Which Patients Should Be Targeted for Mitra Clip
Which Patients Should Be Targeted for Mitra. Clip Procedures? Ted Feldman, M. D. , MSCAI FACC FESC Evanston Hospital CRT Cardiovascular Research Technologies Washington D. C. February 18 -21 st, 2017
Ted Feldman MD, MSCAI FACC FESC Disclosure Information The following relationships exist: Grant support: Abbott, BSC, Cardiokinetics, Corvia, Edwards, WL Gore Consultant: Abbott, BSC, Edwards, WL Gore Stock Options: Mitralign Off label use of products and investigational devices will be discussed in this presentation
Mitra. Clip Patient Selection • Guidelines – Critical data review – Broad community consensus • MR etiology – FMR outcomes remain incompletely defined • Leaflet morphology – Relative and absolute limits of the technology • Patient characteristics – Comorbidities may overwhelm treatment effects
Recommendations for Chronic Primary MR Nishimura, RA et al. 2014 AHA/ACC Valvular Heart Disease Guideline
Interventional Cardiology of the German Society for Cardiology Arbeitsgemeinschaft Interventionelle Kardiologie (AGIK)
Interventional Cardiology of the German Society for Cardiology Percutaneous interventional mitral regurgitation treatment using the Mitra-Clip system Clin Res Cardiol Accepted: 21 August 2013
Interventional Cardiology of the German Society for Cardiology Percutaneous interventional mitral regurgitation treatment using the Mitra-Clip system Clin Res Cardiol Accepted: 21 August 2013
• The role of isolated mitral valve surgery in patients with severe functional mitral regurgitation and severe LV systolic dysfunction (LVEF , 30%) who cannot be revascularized or have non-ischaemic cardiomyopathy is questionable – in most patients conventional medical and device therapy are preferred. • In selected cases, repair may be considered in order to avoid or postpone transplantation. – The decision should be based on comprehensive evaluation within the ‘heart team’. • In patients with HF with moderate-severe, secondary mitral regurgitation who are judged inoperable or at high surgical risk, percutaneous mitral valve intervention may be considered – to improve symptoms and quality of life – no RCT evidence of improvement has been published, only registry studies
Negative Predictors • • • • • coaptation length <2. 7 mm coaptation depth >6. 3 mm distance between papillary muscles >32 mm thickening and calcification of the subvalvular apparatus cleft effective regurgitant orifice area (EROA) mitral valve orifice area (MVOA) <4 cm 2 mean transmitral pressure gradient (TMPG) TAPSE <15 mm TR>2+ EF<25% PASP RV function Ischemic etiology NTPro BNP >10000 NYHA Class 4 CKD, Diabetes, Age >80
COAPT Expanded Enrollment Feb 14 th, 2017 83 active sites < 100 Expanded enrollment n=610 50 Randomized Roll-In Still needed 514 1 st COAPT patient randomized on Dec 27, 2012
Multicentre Study of Percutaneous Mitral Valve Repair Mitra. Clip Device in Patients With Severe Secondary MR (MITRA-FR) • Mitra. Clip vs optimal therapy alone • Estimated Enrollment: 288 at 22 sites- 290 enrolled as of Jan 2017 • Primary Outcome Measures: All-cause mortality and unplanned hospitalizations for heart failure 1 year • Inclusion Criteria – Age > 18 years old – Severe secondary mitral regurgitation confirmed by the Echocardiography Core Laboratory Characterized by a regurgitation volume > 30 m. L/beat or a regurgitant orifice area > 20 mm 2 – New York heart Association Class≥ II. – Left ventricular ejection fraction between 15% and 40% – Minimum of 1 hospitalization for heart failure within 12 months preceding randomization – Assessed by the investigator to be on optimal standard of care therapy for heart failure – Assessed by the heart team to be not eligible to a mitral surgery intervention Profs. Obadia and Vahanian NCT 01920698 https: //clinicaltrials. gov/ct 2/show/NCT 01920698? intr=Mitraclip&cntry 1=EU%3 AFR&rank=1
COAPT Inclusion 1. Symptomatic functional MR ≥ 3+ due to ischemic or non- ischemic cardiomyopathy 2. HF specialist investigator judges subject has been adequately treated, including CAD, LV dysfunction, MR and heart failure e. g. , with CRT, revascularization, and/or GDMT 3. one hospitalization for heart failure in the 12 months and/or a corrected BNP 300 pg/ml or corrected NT-pro. BNP 1500 pg/ml 4. NYHA Functional Class II, III or ambulatory IV. 5. Local Site Heart Team concurs that surgery will not be offered 6. LVEF is 20% and 50% 7. LVESD ≤ 70 mm assessed by TTE 8. The primary regurgitant jet is non-commissural. If a secondary jet exists, it must be considered clinically insignificant. 9. CK-MB obtained within prior 14 days < local laboratory ULN 10. Transseptal and femoral access is feasible
COAPT Exclusions-1 • • • COPD requiring continuous home oxygen or chronic oral steroid use. Untreated clinically significant CAD requiring revascularization. CABG, PCI , CRT or TAVR within 30 days Tricuspid valve disease requiring surgery. Aortic valve disease requiring surgery or transcatheter intervention Cerebrovascular accident, carotid surgery or stenting within 30 days Severe symptomatic carotid stenosis > 70% by ultrasound ACC/AHA Stage D heart failure. Presence of any of the following: – PASP > 70 mm Hg – other structural heart disease – Hemodynamic instability requiring inotropic support or mechanical heart assistance • Physical evidence of right-sided failure with TTE evidence of moderate or severe RV dysfunction
COAPT Exclusions-2 • • Mitral valve orifice area < 4. 0 cm 2 Leaflet anatomy which may preclude Mitra. Clip implantation – – – • • • Insufficient mobile leaflet available for grasping with the Mitra. Clip device Evidence of calcification in the grasping area Presence of a significant cleft in the grasping area Lack of both primary and secondary chordal support in the grasping area Leaflet mobility length < 1 cm Need for any emergent or urgent surgery or planned cardiac surgery < 1 year Life expectancy < 12 months due to non-cardiac conditions. Modified Rankin Scale ≥ 4 disability. Status 1 heart transplant or prior orthotopic heart transplantation. Prior mitral valve leaflet surgery or prosthetic mitral valve, or any prior transcatheter mitral valve procedure. Echocardiographic evidence of intracardiac mass, thrombus or vegetation. Active endocarditis or active rheumatic heart disease or leaflets degenerated from rheumatic disease (i. e. , noncompliant, perforated). Active infections requiring current antibiotic therapy. TEE is contraindicated or high risk.
CARDIOBAND Edwards PASCAL Repair System
What can be asserted without evidence can also be dismissed without evidence. ― Christopher Hitchens
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