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Published on: June 12, 2021
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.
Objective:
Explore causes and timing of death from the CoreValve US Pivotal High-Risk Trial.
Methods:
An independent clinical events committee adjudicated causes of death, followed by post hoc hierarchical classification. Baseline characteristics, early outcomes, and causes of death were evaluated for 3 time periods (selected based on threshold of surgical 30-day mortality and on the differences in the continuous hazard between the 2 groups): early (0-30 days), recovery (31-120 days), and late (121-365 days).
Results:
Differences in the rate of death were evident only during the recovery period (31-120 days), whereas 15 patients undergoing transcatheter aortic valve replacement (TAVR) (4.0%) and 27 surgical aortic valve replacement (SAVR) patients (7.9%) died (P = .025). This mortality difference was largely driven by higher rates of technical failure, surgical complications, and lack of recovery following surgery. From 0 to 30 days, the causes of death were more technical failures in the TAVR group and lack of recovery in the SAVR group. Mortality in the late period (121-365 days) in both arms was most commonly ascribed to other circumstances, comprising death from medical complications from comorbid disease.
Conclusions:
Mortality at 1 year in the CoreValve US Pivotal High-Risk Trial favored TAVR over SAVR. The major contributor was that more SAVR patients died during the recovery period (31-121 days), likely affected by the overall influence of physical stress associated with surgery. Similar rates of technical failure and complications were observed between the 2 groups. This suggests that early TAVR results can improve with technical refinements and that high-risk surgical patients will benefit from reducing complications.
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