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.

Procedural and clinical outcomes of transcatheter aortic valve replacement in bicuspid aortic valve patients: a systematic review and meta-analysis

“…Previous studies have identified several procedural and patient specific variables that may impact the mortality and clinical outcomes in BAV patients undergoing TAVR. These include BAV morphology and degree of calcification, device type/generation, radiological features and surgical approach (14,30,59,(61)(62)(63). Additionally, longterm follow-up data was not included in this study, due to the lack of available studies in the current literature.…”

Application research of three-dimensional transesophageal echocardiography in predicting prosthetic valve size for transcatheter aortic valve implantation

“…Because the bicuspid valve often has an elliptical annulus, severe and asymmetric valve calcification, unequal leaflets, a widened ascending aortic internal diameter, and a leaflet opening smaller than the annular internal diameter, these pathological changes are likely to result in a poor TAVI valve implantation position, poor valve stent expansion, and perivalvular residual leakage. To address these issues, some experts have proposed "supra-annular structure assessment", "supra-annular sizing", and "reshaping TAVR" (6,21,22), whose main idea is to select the valve size based on the leaflet structure and recommended valve size in terms of the annular size to prevent poor valve expansion and rupture of the aortic root structure due to oversized prosthetic valves. Based on the aforementioned suggestion, the present study reduced the intraoperative selection of the prosthetic valve size for the bicuspid aortic valve by 1 valve size compared with the measured annular diameter, and the actual intraoperative implantation of the valve will take into account additional factors in selecting the valve size.…”

The Predictors of Conduction Disturbances Following Transcatheter Aortic Valve Replacement in Patients With Bicuspid Aortic Valve: A Multicenter Study

“…In our single center analysis, the TAVR outcome in bicuspid patients was feasible with high device success rate of 84.5% and good performance even with first generation devices. Several recent studies have also suggested the safety and effectiveness of prosthesis undersizing based on supra-annular sizing methods ( 8 , 10 , 38 , 39 ). LIRA method, known as Level of Implantation at the RAphe (LIRA) method, was applicated in 20 raphe-type BAV patients.…”