Improvement in Aortic Valve Area in Patients With Aortic Stenosis Through Use of a New "Hourglass-Shaped" Valvuloplasty Balloon.

OBJECTIVES: The study aim was to assess the effect of hourglass-shaped V8 and TAV8 balloons (InterValve, Inc) on aortic valve area (AVA) and other outcomes in patients with severe aortic stenosis undergoing balloon aortic valvuloplasty (BAV). BAV has re-emerged with transcatheter therapy. Cylindrical balloons have been the device of choice despite limitations. The hourglass-shaped balloons, with shorter, broader segments separated by a narrowed waist, permit enhanced fixation and better leaflet opening without annular or sinotubular compromise.

METHODS: We compared outcomes of InterValve balloon use in patients undergoing BAV with outcomes of cylindrical balloon use in patients from a BAV database. Patients were propensity matched by age, gender, baseline AVA, left ventricular ejection fraction, and Society of Thoracic Surgeons mortality risk score. Endpoints included change in AVA and aortic insufficiency (AI) by echocardiography, new permanent pacemaker (PPM) implantation, and major adverse events (ie, procedural death, emergency surgery, or stroke).

RESULTS: Forty InterValve balloon patients were matched with 40 cylindrical balloon patients. Postprocedure change in AVA trended strongly in favor of InterValve balloon patients (0.29 ± 0.17 cm² vs 0.22 ± 0.15 cm²; P=.06). Maximum balloon sizes were significantly smaller for InterValve balloon patients. Worsened AI occurred less frequently with InterValve balloons. There was no difference in postprocedure PPM implantations or major adverse events.

CONCLUSIONS: Use of the hourglass-shaped balloons provided larger AVA, as compared with use of cylindrical balloons. Use of the novel balloons was not associated with an increase in AI, PPM, or major adverse events.