Complications after Self-Expanding Transcatheter or Surgical Aortic Valve Replacement

Abstract Objectives Procedural complications following transcatheter (TAVR) or surgical aortic valve replacement (SAVR) are usually reported as retrospective analyses. We report the first comparison of complications following SAVR or self-expanding TAVR from a prospectively randomized study of high risk SAVR patients. Methods A total of 395 TAVR and 402 SAVR patients were prospectively enrolled and randomized 1:1 to TAVR with a CoreValve bioprosthesis or a surgical bioprosthetic valve. The rates of major procedural and vascular complications occurring (periprocedurally (0-3 days) and early (4-30 days)) were compared for TAVR vs SAVR patients. Results All-cause mortality, stroke, myocardial infarction and major infection were similar in both periods post-procedure. Within 0-3 days, the major vascular complication rate was significantly higher with TAVR (p=0.003). Life-threatening or disabling bleeding (p