Department of Interventional Cardiology for Coronary, Valves and Structural Heart Diseases, Cardiology, Institut Cœur Poumon, CHU de Lille, Université Lille, 59037 Lille, France.
ULR 2694, METRICS: Évaluation des Technologies de Santé et des Pratiques Médicales, Université de Lille, Département de Biostatistiques, CHU de Lille, 59000 Lille, France.
Arch Cardiovasc Dis. 2021 Aug-Sep;114(8-9):537-549. doi: 10.1016/j.acvd.2020.12.007. Epub 2021 Apr 22.
Transfemoral percutaneous transcatheter aortic valve implantation (TF-TAVI) is a safe, reproducible and established procedure, mainly performed under local anaesthesia, which is mostly administered and monitored by a dedicated anaesthesia team (regular approach). Our centre has developed a standardized pathway of care, and eligible patients are selected for a minimalist TF-TAVI, entirely managed by operators without the presence of the anaesthesia team in the operating room, like most interventional coronary procedures ("percutaneous coronary intervention-like" approach [PCI approach]).
To compare the safety and efficacy of TF-TAVI performed with the PCI approach versus the regular approach.
The analysis population comprised all patients who underwent TF-TAVI with the PCI or regular approach in our institution from November 2016 to July 2019. The two co-primary endpoints were early safety composite and early efficacy composite at 30days as defined by the Valve Academic Research Consortium-2. The PCI (n=137) and Regular (n=221) approaches were compared using the propensity score based method of inverse probability of treatment weighting.
No differences were observed after comparison of TAVI performed with the PCI or regular approach regarding the composite safety endpoint (7.3% vs. 11.3%; odds ratio 0.63, 95% confidence interval 0.37 to 1.07; P=0.086) or the composite efficacy endpoint (4.4% vs. 6.3%; odds ratio 0.78, 95% confidence interval 0.41 to 1.49; P=0.45).
This study suggests that the efficacy and safety of TF-TAVI entirely managed by a PCI approach for selected patients are not different to those when TF-TAVI is performed with the attendance of a full anaesthesia care team. The PCI approach appears to be a safe and efficient clinical pathway, providing an appropriate and rational utilization of anaesthesiology resources, and could be used for the majority of TF-TAVI procedures.
经股动脉经导管主动脉瓣植入术(TF-TAVI)是一种安全、可重复和成熟的手术,主要在局部麻醉下进行,由专门的麻醉团队进行管理和监测(常规方法)。我们中心制定了一套标准化的护理流程,选择合适的患者进行极简式 TF-TAVI,手术过程中没有麻醉团队在场,由操作者全权管理,就像大多数介入性冠状动脉手术一样(“经皮冠状动脉介入治疗样”方法[PCI 方法])。
比较经皮冠状动脉介入治疗样方法与常规方法行 TF-TAVI 的安全性和疗效。
分析人群包括 2016 年 11 月至 2019 年 7 月在我院接受 TF-TAVI 的所有患者,采用 PCI 或常规方法。两个主要复合终点为 30 天的早期安全性复合终点和早期疗效复合终点,定义为 Valve Academic Research Consortium-2。采用倾向评分逆概率治疗加权法比较 PCI(n=137)和常规(n=221)方法。
比较 PCI 与常规方法行 TAVI 后,复合安全性终点(7.3% vs. 11.3%;比值比 0.63,95%置信区间 0.37 至 1.07;P=0.086)或复合疗效终点(4.4% vs. 6.3%;比值比 0.78,95%置信区间 0.41 至 1.49;P=0.45)均无差异。
本研究表明,对于选定的患者,完全由 PCI 方法管理的 TF-TAVI 的疗效和安全性与有完整麻醉团队参与时行 TF-TAVI 无差异。PCI 方法似乎是一种安全有效的临床途径,合理利用了麻醉资源,可用于大多数 TF-TAVI 手术。