Outcomes following pacemaker implantation after transcatheter aortic valve implantation with CoreValve(®) devices: Results from the FRANCE 2 Registry

Abstract

Aims: Permanent pacemaker (PPM) implantation following high-degree atrioventricular block is frequently required after transcatheter aortic valve implantation (TAVI) using CoreValve(®) . Recent improvement of the delivery system (CoreValve Accutrak(®) ) aimed to ease delivery and reduce the PPM rate. Our study evaluated the incidences of PPM implantation following use of CoreValve(®) or CoreValve Accutrak(®) and the clinical outcome of these patients.

Methods and results: A total of 883 patients (82 ± 7 years; 41.3% female) with severe symptomatic aortic stenosis and self-expanding bioprosthesis implantation were included between January 2010 and October 2011 in 29 centers from the FRANCE 2 Registry. Follow-up data were available in 833 patients. CoreValve(®) and CoreValve Accutrak(®) were used in 343 (41.2%) and 490 (58.8%) patients, respectively. During a mean follow-up of 242 ± 179 days, all-cause mortality was similar in patients with versus without PPM implantation (16.3 vs. 16.9%, P = 0.832).There was no significant difference in the PPM incidence in CoreValve(®) and CoreValve Accutrak(®) patients (30.4% vs. 27.5%, P = 0.846).

Conclusion: PPM implantation remained frequent after TAVI using CoreValve Accutrak(®) . All-cause mortality was similar in patients with or without PPM implantation. The new device failed to show a significant decrease in PPM implantation incidence after TAVI. © 2015 Wiley Periodicals, Inc.

Keywords: aortic valve stenosis; pacemaker; transcatheter aortic valve implantation.