Download slides

When to Repair Functional MR
The Interventional Cardiologist’s Perspective
Ted Feldman, M.D., FSCAI FACC FESC
Evanston Hospital
CRT
Cardiovacular Research Technologies
Washington, D.C.
February 23 – 26, 2013
Ted E. Feldman, MD
Consulting:
Abbott Laboratories
Boston Scientific Corporation
Edwards Lifesciences, LLC
INDICATIONS FOR MITRAL VALVE OPERATION
Mitral valve surgery in heart failure
Acorn Clinical Trial
Serious adverse events by treatment group
Mean age 53.4±12.6 yrs
any in SAE 82%
J Thorac Cardiovasc Surg 2006;132:568-77
With CABG
Guidelines on the management of valvular heart disease 2012
European Heart Journal (2012) 33, 2474
Patient Selection for MR Therapies
 Trial inclusion and exclusion criteria determine patient
population
 Resultant patient profile variable
EVEREST II Key Eligibility Criteria

Age 18 years or older

Moderate to severe (3+) or severe (4+) MR
•
•
Symptomatic
Asymptomatic with LVEF <60% or LVESD >45mm
ACC/AHA Task Force Guidelines JACC 1998;32:1486

MR originates from A2-P2 mal-coaptation

Core lab echo assessment

Candidate for mitral valve surgery including CPB

Transseptal deemed feasible

Key Exclusions
ASE Guideline - JASE 2003;16:777-802
•
•
•
EF < 25% or LVESD > 55 mm
Renal insufficiency
Endocarditis, rheumatic heart disease
EVEREST II Randomized Clinical Trial
Baseline Demographics & Co-morbidities
Device (%) Control (%)
Age (mean)
Male
Congestive heart failure
Coronary artery disease
Myocardial infarction
Atrial fibrillation
Cerebrovascular disease
Cardiomyopathy
Diabetes
Previous cardiovascular surgery
MR Severity: 3+ to 4+
MR Etiology: Degenerative /
Functional
n=184
n=95
P
67.3 years
62.5
90.8
47.0
21.9
33.7
7.6
17.9
7.6
22.3
95.7
65.7 years
66.3
77.9
46.3
21.3
39.3
5.3
14.7
10.5
18.9
92.6
0.32
73 / 27
73 / 27
0.60
<0.01
>0.99
>0.99
0.42
0.62
0.61
0.50
0.54
0.48
0.81
EVEREST II Randomized Clinical Trial
Demographic Comparison
EVEREST II
RCT
2008 STS Database
Isolated 1st Elective
Operation for MR*
n=279
Repair
Replace
High Volume Hospitals
(>140/Yr)
Age yrs (mean)
68
60
61
59
≥65 yrs
58%
37%
45%
n/a
≥75 yrs
32%
n/a
n/a
0%
NYHA Class III or IV
50%
26%
45%
n/a
CHF
86%
41%
58%
n/a
Hypertension
75%
60%
67%
43%
Diabetes Mellitus
9%
13%
23%
6.5%
COPD / Chronic Lung
Disease
15%
17%
29%
n/a
EF (mean)
60%
53%
55%
56%
10
*Gammie JS et al Influence of Hospital Procedural Volume on Care Process and Mortality for Patients Undergoing Elective
Surgery for Mitral Regurgitation. Circ 2007;115:881-887.
EVEREST II
High Risk Registry
Subject
screened for
EVEREST II
Good
Surgical
Candidate?
Yes
Randomized
Evalve Mitraclip
Surgery
No
Predicted operative mortality ≥12%
High Risk
Registry
Primary Endpoint: Mortality at 30 days
High Risk Registry Inclusion Criteria
 STS surgical risk calculator ≥ 12%
 or judgment of surgeon investigator the patient is
considered high risk due to one of the following:
•
•
•
•
•
•
•
•
•
Porcelain aorta or mobile ascending aortic atheoroma
Post-radiation mediastinum
Previous mediastinitis
Functional MR with EF<40
Over 75 years old with EF<40
Re-operation with patent grafts
Two or more prior chest surgeries
Hepatic cirrhosis
Three or more of the following STS high risk factors:
–
–
–
–
Creatinine > 2.5 mg/dL
Prior chest surgery
Age over 75
EF<35
EVEREST II High Surgical Risk and Concurrent Control
Baseline Demographics and Co-morbidities
High Risk
Cohort
N=211
Concurrent
Control
N=36
Not Operated,
N=193
Operated,
N=203
76 ±10
77 ±13
69 ±13
63 ±12
57%
64%
65%
35%
Predicted Mortality*, (%)
15.0%
16.4%
n/a
n/a
Prior Cardiac Surgery, (%)
58%
50%
7%
3%
History Myocardial Infarction, (%)
49%
36%
28%
18%
Prior Stroke, (%)
14%
14%
n/a
n/a
COPD / Chronic Lung Disease, (%)
30%
31%
21%
11%
Moderate to Severe Renal Failure, (%)
31%
31%
n/a
n/a
History Atrial Fibrillation, (%)
64%
53%
36%
32%
Diabetes Mellitus, (%)
40%
42%
21%
10%
Mean Ejection Fraction, (%)
49
55
48
56
LV ESD (mm)
4.2
3.8
41
40
NYHA Class III or IV, (%)
86%
84%
70%
65%
Etiology – Functional MR, (%)
71%
64%
12%
26%
Demographics and
Co-Morbidities
Age (years)
≥ 75 years, (%)
* Based on STS ≥ 12% or an assigned mortality 12% for pre-specified comorbidities
EVEREST II High Surgical Risk Cohort – EuroPCR 2011
Euro Heart Survey^
Mirabel et al. European Heart Journal, 2007











Inclusion criteria
dilated ischaemic or non-ischaemic cardiomyopathy
≥moderate (2+) FMR
LV EF <40%
NYHA class II–IV
6 min walk distance (6MWD) 150–450m
stable heart failure medication for 3 months
Key exclusion criteria
IV inotrope infusion ≤30 days
severe tricuspid regurgitation
serum Cr.2.2 mg/dL
organic mitral valve pathology
pacing lead already in the CS
Clinical Outcomes Assessment of the MitraClip Percutaneous Therapy for High Surgical Risk
~420 patients enrolled at up to 75 US sites
Significant FMR ≥3+ core lab
High risk for mitral valve surgery
Specific valve anatomic criteria
Randomize 1:1
MitraClip
Control group
Standard of care
Safety: Composite death, stroke, worsening renal
function, LVAD implant, heart transplant at 12 months
Effectiveness: Recurrent heart failure hospitalizations
Protocol conditionally approved by FDA July 26, 2012
Key Inclusion Criteria
• Functional MR ≥3+
– ischemic or non-ischemic cardiomyopathy
• Symptomatic
– NYHA class II, III or ambulatory IV
• STS mortality risk is ≥ 8% or Local Site Heart Team concludes
that co-morbidities result in a prohibitive predicted operative risk
of stroke or death
• ≥1 HF hospitalization during prior year
– and/or BNP ≥400 pg/ml
– or nT-proBNP ≥1600 pg/ml ≤90 days
• treated per standards for CAD, LV dysfunction, MR or HF
including CRT, revascularization, OMT
• primary MR jet originates from malcoaptation of A2-P2
scallops
Key Exclusion Criteria
• severe LV dysfunction is defined as LVESD >55mm or LVEF<20%
• MV area <4 cm2
• MI ≤90 days
• Untreated clinically significant CAD requiring revascularization
• CVA or TIA within 6 months or severe carotid stenosis
• Any percutaneous coronary, carotid or endovascular intervention or
carotid surgery within 30 days, or any coronary or endovascular
surgery within 6 months
• CRT and/or ICD implant or revision within 90 days
• Leaflet anatomy which may preclude MitraClip implantation, proper
MitraClip positioning on the leaflets or sufficient reduction in MR
• Severe right ventricular failure or severe tricuspid regurgitation
Mean age 35yrs, LVEF35-39%
… improved survival and a significant decrease in major adverse
outcomes… validates the concept of ventricular reshaping…
Grossi EA, Patel N,
Woo, YJ, Goldberg JD,
Schwartz CF,
Subramanian V,
Feldman T,
Bourge R,
Baumgartner N, Genco
C, Goldman S, Zenati
M, Wolfe JA, Mishra
YK, Trehan N, Mittal S,
Shang S, Mortier TJ,
Schweich CJ J Am Coll
Cardiol 2010; 56:
1984-93
Grossi EA, Patel N, Woo, YJ, Goldberg JD, Schwartz CF, Subramanian V, Feldman
T, Bourge R, Baumgartner N, Genco C, Goldman S, Zenati M, Wolfe JA, Mishra YK,
Trehan N, Mittal S, Shang S, Mortier TJ, Schweich CJ
J Am Coll Cardiol 2010; 56: 1984-93