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Procedural Safety and Device Performance of the PorticoTM Valve from Experienced TAVI Centers: 30-Day Outcomes in the Multicenter CONFIDENCE Registry

H. Mollmann, A. Linke, L. Nombela-Franco, M. Sluka, JFO. Dominguez, M. Montorfano, WK. Kim, M. Arnold, M. Vasa-Nicotera, L. Conradi, A. Camuglia, F. Bedogni, G. Manoharan

. 2022 ; 11 (16) : . [pub] 20220818

Jazyk angličtina Země Švýcarsko

Typ dokumentu časopisecké články

Perzistentní odkaz   https://www.medvik.cz/link/bmc22023499

Grantová podpora
NCT03752866 Abbott (United States)

A total of 1001 subjects (82.0 years, 62.5% female, 63.7% NYHA III/IV at baseline) with severe aortic stenosis at high surgical risk were enrolled in the prospective CONFIDENCE registry and treated with a PorticoTM transcatheter heart valve (THV) using either a first-generation delivery system (DS) or the FlexNavTM DS. The objective of this registry is to characterize the procedural safety and device performance of the PorticoTM THV at 30 days. The study collected 'standard-of-care' clinical and device performance data, with adverse events adjudicated by an independent clinical event committee according to the Valve Academic Research Consortium-2 criteria. The implantation of a single PorticoTM THV was successful in 97.5% of subjects. The 30-day all-cause mortality, cardiovascular mortality, and disabling stroke rates were 2.6%, 2.1%, and 1.8%, respectively. A new pacemaker was implanted in 19.0% of subjects at 30 days. At 30 days, the effective orifice area and mean gradient values were 1.82 cm2 and 7.1 mmHg, respectively. The 30-day rate of moderate paravalvular leak (PVL) was 2.1%, with no occurrence of severe PVL. The PorticoTM THV demonstrated improved hemodynamic performance and low rates of safety events at 30 days in a large cohort of subjects implanted with the PorticoTM THV with either the first-generation DS or FlexNavTM DS.

Citace poskytuje Crossref.org

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