Causes of death from the randomized CoreValve US Pivotal High-Risk Trial

Vincent Gaudiani1, G Michael Deeb2, Jeffrey J Popma3

  • 1Department of Thoracic and Cardiac Surgery, El Camino Hospital, Mountain View, Calif.

Insights

Transcatheter aortic valve replacement (TAVR) showed lower mortality than surgical aortic valve replacement (SAVR) in high-risk patients. SAVR patients experienced higher death rates during the recovery period, likely due to surgical stress.

Area of Science:

  • Cardiovascular Surgery
  • Interventional Cardiology
  • Clinical Trials

Background:

  • Transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR) are options for treating aortic stenosis.
  • High-risk patients present unique challenges for both TAVR and SAVR procedures.

Purpose of the Study:

  • To investigate the causes and timing of death in high-risk patients undergoing TAVR versus SAVR.
  • To compare mortality outcomes between TAVR and SAVR within specific timeframes post-procedure.

Main Methods:

  • Analysis of data from the CoreValve US Pivotal High-Risk Trial.
  • Independent clinical events committee adjudication of causes of death.
  • Post hoc hierarchical classification of mortality across early (0-30 days), recovery (31-120 days), and late (121-365 days) periods.

Main Results:

  • Overall 1-year mortality favored TAVR over SAVR.
  • A significant difference in death rates was observed during the recovery period (31-120 days), with higher mortality in the SAVR group (7.9%) compared to the TAVR group (4.0%).
  • Causes of death varied by period: technical failures and lack of recovery in the early phase, and medical complications from comorbidities in the late phase.

Conclusions:

  • 1-year mortality in high-risk patients favored TAVR over SAVR in the CoreValve US Pivotal High-Risk Trial.
  • Higher mortality in SAVR patients during the recovery phase was a key factor, potentially linked to surgical stress.
  • Technical refinements in TAVR and complication reduction in SAVR are suggested for improving outcomes.
Abstract

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