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Rev katz valve 2014 h&vi annual conf
1. Bon Secours Heart Valve Center
Virginia’s leader for the management and treatment of valvular heart disease!
!!
Marc R. Katz, MD, MPH!
Chief Medical Officer, Bon Secours !
Heart & Vascular Institute!
4. Mitral Regurgitation (MR)
MR occurs when the mitral valve fails to
close completely causing blood flow to
flow backward
Symptoms may include:
• Shortness of breath
• Heart palpitations
• Fatigue
• Lightheadedness
• Cough
• Swollen feet or ankles
• Excessive urination
Mayo Clinic (www.mayoclinic.com)
5. Mitral Regurgitation Etiologies
Degenerative MR
– Also known as primary or organic MR
– Usually caused by an anatomic
defect of one or more structures
comprising the mitral valve apparatus
—the annulus, the
leaflets, the chordae tendineae,
and the papillary muscles
Normal Mitral Valve
Degenerative MR: Prolapse
Functional MR
– Also known as secondary MR
– Results from left ventricular (LV)
dysfunction and dilation, which
causes otherwise normal valve
components to fail and results in
MR
Degenerative MR: Flail
Functional MR
See Important Safety information Referenced Within
6. Mitral Valve Disease is Common
and Increases with Age
Mitral regurgitation (MR) is the most common type of heart valve insufficiency in
the US1,2
12
Prevalence of Valvular Heart Disease by Age
1. Heart Disease and Stroke Statistics 2010 Update: A Report From the American Heart Association. Circulation. 2010;121:e46-e215. 2. Nkomo et al. Burden of Valvular Heart Diseases: A Population-based Study, Lancet, 2006; 368: 1005-11.
Prevalence
increases from
0.5% for 18-44
year olds to 9.3%
for ≥75 year olds
(p<.0001)
See Important Safety information Referenced Within
7. MR Progresses to Heart Failure
MR initiates a cascade of
events progressing to
heart failure, then death, if
untreated2,3
Increasing Mitral
Regurgitation
Increase Load/
Stress
Muscle Damage/
Loss
Dilation of!
Left Ventricle 1 year
Dysfunction!
of Left Ventricle
mortality
up to
57%1
1 Cioffi G, et al. Functional mitral regurgitation predicts 1-year mortality in elderly patients with systolic chronic heart failure. European Journal of Heart Failure 2005 Dec;7(7):1112-7
2 Grigioni F, et al. Outcomes in mitral regurgitation due to flail leaflets a multicenter European study. JACC Cardiovasc Imaging. 2008 Mar;1(2):133-41
3 Enriquez-Sarano M, et al. Quantitative determinants of the outcome of asymptomatic mitral regurgitation. N Engl J Med. 2005 Mar 3;352(9):875-83
8. Heart Failure and MR are an
Economic Burden
• Estimated annual cost of heart failure is
$39.2 billion1
• Majority of treatment costs are due
to hospital care1
• Hospitalization following discharge from
heart failure admission is high (25% -50% at
30 days)2
Distribution of costs for heart failure treatment in the USA1
Physician, 7%
Home Health Care, 9%
Medication, 9%
Nursing Home 13%
Hospital Care, 60%
Annual cost of heart failure places a large
burden on health care budgets in U.S.
Moderate or greater MR is estimated to occur in
59% patients with heart failure, with the number
increasing to 74% in heart failure patients3
1. Braunschweig et al. Europace 2011
2. O’Conner C, et al. J Am Coll Cardiol, 2010; 56:369-371
3. Robbins, et al. Am J Cardiol. 2003 Feb 1;91(3):360-2
See Important Safety information Referenced Within
9. Severe MR Leads to Increased Hospital
Admissions and Lower Survival Rates
Significantly lower survival rates
experienced by patients with
moderate to severe MR1
100%
80%
60%
40%
20%
0%
0 1 2 3 4 5
East West North
Survival Probability
No MR
Mild MR (1+ or 2+)
Mod/sev MR (3+ or 4+)
Years
P= 0.0001
Survival of Heart Failure Patients with MR by Degree
of MR Adjusted for demographics and clinical
variables at baseline
Significantly higher hospital admissions
for HF experienced by patients with
moderate to severe MR2
19
14.3
HF
Re-
Hospit
alizatio
n Rate
(#
events
/ #
patient
s)
9.5
4.8
0
18.8
Higher HF
Readmission Rate
10.5
P= 0.021
79%
No/Mild MR Moderate/Severe MR
Through follow-up ~ 7 yrs (N=218 cases matched 1:1)
1. Trichon BH et al. Am J Card. 2003,91:538-43!
2. Markwick et al. Prognostic Implications of Moderate and Severe Mitral Regurgitation in Contemporary Clinical Care. TCT 2012
10. A Largely Untreated Patient Population
Mitral Regurgitation 2009 U.S. Prevalence
Total MR Patients1,2
Eligible for Treatment3,4
(MR Grade ≥3+)
4,100,000
1,700,000
Annual Incidence3
(MR Grade ≥3+)
Annual MV Surgery5
250,000
30,000
14% Newly Diagnosed
Each Year
Only 2% Treated Surgically
1,670,000
Untreated
Large and Growing
Clinical Unmet Need
1. US Census Bureau. Statistical Abstract of the US: 2006, Table 12.!
2. Nkomo et al. Burden of Valvular Heart Diseases: A Population-based Study, Lancet, 2006; 368: 1005-11.!
3. Patel et al. Mitral Regurgitation in Patients with Advanced Systolic Heart Failure, J of Cardiac Failure, 2004.!
4. ACC/AHA 2008 Guidelines for the Management of Patients with Valvular Heart Disease, Circulation: 2008!
5. Gammie, J et al, Trends in Mitral Valve Surgery in the United States: Results from the STS Adult Cardiac Database, Annals of Thoracic Surgery 2010.
11. Traditional or Open Heart Surgery
• Restricted from driving for
one month
• Limited physical activities
up to six months.
!
12. ! Minimally Invasive Surgery
!
• smaller incision,
approximately 5 cm
• Without cutting the
breastbone
• Return to driving in one
week
• Return to normal
activities after one month.
!
13. Robotic Mitral Valve Surgery
• Small 2 cm incision, between
the ribs, and four 1 cm
instrument ports
• No driving restrictions
• Return to normal activities
within a week or two
14. Repair vs. Replacement
Advantages of Repair!
• Better long-term survival!
• Improved lifestyle!
• Improved heart function and maintain heart
structure!
• Better valve durability!
• Lower risk of stroke and infection (endocarditis)!
• Decreased need for blood thinners
(anticoagulation)!
!
Bon Secours Heart Valve
Center!
99%!
Repair Success Rate
15. Mitral referral Criteria
Moderate to Severe MR (3-4+)
• Supporting Criteria
• LVEF < 60%
• LVESD ≥ 40mmHg
• PASP ≥ 50mmHg
• Vena Contracta ≥ 0.7 cm
• Regurgitant Volume ≥ 30 ml
• Regurgitant Fraction ≥ 50%
• ERO ≥ 0.40 cm2
• Moderate to severe LA enlargement
22. High-risk MR Patients are Not Surgical Candidates
Nearly half of MR patients not considered appropriate for mitral valve
surgery 4
Factors prohibiting Surgical Patients (30K)
surgery include4:
• Impaired LVEF
49%
• High operative risk
High-Risk
1-3
• Multiple comorbidities
Patients*,(860K)
• Advanced age
2%
!
* Note: High-Risk Patients are defined as any patient with an EF<35% or an age of 75+.
1.U.S. Census Bureau, Statistical Abstract of the U.S. 2.Nkomo et al. Burden of Valvular Heart Diseases: A Population-based Study, Lancet, 2006; 368: 1005-11. 3.Patel, et al. Mitral Regurgitation in Patients with Advanced Systolic Heart Failure, J of Cardiac Failure, 2004. 4.Rankin, et al, J of Thoracic and Cardiovascular Surgery, March 2006 5.Nishimura RA, Otto CM, Bonow RO, Carabello BA, Erwin JP III, Guyton RA, O’Gara PT, Ruiz CE, Skubas NJ, Sorajja P. Sundt TM III, Thomas JD, 2014 AHA/ACC Guideline for the
Management of Patients with Valvular Heart Disease, Journal of the American College of Cardiology (2014, doi; 10.1016/j.jacc.2014.02.536
49%
Surgical
Candidates
(850K)
See Important Safety information Referenced Within
“When patients with
VHD are referred for
intervention in a
timely manner, there
is an improved
outcome in
preservation of
ventricular function
as well as enhanced
survival.”5
23. MitraClip® Therapy
Filling a Treatment Gap
• Medical therapy is limited to symptom management!
• MV surgery has been the only option that reliably reduces MR!
• A significant gap exists between medical and surgical options!
• MitraClip® therapy is a first-in-class, percutaneous option to reduce MR*
!
Medical
Therapy
Less Invasive
Increased MR Reduction
!
MV Surgery
!
MitraClip®
*Reference Source: Instructions For Use See important safety information referenced within
24. INDICATION FOR USE:
Prohibitive Risk Primary MR (DMR)
The MitraClip® Clip Delivery System is indicated for the
percutaneous reduction of significant symptomatic mitral
regurgitation (MR ≥ 3+) due to primary abnormality
of the mitral apparatus [degenerative MR] in patients
who have been determined to be at prohibitive risk for
mitral valve surgery by a heart team, which includes a
cardiac surgeon experienced in mitral valve surgery and a
cardiologist experienced in mitral valve disease, and in
whom existing comorbidities would not preclude the
expected benefit from reduction of the mitral regurgitation.
See important safety information referenced within
DMR - Prolapse
DMR - Flail
25. 2014 AHA/ACC Guidelines for the Management of Patients with
Valvular Heart Disease
“Class IIb
3. Transcatheter mitral valve repair may be considered for severely
symptomatic patients (NYHA class III to IV) with chronic severe primary
MR (stage D) who have favorable anatomy for the repair procedure and a
reasonable life expectancy but who have a prohibitive surgical risk because
of severe comorbidities and remain severely symptomatic despite optimal
GDMT for HF (426). (Level of Evidence: B)
!
An RCT of percutaneous mitral valve repair using the MitraClip device versus surgical mitral
repair was conducted in the United States. The clip was found to be safe but less effective
than surgical repair because residual MR was more prevalent in the percutaneous group.
However, the clip did reduce severity of MR, improved symptoms, and led to reverse LV
remodeling. Percutaneous mitral valve repair should only be considered for patients with
chronic primary MR who remain severely symptomatic with NYHA class III to IV HF symptoms
despite optimal GDMT for HF and who are considered inoperable.”¹
¹Source: Nishimura RA, Otto CM, Bonow RO, Carabello BA, Erwin JP III, Guyton RA,O’Gara PT, Ruiz CE, Skubas NJ, Sorajja P, Sundt TM III, Thomas JD, 2014 AHA/ACC Guideline for the
Management of Patients With Valvular Heart Disease, Journal of the American College of Cardiology (2014), doi: 10.1016/j.jacc.2014.02.536.
See important safety information referenced within
26. Patient Selection Criteria:
Prohibitive Risk DMR
For a complete list of patient eligibility criteria, please refer to the MitraClip Clip Delivery System Instructions for Use Reference Source: Instructions For Use See important safety information referenced within
30. Improvement In MR with MitraClip® Therapy1
MR Pre-MitraClip®
Therapy Baseline*
MR Post-MitraClip ®
Therapy 30 Days*
1MitraClip Clip Delivery System
Instructions for Use.
*Actual prohibitive-risk DMR patient.
Data on file with Abbott Vascular.
See important safety information referenced within
31. ®
Procedure Imaging:MitraClip
Procedure is Guided by Echocardiography
Echocardiography !
(Primary Imaging)
Fluoroscopy
(Secondary Imaging)
32. Connect With Your MitraClip® Therapy Center
Do you have patients who could benefit
from this important treatment option? !
!
Screening for TMVR and referring
to MitraClip® therapy could
change your patients’ lives.1,2!
!
To find out if TMVR with MitraClip®
therapy is an appropriate option for your
patients, connect with your local
MitraClip® therapy center.
1. MitraClip Clip Delivery System Instructions for Use.!
2. Lim S, et al. Effectiveness of Transcatheter Mitral Valve Repair for Degenerative Mitral Regurgitation in High Surgical Risk Patients. Presented at: TCT 2012; October 22-26, 2012; Miami, FL.
See important safety information referenced within
33. MitraClip FDA
Approval 2013
Based on EVEREST data, the FDA
approved the MitraClip for:
Degenerative Mitral Regurgitation
Prohibitive Surgical risk
Risk outweighs benefit of
surgery
STS >8%
34. What about functional MR?
Ischemic Cardiomyopathy
Non-ischemic
Tethering
Annular Dilation
Papillary dysfunction
35. COAPT
Clinical Outcomes Assessment of the MitraClip
Percutaneous Therapy for High Surgical Risk Paitents
Prospective randomized multicenter trial for
MitraClip treatment of Functional MR
Randomized 1:1 ratio: MitraClip + best medical
therapy versus best medical therapy alone
Optimal HF therapy stable for > 30-90 days
Inclusion:
3 - 4+ functional MR (corelab confirmed)
LV dysfunction
EF 20-50%; LVESD < 70mm
37. Aortic Stenosis Referral
Aortic Stenosis (AS)!
• Moderate to severe stenosis!
• Supporting Criteria!
• Aortic Valve Area < 1.0 cm2!
• Aortic Vmax ≥ 4 m/s!
• Mean ΔP ≥ 40 mmHg!
38. Aortic Surgical
Traditional or Open Heart Surgery !
Open heart patients are restricted from driving for
one month and have limited physical activities up to six
months.!
!
Minimally Invasive Aortic Valve Surgery !
- Mini sternotomy patients are restricted from driving
for one month and can return to normal activities
within two to three weeks. !
- Thoracotomy approach with an incision between the
ribs (still needs more)
39. Population at Risk for Aortic Stenosis is Increasing
Over 40 Million People in the US
Over the Age of 651!
!
• Aortic stenosis is estimated to
be prevalent in up to 7% of the
population over the age of
652!
• Between 1990 and 2020, the
population from 65 – 74 years
will increase 74% !
• 80% of adults with symptomatic
aortic stenosis are male3
Population: 1960 to 2050
(In Millions)
Elderly
80
60
40
20
0
78.9
75.2
69.4
53.2
39.4
34.7
31.1
25.6
20
16.6
1960 1970 1980 1990 2000 2010 2020 2030 2040 2050
Source: US Census Bureau, (US Census, 2010)1
40. Symptoms of Aortic Stenosis4
• Shortness of breath
• Angina
• Fatigue
• Syncope or presyncope
• Other
• Rapid or irregular
heartbeat
• Palpitations
Sandy
Actual TAVR Patient
Pre-Procedure
Inoperable
The symptoms of aortic disease are commonly misunderstood by
patients as ‘normal’ signs of aging.5 Many patients initially appear
asymptomatic, but on closer examination up to 37% exhibit symptoms.6
41. Severe Aortic Stenosis Is Life Threatening
• After the onset of symptoms, patients with severe aortic stenosis have a survival rate as low as 50% at 2
years and 20% at 5 years without aortic valve replacement2
• The PARTNER Trial demonstrated that 50% of inoperable patients died within 1 year without a valve
replacement
and Progresses Rapidly7
42. 30
23
15
8
0
28
Worse Prognosis than Many
30
12
4
23
Metastatic Cancers
5-Year Survival (Distant Metastasis)8
Survival, %
Breast
Cancer
Lung
Cancer
Colorectal
Cancer
Prostate
Cancer
Ovarian
Cancer
Severe
Inoperable AS*
*Using constant hazard ratio. Data on file, Edwards Lifesciences LLC. Analysis courtesy of Murat Tuczu, MD, Cleveland Clinic
▪ 5 year survival of breast cancer, lung cancer, prostate cancer,
ovarian cancer and severe inoperable aortic stenosis
43. An Under-diagnosed and Under-treated Disease
▪ Studies show at least 40% of severe aortic stenosis (SAS)
patients are not treated with an AVR11-17
44. What Causes Aortic Stenosis in Adults
Less Common More Common
Age-Related
Calcific Aortic
Stenosis
Congenital
Abnormality
Rheumatic
Fever
Images courtesy of John Webb, MD at St. Paul’s Hospital and Renu Virmani, MD at the CVPath Institute
45. Options for Aortic Valve Replacement
Surgery
Low- to
Moderate-
Risk
High Risk Greater Risk
TAVR
Open-Heart Surgery
(AVR)
Minimal Incision !
Valve Surgery!
(MIVS)
Transcatheter Heart
Valve
Surgical Heart Valve
High Risk Patients!
Defined by Risk of
Mortality > 15%
46. Immediate Goals of AS Treatment9
▪ Aortic valve
replacement
is intended to relieve
the stress on the left
ventricle by:!
▪ Maximizing area!
▪ Maximizing
laminar flow!
47. Disease Mechanisms and Time Course of Calcific Aortic Stenosis.
Otto CM, Prendergast B. N Engl J Med 2014;371:744-756
