Comparison of Post-Procedural and 30-day Post-Implantation Transcatheter Aortic Valve Replacement Gradients with and without pre-implantation Balloon Valvuloplasty: A Real-World Analysis of Early Results using a Novel Balloon Expandable Transcatheter Aortic Valve

Objectives: This study describes a real-world experience of implanting a novel balloon expandable transcatheter aortic valve replacement (TAVR) compared to devices commonly used in clinical practice. As a secondary objective, the effect of balloon angioplasty (BAV) before TAVR on the transvalvular gradient 1 and 30 days after implantation was evaluated. Background: For most commercial TAVR valves, the 30-day average mean aortic valve gradients have been reported. Our experience with the Lotus Valve System had indicated higher immediate post-implant gradients than those in the literature. We sought to evaluate both these valves, comparing them to other valves. Methods: We analyzed discharge and 30-day echocardiograms of Lotus valves from 7/5/2019 to 8/27/2020. In response to higher-than-expected post-implant gradients, patients from 11/4/19 to 8/27/20 underwent BAV before the valve implantation, whereas patients from 7/5/19 to 10/18/19 did not (no-BAV). We compared these samples to each other and to a random sampling of TAVR valves implanted by the same interventionalist. Results: At discharge, 27 patients received Lotus valves. The average mean aortic valve gradient was 16.7 mmHg (SD = 5.5 mmHg) for the no-BAV and 14.7 mmHg (SD = 3.7 mmHg) for the BAV (P = 0.177) cohorts. No-BAV Lotus valve mean gradients were significantly higher (P < 0.001) than those of the Sapien valve (M = 12 mmHg, SD = 4.3) and CoreValve (M = 9.18 mmHg, SD = 3.96). At the 30-day assessment, the mean gradients in the no-BAV and BAV groups were similar to those in the literature (M = 11 mmHg SD 3.5; M = 12 mmHg, SD 4.1 (P = 0.287)) and those of other valves. Conclusions: The Lotus valve demonstrated higher post-implantation gradients than other valves. This effect was not attenuated by BAV. These elevated gradients were not significant at the 30-day follow-up.