Original Investigation
Transcatheter Aortic Valve Replacement for Severe Symptomatic Aortic Stenosis Using a Repositionable Valve System: 30-Day Primary Endpoint Results From the REPRISE II Study

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Abstract

Background

Transcatheter aortic valve replacement provides results comparable to those of surgery in patients at high surgical risk, but complications can impact long-term outcomes. The Lotus valve, designed to improve upon earlier devices, is fully repositionable and retrievable, with a unique seal to minimize paravalvular regurgitation (PVR).

Objectives

The prospective, single-arm, multicenter REPRISE II study (REpositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus Valve System: Evaluation of Safety and Performance) evaluated the transcatheter valve system for treatment of severe symptomatic calcific aortic valve stenosis.

Methods

Patients (n = 120; aortic annulus 19 to 27 mm) considered by a multidisciplinary heart team to be at high surgical risk received the valve transfemorally. The primary device performance endpoint, 30-day mean pressure gradient, was assessed by an independent echocardiographic core laboratory and compared with a pre-specified performance goal. The primary safety endpoint was 30-day mortality. Secondary endpoints included safety/effectiveness metrics per Valve Academic Research Consortium criteria.

Results

Mean age was 84.4 years, 57% of the patients were female, and 76% were New York Heart Association functional class III/IV. Mean aortic valve area was 0.7 ± 0.2 cm2. The valve was successfully implanted in all patients, with no cases of valve embolization, ectopic valve deployment, or additional valve implantation. All repositioning (n = 26) and retrieval (n = 6) attempts were successful; 34 patients (28.6%) received a permanent pacemaker. The primary device performance endpoint was met, because the mean gradient improved from 46.4 ± 15.0 mm Hg to 11.5 ± 5.2 mm Hg. At 30 days, the mortality rate was 4.2%, and the rate of disabling stroke was 1.7%; 1 (1.0%) patient had moderate PVR, whereas none had severe PVR.

Conclusions

REPRISE II demonstrates the safety and effectiveness of the Lotus valve in patients with severe aortic stenosis who are at high surgical risk. The valve could be positioned successfully with minimal PVR. (REPRISE II: REpositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus™ Valve System - Evaluation of Safety and Performance; NCT01627691)

Key Words

aortic regurgitation
aortic valve stenosis
TAVR
transfemoral

Abbreviations and Acronyms

CT
computed tomography
LVOT
left ventricular outflow tract
NYHA
New York Heart Association
PG
performance goal
PVR
paravalvular regurgitation
STS
Society of Thoracic Surgeons
TAV
transcatheter aortic valve
TAVR
transcatheter aortic valve replacement
TTE
transthoracic echocardiography
VARC
Valve Academic Research Consortium

Cited by (0)

Boston Scientific Corporation (Marlborough, Massachusetts) provided funding for this study. Dr. Meredith has received consultant fees and honoraria from Boston Scientific and Medtronic; and proctor fees from Boston Scientific. Dr. Walters has received consultant fees and honoraria from Edwards Lifesciences, Medtronic, and Siemens; and proctor fees from Edwards Lifesciences. Dr. Dumonteil has received consultant fees and honoraria from Biotronik, Boston Scientific, Edwards Lifesciences, Medtronic, and Abbott Vascular; and proctor fees from Boston Scientific, Edwards Lifesciences, and Medtronic. Dr. Worthley has received consultant fees and honoraria from Medtronic and St. Jude Medical. Dr. Tchétché has received proctor fees from Boston Scientific. Dr. Manoharan has received proctor fees from Boston Scientific; and consultant fees and honoraria from Medtronic and St. Jude Medical. Dr. Blackman has received consultant fees and honoraria from Boston Scientific and Medtronic. Dr. Rioufol has received consultant fees and honoraria from Medtronic and St. Jude Medical; and grant support from Hexacath. Dr. Hildick-Smith has received proctor fees from Boston Scientific, Edwards Lifesciences, and Medtronic. Dr. Whitbourn has received consultant fees and honoraria from Abbott Vascular; and grant support from Boston Scientific, Kona Medical, and Medtronic. Dr. Lefèvre has received consultant fees and honoraria from Boston Scientific, Edwards Lifesciences, Sanofi, and Tryton; and grant support from Boston Scientific, Direct Flow, Symetis, and The Medicines Company. Dr. Lange has received consultant fees and honoraria from Medtronic. Dr. Müller has received consultant fees and honoraria from Boston Scientific. Dr. Redwood has received proctor fees from Edwards Lifesciences. Drs. Allocco and Dawkins are full-time employees and stockholders of Boston Scientific Corporation.

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