Improvement in aortic valve area using a new "hour glass" shaped valvuloplasty balloon compared with standard cylindrical balloons in severe aortic stenosis patients.

AIM: Balloon aortic valvuloplasty (BAV) has reemerged with transcatheter valve therapy. Cylindrical balloons have been the device of choice despite limitations. An hour glass shaped balloon may permit enhanced fixation and broader leaflet opening without annular compromise. METHODS: We report our initial BAV experience using the V8 balloon (InterValve Inc.) in 20 consecutive patients compared to 20 patients from a 403-patient BAV database using cylindrical balloons. Patients were propensity matched on a 1:1 basis by age, gender, left ventricular ejection fraction (LVEF), baseline aortic valve area (AVA) and Society of Thoracic Surgery (STS) mortality risk score. End points included change in AVA and aortic insufficiency (AI) by echocardiography. New atrioventricular conduction defects (AVCD), need for post procedure pacemaker were documented. Major adverse events (MAE) included procedure related death, emergency surgery or stroke. RESULTS: V8 and cylindrical balloon groups were similar across age, gender, LVEF, AVA and STS score. The change in AVA from baseline to post-procedure strongly trended towards being larger in the V8 group than cylindrical balloon group (mean [SD]; 0.30±0.23 cm2 vs. 0.17±0.21 cm2; P=0.063). There were no differences in outcomes for degree of AI, AVCD, need for pacemaker or MAE. CONCLUSION: Preliminary findings in this small experience suggest an advantage for enhancing AVA when using the V8 compared with cylindrical balloons. Additionally, there was no evidence of increased AI, AVCD or MAE.