Insights into the need for permanent pacemaker following implantation of the repositionable LOTUS valve for transcatheter aortic valve replacement in 250 patients: Results from the REPRISE II trial with extended cohort

Research output: Contribution to journalArticle

Abstract

Aims: This analysis aimed to evaluate the incidence and predictors of the need for permanent pacemaker (PPM) implantation following implantation of the repositionable and fully retrievable LOTUS Aortic Valve Replacement System. Methods and results: The prospective, single-arm, multicentre REPRISE II study with extended cohort enrolled 250 symptomatic, high surgical risk patients with severe aortic stenosis for transfemoral transcatheter aortic valve implantation (TAVI) with a 23 mm or 27 mm LOTUS valve. Echocardiography, computed tomography, and electrocardiography data were evaluated by independent core labs. Post TAVI, 32.0% (72/225) of pacemaker-naïve patients underwent new PPM implantation at 30 days. Most (59/72, 82%) patients were implanted for third-degree atrioventricular block, and >10% overstretch of the LVOT by area was observed in 59.7% (43/72) of PPM patients. Significant independent predictors of PPM at 30 days included baseline RBBB (odds ratio [OR] 12.7, 95% CI: 4.5, 36.2; p<0.001) and LVOT overstretch >10% (OR 3.4, 95% CI: 1.7, 6.7; p<0.001). There was a trend towards a lower 30-day PPM rate in patients with a shallower (≤5 mm) implant depth (23.9% ≤5 mm vs. 36.9% >5 mm depth from LCS; p=0.06). Conclusions: Careful attention to valve sizing and implant depth may help to reduce the rate of PPM with the LOTUS valve.

Details

Authors
  • Nicolas Dumonteil
  • Ian T. Meredith
  • Daniel J. Blackman
  • Didier Tchétché
  • David Hildick-Smith
  • Mark S. Spence
  • Darren L. Walters
  • Jan Harnek
  • Stephen G. Worthley
  • Gilles Rioufol
  • Thierry Lefèvre
  • Thomas Modine
  • Nicolas Van Mieghem
  • Vicki M. Houle
  • Dominic J. Allocco
  • Keith D. Dawkins
External organisations
  • Monash University
  • Skåne University Hospital
  • Lille University Hospital
  • Institut Cardiovasculaire Paris Sud
  • Erasmus University Medical Center
  • Clinique Pasteur, Toulouse
  • Leeds Teaching Hospitals NHS Trust
  • Royal Sussex County Hospital
  • The Prince Charles Hospital
  • Royal Adelaide Hospital
Research areas and keywords

Subject classification (UKÄ) – MANDATORY

  • Surgery

Keywords

  • Aortic stenosis, Aortic valve implantation, Clinical trials, Transcatheter
Original languageEnglish
Pages (from-to)796-803
Number of pages8
JournalEuroIntervention
Volume13
Issue number7
Publication statusPublished - 2017 Sep 1
Publication categoryResearch
Peer-reviewedYes
Externally publishedYes