Systematic review and meta-analysis of controlled trials assessing spinal cord stimulation for inoperable critical leg ischaemia

Ubbink, D.T.; Vermeulen, Hester; Spincemaille, G.H.; Gersbach, P; Berg, P.; Amann, W.

doi:10.1002/bjs.4629

Cited by 82 publications

(55 citation statements)

References 25 publications

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“…The authors observed a stronger trend towards a better rate of amputation-free salvage in the subgroup of patients selected by initial tcpO 2 measurements. 9 Predrini and Magnoni reviewed the efficacy of SCS in patients with untreatable CLI and found that pain relief, ulcer healing, and limb salvage were greater in nondiabetic patients, in diabetic patients without autonomic neuropathy, and in patients with rest pain or ulcer more often than in patients with gangrene. 7 The Cochrane review of SCS for nonreconstructable CLI found that limb salvage after 12 months was significantly higher in patients with the device.…”

Section: Scs and The Arterial Microcirculationmentioning

confidence: 99%

“…3,8 Briefly, spinal cord stimulation requires the insertion of electrodes into the epidural space, with the electrodes connected to an impulse generator. 9 To treat lower-extremity pain in patients with CLI, 4 to 8 electrodes are generally placed in the epidural space between the thoracic 8 and 11 level through a paralaminar level 1 or 2 lumbar puncture. 4,10 The electrodes are usually centered in the spinal canal or directed off-center, depending on the location of the limb with the most significant symptoms.…”

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confidence: 99%

“…Hardware-related complications are the most common and can occur in 11-36% of patients, with infection being the next most common, occurring in 3-6.3% of patients. 8,9,10,12 …”

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confidence: 99%

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Spinal Cord Stimulation for Chronic Limb Ischemia

Naoum

Arbid

2013

Methodist DeBakey Cardiovascular Journal

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The treatment of chronic limb ischemia involves the restoration of pulsatile blood flow to the distal extremity. Some patients cannot be treated with endovascular means or with open surgery; some may have medical comorbidities that render them unfit for surgery, while others may have persistent ischemia or pain even in the face of previous attempts at reperfusion. In spinal cord stimulation (SCS), a device with electrodes is implanted in the epidural space to stimulate sensory fibers. This activates cell-signaling molecules that in turn cause the release of vasodilatory molecules, a decrease in vascular resistance, and relaxation of smooth muscle cells. SCS also suppresses sympathetic vasoconstriction and pain transmission. When patient selection is based on microcirculatory parameters, SCS therapy can significantly improve pain relief, halt the progression of ulcers, and potentially achieve limb salvage.

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Section: Scs and The Arterial Microcirculationmentioning

confidence: 99%

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confidence: 99%

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Spinal Cord Stimulation for Chronic Limb Ischemia

Naoum

Arbid

2013

Methodist DeBakey Cardiovascular Journal

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“…With appropriately selected patients at centers with interdisciplinary expertise, the trial-to-implant conversion rates can be quite encouraging: in the 65%-80% range for various diagnoses, 15 although from a nationwide perspective, the actual conversion rate remains less encouraging at approximately 41%. 7 The utility of this technology has been demonstrated in prospective randomized and observational studies, and in systematic literature reviews for various pathologies, including PPNP after structurally corrective lumbar spinal surgery, 6 complex regional pain syndrome, 27 chronic inoperable limb ischemia, 31 treatment-refractory angina, 28 and painful diabetic neuropathy. 3 Despite its proven efficacy for the PPNP population, there have been a few small studies that reported on the risk experienced by patients undergoing such intervention specifically in the context of managing neuropathic pain after lumbar spinal surgery, and whether those rates of complication are variable by surgical technique.…”

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Complications related to the use of spinal cord stimulation for managing persistent postoperative neuropathic pain after lumbar spinal surgery

Shamji

Westwick

Heary

2015

FOC

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OBJECT Structural spinal surgery yields improvement in pain and disability for selected patients with spinal stenosis, spondylolisthesis, or a herniated intervertebral disc. A significant fraction of patients exhibit persistent postoperative neuropathic pain (PPNP) despite technically appropriate intervention, and such patients can benefit from spinal cord stimulation (SCS) to alleviate suffering. The complication profile of this therapy has not been systematically assessed and, thus, was the goal of this review. METHODS A comprehensive literature search was performed to identify prospective cohorts of patients who had PPNP following structurally corrective lumbar spinal surgery and who underwent SCS device implantation. Data about study design, technique of SCS lead introduction, and complications encountered were collected and analyzed. Comparisons of complication incidence were performed between percutaneously and surgically implanted systems, with the level of significance set at 0.05. RESULTS Review of 11 studies involving 542 patients formed the basis of this work: 2 randomized controlled trials and 9 prospective cohorts. Percutaneous implants were used in 4 studies and surgical implants were used in 4 studies; in the remainder, the types were undefined. Lead migration occurred in 12% of cases, pain at the site of the implantable pulse generator occurred in 9% of cases, and wound-related complications occurred in 5% of cases; the latter 2 occurred more frequently among surgically implanted devices. CONCLUSIONS Spinal cord stimulation can provide for improved pain and suffering and for decreased narcotic medication use among patients with PPNP after lumbar spinal surgery. This study reviewed the prospective studies forming the evidence base for this therapy, to summarize the complications encountered and, thus, best inform patients and clinicians considering its use. There is a significant rate of minor complications, many of which require further surgical intervention to manage, including lead migration or implant infection, although such complications do not directly threaten patient life or function.

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“…Eine Reihe von randomisierten kontrollierten Studien beschrieb zwar einen positiven Effekt auf die Schmerzen durch die SCS, aber unterschiedlichen Ergebnisse bezüglich der Erhaltung der Extremitäten [1,19]. Ein Cochrane Review [45] und eine Metaanalyse [44] mit Pooling der Daten konnten jedoch einen signifikanten Effekt auch hinsichtlich des Extremitätenerhalts nach 12 Monaten nachweisen. Die NNT betrug 9 (95% Konfidenzint.…”

Section: Epidurale Rückenmarkstimulation Bei Peripherer Arterieller Vunclassified

Epidurale Rückenmarkstimulation zur Therapie chronischer Schmerzen

Tronnier

Baron

Birklein

et al. 2011

Schmerz

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Epidural spinal cord stimulation (SCS) is a reversible but invasive procedure which should be used for neuropathic pain, e.g. complex regional pain syndrome I (CRPS) and for mostly chronic radiculopathy in connection with failed back surgery syndrome following unsuccessful conservative therapy. Epidural SCS can also successfully be used after exclusion of curative procedures and conservative therapy attempts for vascular-linked pain, such as in peripheral arterial occlusive disease stages II and III according to Fontaine and refractory angina pectoris. Clinical practice has shown which clinical symptoms cannot be successfully treated by epidural SCS, e.g. pain in complete paraplegia syndrome or atrophy/injury of the sensory pathways of the spinal cord or cancer pain. A decisive factor is a critical patient selection as well as the diagnosis. Epidural SCS should always be used within an interdisciplinary multimodal therapy concept. Implementation should only be carried out in experienced therapy centers which are in a position to deal with potential complications.

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Systematic review and meta-analysis of controlled trials assessing spinal cord stimulation for inoperable critical leg ischaemia

Cited by 82 publications

References 25 publications

Spinal Cord Stimulation for Chronic Limb Ischemia

Spinal Cord Stimulation for Chronic Limb Ischemia

Complications related to the use of spinal cord stimulation for managing persistent postoperative neuropathic pain after lumbar spinal surgery

Epidurale Rückenmarkstimulation zur Therapie chronischer Schmerzen

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