Background

Limited data exist about safety and efficacy of transcatheter aortic valve replacement (TAVR) in patients with pure native aortic regurgitation (AR).

Objectives

This study sought to compare the outcomes of TAVR with early- and new-generation devices in symptomatic patients with pure native AR.

Methods

From the pure native AR TAVR multicenter registry, procedural and clinical outcomes were assessed according to VARC-2 criteria and compared between early- and new-generation devices.

Results

A total of 331 patients with a mean STS score of 6.7 ± 6.7 underwent TAVR. The early- and new-generation devices were used in 119 patients (36.0%) and 212 patients (64.0%), respectively. STS score tended to be lower in the new-generation device group (6.2 ± 6.7 vs. 7.6 ± 6.7; p = 0.08), but transfemoral access was more frequently used in the early-generation device group (87.4% vs. 60.8%; p < 0.001). Compared with the early-generation devices, the new-generation devices were associated with a significantly higher device success rate (81.1% vs. 61.3%; p < 0.001) due to lower rates of second valve implantation (12.7% vs. 24.4%; p = 0.007) and post-procedural AR ≥ moderate (4.2% vs. 18.8%; p < 0.001). There were no significant differences in major 30-day endpoints between the 2 groups. The cumulative rates of all-cause and cardiovascular death at 1-year follow-up were 24.1% and 15.6%, respectively. The 1-year all-cause mortality rate was significantly higher in the patients with post-procedural AR ≥ moderate compared with those with post-procedural AR ≤ mild (46.1% vs. 21.8%; log-rank p = 0.001). On multivariable analysis, post-procedural AR ≥ moderate was independently associated with 1-year all-cause mortality (hazard ratio: 2.85; 95% confidence interval: 1.52 to 5.35; p = 0.001).

Conclusions

Compared with the early-generation devices, TAVR using the new-generation devices was associated with improved procedural outcomes in treating patients with pure native AR. In patients with pure native AR, significant post-procedural AR was independently associated with increased mortality.

中文翻译：

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纯天然主动脉瓣返流的经导管主动脉瓣置换术

背景

关于纯天然主动脉瓣关闭不全（AR）患者经导管主动脉瓣置换术（TAVR）的安全性和有效性的数据有限。

目标

这项研究试图比较有症状的纯天然AR患者TAVR与早期和新一代设备的结局。

方法

从纯天然的AR TAVR多中心注册表中，根据VARC-2标准评估了程序和临床结果，并在早期和新一代设备之间进行了比较。

结果

总共331例平均STS评分为6.7±6.7的患者接受了TAVR。早期和新一代器械分别用于119例患者（36.0％）和212例患者（64.0％）。在新一代器械组中，STS评分往往较低（6.2±6.7与7.6±6.7； p = 0.08），但在早期器械组中，经股动脉入路更为频繁（87.4％vs. 60.8％； P <0.05）。 p <0.001）。与早期设备相比，新一代设备的第二瓣膜植入率较低（分别为12.7％和24.4％；分别为81.1％和61.3％； p <0.001），与设备成功率相关。 p = 0.007）和术后AR≥中度（4.2％vs. 18.8％； p <0.001）。两组之间的主要30天终点没有显着差异。在1年的随访中，全因和心血管死亡的累积发生率分别为24.1％和15.6％。术后AR≥中度患者的1年全因死亡率显着高于术后AR≤中度患者的1年全因死亡率（46.1％vs. 21.8％；对数秩p = 0.001）。在多变量分析中，手术后AR≥中度与1年全因死亡率独立相关（危险比：2.85； 95％置信区间：1.52至5.35； p = 0.001）。

结论

与早期设备相比，使用新一代设备的TAVR在治疗纯天然AR患者中具有改善的手术结局。在患有纯天然AR的患者中，重要的术后AR与死亡率增加独立相关。