Abstract

Background

The comparative mid and long-term durability, including the rates of bioprosthetic valve failure (BVF) of the Sapien XT^® and Sapien 3^® transcatheter heart valve (THV) in patients with intermediate surgical risk has not been reported.

Methods

Consecutive intermediate-risk patients with severe aortic stenosis from the Mexican registry of transcatheter aortic valve replacement (TAVR) with Sapien^® THVs were included. The primary endpoint was to compare the BVF rate between THVs at 2 years of follow-up. Secondary endpoints were comparisons of the composite of global mortality, cardiovascular mortality, and neurological events at 30 d and 24 months of follow-up.

Results

During 2014–2019, 115 (60 Sapien XT^® and 55 Sapien 3^®) patients met the inclusion criteria in five medical centres. The mean age was 77.3 ± 8.4 years. The average Society of Thoracic Surgeons Predicted Risk of Mortality (STS-PROM) was 5.6 ± 2.9. There was no statistically significant difference between the groups in BVF rate. At 30 d, overall, cardiovascular and non-cardiovascular mortality was 4.3%, 2.6%, and 1.7%, respectively. Neurological events rate was 1.73%. The mean long-term follow-up was 25.3 ± 14.2 months with an overall mortality of 9.56% but lower for the Sapien 3^® group (15% vs. 3.6%, p=.037). The only independent predictor of composite mortality and neurological events that occurred in the long term was using a Sapien XT^® [OR 1.6, CI 95%, 1.0–24.9; p=.049].

Conclusions

The BVF rate at 25 months of follow-up was similar with the XT and S3 systems. During this follow-up period, the major composite events of death from any cause and neurological events were significantly lower with the S3 system.

中文翻译：

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生物瓣失效。两种球囊扩张式经导管心脏瓣膜系统在中危患者中的比较试验：倾向评分分析

摘要

背景

^{Sapien XT ®}和 Sapien 3 ^®经导管心脏瓣膜 (THV) 在中度手术风险患者中的中长期耐久性比较，包括生物瓣膜衰竭 (BVF) 的发生率尚未见报道。

方法

^{包括来自墨西哥经导管主动脉瓣置换术 (TAVR) 登记处使用 Sapien ®} THV 的连续中度风险严重主动脉瓣狭窄患者。主要终点是在 2 年的随访中比较 THV 之间的 BVF 率。次要终点是在 30 天和 24 个月的随访中比较全球死亡率、心血管死亡率和神经系统事件的复合终点。

结果

2014-2019 年间，5 个医疗中心的 115 名（60 名 Sapien XT ^®和 55 名 Sapien 3 ^®）患者符合纳入标准。平均年龄为 77.3 ± 8.4 岁。胸外科医师协会平均预测死亡风险 (STS-PROM) 为 5.6 ± 2.9。BVF率各组间差异无统计学意义。在 30 天时，总体而言，心血管和非心血管死亡率分别为 4.3%、2.6% 和 1.7%。神经系统事件发生率为 1.73%。平均长期随访时间为 25.3 ± 14.2 个月，总死亡率为 9.56%，但 Sapien 3 ^®组的死亡率较低（15%对3.6%，p=.037)。长期发生的复合死亡率和神经系统事件的唯一独立预测因子是使用 Sapien XT ^® [OR 1.6, CI 95%, 1.0–24.9; p =.049]。

结论

XT 和 S3 系统在 25 个月的随访中的 BVF 率相似。在此随访期间，使用 S3 系统的全因死亡和神经系统事件的主要复合事件显着降低。