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

To assess outcomes with a new fully repositionable and retrievable valve for transcatheter aortic valve replacement (TAVR).
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 cm2 to 1.5±0.2 cm2 (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.
Initial results support proof-of-concept with the Lotus Valve for TAVR.
AuthorsIan T Meredith, Stephen G Worthley, Robert J Whitbourn, Paul Antonis, Joseph K Montarello, Andrew E Newcomb, Siohban Lockwood, Nicole Haratani, Dominic J Allocco, Keith D Dawkins
JournalEuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology (EuroIntervention) Vol. 9 Issue 11 Pg. 1264-70 (Mar 20 2014) ISSN: 1969-6213 [Electronic] France
PMID24169077 (Publication Type: Clinical Trial, Journal Article)
  • Aged
  • Aged, 80 and over
  • Aortic Valve (surgery)
  • Aortic Valve Stenosis (surgery)
  • Bioprosthesis
  • Echocardiography
  • Female
  • Heart Valve Prosthesis
  • Heart Valve Prosthesis Implantation (adverse effects, methods)
  • Humans
  • Male
  • Pacemaker, Artificial
  • Prospective Studies
  • Risk

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