Balloon-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 BramlageMartin Thoenes, Mauro Romano

Research output: Contribution to journalArticle

Abstract

OBJECTIVE: It 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.

METHODS: Patients 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.

RESULTS: Of 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).

CONCLUSIONS: For 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.

Original languageEnglish
Pages (from-to)915-923
Number of pages9
JournalJournal of Thoracic and Cardiovascular Surgery
Volume155
Issue number3
DOIs
Publication statusPublished - Mar 2018

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Balloon Valvuloplasty
Odds Ratio
Confidence Intervals
Safety
Heart Valves
Switzerland
Contrast Media
Transcatheter Aortic Valve Replacement
Research

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Balloon-expandable transaortic transcatheter aortic valve implantation with or without predilation. / Bonaros, Nikolaos; Kofler, Markus; Frank, Derk; Cocchieri, Riccardo; Jagielak, Dariusz; Aiello, Marco; Lapeze, Joel; Laine, Mika; Chocron, Sidney; Muir, Douglas; Eichinger, Walter; Thielmann, Matthias; Labrousse, Louis; Bapat, Vinayak; Rein, Kjell Arne; Verhoye, Jean-Philippe; Gerosa, Gino; Baumbach, Hardy; Deutsch, Cornelia; Bramlage, Peter; Thoenes, Martin; Romano, Mauro.

In: Journal of Thoracic and Cardiovascular Surgery, Vol. 155, No. 3, 03.2018, p. 915-923.

Research output: Contribution to journalArticle

Bonaros, N, Kofler, M, Frank, D, Cocchieri, R, Jagielak, D, Aiello, M, Lapeze, J, Laine, M, Chocron, S, Muir, D, Eichinger, W, Thielmann, M, Labrousse, L, Bapat, V, Rein, KA, Verhoye, J-P, Gerosa, G, Baumbach, H, Deutsch, C, Bramlage, P, Thoenes, M & Romano, M 2018, 'Balloon-expandable transaortic transcatheter aortic valve implantation with or without predilation', Journal of Thoracic and Cardiovascular Surgery, vol. 155, no. 3, pp. 915-923. https://doi.org/10.1016/j.jtcvs.2017.10.071
Bonaros, Nikolaos ; Kofler, Markus ; Frank, Derk ; Cocchieri, Riccardo ; Jagielak, Dariusz ; Aiello, Marco ; Lapeze, Joel ; Laine, Mika ; Chocron, Sidney ; Muir, Douglas ; Eichinger, Walter ; Thielmann, Matthias ; Labrousse, Louis ; Bapat, Vinayak ; Rein, Kjell Arne ; Verhoye, Jean-Philippe ; Gerosa, Gino ; Baumbach, Hardy ; Deutsch, Cornelia ; Bramlage, Peter ; Thoenes, Martin ; Romano, Mauro. / Balloon-expandable transaortic transcatheter aortic valve implantation with or without predilation. In: Journal of Thoracic and Cardiovascular Surgery. 2018 ; Vol. 155, No. 3. pp. 915-923.
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author = "Nikolaos Bonaros and Markus Kofler and Derk Frank and Riccardo Cocchieri and Dariusz Jagielak and Marco Aiello and Joel Lapeze and Mika Laine and Sidney Chocron and Douglas Muir and Walter Eichinger and Matthias Thielmann and Louis Labrousse and Vinayak Bapat and Rein, {Kjell Arne} and Jean-Philippe Verhoye and Gino Gerosa and Hardy Baumbach and Cornelia Deutsch and Peter Bramlage and Martin Thoenes and Mauro Romano",
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T1 - Balloon-expandable transaortic transcatheter aortic valve implantation with or without predilation

AU - Bonaros, Nikolaos

AU - Kofler, Markus

AU - Frank, Derk

AU - Cocchieri, Riccardo

AU - Jagielak, Dariusz

AU - Aiello, Marco

AU - Lapeze, Joel

AU - Laine, Mika

AU - Chocron, Sidney

AU - Muir, Douglas

AU - Eichinger, Walter

AU - Thielmann, Matthias

AU - Labrousse, Louis

AU - Bapat, Vinayak

AU - Rein, Kjell Arne

AU - Verhoye, Jean-Philippe

AU - Gerosa, Gino

AU - Baumbach, Hardy

AU - Deutsch, Cornelia

AU - Bramlage, Peter

AU - Thoenes, Martin

AU - Romano, Mauro

N1 - Copyright © 2017 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.

PY - 2018/3

Y1 - 2018/3

N2 - OBJECTIVE: It 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.METHODS: Patients 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.RESULTS: Of 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).CONCLUSIONS: For 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.

AB - OBJECTIVE: It 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.METHODS: Patients 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.RESULTS: Of 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).CONCLUSIONS: For 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.

U2 - 10.1016/j.jtcvs.2017.10.071

DO - 10.1016/j.jtcvs.2017.10.071

M3 - Article

C2 - 29221741

VL - 155

SP - 915

EP - 923

JO - Journal of Thoracic and Cardiovascular Surgery

JF - Journal of Thoracic and Cardiovascular Surgery

SN - 0022-5223

IS - 3

ER -