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The Effect of Post-Dilatation on Outcomes in the PARTNER 2 SAPIEN 3 Registry

Rebecca T Hahn1, Philippe Pibarot2, Jonathon Leipsic3

  • 1Columbia University Medical Center/NY Presbyterian Hospital, New York, New York.

JACC. Cardiovascular Interventions
|August 20, 2018
PubMed

Insights

Balloon post-dilatation (BPD) in SAPIEN 3 transcatheter aortic valve replacement is more common in patients with less oversizing and more calcification. BPD does not increase procedural complications or 1-year adverse events like death or stroke.

Area of Science:

  • Cardiovascular Medicine
  • Interventional Cardiology
  • Medical Devices

Background:

  • Outcomes and hemodynamics of balloon post-dilatation (BPD) for the SAPIEN 3 valve have not been previously reported.
  • Aortic stenosis management is evolving with transcatheter aortic valve replacement (TAVR) technologies.

Purpose of the Study:

  • To evaluate the impact of balloon post-dilatation (BPD) on outcomes and procedural complications in patients undergoing TAVR with the SAPIEN 3 valve.
  • To assess the safety and efficacy of BPD in intermediate and high surgical risk patients.

Main Methods:

  • The PARTNER 2 SAPIEN 3 observational study included 1,661 patients (intermediate and high surgical risk).
  • Outcomes and complications were assessed in patients who underwent BPD (n=208) versus those who did not.
  • Baseline characteristics, procedural data, and 30-day and 1-year outcomes were analyzed.

Main Results:

  • BPD was associated with significantly larger aortic valve area but also more paravalvular regurgitation.
  • No increase in permanent pacemaker, annular rupture, or valve embolization was observed with BPD.
  • While 1-year minor stroke incidence was higher in the BPD group initially, this difference was not significant after adjusting for baseline characteristics.

Conclusions:

  • Balloon post-dilatation is frequently used in patients with less oversizing and greater calcification during SAPIEN 3 TAVR.
  • BPD is not linked to increased procedural complications or adverse 1-year outcomes including death, rehospitalization, or stroke.
Abstract

Keywords:
aortic stenosisechocardiographypost-dilatationtranscatheter aortic valve replacement

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