Comparison of the Edwards SAPIEN S3 Versus Medtronic Evolut-R Devices for Transcatheter Aortic Valve Implantation

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• 作者：Jeremy Ben-Shoshan ; MD ; PhD ; ^{be.jeremy@gmail.com} ; Maayan Konigstein ; MD ; David Zahler ; MD ; Gilad Margolis ; MD ; Ehud Chorin ; MD ; PhD ; Arie Steinvil ; MD ; Yaron Arbel ; MD ; Galit Aviram ; MD ; Yoav Granot ; MD ; Michael Barkagan ; MD ; Gad Keren ; MD ; Amir Halkin ; MD ; Shmuel Banai ; MD ; Ariel Finkelstein ; MD
• 刊名：The American Journal of Cardiology
• 出版年：2017
• 出版时间：15 January 2017
• 年：2017
• 卷：119
• 期：2
• 页码：302-307
• 全文大小：322 K
• 卷排序：119

文摘

New generation of the most widely used devices for transcatheter aortic valve implantation have been recently introduced into practice. We compare the short-term outcomes of transcatheter aortic valve implantation with the Edwards SAPIEN S3 and the Medtronic Evolut-R. We performed a retrospective analysis from a single high-volume tertiary center. Valve Academic Research Consortium-2 criteria were used to define composite end points of device success and safety at 30 days. Study population included 232 patients implanted with the SAPIEN S3 (n = 124) and Evolut-R (n = 108). Device success reached 91.9% and 95.4% in the SAPIEN S3 and Evolut-R groups, respectively (p = 0.289). Postprocedural echocardiography showed greater aortic valve gradients (22.8 ± 7 vs 16 ± 9 mm Hg, p <0.001) among SAPIEN S3 group. Paravalvular leak of ≥ moderate severity was observed in 2.4% and 0% in the SAPIEN S3 and Evolut-R groups, respectively (p = 0.251). Similar rates of in-hospital complications, including major bleedings, vascular complications, and pacemaker implantations were recorded in both groups. At 30-day follow-up, the combined safety end point was reached in 5.6% and in 6.5% of patients in the SAPIEN S3 and Evolut-R groups, respectively (p = 0.790). During follow-up of 237 ± 138 days, all-cause mortality was higher in patients implanted with Evolut-R compared with SAPIEN S3 (7 vs 1 cases, respectively, p = 0.006), however, cardiovascular mortality was not significantly different between groups. In conclusions, in a single-center comparative analysis, comparable rate of device success as well as safety profile and long-term cardiovascular mortality were observed with the SAPIEN S3 and Evolut-R valves.