1. Guidelines for primary and elective
PCI WITHOUT surgery back-up & the
related guidelines for rescue PCI
George D. Dangas, MD, PhD, FACC
Professor of Medicine (Cardiovascular Disease)
Mount Sinai Medical Center
New York, NY
2. James B McClurken, MD, FACC, FCCP, FACS, FESC
Director of Thoracic Surgery
The Heart Institute, Doylestown Hospital, PA
Professor of Cardiothoracic Surgery
Temple University Hospital
3. Disclosures - McClurken
I am a Cardiothoracic Surgeon employed by the Village
Improvement Association of Doylestown Hospital,
Doylestown, PA.
I am co-author or reviewer for some of the ACCF/AHA
… guidelines relevant to this topic.
I have vivid recall of the early PTCA/PCI era!
4. Status of Percutaneous Coronary Intervention without On-site
Cardiac Surgical Back-up in the US
Gregory J Dehmer US Cardiology, 2009;6(1):69-74
5. PCI in Hospitals Without On-Site Surgical
Backup: ACC/AHA/SCAI Guideline 2012
CLASS IIa (Level of Evidence: B)
1.Primary PCI is reasonable in hospitals without on-site cardiac surgery, provided that
appropriate planning for program development has been accomplished.
CLASS IIb (Level of Evidence: B)
1.Elective PCI might be considered in hospitals without on-site cardiac surgery,
provided that appropriate planning for program development has been accomplished
and rigorous clinical and angiographic criteria are used for proper patient selection.
(Level of Evidence: B)
CLASS III: HARM (Level of Evidence: C)
1.Primary or elective PCI should not be performed in hospitals without on-site cardiac
surgery capabilities without a proven plan for rapid transport to a cardiac surgery
operating room in a nearby hospital or without appropriate hemodynamic support
capability for transfer.
Levine GN et.al. 2011 ACCF/AHA/SCAI Guideline for Percutaneous Coronary
Intervention. Catheter Cardiovasc Interv. 2012 Feb 15;79(3):453-95.
6. PCI w/o Onsite CABG Back-up
• Must have (part 1):
– Periodic MD/NP/RN meetings to review complications
• ? Outside participation (from CABG affiliated facility)
– Periodic MD/NP/RN meetings to review case selection
implications and appropriateness
• ? Outside participation (from CABG affiliated facility)
– Written protocol for criteria for onsite PCI performance
per clinical syndrome (STEMI, ACS, stable)
– Written protocol for pharmacology (admission to cath
lab) per clinical syndrome
7. PCI w/o Onsite CABG Back-up
• Must have (part 2):
– Periodic meetings (NP/PA/RN) to review
equipment and set-up
– Written protocol for criteria for onsite use of
hemodynamic support (cath lab, CCU, transfer)
– Written protocol for transfer notification,
approval process and fast completion
• Transfer to which hospital?
• Transfer to which doctor?
• Transfer on what meds or support devices?
8. PCI (Primary & Elective) without Surgical Back-up Policy Guidance through
Regulation or Legislation,
AHA Advocacy Department; March 7, 2012
• States should require all PCI programs without surgical back-up
to participate in programs like the Action Registry-Get With The
Guidelines (AR-G), National Cardiovascular Data Registry (NCDR)
or the Atlantic Cardiovascular Patient Outcomes Research Team
(CPORT) to monitor their quality and outcomes, allowing
program leaders to show their commitment to quality by
subjecting their program performance to independent peer
review.
• The programs should adhere to strict patient-selection criteria
(e.g. exclusion of patients with EF < 30%, unprotected Left Main
intervention, intervention on last conduit to the heart).
9. PCI (Primary & Elective) without Surgical Back-up Policy Guidance through
Regulation or Legislation,
AHA Advocacy Department; March 7, 2012
• Have an annual institutional PCI volume of at least
200 to 400 cases.
• Should include only AHA/ACC-qualified operators
who meet standards for training and competency.
• Should demonstrate appropriate planning for
program development and should complete both a
primary PCI development program and an elective
PCI development program. Program development
to include routine care process and case selection
review.
• Agree to develop and maintain a quality and error
management program.
10. PCI (Primary & Elective) without Surgical Back-up Policy Guidance through
Regulation or Legislation,
AHA Advocacy Department; March 7, 2012
• Perform primary PCI 24/7.
• Develop and maintain necessary agreements
with a tertiary facility (which must agree to
accept emergent and non-emergent transfers
for additional medical care, cardiac surgery or
intervention).
• Develop and sustain agreements with an
ambulance service capable of advanced life
support and IABP transfer that guarantees a 30-
minute-or-less response time.
11. Developing a Network
• Thus far we have presented the necessity of the PCI hospital
w/o CABG back-up to belong to an affiliation network with
CABG-able facilities.
• PCI case number is a key criterion.
• An additional source of PCI cases can be derived from another
network:
– PCI site is the center
– Its non-PCI hospital affiliates participate
• The guidelines support Rescue PCI transfers after lytics
• New data support Routine Transfer
12. PCI in non SOS Hospitals
1 year follow-up
[2 hospitals in demonstration project in PA]
Alfred A. Bove, MD PhD
Principal Investigator
Co-investigators:
Abul Kashem MD PhD
Patricia McDOnnell, RN
13. Conclusions
• Fewer complications in selective PCI patients
• Angina persisted in <8% of the PCI patient
population
• Mortality was low
– Overall cardiac mortality ≤1%
– Total non-cardiac mortality for 1-year 3.1%
• Hospitalizations were related to persistent angina
• Event-free survival suggests PCI can be performed
safely in selective non-SOS hospitals
Alfred A. Bove, 2 hospitals PCI w/o SOS PA demonstration project
14. Rescue PCI
• Definition: PCI for failure of fibrinolytics
– Clinical failure assessed at 60-90 minutes after
fibrinolytics
• Persistent chest pain or other active ischemic symptoms
• Development of complications (e.g. heart failure, shock)
• EKG with < 50% ST resolution in lead with previous maximal
elevations suggests absence of reperfusion
• Other clues:
– No “reperfusion arrhythmias” – AIVR
– No rapid release of biomarkers
15. Longer-Term Follow-Up of Patients in
REACT (Rescue Angioplasty Versus Conservative
Treatment or Repeat Thrombolysis) Trial
17. 2011 ACC/AHA PCI Guidelines
Rescue PCI
I IIa IIb III
A strategy of immediate coronary
angiography (or transfer for immediate
coronary angiography) with intent to
perform PCI is reasonable in patients
with coronary angiography with STEMI,
a moderate to large area of myocardium
at risk, and evidence of failed fibrinolysis
Levine, Circulation 2011
18. 2007 STEMI Update
Rescue PCI
A strategy of coronary angiography with
intent to perform PCI (or emergency CABG) is
recommended in patients who have received
fibrinolytic therapy and have
I IIa IIb III
a. Cardiogenic shock in patients <75 years who are
suitable candidates for revascularization
I IIa IIb III
b. Severe congestive heart failure and/or pulmonary
edema (Killip class III)
I IIa IIb III
c. Hemodynamically compromising ventricular
arrhythmias
19. Routine PCI After Fibrinolysis
In patients whose anatomy is suitable, PCI
should be performed for the following
I IIa IIb III
Objective evidence of recurrent MI
I IIa IIb III
Moderate or severe spontaneous/
provocable myocardial ischemia during
recovery from STEMI
I IIa IIb III
Cardiogenic shock or hemodynamic instability
20. Pharmacoinvasive management
• A strategy for patients who cannot be offered immediate primary
PCI
– E.g. non PCI centers where transfer for primary PCI cannot be
achieved in recommended times
• Fibrinolytics administered per current guidelines followed by
transfer to PCI centers
• PCI of the infarct related artery is subsequently performed
• Strategy previously associated with bleeding complications and no
clinical benefit
– TIMI II trial
21. Early Invasive versus Standard Care
after thrombolytics
TRANSFER-AMI Investigators
Primary composite of death, reinfarction, heart failure & shock at 30 days
Cantor WJ. American College of Cardiology 2008 Scientific Sessions. March 30, 2008;
Chicago, IL.
22. Early Invasive versus Standard Care after
thrombolytics
TRANSFER-AMI Investigators
P=0.0013
1059 pts
Time to PCI 192 min
Cantor WJ. American College of Cardiology 2008 Scientific Sessions. March 30, 2008;
Chicago, IL.
23. Ischemic Events at Follow-up in
Pharmaco-invasive Trials
Verheugt, NEJM 2009; 360, 26: 2779-2781
24. 2011 ACC/AHA PCI Guidelines
Pharmaco-invasive strategy
I IIa IIb III A strategy of coronary angiography (or
A transfer for coronary angiography) 3 to
24 hours after initiating fibrinolytic
therapy with intent to perform PCI is
reasonable for hemodynamically stable
patients with STEMI and evidence for
successful fibrinolysis when angiography
and revascularization can be performed
as soon as logistically feasible in this
time frame.
Levine, Circulation 2011
25. Conclusions
• PCI w/o CABG back-up onsite can be performed
• A set of related guidelines indicates the types of clinical
protocols (critical pathways) and transferring affiliation
agreements that ought to be in place
– Longitudinal database participation
– Peer review
• Development of a well-functioning network is key
• The 2012 questions are
– Is it always appropriate?
– Is if financially viable and under what criteria?
