Transfemoral aortic valve replacement with the repositionable Lotus Valve System in high surgical risk patients: the REPRISE I study

被引：94

作者：

Meredith, Ian T. ^{[1
]}

Worthley, Stephen G. ^{[2
]}

Whitbourn, Robert J. ^{[3
]}

Antonis, Paul ^{[1
]}

Montarello, Joseph K. ^{[2
]}

Newcomb, Andrew E. ^{[3
]}

Lockwood, Siohban ^{[1
]}

Haratani, Nicole ^{[4
]}

Allocco, Dominic J. ^{[4
]}

Dawkins, Keith D. ^{[4
]}

机构：

[1] Monash Med Ctr, Southern Hlth, MonashHEART, Clayton, Vic 3168, Australia

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

[3] St Vincents Hosp, Cardiovasc Res Ctr, Melbourne, Vic, Australia

[4] Boston Sci Corp, Natick, MA USA

来源：

EUROINTERVENTION | 2014年 / 9卷 / 11期

关键词：

aortic valve stenosis; paravalvular regurgitation; transcatheter aortic valve replacement (TAVR);

D O I：

10.4244/EIJV9I11A216

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

Aims: To assess outcomes with a new fully repositionable and retrievable valve for transcatheter aortic valve replacement (TAVR). Methods and results: The Lotus Aortic Valve System is designed to facilitate precise positioning and minimise paravalvular regurgitation. REPRISE I enrolled symptomatic, high-surgical-risk patients with severe aortic stenosis. The primary endpoint (clinical procedural success) included successful implantation without major adverse cardiovascular or cerebrovascular events (MACCE). In all patients (N=11) the first Lotus Valve was successfully deployed. Partial resheathing to facilitate accurate placement was attempted and successfully performed in four patients; none required full retrieval. The primary endpoint was achieved in 9/11 with no in-hospital MACCE in 10/11. There was one major stroke; in another patient, discharge mean aortic gradient was 22 mmHg (above the primary endpoint threshold of 20 mmHg), but improved to 15 mmHg at 30 days. The cohort's mean aortic gradient decreased from 53.9 +/- 20.9 mmHg at baseline to 15.4 +/- 4.6 mmHg (p<0.001) at one year; valve area increased from 0.7 +/- 0.2 cm(2) to 1.5 +/- 0.2 cm(2) (p<0.001). Discharge paravalvular aortic regurgitation, adjudicated by an independent core laboratory, was mild (n=2), trivial (n=1), or absent (n=8). Four patients required a permanent pacemaker post-procedure. There were no deaths, myocardial infarctions or new strokes through one year. Conclusions: Initial results support proof-of-concept with the Lotus Valve for TAVR.

引用

页码：1264 / 1270

页数：7

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