title: Spinal cord stimulation for patients with critical limb ischemia: immediate and long-term clinical outcome from the prospective italian register.
abstract: The Prospective Italian Register of spinal cord stimulation (SCS) was designed to evaluate the clinical outcome of patients with severe peripheral arterial occlusive disease (PAOD) treated with SCS. Baseline data were collected for all patients with PAOD undergoing SCS treatment (September 1998 to February 2001) at 34 participating centers. If, after a 2- to 3-week trial, SCS demonstrated significant clinical benefits, a permanent implantable pulse generator was implanted. Follow-up data were evaluated at 4, 8, and 12 months postimplantation. Overall, 250 patients (176 men, 74 women) were enrolled (mean age 72.6 ± 17 years) and classified by Fontaine stage. In total, 77.6% (194/250) of patients received a permanent implant and 43.6% (109/250) reached 1 year of follow-up. Fontaine stage, pain relief, free-walking interval, and drug intake improved significantly during follow-up. Age and Fontaine stage were significantly associated with major amputation. Cumulative limb survival at 1 year for the subgroup of Fontaine stage III patients was 82.2%. The mean number of hospital admissions and stay duration at 1 year postimplantation was significantly reduced compared with 1 year preimplant: 1.5 vs. 0.6 admissions and 27 vs. 6 days, respectively. Among 109 patients evaluable at 12 months, 83 (76.1%) experienced ≥50% reduction in pain. All PAOD parameters improved significantly during follow-up. At 12 months postimplantation, 76.1% of patients were responsive to SCS therapy. The reduction in the use of analgesics and the number and duration of hospital stays offers clear economic advantages.
authors.affiliation: Vascular Surgery Department, Azienda Ospedaliera S. Orsola Malpighi, Bologna University, Bologna, Italy.
authors.forename: Alessandra
authors.initials: A
authors.lastname: Tedesco
authors.forename: Massimo
authors.initials: M
authors.lastname: D'Addato