Unità Operativa di Interventistica Cardiovascolare, Pineta Grande Hospital, Via Domitiana km 30.00, 81030 Castel Volturno, Italy.
J Invasive Cardiol. 2021 Jun;33(6):E474-E478. doi: 10.25270/jic/20.00513. Epub 2021 May 10.
Transcatheter aortic valve implantation (TAVI) is a safe and beneficial treatment for patients with severe symptomatic aortic stenosis at high and intermediate surgical risk. Success rates for TAVI continue to increase due to more refined procedural approaches and devices, and above all, to the improvements in procedural knowledge by TAVI operators. The development of a new delivery system represents an important evolutionary process in the TAVI procedure, both for the type of device and for the operators, as it may substantially expand indications, success rates, and safety. FlexNav (Abbott Cardiovascular) is a novel delivery system designed to improve ease and precision of TAVI using the Abbott Portico valve. Despite limited results on its advantages, such as those provided in the PORTICO investigational device exemption substudy, uncertainty persists on the actual role of FlexNav in real-world practice.
We hereby present our preliminary experience with FlexNav in a consecutive series of 18 patients undergoing TAVI with Portico valve in early 2020 (3 with axillary access). Procedural results were excellent, as shown by the absence of deaths, strokes, and major vascular complications (95% confidence interval, 0%-18.5%), and pacemaker implantation in 3 subjects (21.4%; 95% confidence interval, 4.7%-50.8%).
Despite the small sample size, the present case series suggests that adoption of the FlexNav novel delivery system for TAVI with Portico valve is feasible and safe, and holds the promise of further improving early and long-term results of this procedure.
经导管主动脉瓣植入术(TAVI)是一种安全且有益的治疗方法,适用于高风险和中风险的严重症状性主动脉瓣狭窄患者。由于更精细的手术方法和器械的应用,以及最重要的是 TAVI 操作人员手术知识的提高,TAVI 的成功率不断提高。新输送系统的发展是 TAVI 手术的一个重要演进过程,无论是对于器械类型还是操作人员而言,因为它可能会大大扩大适应证、成功率和安全性。FlexNav(雅培心血管)是一种新型输送系统,旨在使用雅培 Portico 瓣膜提高 TAVI 的简便性和精确性。尽管在 PORTICO 研究性器械豁免子研究中提供了一些关于其优势的有限结果,但对于 FlexNav 在实际实践中的实际作用仍然存在不确定性。
我们在此介绍了我们在 2020 年初对 18 例接受 Portico 瓣膜 TAVI 的连续患者使用 FlexNav 的初步经验(3 例采用腋动脉入路)。手术结果非常出色,无死亡、中风和主要血管并发症(95%置信区间,0%-18.5%),3 例患者(21.4%;95%置信区间,4.7%-50.8%)需要植入起搏器。
尽管样本量较小,但本病例系列表明,采用 FlexNav 新型输送系统进行 Portico 瓣膜 TAVI 是可行且安全的,并有望进一步改善该手术的早期和长期结果。