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交界区对位对瓣上自膨式经导管主动脉瓣血流动力学性能的影响。

Impact of commissural alignment on the hemodynamic performance of supra-annular self-expandable transcatheter aortic valves.

机构信息

Cardiology Department, University Clinic Hospital, Valladolid, Spain.

Centro de investigación biomédica en red - Enfermedades cardiovasculares (CIBERCV), Instituto de salud Carlos III, Madrid, Spain.

出版信息

Catheter Cardiovasc Interv. 2024 Nov;104(5):1060-1070. doi: 10.1002/ccd.31201. Epub 2024 Sep 10.

Abstract

BACKGROUND

Hemodynamic impact of commissural alignment (CA) with self-expandable transcatheter aortic valves (TAVR) has not been investigated yet.

AIMS

To determine hemodynamic impact of CA with self-expandable TAVR.

METHODS

Multicentric ambispective study comparing patients who underwent self-expandable TAVR in seven centers with the Evolut Pro/Pro+ (EP) (Medtronic) and Acurate neo2 (AN2) (Boston Scientific) with and without CA strategies. The degree of commissural misalignment (CMA) was assessed by computed tomography/angiography and 1-year transvalvular gradients/regurgitation evaluated by echocardiography. A matched comparison according to annular dimensions/eccentricity, prosthesis size/type, and baseline left ventricular function and gradients was performed.

RESULTS

A total of 557 patients, mean age 80.7 ± 6.6 years, 61.4% men, and STS score of 4.3 ± 3.1% were analyzed. A CA technique was attempted in 215 patients (38.6%), including 113 patients with AN2 and 102 patients with EP. None/mild CMA was found in 158 (73.5% vs. 43.6% if no CA attempted, p < 0.001) with no differences between devices (AN2:75.2%; EP:71.6%, p = 0.545). Patients with moderate/severe CMA had a greater aortic peak gradient (22.3 ± 8.7 vs. 19.7 ± 8.5, p = 0.001), significantly greater progression of both peak (p = 0.002) and mean gradients (p = 0.001) after matching, and higher rate of central aortic regurgitation (1.2% vs. 0.4%, p = 0.005) at 1-year, but not a greater proportion of patients with mean gradient ≥ 10 mmHg.

CONCLUSIONS

The use of CA strategies significantly reduced the rate of CMA for the self-expandable TAVR devices ACN2 and EP which was associated to lower transvalvular gradients and intra-prosthetic regurgitation progression at 1-year although no criteria of structural deterioration were met at this follow up.

CLINICALTRIALS

org: NCT05097183.

摘要

背景

尚未研究房室瓣对位(CA)对自膨式经导管主动脉瓣置换术(TAVR)血流动力学的影响。

目的

确定 CA 对自膨式 TAVR 的血流动力学影响。

方法

这项多中心前瞻性研究比较了在七个中心接受自膨式 TAVR 的患者,其中 EP(美敦力)和 AN2(波士顿科学)的 Evolut Pro/Pro+ (EP)和 Acurate neo2 (AN2)采用和不采用 CA 策略。通过计算机断层扫描/血管造影评估房室瓣对位不良(CMA)的程度,并通过超声心动图评估 1 年时跨瓣梯度/反流情况。根据瓣环尺寸/偏心度、假体尺寸/类型以及基线左心室功能和梯度进行匹配比较。

结果

共分析了 557 名患者,平均年龄为 80.7±6.6 岁,61.4%为男性,STS 评分为 4.3±3.1%。215 名(38.6%)患者尝试了 CA 技术,其中 113 名患者使用 AN2,102 名患者使用 EP。无/轻度 CMA 见于 158 名患者(如果不尝试 CA,则为 43.6%,p<0.001),且不同器械之间无差异(AN2:75.2%;EP:71.6%,p=0.545)。中/重度 CMA 患者的主动脉峰值梯度更高(22.3±8.7 比 19.7±8.5,p=0.001),匹配后峰值(p=0.002)和平均梯度的进展更显著(p=0.001),1 年时中心性主动脉反流的发生率更高(1.2%比 0.4%,p=0.005),但平均梯度≥10mmHg 的患者比例没有增加。

结论

CA 策略的应用显著降低了自膨式 TAVR 器械 ACN2 和 EP 的 CMA 发生率,这与 1 年时较低的跨瓣梯度和瓣内反流进展相关,尽管在这一随访中没有达到结构性恶化的标准。

临床试验

org:NCT05097183。

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