Tobis J M, Conroy R, Deutsch L S, Gordon I, Honye J, Andrews J, Profeta G, Chatzkel S, Berns M
Division of Cardiology, University of California, Irvine.
Am J Cardiol. 1991 Oct 15;68(10):1079-86. doi: 10.1016/0002-9149(91)90499-b.
A randomized clinical trial was performed to test the hypothesis that a laser-heated probe is superior to standard techniques to reopen occluded femoral arteries. Twenty patients were treated with a standard guidewire and balloon dilation method. In a second group of 20 patients, the laser probe was initially used as a nonheated mechanical device. If the probe was unsuccessful in mechanically reopening the artery, an Argon laser was activated to heat the probe. The mean length of occlusion was 15.9 +/- 10.3 cm. The success rate for the laser probe was 15 of 20 (75%), which was not significantly different from the standard method, 19 of 20 (95%). Most of the success in the laser-probe group was due to the probe's mechanical properties. The laser probe was successful as a cold, mechanical device in 13 of 15 (87%) arteries. It was necessary to heat the probe in 5 patients. When heated, the laser probe assisted recanalization in 2 but perforated the artery in 3 cases. The results of this randomized trial do not support the hypotheses behind the use of the thermal laser probe. The laser probe functions primarily as a mechanical device. The thermal activation does not significantly improve the success rate without increasing the risk of perforation. This small additional benefit does not justify the large cost of current thermal laser devices. This controlled study also demonstrates a higher success rate in long occlusions than previous reports of mechanical balloon recanalization. This is due to a combination approach of retrograde and anterograde probing of the occluded segment.
进行了一项随机临床试验，以检验激光加热探头在重新开通闭塞股动脉方面优于标准技术这一假设。20名患者接受了标准导丝和球囊扩张方法治疗。在另一组20名患者中，激光探头最初用作未加热的机械装置。如果探头在机械性重新开通动脉方面未成功，则启动氩激光加热探头。平均闭塞长度为15.9±10.3厘米。激光探头的成功率为20例中的15例（75%），与标准方法（20例中的19例，95%）相比无显著差异。激光探头组的大多数成功归因于探头的机械性能。激光探头作为冷机械装置在15条动脉中的13条（87%）成功。有5名患者需要加热探头。加热时，激光探头协助再通2例，但有3例导致动脉穿孔。这项随机试验的结果不支持使用热激光探头背后的假设。激光探头主要起机械装置的作用。热激活在不增加穿孔风险的情况下并未显著提高成功率。这种微小的额外益处并不能证明当前热激光设备的高昂成本是合理的。这项对照研究还表明，与先前关于机械球囊再通的报道相比，长段闭塞的成功率更高。这是由于对闭塞段采用了逆行和顺行探查相结合的方法。
