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J. Thorac. Cardiovasc. Surg. · Mar 2018
Multicenter Study Comparative StudyBalloon-expandable transaortic transcatheter aortic valve implantation with or without predilation.
- Nikolaos Bonaros, Markus Kofler, Derk Frank, Riccardo Cocchieri, Dariusz Jagielak, Marco Aiello, Joel Lapeze, Mika Laine, Sidney Chocron, Douglas Muir, Walter Eichinger, Matthias Thielmann, Louis Labrousse, Vinayak Bapat, Kjell Arne Rein, Jean-Philippe Verhoye, Gino Gerosa, Hardy Baumbach, Cornelia Deutsch, Peter Bramlage, Martin Thoenes, and Mauro Romano.
- Department of Cardiac Surgery, Medical University Innsbruck, Innsbruck, Austria. Electronic address: nikolaos.bonaros@i-med.ac.at.
- J. Thorac. Cardiovasc. Surg. 2018 Mar 1; 155 (3): 915-923.
ObjectiveIt has been reported that balloon aortic valvuloplasty immediately before transfemoral or transapical transcatheter aortic valve implantation has mostly little to no clinical value. We aimed to provide data on the need for balloon aortic valvuloplasty in patients undergoing transaortic transcatheter aortic valve implantation.MethodsPatients undergoing transaortic transcatheter aortic valve implantation with the Edwards SAPIEN XT (Nyon, Switzerland) or 3 transcatheter heart valve were prospectively included at 18 sites across Europe. In the present analysis, we compare the periprocedural and 30-day outcomes of patients undergoing conventional (+ balloon aortic valvuloplasty) versus direct (- balloon aortic valvuloplasty) transaortic transcatheter aortic valve implantation.ResultsOf the 300 patients enrolled, 222 underwent conventional and 78 underwent direct transaortic transcatheter aortic valve implantation. Peak and mean transvalvular gradients were improved in both groups with no significant difference between groups. Procedural duration, contrast agent volume, and requirement for postdilation were also comparable. A trend toward fewer periprocedural complications was evident in the direct group (3.9% vs 11.3%; P = .053), with significantly lower rates of permanent pacemaker implantation (0% vs 5.0%; P = .034). Balloon aortic valvuloplasty omission had no significant effect on any of the 30-day safety and efficacy outcomes, including Valve Academic Research Consortium-2 composite end points (early safety events: 22.7% vs 17.4%, odds ratio, 1.17, 95% confidence interval, 0.53-2.62; clinical efficacy events: 20.5% vs 18.7%, odds ratio, 1.14, 95% confidence interval, 0.51-2.55).ConclusionsFor many patients, balloon aortic valvuloplasty predilation seems to have little clinical value in transaortic transcatheter aortic valve implantation using a balloon expandable transcatheter valve and may result in a higher rate of periprocedural complications, particularly in terms of permanent pacemaker implantation.Copyright © 2017 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.
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