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经导管主动脉瓣置换术与外科主动脉瓣置换术在低危患者中的超声心动图结果:PARTNER 3 试验。

Echocardiographic Results of Transcatheter Versus Surgical Aortic Valve Replacement in Low-Risk Patients: The PARTNER 3 Trial.

机构信息

Institut Universitaire de Cardiologie et de Pneumologie de Québec, Canada (P.P., E.S., E.G., M.-S.A., O.T., M.B., J.B., J.T., L.K.).

Cardiovascular Research Foundation, New York, NY (A.D., E.A., M.C.A., M.B.L., R.T.H.).

出版信息

Circulation. 2020 May 12;141(19):1527-1537. doi: 10.1161/CIRCULATIONAHA.119.044574. Epub 2020 Apr 10.

Abstract

BACKGROUND

This study aimed to compare echocardiographic findings in low-risk patients with severe aortic stenosis after surgical aortic valve replacement (SAVR) or transcatheter aortic valve replacement (TAVR).

METHODS

The PARTNER 3 trial (Placement of Aortic Transcatheter Valves) randomized 1000 patients with severe aortic stenosis and low surgical risk to undergo either transfemoral TAVR with the balloon-expandable SAPIEN 3 valve or SAVR. Transthoracic echocardiograms obtained at baseline and at 30 days and 1 year after the procedure were analyzed by a consortium of 2 echocardiography core laboratories.

RESULTS

The percentage of moderate or severe aortic regurgitation (AR) was low and not statistically different between the TAVR and SAVR groups at 30 days (0.8% versus 0.2%; =0.38). Mild AR was more frequent after TAVR than SAVR at 30 days (28.8% versus 4.2%; <0.001). At 1 year, mean transvalvular gradient (13.7±5.6 versus 11.6±5.0 mm Hg; =0.12) and aortic valve area (1.72±0.37 versus 1.76±0.42 cm; =0.12) were similar in TAVR and SAVR. The percentage of severe prosthesis-patient mismatch at 30 days was low and similar between TAVR and SAVR (4.6 versus 6.3%; =0.30). Valvulo-arterial impedance (Z), which reflects total left ventricular hemodynamic burden, was lower with TAVR than SAVR at 1 year (3.7±0.8 versus 3.9±0.9 mm Hg/mL/m; <0.001). Tricuspid annulus plane systolic excursion decreased and the percentage of moderate or severe tricuspid regurgitation increased from baseline to 1 year in SAVR but remained unchanged in TAVR. Irrespective of treatment arm, high Z and low tricuspid annulus plane systolic excursion, but not moderate to severe AR or severe prosthesis-patient mismatch, were associated with increased risk of the composite end point of mortality, stroke, and rehospitalization at 1 year.

CONCLUSIONS

In patients with severe aortic stenosis and low surgical risk, TAVR with the SAPIEN 3 valve was associated with similar percentage of moderate or severe AR compared with SAVR but higher percentage of mild AR. Transprosthetic gradients, valve areas, percentage of severe prosthesis-patient mismatch, and left ventricular mass regression were similar in TAVR and SAVR. SAVR was associated with significant deterioration of right ventricular systolic function and greater tricuspid regurgitation, which persisted at 1 year. High Z and low tricuspid annulus plane systolic excursion were associated with worse outcome at 1 year whereas AR and severe prosthesis-patient mismatch were not. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02675114.

摘要

背景

本研究旨在比较主动脉瓣置换术(SAVR)或经导管主动脉瓣置换术(TAVR)后低危严重主动脉瓣狭窄患者的超声心动图表现。

方法

PARTNER 3 试验(主动脉瓣经导管置换)将 1000 名严重主动脉瓣狭窄且低手术风险的患者随机分为经股 TAVR 组和 SAVR 组,分别采用球囊扩张 SAPIEN 3 瓣膜和 SAVR。由两个超声心动图核心实验室组成的联盟分析了基线时以及手术后 30 天和 1 年时获得的经胸超声心动图。

结果

30 天时,TAVR 组和 SAVR 组中度或重度主动脉瓣反流(AR)的比例较低,且差异无统计学意义(0.8%比 0.2%;=0.38)。30 天时 TAVR 后轻度 AR 较 SAVR 更为常见(28.8%比 4.2%;<0.001)。1 年时,TAVR 和 SAVR 的跨瓣梯度(13.7±5.6 比 11.6±5.0 mm Hg;=0.12)和主动脉瓣面积(1.72±0.37 比 1.76±0.42 cm;=0.12)相似。30 天时,TAVR 和 SAVR 的重度假体-患者不匹配率较低且相似(4.6%比 6.3%;=0.30)。1 年时,TAVR 的瓣环平面收缩期位移(TAPSE)降低,中度或重度三尖瓣反流的比例从基线增加到 1 年,而 SAVR 则保持不变。无论治疗组如何,高 Z 值和低 TAPSE 与 1 年时的死亡率、卒中和再住院的复合终点相关,但中度至重度 AR 或严重假体-患者不匹配与该复合终点无关。

结论

在严重主动脉瓣狭窄且低手术风险的患者中,SAPIEN 3 瓣膜的 TAVR 与 SAVR 相比,中度或重度 AR 的比例相似,但轻度 AR 的比例较高。TAVR 和 SAVR 的跨瓣梯度、瓣面积、重度假体-患者不匹配率和左心室质量恢复相似。SAVR 与右心室收缩功能的显著恶化和更大程度的三尖瓣反流相关,这些在 1 年时仍持续存在。高 Z 值和低 TAPSE 与 1 年时的不良结局相关,而 AR 和严重假体-患者不匹配则无相关性。注册:网址:https://www.clinicaltrials.gov;唯一标识符:NCT02675114。

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