Causes of death in intermediate-risk patients: The Randomized Surgical Replacement and Transcatheter Aortic Valve Implantation Trial

Abstract

Objectives: Examine the causes and timing of death in the Surgical Replacement and Transcatheter Aortic Valve Implantation intermediate-risk randomized trial for transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR).

Methods: Causes of death were adjudicated by an independent clinical event committee and by post-hoc hierarchical classification. Causes of death were evaluated and characteristics and procedural parameters compared between patients who died and survivors for 3 time periods: early (0-30 days), recovery (31-120 days), and late (121-365 days).

Results: All-cause mortality at 1 year was 6.5% after TAVR and 6.7% after SAVR. There were no differences in mortality rates between TAVR and SAVR for any of the 3 time periods. Early mortality was primarily due to technical, procedure-related problems in TAVR and due to complications in SAVR. For TAVR and SAVR, most deaths during recovery were caused by complications. Other causes, including comorbid conditions, accounted for most late deaths.

Conclusions: Mortality rates were similar for patients treated with TAVR or SAVR at any time period including at 1 year. Early cause of death was more commonly technical failure after TAVR and due to complications after SAVR. Recovery phase cause of death was dominated by complications from TAVR and SAVR. Late cause of death appeared to be independent of the procedure in both groups.

Keywords: causes of death; intermediate risk; surgical aortic valve replacement; transcatheter aortic valve replacement.