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

Abstract

ObjectiveExplore causes and timing of death from the CoreValve US Pivotal High-Risk Trial. MethodsAn 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). ResultsDifferences 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. ConclusionsMortality 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.