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Online ISSN 1827-1847
Pedrini L. 1, Gregorini P. 2, Magnoni F. 1, Ballestrazzi M. S. 1, Sensi L. 1, Pisano E. 1
1 Operative Unit of Vascular Surgery, Maggiore Hospital Bologna, Italy
2 Operative Unit of Anesthesiology, Maggiore Hospital Bologna, Italy
Aim. The evidence of the efficacy of spinal cord stimulation (SCS) in patients with untreatable critical limb ischemia (UCLI), was only recently recognized. This study aims to evaluate late results of patients submitted to SCS.
Methods. The reports of 118 consecutive patients affected by UCLI who underwent SCS between 1989 and 2007 have been prospectively recorded and reviewed. Patients were 78 males, 71.2% were at Fontaine stage 4, the mean age was 75 years. Following the angiographic findings they were subdivided into absolute (86 p) and relative indications (32 p).
Results. Only 17 were not responders at the stimulation trial, while 100 (84.75%) had the implantation of the device. The only significant difference between responders and non-responders was diabetes. At three months, in non-responders, survival and limb-salvage rates were 51.3% and 13%, respectively. At one year, (mean follow-up was 1 175 days), the survivorship without amputation was 74.9% in responders at stage 3 and 54.7% at stage 4. Limb salvage was significantly higher in patients treated at stage 3 (87.6% vs 48.99%, P=0.008). At follow-up, 76% of stage 3 patients were asymptomatic, vs 25.7% of stage 4 patients; in this group 44.3% had persistent lesions. After definitive SCS implantation mean Visual Analogue Scale pain was 1.48; moreover 46% patients had complete pain relief. Limb salvage was not influenced by diabetes, both in the whole group (P=0.9) and in responders, and by a previous lumbar sympathectomy (P=0.85). At the univariate analysis, the two variables statistically associated with limb amputation were: absolute indication (P<0.0001), and stage 4 (P<0.002). Late amputation were related to SCS removal (7 cases), progression of the distal arterial occlusion, and concurrent disease. The more frequent complications after definitive SCS implantation were: lead dislocation or fracture, and infections. The mean duration of the battery was 35 months.
Conclusion. Results of SCS in patients selected only on clinical basis after a stimulation trial, confirm the indication to treat patients unfit for revascularization, as it can offer a complete pain relief in 46% and a pain reduction >75% in the other, moreover it offers a good survival-rate without amputation, in particular in patients at preoperative stage 3. For this reason the treatment should be associated with the best medical treatment with a very short delay.