Darren Mylotte1, Thierry Lefevre2, Lars Søndergaard3, Yusuke Watanabe2, Thomas Modine4, Danny Dvir5, Johan Bosmans6, Didier Tchetche7, Ran Kornowski8, Jan-Malte Sinning9, Pascal Thériault-Lauzier10, Crochan J O'Sullivan11, Marco Barbanti12, Nicolas Debry4, Jean Buithieu10, Pablo Codner8, Magdalena Dorfmeister13, Giuseppe Martucci10, Georg Nickenig14, Peter Wenaweser11, Corrado Tamburino12, Eberhard Grube14, John G Webb5, Stephan Windecker11, Ruediger Lange13, Nicolo Piazza15. 1. Department of Cardiology, University Hospital Galway, Galway, Ireland; Division of Cardiology, McGill University Health Centre, Montreal, Quebec, Canada. 2. Department of Interventional Cardiology, Hopital Jacques Cartier, Massy, France. 3. Department of Cardiology, Rigshospitalet, Copenhagen, Denmark. 4. Department of Cardiovascular Surgery, Hôpital Cardiologique, Lille, France. 5. Department of Cardiology, St. Paul's Hospital, Vancouver, British Columbia, Canada. 6. Department of Cardiology, University Hospital Antwerp, Wilrijk, Belgium. 7. Department of Interventional Cardiology, Clinique Pasteur, Toulouse, France. 8. Department of Cardiology, Rabin Medical Center and Tel-Aviv University, Tel-Aviv, Israel. 9. Division of Cardiology, McGill University Health Centre, Montreal, Quebec, Canada; Department of Interventional Cardiology, Hopital Jacques Cartier, Massy, France. 10. Division of Cardiology, McGill University Health Centre, Montreal, Quebec, Canada. 11. Department of Cardiology, Bern University Hospital, Bern, Switzerland. 12. Department of Cardiology, Ferrarotto Hospital, University of Catania, Catania, Italy. 13. Department of Cardiovascular Surgery, German Heart Center, Munich, Germany. 14. Department of Cardiology, Universitätsklinikum Bonn, Rheinische Friedrich-Wilhelms-Universität Bonn, Bonn, Germany. 15. Division of Cardiology, McGill University Health Centre, Montreal, Quebec, Canada; Department of Cardiovascular Surgery, German Heart Center, Munich, Germany. Electronic address: nicolopiazza@mac.com.
Abstract
BACKGROUND: Limited information exists describing the results of transcatheter aortic valve (TAV) replacement in patients with bicuspid aortic valve (BAV) disease (TAV-in-BAV). OBJECTIVES: This study sought to evaluate clinical outcomes of a large cohort of patients undergoing TAV-in-BAV. METHODS: We retrospectively collected baseline characteristics, procedural data, and clinical follow-up findings from 12 centers in Europe and Canada that had performed TAV-in-BAV. RESULTS: A total of 139 patients underwent TAV-in-BAV with the balloon-expandable transcatheter heart valve (THV) (n = 48) or self-expandable THV (n = 91) systems. Patient mean age and Society of Thoracic Surgeons predicted risk of mortality scores were 78.0 ± 8.9 years and 4.9 ± 3.4%, respectively. BAV stenosis occurred in 65.5%, regurgitation in 0.7%, and mixed disease in 33.8% of patients. Incidence of type 0 BAV was 26.7%; type 1 BAV was 68.3%; and type 2 BAV was 5.0%. Multislice computed tomography (MSCT)-based TAV sizing was used in 63.5% of patients (77.1% balloon-expandable THV vs. 56.0% self-expandable THV, p = 0.02). Procedural mortality was 3.6%, with TAV embolization in 2.2% and conversion to surgery in 2.2%. The mean aortic gradient decreased from 48.7 ± 16.5 mm Hg to 11.4 ± 9.9 mm Hg (p < 0.0001). Post-implantation aortic regurgitation (AR) grade ≥ 2 occurred in 28.4% (19.6% balloon-expandable THV vs. 32.2% self-expandable THV, p = 0.11) but was prevalent in only 17.4% when MSCT-based TAV sizing was performed (16.7% balloon-expandable THV vs. 17.6% self-expandable THV, p = 0.99). MSCT sizing was associated with reduced AR on multivariate analysis (odds ratio [OR]: 0.19, 95% confidence intervals [CI]: 0.08 to 0.45; p < 0.0001). Thirty-day device safety, success, and efficacy were noted in 79.1%, 89.9%, and 84.9% of patients, respectively. One-year mortality was 17.5%. Major vascular complications were associated with increased 1-year mortality (OR: 5.66, 95% CI: 1.21 to 26.43; p = 0.03). CONCLUSIONS: TAV-in-BAV is feasible with encouraging short- and intermediate-term clinical outcomes. Importantly, a high incidence of post-implantation AR is observed, which appears to be mitigated by MSCT-based TAV sizing. Given the suboptimal echocardiographic results, further study is required to evaluate long-term efficacy.
BACKGROUND: Limited information exists describing the results of transcatheter aortic valve (TAV) replacement in patients with bicuspid aortic valve (BAV) disease (TAV-in-BAV). OBJECTIVES: This study sought to evaluate clinical outcomes of a large cohort of patients undergoing TAV-in-BAV. METHODS: We retrospectively collected baseline characteristics, procedural data, and clinical follow-up findings from 12 centers in Europe and Canada that had performed TAV-in-BAV. RESULTS: A total of 139 patients underwent TAV-in-BAV with the balloon-expandable transcatheter heart valve (THV) (n = 48) or self-expandable THV (n = 91) systems. Patient mean age and Society of Thoracic Surgeons predicted risk of mortality scores were 78.0 ± 8.9 years and 4.9 ± 3.4%, respectively. BAV stenosis occurred in 65.5%, regurgitation in 0.7%, and mixed disease in 33.8% of patients. Incidence of type 0 BAV was 26.7%; type 1 BAV was 68.3%; and type 2 BAV was 5.0%. Multislice computed tomography (MSCT)-based TAV sizing was used in 63.5% of patients (77.1% balloon-expandable THV vs. 56.0% self-expandable THV, p = 0.02). Procedural mortality was 3.6%, with TAV embolization in 2.2% and conversion to surgery in 2.2%. The mean aortic gradient decreased from 48.7 ± 16.5 mm Hg to 11.4 ± 9.9 mm Hg (p < 0.0001). Post-implantation aortic regurgitation (AR) grade ≥ 2 occurred in 28.4% (19.6% balloon-expandable THV vs. 32.2% self-expandable THV, p = 0.11) but was prevalent in only 17.4% when MSCT-based TAV sizing was performed (16.7% balloon-expandable THV vs. 17.6% self-expandable THV, p = 0.99). MSCT sizing was associated with reduced AR on multivariate analysis (odds ratio [OR]: 0.19, 95% confidence intervals [CI]: 0.08 to 0.45; p < 0.0001). Thirty-day device safety, success, and efficacy were noted in 79.1%, 89.9%, and 84.9% of patients, respectively. One-year mortality was 17.5%. Major vascular complications were associated with increased 1-year mortality (OR: 5.66, 95% CI: 1.21 to 26.43; p = 0.03). CONCLUSIONS:TAV-in-BAV is feasible with encouraging short- and intermediate-term clinical outcomes. Importantly, a high incidence of post-implantation AR is observed, which appears to be mitigated by MSCT-based TAV sizing. Given the suboptimal echocardiographic results, further study is required to evaluate long-term efficacy.
Authors: Ravi S Hira; Sreekanth Vemulapalli; Zhuokai Li; James M McCabe; John S Rumsfeld; Samir R Kapadia; Mahboob Alam; Hani Jneid; Creighton Don; Mark Reisman; Salim S Virani; Neal S Kleiman Journal: JAMA Cardiol Date: 2017-08-01 Impact factor: 14.676
Authors: Wolfgang von Scheidt; A Welz; M Pauschinger; T Fischlein; V Schächinger; H Treede; R Zahn; M Hennersdorf; J M Albes; R Bekeredjian; M Beyer; J Brachmann; C Butter; L Bruch; H Dörge; W Eichinger; U F W Franke; N Friedel; T Giesler; R Gradaus; R Hambrecht; M Haude; H Hausmann; M P Heintzen; W Jung; S Kerber; H Mudra; T Nordt; L Pizzulli; F-U Sack; S Sack; B Schumacher; G Schymik; U Sechtem; C Stellbrink; C Stumpf; H M Hoffmeister Journal: Clin Res Cardiol Date: 2019-08-13 Impact factor: 5.460
Authors: Karin Lavon; Gil Marom; Matteo Bianchi; Rotem Halevi; Ashraf Hamdan; Adi Morany; Ehud Raanani; Danny Bluestein; Rami Haj-Ali Journal: Med Biol Eng Comput Date: 2019-08-01 Impact factor: 2.602