Really Less-Invasive Trans-apical Beating Heart Mitral Valve Repair: Which Patients?
David H. Adams, MDCardiac Surgeon-in-ChiefMount Sinai Health System Marie Josée and Henry R. Kravis Professor and ChairmanDepartment of Cardiovascular SurgeryIcahn School of Medicine at Mount SinaiNew York, NY
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 TrialNational Co-PI: NeoChord System US Pivotal TrialNational Co-PI: Medtronic Apollo US Pivotal Trial
Disclosures: David H. Adams, MD
Seeburger et al. Semin Thorac Cardiovasc Surg 2007;19:289
Minimally Invasive Mitral Surgery!
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
New Era of Truly Less Invasive MV Repair?
Neochordoplasty
Adams et al. Eur Heart J 2010;31:1958-1967
CAUTION: Investigational Device Limited by Federal (United States) Law to Investigational Use
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
Baseline TEE
CAUTION: Investigational Device Limited by Federal (United States) Law to Investigational Use
CAUTION: Investigational Device Limited by Federal (United States) Law to Investigational Use
Post-Tensioning
CAUTION: Investigational Device Limited by Federal (United States) Law to Investigational Use
Discharge TTE
CAUTION: Investigational Device Limited by Federal (United States) Law to Investigational Use
NeoChord Worldwide Experience
CE Mark December 2012
Over 600 patients have been treated worldwide
Colli A et al. Int J Cardiol. 2016 Feb 1;204:23-8
Anatomical Classification
TYPE A: isolated central posterior leaflet prolapse/flail
TYPE B: posterior multisegment prolapse/flail
TYPE C: complex prolapse (BL involvement, calcification, etc)
Colli A et al. Int J Cardiol. 2016 Feb 1;204:23-8
TYPE A TYPE B TYPE C
Colli A et al. Int J Cardiol. 2016 Feb 1;204:23-8
Kaplan—Meier analysis offreedom from MitralRegurgitation (MR) ≥2+ at3 months follow up in TypeA, B and C groups,according to mitral valve(MV) anatomy.
ReChord IDE Trial
Roll-In Cohort Pivotal Cohort High-Risk Registry
Conventional MV Repair
NeoChord MV Repair
60 SubjectsUp to 3 subjects/ center
75 Subjects
585 Subjects Up to 20 Centers
All Subject Eligibility Confirmed by Central Screening Committee
FDA Pivotal Trial Design
12 Sites screening > 40 subjects screened 27 subjects approved
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.
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 re-intervention in the NeoChord group compared to the open mitral valve repair group at 1 year
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
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
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
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)
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
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
The Harpoon Procedure
The Harpoon Device
ePTFE neochords tightened
Patient #1: IntraOp TEE
Trace MR
Gammie JS et al. Circulation. 2016 Jul 19;134(3):189-97
Transcatheter Chords: Clinical Challenges
Other DiseaseMitral Valve
Marginal Leaflet Coaptation
Adjacent Clefts or Billowing
Mitral Annular Dilatation
Concomitant 3+/4+ TR
Concomitant Atrial Fibrillation
Borderline Coaptation
Asymmetric MV Annular Dilatation
Annular dilatation at A3P3 area, other than flail segment location
Adjacent Clefts
Complex Anatomy
Concomitant TR
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
Thank You
