Möllmann Helge, Linke Axel, Nombela-Franco Luis, Sluka Martin, Francisco Oteo Dominguez Juan, Montorfano Matteo, Kim Won-Keun, Arnold Martin, Vasa-Nicotera Mariuca, Fichtlscherer Stephan, Conradi Lenard, Camuglia Anthony, Bedogni Francesco, Kohli Keshav, Manoharan Ganesh
Department of Cardiology, St. Johannes Hospital, Dortmund, Germany.
Department of Internal Medicine/Cardiology, University Hospital of the Technical University of Dresden, Heart Center Dresden, Dresden, Germany.
Struct Heart. 2023 Nov 11;8(1):100226. doi: 10.1016/j.shj.2023.100226. eCollection 2024 Jan.
The CONtrolled delivery For ImproveD outcomEs with cliNiCal Evidence registry was initiated to characterize the clinical safety and device performance from experienced transcatheter aortic valve implantation (TAVI) centers in Europe and Australia that use the Portico valve to treat patients with severe aortic stenosis. We herein report for the first time the valve performance at 30-day across all implanted valve sizes and the 1-year survival from this registry.
This was a prospective, multicenter, single-arm observational clinical investigation of patients clinically indicated for implantation of a Portico valve in experienced TAVI centers. Patients were treated with a commercially available valve (size 23, 25, 27, or 29 mm) using either the first-generation delivery system (DS) (n = 501) or the second-generation (FlexNav) DS (n = 500). Adverse events were adjudicated by an independent clinical events committee according to Valve Academic Research Consortium-2 criteria. Echocardiographic outcomes were assessed at 30 days by an independent core laboratory, and a survival check was performed at 1 year.
We enrolled 1001 patients (82.0 years, 62.5% female, 63.7% New York Heart Association functional class III/IV at baseline) from 27 clinical sites in 8 countries across Europe and one site in Australia. Implantation of a single valve was successful in 97.5% of subjects. Valve hemodynamics at 30 days were substantially improved relative to baseline, with large aortic valve areas and low mean gradients across all implanted valve sizes (aortic valve areas were 1.7 ± 0.4, 1.7 ± 0.5, 1.8 ± 0.5, and 2.0 ± 0.5 cm, and mean gradients were 7.0 ± 2.7, 7.5 ± 4.7, 7.3 ± 3.3, and 6.4 ± 3.3 mmHg for 23, 25, 27, and 29 mm valve sizes, respectively). Across all implanted valve sizes, most patients (77.1%) had no patient-prosthesis mismatch. Death from any cause within 1 year occurred in 13.7% of the patients in the first-generation DS group as compared with 11.0% in the second-generation DS group ( = 0.2).
The Portico valve demonstrated excellent hemodynamic performance across all valve sizes in a large cohort of subjects implanted in experienced TAVI centers. One-year survival rates were favorable when using both the first-generation and second-generation (FlexNav) DSs in this high-risk cohort.
NCT03752866.
启动“基于临床证据的可控输送以改善结局”注册研究，旨在描述欧洲和澳大利亚经验丰富的经导管主动脉瓣植入术（TAVI）中心使用Portico瓣膜治疗严重主动脉瓣狭窄患者的临床安全性和器械性能。我们在此首次报告该注册研究中所有植入瓣膜尺寸的30天瓣膜性能及1年生存率。
这是一项针对经验丰富的TAVI中心临床适合植入Portico瓣膜患者的前瞻性、多中心、单臂观察性临床研究。患者使用第一代输送系统（DS）（n = 501）或第二代（FlexNav）DS（n = 500）植入市售瓣膜（尺寸为23、25、27或29 mm）。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标准判定。30天时由独立核心实验室评估超声心动图结果，并在1年时进行生存检查。
我们从欧洲8个国家的27个临床地点和澳大利亚的1个地点招募了1001例患者（82.0岁，62.5%为女性，基线时63.7%为纽约心脏协会功能分级III/IV级）。97.5%的受试者成功植入单个瓣膜。与基线相比，30天时瓣膜血流动力学有显著改善，所有植入瓣膜尺寸的主动脉瓣面积大且平均梯度低（23、25、27和29 mm瓣膜尺寸的主动脉瓣面积分别为1.7±0.4、1.7±0.5、1.8±0.5和2.0±0.5 cm²，平均梯度分别为7.0±2.7、7.5±4.7、7.3±3.3和6.4±3.3 mmHg）。在所有植入瓣膜尺寸中，大多数患者（77.1%）不存在患者-假体不匹配。第一代DS组13.7%的患者在1年内因任何原因死亡，第二代DS组为11.0%（P = 0.2）。
在经验丰富的TAVI中心植入的大量受试者中，Portico瓣膜在所有瓣膜尺寸上均表现出优异的血流动力学性能。在这个高危队列中，使用第一代和第二代（FlexNav）DS时1年生存率均良好。
NCT03752866。
