John Webb1, Gino Gerosa2, Thierry Lefèvre3, Jonathon Leipsic4, Mark Spence5, Martyn Thomas6, Matthias Thielmann7, Hendrik Treede8, Olaf Wendler9, Thomas Walther10. 1. St. Paul's Hospital, University of British Columbia, Vancouver, Canada. Electronic address: john.webb@vch.ca. 2. Policlinico Universitario, Padova, Italy. 3. Institut Jacques Cartier, Massy, France. 4. St. Paul's Hospital, University of British Columbia, Vancouver, Canada. 5. Royal Victoria Hospital, Belfast, Northern Ireland, United Kingdom. 6. St. Thomas' Hospital, London, United Kingdom. 7. Universitätsklinikum Essen, Essen, Germany. 8. Universitätsklinikum Eppendorf, Hamburg, Germany. 9. King's College Hospital, London, United Kingdom. 10. Kerckhoff Clinic, Bad Nauheim, Germany.
Abstract
BACKGROUND: The SAPIEN 3 (Edwards Lifesciences Inc., Irvine, California) transcatheter valve incorporates features designed to address the well-known deficiencies of transcatheter aortic valve replacement (TAVR). An ultra-low-profile delivery system facilitates safe, controlled, and accurate implantation and an external seal minimizes paravalvular regurgitation. OBJECTIVES: The study evaluated whether TAVR with this third-generation valve would be a viable alternative to high- or intermediate-risk surgery for severe aortic stenosis. METHODS: The prospective study enrolled 150 patients at 16 sites in Europe and Canada. Clinical and echocardiographic outcomes were assessed at baseline, post-procedure, and 30 days. New sizing recommendations were developed during the course of the study. RESULTS: Patients were 83.6 ± 5.0 years of age, with multiple comorbidities reflected by a Society of Thoracic Surgeons score of 7.4 ± 4.5% and logistic EuroSCORE of 21.6 ± 12.3%. A transfemoral approach was chosen in 64.0% and alternative access (transapical/direct aortic) in the remainder. At 30 days, paravalvular regurgitation was none to mild in 96.4% and moderate in 3.5%. No patient had severe regurgitation. Transfemoral implantation was associated with low mortality (2.1%), no disabling stroke (0.0%), and fully percutaneous access and closure in 95.8%. Nontransfemoral alternative access was associated with higher rates of mortality (11.6%) and stroke (5.6%). CONCLUSIONS: This third-generation device addresses major deficiencies of earlier valves in terms of ease of use, accuracy of positioning, and paravalvular sealing. The rates of mortality and stroke with transfemoral access are among the lowest reported and support further evaluation as an alternative to open surgery in intermediate-risk patients. (Safety and Performance Study of the Edwards SAPIEN 3 Transcatheter Heart Valve [SAPIEN3]; NCT01808287).
BACKGROUND: The SAPIEN 3 (Edwards Lifesciences Inc., Irvine, California) transcatheter valve incorporates features designed to address the well-known deficiencies of transcatheter aortic valve replacement (TAVR). An ultra-low-profile delivery system facilitates safe, controlled, and accurate implantation and an external seal minimizes paravalvular regurgitation. OBJECTIVES: The study evaluated whether TAVR with this third-generation valve would be a viable alternative to high- or intermediate-risk surgery for severe aortic stenosis. METHODS: The prospective study enrolled 150 patients at 16 sites in Europe and Canada. Clinical and echocardiographic outcomes were assessed at baseline, post-procedure, and 30 days. New sizing recommendations were developed during the course of the study. RESULTS:Patients were 83.6 ± 5.0 years of age, with multiple comorbidities reflected by a Society of Thoracic Surgeons score of 7.4 ± 4.5% and logistic EuroSCORE of 21.6 ± 12.3%. A transfemoral approach was chosen in 64.0% and alternative access (transapical/direct aortic) in the remainder. At 30 days, paravalvular regurgitation was none to mild in 96.4% and moderate in 3.5%. No patient had severe regurgitation. Transfemoral implantation was associated with low mortality (2.1%), no disabling stroke (0.0%), and fully percutaneous access and closure in 95.8%. Nontransfemoral alternative access was associated with higher rates of mortality (11.6%) and stroke (5.6%). CONCLUSIONS: This third-generation device addresses major deficiencies of earlier valves in terms of ease of use, accuracy of positioning, and paravalvular sealing. The rates of mortality and stroke with transfemoral access are among the lowest reported and support further evaluation as an alternative to open surgery in intermediate-risk patients. (Safety and Performance Study of the Edwards SAPIEN 3 Transcatheter Heart Valve [SAPIEN3]; NCT01808287).
Authors: Won-Keun Kim; Johannes Blumenstein; Christoph Liebetrau; Andreas Rolf; Luise Gaede; Arnaud Van Linden; Mani Arsalan; Mirko Doss; Jan G P Tijssen; Christian W Hamm; Thomas Walther; Helge Möllmann Journal: Clin Res Cardiol Date: 2017-08-09 Impact factor: 5.460