Computed Tomography Geometry of Extremely Undersized SAPIEN 3 Transcatheter Aortic Valves With Balloon Overfilling

Abstract

Overfilling the balloon-expandable Sapien 3/Ultra (S3) transcatheter heart valves in undersized aortic valve anatomies is associated with favorable outcomes. The expansion of S3 valves beyond nominal values is feasible on benchtop testing. Still, a dearth of information exists on the actual valve area achieved when these valves are filled beyond nominal volumes. We herein assess post-transcatheter aortic valve replacement (TAVR) computed tomography (CT) derived geometry of overfilled, extremely undersized balloon-expandable transcatheter heart valves. A total of 23 patients (mean age 76±7.2 years, 17.4% female) treated had annular undersizing: 10.3±2.0% for 23mm, 7.8±4.8% for 26mm and 12.3±6.3% for 29mm. The mean volumes added to 23mm, 26mm, and 29mm S3 valves were 1.9±0.3 mL, 2.2±0.7mL, 3.2 ±1.3 mL, respectively. CT analysis at 30 days found that no valve achieved an expansion index >1 at the mid-frame portion, i.e., greater than the respective valve’s nominal valve area, but 29mm S3 had an expansion index >1 at inflow and outflow. Aortic valve gradients were favourable, and there was no moderate/severe PVL or transvalvular regurgitation at 30-day follow-up. We hypothesize that the approach of undersizing for annular anatomies and overfilling the balloon may achieve more optimal valve expansion.