Sung-Han Yoon1, Thierry Lefèvre2, Jung-Ming Ahn3, Gidon Y Perlman4, Danny Dvir4, Azeem Latib5, Marco Barbanti6, Florian Deuschl7, Ole De Backer8, Philipp Blanke4, Thomas Modine9, Gregor Pache10, Franz-Josef Neumann11, Philipp Ruile11, Takahide Arai2, Yohei Ohno6, Hidehiro Kaneko12, Edgar Tay13, Niklas Schofer7, Erik W Holy14, Ngai H V Luk8, Gerald Yong15, Qingsheng Lu16, William K F Kong17, Jimmy Hon13, Hsien-Li Kao18, Michael Lee19, Wei-Hsian Yin20, Duk-Woo Park1, Soo-Jin Kang1, Seung-Whan Lee1, Young-Hak Kim1, Cheol Whan Lee1, Seong-Wook Park1, Hyo-Soo Kim21, Christian Butter12, Omar K Khalique22, Ulrich Schaefer7, Fabian Nietlispach14, Susheel K Kodali22, Martin B Leon22, Jian Ye4, Bernard Chevalier2, Jonathon Leipsic4, Victoria Delgado18, Jeroen J Bax18, Corrado Tamburino6, Antonio Colombo5, Lars Søndergaard8, John G Webb4, Seung-Jung Park1. 1. Division of Cardiology, University of Ulsan, Asan Medical Center, Seoul, Korea. 2. Générale de Santé, Institut Cardiovasculaire Paris Sud, Hôpital Privé Jacques Cartier, Massy, France. 3. Division of Cardiology, University of Ulsan, Asan Medical Center, Seoul, Korea. Electronic address: drjmahn@gmail.com. 4. Department of Cardiology, St Paul's Hospital, University of British Columbia, Vancouver, British Columbia, Canada. 5. Interventional Cardiology Unit, EMO-GVM Centro Cuore Columbus & San Raffaele Scientific Institute, Milan, Italy San Raffaele Hospital, Milan, Italy. 6. Division of Cardiology, Ferrarotto Hospital, University of Catania, Catania, Italy. 7. Department for General and Interventional Cardiology, University Heart Center, University Hospital Hamburg-Eppendorf (UKE), Hamburg, Germany. 8. The Heart Centre, Rigshospitalet University Hospital, Copenhagen, Denmark. 9. Department of Cardiovascular Surgery, Hospital Cardiologique, Lille, France. 10. Department of Radiology, Section of Cardiovascular Radiology, University of Freiburg, Bad Krozingen, Germany. 11. Department of Cardiology & Angiology II, University Heart Center Freiburg-Bad Krozingen, Bad Krozingen, Germany. 12. Heart Center Brandenburg in Bernau, Bernau, Germany. 13. Department of Cardiology, National University Heart Centre, Singapore. 14. University Heart Center, Cardiology and Cardiovascular Surgery, University Hospital Zürich, Zurich, Switzerland. 15. Division of Cardiology, Royal Perth Hospital, Perth, Western Australia, Australia. 16. Division of Vascular Surgery, Changhai Hospital, Shanghai, China. 17. Department of Cardiology, National University Heart Centre, Singapore; Department of Cardiology, Leiden University Medical Center, Leiden, the Netherlands. 18. Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan. 19. Division of Cardiology, Queen Elizabeth Hospital, Kowloon, Hong Kong. 20. Division of Cardiology, Heart Center, Cheng Hsin General Hospital, Taipei, Taiwan. 21. Department of Internal Medicine and Cardiovascular Center, Seoul National University Hospital, Seoul, Korea. 22. Columbia University Medical Center/New York Presbyterian Hospital, New York, New York.
Abstract
BACKGROUND: Few studies have evaluated the clinical outcomes of transcatheter aortic valve replacement (TAVR) in patients with bicuspid aortic valve stenosis (AS). Particularly, limited data exist comparing the results of TAVR with new-generation devices versus early-generation devices. OBJECTIVES: This study sought to evaluate the clinical outcomes of TAVR for bicuspid AS with early- and new-generation devices. METHODS: The Bicuspid TAVR Registry is an international multicenter study enrolling consecutive patients with bicuspid AS undergoing TAVR between April 2005 and May 2015. RESULTS: Of 301 patients, 199 patients (71.1%) were treated with early-generation devices (Sapien XT [Edwards Lifesciences Corporation, Irvine, California]: n = 87; CoreValve [Medtronic, Minneapolis, Minnesota]: n = 112) and 102 with new-generation devices (Sapien 3 [Edwards Lifesciences Corporation]: n = 91; Lotus [Boston Scientific Corporation, Marlborough, Massachusetts]: n = 11). The mean Society of Thoracic Surgeons score was 4.7 ± 5.2 without significant differences between groups (4.6 ± 5.1 vs. 4.9 ± 5.4; p = 0.57). Overall, all-cause mortality rates were 4.3% at 30 days and 14.4% at 1 year. Moderate or severe paravalvular leak was absent and significantly less frequent with new-generation compared to early-generation devices (0.0% vs. 8.5%; p = 0.002), which resulted in a higher device success rate (92.2% vs. 80.9%; p = 0.01). There were no differences between early- and new-generation devices in stroke (2.5% vs. 2.0%; p > 0.99), life-threatening bleeding (3.5% vs. 2.9%; p > 0.99), major vascular complication (4.5% vs. 2.9%; p = 0.76), stage 2 to 3 acute kidney injury (2.5% vs. 2.9%; p > 0.99), early safety endpoints (15.1% vs. 10.8%; p = 0.30), and 30-day all-cause mortality (4.5% vs. 3.9%; p > 0.99). CONCLUSIONS: The clinical outcomes of TAVR in patients with bicuspid AS were favorable. New-generation devices were associated with less paravalvular leak and, hence, a higher device success rate than early-generation devices. (The Bicuspid Aortic Stenosis Following Transcatheter Aortic Valve Replacement Registry [Bicuspid TAVR]; NCT02394184).
BACKGROUND: Few studies have evaluated the clinical outcomes of transcatheter aortic valve replacement (TAVR) in patients with bicuspid aortic valve stenosis (AS). Particularly, limited data exist comparing the results of TAVR with new-generation devices versus early-generation devices. OBJECTIVES: This study sought to evaluate the clinical outcomes of TAVR for bicuspid AS with early- and new-generation devices. METHODS: The Bicuspid TAVR Registry is an international multicenter study enrolling consecutive patients with bicuspid AS undergoing TAVR between April 2005 and May 2015. RESULTS: Of 301 patients, 199 patients (71.1%) were treated with early-generation devices (Sapien XT [Edwards Lifesciences Corporation, Irvine, California]: n = 87; CoreValve [Medtronic, Minneapolis, Minnesota]: n = 112) and 102 with new-generation devices (Sapien 3 [Edwards Lifesciences Corporation]: n = 91; Lotus [Boston Scientific Corporation, Marlborough, Massachusetts]: n = 11). The mean Society of Thoracic Surgeons score was 4.7 ± 5.2 without significant differences between groups (4.6 ± 5.1 vs. 4.9 ± 5.4; p = 0.57). Overall, all-cause mortality rates were 4.3% at 30 days and 14.4% at 1 year. Moderate or severe paravalvular leak was absent and significantly less frequent with new-generation compared to early-generation devices (0.0% vs. 8.5%; p = 0.002), which resulted in a higher device success rate (92.2% vs. 80.9%; p = 0.01). There were no differences between early- and new-generation devices in stroke (2.5% vs. 2.0%; p > 0.99), life-threatening bleeding (3.5% vs. 2.9%; p > 0.99), major vascular complication (4.5% vs. 2.9%; p = 0.76), stage 2 to 3 acute kidney injury (2.5% vs. 2.9%; p > 0.99), early safety endpoints (15.1% vs. 10.8%; p = 0.30), and 30-day all-cause mortality (4.5% vs. 3.9%; p > 0.99). CONCLUSIONS: The clinical outcomes of TAVR in patients with bicuspid AS were favorable. New-generation devices were associated with less paravalvular leak and, hence, a higher device success rate than early-generation devices. (The Bicuspid Aortic Stenosis Following Transcatheter Aortic Valve Replacement Registry [Bicuspid TAVR]; NCT02394184).
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