A clinical trial of laser thermal angioplasty in patients with advanced peripheral vascular disease.

A 3-year prospective trial of laser thermal-assisted balloon angioplasty in 28 patients included 27 who had advanced peripheral vascular disease (severe tissue loss, gangrene, infection, and rest pain), 7 who were failures of previous therapy (surgery and thrombolysis), and 4 who were high risk for operation (myocardial infarction within 6 weeks and/or ejection fractions of less than or equal to 20%). Laser angioplasty was performed in the operating room via a groin incision by a surgeon-radiologist team. In the 27 patients with advanced peripheral vascular disease (ankle-brachial systolic pressure index [ABI] 0.27 +/- 0.2 in 10 nondiabetic, and 0.46 +/- 0.1 in 17 diabetic patients), recanalization of the native vessel was successful in 16, and patency was restored in 2 chronically occluded polytetrafluorethylene (PTFE) grafts. In these 18 (67%) successfully recanalized patients, however, five amputations were required within 1 month, and another six were needed between 8 and 12 months. Early amputations were caused by a failure of wound healing, even through angioplasty sites were patent. Late amputations were caused by reocclusion of the treated site in five of six patients. In the remaining seven patients in whom laser angioplasty alone was successful, five had healed limbs at 6 to 24 months and two remain incompletely healed but functional. The patency for successful procedures ranged from 48 hours to 25 months (5.6 +/- 6.4 mean months, +/- SD), with cumulative patency by life-table analysis of 55.5% at 3 months, 38.8% at 6 months, and 11.1% at 12 months. There were no procedure-related deaths. Complications included seven arterial wall perforations by the laser probe. We conclude that laser angioplasty has a limited role in advanced peripheral vascular disease but may provide an interval patency, thus allowing postponement of operation for high-risk patients until their medical conditions permits surgery, or to correct local tissue necrosis or infection in the operative field before reconstruction, and to restore patency to thrombosed PTFE grafts.