First Report of Three-Year Outcomes With the Repositionable and Fully Retrievable Lotus™ Aortic Valve Replacement System: Results From the REPRISE I.

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Presentation transcript:

First Report of Three-Year Outcomes With the Repositionable and Fully Retrievable Lotus™ Aortic Valve Replacement System: Results From the REPRISE I Feasibility Study TCT-615 Ian T. Meredith AM, MBBS, PhD1; Stephen G. Worthley, MD2; Robert J. Whitbourn, MBBS, BMedSc, BSc3; Joseph Montarello, MBBS2; Andrew E. Newcomb, MBBS3; Dominic J. Allocco, MD4; Keith D. Dawkins, MD4 1MonashHeart, Clayton, Victoria, Australia; 2Royal Adelaide Hospital, Adelaide, South Australia, Australia; 3St. Vincent’s Hospital, University of Melbourne, Fitzroy, Victoria, Australia; 4Boston Scientific Corporation, Marlborough, MA, USA Introduction & Study Design Patients Safety Valve Hemodynamics Baseline Characteristics (N=11) Age (years) 83.0±3.6 Gender (female) 11/11 STS Score (%) 4.9±2.5 Logistic euroSCORE (%) 9.5±4.4 NYHA Class III or IV 5/11 Diabetes, medically treated 2/11 Hypertension, medically treated 10/11 History of coronary artery disease History of cerebrovascular accident Atrial fibrillation STUDY OBJECTIVE: Assess acute safety & performance of the Lotus Valve System (23mm valve) for TAVR DESIGN: Prospective, single-arm feasibility study PRIMARY ENDPOINT: Device success (VARC-1 definition) without in-hospital MACCE through discharge/7 days ANALYSIS OBJECTIVE: to assess the long-term (3-year) outcomes with the Lotus Valve Patients aged ≥70 years with: Aortic valve stenosis and NYHA Class ≥II AVA <1.0cm2 (or AVA index <0.6cm2/m2) plus either MPG >40mmHg or jet velocity >4m/s High risk for surgical AVR Aortic Annulus size 19-22mm (23mm valve used) Safety Event Rates At 3 Years n/11 MACCE 2 All cause mortalitya 1 Peri-procedural MI (≤72 hours) Major stroke Urgent or emergent conversion to surgery or repeat procedure for valve-related dysfunction Life-threatening/disabling bleedingb Acute kidney injury – Stage 2 or Stage 3 Major vascular complicationc Major bleedingd 3 Conduction disturbance requiring new pacemaker 4 Myocardial infarction Minor stroke a: Death (non-cardiovascular; uncontrolled sepsis) at 843 days post procedure b: Events at 14 days (pericardial effusion from pacemaker implant) and 20 days (GI bleed) post procedure c: Left femoral artery dissection treated by cross-over contralateral balloon angioplasty d: All unrelated to TAVR access 53.920.9 13.73.7 11.73.0 15.54.4 15.44.6 15.64.4 0.70.2 1.50.2 1.60.2 Mean AV Gradient (mmHg) Mean Aortic Valve Area (cm2) n=11 n=8 Measurement P value Mean AV Gradient Mean AVA Baseline to Discharge <0.001 Baseline to 3 Years Discharge to 3 Years 0.542 0.909 P values from repeated measures and random effects ANOVA model Independent Core Lab adjudication NYHA Class to 3 Years Aortic Valve Regurgitation Intent-To-Treat (N=11) No Lotus Valve Implanted (N=0) Lotus Valve Implanted (N=11) 30-Day Clinical Follow-Up 100% (11/11) 3-Year Clinical Follow-Up Available or had a Clinical Event 90.9% (10/11) Patients (%) P=0.004 n=11 n=8 None Trivial Moderate Mild Severe Paravalvular Regurgitation Patients (%) N=11 N=11 N=11 N=11 N=8 New Safety Events Between 2 Years and 3 Years Conclusions Transient ischemic attack in 1 patient at Day 1037; resolved without residual effects Thromboembolic stroke (minor) in 1 patient at Day 818; resolved without residual effects Patient had a history of atrial fibrillation and experienced non-cardiovascular death (uncontrolled sepsis) at Day 843 Three-year results from the REPRISE I study demonstrate excellent valve function with minimal paravalvular regurgitation and low clinical event rates. These data support the safety and performance of the Lotus Valve for the treatment of patients with severe aortic stenosis. Disclosures: IM: Consultant Fees/Honoraria/Speaker’s Bureau: Boston Scientific (significant); SW: Grant support/Research contract: Medtronic, St Jude Medical (significant), Consultant Fees/Honoraria/Speaker’s Bureau: Medtronic (modest); AN: Grant support/Research contract: Boston Scientific (modest), Consultant Fees/Honoraria/Speaker’s Bureau: Medtronic, Edwards Lifesciences (modest); DJA & KDD: Salary & Equity: Boston Scientific (significant); RW & JM: none Poster presented at: Transcatheter and Cardiovascular Therapeutics 2015, October 13, 2015; San Francisco, CA, USA. FOR INTERNAL USE ONLY