Mollmann Helge, Linke Axel, Nombela-Franco Luis, Sluka Martin, Dominguez Juan Francisco Oteo, Montorfano Matteo, Kim Won-Keun, Arnold Martin, Vasa-Nicotera Mariuca, Conradi Lenard, Camuglia Anthony, Bedogni Francesco, Manoharan Ganesh
Department of Cardiology, St. Johannes Hospital, 44137 Dortmund, Germany.
Klinik für Innere Medizin/Kardiologie, Universitätsklinik Technische Universität Dresden, Herzzentrum Dresden Fetscherstraße 76, 01307 Dresden, Germany.
J Clin Med. 2022 Aug 18;11(16):4839. doi: 10.3390/jcm11164839.
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 cm 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.
共有1001名具有高手术风险的严重主动脉瓣狭窄患者（年龄82.0岁，女性占62.5%，基线时63.7%为纽约心脏协会III/IV级）被纳入前瞻性CONFIDENCE注册研究，并使用第一代输送系统（DS）或FlexNav™ DS接受Portico™经导管心脏瓣膜（THV）治疗。该注册研究的目的是描述Portico™ THV在30天时的手术安全性和器械性能。该研究收集了“标准治疗”的临床和器械性能数据，不良事件由独立临床事件委员会根据瓣膜学术研究联盟-2标准进行判定。97.5%的受试者成功植入了单个Portico™ THV。30天全因死亡率、心血管死亡率和致残性卒中发生率分别为2.6%、2.1%和1.8%。30天时，19.0%的受试者植入了新的起搏器。30天时，有效瓣口面积和平均压差分别为1.82 cm和7.1 mmHg。30天中度瓣周漏（PVL）发生率为2.1%，未发生严重PVL。在一大群使用第一代DS或FlexNav™ DS植入Portico™ THV的受试者中，Portico™ THV在30天时显示出改善的血流动力学性能和低安全事件发生率。
