TRACER: 6-Month Outcomes of ePTFE Cordal Repair for Severe Primary Mitral Regurgitation Dr. Alison Duncan, MBBS, PhD 6 James S. Gammie, MD 1 Ms. Rashmi Yadev, MBBS, PhD, FRCS (CTh) 6 Andrzej Gackowski, MD, PhD 2 Augusto D’Onofrio, MD 7 Judy Hung, MD 5 Michael N. D ’ Ambra, MD 4 Gino Gerosa, MD, PhD 7 TCT First Report Investigation Mr. Steve Livesey, FRCS 8 Piotr Kolsut, MD 3 Nov 1, 2017 Dr. Paul Diprose, FRCA 8 Piotr Szymanski, MD, PhD 3 Paolo Denti, MD 9 Boguslaw Kapelak, MD, PhD 2 Denver, CO, USA Giovanni La Canna, MD 9 Agata Bilewska, MD, PhD 3 Ottavio Alfieri, MD, PhD 9 Mariusz Kusmierczyk, MD, PhD 3 Michele De Bonis, MD 9 Mr. Neil Moat, MBBS, FRCS 6 Krzysztof Bartus, MD, PhD 2 1 University of Maryland School of Medicine, Baltimore, MD, USA 2 Jagellonian University John Paul II Hospital, Krakow Poland 3 Institute of Cardiology, Warsaw Poland 4 Brigham and Women’s Hospital , Boston, MA, USA 5 Massachusetts General Hospital, Boston, MA, USA 6 The Royal Brompton & Harefield NHS Foundation Trust, London UK 7 Padova University Hospital, Padova Italy 8 University Hospital Southampton NHS Foundation Trust UK 9 Ospedale San Raffaele, Milan Italy
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 • • Major Stock Shareholder/Equity Harpoon Medical
Background • Mitral regurgitation (MR) most common valve disease • Affects 4 million people in USA; 1 in 10 adults > 65 years • 2/3rds mitral operations for degenerative MR (DMR) • Superior outcomes for repair vs. replacement • Conventional surgery successful BUT: Sternotomy/thoracotomy, CPB, XC: disability, morbidity Results unpredictable: global 20 – 40 % replacement rate Repair quality and durability uneven
Harpoon mitral valve repair system (H-MVRS) Beating-heart image-guided cordal mitral valve repair Goal: ▪ Replicate ePTFE Non-Resectional MV Repair ▪ Transventricular, Beating-Heart Courtesy A. M. Gillinov, MD
Harpoon Enabling Technology: Beating-Heart Mitral Valve Repair 1 Simplified off-pump repair of degenerative MR 2 Image guided placement & anchoring of ePTFE cords 3 Real-time adjustment of cords to maximize coaptation
Harpoon: Technology 21-gauge needle with pre-wound Hemostatic introducer to ePTFE suture in preformed knot reduce blood loss configuration Double helix anchor with ePTFE Delivered to the valve via a low profile suture as the only implant 3mm delivery system
Harpoon Procedure
Harpoon Procedure
Harpoon: Real-Time Titration of ePTFE Cordal Length
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Background: Harpoon Mitral Valve Repair Circulation. 2016;134:189 – 197 Early Feasibility Study First 11 Patients -Safe -Effective MR Reduction (follow-up ongoing)
TRACER CE Study Design: Harpoon MVRS TRACER (Mitral TransApical Cordal Echo-Guided Repair) Trial Prospective, multicenter Study Safety and performance of Harpoon Mitral Valve Repair System Methods: 6 European Sites 30 Patients (March – December 2016) Scheduled F/U at 30 days, 6, 12, 24 Months Echocardiography Core Lab: Massachusetts General Hospital (J. Hung, MD) ASE Grading of MR: None/Trace Mild Moderate Severe
Harpoon Mitral Valve Repair – TRACER Primary Endpoints : • Performance: successful implantation of 1 or more ePTFE Cords with MR reduction to </= Moderate MR at 30 days • Safety: Rate of Serious Adverse Events (SAEs) through 30 days Inclusion Criteria: • Severe degenerative Mitral Regurgitation • Isolated posterior leaflet prolapse • Good predicted surface of coaptation
TRACER Study Results: Patient Characteristics N = 30 Characteristic No. (%), or Mean Cardiac Structure/Function LV Ejection Fraction, mean, % 69 ± 7 Age (years) 61 ± 13 LA Diameter, mm 46 ± 7 Male gender 23 (77%) LV end-diastolic diameter, mm 53 ± 6 BMI (Kg/m2) 26.2 ± 3.7 LV end-systolic diameter, mm 32 +/- 6 NYHA Class – no. (%) sPAP (mm Hg) 42 ± 13 I 15 (50 %) II 10 (33 %) III 5 (17 %) STS PROM (%) 0.69 ± 0.72 Atrial fibrillation 9 (30 %) Hypertension 22 (73 %) GFR 79 ± 15 mL/min/m2
TRACER Study Results: Patient Characteristics N = 30 Characteristic No. (%), or Mean Cardiac Structure/Function LV Ejection Fraction, mean, % 69 ± 7 Age (years) 61 ± 13 LA Diameter, mm 46 ± 7 Male gender 23 (77%) LV end-diastolic diameter, mm 53 ± 6 BMI (Kg/m2) 26.2 ± 3.7 LV end-systolic diameter, mm 32 +/- 6 NYHA Class – no. (%) sPAP (mm Hg) 42 ± 13 I 15 (50 %) II 10 (33 %) III 5 (17 %) STS PROM (%) 0.69 ± 0.72 Atrial fibrillation 9 (30 %) Hypertension 22 (73 %) GFR 79 ± 15 mL/min/m2
TRACER Study Results: Patient Characteristics N = 30 Characteristic No. (%), or Mean Cardiac Structure/Function LV Ejection Fraction, mean, % 69 ± 7 Age (years) 61 ± 13 LA Diameter, mm 46 ± 7 Male gender 23 (77%) LV end-diastolic diameter, mm 53 ± 6 BMI (Kg/m2) 26.2 ± 3.7 LV end-systolic diameter, mm 32 +/- 6 NYHA Class – no. (%) sPAP (mm Hg) 42 ± 13 I 15 (50 %) II 10 (33 %) III 5 (17 %) STS PROM (%) 0.69 ± 0.72 Atrial fibrillation 9 (30 %) Hypertension 22 (73 %) GFR 79 ± 15 mL/min/m2
TRACER Study Results: Performance Endpoint Technical success rate: 93 % (28/30) 4.1 (1-5) ePTFE cordal pairs inserted Procedural time = 125 ± 43 min Blood loss 275 cc Two intraoperative conversions to conventional surgery -Patient #1 Imaging equipment dysfunction, insufficient MR reduction -Patient #10 Imaging equipment dysfunction, access site bleeding Both received MV repair with ePTFE cords, No MR at D/C MR reduced to: None/Trace in 24/28 (86 %); Mild in 4/28 (14%)
TRACER Study Results: Performance Endpoint Technical success rate: 93 % (28/30) 4.1 (1-5) ePTFE cordal pairs inserted Procedural Time = 125 ± 43 min Two intraoperative conversions to conventional surgery -Patient #1 Imaging equipment dysfunction, insufficient MR reduction -Patient #10 Imaging equipment dysfunction, access site bleeding Both received MV repair with ePTFE cords, No MR at D/C MR reduced to: None/Trace in 24/28 (86 %); Mild in 4/28 (14%)
TRACER Results: Performance Endpoint Primary Endpoint at 30 days: 90% (27/30) One repaired valve MSSA infective endocarditis POD #27 Preop elevated WBC, dental disease unrecognized: successful MV replacement MR reduced to: </= Mild in 24/27 (89 %); Moderate in 3/27 (11%)
Harpoon TRACER Results: Safety Outcome N (%) Mortality 0 Stroke 0 Renal Failure 0 Blood Transfusion 1 (3 %) (intraoperative conversion) Permanent Pacemaker 0 Intraoperative Inotrope 0 Myocardial Infarction 0 New Postoperative AF 2/21 (10 %) Serious Adverse Events: 8: 2 Operative Conversions Repaired Valve IE (POD 27) 2 Pleural Effusions (POD 8, 9) Chronic Cholecystitis (POD 36) Chest Pain (POD 5) Atrial Flutter (POD 38) No Late stroke, Reoperation, Thromboembolism or Death
Harpoon TRACER Results: Safety Outcome N (%) Mortality 0 Stroke 0 Renal Failure 0 Blood Transfusion 1 (3 %) (intraoperative conversion) Permanent Pacemaker 0 Intraoperative Inotrope 0 Myocardial Infarction 0 New Postoperative AF 2/21 (10 %) Serious Adverse Events: 8: 2 Operative Conversions Repaired Valve IE (POD 27) 2 Pleural Effusions (POD 8, 9) Chronic Cholecystitis (POD 36) Chest Pain (POD 5) Atrial Flutter (POD 38) No Late stroke, Reoperation, Thromboembolism or Death
Harpoon TRACER Results: Safety Outcome N (%) Mortality 0 Stroke 0 Renal Failure 0 Blood Transfusion 1 (3 %) (intraoperative conversion) Permanent Pacemaker 0 Intraoperative Inotrope 0 Myocardial Infarction 0 New Postoperative AF 2/21 (10 %) Serious Adverse Events: 8: 2 Operative Conversions Repaired Valve IE (POD 27) 2 Pleural Effusions (POD 8, 9) Chronic Cholecystitis (POD 36) Chest Pain (POD 5) Atrial Flutter (POD 38) No Late stroke, Reoperation, Thromboembolism or Death
Harpoon TRACER Results: Safety Outcome N (%) Mortality 0 Stroke 0 Renal Failure 0 Blood Transfusion 1 (3 %) (intraoperative conversion) Permanent Pacemaker 0 Intraoperative Inotrope 0 Myocardial Infarction 0 New Postoperative AF 2/21 (10 %) Serious Adverse Events: 8: 2 Operative Conversions Repaired Valve IE (POD 27) 2 Pleural Effusions (POD 8, 9) Chronic Cholecystitis (POD 36) Chest Pain (POD 5) Atrial Flutter (POD 38) No Late stroke, Reoperation, Thromboembolism or Death
Harpoon Mitral Valve Repair: MR Grades 6 Months 100% 8% 11% 8% 80% 60% Severe 100% 100% 100% 89% Moderate 85% 40% Mild or Less 20% 0% Baseline Procedure Discharge 30-Day 6-Month (30) (28) (25) (27) (26) * Excludes 3 conversions prior to 30 days
Harpoon Mitral Valve Repair: MR Grades 6 Months 100% 8% 11% 8% 80% 85 % None/Trace or Mild MR at 6 Months 60% Severe 100% 100% 100% 89% Moderate 85% 40% Mild or Less 20% 0% Baseline Procedure Discharge 30-Day 6-Month (30) (28) (25) (27) (26) * Excludes 3 conversions prior to 30 days
Harpoon Mitral Valve Repair: Functional Status 30 Days: 93 % NYHA Class I 6 Months: 100 % NYHA Class I
Harpoon Mitral Valve Repair: One-Year Echo
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