Introduction

Spinal cord stimulation (SCS) can improve pain relief, limb salvage, and microcirculatory blood flow in patients suffering from intractable ischemic pain due to peripheral vascular disease (PVD) who are not suitable for revascularization¹. Herein, we present long-term effectiveness and safety outcomes using SCS for PVD at a single center.

Materials / Methods

51 patients (37 men [mean age 68.9 ± 10.2 y], 14 women [mean age (68.7 ± 14.6 y]) underwent SCS (n = 49) or Dorsal Root Ganglion Stimulation (DRG-S, n = 2) implantation due to intractable ischemic pain because of PVD (Rutherford 3, 4 and 5) from 03/2007 – 04/2022. Patients were classified as Rutherford’s class 3 (n = 21), class 4 (n = 12), or class 5 (n = 8)[RM(2] . Walking distance (m), pain intensity (NRS), opioid consumption (mg MME [morphine milligram equivalents]/d), and quality of life (EQ-5D VAS) were determined during follow-up. Two patients were excluded due to loss to follow-up within 6 months. Relevant comorbidities, major amputations, and deaths were documented. The Kaplan-Meier survival curve was used for the primary endpoint analysis for survival and amputation rates. Because of the observed mortality over the total period of eleven years, the 48-month follow-up was chosen as the cut-off time to ensure a sufficient sample size (IBM SPSS Statistics 29, Armonk, NY, USA).

Results

The number of patients with follow-up data at respective time points includes n = 49 patients at 6M, 41 at 1Y, 37 at 2Y, 27 at 3Y, 21 at 4Y, 16 at 5Y, 14 at 6Y, 13 at 7Y, 8 at 8Y and 1 patient at 9 and 10Y. We observed a statistically highly significant reduction in the level of pain at rest and likewise in load-dependent pain. 75% of patients were walking more than 200 m at 48M. 42/49 did not undergo a major amputation post-implant. We observed a significant reduction in opioid consumption and an improvement in the quality of life of treated patients.

Discussion

Neuromodulation reduces pain and improves the functionality of the affected limb and patient quality of life for patients suffering from severe PVD. Compared to existing literature (SCS can reduce the amputation rate and pain in selected patients over a period of 12 months^{2, 3}) our data demonstrate a long-lasting therapeutic effect.

Conclusions

According to these results, neuromodulative therapy should be recommended for patients with non-reconstructable and non-unstable stage (Rutherford 3, 4, and 5) disease and shows favorable long-term results.

References

¹Giannopoulos, S. & Armstrong, E. J. Medical therapy for cardiovascular and limb-related risk reduction in critical limb ischemia. Vascular Medicine 26, 210-224, doi:10.1177/1358863X20987612 (2021).Asimakidou, E. & Matis, G. K. Spinal cord stimulation in the treatment of peripheral vascular disease: a systematic review – revival of a promising therapeutic option? Brit J Neurosurg, 1-9, doi:10.1080/02688697.2021.1884189 PMID - 33703962 (2021).

²Asimakidou, E. & Matis, G. K. Spinal cord stimulation in the treatment of peripheral vascular disease: a systematic review – revival of a promising therapeutic option? Brit J Neurosurg, 1-9, doi:10.1080/02688697.2021.1884189 PMID - 33703962 (2021).

³Cucuruz, B. et al. Treatment of end-stage peripheral artery disease by neuromodulation. Clinical hemorheology and microcirculation 81, 315-324, doi:10.3233/ch-221436 (2022).

Learning Objectives

1. Spinal cord stimulation (SCS) can improve pain relief, limb salvage, and microcirculatory blood flow in patients suffering from intractable ischemic pain due to peripheral vascular disease (PVD).

2. This form of therapy shows favorable long-term efficacy, is safe and has only minimal side effects.

3. According to these results, neuromodulative therapy should be recommended for patients with non-reconstructable and non-unstable stage (Rutherford 3, 4, and 5) disease.