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The New England Journal of MedicineSelf-Expanding or Balloon-Expandable TAVR in Patients with a Small Aortic Annulus

Comparative Efficacy of TAVR Valves in Patients with Small Aortic Annuli

In a recent randomized study, outcomes of transcatheter aortic-valve replacement (TAVR) were compared between self-expanding and balloon-expandable valves in patients with severe aortic stenosis and a small aortic annulus. This study is critical as it addresses the optimal valve choice to improve clinical and hemodynamic outcomes in this high-risk patient group.

Study Design:

  • Participants: 716 patients with symptomatic severe aortic stenosis and an aortic-valve annulus area ≤ 430 mm².
  • Settings: The study was conducted across 83 sites in 13 countries.
  • Demographics: Average age of participants was 80 years, with 87% being women and an average Society of Thoracic Surgeons Predicted Risk of Mortality score of 3.3%.
  • Randomization: Patients were assigned in a 1:1 ratio to receive either a self-expanding supraannular valve or a balloon-expandable valve.
  • Endpoints: Coprimary endpoints included a composite of death, disabling stroke, or rehospitalization for heart failure assessed through 12 months (for noninferiority), and bioprosthetic-valve dysfunction (for superiority).

Key Findings:

  • Clinical outcomes: The self-expanding valve demonstrated noninferiority with a 9.4% incidence of the primary composite outcome compared to 10.6% in the balloon-expandable valve group.
  • Valve dysfunction: Significant superiority in preventing bioprosthetic-valve dysfunction was observed with the self-expanding valve (9.4% vs. 41.6% in the balloon-expandable group).
  • Hemodynamic performance: Mean aortic-valve gradient at 12 months was significantly lower in the self-expanding valve group (7.7 mm Hg vs. 15.7 mm Hg).
  • Prosthesis-patient mismatch: Less frequent in the self-expanding valve group (11.2% vs. 35.3%).
  • Safety endpoints: Major safety endpoints were similar between the two groups.

HCN Medical Memo
This study highlights the importance of valve type selection in TAVR procedures for patients with small aortic annuli. Given the clear differences in valve performance and clinical outcomes, it is essential for clinicians to consider individual patient anatomical characteristics when choosing the appropriate TAVR valve to optimize both the safety and effectiveness of the procedure.

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