Outcomes of transfemoral balloon expandable transcatheter aortic valve implantation: Comparison of two subsequent valve generations.

Schymik G, Wendler O, Hengstenberg C, Ohlmann P, Gilard M, Digne F, Souteyrand G, Letocart V, Van Belle E, Bramlage P, Tarantini G (2020)

Publication Type: Journal article

Publication year: 2020

Journal

Catheterization and Cardiovascular Interventions Wiley-Blackwell

Book Volume: 96

Pages Range: 930-939

Journal Issue: 4

DOI: 10.1002/ccd.28621

Abstract

BACKGROUND: The SAPIEN 3 (S3) addresses several limitations of the SAPIEN XT (SXT) for the performance of transfemoral (TF-) balloon expandable transcatheter aortic valve implantation (TAVI). OBJECTIVES: We aimed to determine whether their altered features translate into improved outcomes in a real-world TF-TAVI patient population. METHODS: Data for 3,314 patients were extracted from the European registries SOURCE-XT and SOURCE-3. Patients were propensity-score (PS) matched (n = 1,169/group). RESULTS: In the PS matched comparison, device success was higher in the S3 (99.2%) compared to the SXT group (98.2%; p = .04). S3 patients experienced a lower rate of procedural death (0.7 vs. 2.6%; p = .0004), moderate/severe paravalvular leakage (PVL; 1.4 vs. 5.5%; p < .0001), and procedure-related stroke (1.2 vs. 2.4%; p = .04) while higher rates of mean aortic valve gradients ≥20 mmHg, and new permanent pacemaker implantations were seen. At 30 days a lower rate of all-cause mortality was seen (2.1% vs. 4.3%; p = .003), which was preserved after 1 year (10.7% vs. 14.9%; p = .002). A Cox regression predicting 1-year mortality resulted in a hazard ratio of 0.684 in favor of S3 (p = .0026). The same was true of stroke (2.8% vs. 5.7%; p = .0007), and moderate/severe PVL (2.7 vs. 7.3%; p = .0002) at 1 year. The rate of new pacemaker implantations (13.6% vs. 9.5%; p = .001) and NYHA III/IV (12.8 vs. 8.6%; p = .004) was higher with the S3. CONCLUSIONS: The improved features of the S3 appear to translate into improved survival and reduced rates of adverse complications, with the exception of a higher rate of new pacemaker implantations.

Involved external institutions

Städtisches Klinikum Karlsruhe DE Germany (DE) Medizinische Universität Wien AT Austria (AT) King's Health Partners GB United Kingdom (GB) L'Hôpital de la Cavale Blanche á Brest FR France (FR) Centre Hospitalier Régional Universitaire de Lille (CHRU de Lille) FR France (FR) University of Padua / Universita degli Studi di Padova IT Italy (IT) Universitätsklinikum Clermont-Ferrand / University Hospital of Clermont-Ferrand FR France (FR) Hôpitaux universitaires de Strasbourg (HUS) / University Hospital Strasbourg FR France (FR) Centre Cardiologique du Nord (CCN) FR France (FR) Nantes University Hospital / Centre hospitalier universitaire de Nantes (CHU) FR France (FR) Institut für Pharmakologie und präventive Medizin (IPPMed GmbH) DE Germany (DE)

How to cite

APA:

Schymik, G., Wendler, O., Hengstenberg, C., Ohlmann, P., Gilard, M., Digne, F.,... Tarantini, G. (2020). Outcomes of transfemoral balloon expandable transcatheter aortic valve implantation: Comparison of two subsequent valve generations. Catheterization and Cardiovascular Interventions, 96(4), 930-939. https://dx.doi.org/10.1002/ccd.28621

MLA:

Schymik, Gerhard, et al. "Outcomes of transfemoral balloon expandable transcatheter aortic valve implantation: Comparison of two subsequent valve generations." Catheterization and Cardiovascular Interventions 96.4 (2020): 930-939.

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