Cardiovascular Research Department, Madani Heart Centre, Tabriz, Iran.
Kardiol Pol. 2011;69(5):445-50.
Percutaneous transvenous mitral commissurotomy (PTMC) is an alternative approach to open heart surgery in patients with symptomatic mitral stenosis (MS).
To compare the outcome of performing PTMC with or without heparin administration.
In this randomised clinical trial, 480 patients with symptomatic MS were randomly allocated to one of two groups, with or without heparin administration as part of the procedure. Echocardiographic and clinical outcomes of PTMC assessed before the procedure, during hospitalisation, and after the one-month follow-up, were compared between the two groups.
Baseline demographic and clinical characteristics were similar in the 240 patients with heparin administration (the Hep [+] group) and the 240 patients without heparin administration (the Hep [-] group) during the procedure. In the whole study group mitral valve area (MVA) was 0.94 ± 0.03 cm(2) prior to PTMC, and increased to 1.85 ± 0.06 cm(2) after the procedure (p = 0.0001). The mean increase in MVA was 0.85 ± 0.27 cm(2) in the Hep (+) group and 0.88 ± 0.2 cm(2) in the Hep (-) group (NS). During the procedure, or immediately after PTMC, embolic events were recorded in two (0.83%) Hep (+) patients and one (0.42%) Hep (-) patient (NS). The frequency of haematoma at puncture site (three [1.25%] Hep [+] vs two [0.83%] Hep [-]), and the need for urgent surgery (two [0.83%] Hep [+] vs five [2.1%] Hep [-]), were similar in both groups. There were no embolic events after discharge or during the one month follow-up period.
Our study revealed that in high volume centres and in selected patients without left atrial thrombus, heparin administration during PTMC is not associated with any additional protective effect against embolic events during short-term follow-up.
经皮经静脉二尖瓣交界分离术（PTMC）是一种替代心脏直视手术治疗有症状二尖瓣狭窄（MS）患者的方法。
比较行 PTMC 时是否给予肝素的效果。
在这项随机临床试验中，480 例有症状 MS 的患者被随机分配到两组，一组在操作过程中给予肝素，另一组不给予肝素。比较两组患者在操作前、住院期间和术后 1 个月的超声心动图和临床结果。
两组患者在操作过程中肝素使用组（Hep[+]组）和肝素不使用组（Hep[-]组）的基线人口统计学和临床特征相似。在整个研究组中，二尖瓣瓣口面积（MVA）在 PTMC 前为 0.94±0.03cm2，术后增加至 1.85±0.06cm2（p=0.0001）。MVA 的平均增加量在 Hep[+]组为 0.85±0.27cm2，在 Hep[-]组为 0.88±0.2cm2（NS）。在操作过程中或在 PTMC 后立即，有 2 例（0.83%）Hep[+]患者和 1 例（0.42%）Hep[-]患者发生栓塞事件（NS）。穿刺部位血肿的发生率（Hep[+]组 3 例[1.25%]与 Hep[-]组 2 例[0.83%]）和需要紧急手术的发生率（Hep[+]组 2 例[0.83%]与 Hep[-]组 5 例[2.1%]）在两组之间相似。出院后或在 1 个月随访期间均未发生栓塞事件。
我们的研究表明，在高容量中心和选择无左心房血栓的患者中，PTMC 期间给予肝素并不能在短期内随访中提供任何额外的抗栓塞作用。
