经胸超声心动图测量二尖瓣瓣环交界间距指导二尖瓣球囊成形术的随机对照研究

Percutaneous mitral valvuloplasty using echocardiographic intercommissural diameter as reference for balloon sizing: a randomized controlled trial.

机构信息

Cardiovascular Intervention Research Center, Rajaei Cardiovascular, Medical and Research Center, Tehran University of Medical Sciences, Tehran, Iran.

出版信息

Clin Cardiol. 2012 Dec;35(12):749-54. doi: 10.1002/clc.22013. Epub 2012 Jun 6.

DOI:10.1002/clc.22013

PMID:22674095

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6652369/

Abstract

BACKGROUND

Percutaneous balloon mitral valvuloplasty is the preferred therapeutic strategy in patients with mitral stenosis, but it has shortcomings in a subset of patients.

HYPOTHESIS

A new method of balloon sizing through echocardiographic measurement of the intercommissural diameter would be safe and effective and lead to better outcomes.

METHODS

Eighty-six mitral-stenosis patients were randomly assigned to undergo balloon mitral valvuloplasty either with height-based balloon reference sizing (HBRS group, n = 43) or with balloons sized by the echocardiographic measurement of intercommissural diameter (EBRS group, n = 43). Postprocedural mitral valve area (MVA) and severity of mitral regurgitation (MR) were assessed via echocardiography and ventriculography. Intention-to-treat approach was applied for the statistical analysis.

RESULTS

Baseline characteristics were not different between the groups. The mean of the estimated balloon reference sizes was significantly higher in the HBRS patients than in the EBRS group (26.4 ± 0.92 mm, 95% confidence interval [CI]: 26.2-26.6 vs 24.5 ± 1.03 mm, 95% CI: 24.2-24.7, respectively; P = 0.006). Final MVAs were significantly larger in the EBRS group (1.5 ± 0.2 cm(2), 95% CI: 1.46-1.59 vs 1.4 ± 0.2 cm(2), 95% CI: 1.35-1.47, respectively; P = 0.01). The occurrence of new or aggravated MR was significantly lower in the EBRS group as assessed both by echocardiography (P = 0.04) and ventriculography (P = 0.05). Mitral regurgitation was aggravated in 13 (29.3%) patients in the HBRS group and in 5 (11.5%) patients in the EBRS group.

CONCLUSIONS

Percutaneous balloon mitral valvuloplasty via the Inoue technique using balloons sized by the echocardiographic measurement of the maximal commissural diameter is an effective and safe method that might lead to an acceptable increase in the MVA and significant decrease in the rate and severity of iatrogenic MR.

摘要

背景

经皮球囊二尖瓣成形术是二尖瓣狭窄患者的首选治疗策略，但在一部分患者中存在缺点。

假设

通过超声测量瓣环间径来确定球囊大小的新方法是安全有效的，并且会带来更好的结果。

方法

86 例二尖瓣狭窄患者被随机分为两组，分别接受基于身高的球囊参考尺寸（HBRS 组，n = 43）或通过超声测量瓣环间径（EBRS 组，n = 43）来确定球囊大小的球囊二尖瓣成形术。通过超声心动图和心室造影术评估术后二尖瓣瓣口面积（MVA）和二尖瓣反流（MR）的严重程度。统计分析采用意向治疗方法。

结果

两组患者的基线特征无差异。HBRS 组患者的估计球囊参考尺寸平均值明显高于 EBRS 组（26.4 ± 0.92mm，95%置信区间 [CI]：26.2-26.6 与 24.5 ± 1.03mm，95%CI：24.2-24.7，P = 0.006）。EBRS 组患者的终末 MVAs 明显较大（1.5 ± 0.2cm²，95%CI：1.46-1.59 与 1.4 ± 0.2cm²，95%CI：1.35-1.47，P = 0.01）。EBRS 组新出现或加重的 MR 发生率通过超声心动图（P = 0.04）和心室造影（P = 0.05）评估均明显较低。HBRS 组有 13 例（29.3%）患者和 EBRS 组有 5 例（11.5%）患者出现 MR 加重。