Reshaping bicuspid aortic valve stenosis with an hourglass-shaped balloon for transcatheter aortic valve replacement: A pilot study.
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.
['Zhao|Zhen-Gang|ZG|', 'Feng|Yuan|Y|', 'Liao|Yan-Biao|YB|', 'Li|Yi-Jian|YJ|', 'Xiong|Tian-Yuan|TY|', 'Ou|Yuan-Weixiang|YW|', 'Wang|Zi-Jie|ZJ|', 'Wei|Jia-Fu|JF|', 'Peng|Yong|Y|', 'Wei|Xin|X|', 'Xu|Yuan-Ning|YN|', 'Pedersen|Wesley R|WR|', 'Chen|Mao|M|', 'Leon|Martin B|MB|']
D000368:Aged D000369:Aged, 80 and over D001024:Aortic Valve Stenosis D063126:Balloon Valvuloplasty D000082882:Bicuspid Aortic Valve Disease D005260:Female D006350:Heart Valve Prosthesis D006801:Humans D008297:Male D010865:Pilot Projects D011183:Postoperative Complications D012307:Risk Factors D065467:Transcatheter Aortic Valve Replacement D016896:Treatment Outcome
dilatation balloon valvuloplasty aortic valve insufficiency