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

Abstract

Introduction: Spinal cord stimulation (SCS) or Dorsal root ganglion stimulation (DRG-S) can improve limb salvage, microcirculatory blood flow, and pain relief in patients with peripheral arterial disease (PAD) who are not candidates for revascularization or who have persistent ischemic-related pain after revascularization This retrospective analysis presents 10-year data on the effectiveness and safety outcomes of neuromodulation for PAD at a single center. Objective: This study evaluated the survival and amputation outcome of subjects who received neuromodulation therapy for the management of PAD. Descriptive outcomes such as Walking distance (m), pain intensity (NRS), opioid consumption (MME [morphine milligram equivalents]/d), and self-rated health (EQ-VAS) were also analysed. Methods: This study retrospectively reviews the health data of a single cohort of 51 patients who received an SCS or DRG-S from 2007 to 2022 in a single German center. Survival rate was determined using the Kaplan Meier (KM) curve and major amputation was determined as the amputation of a major limb above the ankle. Patients who received a toe amputation were excluded from the amputation analysis. Pain, quality of life, walking distance, and opioid usage were assessed before implantation (baseline), 1, 6, and 12 months after implantation, and then annually. Results: 51 patients (37 men [mean age 68.9 ± 10.2], 14 women [mean age (68.7 ± 14.6]) underwent SCS (n = 49) or DRG-S (n = 2) implantation due to persistent ischemic pain. The follow-up mean years ± SD is 4.04 ± 2.73. At baseline, patients were classified as Rutherford's Category 3 (n = 23), Category 4 (n = 15), or Category 5 (n = 9). At 24M, 42/47 patients did not require a major amputation following the implant. All patients reported complete pain relief from pain at rest. A total of 75% of patients were able to walk more than 200m and 87% of patients who used opioids at baseline were off this medication at 24 months. Overall, 93% of patients reported an improvement in their overall health assessment. These improved outcomes were sustained through years 3-10 for patients who have reported outcomes. Conclusions: Our single center data supports the efficacy of spinal neuromodulation for improvements in limb salvage, pain relief, mobility, and quality of life. Also, the data show that neuromodulative therapy has a long-term therapeutic effect in patients with chronic limb pain with Rutherford class 3, 4, and 5 peripheral arterial disease (both reconstructable and non-reconstructable).