Spinal cord stimulation in non-reconstructable critical limb ischemia: a retrospective study of 71 cases

Background: Spinal cord stimulation (SCS) is a therapeutic option for patients with a peripheral arterial disease with critical limb ischemia (CLI) and consequent ischemic rest pain. Neuromodulation is chosen when vascular reconstruction is not possible or failed. Data about the effect of SCS over limb salvage rates are dissonant.

Method: We report on a retrospective cohort of CLI patients who were implanted with SCS systems between July 2010 and December 2013 in a single center. Major amputation, postoperative complications, and death were recorded.

Results: Seventy-two CLI patients underwent SCS implantation, with 35 of them classified as non-reconstructable and 37 with previous but failed or only partially successful vascular procedures. A total of 21 subjects were at Fontaine's stage III (29.2%), and the remaining 51 were at stage IV (70.8%). In total, 26.4% of the patients had diabetes (n = 19), two of them at Fontaine's stage III. The mean follow-up was 17.1 ± 10.5 months. At the last follow-up, 59.2% of all patients (42/71), 85.7% of Fontaine's stage III (18/21), 48.0% of Fontaine's stage IV (24/50), and 52.6% of diabetic patients (10/19) were alive without major amputation. The probability of limb survival at 12 months was 72% for all patients, 94% for Fontaine's stage III, 62% for Fontaine's stage IV, and 61% for diabetic patients. The probability of survival at 12 months for patients who underwent major limb amputation (n = 25) was 86% with a mean survival time of 31.03 ± 4.63 months.

Conclusions: Non-reconstructable CLI patients treated with SCS can achieve meaningful clinical outcomes with few procedure-related complications. The therapy may be more beneficial in patients classified as Fontaine's Stage III.