Multicenter Evaluation of Prosthesis Oversizing of the SAPIEN 3 Transcatheter Heart Valve. Impact on Device Failure and New Pacemaker Implantations

Rev Esp Cardiol (Engl Ed). 2019 Aug;72(8):641-648. doi: 10.1016/j.rec.2018.06.005. Epub 2018 Jul 17.
[Article in English, Spanish]

Abstract

Introduction and objectives: A certain degree of prosthesis oversizing (OS) is recommended for the SAPIEN 3 to achieve device success. However, an increase in OS may increase permanent pacemaker implantation (PPI) rates. We therefore investigated the influence of OS on device failure and PPI.

Methods: A total of 804 patients were treated with SAPIEN 3 at 3 centers. Multislice computed tomography-derived OS was calculated and analyzed both as a continuous variable and categorized in 5% increments with -4% to 0% as reference.

Results: Device failure occurred in 8.8% of patients. Median OS was lower in patients with device failure vs those with device success (+4% vs +8%; P=.038). A nonlinear risk pattern was shown for OS with a significantly reduced device failure rate within 4% to +22% of OS. There was no case of paravalvular leakage II+ between +10% to +20% of OS. The overall PPI rate was 16.2% and the median OS was significantly larger in patients with PPI (PPI: +9% vs no PPI: +7%; P = .025), while implantation depth did not vary in patients with vs without PPI (6.9±1.7 mm vs 6.6±1.9 mm; P=.101). The risk of PPI increased with increasing OS and was highest in the 2 highest categories.

Conclusions: An increase in OS reduces the risk for device failure but increases the risk for PPI. There was no ideal range of OS to minimize both device failure and PPI.

Keywords: Device failure; Dimensionamiento de la prótesis; Fallo de dispositivo; Implante percutáneo de válvula aórtica; Marcapasos; Pacemaker; Sizing; Transcatheter aortic valve implantation.

Publication types

  • Multicenter Study

MeSH terms

  • Aged, 80 and over
  • Aortic Valve / diagnostic imaging
  • Aortic Valve / surgery*
  • Aortic Valve Stenosis / diagnosis
  • Aortic Valve Stenosis / surgery*
  • Female
  • Follow-Up Studies
  • Heart Valve Prosthesis / adverse effects*
  • Humans
  • Male
  • Multidetector Computed Tomography
  • Pacemaker, Artificial*
  • Postoperative Complications / etiology
  • Postoperative Complications / therapy*
  • Prosthesis Failure
  • Retrospective Studies
  • Transcatheter Aortic Valve Replacement / adverse effects*
  • Treatment Outcome