Background
Peripheral arterial disease (PAD) refers to a common condition of narrowing of the arteries of the lower limbs that restricts blood flow; in the most severe cases, PAD can cause pain at rest, ulcers and gangrene. Amputation may be required if resistant pain or sepsis ensues, unless an intervention is undertaken to improve arterial perfusion (delivery of blood to cells and tissues). One such intervention is lumbar sympathectomy, whereby nerves that stimulate constriction of arteries are destroyed. This is done mainly when other treatments such as reconstruction are not possible and when no treatment would result in amputation.
Key results
No randomised controlled trials (current until January 2016) have assessed effects of lumbar sympathectomy by open, laparoscopic and percutaneous methods compared with no treatment or compared with any other method of lumbar sympathectomy in patients with critical lower limb ischaemia (CLI) due to non-reconstructable peripheral arterial disease (PAD). Our inclusion criteria were based on objective tests proposed by the Second European Consensus document on chronic critical leg ischaemia and the Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II). Randomised trials identified by the literature search were performed before such objective criteria for selection were applied and therefore were not eligible for inclusion in the review. High-quality studies are needed.
Quality of evidence
It was not possible to evaluate the quality of evidence in the absence of studies eligible for inclusion in the review.
We identified no RCTs assessing effects of lumbar sympathectomy by open, laparoscopic and percutaneous methods compared with no treatment or compared with any other method of lumbar sympathectomy in patients with CLI due to non-reconstructable PAD. High-quality studies are needed.
Critical lower limb ischaemia (CLI) is a manifestation of peripheral arterial disease (PAD) that is seen in patients with typical chronic ischaemic rest pain or patients with ischaemic skin lesions - ulcers or gangrene - for longer than 2 weeks. Critical lower limb ischaemia is the most severe form of PAD, and interventions to improve arterial perfusion become necessary. Although surgical bypass has been the gold standard for revascularisation, the extent or the site of disease may be such that the artery cannot be reconstructed or bypassed. These patients require other modalities of treatment, for example, vasodilatation by drugs or lumbar sympathectomy to relieve pain at rest and to avoid amputations. A systematic review of randomised controlled trials is required to evaluate the effects of lumbar sympathectomy in treating patients with CLI due to non-reconstructable PAD.
The objective of this review is to assess the effects of lumbar sympathectomy by open, laparoscopic and percutaneous methods compared with no treatment or compared with any other method of lumbar sympathectomy in patients with CLI due to non-reconstructable PAD.
The Cochrane Vascular Information Specialist (CIS) searched the Specialised Register (January 2016) and the Cochrane Central Register of Controlled Trials (CENTRAL; 2015, Issue 12). In addition, the CIS searched clinical trials databases for details of ongoing and unpublished studies.
Randomised controlled trials (RCTs) comparing any of the treatment modalities of lumbar sympathectomy, such as open, laparoscopic and chemical percutaneous methods, with no treatment or with any other method of lumbar sympathectomy for CLI due to non-reconstructable PAD were eligible. To decrease the bias of including participants that may be incorrectly diagnosed with CLI, review authors defined CLI as persistently recurring ischaemic rest pain requiring regular analgesia for more than two weeks, or ulceration or gangrene of the foot or toes, attributable to objectively proven arterial occlusive disease by measurement of ankle pressure of < 50 mmHg or toe pressure < 30 mmHg. We defined non-reconstructable PAD as a resting ankle brachial index (ABI) < 0.9 when no reasonable open surgical or endovascular revascularisation treatment option is available, as determined by individual trial vascular specialists.
Two review authors independently assessed studies identified for potential inclusion in the review. We planned to conduct data collection and analysis in accordance with the Cochrane Handbook for Systematic Review of Interventions.
We identified no studies that met the predefined inclusion criteria. To decrease the bias of including participants who may be incorrectly diagnosed with CLI, we based our inclusion criteria on objective tests, as described above. The randomised trials identified by the literature search were performed before such objective criteria for selection were applied and therefore were not eligible for inclusion in the review.