背景:使用SAPIEN3瓣膜的经皮肺动脉瓣植入术(PPVI)可有效治疗右心室流出道(RVOT)功能障碍。使用保护性瓣膜递送方法开发了一种无需预支架的改良技术。我们旨在比较改良技术组(MTG)与常规技术组(CTG)患者的手术结果。
方法:我们设计了匹配的前后研究。所有连续PPVI与SAPIEN3在MTG中进行了9个月以上的匹配,根据RVOT类型和大小,以前使用SAPIEN3执行的连续程序。
结果:共纳入54例患者,平均分布在两组中。SAPIEN3瓣膜的尺寸为23毫米(n=9),26毫米(n=9),29mm(n=36)。两组的人口统计数据相似,RVOT类型,术前血流动力学.PPVI在MTG的所有患者中进行了一次手术,而CTG组的6例(22.2%)患者首先进行了支架置入术,然后进行了瓣膜植入术(p=0.02).程序在所有情况下都是成功的。据报道,CTG中有2例患者(7.4%)发生支架栓塞,影响了肺动脉。在一种情况下(3.7%),在MTG中,不稳定的29mmSAPIEN3瓣膜通过两个支架和额外的瓣内瓣膜植入术来稳定.所有病例的血流动力学结果都很好,两组之间无显著差异。MTG的手术持续时间和透视时间显著减少(48.1对82.6分钟,p<0.0001;15.2对29.8分钟,p=0.0002)。随访期间,两组均未发现支架骨折和瓣膜功能障碍。
结论:PPVI无支架置入和SAPIEN3瓣膜的保护性输送方法显著降低了手术的复杂性,持续时间,和照射,同时保持良好的血液动力学结果在选定的情况下。
BACKGROUND: Percutaneous pulmonary valve implantation (PPVI) with a SAPIEN 3 valve is effective for treating treat right ventricle outflow (RVOT) dysfunction. A modified technique was developed without prestenting using a protective valve delivery method. We aimed to compare the procedural results of the modified technique group (MTG) to those of patients in a conventional technique group (CTG).
METHODS: We designed a matched before-after
study. All consecutive PPVI with SAPIEN 3 performed in the MTG over 9 months were matched, based on the RVOT type and size, to consecutive procedures performed previously with SAPIEN 3.
RESULTS: A total of 54 patients were included, equally distributed in the two groups. The sizes of the SAPIEN 3 valves were 23 mm (n = 9), 26 mm (n = 9), 29 mm (n = 36). The two groups were similar regarding demographic data, RVOT type, and pre-procedure hemodynamics. PPVI was performed in a single procedure in all patients of the MTG, whereas six (22.2%) patients of the CTG group underwent prestenting as a first step and valve implantation later (p = 0.02). The procedures were successful in all cases. Stent embolization was reported in two patients (7.4%) in the CTG, which were impacted in pulmonary arteries. In one case (3.7%), in the MTG, an unstable 29 mm SAPIEN 3 valve was stabilized with two stents and additional valve-in-valve implantation. The hemodynamics results were good in all cases, without significant differences between the two groups. The procedures\' durations and fluoroscopy times were significantly reduced in the MTG (48.1 versus 82.6 min, p < 0.0001; 15.2 versus 29.8 min, p = 0.0002). During follow-up, neither stent fracture nor valve dysfunction was noticed in either group.
CONCLUSIONS: PPVI without prestenting and with a protective delivery method of the SAPIEN 3 valve significantly reduces the procedure\'s complexity, the duration, and the irradiation while maintaining excellent hemodynamics results in selected cases.