Late Outcome of Spinal Cord Stimulation for Unreconstructable and Limb-threatening Lower Limb Ischemia

Gersbach, P; Argitis, V.; Gardaz, J. P.; Segesser, Ludwig Karl von; Haesler, Erik

doi:10.1016/j.ejvs.2006.12.012

Cited by 25 publications

(11 citation statements)

References 30 publications

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“…In recent years the number of papers with optimistic results has been increasing [21,22,23]. In everyday surgical practice, most vascular surgeons in patients without the option for femorodistal reconstructions consider the application of drugs (antiplatelet agents or prostanoids), spinal cord stimulation, and hyperbaric oxigenotherapy, but these are still limited and with modest results [24,25]. …”

Section: Discussionmentioning

confidence: 99%

Distal Venous Arterialization and Reperfusion Injury: Focus on Oxidative Status

et al. 2012

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In patients with unreconstructable arterial occlusive disease distal venous arterialization (DVA) seems to be a promising option in the treatment. The goals of this prospective study were to assess clinical efficiency and possible impact of DVA on tissue damage by estimating oxidative status of patients with critical limb ischemia treated with this procedure. The subjects were 60 randomized patients: 30 were undergoing DVA and 30 were treated with antiaggregation therapy. During the mean follow-up period (6.13 ± 4.32 months for DVA vs. 6.74 ± 0.5 months for antiaggregation therapy) survival (p < 0.01), limb salvage (p < 0.001), pain relief (p < 0.001) and wound healing (p < 0.001) rates were significantly different between the two groups of patients in favor of the DVA group. Ten minutes after declamping we observed a decreasing trend in the lactate level in the blood of the deep venous system (p < 0.001). Also, on postoperative day 7 digital systolic pressure and digital-brachial index were higher than before the operation (p < 0.001). In blood samples collected immediately before and successively at 1, 3, 5 and 10 min postoperatively, prooxidative status (thiobarbituric acid reactive substances, O₂^–, H₂O₂ and nitric oxide) and antioxidative enzymes (superoxide dismutase, catalase and glutathione reductase) were determined spectrophotometrically. Using the nonparametric Friedman test, we noted statistically nonsignificant differences (p > 0.05) in values of both prooxidative parameters and enzymes of the antioxidative defense system, before and successively at 1, 3, 5 and 10 min after operation. These results indicate that there was no statistically significant reperfusion injury after revascularization, which could have been expected after this surgical procedure, thus confirming its validity in these patients.

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Section: Discussionmentioning

confidence: 99%

Distal Venous Arterialization and Reperfusion Injury: Focus on Oxidative Status

et al. 2012

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“…SCS has been used for a variety of pain conditions with the most common indications in the United States being failed back surgery syndrome (FBSS) and complex regional pain syndrome (CRPS). Labeled indications are considerably broader in Europe, Canada, and Australia, where the evidence requirements for approval are different . As clinical experience and basic science have progressed, it has become apparent that the use of SCS in certain pathologies yields a higher success rate than in others.…”

Section: Indicationsmentioning

confidence: 99%

Current Challenges in Spinal Cord Stimulation

Kumar

Caraway

Rizvi

et al. 2014

Neuromodulation: Technology at the Neural Interface

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“…The utilization of SCS in treatment of CLI is supported by clinical studies (prevalently nonrandomized cohort studies and some RCTs) [8][9][10][11][12][13] and by microcirculatory studies, which have shown an increased number of perfused capillaries without an increase in their diameter; 14 an increase in capillary density at 3 months; 5 and an increase in the peak-rest erythrocyte velocity during reactive hyperemia. 15 The first edition of TASC, 2 however, available when the study was designed, concluded that SCS cannot be recommended on the basis of available studies.…”

Section: Discussionmentioning

confidence: 99%

Spinal cord stimulation or prostacyclin in unrevascularizable arteriopathy of lower limbs (SPINAL) study: interim analysis results

Pedrini¹,

Ballestrazzi²,

Chierichetti³

et al. 2014

JVD

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The aim of this study was to compare the clinical efficacy and the safety of spinal cord stimulation (SCS) plus medical treatment versus iloprost plus medical treatment in patients with severe unrevascularizable ischemia of the lower limbs due to atherosclerotic disease of the limbs and to identify predictive parameters for a positive outcome of SCS. Methods: A multicenter randomized controlled trial (RCT) with central randomization and core laboratory evaluation of angiography, subdivided into two treatment arms (SCS and iloprost) and two subgroups (rest pain and ulcer/gangrene). After the 15-day clinical efficacy evaluation, responder patients continued follow-up in their arm, while nonresponders could change arms or decline participation. The primary endpoint was 1-year limb salvage. Principal secondary endpoints were: survival rate; minor amputations and stump healing; ulcer healing; pain relief and analgesic intake; and predictive criteria for SCS treatment. Results: The trial was stopped at 35.6% of the expected sample due to low accrual rate. Fiftytwo patients (55 legs) entered the study. At the 15-day efficacy evaluation, responders (reduced pain, no increase of ulcer area) comprised 74% of the SCS arm and 26% of the iloprost arm, (P=0.003). Nine nonresponders in the iloprost arm underwent SCS implantation. Three severe adverse events (one fatal) were recorded in the iloprost arm and four in SCS treatments. Oneyear limb salvage rates in SCS, iloprost treatment, and iloprost plus SCS implantation (I-SCS) were 66.8%, 57.1%, and 100%, respectively (P=0.09), and survival rates were 73.2%, 93.9%, and 88.9%, respectively (P=0.45), confirming results of other studies that showed a trend toward better amputation-free salvage in the SCS group. The small number of recruited patients prevented statistical significance being reached. Pain reduction was obtained in 87% of SCS patients and 35% of those in the iloprost arm (P=0.001). Among the examined parameters, only the angiographic resistance index was an independent predictive value of good results after SCS implantation. Discussion and conclusion: The SPINAL study is the first RCT comparing SCS and iloprost. Although incomplete, it evaluated a sample greater than those studied in three out of five available RCTs on SCS. However, the small sample size reduced the statistical power of the study, with possible type II errors. SCS was associated with a quick and more effective answer to pain, with better tolerability and better early results, than iloprost, but without significant 1-year limb salvage-rate improvement. Iloprost improved the 1-year survival in spite of adverse events, and, following these results, perhaps should be administered before other treatments. The results of this trial suggest that prostanoids and SCS are not alternative treatments: as prostanoids present many contraindications and side effects, SCS can be considered the complementary and consecutive treatment for patients who are no longer treatable with open or endovascular revascularizations...

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Late Outcome of Spinal Cord Stimulation for Unreconstructable and Limb-threatening Lower Limb Ischemia

Abstract: In CLI patients the beneficial effects of SCS persist far beyond the first year of treatment and major amputation becomes infrequent after the second year.

Cited by 25 publications

References 30 publications

Distal Venous Arterialization and Reperfusion Injury: Focus on Oxidative Status

Distal Venous Arterialization and Reperfusion Injury: Focus on Oxidative Status

Current Challenges in Spinal Cord Stimulation

Spinal cord stimulation or prostacyclin in unrevascularizable arteriopathy of lower limbs (SPINAL) study: interim analysis results

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