Transcatheter aortic valve implantation in patients with bicuspid aortic valve stenosis utilizing the next-generation fully retrievable and repositionable valve system: mid-term results from a prospective multicentre registry

Clin Res Cardiol. 2020 May;109(5):570-580. doi: 10.1007/s00392-019-01541-8. Epub 2019 Sep 2.

Abstract

Background: The aim of this study was to evaluate the outcomes of transcatheter aortic valve implantation (TAVI) in bicuspid aortic valve (BiAV) stenosis using a mechanically expanded Lotus™ device. The prior experience with first-generation devices showed disappointing results mainly due to increased prevalence of aortic regurgitation (AR) that exceeded those observed in tricuspid stenosis.

Methods and results: We collected baseline, in-hospital, 30-day and 2-year follow-up data from a prospective, multicentre registry of patients with BiAV undergoing TAVI using Lotus™ valve. Safety and efficacy endpoints were assessed according to VARC-2 criteria. The study group comprised 24 patients. The mean age was 73.5 years and the mean EuroSCORE 2 was 4.35 ± 2.56%. MDCT analysis revealed Type 1 BiAV in 75% of patients. The mean gradient decreased from 60.1 ± 18.3 to 15 ± 6.4 mm Hg, the AVA increased from 0.6 ± 0.19 to 1.7 ± 0.21 cm2. One in-hospital death was observed secondary to aortic perforation. There was no severe AR and the rate of moderate AR equalled 9% at 30 days (n = 2). Device success was achieved in 83% and the 30-day safety endpoint was 17%. In the 2-year follow-up, the overall mortality was 12.5% and the 2-year composite clinical efficacy endpoint was met in 25% of the patients (n = 6) CONCLUSIONS: The TAVI in selected BiAV patients using the Lotus™ is feasible and characterized by encouraging valve performance and mid-term clinical outcomes.

Keywords: Bicuspid aortic valve; Lotus™ valve; Transcatheter aortic valve implantation.

Publication types

  • Multicenter Study

MeSH terms

  • Aged
  • Aged, 80 and over
  • Aortic Valve Insufficiency / epidemiology
  • Aortic Valve Stenosis / surgery*
  • Bicuspid Aortic Valve Disease / surgery*
  • Female
  • Humans
  • Male
  • Postoperative Complications / epidemiology
  • Prospective Studies
  • Prosthesis Design
  • Registries
  • Transcatheter Aortic Valve Replacement / adverse effects
  • Transcatheter Aortic Valve Replacement / instrumentation*
  • Transcatheter Aortic Valve Replacement / methods
  • Treatment Outcome