Turi Z G, Reyes V P, Raju B S, Raju A R, Kumar D N, Rajagopal P, Sathyanarayana P V, Rao D P, Srinath K, Peters P
Department of Medicine, Harper Hospital, Detroit, MI 48201.
Circulation. 1991 Apr;83(4):1179-85. doi: 10.1161/01.cir.83.4.1179.
We performed a prospective, randomized trial comparing percutaneous balloon commissurotomy with surgical closed commissurotomy in 40 patients with severe rheumatic mitral stenosis.
Data were analyzed by investigators who were masked to treatment assignment or phase of study. Patients randomized to balloon (n = 20) or surgical (n = 20) commissurotomy had severe mitral stenosis without significant baseline differences (left atrial pressure, 26.1 +/- 4.2 versus 27.6 +/- 6.2 mm Hg; mitral valve gradient, 18.0 +/- 4.2 versus 19.7 +/- 6.3 mm Hg; mitral valve area, 1.0 +/- 0.2 versus 1.0 +/- 0.4 cm2, respectively). At 1-week follow-up after balloon commissurotomy, pulmonary wedge pressure was 14.3 +/- 7.2 mm Hg; mitral valve gradient was 9.6 +/- 5.1 mm Hg; and mitral valve area was 1.6 +/- 0.6 cm2 (all p less than 0.0001). At 1-week follow-up after surgical closed commissurotomy, wedge pressure was 13.7 +/- 5.4 mm Hg; mitral valve gradient was 9.4 +/- 4.2 mm Hg (both p less than 0.0001); and mitral valve area was 1.6 +/- 0.7 cm2 (p less than 0.003). At 8-month follow-up, improvement occurred in both groups: Mitral valve area was 1.6 +/- 0.6 cm2 in the balloon commissurotomy group (p less than 0.002) and was 1.8 +/- 0.6 cm2 in the surgical closed commissurotomy group (p less than 0.0001). There was no difference between the groups at 1-week or 8-month follow-up (all p greater than 0.4). One case of severe mitral regurgitation occurred in each group; complications were otherwise related to transseptal catheterization. There was no death, stroke, or myocardial infarction. Cost analysis revealed that balloon commissurotomy may substantially exceed the cost of surgical commissurotomy in developing countries, whereas it may represent a significant savings in industrialized nations.
We conclude that percutaneous balloon commissurotomy and surgical closed commissurotomy result in comparable hemodynamic improvement that is sustained through 8 months of follow-up.
我们进行了一项前瞻性随机试验，比较经皮球囊二尖瓣交界切开术与闭式二尖瓣交界切开术在40例重度风湿性二尖瓣狭窄患者中的疗效。
由对治疗分配或研究阶段不知情的研究人员对数据进行分析。随机分为球囊组（n = 20）和手术组（n = 20）的患者均患有重度二尖瓣狭窄，基线无显著差异（左心房压力分别为26.1±4.2与27.6±6.2 mmHg；二尖瓣跨瓣压差分别为18.0±4.2与19.7±6.3 mmHg；二尖瓣瓣口面积分别为1.0±0.2与1.0±0.4 cm²）。球囊二尖瓣交界切开术后1周随访时，肺楔压为14.3±7.2 mmHg；二尖瓣跨瓣压差为9.6±5.1 mmHg；二尖瓣瓣口面积为1.6±0.6 cm²（所有p均小于0.0001）。闭式二尖瓣交界切开术后1周随访时，楔压为13.7±5.4 mmHg；二尖瓣跨瓣压差为9.4±4.2 mmHg（两者p均小于0.0001）；二尖瓣瓣口面积为1.6±0.7 cm²（p小于0.003）。在8个月随访时，两组均有改善：球囊二尖瓣交界切开术组二尖瓣瓣口面积为1.6±0.6 cm²（p小于0.002），闭式二尖瓣交界切开术组为1.8±0.6 cm²（p小于0.0001）。两组在1周或8个月随访时无差异（所有p均大于0.4）。每组各发生1例严重二尖瓣反流；其他并发症与经房间隔穿刺有关。无死亡、卒中或心肌梗死发生。成本分析显示，在发展中国家，球囊二尖瓣交界切开术的成本可能大大超过闭式二尖瓣交界切开术，而在工业化国家，它可能节省大量费用。
我们得出结论，经皮球囊二尖瓣交界切开术和闭式二尖瓣交界切开术在血流动力学改善方面效果相当，且在8个月的随访期内持续有效。
