Rhythm. 2011;8:1088–94.
27. Wilkoff BL, Cook JR, Epstein AE, et al. Dual-chamber pacing or ven-
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28. Adelstein E, Schwartzman D, Gorcsan J 3rd, Saba S. Predicting hyper-
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29. Vatankulu MA, Goktekin O, Kaya MG, et al. Effect of long-term
resynchronization therapy on left ventricular remodeling in pacemaker
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30. Rickard J, Bassiouny M, Cronin EM, et al. Predictors of response to car-
diac resynchronization therapy in patients with a non–left bundle branch
block morphology. Am J Cardiol. 2011;108:1576–80.
31. Masci PG, Marinelli M, Piacenti M, et al. Myocardial structural, perfu-
sion, and metabolic correlates of left bundle branch block mechanical
derangement in patients with dilated cardiomyopathy: a tagged cardiac
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diovasc Imaging. 2010;3:482–90.
32. Kashani A, Barold SS. Significance of QRS complex duration in patients
with heart failure. J Am Coll Cardiol. 2005;46:2183–92.
33. Doval HC, Nul DR, Grancelli HO, et al. Randomised trial of low-dose
amiodarone in severe congestive heart failure: Grupo de Estudio de la
Sobrevida en la Insuficiencia Cardiaca en Argentina (GESICA). Lancet.
1994;344:493–8.
34. Bleeker GB, Schalij MJ, Molhoek SG, et al. Relationship between QRS
duration and left ventricular dyssynchrony in patients with end-stage heart
failure. J Cardiovasc Electrophysiol. 2004;15:544–9.
35. Blanc JJ, Etienne Y, Gilard M, et al. Evaluation of different ventricular
pacing sites in patients with severe heart failure: results of an acute hemo-
dynamic study. Circulation. 1997;96:3273–7.
36. Prinzen FW, Vernooy K, De Boeck BWL, et al. Mechano-energetics
of the asynchronous and resynchronized heart. Heart Fail Rev. 2011;
16:215–24.
37. Ukkonen H, Sundell J, Knuuti J. Effects of CRT on myocardial innervation,
perfusion and metabolism. Europace. 2008;10(suppl 3):iii114--iii117.
38. Cazeau S, Leclercq C, Lavergne T, et al. Effects of multisite biventricular
pacing in patients with heart failure and intraventricular conduction delay.
N Engl J Med. 2001;344:873–80.
39. Stellbrink C, Breithardt OA, Franke A, et al. Impact of cardiac resynchro-
nization therapy using hemodynamically optimized pacing on left ventric-
ular remodeling in patients with congestive heart failure and ventricular
conduction disturbances. J Am Coll Cardiol. 2001;38:1957–65.
40. Bradley DJ, Bradley EA, Baughman KL, et al. Cardiac resynchronization
and death from progressive heart failure: a meta-analysis of randomized
controlled trials. JAMA. 2003;289:730–40.
41. Haghjoo M, Bagherzadeh A, Fazelifar AF, et al. Prevalence of mechanical
dyssynchrony in heart failure patients with different QRS durations. Pac-
ing Clin Electrophysiol. 2007;30:616–22.
42. Stavrakis S, Lazzara R, Thadani U. The benefit of cardiac resynchroni-
zation therapy and QRS duration: a meta-analysis. J Cardiovasc Electro-
physiol. 2012;23:163–8.
43. Sipahi I, Carrigan TP, Rowland DY, et al. Impact of QRS ­duration on
clinical event reduction with cardiac resynchronization therapy: meta-
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43a.Sipahi I, Chou JC, Hyden M, et al. Effect of QRS morphology on clinical
event reduction with cardiac resynchronization therapy: meta-analysis of
randomized controlled trials. Am Heart J. 2012;163:260–7.
44. Saxon LA, Ellenbogen KA. Resynchronization therapy for the treatment
of heart failure. Circulation. 2003;108:1044–8.
45.	 Bilchick KC, Kamath S, DiMarco JP, Stukenborg GJ. Bundle-branch block
morphology and other predictors of outcome after cardiac resynchroniza-
tion therapy in Medicare patients. Circulation. 2010;122:2022–30.
46.	 Adelstein EC, Saba S. Usefulness of baseline electrocardiographic QRS
complex pattern to predict response to cardiac resynchronization. Am J
Cardiol. 2009;103:238–42.
47.	 Rickard J, Kumbhani DJ, Gorodeski EZ, et al. Cardiac resynchronization
therapy in non–left bundle branch block morphologies. Pacing Clin Elec-
trophysiol. 2010;33:590–5.
48.	 Upadhyay GA, Choudhry NK, Auricchio A, et al. Cardiac resynchroni-
zation in patients with atrial fibrillation: a meta-analysis of prospective
cohort studies. J Am Coll Cardiol. 2008;52:1239–46.
49.	Beshai JF, Grimm RA, Nagueh SF, et al. Cardiac-resynchronization
therapy in heart failure with narrow QRS complexes. N Engl J Med.
2007;357:2461–71.
50.	Ariga R, Tayebjee MH, Benfield A, et al. Greater three-dimensional
ventricular lead tip separation is associated with improved outcome
after cardiac resynchronization therapy. Pacing Clin Electrophysiol.
2010;33:1490–6.
51.	 Singh JP, Klein HU, Huang DT, et al. Left ventricular lead position and
clinical outcome in the multicenter automatic defibrillator implantation
trial-cardiac resynchronization therapy (MADIT-CRT) trial. Circulation.
2011;123:1159–66.
52.	 Linde C, Leclercq C, Rex S, et al. Long-term benefits of biventricular pac-
ing in congestive heart failure: results from the MUltisite STimulation in
cardiomyopathy (MUSTIC) study. J Am Coll Cardiol. 2002;40:111–8.
53.	 Sweeney MO, Prinzen FW. A new paradigm for physiologic ventricular
pacing. J Am Coll Cardiol. 2006;47:282–8.
54.	Sharma AD, Rizo-Patron C, Hallstrom AP, et al. Percent right ven-
tricular pacing predicts outcomes in the DAVID trial. Heart Rhythm.
2005;2:830–4.
55.	 Steinberg JS, Fischer A, Wang P, et al. The clinical implications of cumu-
lative right ventricular pacing in the Multicenter Automatic Defibrillator
Trial II. J Cardiovasc Electrophysiol. 2005;16:359–65.
56.	 Lindenfeld J, Feldman AM, Saxon L, et al. Effects of cardiac resynchroni-
zation therapy with or without a defibrillator on survival and hospitaliza-
tions in patients with New York Heart Association class IV heart failure.
Circulation. 2007;115:204–12.
57.	Amin MS, Fox AD, Kalahasty G, et al. Benefit of primary preven-
tion implantable cardioverter-defibrillators in the setting of chronic
kidney disease: a decision model analysis. J Cardiovasc Electrophysiol.
2008;19:1275–80.
58.	Abraham WT, Young JB, León AR, et al. Effects of cardiac resyn-
chronization on disease progression in patients with left ventricular
systolic dysfunction, an indication for an implantable cardioverter-de-
fibrillator, and mildly symptomatic chronic heart failure. Circulation.
2004;110:2864–8.
59.	 Daubert C, Gold MR, Abraham WT, et al. Prevention of disease progres-
sion by cardiac resynchronization therapy in patients with asymptomatic
or mildly symptomatic left ventricular dysfunction: insights from the
European cohort of the REVERSE (Resynchronization Reverses Remod-
eling in Systolic Left Ventricular Dysfunction) trial. J Am Coll Cardiol.
2009;54:1837–46.
60.	 Singh JP, Gras D. Biventricular pacing: current trends and future strate-
gies. Eur Heart J. 2012;33:305–13.
61.	 Stevenson WG, Hernandez AF, Carson PE, et al. Indications for cardiac
resynchronization therapy: 2011 update from the Heart Failure Society
of America Guideline Committee. J Card Fail. 2012;18:94–106.
62.	 Dickstein K, Vardas PE, Auricchio A, et al. 2010 Focused update of ESC
guidelines on device therapy in heart failure: an update of the 2008 ESC
guidelines for the diagnosis and treatment of acute and chronic heart
failure and the 2007 ESC guidelines for cardiac and resynchronization
therapy. Eur Heart J. 2010;31:2677–87.
63.	 Dubner S, Auricchio A, Steinberg JS, et al. ISHNE/EHRA expert consen-
sus on remote monitoring of cardiovascular implantable electronic devices
(CIEDs). Europace. 2012;14:278–93.
64.	 Crossley GH, Chen J, Choucair W, et al. Clinical benefits of remote versus
transtelephonic monitoring of implanted pacemakers. J Am Coll Cardiol.
2009;54:2012–9.
65.	 Crossley GH, Boyle A, Vitense H, et al. The CONNECT (Clinical Evalua-
tion of Remote Notification to Reduce Time to Clinical Decision) trial: the
value of wireless remote monitoring with automatic clinician alerts. J Am
Coll Cardiol. 2011;57:1181–9.
66.	 Varma N, Epstein AE, Irimpen A, et al. Efficacy and safety of automatic
remote monitoring for implantable cardioverter-defibrillator follow-up:
the Lumos-T Safely Reduces Routine Office Device Follow-up (TRUST)
trial. Circulation. 2010;122:325–32.
67.	 Mabo P, Victor F, Bazin P, et al. A randomized trial of long-term remote
monitoring of pacemaker recipients (the COMPAS trial). Eur Heart J.
2012;33:1105–11.
68.	 Saxon LA, Hayes DL, Gilliam FR, et al. Long-term outcome after ICD
and CRT implantation and influence of remote device follow-up: the AL-
TITUDE survival study. Circulation. 2010;122:2359–67.
KEY WORDS: AHA Scientific Statements ■ arrhythmias
■ cardiac resynchronization therapy ■ focused update ■ heart failure
■ pacemaker
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1796  Circulation  October 2, 2012
Appendix 1.  Author Relationships With Industry and Other Entities (Relevant)—2012 ACCF/AHA/HRS Focused Update of the 2008
Guidelines for Device-Based Therapy of Cardiac Rhythm Abnormalities
Committee
Member Employment Consultant
Speaker’s
Bureau
Ownership/
Partnership/
Principal Personal Research
Institutional,
Organizational, or
Other Financial
Benefit
Expert
Witness
Voting
Recusals by
Section*
Cynthia M.
Tracy, Chair
George Washington
University Medical
Center—Associate Director
and Professor of Medicine
None None None None None None None
Andrew E.
Epstein, Vice
Chair
University of
Pennsylvania—Professor of
Medicine
Philadelphia VA Medical
Center—Chief, Cardiology
Section
• Boston Scientific
(DSMB)†
• Medtronic‡
• Medtronic/
CryoCath (DSMB)
• St. Jude Medical
(DSMB)†
• ZOLL—Advisory
Board
None None • Biotronik
• Boston Scientific†
• Cameron Health†
• Medtronic†
• St. Jude Medical†
• Boston Scientific
• Medtronic
• St. Jude Medical
None 2.4.1
Dawood
Darbar
Vanderbilt University School
of Medicine—C. Sydney
Burwell Associate Professor
Medicine Pharmacology
Vanderbilt Arrhythmia
Service—Director
None None None None None None None
JohnP.DiMarco University of
Virginia—Director,
Clinical EP Laboratory
• Medtronic None None • Boston Scientific None None 2.4.1
• St. Jude Medical
Sandra B.
Dunbar
Emory University, Nell
Hodgson Woodruff School
of Nursing—Associate
Dean for Academic
Advancement, Charles
Howard Candler Professor
None None None None None None None
N.A. Mark
Estes III
Tufts University—Professor of
Medicine
• Boston Scientific† None None • Boston Scientific—
MADIT-RIT (Co-PI)
None None 2.4.1
• Boston Scientific,
EP Fellowship
Educational
Symposium†
• Medtronic
T. Bruce
Ferguson, Jr
East Carolina
University—Professor of
Surgery and Physiology
• United

Healthcare—
Advisory Board
None None None None None 2.4.1
Stephen C.
Hammill
Mayo Clinic—Professor of
Medicine
None None None None None None None
Pamela E. Georgetown University None None None None None None None
Karasik Medical School—Associate
Professor of Medicine
VA Medical Center,
Washington, DC—Acting
Chief of Cardiology
Mark S. Link Tufts Medical
Center—Professor of
Medicine
None None None • Boston Scientific—
MADIT-RIT (Co-PI)
None None 2.4.1
Joseph E.
Marine
Johns Hopkins
University—Associate
Professor of Medicine
None None None None None None None
Mark H.
Schoenfeld
Yale University School of
Medicine—Clinical
Professor of Medicine
• United
Healthcare—
Advisory Board
None None None None None 2.4.1
Amit J.
Shanker
Center for Advanced
Arrhythmia Medicine—
Director
Columbia University College
of Physicians and
Surgeons—Assistant
Professor of Medicine
None None None None None None None
(Continued)
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Tracy et al    2012 Device-Based Therapy Guideline Focused Update   1797
Appendix 1.  Continued
Committee
Member Employment Consultant
Speaker’s
Bureau
Ownership/
Partnership/
Principal Personal Research
Institutional,
Organizational, or
Other Financial
Benefit
Expert
Witness
Voting
Recusals by
Section*
Michael J.
Silka
University of Southern
California—Professor of
Pediatrics Children’s Hospital
Los Angeles—Chief, Division of
Cardiology
None None None None None None None
Lynne
Warner
Stevenson
Brigham  Women’s
Hospital—Director,
Cardiomyopathy and Heart Failure
None None None • Biosense Webster‡ None None 2.4.1
William G.
Stevenson
Brigham  Women’s
Hospital—Director, Clinical
Cardiac EP
None None None • Biosense Webster‡ None None 2.4.1
Paul D.
Varosy
VA Eastern Colorado Health
Care System—Director of
Cardiac EP University of
Colorado Denver—Assistant
Professor of Medicine
None None None None None None None
This table represents the relationships of committee members with industry and other entities that were determined to be relevant to this document.
These relationships were reviewed and updated in conjunction with all meetings and/or conference calls of the writing group during the document
development process. The table does not necessarily reflect relationships with industry at the time of publication. A person is deemed to have a
significant interest in a business if the interest represents ownership of ≥5% of the voting stock or share of the business entity, or if the interest
represents ownership of ≥$10 000 of the fair market value of the business entity, or if funds received by the person from the business entity exceed 5%
of the person’s gross income for the previous year. Relationships that exist with no financial benefit are also included for the purpose of transparency.
Relationships in this table are modest unless otherwise noted.
According to the ACCF/AHA, a person has a relevant relationship IF: (a) the relationship or interest relates to the same or similar subject matter,
intellectual property or asset, topic, or issue addressed in the document; or (b) the company/entity (with whom the relationship exists) makes a drug,
drug class, or device addressed in the document or makes a competing drug or device addressed in the document; or (c) the person or a member of the
person’s household has a reasonable potential for financial, professional, or other personal gain or loss as a result of the issues or content addressed
in the document.
*Writing group members are required to recuse themselves from voting on sections to which their specific relationships with industry and other
entities may apply. Section numbers pertain to those in the full-text guideline.
†Significant relationship.
‡No financial benefit.
DSMB indicates Data Safety Monitoring Board; EP, electrophysiology; MADIT-RIT, Multicenter Automatic Defibrillator Implantation Trial–Reduce
Inappropriate Therapy; PI, principal investigator; and VA, Veterans Affairs.
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1798  Circulation  October 2, 2012
Appendix 2.  Reviewer Relationships With Industry and Other Entities (Relevant)—2012 ACCF/AHA/HRS Focused Update of the
2008 Guidelines for Device-Based Therapy of Cardiac Rhythm Abnormalities
Peer Reviewer Representation Employment Consultant
Speaker’s
Bureau
Ownership/
Partnership/
Principal Personal Research
Institutional,
Organizational, or
Other Financial
Benefit Expert Witness
Sana Al-Khatib Official Reviewer—AHA Duke Clinical Research
Institute and Duke
University Medical
Center
None • Medtronic None None None None
Hugh Calkins Official Reviewer—HRS Johns Hopkins Hospital • Biosense Webster
• Boston Scientific
• Medtronic*
None None • Boston Scientific*
• Medtronic*
• St. Jude Medical*
None None
James R.
Edgerton
Official Reviewer—STS The Heart Hospital
Baylor Plano
None None None None None None
Michael M.
Givertz
Official Reviewer—HFSA Brigham and
Women’s Hospital
None None None None None None
Jonathan L.
Halperin
Official
Reviewer—ACCF/AHA
Task Force on Practice
Guidelines
Mount Sinai Medical
Center
• Biotronik*
None None None None None
Bradley P.
Knight
Official Reviewer—HRS Northwestern Medical
Center
• Boston Scientific
• Cameron Health†
• Biosense
Webster
• Biotronik
• Boston
Scientific
• Medtronic
None • Cameron Health*
None None
Thomas J.
Lewandowski
Official Reviewer—ACCF
Board of Governors
Appleton Cardiology
Thedacare
None None None None None None
Henry M.
Spotnitz
Official Reviewer—AATS Columbia University None None • Strategic Pacing
Systems†
None None None
C. Michael
Valentine
Official Reviewer—ACCF
Board of Trustees
The Cardiovascular
Group
• Medtronic*
None None None None None
Paul J. Wang Official Reviewer—AHA Stanford University
Medical Center
• Medtronic None None • Medtronic*
None None
John F. Beshai Content
Reviewer—ACCF EP
Committee
University of Chicago
Medical Center
None None None None • Medtronic*
• St. Jude Medical*
None
George H.
Crossley
Content Reviewer St. Thomas Heart • Boston Scientific
• Medtronic
• Boston
Scientific
• Medtronic
None None • Boston Scientific
• Medtronic*
None
Jennifer E.
Cummings
Content Reviewer—ACCF
EP Committee
University of Toledo None • Boston
Scientific
• Medtronic
• St. Jude
None None None None
Kenneth A.
Ellenbogen
Content Reviewer Virginia Commonwealth
University Medical
Center
• Cameron Health
• Boston Scientific
• Medtronic
• Biotronik
• Boston
Scientific
• Medtronic
• St. Jude
Medical
None None • Biosense Webster*
• Boston Scientific*
• Medtronic*
• St. Jude Medical*
None
Roger A.
Freedman
Content Reviewer University of Utah
Health Sciences Center
• Boston Scientific
• Sorin
• Spectranetics
• St. Jude Medical
None None • Medtronic*
• St. Jude Medical*
None • Defendant, 2011,
pacemaker
battery depletion
Gabriel
Gregoratos
Content Reviewer University of
California–San Francisco
None None None None None None
David L.
Hayes
Content Reviewer Mayo Clinic • Biotronik
• Boston Scientific
• Medtronic*
• Sorin
• St. Jude Medical
None None None None None
Mark A. Hlatky Content Reviewer Stanford University
School of Medicine
None None None None None None
Sandeep K. Jain Content Reviewer University of Pittsburgh
Physicians, UPMC
Heart and Vascular
Institute
None None None • Medtronic*
None None
Samuel O.
Jones
Content Reviewer San Antonio Military
Medical Center
None None None None • Medtronic†
• St. Jude Medical†
None
Kousik
Krishnan
Content Reviewer Rush University
Medical Center
• Boston Scientific
• St. Jude Medical
None None None • Biotronik* None
• Boston Scientific—
MADIT-RIT*
• Medtronic*
Michael
Mansour
Content Reviewer Cardiovascular
Physicians
None None None None None None
(Continued)
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Tracy et al    2012 Device-Based Therapy Guideline Focused Update   1799
Steven M.
Markowitz
Content
Reviewer—ACCF EP
Committee
New York Hospital • Biotronik None None None • Biosense Webster* None
• Boston Scientific • Boston Scientific*
• Medtronic • Medtronic*
• St. Jude Medical • St. Jude Medical*
Marco A. Mercader Content Reviewer George Washington
University
None None None None None None
Simone Musco Content Reviewer Saint Patrick Hospital • Boston Scientific None None None None None
L. Kristin
Newby
Content Reviewer Duke University
Medical Center
None None None None None None
Brian
Olshansky
Content
Reviewer—ACCF EP
Committee
University of Iowa
Hospitals
• Boston Scientific–
Guidant
None None None None None
• Medtronic
Richard L.
Page
Content Reviewer University of Wisconsin
Hospital and Clinics
None None None None None None
Allen J.
Solomon
Content Reviewer Medical Faculty
Associates
None None None None None None
John S.
Strobel
Content Reviewer Internal Medicine
Associates
None None None • Medtronic*
None None
Stephen L.
Winters
Content Reviewer Morristown Medical
Center
• Biosense Webster None None None • Boston Scientific • Defendant,
2011,
complication of
ICD placement
• Medtronic
• St. Jude Medical
This table represents the relationships of reviewers with industry and other entities that were disclosed at the time of peer review and determined to be relevant. It
does not necessarily reflect relationships with industry at the time of publication. A person is deemed to have a significant interest in a business if the interest represents
ownership of ≥5% of the voting stock or share of the business entity, or if the interest represents ownership of ≥$10 000 of the fair market value of the business entity,
or if funds received by the person from the business entity exceed 5% of the person’s gross income for the previous year. A relationship is considered to be modest if it
is less than significant under the preceding definition. Relationships that exist with no financial benefit are also included for the purpose of transparency. Relationships
in this table are modest unless otherwise noted. Names are listed in alphabetical order within each category of review.
According to the ACCF/AHA, a person has a relevant relationship IF: (a) the relationship or interest relates to the same or similar subject matter, intellectual property
or asset, topic, or issue addressed in the document; or (b) the company/entity (with whom the relationship exists) makes a drug, drug class, or device addressed in the
document or makes a competing drug or device addressed in the document; or (c) the person or a member of the person’s household has a reasonable potential for
financial, professional, or other personal gain or loss as a result of the issues or content addressed in the document.
*Significant relationship.
†No financial benefit.
AATS indicates American Association for Thoracic Surgery; ACCF, American College of Cardiology Foundation; AHA, American Heart Association; EP, Electrophysiology;
HFSA, Heart Failure Society of America; HRS, Heart Rhythm Society; ICD, implantable cardioverter-defibrillator; MADIT-RIT, Multicenter Automatic Defibrillator
Implantation Trial–Reduce Inappropriate Therapy; and STS, Society of Thoracic Surgeons.
Appendix 2.  Continued
Peer Reviewer Representation Employment Consultant
Speaker’s
Bureau
Ownership/
Partnership/
Principal Personal Research
Institutional,
Organizational, or
Other Financial
Benefit Expert Witness
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1800  Circulation  October 2, 2012
Appendix 3.  Indications for CRT Therapy—Algorithm
CRT indicates cardiac resynchronization therapy; CRT-D indicates cardiac resynchronization therapy defibrillator; GDMT, guideline-directed medical therapy; ICD,
implantable cardioverter-defibrillator; LV, left ventricular; LVEF, left ventricular ejection fraction; LBBB, left bundle-branch block; MI, myocardial infarction; and NYHA,
New York Heart Association.
by guest on June 7, 2013http://circ.ahajournals.org/Downloaded from
© American College of Cardiology Foundation; American Heart Association, Inc.; and Heart Rhythm Society
2012 ACCF/AHA/HRS Focused Update of the 2008 Guidelines for Device-Based Therapy of Cardiac Rhythm Abnormalities
Online Data Supplement. Cardiac Resynchronization Therapy
Study/Aim Type
of
Study
N
(total)
n
(Exp/
Interv
CRT)
n (Placebo/
Comparator)
Follow-
Up (Mo)
Baseline
Treatment
NYHA
Class
EF
(%)
QRS
Duration
(ms)
Exclusion Criteria QRS
Subgroups
by Duration
(ms)
Composite
Endpoint
(for QRS
Subgroups)
Results
CARE HF (1)
Aim of trial was to analyze
the effects of a CRT-P on
the risk of complications and
death among patients who
were receiving standard
medical therapy for
moderate or severe HF and
demonstrated cardiac
dyssynchrony by
echocardiography and/or
intraventricular conduction
delay.
RCT 813 409 Medical
therapy*: 404
29.4 ACEI, beta-
blockers, and
spironolactone
III or IV 35 120 Patients who had a major
cardiovascular event in the
previous 6 wk, those who
had conventional indications
for a pacemaker or an ICD,
and those with HF requiring
continuous IV therapy and
those with AF were
excluded.
120 to 159
(n=290);
159
(n=505)
All-cause
mortality or
hospitalizations
for major
cardiovascular
event including
HF
hospitalization
HR: 0.63; 95% CI: 0.51 to 0.77;
(p0.001), CRT primary and
significant improvement NYHA,
MLHF, euroqol.
COMPANION (2)
Aim of trial was to compare
optimal pharmacologic
therapy plus a CRT-
Pacemaker, optimal
pharmacologic therapy plus
a CRT-Defibrillator, and
optimal pharmacologic
therapy alone in a
population with advanced
HF and intraventricular
conduction delays.
RCT 1,520 CRT-
P: 617;
CRT-
D: 595
Medical
therapy*: 308;
16.2
(CRT-
P),15.7
(CRT-D)
11.9
(medical)
ACEI, beta-
blockers, and
spironolactone
III or IV 35 120 AF, clinical indication for a
pacemaker or implantable
defibrillator, a
hospitalization for the
treatment of HF or the
equivalent in the preceding
12 mo.
120 to 147
(n=324);
148 to *168
(n=314);
168
(n=287)
All-cause
mortality or
hospitalizations.
HR: 0.81(p=0.014) for primary
endpoint for CRT-P and HR: 0.80
(p=0.01) for CRT-D. HR: 0.76;
95% CI: 0.58 to 1.01for CRT-P
reducing all-cause mortality
(p=0.059). CRT-D by HR: 0.64;
95% CI: 0.48 to 0.86; (p=0.003).
N/S between CRT-P and CRT-D,
6MW, MLHF, NYHA
significantly improved with both.
MADIT-CRT (3)
Aim of trial was to
determine whether a CRT-D
would reduce the risk of
death or HF events in
patients with mild NYHA
functional class I-II cardiac
symptoms (NYHA I or II
RCT 1,820 1,089 Medical
therapy*: 731
28.8 ACEI, beta-
blockers, and
spironolactone
.
1 or II 30 130 Patients were excluded from
enrollment for a variety of
reasons, including an
existing indication for CRT;
having an implanted
pacemaker, ICD, or
resynchronization device;
NYHA class III or IV
symptoms, previous CABG,
130 to 149
(n=645);
149
(n=1175)
All-cause
mortality or HF
event (HF
hospitalization
or outpatient
intravenous
diuretic
therapy).
HR: 0.66; 95% CI: 0.52 to 0.84;
(p=0.001), death 3% per y in both
groups.
by guest on June 7, 2013http://circ.ahajournals.org/Downloaded from
© American College of Cardiology Foundation; American Heart Association, Inc.; and Heart Rhythm Society
[ischemic cardiomyopathy]
or NYHA II [nonischemic]),
a reduced EF, and a wide
QRS complex.
PCI, or an enzyme-positive
MI within 3 mo before
enrollment; AF within 1 mo
before enrollment.
MIRACLE (4)
Aim of trial was to evaluate
the therapeutic approach of
CRT in patients with HF
who have an intraventricular
conduction delay.
RCT 453 228 225 6 Diuretic, ACEI
or an ARB,
and (usually)
digitalis and a
beta-blocker.
III or IV 35 130 Patients were excluded if
they had a pacemaker, ICD,
an indication for or a
contraindication to cardiac
pacing, a cardiac or cerebral
ischemic event within the
previous 3 mo, or if they
had had an atrial arrhythmia
within the previous mo. In
addition, patients were not
allowed to participate if they
had a systolic blood
pressure of 170 or 80 mm
Hg, a heart rate of 140
bpm, a serum creatinine
level of 3.0 mg per
deciliter (265 μmol per
liter), or serum
aminotransferase levels  3
times the upper limit of
normal.
Primary
endpoints were
the NYHA
functional class,
quality of life,
and the distance
walked in 6
min.
Compared to the control group,
patients in the CRT group
experienced an improvement
6MW p=0.005, NYHA.
(p0.001), quality of life.
MIRACLE ICD (5)
The trial examined the
efficacy and safety of
combined CRT and ICD
therapy in patients with
NYHA class III or IV
congestive HF despite
appropriate medical
management.
RCT 369 187 -
ICD
activat
ed,
CRT
on
182 - ICD
activated, CRT
off
6 Optimized
medical
treatment.
3 or 4 35 130 Estimated survival 6 mo,
baseline 6 min, walk test
450 m. Bradycardia
requiring pacemaker,
unstable angina, MI, CABG,
percutaneous transluminal
coronary angioplasty,
cerebral vascular accident,
or transient ischemic attack
within previous 3 mo, 2
infusions of inotropic drug
per wk, SBP 80 mm Hg or
170 mm Hg, resting heart
rate 140/min, serum
creatinine 3 mg/dL (265
μmol/L) Hepatic enzymes
The primary double-blind study
end points were changes
between baseline and 6 mo in
quality of life, functional class,
and distance covered during a 6
min walk. At 6 mo, patients
assigned to CRT had a greater
improvement in median (95% CI)
quality of life score (–17.5 [–21 to
–14] vs. –11.0 [–16 to –7],
p=0.02) and functional class (–1
[–1 to –1] vs. 0 [–1 to 0],
p=0.007) than controls but were
no different in the change in
distance walked in 6 min (55 m
[44-79] vs. 53 m [43-75], p=0.36).
by guest on June 7, 2013http://circ.ahajournals.org/Downloaded from
© American College of Cardiology Foundation; American Heart Association, Inc.; and Heart Rhythm Society
3-fold upper normal values,
severe lung disease, chronic
atrial arrhythmias, or
cardioversion, or
paroxysmal AF within
previous 1 mo heart
transplant recipient, severe
VHD.
Peak oxygen consumption
increased by 1.1 mL/kg per min
(0.7-1.6) in the CRT group vs. 0.1
mL/kg per min (–0.1 to 0.8) in
controls (p=0.04), although
treadmill exercise duration
increased by 56 sec (30-79) in the
CRT group and decreased by 11
sec (–55 to 12) in controls
(P=0.001). No significant
differences were observed in
changes in left ventricular size or
function, overall HF status,
survival, and rates of
hospitalization. No proarrhythmia
was observed and arrhythmia
termination capabilities were not
impaired.
RAFT (6)
Aim of trial was to evaluate
whether adding CRT to an
ICD and optimal medical
therapy might reduce
mortality and morbidity
among patients with
EF30%, class II, III HF,
QRS 120, paced QRS ≥200
msec.
RCT 1,798 894 No CRT: 904 40 ACEI, beta-
blockers, and
spironolactone
.
II or III 30 120 Patients with a major
coexisting illness or a recent
cardiovascular event such as
ACS or use of IV inotropic
therapy were excluded.
Other exclusion criteria
included uncorrected VHD,
restrictive or HCM, cor
pulmonale, prosthetic
tricuspid valve, or
preexisting ICD.
120 to 149
(n=627);
149
(n=1036)
All-cause
mortality or HF
hospitalization.
33% vs. 40% primary, HR: 0.75;
95%CI 0.64 to 0.87, p0.001,
death: HR: 0.75; 95% CI: 0.62 to
0.91, HF hospitalization: HR:
0.68; 95% CI: 0.56 to 0.83;
(p0.001), adverse events: 124 vs.
58. Benefit comparable in NYHA
class II and III, No benefit if
RBBB, IVCD, paced, or
permanent AF, or QRS 150.
REVERSE (7)
Aim of trial was to
determine the effects of
CRT in NYHA functional
class II HF and NYHA
functional class I
(ACC/AHA stage C)
patients with previous HF
symptoms.
RCT 610 419 CRT-off: 191 12 ACEI, beta-
blockers, and
spironolactone
.
1 or II 40 120 Patients were excluded if in
the 3 mo before enrollment
they were classified as
NYHA functional
class III or IV or had been
hospitalized for HF. Those
in need of cardiac pacing,
those who had been paced
from a previous device, or
those with permanent or
persistent atrial arrhythmias
also were excluded.
120 to 151
(n=303);
151
(n=307)
HF clinical
composite
response, which
scores patients
as improved,
unchanged, or
worsened.
N/S primary worsened 16% vs.
21% off, p=0.10, secondary time
to hospital, HR: 0.47, p=0.03,
LVESV smaller -18 vs. -1,
p0.0001.
*Diuretics, ACE inhibitors, beta-blockers, and spironolactone.
by guest on June 7, 2013http://circ.ahajournals.org/Downloaded from
© American College of Cardiology Foundation; American Heart Association, Inc.; and Heart Rhythm Society
6MW indicates distance walked in 6 minutes; ACC/AHA, American College of Cardiology/American Heart Association; ACEI, angiotensin-converting enzyme inhibitor; ACS, acute coronary syndrome; AF, atrial
fibrillation; ARB, angiotensin-receptor blocker; bpm, beats per minute; CABG, coronary-artery bypass grafting; CARE-HF, Cardiac resynchronization in heart failure; CI, confidence interval; COMPANION,
Comparisons of medical therapy, pacing, and defibrillation in heart failure; CRT, cardiac resynchronization therapy; CRT-D, cardiac resynchronization therapy defibrillator; CRT-P, cardiac resynchronization therapy
pacemaker; EF, ejection fraction; euroqol, European Quality of Life -5 Dimensions instrument; HCM, hypertrophic cardiomyopathy; HF, heart failure; HR, hazard ratio; ICD, implantable cardioverter-defibrillator; IVCD,
intraventricular conduction delay; LVESV, left ventricular end-systolic volume; MADIT-CRT, Multicenter automatic defibrillator implantation trial-cardiac resynchronization therapy; MI, myocardial infarction;
MIRACLE, Multicenter InSync Randomized Clinical Evaluation; MIRACLE ICD, Multicenter InSync Implantable Cardioversion Defibrillation Randomized Clinical Evaluation; MLHF, Minnesota Living with Heart
Failure questionnaire, range from 0 to 105, with higher scores reflecting a poorer quality of life; n, subgroup of N; N/S, not significant; NYHA, New York Heart Association; PCI, percutaneous coronary intervention;
RAFT, Resynchronization-defibrillation for ambulatory heart failure trial; RBBB, right bundle-branch block; RCT, randomized controlled trial; REVERSE, Resynchronization reverses remodeling in systolic left
ventricular dysfunction; SBP, systolic blood pressure; and VHD, valvular heart disease.
by guest on June 7, 2013http://circ.ahajournals.org/Downloaded from
Circulation 2012-tracy-1784-800 device therapy of rhythm abnormalities
Circulation 2012-tracy-1784-800 device therapy of rhythm abnormalities
Circulation 2012-tracy-1784-800 device therapy of rhythm abnormalities
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Circulation 2012-tracy-1784-800 device therapy of rhythm abnormalities

  • 1. Stevenson, William G. Stevenson and Paul D. Varosy Link, Joseph E. Marine, Mark H. Schoenfeld, Amit J. Shanker, Michael J. Silka, Lynne Warner N.A. Mark Estes III, T. Bruce Ferguson, Jr, Stephen C. Hammill, Pamela E. Karasik, Mark S. Cynthia M. Tracy, Andrew E. Epstein, Dawood Darbar, John P. DiMarco, Sandra B. Dunbar, Rhythm Society Foundation/American Heart Association Task Force on Practice Guidelines and the Heart of Cardiac Rhythm Abnormalities : A Report of the American College of Cardiology 2012 ACCF/AHA/HRS Focused Update of the 2008 Guidelines for Device-Based Therapy Print ISSN: 0009-7322. Online ISSN: 1524-4539 Copyright © 2012 American Heart Association, Inc. All rights reserved. is published by the American Heart Association, 7272 Greenville Avenue, Dallas, TX 75231Circulation doi: 10.1161/CIR.0b013e3182618569 2012;126:1784-1800; originally published online September 10, 2012;Circulation. http://circ.ahajournals.org/content/126/14/1784 World Wide Web at: The online version of this article, along with updated information and services, is located on the http://circ.ahajournals.org/content/suppl/2012/08/14/CIR.0b013e3182618569.DC2.html http://circ.ahajournals.org/content/suppl/2012/08/14/CIR.0b013e3182618569.DC1.html Data Supplement (unedited) at: http://circ.ahajournals.org//subscriptions/ is online at:CirculationInformation about subscribing toSubscriptions: http://www.lww.com/reprints Information about reprints can be found online at:Reprints: document.Permissions and Rights Question and Answerthis process is available in the click Request Permissions in the middle column of the Web page under Services. Further information about Office. Once the online version of the published article for which permission is being requested is located, can be obtained via RightsLink, a service of the Copyright Clearance Center, not the EditorialCirculationin Requests for permissions to reproduce figures, tables, or portions of articles originally publishedPermissions: by guest on June 7, 2013http://circ.ahajournals.org/Downloaded from
  • 2. ACCF/AHA/HRS Focused Update     1784 (Circulation. 2012;126:1784-1800.) © 2012 by the American College of Cardiology Foundation, the American Heart Association, Inc., and the Heart Rhythm Society. Circulation is available at http://circ.ahajournals.org DOI: 10.1161/CIR.0b013e3182618569 *Writing group members are required to recuse themselves from voting on sections to which their specific relationships with industry and other entities may apply; see Appendix 1 for recusal information. †ACCF/AHA Representative. ‡Heart Rhythm Society Representative. §ACCF/AHA Task Force on Performance Measures Liaison. ‖American Association for Thoracic Surgery Representative. ¶Society of Thoracic Surgeons Representative. #Heart Failure Society of America Representative. **ACCF/AHA Task Force on Practice Guidelines Liaison. This document was approved by the American College of Cardiology Foundation Board of Trustees, the American Heart Association Science Advisory and Coordinating Committee, and the Heart Rhythm Society Board of Trustees in May 2012. The online-only Data Supplement is available with this article at http://circ.ahajournals.org/lookup/suppl/doi:10.1161/CIR.0b013e3182618569/-/DC1. Theonline-onlyComprehensiveRelationshipsWithIndustrytableisavailablewiththisarticleathttp://circ.ahajournals.org/lookup/suppl/doi:10.1161/ CIR.0b013e3182618569/-/DC2 The American Heart Association requests that this document be cited as follows: Tracy CM, Epstein AE, Darbar D, DiMarco JP, Dunbar SB, Estes NAM 3rd, Ferguson TB Jr, Hammill SC, Karasik PE, Link MS, Marine JE, Schoenfeld MH, Shanker AJ, Silka MJ, Stevenson LW, Stevenson WG, Varosy PD. 2012 ACCF/AHA/HRS focused update of the 2008 guidelines for device-based therapy of cardiac rhythm abnormalities: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines and the Heart Rhythm Society. Circulation. 2012;126:1784–1800. This article is copublished in the Journal of the American College of Cardiology, Heart Rhythm, and Journal of Thoracic and Cardiovascular Surgery. Copies: This document is available on the World Wide Web sites of the American College of Cardiology (www.cardiosource.org), the American Heart Association (my.americanheart.org), and the Heart Rhythm Society (www.hrsonline.org). A copy of the document is available at http://my.americanheart. org/statements by selecting either the “By Topic” link or the “By Publication Date” link. To purchase additional reprints, call 843-216-2533 or e-mail kelle.ramsay@wolterskluwer.com. Expert peer review of AHA Scientific Statements is conducted by the AHA Office of Science Operations. For more on AHA statements and guidelines development, visit http://my.americanheart.org/statements and select the “Policies and Development” link. Permissions: Multiple copies, modification, alteration, enhancement, and/or distribution of this document are not permitted without the express permission of the American Heart Association. Instructions for obtaining permission are located at http://www.heart.org/HEARTORG/General/Copyright- Permission-Guidelines_UCM_300404_Article.jsp. A link to the “Copyright Permissions Request Form” appears on the right side of the page. 2012 ACCF/AHA/HRS Focused Update of the 2008 Guidelines for Device-Based Therapy of Cardiac Rhythm Abnormalities A Report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines and the Heart Rhythm Society Developed in Collaboration With the American Association for Thoracic Surgery, Heart Failure Society of America, and Society of Thoracic Surgeons 2012 WRITING GROUP MEMBERS* Cynthia M. Tracy, MD, FACC, FAHA, Chair; Andrew E. Epstein, MD, FACC, FAHA, FHRS, Vice Chair*; Dawood Darbar, MD, FACC, FHRS†; John P. DiMarco, MD, PhD, FACC, FHRS*‡; Sandra B. Dunbar, RN, DSN, FAAN, FAHA†; N.A. Mark Estes III, MD, FACC, FAHA, FHRS*§; T. Bruce Ferguson, Jr, MD, FACC, FAHA*‖¶; Stephen C. Hammill, MD, FACC, FHRS‡; Pamela E. Karasik, MD, FACC, FHRS†; Mark S. Link, MD, FACC, FHRS*†; Joseph E. Marine, MD, FACC, FHRS†; Mark H. Schoenfeld, MD, FACC, FAHA, FHRS*†; Amit J. Shanker, MD, FACC, FHRS‡; Michael J. Silka, MD, FACC†; Lynne Warner Stevenson, MD, FACC*#; William G. Stevenson, MD, FACC, FAHA, FHRS***; Paul D. Varosy, MD, FACC, FHRS† 2008 WRITING COMMITTEE MEMBERS Andrew E. Epstein, MD, FACC, FAHA, FHRS, Chair; John P. DiMarco, MD, PhD, FACC, FHRS; Kenneth A. Ellenbogen, MD, FACC, FAHA, FHRS; N.A. Mark Estes III, MD, FACC, FAHA, FHRS; Roger A. Freedman, MD, FACC, FHRS; Leonard S. Gettes, MD, FACC, FAHA; A. Marc Gillinov, MD, FACC, FAHA; Gabriel Gregoratos, MD, FACC, FAHA; Stephen C. Hammill, MD, FACC, FHRS; David L. Hayes, MD, FACC, FAHA, FHRS; Mark A. Hlatky, MD, FACC, FAHA; L. Kristin Newby, MD, FACC, FAHA; Richard L. Page, MD, FACC, FAHA, FHRS; Mark H. Schoenfeld, MD, FACC, FAHA, FHRS; Michael J. Silka, MD, FACC; Lynne Warner Stevenson, MD, FACC; Michael O. Sweeney, MD, FACC by guest on June 7, 2013http://circ.ahajournals.org/Downloaded from
  • 3. Tracy et al    2012 Device-Based Therapy Guideline Focused Update   1785 ACCF/AHA TASK FORCE MEMBERS Jeffrey L. Anderson, MD, FACC, FAHA, Chair; Alice K. Jacobs, MD, FACC, FAHA, Immediate Past Chair; Jonathan L. Halperin, MD, FACC, FAHA, Chair-Elect; Nancy M. Albert, PhD, CCNS, CCRN; Mark A. Creager, MD, FACC, FAHA; David DeMets, PhD; Steven M. Ettinger, MD, FACC; Robert A. Guyton, MD, FACC; Judith S. Hochman, MD, FACC, FAHA; Frederick G. Kushner, MD, FACC, FAHA; E. Magnus Ohman, MD, FACC; William Stevenson, MD, FACC, FAHA; Clyde W. Yancy, MD, FACC, FAHA Table of Contents Preambl����������������������������������������������������������������������������1785 1. Introduction������������������������������������������������������������������1787 1.1. Methodology and Evidence Review����������������������1787 1.2. Organization of the Writing Group������������������������1787 1.3. Document Review and Approval���������������������������1788 1.4. Scope of the Focused Update��������������������������������1788 2. Indications for Pacing��������������������������������������������������1789 2.4. Pacing for Hemodynamic Indications�������������������1789 2.4.1. Cardiac Resynchronization Therapy�����������1789 2.8. Pacemaker Follow-Up�������������������������������������������1792 2.8.3. Remote Follow-Up and Monitoring������������1792 References������������������������������������������������������������������������1793 Appendix 1. Author Relationships With Industry and Other Entities (Relevant)�����������������������������1796 Appendix 2. Reviewer Relationships With Industry and Other Entities (Relevant)�����������������������������1798 Appendix 3. Indications for CRT Therapy—Algorithm��1800 Preamble Keeping pace with the stream of new data and evolving evidence on which guideline recommendations are based is an ongoing challenge to timely development of clinical practice guidelines. In an effort to respond promptly to new evidence, the American College of Cardiology Foundation (ACCF)/American Heart Association (AHA) Task Force on Practice Guidelines (Task Force) has created a “focused update” process to revise the existingguidelinerecommendationsthatareaffectedbyevolving data or opinion. New evidence is reviewed in an ongoing fashion to more efficiently respond to important science and treatment trends that could have a major impact on patient outcomes and quality of care. Evidence is reviewed at least twice a year, and updates are initiated on an as-needed basis and completed as quickly as possible while maintaining the rigorous methodology that theACCF andAHA have developed during their partnership of 20 years. These focused updates are prompted following a thorough review of late-breaking clinical trials presented at national and international meetings, in addition to other new published data deemed to have an impact on patient care (Section 1.1, “Methodology and Evidence Review”). Through a broad- based vetting process, the studies included are identified as being important to the relevant patient population. The focused update is not intended to be based on a complete lit- erature review from the date of the previous guideline publica- tion but rather to include pivotal new evidence that may affect changes to current recommendations. Specific criteria or considerations for inclusion of new data include the following: • publication in a peer-reviewed journal; • large, randomized, placebo-controlled trial(s); • nonrandomized data deemed important on the basis of results affecting current safety and efficacy assumptions, including observational studies and meta-analyses; • strength/weakness of research methodology and findings; • likelihood of additional studies influencing current findings; • impact on current and/or likelihood of need to develop new performance measure(s); • request(s) and requirement(s) for review and update from the practice community, key stakeholders, and other sources free of industry relationships or other potential bias; • number of previous trials showing consistent results; and • need for consistency with a new guideline or guideline updates or revisions. In analyzing the data and developing recommendations and supporting text, the writing group uses evidence-based methodologies developed by the Task Force.1 The Class of Recommendation (COR) is an estimate of the size of the treat- ment effect, with consideration given to risks versus benefits, as well as evidence and/or agreement that a given treatment or procedure is or is not useful/effective and in some situations may cause harm. The Level of Evidence (LOE) is an estimate of the certainty or precision of the treatment effect. The writ- ing group reviews and ranks evidence supporting each recom- mendation, with the weight of evidence ranked as LOE A, B, or C, according to specific definitions that are included in Table 1. Studies are identified as observational, retrospective, prospective, or randomized, as appropriate. For certain condi- tions for which inadequate data are available, recommenda- tions are based on expert consensus and clinical experience and are ranked as LOE C. When recommendations at LOE C are supported by historical clinical data, appropriate references (including clinical reviews) are cited if available. For issues for which sparse data are available, a survey of current practice among the clinicians on the writing group is the basis for LOE C recommendations, and no references are cited. The schema for COR and LOE is summarized in Table 1, which also pro- vides suggested phrases for writing recommendations within each COR. A new addition to this methodology is separation of the Class III ­recommendations to delineate whether the ­recommendation is determined to be of “no benefit” or is asso- ciated with “harm” to the patient. In addition, in view of the increasing number of comparative effectiveness studies, com- by guest on June 7, 2013http://circ.ahajournals.org/Downloaded from
  • 4. 1786  Circulation  October 2, 2012 parator verbs and suggested phrases for writing recommenda- tionsforthecomparativeeffectivenessofonetreatmentorstrategy versus another have been added for COR I and IIa, LOE A or B only. In view of the advances in medical therapy across the spec- trum of cardiovascular diseases, the Task Force has desig- nated the term guideline-directed medical therapy (GDMT) to represent optimal medical therapy as defined by ACCF/ AHA guideline (primarily Class I)–recommended therapies. This new term, GDMT, will be used herein and throughout all future guidelines. Because the ACCF/AHA practice guidelines address patient populations (and healthcare providers) residing in North America, drugs that are not currently available in North America are discussed in the text without a specific COR. For studies performed in large numbers of subjects outside North America, each writing group reviews the potential impact of different practice patterns and patient populations on the treat- ment effect and relevance to the ACCF/AHA target population to determine whether the findings should inform a specific recommendation. The ACCF/AHA practice guidelines are intended to assist healthcare providers in clinical decision making by describ- ing a range of generally acceptable approaches to the diag- nosis, management, and prevention of specific diseases or conditions. The guidelines attempt to define practices that Table 1.  Applying Classification of Recommendations and Level of Evidence A recommendation with Level of Evidence B or C does not imply that the recommendation is weak. Many important clinical questions addressed in the guidelines do not lend themselves to clinical trials. Although randomized trials are unavailable, there may be a very clear clinical consensus that a particular test or therapy is useful or effective. *Data available from clinical trials or registries about the usefulness/efficacy in different subpopulations, such as sex, age, history of diabetes, history of prior myocardial infarction, history of heart failure, and prior aspirin use. †For comparative effectiveness recommendations (Class I and IIa; Level of Evidence A and B only), studies that support the use of comparator verbs should involve direct comparisons of the treatments or strategies being evaluated. by guest on June 7, 2013http://circ.ahajournals.org/Downloaded from
  • 5. Tracy et al    2012 Device-Based Therapy Guideline Focused Update   1787 meet the needs of most patients in most circumstances. The ultimate judgment about care of a particular patient must be made by the healthcare provider and patient in light of all the circumstances presented by that patient. As a result, situations may arise in which deviations from these guide- lines may be appropriate. Clinical decision making should consider the quality and availability of expertise in the area where care is provided. When these guidelines are used as the basis for regulatory or payer decisions, the goal should be improvement in quality of care. The Task Force rec- ognizes that situations arise in which additional data are needed to inform patient care more effectively; these areas will be identified within each respective guideline when appropriate. Prescribed courses of treatment in accordance with these recommendations are effective only if they are followed. Because lack of patient understanding and adherence may adversely affect outcomes, physicians and other healthcare providers should make every effort to engage the patient’s active participation in prescribed medical regimens and life- styles. In addition, patients should be informed of the risks, benefits, and alternatives to a particular treatment and should be involved in shared decision making whenever feasible, particularly for COR IIa and IIb, for which the benefit-to-risk ratio may be lower. The Task Force makes every effort to avoid actual, potential, or perceived conflicts of interest that may arise as a result of industry relationships or personal interests among the members of the writing group. All writing group members and peer reviewers of the guideline are required to disclose all current healthcare-related relationships, including those existing 12 months before initiation of the writing effort. In December 2009, the ACCF and AHA implemented a new policy for relationships with industry and other entities (RWI) that requires the writing group chair plus a minimum of 50% of the writing group to have no relevant RWI (Appendix 1 includes the ACCF/AHA definition of relevance). These statements are reviewed by the Task Force and all members during each conference call and/or meeting of the writing group and are updated as changes occur. All guideline recommendations require a confidential vote by the writing group and must be approved by a consensus of the voting members. Members are not permitted to draft or vote on any text or recommendations pertaining to their RWI. Members who recused themselves from voting are indicated in the list of writing group members, and specific section recusals are noted in Appendix 1. Authors’ and peer reviewers’ RWI pertinent to this guideline are disclosed in Appendixes 1 and 2, respectively. Additionally, to ensure complete transparency, writing group members’ comprehensive disclosure information—including RWI not pertinent to this document—is available as an online supplement. Comprehensive disclosure information for the Task Force is also available online at www.cardiosource.org/ ACC/About-ACC/Leadership/Guidelines-and-Documents- Task-Forces.aspx. The work of the writing group is supported exclusively by the ACCF, AHA, and the Heart Rhythm Society (HRS) without commercial support. Writing group members volunteered their time for this activity. In an effort to maintain relevance at the point of care for prac- ticing physicians, the Task Force continues to oversee an ongo- ing process improvement initiative. As a result, in response to pilot projects, several changes to these guidelines will be appar- ent, including limited narrative text, a focus on summary and evidence tables (with references linked to abstracts in PubMed), and more liberal use of summary recommendation tables (with references that support LOE) to serve as a quick reference. In April 2011, the Institute of Medicine released 2 reports: Finding What Works in Health Care: Standards for Systematic Reviews and Clinical Practice Guidelines We Can Trust.2,3 It is noteworthy that the ACCF/AHA practice guidelines were cited as being compliant with many of the standards that were pro- posed.A thorough review of these reports and our current meth- odology is under way, with further enhancements anticipated. The recommendations in this focused update are considered current until they are superseded in another focused update or the full-text guideline is revised. Guidelines are official policy of both the ACCF and AHA. Jeffrey L. Anderson, MD, FACC, FAHA Chair, ACCF/AHA Task Force on Practice Guidelines 1. Introduction 1.1. Methodology and Evidence Review Late-breaking clinical trials presented at the annual scientific meetings of the ACC, AHA, HRS, and European Society of Cardiology (2008 through 2010), as well as other selected data reported through February 2012, were reviewed by the guideline writing group along with the Task Force and other experts to identify trials and other key data that might affect guideline recommendations. On the basis of the criteria and ­considerations noted previously (Preamble), recently pub- lished trial data and other clinical information were consid- ered important enough to prompt a focused update of the “ACC/AHA/HRS 2008 Guidelines for Device-Based Therapy of Cardiac Rhythm Abnormalities.”4 To provide clinicians with a comprehensive set of data, the absolute risk difference and number needed to treat or harm, if they were published and their inclusion was deemed appropri- ate, are provided in the guideline, along with confidence inter- vals (CIs) and data related to the relative treatment effects, such as odds ratio, relative risk (RR), hazard ratio (HR), or incidence rate ratio. Consult the full-text version of the “ACC/AHA/HRS 2008 Guidelines for Device-Based Therapy of Cardiac Rhythm Abnormalities” for policy on clinical areas not covered by the focused update.4 The individual recommendations in this focused update will be incorporated into future revisions or updates of the full-text guideline. 1.2. Organization of the Writing Group For this focused update, selected members of the 2008 ­Device-Based Therapy (DBT) Writing Committee were invited to participate on the basis of areas of expertise, by guest on June 7, 2013http://circ.ahajournals.org/Downloaded from
  • 6. 1788  Circulation  October 2, 2012 requirements for committee rotation, and the current RWI policy; those who agreed are referred to as the 2012 Focused Update Writing Group. The HRS was invited to be a partner on this focused update and has provided representation. The writing group also included representatives from the Ameri- can Association for Thoracic Surgery, Heart Failure Society of America, and Society of Thoracic Surgeons. 1.3. Document Review and Approval This document was reviewed by 2 official reviewers each nominated by the ACCF, AHA, and HRS, as well as 1 reviewer each from the American Association for Thoracic Surgery, Heart Failure Society of America, and Society of Thoracic Surgeons, and 21 individual content reviewers. All information on reviewers’ RWI was collected and distrib- uted to the writing group and is published in this document (Appendix 2). This document was approved for publication by the governing bodies of the ACCF, AHA, and HRS and was endorsed by the American Association for Thoracic Surgery, Heart Failure Society of America, and Society of Thoracic Surgeons. 1.4. Scope of the Focused Update Studies relevant to the management of patients treated with DBT for cardiac rhythm abnormalities were identified and reviewedasdescribedpreviouslyinSection1.1,“Methodology and Evidence Review.” On the basis of these data, the writing group determined that updates to the 2008 guideline were necessary for cardiac resynchronization therapy (CRT) and device follow-up. Many clinical circumstances come into question in daily practice as to the appropriate use of implantable cardio- verter-defibrillator (ICD)/CRT devices. Many of these clini- cal scenarios are both common and of great importance but have not or cannot be addressed by multicenter clinical trials, so many of these will be addressed in the “Appropriate Use Criteria (AUC) for Implantable Cardioverter-Defibrillators and Cardiac Resynchronization Therapy” document that is currently in development. Unlike comprehensive guide- lines, AUC documents blend evidence-based information and clinical experience that can help guide allocation of healthcare resources, and they focus on the most common patient scenarios for which procedures may be considered. The AUC document will help define when it is reasonable to perform a procedure and, importantly, when it is not rea- sonable. Some of the scenarios included in the AUC may be outside guideline indications. As such, AUC are comple- mentary to guidelines and should be used in conjunction with them for determining patient care. Furthermore, the ACCF and AHA are currently undertaking a revision of the guidelines for management of heart failure (HF). The DBT and HF guideline writing committees have worked to main- tain concordance on the recommendations with regard to indications for CRT. The writing group also thoroughly reviewed the following sections from the 2008 DBT guideline4 and determined that although some new information may be available, the recom- mendations remain current. 1. Hypertrophic Cardiomyopathy—The management of hypertrophic cardiomyopathy is addressed in the “2011 ACCF/AHA Guideline for the Diagnosis and Treatment of Hypertrophic Cardiomyopathy.”5 In that document, the indications for ICDs have been modified on the basis of reassessment of significance of risk factors. The present writing group did not analyze the source documents that led to these changes and refer the reader to the ACCF/ AHA Guideline for full discussion of ICDs in hypertro- phic cardiomyopathy. 2. Arrhythmogenic Right Ventricular Dysplasia/ Cardiomyopathy—The writing group reviewed all pub- lished evidence since the publication of the 2008 DBT guide- line related to arrhythmogenic right ventricular dysplasia/ cardiomyopathy and determined that no changes to the cur- rent recommendations for ICD indications were warranted. 3. Genetic Arrhythmia Syndromes—The writing group acknowledges that recent guidelines and data suggest that there may be a limited role for primary-prevention ICDs in individuals with a genetically confirmed diagnosis of long QT but without symptoms.6–8 Nevertheless, it is the consensus of this writing group that until more definitive trials or studies are completed, further refinement of crite- ria for ICD implantation in this patient group would not be appropriate. Therefore, the class of recommendations for ICD implantation in asymptomatic patients with a geneti- cally confirmed mutation will remain unchanged. 4. Congenital Heart Disease—As with other forms of structural heart disease, there has been increased use of ICDs for primary prevention of sudden cardiac death in patients with congenital heart disease.4,9 Although ran- domized clinical trials have not been performed, multiple observational studies have consistently reported that sys- temic ventricular dysfunction in patients with congenital heart disease is the risk factor most predictive of subse- quent sudden cardiac death or appropriate ICD rescue.10–12 These studies support consideration of an expanded role of ICDs in future revisions of the guideline, provided that consistent benefit with the use of ICDs in patients with congenital heart disease and advanced ventricular dys- function is demonstrated. Nevertheless, the current rec- ommendations are not changed at this time. There remain insufficient data to make specific recommendations about CRT in patients with congenital heart disease.13 5. Primary Electrical Disease—The writing group re- viewed all published evidence since the publication of the 2008 DBT guideline related to primary electrical disease and determined that no changes were warranted in the current recommendations for ICD indications with regard to idiopathic ventricular fibrillation, short-QT syndrome, Brugada syndrome, and catecholaminergic polymorphic ventricular tachycardia. 6. Terminal Care—Patients with cardiovascular implant- able electronic devices (CIEDs) are living longer, with more surviving to develop comorbid conditions such as dementia or malignancy that may ultimately define their clinical course. This was recognized in the terminal care section of the 2008 DBT guideline. Recommendations by guest on June 7, 2013http://circ.ahajournals.org/Downloaded from
  • 7. Tracy et al    2012 Device-Based Therapy Guideline Focused Update   1789 on management of CIEDs in patients nearing end of life or requesting withdrawal of therapy were expanded upon in 2 subsequent HRS expert consensus statements in an effort to provide guidance to caregivers dealing with this increasingly prevalent and difficult issue.14,15 2. Indications for Pacing 2.4. Pacing for Hemodynamic Indications Although most commonly used to treat or prevent abnor- mal rhythms, pacing can alter the activation sequence in the paced chambers, influencing regional contractility and ­hemodynamics. These changes are frequently insignificant clinically but can be beneficial or harmful in some conditions. Pacing to decrease symptoms for patients with obstructive hypertrophic cardiomyopathy is discussed separately in the full-text guideline, Section 2.4.2, “Obstructive Hypertrophic Cardiomyopathy.” 2.4.1. Cardiac Resynchronization Therapy (See Table 2 and the Online Data Supplement for additional data on the trials that comprise the basis for the recommenda- tions in this focused update.) The present document proposes several changes in rec- ommendations for CRT, compared with the 2008 document. The most significant changes are 1) limitation of the Class I indication to patients with QRS duration ≥150 ms; 2) Table 2.  Recommendations for CRT in Patients With Systolic Heart Failure 2012 DBT Focused Update Recommendations Comments Class I   1. CRT is indicated for patients who have LVEF less than or equal to 35%, sinus rhythm, LBBB with a QRS duration greater than or equal to 150 ms, and NYHA class II, III, or ambulatory IV symptoms on GDMT. (Level of Evidence: A for NYHA class III/IV16–19 ; Level of Evidence: B for NYHA class II20,21 ) Modified recommendation (specifying CRT in patients with LBBB of ≥150 ms; expanded to include those with NYHA class II symptoms). Class IIa   1. CRT can be useful for patients who have LVEF less than or equal to 35%, sinus rhythm, LBBB with a QRS duration 120 to 149 ms, and NYHA class II, III, or ambulatory IV symptoms on GDMT.16–18,20–22 (Level of Evidence: B) New recommendation   2. CRT can be useful for patients who have LVEF less than or equal to 35%, sinus rhythm, a non-LBBB pattern with a QRS duration greater than or equal to 150 ms, and NYHA class III/ambulatory class IV symptoms on GDMT.16–18,21 (Level of Evidence: A) New recommendation   3. CRT can be useful in patients with atrial fibrillation and LVEF less than or equal to 35% on GDMT if a) the patient requires ventricular pacing or otherwise meets CRT criteria and b) AV nodal ablation or pharmacologic rate control will allow near 100% ventricular pacing with CRT.23–26,26a,48 (Level of Evidence: B) Modified recommendation (wording changed to indicate benefit based on ejection fraction rather than NYHA class; level of evidence changed from C to B).   4. CRT can be useful for patients on GDMT who have LVEF less than or equal to 35% and are undergoing new or replacement device placement with anticipated requirement for significant (_40%) ventricular pacing.25,27–29 (Level of Evidence: C) Modified recommendation (wording changed to indicate benefit based on ejection fraction and need for pacing rather than NYHA class; class changed from IIb to IIa). Class IIb   1. CRT may be considered for patients who have LVEF less than or equal to 30%, ischemic etiology of heart failure, sinus rhythm, LBBB with a QRS duration of greater than or equal to 150 ms, and NYHA class I symptoms on GDMT.20,21 (Level of Evidence: C) New recommendation   2. CRT may be considered for patients who have LVEF less than or equal to 35%, sinus rhythm, a non-LBBB pattern with QRS duration 120 to 149 ms, and NYHA class III/ambulatory class IV on GDMT.21,30 (Level of Evidence: B) New recommendation   3. CRT may be considered for patients who have LVEF less than or equal to 35%, sinus rhythm, a non-LBBB pattern with a QRS duration greater than or equal to 150 ms, and NYHA class II symptoms on GDMT.20,21 (Level of Evidence: B) New recommendation Class III: No Benefit   1. CRT is not recommended for patients with NYHA class I or II symptoms and non-LBBB pattern with QRS duration less than 150 ms.20,21,30 (Level of Evidence: B) New recommendation   2. CRT is not indicated for patients whose comorbidities and/or frailty limit survival with good functional capacity to less than 1 year.19 (Level of Evidence: C) Modified recommendation (wording changed to include cardiac as well as noncardiac comorbidities). See Appendix 3, “Indications for CRT Therapy—Algorithm.” CRT indicates cardiac resynchronization therapy; DBT, device-based therapy; GDMT, guideline-directed medical therapy; LBBB, left bundle-branch block; LVEF, left ventricular ejection fraction; and NYHA, New York Heart Association. by guest on June 7, 2013http://circ.ahajournals.org/Downloaded from
  • 8. 1790  Circulation  October 2, 2012 limitation of the Class I indication to patients with left bun- dle-branch block (LBBB) pattern; 3) expansion of Class I indication to New York Heart Association (NYHA) class II (and with LBBB with QRS duration ≥150 ms); and 4) the addition of a Class IIb recommendation for patients who have left ventricular ejection fraction (LVEF) ≤30%, ischemic eti- ology of HF, sinus rhythm, LBBB with a QRS duration ≥150 ms, and NYHA class I symptoms. These changes may have important implications for patient selection in clinical prac- tice, and the justification for these changes is discussed in the following paragraphs. Progression of left ventricular (LV) systolic dysfunction to clinical HF is frequently accompanied by impaired elec- tromechanical coupling, which may further diminish effec- tive ventricular contractility. The most common disruptions are prolonged atrioventricular conduction (first-degree atrioventricular block) and prolonged interventricular con- duction, most commonly LBBB. Prolonged interventricular and intraventricular conduction causes regional mechanical delay within the left ventricle that can result in reduced ven- tricular systolic function, altered myocardial metabolism, functional mitral regurgitation, and adverse remodeling with ventricular dilatation.31 Prolongation of the QRS duration occurs in approximately one third of patients with advanced HF32,33 and has been associated with ventricular electrome- chanical delay (“dyssynchrony”), as identified by multiple sophisticated echocardiographic indices. QRS duration and dyssynchrony both have been identified as predictors of worsening HF, sudden cardiac death, and total death.34 Modification of ventricular electromechanical delay with multisite ventricular pacing (commonly called “biventricular pacing” or CRT) can improve ventricular systolic function, reduce metabolic costs, ameliorate functional mitral regurgitation, and, in some patients, induce favorable remodeling with reduction of cardiac chamber dimensions.35–37 Functional improvement has been demonstrated for exercise capacity, with peak oxygen consumption in the range of 1 to 2 mL/kg/min and a 50- to 70-meter increase in 6-minute walking distance, as well as a 10-point or greater reduction of HF symptoms on the 105- point Minnesota Living with Heart Failure scale.16,38,39 Meta-analysesofinitialclinicalexperiencesandlargersubse- quent trials of CRT confirmed an approximately 30% decrease in hospitalizations and a mortality rate benefit of 24% to 36%.40 In the COMPANION (Comparison of MedicalTherapy, Pacing, and Defibrillation in Heart Failure) trial (NYHA class III/IV HF, QRS duration 120 ms, and LVEF ≤35% on GDMT), GDMT was compared to CRT pacing therapy without backup defibril- lation (CRT-Pacemaker) and to CRT therapy with defibrillation backup (CRT-D).17 Both CRT-Pacemaker and CRT-D reduced the risk of the primary composite endpoint by approximately 20% as compared with GDMT alone. CRT-D reduced the mor- tality rate by 36% compared with medical therapy, but there was insufficient evidence to conclude that CRT-Pacemaker was inferior to CRT-D. The CARE-HF (Cardiac Resynchronization in Heart Failure) trial18 limited subjects to a QRS duration 150 ms (89% of patients) or QRS duration 120 to 150 ms with echocardiographic evidence of dyssynchrony (11% of pa- tients). It was the first study to show a significant (36%) reduc- tion in death rate for resynchronization therapy unaccompa- nied by backup defibrillation compared with GDMT.18 In the present document, we give a Class I recommenda- tion for CRT in patients with QRS duration ≥150 ms. The dif- ferential classification seen in this document related to QRS duration is based on the results of multiple analyses of CRT benefit. The prevalence of mechanical dyssynchrony has been documented in 40% of patients with dilated cardiomyopathy and QRS duration 120 ms, and is as high as 70% among patients with QRS duration 150 ms and intraventricular mechanical delay, as identified by several echocardiographic techniques.34,41 However, the aggregate clinical experience has consistently demonstrated that a significant clinical benefit from CRT is greatest among patients with QRS duration 150 ms.42,43 In a meta-analysis of 5 trials involving 6501 patients, CRT significantly decreased the primary endpoint of death or hospitalization for HF in patients with QRS duration ≥150 ms (HR: 0.58; 95% CI: 0.50 to 0.68; P0.00001) but not in patients with QRS duration 150 ms (HR: 0.95; 95% CI: 0.83 to 1.10; P=0.51).42 In addition, subgroup analyses from sev- eral studies have suggested that a QRS duration 150 ms is a risk factor for failure to respond to CRT therapy.43,44 The observed differential benefit of CRT was seen across patients in NYHA classes I through IV. It has not been possible to reliably identify those with shorter QRS durations who may benefit. Patients with shorter QRS durations who otherwise qualify for CRT are afforded Class II recommendations in these guidelines. An additional difference in the present document com- pared with the 2008 DBT guideline4 is the limitation of the recommendation for Class I indication to patients with LBBB pattern as compared to those with non-LBBB. For patients with QRS duration ≥120 ms who do not have a complete LBBB (non-LBBB patterns), evidence for benefit with CRT is less compelling than in the presence of LBBB.45–47 The impact of the specific QRS morphology on clinical event reduction with CRT was evaluated in a meta-analysis of 4 clinical trials including 5356 patients.43a In those with LBBB, CRT significantly reduced composite adverse clinical events (RR: 0.64; 95% CI: 0.52 to 0.77; P=0.00001). No benefit was observed for patients with non-LBBB conduction abnormali- ties (RR: 0.97; 95% CI: 0.82 to 1.15; P=0.75). Specifically, there was no benefit in patients with right bundle-branch block (RR: 0.91; 95% CI: 0.69 to 1.20; P=0.49) or nonspe- cific intraventricular conduction delay (RR: 1.19; 95% CI: 0.87 to 1.63; P=0.28). Overall, the difference in effect of CRT between LBBB versus non-LBBB patients was highly statistically significant (P=0.0001).43a Nevertheless, other studies have shown that CRT is more likely to be effective in patients with advanced HF and non-LBBB morphologies if they have a markedly prolonged QRS duration21,30 (see RAFT [Resynchronization-Defibrillation for Ambulatory Heart Failure Trial]21 discussion below). Furthermore, patients with QRS prolongation due to frequent right ventricular apical pacing may benefit from CRT when other criteria for CRT are met.23,25,48 No large trial has yet demonstrated clinical ­benefit among patients without QRS prolongation, even when they by guest on June 7, 2013http://circ.ahajournals.org/Downloaded from
  • 9. Tracy et al    2012 Device-Based Therapy Guideline Focused Update   1791 have been selected with ­echocardiographic measures of dyssynchrony.49 The observed heterogeneity of response even among those who would appear to be excellent candidates for CRT also may result from factors such as suboptimal lead location and the location of conduction block from fibrosis in relation to the pacing site. Several recent studies have emphasized the importance of LV lead placement. For example, wider LV– right ventricular lead separation has been shown to provide better results.50 A subanalysis of MADIT-CRT (Multicenter Automatic Defibrillator Implantation Trial with Cardiac Resynchronization Therapy)20 showed that an apical LV lead position, as compared with a basal or midventricular position, resulted in a significant increased risk for HF or death.51 Clinical trials of resynchronization included mainly patients in sinus rhythm. However, prospective experience among patients with permanent atrial fibrillation and with decreased LV systolic function suggests that benefit may result from biventricular pacing when the QRS duration is 120 ms, although it may be most evident in patients in whom atrioventricular nodal ablation has been performed, such that right ventricular pacing is obligate.24,26,52 The benefit of CRT in patients with atrial fibrillation is more pronounced in those with depressed ejection fraction.25 Similarly, patients receiv- ing prophylactic ICDs often evolve progressively to dominant ventricular pacing, which may reflect both intrinsic chrono- tropic incompetence and aggressive up-titration of beta-adren- ergic–blocking agents. When device implantation or reimplantation is being considered for patients who require ventricular pacing, it is prudent to recall the results of the DAVID (Dual Chamber and VVI Implantable Defibrillator) trial.53 In this trial, dual- chamber rate-responsive pacing increased HF admissions and mortality rate as compared to sinus rhythm. A cutoff of approximately 40% right ventricular pacing was seen as dele- terious.54 Similarly, in a substudy from MADIT-II (Multicenter Automatic Defibrillator Implantation Trial II), patients who were right ventricular paced 50% of the time had a higher rate of new or worsened HF than those right ventricular paced ≤50% of the time.55 The major experience with resynchronization derives from patients with NYHA class III symptoms of HF and LVEF ≤35%. Patients with NYHA class IV symptoms of HF have accounted for only 10% of all patients in clinical trials of resynchronization therapy. These patients were highly selected ambulatory outpatients who were taking oral medications and had no history of recent hospitalization.56 Although a benefit has occasionally been described in patients with more severe acute decompensation that required brief positive intravenous inotropic therapy to aid diuresis, CRT is not generally used as a “rescue therapy” for such patients. Patients with dependence on intravenous inotropic therapy, refractory fluid retention, or advanced chronic kidney disease represent the highest-risk population for complications of any procedure and for early death after hospital discharge, and they are also unlikely to receive a meaningful mortality risk benefit from concomitant defibrillator therapy.19,57 Patients with NYHA class IV HF symptoms who derive functional benefit from resynchronization therapy may return to a better functional status, in which prevention of sudden death becomes a relevant goal. Even among the selected NYHA class IV patients identified within the COMPANION trial,17 there was no difference in 2-year survival rate between the CRT patients with and without backup defibrillation, although more of the deaths in the CRT-Pacemaker group were classified as sudden deaths.56 Perhaps the most significant changes in the present docu- ment compared to the 2008 DBT Guideline4 are the expan- sion of the Class I recommendation for CRT to include patients with LBBB, QRS duration ≥150 ms, and NYHA class II and the addition of a Class IIb recommendation for patients who have LVEF ≤30%, ischemic etiology of HF, sinus rhythm, LBBB with a QRS duration of ≥150 ms, and NYHA class I symptoms. These recommendations are based on 4 studies in which CRT was evaluated in patients with minimal or mild symptoms of HF in the setting of low LVEF. These include MADIT-CRT, RAFT, REVERSE (Resynchronization Reverses Remodeling in Systolic Left Ventricular Dysfunction), and MIRACLE ICD II (Multicenter InSync ICD Randomized Clinical Evaluation II), all of which are discussed in the following paragraphs.20-22,58 MADIT-CRT20 randomized patients with NYHA class I or II ischemic and NYHA class II nonischemic cardiomyopa- thy, LVEF ≤30%, and QRS duration ≥130 ms on GDMT to CRT-D or ICD alone. Of note, only 15% of the total cohort of patients were NYHA class I. The primary endpoint, a com- posite of death or HF event, was reduced by 34% by CRT-D (HR: 0.66), with comparable benefit for both ischemic and nonischemic etiology of HF. HF events were reduced by 41%, without significant reduction in mortality rate. CRT-D therapy was demonstrated to be of more benefit in women than in men (HR: 0.37 and 0.76, respectively) and in patients with QRS duration ≥150 ms than in patients with QRS dura- tion 150 ms (HR: 0.48 and 1.06, respectively).20 Patients with LBBB had a significant reduction in ventricular tachy- cardia, ventricular fibrillation, and death compared to non- LBBB patients, who derived no benefit (HR: 0.47 and 1.24, respectively).10 RAFT21 reported the use of CRT-D in patients with NYHA class II or class III ischemic or nonischemic cardiomyopa- thy, LVEF ≤30%, and QRS duration ≥120 ms, as compared to those treated with an ICD alone. The primary outcome of death or hospitalization for HF occurred in 33% of patients receiving CRT-D and in 40% of patients receiving ICD only. RAFT not only showed a significant reduction in hospital- ization for HF (HR: 0.68; 95% CI: 0.56 to 0.83; P0.001) but also was the first study to show a statistically significant reduction in death (HR: 0.75; 95% CI: 0.62 to 0.91; P=0.003) in mildly symptomatic patients with NYHA class II symp- toms. However, CRT-D was associated with a higher risk of adverse device- or implantation-related complications at 30 days after implantation (P0.001) compared with an ICD and no CRT. Patients with LBBB had a better outcome than did non-LBBB patients, but the statistical interaction between benefit and QRS morphology was weak in this trial (P=0.046). CRT-D therapy was effective in patients with QRS duration ≥150 ms but of no benefit in patients with QRS duration 150 ms (HR for QRS duration ≥150 ms: by guest on June 7, 2013http://circ.ahajournals.org/Downloaded from
  • 10. 1792  Circulation  October 2, 2012 0.59; 95% CI: 0.48 to 0.73; HR for QRS duration 150 ms: 0.99; 95% CI: 0.77 to 1.27; P=0.002 for interaction). Thus, both MADIT-CRT and RAFT showed benefit in NYHA class II patients treated with CRT-D and demonstrated that the benefit was primarily achieved in patients with QRS duration ≥150 ms and LBBB.20,21 The REVERSE trial consisted of 610 patients. This study assessed CRT-D therapy in patients with NYHA class I or II HF symptoms on maximum medical therapy, LVEF ≤40%, and QRS duration ≥120 ms followed for 12 months and showed that 16% of patients receiving CRT and 21% with- out CRT worsened (P=0.10). The time to first HF hospital- ization was delayed in patients receiving CRT therapy (HR: 0.47). The primary echocardiographic endpoint of ventricular remodeling assessed by LV end-systolic volume index was sig- nificantly improved (reduction in end-systolic volume index) in patients treated with CRT therapy (P0.0001). REVERSE did not report a mortality rate benefit of CRT-D therapy.22 The lack of reported mortality rate benefit may be related to the higher ejection fraction enrollment criterion (LVEF ≤40%) and the relatively short-term follow-up (12 months).22 MIRACLE ICD II included patients with NYHA class II HF on GDMT with LVEF ≤35% and QRS duration ≥130 ms who were undergoing implantation of an otherwise indi- cated ICD.58 In these patients, CRT did not alter exercise capacity but did result in significant improvement in cardiac structure and function and composite clinical response over 6 months. Analysis of the multiple clinical trials of CRT is compli- cated because trials encompass a range of LVEFs in their entry criteria, as well as a range of measured outcomes. For mortality rate, the trials showing benefit in NYHA class III and IV patients typically included those with LVEF ≤35%.22,58 For patients with NYHA class II, trials showing mortality rate benefit included those with LVEF ≤30%.20,21 A mortal- ity rate benefit with CRT has not been shown for patients who are NYHA class I.21 In terms of demonstrating improve- ment in cardiac function (eg, significant reduction in LV size and improvement in ejection fraction), trials have included patients with LVEF ≤35% who are NYHA class III and IV.58 Similarly, for patients with LVEF ≤40%, trials demonstrating improvement in function have included those who are NYHA class I and II.22 The congruence of results from the totality of CRT trials with regard to remodeling and HF events pro- vides evidence supporting a common threshold of 35% for benefit from CRT in patients with NYHA class II through IV HF symptoms. Although there is evidence for benefit in both CRT-D and CRT-Pacemaker patients with NYHA class III and IV symptoms, for NYHA class I and II HF, all of the tri- als tested only CRT-D and not CRT-Pacemaker, and as such, recommendations for these classes of patients can be made only for CRT-D.20-22,58 Taken together, the evidence from the randomized trials of CRT-D in patients with reduced LVEF and NYHA class I or II shows that CRT can provide functional ­improvement and decreasetheriskofHFeventsandcomposite­outcomes.20,22,58,59 Still, CRT-D also has been shown to decrease the mortal- ity rate for patients with NYHA class II but not for those who have NYHA class I HF.20,21 As a result, the data support a Class I recommendation for CRT implantation in patients with LBBB and QRS duration ≥150 ms and NYHA class II. Because of the lack of mortality rate benefit and smaller sample size, we believe CRT may be considered for patients who have LVEF 30%, ischemic etiology of HF, sinus rhythm, LBBB with a QRS duration ≥150 ms, and NYHA class I symptoms on GDMT (Class IIb; LOE: B). For all patients, optimal outcomes with CRT require effec- tive placement of ventricular leads, ongoing HF management with neurohormonal antagonists and diuretic therapy, and in some cases, later optimization of device programming, especially atrioventricular (A-V) and interventricular (V-V) intervals.51,60 Consistent with entry criteria for studies upon which these recommendations are based, CRT implantation should be performed only when the LVEF meets guideline criteria for patients with nonischemic cardiomyopathy who have received 3 months of GDMT, or for patients with ischemic cardiomyopathy 40 days after myocardial infarction receiv- ing GDMT when there was no intervening revasculariza- tion, or 3 months if revascularization was performed. It is assumed that the final decision to recommend CRT will be based on an assessment of LVEF made after any appropriate waiting period has concluded, during which GDMT has been applied. Finally, the pivotal trials demonstrating the efficacy of CRT took place in centers that provided expertise in device and HF therapy both at implantation and during long-term follow-up. Two other organizational guidelines by the Heart Failure Society of America61 and the European Society of Cardiology62 have recently been published that address indications for CRT. For the patient categories in common between the Heart Failure Society of America document and the present focused update, there was a good deal of concordance. Although there are many areas of agreement, some differences exist between the present guideline and the European Society of Cardiology document. One difference is that in the present guideline, CRT is recommended in NYHA class I patients who have LVEF ≤30%, have ischemic heart disease, are in sinus rhythm, and have a LBBB with a QRS duration ≥150 ms (Class IIb; LOE: C).20,21 There is no simi- lar recommendation in the European Society of Cardiology document. The European Society of Cardiology recom- mendations include patients with QRS duration 120 ms. We have not recommended CRT for any functional class or ejection fraction with QRS durations 120 ms. We also have elected to consider the presence of LBBB versus non-LBBB in the class of recommendations, on the basis of perceived differential benefit by functional class, QRS morphology, and QRS duration. 2.8. Pacemaker Follow-Up 2.8.3. Remote Follow-Up and Monitoring Since the publication of the 2008 DBT guideline, important changes have occurred related to follow-up and remote mon- itoring of CIEDs.4,15,63 CIEDs include pacemakers, ICDs, CRTs, implantable loop recorders, and implantable cardio- vascular monitors. The current technology for follow-up, by guest on June 7, 2013http://circ.ahajournals.org/Downloaded from
  • 11. Tracy et al    2012 Device-Based Therapy Guideline Focused Update   1793 evidence supporting its use, and clinical practice of CIED monitoring have evolved. Routine in-person office follow- up supplemented by transtelephonic monitoring with limited remote follow-up for pacemakers was the standard approach before 2008.4,15 Transtelephonic monitoring, with moni- tors that transmit the patient’s heart rhythm by converting electrocardiographic information to sound and transmit- ting it via telephone lines to a decoding machine that then converts the sound back into a rhythm strip, is now a dated ­technique4,15,63 because it allows for limited moni- toring of heart rate, rhythm, and battery status of only pacemakers.63 Contemporary remote monitoring uses bidirectional telemetry with encoded and encrypted radiofrequency sig- nals, allowing transmission and receipt of information from CIEDs (pacemakers, ICDs, CRTs, implantable loop record- ers, and implantable hemodynamic monitors).63 All major CIED manufacturers have developed proprietary systems to allow patients to have their devices interrogated remotely, and many use wireless cellular technology to extend the bidirectional telemetry links into the patient’s location.15,63 The information is analyzed, formatted, and transmitted to a central server, where it can be accessed by clinicians through the Internet. Information provided through remote follow-up includes virtually all of the stored information that would be obtained in an in-office visit, including bat- tery voltage, charge time in ICDs, percent pacing, sens- ing thresholds, automatically measured pacing thresholds when available, pacing and shock impedance, and stored arrhythmia events with electrograms.15,63 CIEDs with wire- less telemetry capability may be programmed at a face-to- face evaluation to subsequently send automatic alerts for a variety of issues that the clinician deems significant, such as abnormal battery voltage, abnormal lead parameters, or increased duration or frequency of arrhythmia episodes.15 Remote transmissions can be made at predetermined inter- vals or at unscheduled times for prespecified alerts related to device function or activated by the patient for clinical reasons.63 A detailed description of techniques, indications, personnel, and frequency has been published as a consensus document.15 Several prospective randomized trials have been conducted evaluating the effect of remote monitoring on clinical out- comes64–67 since the publication of the 2008 DBT Guideline.4 Collectively, these trials have demonstrated that remote moni- toring is a safe alternative to office visits to evaluate CIEDs. Compared with in-person office visits to evaluate CIEDs, remote monitoring leads to early discovery of clinically action- able events, decreased time to clinical decision in response to these events, and fewer office visits.64–67 Long-term survival rates of patients monitored remotely with ICDs in a practice setting compare favorably with survival rates of patients in clinical trials.68 Current suggestions for the minimum frequency of in-office and remote monitoring of patients with CIEDs are summa- rized in Table 3.15 Issues such as lead malfunction, unreliable battery life indicators, and other device or lead recalls influ- ence clinical decisions, which may change the appropriate minimum follow-up. Presidents and Staff American College of Cardiology Foundation William A. Zoghbi, MD, FACC, President Thomas E. Arend, Jr, Esq, CAE, Interim Chief Staff Officer Charlene May, Senior Director, Science and Clinical Policy American College of Cardiology Foundation/American Heart Association Lisa Bradfield, CAE, Director, Science and Clinical Policy Debjani Mukherjee, MPH, Associate Director, Evidence- Based Medicine Ezaldeen Ramadhan III, Specialist, Science and Clinical Policy American Heart Association Gordon F. Tomaselli, MD, FAHA, President Nancy Brown, Chief Executive Officer Rose Marie Robertson, MD, FAHA, Chief Science Officer Gayle R. Whitman, PhD, RN, FAHA, FAAN, Senior Vice President, Office of Science Operations Judy L. Bezanson, DSN, RN, CNS-MS, FAHA, Science and Medicine Advisor, Office of Science Operations Jody Hundley, Production Manager, Scientific Publications, Office of Science Operations References 1. ACCF/AHA Task Force on Practice Guidelines. Methodology Manual and Policies From the ACCF/AHA Task Force on Practice Guidelines. American College of Cardiology Foundation andAmerican HeartAssociation, Inc. 2010. Available at: http://assets.cardiosource.com/Methodology_Manual_for_ACC_ AHA_Writing_Committees.pdf and http://my.americanheart.org/idc/groups/ Table 3.  Minimum Frequency of CIED In-Person or Remote Monitoring* Type and Frequency Method Pacemaker/ICD/CRT Within 72 h of CIED implantation In person 2–12 wk postimplantation In person Every 3–12 mo for pacemaker/CRT- Pacemaker In person or remote Every 3–6 mo for ICD/CRT-D In person or remote Annually until battery depletion In person Every 1–3 mo at signs of battery depletion In person or remote Implantable loop recorder Every 1–6 mo depending on patient In person or remote symptoms and indication Implantable hemodynamic monitor Every 1–6 mo depending on indication In person or remote More frequent assessment as clinically In person or remote Indicated *More frequent in-person or remote monitoring may be required for all the above devices as clinically indicated. CIED indicates cardiovascular implantable electronic device; CRT, cardiac resynchronization therapy; CRT-D, cardiac resynchronization therapy defibril- lator; CRT-Pacemaker, cardiac resynchronization therapy pacemaker; and ICD, implantable cardioverter-defibrillator. Modified from Wilkoff et al.15 by guest on June 7, 2013http://circ.ahajournals.org/Downloaded from
  • 12. 1794  Circulation  October 2, 2012 ahamah-public/@wcm/@sop/documents/downloadable/ucm_319826.pdf. Accessed May 16, 2012. 2. Committee on Standards for Systematic Reviews of Comparative Effective- ness Research, Institute of Medicine. Finding What Works in Health Care: Standards for Systematic Reviews. Washington, DC: The National Acad- emies Press; 2011. 3. Committee on Standards for Developing Trustworthy Clinical Practice Guidelines, Institute of Medicine. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press; 2011. 4. Epstein AE, DiMarco JP, Ellenbogen KA, et al. ACC/AHA/HRS 2008 guidelines for device-based therapy of cardiac rhythm abnormalities: a report of the American College of Cardiology/American Heart Asso- ciation Task Force on Practice Guidelines (Writing Committee to Re- vise the ACC/AHA/NASPE 2002 Guideline Update for Implantation of Cardiac Pacemakers and Antiarrhythmia Devices). 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Four-year efficacy of cardiac resynchronization therapy on exercise tolerance and disease progression: the importance of performing atrioventricular junction ablation in patients with atrial fibrillation. J Am Coll Cardiol. 2006;48:734–43. 26a.Wilton SB, Leung AA, Ghali WA, et al. Outcomes of cardiac resynchro- nization therapy in patients with versus those without atrial fibrillation: a systematic review and meta-analysis. Heart Rhythm. 2011;8:1088–94. 27. Wilkoff BL, Cook JR, Epstein AE, et al. Dual-chamber pacing or ven- tricular backup pacing in patients with an implantable defibrillator: the Dual Chamber and VVI Implantable Defibrillator (DAVID) Trial. JAMA. 2002;288:3115–23. 28. Adelstein E, Schwartzman D, Gorcsan J 3rd, Saba S. Predicting hyper- response among pacemaker-dependent nonischemic cardiomyopathy pa- tients upgraded to cardiac resynchronization. J Cardiovasc Electrophysiol. 2011;22:905–11. 29. Vatankulu MA, Goktekin O, Kaya MG, et al. Effect of long-term resynchronization therapy on left ventricular remodeling in pacemaker patients upgraded to biventricular devices. Am J Cardiol. 2009;103: 1280–4. 30. Rickard J, Bassiouny M, Cronin EM, et al. Predictors of response to car- diac resynchronization therapy in patients with a non–left bundle branch block morphology. Am J Cardiol. 2011;108:1576–80. 31. Masci PG, Marinelli M, Piacenti M, et al. Myocardial structural, perfu- sion, and metabolic correlates of left bundle branch block mechanical derangement in patients with dilated cardiomyopathy: a tagged cardiac magnetic resonance and positron emission tomography study. Circ Car- diovasc Imaging. 2010;3:482–90. 32. Kashani A, Barold SS. Significance of QRS complex duration in patients with heart failure. J Am Coll Cardiol. 2005;46:2183–92. 33. Doval HC, Nul DR, Grancelli HO, et al. 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Pacing Clin Elec- trophysiol. 2010;33:590–5. 48. Upadhyay GA, Choudhry NK, Auricchio A, et al. Cardiac resynchroni- zation in patients with atrial fibrillation: a meta-analysis of prospective cohort studies. J Am Coll Cardiol. 2008;52:1239–46. 49. Beshai JF, Grimm RA, Nagueh SF, et al. Cardiac-resynchronization therapy in heart failure with narrow QRS complexes. N Engl J Med. 2007;357:2461–71. 50. Ariga R, Tayebjee MH, Benfield A, et al. Greater three-dimensional ventricular lead tip separation is associated with improved outcome after cardiac resynchronization therapy. Pacing Clin Electrophysiol. 2010;33:1490–6. 51. Singh JP, Klein HU, Huang DT, et al. Left ventricular lead position and clinical outcome in the multicenter automatic defibrillator implantation trial-cardiac resynchronization therapy (MADIT-CRT) trial. Circulation. 2011;123:1159–66. 52. Linde C, Leclercq C, Rex S, et al. 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KEY WORDS: AHA Scientific Statements ■ arrhythmias ■ cardiac resynchronization therapy ■ focused update ■ heart failure ■ pacemaker by guest on June 7, 2013http://circ.ahajournals.org/Downloaded from
  • 14. 1796  Circulation  October 2, 2012 Appendix 1.  Author Relationships With Industry and Other Entities (Relevant)—2012 ACCF/AHA/HRS Focused Update of the 2008 Guidelines for Device-Based Therapy of Cardiac Rhythm Abnormalities Committee Member Employment Consultant Speaker’s Bureau Ownership/ Partnership/ Principal Personal Research Institutional, Organizational, or Other Financial Benefit Expert Witness Voting Recusals by Section* Cynthia M. Tracy, Chair George Washington University Medical Center—Associate Director and Professor of Medicine None None None None None None None Andrew E. Epstein, Vice Chair University of Pennsylvania—Professor of Medicine Philadelphia VA Medical Center—Chief, Cardiology Section • Boston Scientific (DSMB)† • Medtronic‡ • Medtronic/ CryoCath (DSMB) • St. Jude Medical (DSMB)† • ZOLL—Advisory Board None None • Biotronik • Boston Scientific† • Cameron Health† • Medtronic† • St. Jude Medical† • Boston Scientific • Medtronic • St. Jude Medical None 2.4.1 Dawood Darbar Vanderbilt University School of Medicine—C. Sydney Burwell Associate Professor Medicine Pharmacology Vanderbilt Arrhythmia Service—Director None None None None None None None JohnP.DiMarco University of Virginia—Director, Clinical EP Laboratory • Medtronic None None • Boston Scientific None None 2.4.1 • St. Jude Medical Sandra B. Dunbar Emory University, Nell Hodgson Woodruff School of Nursing—Associate Dean for Academic Advancement, Charles Howard Candler Professor None None None None None None None N.A. Mark Estes III Tufts University—Professor of Medicine • Boston Scientific† None None • Boston Scientific— MADIT-RIT (Co-PI) None None 2.4.1 • Boston Scientific, EP Fellowship Educational Symposium† • Medtronic T. Bruce Ferguson, Jr East Carolina University—Professor of Surgery and Physiology • United Healthcare— Advisory Board None None None None None 2.4.1 Stephen C. Hammill Mayo Clinic—Professor of Medicine None None None None None None None Pamela E. Georgetown University None None None None None None None Karasik Medical School—Associate Professor of Medicine VA Medical Center, Washington, DC—Acting Chief of Cardiology Mark S. Link Tufts Medical Center—Professor of Medicine None None None • Boston Scientific— MADIT-RIT (Co-PI) None None 2.4.1 Joseph E. Marine Johns Hopkins University—Associate Professor of Medicine None None None None None None None Mark H. Schoenfeld Yale University School of Medicine—Clinical Professor of Medicine • United Healthcare— Advisory Board None None None None None 2.4.1 Amit J. Shanker Center for Advanced Arrhythmia Medicine— Director Columbia University College of Physicians and Surgeons—Assistant Professor of Medicine None None None None None None None (Continued) by guest on June 7, 2013http://circ.ahajournals.org/Downloaded from
  • 15. Tracy et al    2012 Device-Based Therapy Guideline Focused Update   1797 Appendix 1.  Continued Committee Member Employment Consultant Speaker’s Bureau Ownership/ Partnership/ Principal Personal Research Institutional, Organizational, or Other Financial Benefit Expert Witness Voting Recusals by Section* Michael J. Silka University of Southern California—Professor of Pediatrics Children’s Hospital Los Angeles—Chief, Division of Cardiology None None None None None None None Lynne Warner Stevenson Brigham Women’s Hospital—Director, Cardiomyopathy and Heart Failure None None None • Biosense Webster‡ None None 2.4.1 William G. Stevenson Brigham Women’s Hospital—Director, Clinical Cardiac EP None None None • Biosense Webster‡ None None 2.4.1 Paul D. Varosy VA Eastern Colorado Health Care System—Director of Cardiac EP University of Colorado Denver—Assistant Professor of Medicine None None None None None None None This table represents the relationships of committee members with industry and other entities that were determined to be relevant to this document. These relationships were reviewed and updated in conjunction with all meetings and/or conference calls of the writing group during the document development process. The table does not necessarily reflect relationships with industry at the time of publication. A person is deemed to have a significant interest in a business if the interest represents ownership of ≥5% of the voting stock or share of the business entity, or if the interest represents ownership of ≥$10 000 of the fair market value of the business entity, or if funds received by the person from the business entity exceed 5% of the person’s gross income for the previous year. Relationships that exist with no financial benefit are also included for the purpose of transparency. Relationships in this table are modest unless otherwise noted. According to the ACCF/AHA, a person has a relevant relationship IF: (a) the relationship or interest relates to the same or similar subject matter, intellectual property or asset, topic, or issue addressed in the document; or (b) the company/entity (with whom the relationship exists) makes a drug, drug class, or device addressed in the document or makes a competing drug or device addressed in the document; or (c) the person or a member of the person’s household has a reasonable potential for financial, professional, or other personal gain or loss as a result of the issues or content addressed in the document. *Writing group members are required to recuse themselves from voting on sections to which their specific relationships with industry and other entities may apply. Section numbers pertain to those in the full-text guideline. †Significant relationship. ‡No financial benefit. DSMB indicates Data Safety Monitoring Board; EP, electrophysiology; MADIT-RIT, Multicenter Automatic Defibrillator Implantation Trial–Reduce Inappropriate Therapy; PI, principal investigator; and VA, Veterans Affairs. by guest on June 7, 2013http://circ.ahajournals.org/Downloaded from
  • 16. 1798  Circulation  October 2, 2012 Appendix 2.  Reviewer Relationships With Industry and Other Entities (Relevant)—2012 ACCF/AHA/HRS Focused Update of the 2008 Guidelines for Device-Based Therapy of Cardiac Rhythm Abnormalities Peer Reviewer Representation Employment Consultant Speaker’s Bureau Ownership/ Partnership/ Principal Personal Research Institutional, Organizational, or Other Financial Benefit Expert Witness Sana Al-Khatib Official Reviewer—AHA Duke Clinical Research Institute and Duke University Medical Center None • Medtronic None None None None Hugh Calkins Official Reviewer—HRS Johns Hopkins Hospital • Biosense Webster • Boston Scientific • Medtronic* None None • Boston Scientific* • Medtronic* • St. Jude Medical* None None James R. Edgerton Official Reviewer—STS The Heart Hospital Baylor Plano None None None None None None Michael M. Givertz Official Reviewer—HFSA Brigham and Women’s Hospital None None None None None None Jonathan L. Halperin Official Reviewer—ACCF/AHA Task Force on Practice Guidelines Mount Sinai Medical Center • Biotronik* None None None None None Bradley P. Knight Official Reviewer—HRS Northwestern Medical Center • Boston Scientific • Cameron Health† • Biosense Webster • Biotronik • Boston Scientific • Medtronic None • Cameron Health* None None Thomas J. Lewandowski Official Reviewer—ACCF Board of Governors Appleton Cardiology Thedacare None None None None None None Henry M. Spotnitz Official Reviewer—AATS Columbia University None None • Strategic Pacing Systems† None None None C. Michael Valentine Official Reviewer—ACCF Board of Trustees The Cardiovascular Group • Medtronic* None None None None None Paul J. Wang Official Reviewer—AHA Stanford University Medical Center • Medtronic None None • Medtronic* None None John F. Beshai Content Reviewer—ACCF EP Committee University of Chicago Medical Center None None None None • Medtronic* • St. Jude Medical* None George H. Crossley Content Reviewer St. Thomas Heart • Boston Scientific • Medtronic • Boston Scientific • Medtronic None None • Boston Scientific • Medtronic* None Jennifer E. Cummings Content Reviewer—ACCF EP Committee University of Toledo None • Boston Scientific • Medtronic • St. Jude None None None None Kenneth A. Ellenbogen Content Reviewer Virginia Commonwealth University Medical Center • Cameron Health • Boston Scientific • Medtronic • Biotronik • Boston Scientific • Medtronic • St. Jude Medical None None • Biosense Webster* • Boston Scientific* • Medtronic* • St. Jude Medical* None Roger A. Freedman Content Reviewer University of Utah Health Sciences Center • Boston Scientific • Sorin • Spectranetics • St. Jude Medical None None • Medtronic* • St. Jude Medical* None • Defendant, 2011, pacemaker battery depletion Gabriel Gregoratos Content Reviewer University of California–San Francisco None None None None None None David L. Hayes Content Reviewer Mayo Clinic • Biotronik • Boston Scientific • Medtronic* • Sorin • St. Jude Medical None None None None None Mark A. Hlatky Content Reviewer Stanford University School of Medicine None None None None None None Sandeep K. Jain Content Reviewer University of Pittsburgh Physicians, UPMC Heart and Vascular Institute None None None • Medtronic* None None Samuel O. Jones Content Reviewer San Antonio Military Medical Center None None None None • Medtronic† • St. Jude Medical† None Kousik Krishnan Content Reviewer Rush University Medical Center • Boston Scientific • St. Jude Medical None None None • Biotronik* None • Boston Scientific— MADIT-RIT* • Medtronic* Michael Mansour Content Reviewer Cardiovascular Physicians None None None None None None (Continued) by guest on June 7, 2013http://circ.ahajournals.org/Downloaded from
  • 17. Tracy et al    2012 Device-Based Therapy Guideline Focused Update   1799 Steven M. Markowitz Content Reviewer—ACCF EP Committee New York Hospital • Biotronik None None None • Biosense Webster* None • Boston Scientific • Boston Scientific* • Medtronic • Medtronic* • St. Jude Medical • St. Jude Medical* Marco A. Mercader Content Reviewer George Washington University None None None None None None Simone Musco Content Reviewer Saint Patrick Hospital • Boston Scientific None None None None None L. Kristin Newby Content Reviewer Duke University Medical Center None None None None None None Brian Olshansky Content Reviewer—ACCF EP Committee University of Iowa Hospitals • Boston Scientific– Guidant None None None None None • Medtronic Richard L. Page Content Reviewer University of Wisconsin Hospital and Clinics None None None None None None Allen J. Solomon Content Reviewer Medical Faculty Associates None None None None None None John S. Strobel Content Reviewer Internal Medicine Associates None None None • Medtronic* None None Stephen L. Winters Content Reviewer Morristown Medical Center • Biosense Webster None None None • Boston Scientific • Defendant, 2011, complication of ICD placement • Medtronic • St. Jude Medical This table represents the relationships of reviewers with industry and other entities that were disclosed at the time of peer review and determined to be relevant. It does not necessarily reflect relationships with industry at the time of publication. A person is deemed to have a significant interest in a business if the interest represents ownership of ≥5% of the voting stock or share of the business entity, or if the interest represents ownership of ≥$10 000 of the fair market value of the business entity, or if funds received by the person from the business entity exceed 5% of the person’s gross income for the previous year. A relationship is considered to be modest if it is less than significant under the preceding definition. Relationships that exist with no financial benefit are also included for the purpose of transparency. Relationships in this table are modest unless otherwise noted. Names are listed in alphabetical order within each category of review. According to the ACCF/AHA, a person has a relevant relationship IF: (a) the relationship or interest relates to the same or similar subject matter, intellectual property or asset, topic, or issue addressed in the document; or (b) the company/entity (with whom the relationship exists) makes a drug, drug class, or device addressed in the document or makes a competing drug or device addressed in the document; or (c) the person or a member of the person’s household has a reasonable potential for financial, professional, or other personal gain or loss as a result of the issues or content addressed in the document. *Significant relationship. †No financial benefit. AATS indicates American Association for Thoracic Surgery; ACCF, American College of Cardiology Foundation; AHA, American Heart Association; EP, Electrophysiology; HFSA, Heart Failure Society of America; HRS, Heart Rhythm Society; ICD, implantable cardioverter-defibrillator; MADIT-RIT, Multicenter Automatic Defibrillator Implantation Trial–Reduce Inappropriate Therapy; and STS, Society of Thoracic Surgeons. Appendix 2.  Continued Peer Reviewer Representation Employment Consultant Speaker’s Bureau Ownership/ Partnership/ Principal Personal Research Institutional, Organizational, or Other Financial Benefit Expert Witness by guest on June 7, 2013http://circ.ahajournals.org/Downloaded from
  • 18. 1800  Circulation  October 2, 2012 Appendix 3.  Indications for CRT Therapy—Algorithm CRT indicates cardiac resynchronization therapy; CRT-D indicates cardiac resynchronization therapy defibrillator; GDMT, guideline-directed medical therapy; ICD, implantable cardioverter-defibrillator; LV, left ventricular; LVEF, left ventricular ejection fraction; LBBB, left bundle-branch block; MI, myocardial infarction; and NYHA, New York Heart Association. by guest on June 7, 2013http://circ.ahajournals.org/Downloaded from
  • 19. © American College of Cardiology Foundation; American Heart Association, Inc.; and Heart Rhythm Society 2012 ACCF/AHA/HRS Focused Update of the 2008 Guidelines for Device-Based Therapy of Cardiac Rhythm Abnormalities Online Data Supplement. Cardiac Resynchronization Therapy Study/Aim Type of Study N (total) n (Exp/ Interv CRT) n (Placebo/ Comparator) Follow- Up (Mo) Baseline Treatment NYHA Class EF (%) QRS Duration (ms) Exclusion Criteria QRS Subgroups by Duration (ms) Composite Endpoint (for QRS Subgroups) Results CARE HF (1) Aim of trial was to analyze the effects of a CRT-P on the risk of complications and death among patients who were receiving standard medical therapy for moderate or severe HF and demonstrated cardiac dyssynchrony by echocardiography and/or intraventricular conduction delay. RCT 813 409 Medical therapy*: 404 29.4 ACEI, beta- blockers, and spironolactone III or IV 35 120 Patients who had a major cardiovascular event in the previous 6 wk, those who had conventional indications for a pacemaker or an ICD, and those with HF requiring continuous IV therapy and those with AF were excluded. 120 to 159 (n=290); 159 (n=505) All-cause mortality or hospitalizations for major cardiovascular event including HF hospitalization HR: 0.63; 95% CI: 0.51 to 0.77; (p0.001), CRT primary and significant improvement NYHA, MLHF, euroqol. COMPANION (2) Aim of trial was to compare optimal pharmacologic therapy plus a CRT- Pacemaker, optimal pharmacologic therapy plus a CRT-Defibrillator, and optimal pharmacologic therapy alone in a population with advanced HF and intraventricular conduction delays. RCT 1,520 CRT- P: 617; CRT- D: 595 Medical therapy*: 308; 16.2 (CRT- P),15.7 (CRT-D) 11.9 (medical) ACEI, beta- blockers, and spironolactone III or IV 35 120 AF, clinical indication for a pacemaker or implantable defibrillator, a hospitalization for the treatment of HF or the equivalent in the preceding 12 mo. 120 to 147 (n=324); 148 to *168 (n=314); 168 (n=287) All-cause mortality or hospitalizations. HR: 0.81(p=0.014) for primary endpoint for CRT-P and HR: 0.80 (p=0.01) for CRT-D. HR: 0.76; 95% CI: 0.58 to 1.01for CRT-P reducing all-cause mortality (p=0.059). CRT-D by HR: 0.64; 95% CI: 0.48 to 0.86; (p=0.003). N/S between CRT-P and CRT-D, 6MW, MLHF, NYHA significantly improved with both. MADIT-CRT (3) Aim of trial was to determine whether a CRT-D would reduce the risk of death or HF events in patients with mild NYHA functional class I-II cardiac symptoms (NYHA I or II RCT 1,820 1,089 Medical therapy*: 731 28.8 ACEI, beta- blockers, and spironolactone . 1 or II 30 130 Patients were excluded from enrollment for a variety of reasons, including an existing indication for CRT; having an implanted pacemaker, ICD, or resynchronization device; NYHA class III or IV symptoms, previous CABG, 130 to 149 (n=645); 149 (n=1175) All-cause mortality or HF event (HF hospitalization or outpatient intravenous diuretic therapy). HR: 0.66; 95% CI: 0.52 to 0.84; (p=0.001), death 3% per y in both groups. by guest on June 7, 2013http://circ.ahajournals.org/Downloaded from
  • 20. © American College of Cardiology Foundation; American Heart Association, Inc.; and Heart Rhythm Society [ischemic cardiomyopathy] or NYHA II [nonischemic]), a reduced EF, and a wide QRS complex. PCI, or an enzyme-positive MI within 3 mo before enrollment; AF within 1 mo before enrollment. MIRACLE (4) Aim of trial was to evaluate the therapeutic approach of CRT in patients with HF who have an intraventricular conduction delay. RCT 453 228 225 6 Diuretic, ACEI or an ARB, and (usually) digitalis and a beta-blocker. III or IV 35 130 Patients were excluded if they had a pacemaker, ICD, an indication for or a contraindication to cardiac pacing, a cardiac or cerebral ischemic event within the previous 3 mo, or if they had had an atrial arrhythmia within the previous mo. In addition, patients were not allowed to participate if they had a systolic blood pressure of 170 or 80 mm Hg, a heart rate of 140 bpm, a serum creatinine level of 3.0 mg per deciliter (265 μmol per liter), or serum aminotransferase levels 3 times the upper limit of normal. Primary endpoints were the NYHA functional class, quality of life, and the distance walked in 6 min. Compared to the control group, patients in the CRT group experienced an improvement 6MW p=0.005, NYHA. (p0.001), quality of life. MIRACLE ICD (5) The trial examined the efficacy and safety of combined CRT and ICD therapy in patients with NYHA class III or IV congestive HF despite appropriate medical management. RCT 369 187 - ICD activat ed, CRT on 182 - ICD activated, CRT off 6 Optimized medical treatment. 3 or 4 35 130 Estimated survival 6 mo, baseline 6 min, walk test 450 m. Bradycardia requiring pacemaker, unstable angina, MI, CABG, percutaneous transluminal coronary angioplasty, cerebral vascular accident, or transient ischemic attack within previous 3 mo, 2 infusions of inotropic drug per wk, SBP 80 mm Hg or 170 mm Hg, resting heart rate 140/min, serum creatinine 3 mg/dL (265 μmol/L) Hepatic enzymes The primary double-blind study end points were changes between baseline and 6 mo in quality of life, functional class, and distance covered during a 6 min walk. At 6 mo, patients assigned to CRT had a greater improvement in median (95% CI) quality of life score (–17.5 [–21 to –14] vs. –11.0 [–16 to –7], p=0.02) and functional class (–1 [–1 to –1] vs. 0 [–1 to 0], p=0.007) than controls but were no different in the change in distance walked in 6 min (55 m [44-79] vs. 53 m [43-75], p=0.36). by guest on June 7, 2013http://circ.ahajournals.org/Downloaded from
  • 21. © American College of Cardiology Foundation; American Heart Association, Inc.; and Heart Rhythm Society 3-fold upper normal values, severe lung disease, chronic atrial arrhythmias, or cardioversion, or paroxysmal AF within previous 1 mo heart transplant recipient, severe VHD. Peak oxygen consumption increased by 1.1 mL/kg per min (0.7-1.6) in the CRT group vs. 0.1 mL/kg per min (–0.1 to 0.8) in controls (p=0.04), although treadmill exercise duration increased by 56 sec (30-79) in the CRT group and decreased by 11 sec (–55 to 12) in controls (P=0.001). No significant differences were observed in changes in left ventricular size or function, overall HF status, survival, and rates of hospitalization. No proarrhythmia was observed and arrhythmia termination capabilities were not impaired. RAFT (6) Aim of trial was to evaluate whether adding CRT to an ICD and optimal medical therapy might reduce mortality and morbidity among patients with EF30%, class II, III HF, QRS 120, paced QRS ≥200 msec. RCT 1,798 894 No CRT: 904 40 ACEI, beta- blockers, and spironolactone . II or III 30 120 Patients with a major coexisting illness or a recent cardiovascular event such as ACS or use of IV inotropic therapy were excluded. Other exclusion criteria included uncorrected VHD, restrictive or HCM, cor pulmonale, prosthetic tricuspid valve, or preexisting ICD. 120 to 149 (n=627); 149 (n=1036) All-cause mortality or HF hospitalization. 33% vs. 40% primary, HR: 0.75; 95%CI 0.64 to 0.87, p0.001, death: HR: 0.75; 95% CI: 0.62 to 0.91, HF hospitalization: HR: 0.68; 95% CI: 0.56 to 0.83; (p0.001), adverse events: 124 vs. 58. Benefit comparable in NYHA class II and III, No benefit if RBBB, IVCD, paced, or permanent AF, or QRS 150. REVERSE (7) Aim of trial was to determine the effects of CRT in NYHA functional class II HF and NYHA functional class I (ACC/AHA stage C) patients with previous HF symptoms. RCT 610 419 CRT-off: 191 12 ACEI, beta- blockers, and spironolactone . 1 or II 40 120 Patients were excluded if in the 3 mo before enrollment they were classified as NYHA functional class III or IV or had been hospitalized for HF. Those in need of cardiac pacing, those who had been paced from a previous device, or those with permanent or persistent atrial arrhythmias also were excluded. 120 to 151 (n=303); 151 (n=307) HF clinical composite response, which scores patients as improved, unchanged, or worsened. N/S primary worsened 16% vs. 21% off, p=0.10, secondary time to hospital, HR: 0.47, p=0.03, LVESV smaller -18 vs. -1, p0.0001. *Diuretics, ACE inhibitors, beta-blockers, and spironolactone. by guest on June 7, 2013http://circ.ahajournals.org/Downloaded from
  • 22. © American College of Cardiology Foundation; American Heart Association, Inc.; and Heart Rhythm Society 6MW indicates distance walked in 6 minutes; ACC/AHA, American College of Cardiology/American Heart Association; ACEI, angiotensin-converting enzyme inhibitor; ACS, acute coronary syndrome; AF, atrial fibrillation; ARB, angiotensin-receptor blocker; bpm, beats per minute; CABG, coronary-artery bypass grafting; CARE-HF, Cardiac resynchronization in heart failure; CI, confidence interval; COMPANION, Comparisons of medical therapy, pacing, and defibrillation in heart failure; CRT, cardiac resynchronization therapy; CRT-D, cardiac resynchronization therapy defibrillator; CRT-P, cardiac resynchronization therapy pacemaker; EF, ejection fraction; euroqol, European Quality of Life -5 Dimensions instrument; HCM, hypertrophic cardiomyopathy; HF, heart failure; HR, hazard ratio; ICD, implantable cardioverter-defibrillator; IVCD, intraventricular conduction delay; LVESV, left ventricular end-systolic volume; MADIT-CRT, Multicenter automatic defibrillator implantation trial-cardiac resynchronization therapy; MI, myocardial infarction; MIRACLE, Multicenter InSync Randomized Clinical Evaluation; MIRACLE ICD, Multicenter InSync Implantable Cardioversion Defibrillation Randomized Clinical Evaluation; MLHF, Minnesota Living with Heart Failure questionnaire, range from 0 to 105, with higher scores reflecting a poorer quality of life; n, subgroup of N; N/S, not significant; NYHA, New York Heart Association; PCI, percutaneous coronary intervention; RAFT, Resynchronization-defibrillation for ambulatory heart failure trial; RBBB, right bundle-branch block; RCT, randomized controlled trial; REVERSE, Resynchronization reverses remodeling in systolic left ventricular dysfunction; SBP, systolic blood pressure; and VHD, valvular heart disease. by guest on June 7, 2013http://circ.ahajournals.org/Downloaded from