Nikolaos Bonaros1, Markus Kofler2, Derk Frank3, Riccardo Cocchieri4, Dariusz Jagielak5, Marco Aiello6, Joel Lapeze7, Mika Laine8, Sidney Chocron9, Douglas Muir10, Walter Eichinger11, Matthias Thielmann12, Louis Labrousse13, Vinayak Bapat14, Kjell Arne Rein15, Jean-Philippe Verhoye16, Gino Gerosa17, Hardy Baumbach18, Cornelia Deutsch19, Peter Bramlage19, Martin Thoenes20, Mauro Romano21. 1. Department of Cardiac Surgery, Medical University Innsbruck, Innsbruck, Austria. Electronic address: nikolaos.bonaros@i-med.ac.at. 2. Department of Cardiac Surgery, Medical University Innsbruck, Innsbruck, Austria. 3. Department of Internal Medicine III (Cardiology and Angiology) UKSH, Campus Kiel, Kiel, Germany. 4. Heart Centre, Academic Medical Centre, University of Amsterdam, Amsterdam, The Netherlands. 5. Department of Cardiac and Vascular Surgery, Medical University of Gdansk, Gdansk, Poland. 6. Department of Cardiothoracic Surgery, Foundation IRCCS Policlinico S Matteo, Pavia University School of Medicine, Pavia, Italy. 7. Department of Cardiovascular Surgery, Hospital Louis Pradel, Lyon, France. 8. Division of Cardiology, Helsinki University Central Hospital, Helsinki, Finland. 9. Cardiothoracic Surgery, Hospital Jean Minjoz, University Hospital of Besancon, Besancon, France. 10. Cardiothoracic Division, James Cook Hospital, Middlesbrough, United Kingdom. 11. Department of Cardiothoracic Surgery, Klinikum Bogenhausen, Munich, Germany. 12. Department of Thoracic and Cardiovascular Surgery, West-German Heart Centre, University Hospital Essen, Essen, Germany. 13. Department of Cardiovascular Surgery, CHU Hospital of Bordeaux, Bordeaux, France. 14. St Thomas' Hospital, London, United Kingdom. 15. Department of Cardiothoracic Surgery, Rikshospital Oslo, Oslo, Norway. 16. Department of Cardiovascular Surgery, CHU Rennes, Rennes, France. 17. Department of Cardiac Surgery, University of Padova, Padova, Italy. 18. Department of Cardiovascular Surgery, Robert-Bosch-Krankenhaus Stuttgart, Stuttgart, Germany. 19. Institute for Pharmacology and Preventive Medicine, Cloppenburg, Germany. 20. Edwards Lifesciences, Medical Affairs/Professional Education, Nyon, Switzerland. 21. Institut Hospitalier Jacques Cartier, Massy, France.
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.
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.
Authors: Jannik Ole Ashauer; Nikolaos Bonaros; Markus Kofler; Gerhard Schymik; Christian Butter; Mauro Romano; Vinayak Bapat; Justus Strauch; Holger Schröfel; Andreas Busjahn; Cornelia Deutsch; Peter Bramlage; Jana Kurucova; Martin Thoenes; Stephan Baldus; Tanja K Rudolph Journal: BMC Cardiovasc Disord Date: 2019-07-19 Impact factor: 2.298
Authors: Gerhard Schymik; Tanja Rudolph; Claudius Jacobshagen; Jürgen Rothe; Hendrik Treede; Sebastian Kerber; Derk Frank; Lenka Sykorova; Maki Okamoto; Martin Thoenes; Cornelia Deutsch; Peter Bramlage; Christian Butter Journal: Open Heart Date: 2019-10-03