Abstract 20126: Associations of Known Complications of Transcatheter Implantation of Balloon-expandable Edwards-Sapien XT Aortic Valves With Peri-procedural Mortality - An Insight From the 2014-2015 Reports From the FDA MAUDE Database

Abstract

Background: Transcatheter implantation of aortic valves (TAVR) has revolutionized the management of severe aortic stenosis. However, specific complications have been noted with the valves. Details of such were sought from the US Food and Drug Administration (FDA) maintained MAUDE database which houses medical device reports submitted to the FDA by mandatory reporters (manufacturers, importers and device user facilities) and voluntary reporters such as health care professionals, patients and consumers. Methods: A detailed search was conducted in PubMed, Cochrane Library, EMBASE and CINAHL to identify adverse events reported with the implantation of the Edwards-Sapien XT valves. Then the FDA MAUDE database was queried from June 2014 to May 2015 to identify prevalence of the same complications as reported to the FDA. Individual patient reports were identified and relevant data on such complications were abstracted. Finally, mortality outcomes from such patients were abstracted, and associations of these for each individual reported complication were identified in a multivariate logistic regression model. Results: FDA MAUDE revealed 730 unique reports of complications with the first- generation Edwards-Sapien valves. A total of 106 patients died peri-procedurally. The complications most strongly associated with peri-procedural mortality were development of peri-procedural vascular complications, need for permanent pacemaker, renal failure, atrial fibrillation, stroke, need for surgical valve implantation and need for valve in valve procedure. (Table 1) Conclusions: Specific complications with the new Edwards XT valves were strongly associated with mortality, and focused strategies to mitigate these complications may improve outcomes with future generations of this exciting new technology.