Reshaping bicuspid aortic valve stenosis with an hourglass‐shaped balloon for transcatheter aortic valve replacement: A pilot study

Abstract Objectives We evaluated the safety and usefulness of preparatory anatomical reshaping with a geometric hourglass‐shaped balloon to optimize transcatheter aortic valve replacement (TAVR) outcomes in bicuspid aortic valve (BAV) stenosis. Background TAVR has been increasingly performed for BAV stenosis; however, technical challenges remain. Procedural results are suboptimal given unfavorable valvular anatomies. Methods Eligible patients with BAV stenosis were enrolled to undergo aortic valve predilatation with the hourglass‐shaped TAV8 balloon before TAVR using the self‐expandable Venus A‐Valve. Procedural details and outcomes were compared to a sequential group of patients with BAV who underwent TAVR with the same device following preparatory dilatation using a cylindrical balloon. Results A total of 22 patients were enrolled in the TAV8 group and 53 were included in the control group. Valve downsizing was less common in the TAV8 group (36.4 vs. 67.9%; p = .012). Stable valve release and optimal implant depth were consistently achieved in the TAV8 group with no requirement for a second valve (0 vs. 17.0%; p = .039) and with higher device success rates (100.0 vs 77.4%; p = .014). Residual aortic regurgitation graded as ≥mild was less common in the TAV8 group (13.6 vs 45.3%; p = .009). Mortality was similar (0 vs. 3.8%; p = 1); no major/disabling stroke or conversion to open‐heart surgery was seen in either group within 30 days. Conclusions Compared with standard cylindrical balloon valvuloplasty, preparatory reshaping with the hourglass‐shaped balloon before self‐expandable TAVR in BAV was associated with significantly better procedural results and may encourage more promising outcomes.