1-year outcomes with the fully repositionable and retrievable lotus transcatheter aortic replacement valve in 120 high-risk surgical patients with severe aortic stenosis: results of the REPRISE II study

Meredith, Ian T., Walters, Darren L., Dumonteil, Nicolas, Worthley, Stephen G., Tchetche, Didier, Manoharan, Ganesh, Blackman, Daniel J., Rioufol, Gilles, Hildick-Smith, David, Whitbourn, Robert J., Lefevre, Thierry, Lange, Rudiger, Muller, Ralf, Redwood, Simon, Feldman, Ted E., Allocco, Dominic J. and Dawkins, Keith D. (2016) 1-year outcomes with the fully repositionable and retrievable lotus transcatheter aortic replacement valve in 120 high-risk surgical patients with severe aortic stenosis: results of the REPRISE II study. JACC: Cardiovascular Interventions, 9 4: 376-384. doi:10.1016/j.jcin.2015.10.024


Author Meredith, Ian T.
Walters, Darren L.
Dumonteil, Nicolas
Worthley, Stephen G.
Tchetche, Didier
Manoharan, Ganesh
Blackman, Daniel J.
Rioufol, Gilles
Hildick-Smith, David
Whitbourn, Robert J.
Lefevre, Thierry
Lange, Rudiger
Muller, Ralf
Redwood, Simon
Feldman, Ted E.
Allocco, Dominic J.
Dawkins, Keith D.
Title 1-year outcomes with the fully repositionable and retrievable lotus transcatheter aortic replacement valve in 120 high-risk surgical patients with severe aortic stenosis: results of the REPRISE II study
Journal name JACC: Cardiovascular Interventions   Check publisher's open access policy
ISSN 1876-7605
1936-8798
Publication date 2016-02-22
Year available 2016
Sub-type Article (original research)
DOI 10.1016/j.jcin.2015.10.024
Open Access Status DOI
Volume 9
Issue 4
Start page 376
End page 384
Total pages 9
Place of publication New York, NY, United States
Publisher Elsevier
Collection year 2017
Language eng
Formatted abstract
Objectives: This analysis presents the first report of 1-year outcomes of the 120 patients enrolled in the REPRISE II (Repositionable Percutaneous Placement of Stenotic Aortic Valve Through Implantation of Lotus Valve System-Evaluation of Safety and Performance) study.

Background: The fully repositionable and retrievable Lotus Valve (Boston Scientific, Marlborough, Massachusetts) was designed to facilitate accurate positioning, early valve function, and hemodynamic stability during deployment and to minimize paravalvular regurgitation in patients undergoing transcatheter aortic valve replacement.

Methods: The study enrolled 120 symptomatic patients 70 years of age or older at 14 centers in Australia and Europe. Patients had severe calcific aortic stenosis and were deemed to be at high or extreme risk of surgery based on assessment by the heart team.

Results: The mean age was 84.4 ± 5.3 years, 57% (68 of 120) of patients were women, and the mean Society of Thoracic Surgeons score was 7.1 ± 4.6. The mean baseline aortic valve area was 0.7 ± 0.2 cm2, and the mean transvalvular pressure gradient was 46.4 ± 15.0 mm Hg. All patients were successfully implanted with a Lotus Valve, and 1-year clinical follow-up was available for 99.2% (119 of 120 of patients). The mean 1-year transvalvular aortic pressure gradient was 12.6 ± 5.7 mm Hg, and the mean valve area was 1.7 ± 0.5 cm2. A total of 88.6% patients had no or trivial paravalvular aortic regurgitation at 1 year by independent core lab adjudication, and 97.1% of patients were New York Heart Association functional class I or II. At 1 year, the all-cause mortality rate was 10.9% (13 of 119 patients), disabling stroke rate was 3.4% (4 of 119 patients), disabling bleeding rate was 5.9% (7 of 119 patients), with no repeat procedures for valve-related dysfunction. A total of 31.9% (38 of 119 patients) underwent new permanent pacemaker implantation at 1 year.

Conclusions: At 1 year of follow-up, the Lotus Valve demonstrated excellent valve hemodynamics, no moderate or severe paravalvular regurgitation, and significant and sustained improvement in New York Heart Association functional class status, with good clinical outcomes. (Repositionable Percutaneous Placement of Stenotic Aortic Valve Through Implantation of Lotus Valve System-Evaluation of Safety and Performance [REPRISE II]; NCT01627691)
Keyword Aortic stenosis
TAVR
Transcatheter aortic valve implantation
Transfemoral
Q-Index Code C1
Q-Index Status Provisional Code
Institutional Status UQ

Document type: Journal Article
Sub-type: Article (original research)
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