Professor and Chief, Division of Cardiac Surgery Chief Medical Officer, Harpoon Medical. The Houston Aortic Symposium February 23-25, 2017
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1 James S. Gammie, MD Professor and Chief, Division of Cardiac Surgery Chief Medical Officer, Harpoon Medical The Houston Aortic Symposium February 2-25, 2017
2 Disclosure Statement of Financial Interest Within the past 12 months, I or my spouse/partner have had a financial interest/arrangement or affiliation with the organization(s) listed below. Affiliation/Financial Relationship Company Consulting Fees/Honoraria Edwards Lifesciences Correx Ownership/Founder Harpoon Medical
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4 Surgery for Mitral Regurgitation: Who Are We Operating on Today? Degenerative Disease N = 1,15 Society of Thoracic Surgeons Adult Cardiac Database; 2011
5 FOR DEGENERATIVE MR: REPAIR BEATS REPLACEMENT EVERY TIME REPAIR Advantages of Repair Compared to Replacement Lower operative mortality Improved left ventricular function Lower risk of stroke Lower risk of infection Freedom from anticoagulation and reoperation Superior long-term survival
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7 Mitral Valve Repair or Replacement A Patient with a Mitral Prosthesis Is a Patient for Life Robert W.M. Frater, MD
8 Advantages of Mitral Valve Repair Compared to Replacement
9 N = 58,70 Mitral Operations Trends in Mitral Valve Surgery in the United States: Results from the Society of Thoracic Surgeons Adult Cardiac Database Ann Thorac Surg 2009;87:11-19
10 Procedure N # of deaths Observed Mortality MV Repair MV Replace Odds ratio (95% CI) (MV repair vs MV replacement) Unadjusted Adjusted 0. (.0,.9) 0.52 (.5,.59) (reference) (reference) * Adjusted for 25 risk factors plus year of surgery; p < repair compared to replacement ** Directly adjusted across 10 propensity groups; p < Risk standardized mortality % (95 % CI)** 1.65 (1.9, 1.80) 2.96 (2.72,.20)
11 REPAIR REPLACE STROKE / YR /- 0.1 % 2.2 +/- 0. % INFECTION (PVE) / YR 0.1 % 1% Russo A, J. Am. Coll. Cardiol. 2008;51; Wang A, JAMA. 2007;297:15-161
12 REPAIR REPLACE STROKE / YR /- 0.1 % 2.2 +/- 0. % INFECTION (PVE) / YR 0.1 % 1% Russo A, J. Am. Coll. Cardiol. 2008;51; Wang A, JAMA. 2007;297:15-161
13 REPAIR REPLACE STROKE / YR /- 0.1 % 2.2 +/- 0. % INFECTION (PVE) / YR 0.1 % 1% Russo A, J. Am. Coll. Cardiol. 2008;51; Wang A, JAMA. 2007;297:15-161
14 Advantages of Mitral Valve Repair
15 Mitral Valve Disease Segmentation Primary (Degenerative) Functional Percent of Total MR population*: 50 % 50% Indications for Intervention: Well Established Not Clear (IIB) COAPT? Operative Therapy: Repair Replacement Good Operative Therapy? YES NO Is Therapy Applied Consistently? NO (replacement) NO Patients with MR USA*: 800, ,000 Annual Mitral Valve Surgery Rate: 5% 0.75 % *Canaccord Genuity 2016
16 Future of Catheter-Based Mitral Intervention Near Future: TMVR: BIG HURDLES: Access, Thrombosis, Paravalvular leak, LVOT obstruction, etc. BIG Investment BIG Engineering When it works IT IS STILL A MITRAL REPLACEMENT! Repair for Degenerative Disease: Goal:Mitraclip: suboptimal (lessons from surgery) Replicate eptfe Non-Resectional MV Repair Transapical, Beating-Heart *Canaccord Genuity 2016
17 Evolution of Repair for Degenerative Disease
18 Evolution of Repair for Degenerative Disease University of Maryland Experience 100 Leaflet resection Neochordal Insertion Year
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20 Mitralvalverepair.org Vol 6, Supplement 1 (March 201): Journal of Thoracic Disease
21 Mitralvalverepair.org Vol 6, Supplement 1 (March 201): Journal of Thoracic Disease
22 Courtesy A. M. Gillinov, MD
23 CONFIDENTIAL Slide 2 2/2/2017
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25 Image-Guided Trans-Apical Mitral Valve Repair: A Better Way J.S. Gammie COMPREHENSIVE HEART CENTER
26 Harpoon: Fast Simple Procedure
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28 Real-Time Titration of eptfe Cordal Length
29 Harpoon Mitral Valve Repair System Beating-Heart Surgical Repair in DMR Patients Initial Focus: Posterior Prolapse Applicable Pts: >60% of DMR today Small mm shaft profile houses 21 gauge needle with pre-wound eptfe suture Strong proprietary anchor, place cords anywhere, no need to catch the leaflet Key Benefits Dedicated 9 Fr hemostatic introducer minimizes trauma & blood loss Simplified Repair Improved Safety Profile Surgical-Like Outcomes
30 Harpoon Technology: Anchoring EQUIVALENT to surgical eptfe: Pull-out Force (N) Conventional Harpoon 8. ± ±. N = 11 Hearts; P=0.9 *Normal Chordal Force = N
31 Harpoon Transapical Repair Patient # 1
32 Intraprocedural TEE (Knot deployment)
33 Intraprocedural TEE (eptfe artificial cords tightened)
34 Intraprocedural TEE (eptfe artificial cords tightened)
35 6 MONTH TTE MR Grade: NONE/TRACE
36 ONE YEAR TTE MR Grade: NONE/TRACE
37 TWO YEAR TTE MR Grade: NONE/TRACE
38 Clinical Results: Early Feasibility Study Two Study Centers: Jagellonian University John Paul II Hospital, Krakow Institute of Cardiology, Warsaw Enrollment Complete: 1 patients enrolled with follow-up ongoing February 2015 February 2016 Echocardiography Core Lab: Massachusetts General Hospital (J. Hung, MD) ASE Grading of MR None/Trace Mild Moderate
39 Study Objective: Evaluate Safety and Performance of the Harpoon Device Primary Endpoints: Harpoon Device Performs as Designed, Successfully Implant 1 or more eptfe Cords Demonstrate MR Reduction from to </= Moderate MR Measure of adverse events in accordance with MVARC Inclusion Criteria: Degenerative Mitral Regurgitation Isolated Posterior Leaflet Prolapse Good Predicted Surface of Coaptation Exclusion Criteria: STS PROM Risk > 6 EF < 0 %
40 PT # Sex Age STS Risk F M M M M M M M M M M M M MEAN NYHA Class LVEF II III II II II II I III II I III III III
41 PT # Sex Age STS Risk F M M M M M M M M M M M M MEAN NYHA Class LVEF II III II II II II I III II I III III III
42 PT # Days Post Procedure eptfe Cords Implanted Introducer Time Skin-to-Skin Time Residual MR : 0:21 0:8 0:58 0:27 0:55 0:25 0:20 0:0 0:9 0:51 0:1 0:7 1:9 1:5 1:57 2:7 1:2 2: 1:29 1:5 1:1 1:12 2:08 1:51 2:01 NONE/TRACE NONE/TRACE NONE/TRACE MILD NONE/TRACE MILD NONE/TRACE MILD NONE/TRACE NONE/TRACE NONE/TRACE NONE/TRACE NONE/TRACE.7 0:8 1:50 MEAN
43 PT # Days Post Procedure eptfe Cords Implanted Introducer Time Skin-to-Skin Time Residual MR : 0:21 0:8 0:58 0:27 0:55 0:25 0:20 0:0 0:9 0:51 0:1 0:7 1:9 1:5 1:57 2:7 1:2 2: 1:29 1:5 1:1 1:12 2:08 1:51 2:01 NONE/TRACE NONE/TRACE NONE/TRACE MILD NONE/TRACE MILD NONE/TRACE MILD NONE/TRACE NONE/TRACE NONE/TRACE NONE/TRACE NONE/TRACE.7 0:8 1:50 MEAN
44 No Mortality No Stroke No Renal Failure No Myocardial Infarction No Blood Transfusion No Conversion to Open Heart Surgery
45 Two Reoperations for Pericardial Effusions (POD 5, 1) Two Reoperations for Recurrent MR (POD 72, 21) 1st Patient eptfe cord untied at apical pledget 2nd Patient native anterior chord ruptured Both patients received successful reoperations, are alive and doing well
46 Reoperation Six Months: MR Grade: Bicommissural view Red arrows: Harpoon knots Green Arrow: unsupported lateral aspect of posterior leaflet
47 eptfe knots well-incorporated: Suboptimal (basal) targeting Excellent endothelialization at 7 months No leaflet destruction from Harpoon eptfe cords
48 Transapical Artificial eptfe Cordal Repair Does NOT Preclude Subsequent Conventional Repair Harpoon Mitraclip Geidel S et al Submitted for Publication
49 Preop 0 Day P Value 5 7 < EDV (ml) LVEF (%) LA Dimension (mm) LA Volume (ml) Mitral Annular Dimension (mm) RVSP (mmhg) LVEDD (mm)
50 Preop 0 Day P Value 5 7 < EDV (ml) LVEF (%) LA Dimension (mm) LA Volume (ml) Mitral Annular Dimension (mm) RVSP (mmhg) LVEDD (mm)
51 Preop 0 Day P Value 5 7 < EDV (ml) LVEF (%) LA Dimension (mm) LA Volume (ml) Mitral Annular Dimension (mm) RVSP (mmhg) LVEDD (mm)
52 Transapical eptfe Replacement Treats SAM! SAM NO SAM
53 Patient Number of Screening / Baseline Chords 0 0 Days 6 Months 1 Mild None/Trace 2 None/Trace Moderate None/Trace None/Trace Moderate Converted 5 None/Trace None/Trace 6 Moderate Moderate 7 Mild Mild 8 Mild None/Trace 9 5 Mild Mild 10 Mild 11 None/Trace Mild 12 Mild Mild 1 None/Trace None/Trace
54 Patient Number of Screening / Baseline Chords 0 0 Days 6 Months 1 Mild None/Trace 2 None/Trace Moderate None/Trace None/Trace Moderate Converted 5 None/Trace None/Trace 6 Moderate Moderate 7 Mild Mild 8 Mild None/Trace 9 5 Mild Mild 10 Mild 11 None/Trace Mild 12 Mild Mild 1 None/Trace None/Trace
55 Patient Number of Screening / Baseline Chords 0 0 Days 6 Months 1 Mild None/Trace 2 None/Trace Moderate None/Trace None/Trace Moderate Converted 5 None/Trace None/Trace 6 Moderate Moderate 7 Mild Mild 8 Mild None/Trace 9 5 Mild Mild 10 Mild 11 None/Trace Mild 12 Mild Mild 1 None/Trace None/Trace
56 Median Follow-Up 580 Days (86-787) 100% Survival No Late Stroke No Thromboembolism No Repaired Valve Infective Endocarditis
57 Harpoon: CE trial enrolling; CE Mark est. Q US IDE Trials: Randomized vs. Surgery Ongoing Device Iteration Patient Selection and Procedural Refinement
58 CONCLUSIONS INITIAL CLINICAL EXPERIENCE BEATING-HEART, IMAGE-GUIDED, TRANSAPICAL MITRAL VALVE REPAIR: Safe 100 % Procedural Success Effective and Durable MR Reduction Adoptable Does Not Preclude Subsequent Open Mitral Valve Repair Can Address the Large Majority of Degenerative Mitral Valve Pathology Favorable Reverse Remodeling
59 CONCLUSIONS INITIAL CLINICAL EXPERIENCE BEATING-HEART, IMAGE-GUIDED, TRANSAPICAL MITRAL VALVE REPAIR: Real-time Titration of eptfe Cords on Beating Heart Provides tactile / haptic feedback to operator Maximize Coaptation Only Implant = eptfe Suture NO: sternotomy, cross clamp, cardioplegia, or bypass
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61 Patients Treated with Transapical eptfe Artificial Cords Year
62 Transapical eptfe Cordal Mitral Repair Conclusions Key Advantages: Sole Implant = eptfe Suture Beating-Heart, Less Invasive NO: sternotomy, cross clamp, cardioplegia, or bypass Outstanding Safety Profile No Fluoroscopy/Radiation Provides Haptic Feedback to Operator Easy to Learn; Reference-quality Repair Accessible to All
63 Transapical eptfe Cordal Mitral Repair Conclusions Key Advantages: Real-time Titration of eptfe Cordal Length on Loaded Heart: Maximize Coaptation and Repair Quality Encourage Earlier Intervention In MR SAM is easily treatable Favorable Reverse Ventricular Remodeling Does NOT Preclude Subsequent Conventional Repair Effective, Durable MR Reduction
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