Plaque excision in the management of lower-limb ischemia of atherosclerosis and in-stent restenosis with the SilverHawk atherectomy catheter.

Aim: Aim of the present study was to compare the effectiveness of plaque excision in management of lower limb ischemia of atherosclerosis and in-stent restenosis with the SilverHawk atherectomy catheter.

Methods: From November 2010, to August 2011, 43 patients were involved and completed follow-up. They were divided into two groups: group A is the atherosclerotic plaque group (16 cases, 37.2%) and group B is the in-stent restenosis/occlusion lesion group (27 cases, 62.8%). The average age of group A was 68.3 years and group B was 72 years, the mean duration was 27.4 months and 26 months, respectively. Intermittent claudication was 8 cases and 16 cases respectively, and rest pain both was 4 cases, foot ulcer was 1 case and 4 cases, toe gangrene both was 3 cases. Ankle Brachial Index (ABI)≤0.4 was 2 in group A and 8 in group B, ABI>0.4 was 12 and 16, ABI=0 was 2 and 3, respectively. Excision with protective devices in 6 cases. Nine cases and 17 cases received treatment for proximal and distal lesions over the same period, respectively, included the proximal iliac artery stenting 1 case in group A and 5 cases in group B, distal calf arteries stenting 6 cases in group A and 11 cases in group B, balloon angioplasty 2 in group A and 1 in group B. Endpoints included postoperative mortality or amputation of target limb.

Results: Forty-one operations were successful, the technical success rate was 95.3%, one case in group B suffered above-knee amputation. The target vessels of 41 patients maintain patency after discharge. Postoperative claudication distance increased to 500 meters except for one case in each group, all 4 rest pain patients got alleviated, reduced toe ulcer area happened in 1 and 2 cases respectively, all 3 cases of gangrene dried up/infection controlled in each group. Postoperative ABI result 0.7-0.8: 4 in group A and 5 in group B; 0.81-0.9 was 5 and 8; >0.91 was 6 and 13, respectively. Symptom improvement result had no significant difference between the two groups (P>0.05). Follow-up covered 41 patients, average 17.5±3.3 months. Group A patients stayed in good condition, 7 claudication patients's walking distance above 500 meters remains; rest pain no recurrence, one ulcer healing, 2 of 3 toe gangrene self-shedding and stump healing, 1 toe gangrene removed by surgery and wound healing. Group B, 4 of 15 claudication cases recurrence, and received plaque excision again. Rest pain no recurrence. 3 of 4 ulcer healing, 1 ulcer area reduced significantly. One out of 3 gangrene received below knee amputation (toe osteomyelitis), wound healing. One recurrence, angiography showed in-stent severe restenosis, received plaque excision again. One toe gangrene removed by surgery and wound healing.

Conclusion: Plaque excision with "SilverHawk" treatment for lower limb ischemia of atherosclerosis or in-stent restenosis is safe and effective. No significant difference for these two lesions in efficacy. Long term follow-up and larger randomized study is needed for further information on treatment.