Really Less-Invasive Trans-apical Beating Heart Mitral Valve Repair: Which Patients?

Transcription

1 Really Less-Invasive Trans-apical Beating Heart Mitral Valve Repair: Which Patients? David H. Adams, MD Cardiac Surgeon-in-Chief Mount Sinai Health System Marie Josée and Henry R. Kravis Professor and Chairman Department of Cardiovascular Surgery Icahn School of Medicine at Mount Sinai New York, NY

2 Disclosures: David H. Adams, MD Icahn School of Medicine at Mount Sinai has royalty agreements with Edwards Lifesciences and Medtronic: Physio II Mitral Annuloplasty Ring IMR ETlogix Mitral Annuloplasty Ring TriAd Tricuspid Annuloplasty Ring National Co-PI: Medtronic CoreValve US Pivotal Trial National Co-PI: NeoChord System US Pivotal Trial National Co-PI: Medtronic Apollo US Pivotal Trial

3 Minimally Invasive Mitral Surgery! Seeburger et al. Semin Thorac Cardiovasc Surg 2007;19:289

4 New Era of Truly Less Invasive MV Repair? 4 cm incision mini-left thoracotomy No cardiopulmonary bypass Apical access and totally echo guided placement of neochordae with physiologic height adjustment to eliminate MR

5 Neochordoplasty Adams et al. Eur Heart J 2010;31:

6 CAUTION: Investigational Device Limited by Federal (United States) Law to Investigational Use

7 Case 67 year old, asymptomatic Incidental finding of severe MR during work-up for hernia repair Latest echocardiogram: LVEDD 5.6cm, LVESD 4.2cm, EF 55% Referred for surgical opinion CAUTION: Investigational Device Limited by Federal (United States) Law to Investigational Use

8 Baseline TEE CAUTION: Investigational Device Limited by Federal (United States) Law to Investigational Use

9 CAUTION: Investigational Device Limited by Federal (United States) Law to Investigational Use

10 Post-Tensioning CAUTION: Investigational Device Limited by Federal (United States) Law to Investigational Use

11 Discharge TTE CAUTION: Investigational Device Limited by Federal (United States) Law to Investigational Use

12 NeoChord Worldwide Experience CE Mark December 2012 Over 600 patients have been treated worldwide

13 Colli A et al. Int J Cardiol Feb 1;204:23-8

14 Anatomical Classification TYPE A: isolated central posterior leaflet prolapse/flail TYPE B: posterior multisegment prolapse/flail TYPE C: complex prolapse (BL involvement, calcification, etc) TYPE A TYPE B TYPE C Colli A et al. Int J Cardiol Feb 1;204:23-8

15 Kaplan Meier analysis of freedom from Mitral Regurgitation (MR) 2+ at 3 months follow up in Type A, B and C groups, according to mitral valve (MV) anatomy. Colli A et al. Int J Cardiol Feb 1;204:23-8

16 FDA Pivotal Trial Design ReChord IDE Trial Roll-In Cohort Pivotal Cohort High-Risk Registry 60 Subjects Up to 3 subjects/ center 75 Subjects Conventional MV Repair NeoChord MV Repair 585 Subjects Up to 20 Centers 12 Sites screening > 40 subjects screened 27 subjects approved All Subject Eligibility Confirmed by Central Screening Committee

17 Study Administration Co-Principal Investigators: David Adams and Michael Borger Chair, Trial Executive Committee: Randolph Chitwood Chair, Central Screening Committee: Julie Swain Chair, Echo Core Laboratory: Paul Grayburn Chair, Clinical Events Committee: Scott Goldman Sponsor: NeoChord, Inc.

18 Trial Primary Endpoints Primary Safety Endpoint: Superiority analysis of the proportion of patients free from Major Adverse Events in the NeoChord group compared to the open mitral valve repair measured at POD 30 or on hospital discharge Primary Effectiveness Endpoint: Non-inferiority analysis of the proportion of patients free from moderate or severe mitral regurgitation, mitral valve replacement, or mitral valve reintervention in the NeoChord group compared to the open mitral valve repair group at 1 year

19 Inclusion Criteria Inclusion Criteria Guideline indication for isolated surgical mitral valve repair for prolapse Candidate for either treatment strategy including mitral valve repair with cardiopulmonary bypass Isolated segmental prolapse of the A2 or P2 segment and anterior leaflet covers at least 65% of anterior-posterior annular distance

20 Exclusion Criteria Exclusion Criteria (selected) Other cardiac valve disease that requires intervention or prior mitral valve surgery Active endocarditis or endocarditis within 3 months (90 days) of the scheduled index procedure Coronary artery disease that requires intervention or treatment or has had coronary artery disease that required intervention or treatment within 3 months (90 days) of the scheduled index procedure Atrial Fibrillation that requires surgical intervention

21 High-Risk Registry Cohort Inclusion Criteria High operative risk or not a candidate for conventional mitral valve repair on cardiopulmonary bypass but otherwise meets pivotal trial inclusion criteria

22 High-Risk Registry Cohort Exclusion Criteria (selected) Hemodynamic instability defined as systolic pressure < 90mm Hg without afterload reduction or cardiogenic shock or the need for inotropic support or intra-aortic balloon pump Need for emergent surgery for any reason Life expectancy of less than 2 years (24 months)

23 The Harpoon Device FACILITATES Image-guided Placement and Anchoring of eptfe Neochords ENABLES Real-time Titration of Neochords on the Beating Heart and Maximization of Coaptation

24 The Harpoon Device Low-profile (8 F) Delivery System Preformed eptfe Knot Knot Formed on Atrial Surface of Mitral Leaflet Secure Anchoring of eptfe Suture to Leaflet

25 The Harpoon Procedure

26 The Harpoon Device

27 Patient #1: IntraOp TEE eptfe neochords tightened Trace MR

28 Gammie JS et al. Circulation Jul 19;134(3):189-97

29 Transcatheter Chords: Clinical Challenges Mitral Valve Other Disease Marginal Leaflet Coaptation Mitral Annular Dilatation Adjacent Clefts or Billowing Concomitant 3+/4+ TR Concomitant Atrial Fibrillation

30 Borderline Coaptation

31 Asymmetric MV Annular Dilatation Annular dilatation at A3P3 area, other than flail segment location

32 Adjacent Clefts

33 Complex Anatomy

34 Concomitant TR

35 Take Home Points Truly minimally invasive MV repair therapy Feasible with stable results in anatomically appropriate patients Pivotal trials comparing outcomes to open surgery will tell the story

36 Thank You