Eulogio Garcia MD Hospital Clínico San Carlos Madrid - Spain

Transcription

1 Eulogio Garcia MD Hospital Clínico San Carlos Madrid - Spain

2 Device Landscape 2010

3 PERCUTANEOUS TECHNIQUES Percutaneous indirect annuloplasty Percutaneous direct annuloplasty Edge to Edge ( E-Valve ) Non Randomized studies Randomized study Results on degenerative and functional MR

4 Percutaneous Coronary Sinus Annuloplasty Devices DEVICE PRODUCT DESCRIPTION MONARC Annular repair via CS using 2 stents with a tensioning member that shortens over time CARILLON Annular repair via CS that uses traction between 2 anchors VIACOR PTMA Reshaping of mitral annulus via the CS using a rigid bar that can be sized and easily removed

5 Percutaneous Mitral Annuloplasty Feasibility / Safety at 30 Day Monarc* Carillon Viacor n= Success implantation (%) In-hospital death (%) Myocardial infarction (%) Tamponade (%) Dissection of coron. sinus (%) 0 6 N/A * TCT 2009 Circulation 2009;120: Circ Cardiovasc Intervention 2009;2:277-84

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7 Device Malfunctions seen on Routine Angiography at 90-days EVOLUTION I 5 device malfunctions with no clinical complication One partial migration of the distal anchor (undersized distal anchor) 4 separations at the level of the proximal anchor No coronary sinus thrombosis

8 Monarc Potential Limitations of Percutaneous Coronary SinusAnnuloplasty 50 Patients Baseline & 90-Day Angio Coronary Compression 5 Faulty devices 4 Device separation 1 Device slippage 35 Patients No Coronary Vessel Changes 15 Patients (30%) Coronary Vessel Changes ( 3MI s (1death)) 9 Patients Bridge Compression (Schofer et al. Circulation 2009;120:326-33) 5 Patients Anchor Compression 1 Patient Anchor & Bridge Compression Carillon 6 cases (12%) of coronary compression (device recaptured)

9 Coronary Sinus Annuloplasty Clinical Summary All 3 devices have been implanted in phase I trials They result in modest reductions in MR, with improved functional class Longer term efficacy and durability are unknown Circumflex compression occurs 20-35% of the time

10 PERCUTANEOUS TECHNIQUES Percutaneous indirect annuloplasty Percutaneous direct annuloplasty Edge to Edge ( E-Valve ) Non Randomized studies Randomized study Results on degenerative and functional MR

11 Mitralign Percutaneous Annuloplasty System Surgical Basis Mimics surgical suture annuloplasty of Paneth and Burr Percutaneous Approach Left ventricular approach Complementary Imaging fluoro & echo Procedure does not preclude future surgical options Aybek et al., JTCS. 2006; Burr LH, Paneth M, et al. JTCVS

12 GDS Percutaneous Accucinch Direct reduction of annular dilatation based on proven surgical plication Femoral artery access 14 Fr delivery system, steerable guide cath Retrograde across AoV (no transseptal) Fluoroscopic guidance Reversible, removable, adjustable deployment

13 Micardia Dynaplasty Shape Memory Technology Implant Shape Post Activation Shape AP + or - adjustment to improve leaflet coaptation Currently activated intraoperatively off CPB on beating heart (n=27 implanted). Soon: transcutaneously via access port months later PerQ implanted device is feasible

14 PERCUTANEOUS TECHNIQUES Percutaneous indirect annuloplasty Percutaneous direct annuloplasty Edge to Edge ( E-Valve ) Non Randomized study Randomized study Results on degenerative and functional MR

15 Edge to Edge (Evalve) Human S/P surgical Alfieri Circulation. 2002;106:e173 Evalve clip repair in porcine heart (6 mos post repair) Circulation 2003;108(Supp IV):493

16 Endovascular CVRS for E2E Mitral Repair Cardiovascular Valve Repair System

17 Clinical Experience *Percutaneous Mitral Valve Repair Using the Edge-to-Edge Repair: Six months Results of the EVEREST Phase I Clinical trial, JACC 2005;46: Percutaneous Mitral Repair with the MitraClip System: Safety and Midterm Durability in the Initial EVEREST Cohort, JACC 2009; 54:

18 PERCUTANEOUS TECHNIQUES Percutaneous indirect annuloplasty Percutaneous direct annuloplasty Edge to Edge ( E-Valve ) Non Randomized study Randomized study Results on degenerative and functional MR

19 EVEREST HRR Study Algorithm KEY INCLUSION CRITERIA Predicted procedural mortality 12% STS or Surgeon estimated Symptomatic 3+ or 4+ MR Degenerative or Functional 78 Enrolled 36 Concurrent Control KEY EXCLUSION CRITERIA EF 20% and/or LVESD >60mm MVA <4cm2 Leaflet anatomy unsuitable 46 FMR - 59% 50% met all inc/ exclusion criteria 50% met all but clip anatomical criteria

20 HRR FMR: Mitral Regurgitation Sustained MR reduction at 12 months 52% of patients had MR < 2+ at 12 mos: 74% 1 or 2+ n=34, Matched Data

21 HRR FMR: LV Function MitraClip therapy: reverses LV 12mos LV End Diastolic & Systolic Volumes n=34, Matched Data

22 HRR FMR: Hospitalization for CHF

23 HRR FMR: NYHA Class 9% NYHA II 74% NYHA I & II n=34, Matched Data

24 Summary: EVEREST Functional MR High Risk Registry Maybe reduction of MR to 2+ or less is enough to improve outcomes in selected pts

25 PERCUTANEOUS TECHNIQUES Percutaneous indirect annuloplasty Percutaneous direct annuloplasty Edge to Edge ( E-Valve ) Non Randomized study Randomized study Results on degenerative and functional MR

26 EVEREST II Randomized Clinical Trial Study Design 279 Patients enrolled at 37 sites Significant MR (3+-4+) Specific Anatomical Criteria Randomized 2:1 Device Group MitraClip System N=184 Control Group Surgical Repair or Replacement N=95 Echocardiography Core Lab and Clinical Follow-Up: Baseline, 30 days, 6 months, 1 year, 18 months, and annually through 5 years

27 EVEREST II Randomized Clinical Trial Key Inclusion/Exclusion Criteria Inclusion Candidate for MV Surgery Moderate to severe (3+) or severe (4+) MR Symptomatic >25% EF & LVESD 55mm Asymptomatic with one or more of the following LVEF 25-60% LVESD 40mm New onset atrial fibrillation Pulmonary hypertension ACC/AHA Guidelines JACC 52:e1-e142, 2008 Exclusion AMI within 12 weeks Need for other cardiac surgery Renal insufficiency Creatinine >2.5mg/dl Endocarditis Rheumatic heart disease MV anatomical exclusions Mitral valve area <4.0cm2 Leaflet flail width ( 15mm) and gap ( 10mm) Leaflet tethering/coaptation depth (>11mm) and length (<2mm)

28 EVEREST II Randomized Clinical Trial Endpoints Safety Major Adverse Event Rate at 30 days Effectiveness / Clinical Success Rate Freedom from the combined outcome of Death MV surgery or re-operation for MV dysfunction MR >2+ at 12 months Clinical Benefit Left Ventricular Function NYHA Functional Class Quality of Life (SF-36 Survey) Pre-Specified MAEs Death Major Stroke Re-operation of Mitral Valve Urgent / Emergent CV Surgery Myocardial Infarction Renal Failure Deep Wound Infection Ventilation >48 hrs New Onset Permanent Atrial Fib Septicemia GI Complication Requiring Surgery All Transfusions 2 units

29 EII RCT: Safety & Effectiveness Endpoints Intention to Treat Cohort

30 EVEREST II RCT: MR Reduction Per Protocol Cohort

31 PERCUTANEOUS TECHNIQUES Percutaneous indirect annuloplasty Percutaneous direct annuloplasty Edge to Edge ( E-Valve ) Non Randomized studies Randomized study Results on degenerative and functional MR

32 EVEREST II RCT: MitraClip Device 30 day Modified* Major Adverse Event Rate by Etiology Intention to Treat

33 EVEREST II RCT MitraClip Device MR Reduction by Etiology

34 EVEREST II RCT MitraClip Device NYHA Functional Class by Etiology

35 EVEREST II RCT MitraClip Device Quality of Life, SF-36 Survey by Etiology PSC = Physical Component Summary MCS = Mental Component Summary

36 EVEREST II RCT: Conclusion The MitraClip procedure is an important therapeutic option for selected patients with significant mitral regurgitation of either DMR or FMR etiology.

37 Answer YES. The MitraClip procedure will be an important alternative for selected patients with significant mitral regurgitation of FMR etiology. Other percutaneous procedures, namely coronary sinus and direct annuloplasty could in the future represent a valid therapeutic alternative and are under important technical evolution

38 Back up slides

39 EII RCT: Modified ITT Safety Endpoi

40 EVEREST II RCT: Patient Flow Intervention Post MitraClip Procedure

41 Partial Clip Detachment

42 EVEREST II RCT: MitraClip Device 30 day Modified* Major Adverse Event Rate by Etiology Intention to Treat * Major Bleeding Complications in place of transfusions

43 EII RCT: Safety and Effectiveness Endpoints * Major Bleeding Complications in place of transfusions

44 EVEREST II RCT MitraClip Device Baseline Demographics & Co-morbidities by MR Etiology

45 EVEREST II RCT MitraClip Device Left Ventricular Function by Etiology LV End Diastolic and End Systolic Volumes LVEDV = left ventricular end diastolic volume LVESV = left ventricular end systolic volume

46 EVEREST II Randomized Comparison of MitralClip vs Surgery for MR More effective reduction with surgery Favorable LV remodeling with both MitraClip & surgery Better NYHA & SF-36 with MitralClip Imbalance in baseline CHF

47 EVEREST II RCT MitraClip Device Baseline Demographics & Co-morbidities by MR Etiology