Mitral valve apparatus

Transcription

1 Mitral Valvular Disease: An explosion of multiple new non-surgical options Disclosure Statement of Financial Interest Saibal Kar, MD, FACC Within the past 12 months, I or my spouse/partner have had a financial interest/arrangement or affiliation with the organization(s) listed below. Saibal Kar, MD, FACC, FAHA, FSCAI Director of Interventional Cardiac Research Heart Institute, Cedars-Sinai Medical Center, Los Angeles, CA Affiliation/Financial Relationship Grant/Research Support Consulting Fees/Honoraria Other Financial Benefit Company Abbott Vascular,Boston Scientific, St Jude Medical, Gore Medical Abbott Vascular, Boston Scientific, St Jude Medical, Gore Mitral valve apparatus Mitral valve is an apparatus rather than a single structure and each of the components may cause MV malfunction. Anterior annulus Anterior leaflet Anteromedial commissure Posterolateral commissure Posterior leaflet Posterior annulus Chordae tendineae Primary Disorder of the Mitral Valve Apparatus (annulus, leaflets, chords, papillary muscle Valve makes the Ventricle Sick Mitral Regurgitation (MR) Functional MR: Leaflets appear normal, MR due to abnormal LV geometry Ventricle makes the Valve Sick Anterolateral papillary muscle Left ventricular free wall Otto N Engl J Med 2001:345: Posteromedial papillary muscle Functional Mitral Regurgitation Mechanical Solution: Open Surgical /Transcatheter repair/replacement Medical treatment for LV dysfunction Mechanical reduction of MR? Standard of Care Percutaneous Mitral Approaches Emerging options Leaflet repair MitraClip ( Abbott Vascular ) Leaflet folding( St Jude Medical) Coronary sinus annuloplasty Cardiac Dimensions Carillon Direct annuloplasty Mitralign Suture-Based Plication Guided Delivery Anchor-Cinch Plication Quantum Cor Cardioband (Valtec Cardio, Or Yehuda, Israel) Chordal replacement NeoChord, V-Chordal(Valtec) MitraFlex Transcatheter Mitral Valve Replacement Standard of Care Percutaneous Mitral Approaches Leaflet repair MitraClip ( Abbott Vascular ) Leaflet folding( St Jude Medical) Coronary sinus annuloplasty Cardiac Dimensions Carillon Direct annuloplasty Mitralign Suture-Based Plication Guided Delivery Anchor-Cinch Plication Quantum Cor Cardioband (Valtec Cardio, Or Yehuda, Israel) Chordal replacement NeoChord, V-Chordal(Valtec) MitraFlex Transcatheter Mitral Valve Replacement 1

2 Concept Technical aspects Case selection MitraClip Concept: Edge to Edge repair (Alfieri stitch) Simple solution for a complex problem Selected patients of degenerative and functional MR Not effective in rheumatic MR Longterm data MitraClip Creation of double orifice valve MitraClip Concepts MitraClip Coaptation of Leaflets Reduces MR Creates tissue bridge Limits dilatation of annulus Septal-lateral (A-P) dimension Supports durability of repair Restrains LV wall Limits LV dilatation Concept Technical aspects Case selection Longterm data 2

3 Case Selection: Suitable Anatomy Non rheumatic MR originating from a localized area of the valve Etiology: degenerative or functional Sufficient leaflet tissue for mechanical coaptation Valve anatomic exclusions Flail gap >10mm Flail width >15mm Calcified leaflet Expanded indications of the MitraClip: Beyond the EVEREST criteria A1P1 or A3P3 flail or prolapse Failed surgical repair Ring annuloplasty, or snapping of artificial chord HOCM : Systolic anterior motion with MR End stage heart failure with MR Delay heart transplantation or VAD MVA 4 sq cm Flail P2/P3 segment MitraClip for a Flail P2/P3 MitraClip Therapy Worldwide Experience ( ) GLOBAL MITRACLIP EXPERIENCE 1200 cases in month of June > Cases 30 June Includes clinical and commercial procedures as of 06/30/2016. Source: Data on file at Abbott Vascular 3

4 Clinical summary using MitraClip > 35,000 cases performed worldwide Most patients are high surgical risk patients In US Oct 2013: FDA approved the MitraClip for prohibitive risk primary MR (degenerative) Functional MR: Investigational Ongoing clinical trials for Functional MR. Key MitraClip Data Safety Impeccably safe in experienced hands No early or late safety events Effective Selected patients with both degenerative or functional MR Durability New data supports durability. Freedom From Mortality and MV Surgery/Re-operation EVEREST II RCT Kaplan-Meier Freedom From Mortality Kaplan-Meier Freedom From Mitral Valve Surgery/Re-operation Feldman et al ACC 2014 Patients (%) EVEREST II 5 year: Sustained reduction of MR 40% MitraClip (N=178) MR at 1 and 5 Years Surgery (N=80) MR at 1 and 5 Years p<0.005 p<0.005 p<0.005 p< % 82% 99% 98% Patients (%) 0% 0% BL 1 Year BL 5 Years BL 1 Year BL 5 Years N=149 N=106 N=66 N=41 Feldman et al ACC % EVEREST II RCT MitraClip in High Risk patients Final 5 Year Results of the EVEREST II High Risk Registry 4

5 MR Grade and NYHA Functional Class EVEREST II HRR Mitral Regurgitation Grade NYHA Functional Class REALISM ( degenerative MR Cohort) Patients (%) 40% 0% p < p = 0.01 p < p = % 75% 74% 83% II II I I III III II 40% II IV III IV III BL 1 Year BL 5 0% IV Years BL 1 Year BL 5 Years N=24 N=54 N=24 N=54 Patients (%) Kar et alacc 2014 Freedom From MV Surgery in DMR: EVEREST II RCT, REALISM Non-High Risk and REALISM High Risk Event Free Survival 90% 70% 50% 40% 30% 30 Days 98.9% 95.6% 90.0% REALISM Non-High Risk DMR REALISM High Risk DMR EVERESTII RCT DMRMitraClip 1 Year 97.8% 89.9% 75.1% Learning Curve Experience in the MitraClip REALISM Trial: An Analysis of 899 High Risk and Non-High Risk Subjects 10% 0% # At Risk Baseline 30 Days 6 Months 12 Months High Risk DMR Non-High Risk DMR RCT DMR MitraClip Kar et al ESC 2015 SeeImportant SafetyInformationReferencedWithin.Notto be reproduced, distributedor excerpted Abbott. All rights reserved. AP US Rev. A APS Rate Acute Procedural Success Rate p=0.020 p=0.038 p= % 40% 79% 81% Surgery following failed MitraClip Repair can be done following failed MitraClip even upto 5 years later The surgical risk is not increased Surgical options are preserved since there is no loss leaflet tissue 0% Cohort A (n=354) Cohort B (n=250) Cohort C (n=115) Cohort D (n=180) No of cases ( 0-10) (11 20) (21 30) ( > 31 ) Kar et al TCT 2015 See Important Safety Information Referenced Within. Not to be reproduced, distributed or excerpted. 2015Abbott.All rights reserved. AP US Rev.A 5

6 European Heart Journal (2012) 33, doi: /eurheartj/ehs109 ESC Committee for Practice Guidelines (CPG): Jeroen J. Bax (Chairperson) (T he Netherlands), Helmut Baumgartner (Germany), Claudio Ceconi (Italy), Veronica Dean (France), Christi Deaton (UK), Robert Fagard (Belgium), Christian Funck-Brentano (France), David Hasdai (Israel), Arno Hoes(The Netherlands), Paulus Kirchhof (United Kingdom), Juhani Knuuti (Finland), Philippe Kolh (Belgium), Theresa McDonagh (UK), Cyril Moulin (France), Bogdan A. Popescu (Romania), Željko Reiner (Croatia), Udo Sechtem (Germany), Per Anton Sirnes (Norway), Michal Tendera (Poland), Adam Torbicki (Poland), Alec Vahanian (France), Stephan W indecker (Switzerland) Document Reviewers:: Bogdan A. Popescu (ESC CPG Review Coordinator) (Romania), Ludwig Von Segesser (EACTS Review Coordinator) (Switzerland), Luigi P. Badano (Italy), Matjaž Bunc (Slovenia), Marc J. Claeys(Belgium), Niksa Drinkovic (Croatia),Gerasimos Filippatos(Greece),Gilbert Habib (France), A.Pieter Kappetein (TheNetherlands), Roland Kassab (Lebanon), Gregory Y.H. Lip (UK),Neil Moat (UK),Georg Nickenig (Germany), Catherine M. Otto (USA), John Pepper, (UK), Nicolo Piazza (Germany), Petronella G. Pieper (The Netherlands), Raphael Rosenhek (Austria), Naltin Shuka (Albania), Ehud Schwammenthal (Israel ), Juerg Schwitter (Switzerland), Pilar Tornos Mas(Spain), Pedro T. Trindade (Switzerland), Thomas W alther (Germany) Thedisclosureformsof theauthorsand reviewersareavailable on theesc website Online publish-ahead-of-print 24 August 2012 * Correspondingauthors: AlecVahanian, Service decardiologie, HopitalBichat AP-HP,46rueHenriHuchard, 75018Paris,France. Tel: ;Fax: alec.vahanian@bch.aphp.fr Ottavio Alfieri, S. Raffaele University Hospital, Milan, Italy. Tel: ; Fax: ottavio.alfieri@hsr.it Other ESC entities having participated in the development of this document: Associations: European Association of Echocardiography (EAE), European Association of PercutaneousCardiovascular Interventions (EAPCI), Heart Failure Association (HFA) Working Groups: Acute Cardiac Care, Cardiovascular Surgery, Valvular Heart Disease, Thrombosis, Grown-up Congenital Heart Disease Councils: Cardiology Practice, Cardiovascular Imaging Thecontent oftheseeuropean SocietyofCardiology (ESC) Guidelineshasbeen published for personal and educational useonly. No commercial use isauthorized.no part ofthe ESC Guidelinesmaybetranslated or reproduced in anyformwithout written permission fromthe ESC. Permission can beobtaineduponsubmission ofawritten request to Oxford University Press, the publisher of the European Heart Journal, and the party authorized to handle such permissions on behalf ofthe ESC. Disclaimer. The ESC/EACTSGuidelinesrepresent theviewsofthe ESC and the EACTSand were arrived at after careful consideration of theavailable evidence at the time they were written.health professionalsareencouraged to take themfullyinto account when exercisingtheir clinical judgement. Theguidelinesdo not, however, override the individual responsibility of health professionals to make appropriate decisions in the circumstances of the individual patients, in consultation with that patient and, where appropriate and necessary, the patient s guardian or carer. It is also the health professional s responsibility to verify the rules and regulations applicable to drugs and devices at the time of prescription. & The European Society of Cardiology All rights reserved. For permissions please journals.permissions@oup.com 2016/10/13 Robotic surgical repair; 6 years following MitraClip What if a surgeon wants to replace a valve following failed mitraclip Replace the surgeon, don t replace the valve AHA/ACC Guideline 2014 ESC Guideline 2012 ESC/EACTS GUIDELINES Guidelines on the management of valvular heart disease (version 2012) The Joint Task Force on the Management of Valvular Heart Disease of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS) Authors/Task Force Member s: Alec Vahanian (Chairperson) (France) *, Ottavio Alfieri (Chairperson)* (Italy), Felicita Andreotti (Italy), Manuel J. Antunes (Portugal), Gonzalo Barón-Esquivias (Spain), Helmut Baumgartner (Germany), Michael Andr ew Borger (Germany), Thierr y P. Carrel (Switzer land), Michele De Bonis (Italy), Arturo Evangelista (Spain), Volkmar Falk (Switzerland), Bernard Iung (France), Patrizio Lancellotti (Belgium), Luc Pierard (Belgium ), Susanna Price (UK), Hans-Joachim Schäfers (Germany), Gerhard Schuler (Germany), JaninaStepinska (Poland), Karl Swedberg (Sweden), Johanna Takkenberg (The Netherlands), UlrichOtto VonOppell (UK), StephanWindecker (Switzerland), JoseLuisZamorano (Spain), Mar ian Zembala (Poland) Downloaded from at Cedars Sinai Medical Center Medical Library on May 21, 2014 The guideline recommends the MitraClip therapy as class IIb indication for both degenerative and functional MR Circulation Mar 3] Treatment of FMR What about Functional MR Medical treatment is the mainstay The role of surgery is controversial Often high risk since patients have low EF Symptomatic improvement High recurrence No mortality benefit No census whether repair is better than replacement 6

7 MitraClip for Functional MR Majority of patients outside US are high risk functional MR Evidence of safety and possible efficacy No randomized studies in this subgroup to demonstrate survival benefit Ongoing Studies for MitraClip for FMR COAPT Trial ( US and Canada) RESHAPE trial (Europe) 430 patients enrolled at up to 85 US sites Significant FMR ( by core lab) treated per standard of ccare Deemed not suitable for mitral valve surgery MitraClip N=215 Trial design Specific valve anatomic criteria Randomize 1:1 Study has been extended 468 patients have been randomized Control group Standard of care N=215 COAPT : TOP ENROLLERS HIGHLIGHT! Clinical and TTE follow-up: 1, 6, 12, 18, 24, 36, 48, 60 months Patient: 45-year-old man Case summary 45 year old male with non ischemic dilated cardiomyopathy Class IV on inotropes Destination IA for transplant/vad Parasternal short axis view 4ch view 3ch view Clinical Presentation: Shortness of breath (NYHA functional class IV) Acute decompensated CHF (Dopamine; 3 mg/kg/min) Past Medical History: Endstage non-ischemic cardiomyopathy Hypertension Past Surgical History: CRT-D implantation [2012] Severe functional MR with LV dysfunction EROA = 0.46 cm 2 LVEF = 23%, LVID d/s = 63/59 mm 7

8 MitraClip procedure Post 3rd clip deployment 12 Month Follow-up : NYHA I off the transplant list Parasternal long axis view 4ch view 3ch view Cardiac output increased from 2.9 to 3.7 L/min Cedars Sinai Experience ( 2005 to 2016) Cedars Sinai Experience Total number of patients treated: 502 Clinical Trials: 198 EVEREST II REALISM COAPT Comercial(since Oct 2013) 304 Total number of procedures: Numberof MitraClip Procedures in CSMC 109 Commercial approval Oct MitraClip Trials commercial Cedars Sinai Experience(Results) Total No patients treated 502 Primary success 96% In hospital mortality ( 2 case) 0.4% Partial clip detachment 1% Stroke 0.6% No case of urgent open heart surgery Surgery for failed clip procedure 4% 30 day and 1 year mortality for 0% 8

9 Conclusion Transacatheter MV repair is a safe and effective treatment for selected patients with MR who are at high risk for surgery. MitraClip is the leader in the field, though other technologies are in development Limitation of transcatheter repair include Adverse leaflet pathology Residual MR Conclusion Transcatheter MV repair using the MitraClip is a safe and effective treatment for selected patients significant MR Evidence of safety, efficacy and durability In US the MitraClip is approved for treatment of high risk primary (degenerative) MR The true role of MitraClip is being evaluated in the ongoing COAPT trial. 62 yr old male with flail P2 treated with MitraClip in May years later NYHA I Low risk patients Heart Team Is MitraClip and effective and durable treatment option for intermediate risk degenerative MR patients Probably yes In the right patient In the right hands In the right time 9