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

JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY

卷:64

Article

Meredith, Ian T.^1,2  Walters, Darren L.^3,4  Dumonteil, Nicolas⁵  Worthley, Stephen G.⁶  Tchetche, Didier⁷  Manoharan, Ganesh⁸  Blackman, Daniel J.⁹  Rioufol, Gilles¹⁰  Hildick-Smith, David¹¹  Whitbourn, Robert J.¹²  Lefevre, Thierry¹³  Lange, Ruediger¹⁴  Mueller, Ralf¹⁵  Redwood, Simon¹⁶  Allocco, Dominic J.¹⁷  Dawkins, Keith D.¹⁷ 

[1] Monash Hlth, MonashHEART, Clayton, Vic, Australia

[2] Monash Univ, Clayton, Vic, Australia

[3] Prince Charles Hosp, Brisbane, Qld 4032, Australia

[4] Univ Queensland, Brisbane, Qld, Australia

[5] Ctr Hosp Univ Rangueil, Pole Cardiovasc & Metab, Toulouse, France

[6] Royal Adelaide Hosp, Adelaide, SA 5000, Australia

[7] Clin Pasteur, Toulouse, France

[8] Royal Victoria Hosp, Belfast BT12 6BA, Antrim, North Ireland

[9] Leeds Gen Infirm, Leeds, W Yorkshire, England

[10] Hosp Civils Lyon, Hop Cardiol, Lyon, France

[11] Brighton & Sussex Univ Hosp, Sussex Cardiac Ctr, Brighton, E Sussex, England

[12] St Vincents Hosp, Fitzroy, Vic 3065, Australia

[13] Inst Cardiovasc, Paris, Massy, France

[14] Deutsch Herzzentrum Munich, Munich, Germany

[15] HELIOS Klini Siegburg, Siegburg, Germany

[16] Guys & St Thomas NHS Fdn Trust, London, England

[17] Boston Sci Corp, Marlborough, MA USA

关键词: aortic regurgitation;    aortic valve stenosis;    TAVR;    transfemoral;   

DOI  :  10.1016/j.jacc.2014.05.067

来源: Elsevier

【 摘 要 】

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 cm(2). 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 perpendicular to 15.0 mm Hg to 11.5 perpendicular to 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. (C) 2014 by the American College of Cardiology Foundation.

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