Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2021 May;55(4):367-373.
doi: 10.1177/1538574420985765. Epub 2021 Feb 8.

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

Affiliations

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

Anna E Cyrek et al. Vasc Endovascular Surg. 2021 May.

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.

Keywords: critical ischemia; limb salvage; spinal cord stimulation.

PubMed Disclaimer

Conflict of interest statement

Declaration of Conflicting Interests: The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Figures

Figure 1.
Figure 1.
Kaplan-Meier estimator. The visit at which the spinal cord stimulator was implanted was counted as time point 0; individuals were subsequently followed until a major end point (major amputation or death) was reached. Panel A and C show the Kaplan-Meier analysis for overall and limb survival, respectively. Panel B and D show the Kaplan-Meier analysis for overall and limb survival according to Fontaine stage, respectively. Full line represents the outcome for Fontaine stage III patients, while the dotted line represents the outcome for Fontaine stage IV patients.

References

    1. Norgren L, Hiatt WR, Dormandy JA, et al. Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II). Eur J Vasc Endovasc Surg. 2007;33(Suppl S):S1–75. doi:10.1016/j.ejvs.2006.09.024 - PubMed
    1. Hooi JD, Stoffers HE, Knottnerus JA, van Ree JW. The prognosis of non-critical limb ischaemia: a systematic review of population-based evidence. Br J Gen Pract. 1999;49(438):49–55. - PMC - PubMed
    1. Creager MA, Luscher TF, Cosentino F, Beckman JA. Diabetes and vascular disease: pathophysiology, clinical consequences, and medical therapy: part I. Circulation. 2003;108(12):1527–1532. doi:10.1161/01.CIR.0000091257.27563.32 - PubMed
    1. Luscher TF, Creager MA, Beckman JA, Cosentino F. Diabetes and vascular disease: pathophysiology, clinical consequences, and medical therapy: part II. Circulation. 2003;108(13):1655–1661. doi:10.1161/01.CIR.0000089189.70578.E2 - PubMed
    1. Mills JL. The application of the Society for Vascular Surgery Wound, Ischemia, and foot Infection (WIFI) classification to stratify amputation risk. J Vasc Surg. 2017;65(3):591–593. doi:10.1016/j.jvs.2016.12.090 - PubMed

MeSH terms