Neuromodulation : journal of the International Neuromodulation Society · 2024
Spinal Neuromodulation for Peripheral Arterial Disease of Lower Extremities: A Ten-Year Retrospective Analysis.
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Kretzschmar Michael, Okaro Udoka, Schwarz Marcus, Reining Marco, Lesser Thomas
Аннотация
OBJECTIVE: This long-term retrospective study evaluated the survival and amputation outcome of subjects who received neuromodulation therapy for the management of peripheral arterial disease (PAD).
MATERIALS AND METHODS: The study reviews the health data of a single cohort of 51 patients who received spinal neuromodulation (spinal cord stimulation [SCS] or dorsal root ganglion stimulation [DRG-S]) for PAD from 2007 to 2022 in a single German center. Survival rate and major amputation rate were determined. Pain, quality of life, walking distance, and opioid usage were assessed before implantation (baseline), one, six, and 12 months (M) after implantation, and then annually (during a follow-up visit). Implant-related complications also were documented.
RESULTS: In total, 51 patients (37 men [mean age 68.9 ± 10.2 years], 14 women [mean age (68.7 ± 14.6 years]) underwent SCS (n = 49) or DRG-S (n = 2) implantation owing 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 24 M, 42 of 47 patients did not require a major amputation after the implant. All the patients reported nearly complete pain relief from pain at rest. A total of 75% of patients were able to walk >200 m, and 87% of patients who used opioids at baseline were off this medication at 24 M. Overall, 93% of patients reported an improvement in their overall health assessment. These improved outcomes were sustained through years three to 10 for patients who have reported outcomes.
CONCLUSIONS: Our single-center data support the efficacy of spinal neuromodulation for improvements in limb salvage, pain relief, mobility, and quality of life. The data also show that neuromodulative therapy has a long-term therapeutic effect in patients with chronic limb pain with Rutherford category 3, 4, and 5 PAD.
MATERIALS AND METHODS: The study reviews the health data of a single cohort of 51 patients who received spinal neuromodulation (spinal cord stimulation [SCS] or dorsal root ganglion stimulation [DRG-S]) for PAD from 2007 to 2022 in a single German center. Survival rate and major amputation rate were determined. Pain, quality of life, walking distance, and opioid usage were assessed before implantation (baseline), one, six, and 12 months (M) after implantation, and then annually (during a follow-up visit). Implant-related complications also were documented.
RESULTS: In total, 51 patients (37 men [mean age 68.9 ± 10.2 years], 14 women [mean age (68.7 ± 14.6 years]) underwent SCS (n = 49) or DRG-S (n = 2) implantation owing 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 24 M, 42 of 47 patients did not require a major amputation after the implant. All the patients reported nearly complete pain relief from pain at rest. A total of 75% of patients were able to walk >200 m, and 87% of patients who used opioids at baseline were off this medication at 24 M. Overall, 93% of patients reported an improvement in their overall health assessment. These improved outcomes were sustained through years three to 10 for patients who have reported outcomes.
CONCLUSIONS: Our single-center data support the efficacy of spinal neuromodulation for improvements in limb salvage, pain relief, mobility, and quality of life. The data also show that neuromodulative therapy has a long-term therapeutic effect in patients with chronic limb pain with Rutherford category 3, 4, and 5 PAD.