European Journal of Vascular and Endovascular Surgery vol:29 issue:6 pages:613-619
BACKGROUND: The purpose of this study was to assess the safety and efficacy of translating into national practice methodology for infrainguinal excimer laser-assisted angioplasty, for the treatment of critical limb ischemia in poor surgical bypass candidates. METHODS: A prospective five centre Belgian registry enrolled 48 patients, who presented with 51 chronic critically ischemic limbs (Rutherford category 4, 5 or 6) and were poor candidates for bypass surgery. Treatment included crossing the occlusion or stenosis by conventional guidewire followed by excimer laser angioplasty with, or without, adjunctive balloon angioplasty or stenting. A step-by-step technique was used in cases where the guidewire could not pass the occluded site. The primary endpoint was limb salvage, at 6 months, of the treated limb. RESULTS: Initial treatment was successful in all 51 limbs. By 6 months there had been six deaths, six minor and four major amputations and further intervention was required in four patients. Among survivors, limb salvage rate at 6 month was 38/42 (90.5%), with freedom from critical limb ischemia in 86%. CONCLUSIONS: This Belgian study of excimer laser assisted angioplasty, in high-risk patients who were poor candidates for surgical re-vascularisation, had a low incidence of surgical re-interventions and limb salvage rate in excess of 90%.