Optimal Degree of Oversizing for TAVR Devices Evaluated

April 20, 2015—Danny Dvir, MD, et al published findings from an analysis of the association between CT-derived degrees of device oversizing and clinical outcomes during transcatheter aortic valve replacement (TAVR) using either the Sapien XT (Edwards Lifesciences) or the CoreValve (Medtronic plc) device. The study is available online ahead of print in Catheterization and Cardiovascular Interventions.

The investigators concluded that optimal clinical performance of CoreValve and Sapien XT appears to be reached with different degrees of oversizing and that certain annular sizes that allow for only moderate or large oversizing, but not both, appear to benefit from a device-specific approach.

According to the investigators, the background of the study is that previous reports suggest that different devices reach optimal results with different degrees of device oversizing. Therefore, similarly sized devices of different types (Sapien XT and CoreValve) may be favored in different annular ranges, and a case considered borderline between two sizes of a specific device might be within a favorable range of another.

As summarized in Catheterization and Cardiovascular Interventions, the investigators evaluated a multicenter registry of 615 consecutive transfemoral TAVR procedures using either Sapien XT or CoreValve. A first group of 190 patients had annular sizes for which only moderate oversizing degree was feasible (5–20% by area or 2.5–9.5% by perimeter). A second group included 178 patients that had annulus size for which only large oversizing degree was feasible (20.1–35% by area or 9.6–16.2% by perimeter).

In the “only large oversizing feasible" group, there were more annular rupture events in patients treated by Sapien XT valve as compared to those treated by CoreValve (3.4% vs 0%; P =  .04). In the “only moderate oversizing feasible" group, those treated by CoreValve had more postballoon dilatation and 30-day major stroke in comparison with those treated by Sapien XT (16.1% vs 7.7%; P = .04 and 8% vs 1.3%; P =  .02, respectively), reported the investigators in Catheterization and Cardiovascular Interventions.