title: Comparison of the Edwards SAPIEN S3 Versus Medtronic Evolut-R Devices for Transcatheter Aortic Valve Implantation.
abstract: 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.
authors.affiliation: Department of Cardiology, Tel-Aviv Sourasky Medical Center Affiliated to the Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel. Electronic address: be.jeremy@gmail.com.
authors.forename: Jeremy
authors.initials: J
authors.lastname: Ben-Shoshan
authors.affiliation: Department of Cardiology, Tel-Aviv Sourasky Medical Center Affiliated to the Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel.
authors.forename: Maayan
authors.initials: M
authors.lastname: Konigstein
authors.affiliation: Department of Cardiology, Tel-Aviv Sourasky Medical Center Affiliated to the Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel.
authors.forename: David
authors.initials: D
authors.lastname: Zahler
authors.affiliation: Department of Cardiology, Tel-Aviv Sourasky Medical Center Affiliated to the Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel.
authors.forename: Gilad
authors.initials: G
authors.lastname: Margolis
authors.affiliation: Department of Cardiology, Tel-Aviv Sourasky Medical Center Affiliated to the Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel.
authors.forename: Ehud
authors.initials: E
authors.lastname: Chorin
authors.affiliation: Department of Cardiology, Tel-Aviv Sourasky Medical Center Affiliated to the Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel.
authors.forename: Arie
authors.initials: A
authors.lastname: Steinvil
authors.affiliation: Department of Cardiology, Tel-Aviv Sourasky Medical Center Affiliated to the Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel.
authors.forename: Yaron
authors.initials: Y
authors.lastname: Arbel
authors.affiliation: Department of Cardiology, Tel-Aviv Sourasky Medical Center Affiliated to the Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel.
authors.forename: Galit
authors.initials: G
authors.lastname: Aviram
authors.affiliation: Department of Cardiology, Tel-Aviv Sourasky Medical Center Affiliated to the Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel.
authors.forename: Yoav
authors.initials: Y
authors.lastname: Granot
authors.affiliation: Department of Cardiology, Tel-Aviv Sourasky Medical Center Affiliated to the Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel.
authors.forename: Michael
authors.initials: M
authors.lastname: Barkagan
authors.affiliation: Department of Cardiology, Tel-Aviv Sourasky Medical Center Affiliated to the Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel.
authors.forename: Gad
authors.initials: G
authors.lastname: Keren
authors.affiliation: Department of Cardiology, Tel-Aviv Sourasky Medical Center Affiliated to the Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel.
authors.forename: Amir
authors.initials: A
authors.lastname: Halkin
authors.affiliation: Department of Cardiology, Tel-Aviv Sourasky Medical Center Affiliated to the Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel.
authors.forename: Shmuel
authors.initials: S
authors.lastname: Banai
authors.affiliation: Department of Cardiology, Tel-Aviv Sourasky Medical Center Affiliated to the Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel.
authors.forename: Ariel
authors.initials: A
authors.lastname: Finkelstein
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001024:Aortic Valve Stenosis / Q000150:complications / Q000401:mortality / Q000628:therapy*; D005260:Female; D005500:Follow-Up Studies; D006350:Heart Valve Prosthesis; D006801:Humans; D008297:Male; D011474:Prosthesis Design; D012189:Retrospective Studies; D015996:Survival Rate; D013997:Time Factors; D065467:Transcatheter Aortic Valve Replacement / Q000295:instrumentation*; D016896:Treatment Outcome