Design Changes Can Explain The Trends Of Reported Adverse Events Associated With Balloon Expandable And Self-expandable Transcatheter Aortic Valves
Bruce Murphy, Travis Davis, Sam Coffey, Corinna Welker, Deirdre Moroney, Jack Halpin.
Trinity College Dublin, Dublin, Ireland.
Over the last decade transcatheter aortic valve replacement has rapidly been adopted for patients with severe aortic stenosis. However, it can be difficult to decipher the trends of adverse events associated with different device designs from the clinical literature. To this end, to give a better picture of the trends in adverse events we analysed the adverse events in the FDA MAUDE database related to multiple generations of Edwards Sapien TAVR devices and two generations of Medtronic Corevalve devices.
Data was sourced from the FDA's MAUDE database. Edwards Sapien data was retrieved over the period September 2011 to December 2012, similarly data for the Edwards SapienXT was retrieved over the period February 2014 to December 2014, and the Sapien3 data was sourced over the period July 2015 to May 2016. While data for the Medtronic Corevalve was acquired over the period February 2014 to January 2015 and data for the Corevalve Evolut-R was collected over the period July 2015 to May 2016. We analysed a total of 2,909 eligible reports. We subdivided the adverse events into 21 categories and reported the data as a % of the overall number of adverse events. Note: the %'s will not add up to 100%, as each adverse event may have more than one category e.g. more than one valve implanted and permanent pacemaker implanted could be reported in one event description.
The Edwards' valves had a significant alteration in the pattern of adverse events reported over the three generations of devices. This included: reduced malpositioning events, reduction in paravalvular leakage and central aortic insufficiency, and an increase in pacemaker implantation numbers. In the case of the Corevalve the number of second valve implantations increased, similarly paravalvular leakage events increased, while pacemaker implantation rates decreased. See the figure below.
CONCLUSIONS: We believe the alterations in the pattern of adverse events can be explained by the different design changes over the course of multiple different device generations.
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