Background

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]).

Aim

To compare the safety and efficacy of TF-TAVI performed with the PCI approach versus the regular approach.

Methods

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 30 days 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.

Results

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).

Conclusions

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.

中文翻译：

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采用类似经皮冠状动脉介入治疗的方法进行经股动脉主动脉瓣植入术的可行性和安全性

背景

经股经皮经导管主动脉瓣植入术 (TF-TAVI) 是一种安全、可重复且成熟的手术，主要在局部麻醉下进行，主要由专门的麻醉团队进行管理和监测（常规方法）。我们中心制定了标准化的护理途径，并为符合条件的患者选择了极简的 TF-TAVI，完全由操作员管理，手术室中没有麻醉团队，就像大多数冠状动脉介入手术一样（“经皮冠状动脉介入术”方法 [PCI 方法]）。

目的

比较 PCI 方法与常规方法进行的 TF-TAVI 的安全性和有效性。

方法

分析人群包括 2016 年 11 月至 2019 年 7 月在我们机构接受 PCI 或常规方法 TF-TAVI 的所有患者。 两个共同主要终点是 Valve Academic 定义的30天早期安全性复合终点和早期疗效复合终点研究联盟-2。使用基于倾向评分的治疗加权逆概率方法比较PCI ( n  =  137) 和常规 ( n  =  221) 方法。

结果

比较 TAVI 与 PCI 或常规方法在复合安全终点（7.3% 对 11.3%；优势比 0.63，95% 置信区间 0.37 至 1.07；P  =  0.086）或复合疗效终点（ 4.4% 与 6.3%；优势比为 0.78，95% 置信区间为 0.41 至 1.49；P  =  0.45）。

结论

该研究表明，对于选定患者，完全由 PCI 方法管理的 TF-TAVI 的有效性和安全性与在全麻护理团队的参与下进行 TF-TAVI 时的疗效和安全性没有什么不同。PCI 方法似乎是一种安全有效的临床路径，提供了对麻醉学资源的适当和合理利用，可用于大多数 TF-TAVI 程序。