TY - JOUR
T1 - Improvement in Aortic Valve Area in Patients with Aortic Stenosis Through Use of a New "hourglass-Shaped" Valvuloplasty Balloon
AU - Goldenberg, Elizabeth
AU - Pedersen, Wesley
AU - Brilakis, Emmanouil S.
AU - Mooney, Michael
AU - Gössl, Mario
AU - Poulose, Anil
AU - Murad, Bilal
AU - Kolbeck, James
AU - Sorajja, Paul
N1 - Copyright:
Copyright 2018 Elsevier B.V., All rights reserved.
PY - 2017/12
Y1 - 2017/12
N2 - 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.
AB - 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.
KW - Balloon aortic valvuloplasty
KW - new device
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M3 - Article
C2 - 29207363
AN - SCOPUS:85037834390
SN - 1042-3931
VL - 29
SP - 411
EP - 415
JO - Journal of Invasive Cardiology
JF - Journal of Invasive Cardiology
IS - 12
ER -