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Spinal Cord Stimulation for Non-Reconstructable Chronic Limb-Threatening Ischemia: A Real-World, Multidisciplinary,
Naoufel Ouerchefani1, Edward Goldberg2, Pascal Desgranges3
1Neurosurgery Department, Foch University Hospital, 92150 Suresnes, France.
Insights
Spinal cord stimulation (SCS) significantly improved pain and walking distance for chronic limb-threatening ischemia (CLTI) patients. This therapy may also reduce amputation risk, particularly in earlier CLTI stages, with no major complications reported.
Area of Science:
- Vascular Surgery
- Neuromodulation
- Peripheral Artery Disease Management
Background:
- Chronic limb-threatening ischemia (CLTI) is a severe peripheral artery disease stage.
- CLTI presents with ischemic rest pain or ulcer necrosis, significantly impacting quality of life.
- Spinal cord stimulation (SCS) is a European treatment option for CLTI patients experiencing chronic pain.
Purpose of the Study:
- To evaluate the long-term, real-world effectiveness of SCS therapy in CLTI patients.
- To assess improvements in pain, mobility, and limb preservation following SCS treatment.
- To identify factors associated with amputation risk after SCS intervention.
Main Methods:
- Observational study utilizing medical chart review.
- Analysis of consecutive CLTI patients who underwent SCS implantation between 2013 and 2022.
- Assessment of outcomes including pain scores, walking distance, skin lesion status, and limb survival rates.
Main Results:
- Significant reduction in pain intensity (NRS 9.4 to 3.7) and increase in walking distance (>350m) at 2 years post-SCS.
- Stabilization of skin lesions in 63% of patients.
- 12-month limb survival rates of 90% (Fontaine IIb/III) and 70% (Fontaine IV); amputation risk associated with Fontaine Stage, smoking, hypertension, and prior amputation.
- No major complications reported.
Conclusions:
- SCS therapy offers significant and durable improvements in ischemic pain and functional outcomes for CLTI patients.
- SCS may reduce the risk of major amputation in CLTI, especially when initiated in earlier disease stages.
- Real-world data support SCS as a valuable treatment modality for managing CLTI.
Abstract:
Background/Objectives: Chronic limb-threatening ischemia (CLTI) is a severe form of peripheral artery disease characterized by ischemic rest pain or ulcer necrosis. In Europe, spinal cord stimulation (SCS) can be offered to CLTI patients with chronic pain to improve mobility and prolong limb preservation. We evaluated the long-term, real-world outcomes of SCS therapy in patients with CLTI. Methods: In this observational study, medical chart review data from consecutive CLTI patients treated with SCS were analyzed. Results: Fifty-three patients (56.6% Fontaine Stage III, 39.6% Fontaine Stage IV, 3.8% Fontaine Stage IIb) had a single-stage SCS implant procedure between 2013 and 2022. Two years after SCS therapy activation, claudication pain intensity had significantly improved; the overall numerical rating scale pain score decreased from 9.4 ± 0.9 at baseline to 3.7 ± 3.2 (p < 0.0001). In addition, walking distance increased by more than 350 m (from 70 ± 87 to 429 ± 320 m, p < 0.0001), and pre-existing skin lesions stabilized in ten patients (63%). The probability of limb survival in Fontaine's stage IIb/III and Fontaine's stage IV patients at 12 months was 90% and 70%, respectively (log-rank p-value = 0.04). Finally, significant associations were found between the occurrence of an amputation after SCS and Fontaine Stage (p = 0.01), active smoking (p = 0.02), hypertension (p = 0.04), and prior minor amputation (p = 0.02). No major complications were reported. Conclusions: Our real-world experience suggests that SCS for CLTI patients provides significant and durable improvements in ischemic pain and functional outcomes. SCS may also help reduce the natural risk of major amputation, especially when implemented at early CLTI stages.
