Efficacy and safety of the Lotus Valve System for treatment of patients with severe aortic valve stenosis and intermediate surgical risk: Results from the Nordic Lotus-TAVR registry

Research output: Contribution to journalArticle

Abstract

Background Transcatheter aortic valve replacement (TAVR) has become an established therapeutic option for patients with symptomatic, severe aortic valve stenosis (AS) who are ineligible or at high risk for conventional valvular surgery. In Northwestern Europe, the TAVR technology is also increasingly used to treat patients with an intermediate risk profile. Methods and results The study was designed as an independent Nordic multicenter registry of intermediate risk patients treated with the Lotus Valve System (Boston Scientific, MA, USA; N = 154). Valve Academic Research Consortium (VARC)-defined device success was obtained in 97.4%. A Lotus Valve was successfully implanted in all patients. There was no valve migration, embolization, ectopic valve deployment, or TAV-in-TAV deployment. The VARC-defined combined safety rate at 30 days was 92.2%, with a mortality rate of 1.9% and stroke rate of 3.2%. The clinical efficacy rate after 30 days was 91.6% - only one patient had moderate aortic regurgitation. When considering only those patients in the late experience group (N = 79), the combined safety and clinical efficacy rates were 93.7% and 92.4%, respectively. The pacemaker implantation rate was 27.9% - this rate was 12.8% in case of a combined implantation depth <4 mm and a device/annulus ratio <1.05. Conclusions The present study demonstrates the efficacy and safety of the repositionable, retrievable Lotus Valve System in intermediate risk patients with AS. The VARC-defined device success rate was 97.4% with a 30-day patient safety and clinical efficacy rate of more than 90%. Less than moderate aortic regurgitation was obtained in 99.4% of patients.

Details

Authors
  • Ole De Backer
  • Matthias Götberg
  • Leo Ihlberg
  • Erik Packer
  • Mikko Savontaus
  • Niels E. Nielsen
  • Troels H. Jørgensen
  • Antti Nykänen
  • Jacek Baranowski
  • Matti Niemelä
  • Markku Eskola
  • Henrik Bjursten
  • Lars Søndergaard
External organisations
  • Skåne University Hospital
  • Haukeland University Hospital
  • Turku University Hospital
  • Oulu University Hospital
  • Tampere University Hospital
  • Copenhagen University Hospital
  • Linköping University Hospital
  • Helsinki University Central Hospital
Research areas and keywords

Subject classification (UKÄ) – MANDATORY

  • Cardiac and Cardiovascular Systems

Keywords

  • Aortic valve stenosis, Efficacy, Intermediate risk, Safety, Transcatheter aortic valve replacement
Original languageEnglish
Pages (from-to)92-97
Number of pages6
JournalInternational Journal of Cardiology
Volume219
Publication statusPublished - 2016 Sep
Publication categoryResearch
Peer-reviewedYes
Externally publishedYes