Optimized Implantation Height of the Edwards SAPIEN 3 Valve to Minimize Pacemaker Implantation After TAVI

J Interv Cardiol. 2016 Aug;29(4):370-4. doi: 10.1111/joic.12302. Epub 2016 May 31.

Abstract

Aim: The transcatheter aortic valve SAPIEN 3 aims at reducing paravalvular leakage (PVL). The new design with outer sealing cuff may increase the risk of permanent pacemaker implantation (PPM). The aim of our study was to evaluate the optimal implantation height of the SAPIEN 3.

Methods and results: We analysed the correlation between the implantation height of the valve and the need for PPM in 131 patients. The PPM rate for the entire group after TAVI was 18% (n = 24). In patients with a marker distance <2 mm ("low implantation"), the PPM rate was 32%, whereas in patients with a distance ≥2 mm ("high implantation"), the rate was only 4.7% (OR of 0.1 (0.03-0.37, P < 0.001)).

Conclusion: The risk of periprocedural PPM with the Edwards SAPIEN 3 depends on implantation height; it is increased when using conventional implantation techniques. This risk can be minimized below 5% PPM by choosing a higher implantation technique with the central marker 2 mm or more over the annulus plane.

MeSH terms

  • Aged
  • Aged, 80 and over
  • Aortic Valve Stenosis* / diagnosis
  • Aortic Valve Stenosis* / surgery
  • Aortic Valve* / diagnostic imaging
  • Aortic Valve* / surgery
  • Equipment Failure Analysis
  • Female
  • Germany
  • Heart Valve Prosthesis*
  • Humans
  • Male
  • Pacemaker, Artificial / statistics & numerical data*
  • Postoperative Complications* / etiology
  • Postoperative Complications* / prevention & control
  • Prosthesis Design
  • Prosthesis Fitting* / adverse effects
  • Prosthesis Fitting* / instrumentation
  • Prosthesis Fitting* / methods
  • Transcatheter Aortic Valve Replacement* / adverse effects
  • Transcatheter Aortic Valve Replacement* / instrumentation
  • Transcatheter Aortic Valve Replacement* / methods
  • Treatment Outcome