Improving Limb Salvage for Chronic Limb-Threatening Ischemia With Spinal Cord Stimulation: A Retrospective Analysis

Abstract

Introduction: Chronic limb-threatening ischemia (CLTI) represents the most severe form of peripheral artery disease (PAD). Up to a third of CLTI patients are not eligible to receive first-line treatments such as bypass surgery or endovascular interventions. Epidural spinal cord stimulation (SCS) has been used as a method to improve microcirculatory blood flow and relieve ischemic pain in CTLI patients. The aim of the study was to evaluate limb salvage, ulcer closure, and clinical changes of SCS implanted CTLI patients at 1-year follow-up. Methods: Eligible patients had end-stage lower limb PAD unresponsive to medical therapy and not amenable to surgical reconstruction. Patients were candidates for amputation, but limb loss was not inevitable (Fontaine stage III and IV). Pain intensity and skin temperature in the ischemic area (visual analogue scale), quality of life (WHOQoL-BREF), and ankle/brachial blood pressure index (ABI) were recorded at routine follow-up visits. Data were analyzed retrospectively. Results: 29 patients underwent SCS implantation at one vascular center. The minimum follow-up period was 30 months. Limb survival at 1-year follow-up was 97% (28/29) and 73% (11/15) had complete closure of limb ulcers. Pain intensity, skin temperature, and quality of life progressively improved up to 12 months after implant, with Fontaine stage III patients improving more substantially than Fontaine stage IV patients. SCS therapy did not affect ABI measurement. No complications related to the device or procedure occurred. Conclusions: SCS is a valid alternative in patients unsuitable for revascularization. The quality of results depends on both a strict selection of patients by vascular specialists and the frequency of follow-up controls. The therapy may be more beneficial in patients classified as Fontaine stage III.

Clinical outcomes of spinal cord stimulation in patients with intractable leg pain in Japan

“…A preoperative stimulation trial was performed for 12 of 20 patients (60%). The implantation methodology used is similar to that reported by Cyrek et al 6 A thin multielectrode lead was introduced under radiological control. Intraoperative paresthesia mapping confirmed coverage of the diseased areas.…”

Neuromodulation for peripheral arterial disease of lower extremities: A 10-year analysis

“…The progression of PAD to CLTI imposes other CLTI complications such as ischemic rest pain, tissue loss (ulceration or gangrene), and limb amputation. 22 CLTI patients have worse quality of life and systemic outcomes (death, myocardial infarction, and stroke), limb outcomes (amputation, wounds, and infections), and functional outcomes (permanent disability and mobility restrictions) than any other group of patients with atherosclerotic cardiovascular disease. 23 Endovascular interventions, 4 surgical revascularizations, primary amputation, pain management, 4,24 , or conservative therapies such as smoking cessation, 1,4,8 walking or supervised exercise 21,25 are available treatment options.…”

“…37 A different single-center, retrospective study of 29 patients evaluated the effect of SCS on limb salvage, ulcer closure, and clinical changes of CTLI patients at 1year follow-up. 22 Cyreck et al(2021) 22 report a limb survival of 97% one-year post-implant with additional improvements in ulcer closure and quality of life. A systematic review by Asimakidou and Matias (2020) 35 compared the efficacy of SCS in the treatment of non-reconstructable CLTI to conservative treatment in terms of limb salvage, ulcer healing, pain relief, improvement of microcirculatory parameters, and quality of life after 6 months.…”

Improvement of brain perfusion in patients with chronic brain ischemia at epidural spinal cord electrical stimulation

“…The high social significance and prevalence of these disorders determines the relevance of finding new ways to correct these conditions, however, existing pharmacological methods that improve the functional state of the central nervous system (CNS) do not always meet the expectations of both doctors and patients (3,4). In recent years, various methods of neuromodulation based on epidural electrical stimulation of the spinal cord have been proposed in clinical practice for the correction of peripheral hemodynamic disorders in patients suffering from refractory angina pectoris or peripheral vasculopathy (6)(7)(8)(9)(10)(11). Also, in many experimental and clinical studies, a positive effect of electrical stimulation of the spinal cord on the hemodynamic and functional parameters of the brain was noted in certain pathological conditions associated with dysfunction of the vascular bed, such as ischemia, subarachnoid hemorrhage, head trauma and brain tumors (10,(12)(13)(14)(15)(16).…”