Altayyeb Yousef1, Trevor Simard1, John Webb2, Josep Rodés-Cabau3, Charis Costopoulos4, Janusz Kochman5, José M Hernández-Garcia6, Paul T L Chiam7, Robert C Welsh8, Harindra C Wijeysundera9, Eulogio García10, Henrique B Ribeiro3, Azeem Latib11, Zenon Huczek5, Miriam Shanks8, Luca Testa12, Michael E Farkouh13, Danny Dvir2, James L Velianou14, Buu-Khanh Lam1, Ali Pourdjabbar1, Christopher Glover1, Benjamin Hibbert1, Marino Labinaz15. 1. Division of Cardiology, University of Ottawa Heart Institute, Ottawa, Ontario, Canada. 2. Division of Cardiology, St. Paul's Hospital, University of British Columbia, Vancouver, British Columbia, Canada. 3. Quebec Heart and Lung Institute, Quebec City, Quebec, Canada. 4. Interventional Cardiology Unit, San Raffaele Scientific Institute, Milan, Italy; Interventional Cardiology Unit, EMO-GVM Centro Cuore Columbus, Milan, Italy; Interventional Cardiology Unit, Imperial College London, London, United Kingdom. 5. Ist Department of Cardiology, The Medical University of Warsaw, Poland. 6. Hospital Universitario Virgen de la Victoria, Málaga, Spain. 7. Department of Cardiology, National Heart Centre Singapore, The Heart And Vascular Centre, Mount Elizabeth Medical Centre, Singapore. 8. Department of Cardiology, Mazankowski Alberta Heart Institute, University of Alberta, Alberta, Canada. 9. Schulich Heart Center, Department of Medicine, Sunnybrok Health Sciences Center, University of Toronto, Toronto, Ontario, Canada; Institute for Clinical Evaluative Sciences (ICES), Toronto, Canada; Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, Canada. 10. Hospital Universitario Clínico San Carlos, Madrid, Spain. 11. Interventional Cardiology Unit, San Raffaele Scientific Institute, Milan, Italy; Interventional Cardiology Unit, EMO-GVM Centro Cuore Columbus, Milan, Italy. 12. Department of Cardiology, IRCCS Pol. San Donato, San Donato Milanese, Milan, Italy. 13. Peter Munk Center, University Health Network, Toronto, Ontario, Canada; Richard Lewar Centre in Cardiovascular Research, University of Toronto, Toronto, Ontario, Canada. 14. Hamilton Health Sciences, McMaster University, Hamilton, Ontario, Canada. 15. Division of Cardiology, University of Ottawa Heart Institute, Ottawa, Ontario, Canada. Electronic address: mlabinaz@ottawaheart.ca.
Abstract
OBJECTIVE: We sought to evaluate the safety and efficacy of transcatheter aortic valve implantation (TAVI) in patients with bicuspid aortic valve (BiAV). BACKGROUND: BiAV remains a relative contraindication to TAVI resulting in exclusion from TAVI trials and thus limiting data on the clinical performance of transcatheter valves in these patients. METHODOLOGY: We conducted an international patient level multicenter analysis on outcomes in patients with BiAV undergoing TAVI. The primary outcome of the study was the combined early safety endpoint--a composite of 30 day mortality, stroke, life-threatening bleeding, acute kidney injury, coronary artery obstruction, major vascular complication and valve related dysfunction. Secondary endpoints included the individual components of the primary endpoint as well as post-TAVI paravalvular leak (PVL), rehospitalization, new pacemaker insertion and device success rates at 30 days and 1 year. RESULTS: A total of 108 patients with BiAV were identified in 21 centers in Canada, Spain, Italy, Poland and Singapore who underwent TAVI between January 2005 and March 2014. The composite primary outcome occurred in one quarter of patients (26.9%)--mainly driven by re-intervention for valve malposition (9.3%). The 30-day and 1 year mortality rates were 8.3% and 16.9% respectively with AR ≥ 3+ occurring in 9.6% of patients. Device success was achieved in 85.2% of cases with pacemaker insertion in 19.4%. While PVL was not associated with an increased risk of 30 day or 1 year mortality--Type I BiAV anatomy with left and right cusp fusion had significantly better outcomes than other valve variants. CONCLUSION: In selected patients with BiAV and severe aortic stenosis, TAVI appears both safe and feasible with acceptable clinical outcomes. Clinical studies of TAVI in this patient population are warranted.
OBJECTIVE: We sought to evaluate the safety and efficacy of transcatheter aortic valve implantation (TAVI) in patients with bicuspid aortic valve (BiAV). BACKGROUND: BiAV remains a relative contraindication to TAVI resulting in exclusion from TAVI trials and thus limiting data on the clinical performance of transcatheter valves in these patients. METHODOLOGY: We conducted an international patient level multicenter analysis on outcomes in patients with BiAV undergoing TAVI. The primary outcome of the study was the combined early safety endpoint--a composite of 30 day mortality, stroke, life-threatening bleeding, acute kidney injury, coronary artery obstruction, major vascular complication and valve related dysfunction. Secondary endpoints included the individual components of the primary endpoint as well as post-TAVI paravalvular leak (PVL), rehospitalization, new pacemaker insertion and device success rates at 30 days and 1 year. RESULTS: A total of 108 patients with BiAV were identified in 21 centers in Canada, Spain, Italy, Poland and Singapore who underwent TAVI between January 2005 and March 2014. The composite primary outcome occurred in one quarter of patients (26.9%)--mainly driven by re-intervention for valve malposition (9.3%). The 30-day and 1 year mortality rates were 8.3% and 16.9% respectively with AR ≥ 3+ occurring in 9.6% of patients. Device success was achieved in 85.2% of cases with pacemaker insertion in 19.4%. While PVL was not associated with an increased risk of 30 day or 1 year mortality--Type I BiAV anatomy with left and right cusp fusion had significantly better outcomes than other valve variants. CONCLUSION: In selected patients with BiAV and severe aortic stenosis, TAVI appears both safe and feasible with acceptable clinical outcomes. Clinical studies of TAVI in this patient population are warranted.
Authors: Antonio H Frangieh; Jonathan Michel; Oliver Deutsch; Michael Joner; Costanza Pellegrini; Tobias Rheude; Sabine Bleiziffer; Albert Markus Kasel Journal: Clin Res Cardiol Date: 2018-06-14 Impact factor: 5.460
Authors: Bo Fu; Qingliang Chen; Feng Zhao; Zhigang Guo; Nan Jiang; Xu Wang; Wei Wang; Jiange Han; Li Yang; Yanbo Zhu; Yanhe Ma Journal: Ann Transl Med Date: 2020-07