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 Portico™ transcatheter heart valve (THV) using either a first-generation delivery system (DS) or the FlexNav™ DS. The objective of this registry is to characterize the procedural safety and device performance of the Portico™ 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 Portico™ 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 Portico™ THV demonstrated improved hemodynamic performance and low rates of safety events at 30 days in a large cohort of subjects implanted with the Portico™ THV with either the first-generation DS or FlexNav™ DS.

Cardiovascular Institute Hospital Clinico San Carlos Instituto de Investigación Sanitaria Hospital Clínico San Carlos 28040 Madrid Spain

Department of Cardiology Friedrich Alexander Universität Erlangen Nuremberg 91054 Erlangen Germany

Department of Cardiology IRCCS Policlinico San Donato 20097 Milan Italy

Department of Cardiology Royal Victoria Hospital Belfast BT12 6BA UK

Department of Cardiology St Johannes Hospital 44137 Dortmund Germany

Department of Cardiology The Wesley Hospital Brisbane QLD 4066 Australia

Department of Cardiology University of Queensland Brisbane QLD 4072 Australia

Department of Cardiovascular Surgery University Heart and Vascular Center 20251 Hamburg Germany

Department of Medicine Cardiology University Hospital Olomouc 779 00 Olomouc Czech Republic

Interventional Cardiology Unit Hospital Universitario Puerta de Hierro Hospital 28222 Madrid Spain

Interventional Cardiology Unit IRCCS Ospedale San Raffaele 20132 Milan Italy

Kerckhoff Heart and Thorax Centre 61231 Bad Nauheim Germany

Klinik für Innere Medizin Kardiologie Universitätsklinik Technische Universität Dresden Herzzentrum Dresden Fetscherstraße 76 01307 Dresden Germany

Klinikum der Johann Wolfgang Goethe Universitaet Frankfurt 60596 Frankfurt Germany

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Valve Hemodynamics by Valve Size and 1-Year Survival Following Implantation of the Portico Valve in the Multicenter CONFIDENCE Registry