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Fulltext Lumbar sympathectomy techniques for critical lower limb ischaemia due to non-reconstructable peripheral arterial disease

Karanth VK, Karanth TK, Karanth L

Cochrane Database Syst Rev, 2016 12 13;12:CD011519.
PMID: 27959471 DOI: 10.1002/14651858.CD011519.pub2

BACKGROUND: 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.
OBJECTIVES: 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.
SEARCH METHODS: 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 In addition, the CIS searched clinical trials databases for details of ongoing and unpublished studies.
SELECTION CRITERIA: 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.
DATA COLLECTION AND ANALYSIS: 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.
MAIN RESULTS: 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.
AUTHORS' CONCLUSIONS: 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.

Matched MeSH terms: Peripheral Arterial Disease/complications*
Intra-arterial allogeneic mesenchymal stem cells for critical limb ischemia are safe and efficacious: report of a phase I study

Das AK, Bin Abdullah BJ, Dhillon SS, Vijanari A, Anoop CH, Gupta PK

World J Surg, 2013 Apr;37(4):915-22.
PMID: 23307180 DOI: 10.1007/s00268-012-1892-6

BACKGROUND: Critical limb ischemia (CLI) caused by peripheral arterial disease is associated with significant morbidity and mortality. This condition is associated with a 30 % amputation rate as well as mortality levels which might be as high as 25 %. There is no pharmacological therapy available, but several reports have suggested that mesenchymal stem cells (MSCs) may be a useful therapeutic option.
METHODS: This study, done at a university hospital, evaluated 13 patients for a phase I trial to investigate the safety and efficacy of intra-arterial MSCs in CLI patients. Eight patients with ten affected limbs were recruited for the study. As two patients (three limbs) died of ischemic cardiac events during the 6-month follow-up period, seven limbs were finally evaluated for the study.
RESULTS: There was significant pain relief. Visual analog scale (VAS) scores decreased from 2.29 ± 0.29 to 0.5 ± 0.34 (p < 0.05), ankle brachial pressure index (ABPI) increased significantly from 0.56 ± 0.02 to 0.67 ± 0.021 (p < 0.01), and transcutaneous oxygen pressure (TcPO2) also increased significantly in the foot from 13.57 ± 3.63 to 38 ± 3.47. Similar improvement was seen in the leg as well as the thigh. There was 86 % limb salvage and six of seven ulcers showed complete or partial healing.
CONCLUSION: It was concluded that intra-arterial MSCs could be safely administered to patients with CLI and was associated with significant therapeutic benefits.

Matched MeSH terms: Peripheral Arterial Disease/complications*
Fulltext Contemporary critical limb ischemia: Asian multidisciplinary consensus statement on the collaboration between endovascular therapy and wound care

Kawarada O, Zen K, Hozawa K, Ayabe S, Huang HL, Choi D, et al.

Cardiovasc Interv Ther, 2018 Oct;33(4):297-312.
PMID: 29654408 DOI: 10.1007/s12928-018-0523-z

The burden of peripheral artery disease (PAD) and diabetes in Asia is projected to increase. Asia also has the highest incidence and prevalence of end-stage renal disease (ESRD) in the world. Therefore, most Asian patients with PAD might have diabetic PAD or ESRD-related PAD. Given these pandemic conditions, critical limb ischemia (CLI) with diabetes or ESRD, the most advanced and challenging subset of PAD, is an emerging public health issue in Asian countries. Given that diabetic and ESRD-related CLI have complex pathophysiology that involve arterial insufficiency, bacterial infection, neuropathy, and foot deformity, a coordinated approach that involves endovascular therapy and wound care is vital. Recently, there is increasing interaction among cardiologists, vascular surgeons, radiologists, orthopedic surgeons, and plastic surgeons beyond specialty and country boundaries in Asia. This article is intended to share practical Asian multidisciplinary consensus statement on the collaboration between endovascular therapy and wound care for CLI.

Matched MeSH terms: Peripheral Arterial Disease/complications
Fulltext Review of the Long-term Effects of Autologous Bone-Marrow Mononuclear Cell Implantation on Clinical Outcomes in Patients with Critical Limb Ischemia

Yusoff FM, Kajikawa M, Matsui S, Hashimoto H, Kishimoto S, Maruhashi T, et al.

Sci Rep, 2019 05 22;9(1):7711.
PMID: 31118440 DOI: 10.1038/s41598-019-44176-5

Critical limb ischemia (CLI) is associated with a high risk of limb amputation. It has been shown that cell therapy is safe and has beneficial effects on ischemic clinical symptoms in patients with CLI. The aim of this study was to further investigate the outcomes of intramuscular injection of autologous bone-marrow mononuclear cells (BM-MNCs) in a long-term follow-up period in atherosclerotic peripheral arterial disease (PAD) patients who have no optional therapy. This study was a retrospective and observational study that was carried out to evaluate long-term clinical outcomes in 42 lower limbs of 30 patients with atherosclerotic PAD who underwent BM-MNC implantation. The median follow-up period was 9.25 (range, 6-16) years. The overall amputation-free rates were 73.0% at 5 years after BM-MNC implantation and 70.4% at 10 years in patients with atherosclerotic PAD. The overall amputation-free rates at 5 years and at 10 years after implantation of BM-MNCs were significantly higher in atherosclerotic PAD patients than in internal controls and historical controls. There were no significant differences in amputation rates between the internal control group and historical control group. The rate of overall survival was not significantly different between the BM-MNC implantation group and the historical control group. Implantation of autologous BM-MNCs is feasible for a long-term follow-up period in patients with CLI who have no optional therapy.

Matched MeSH terms: Peripheral Arterial Disease/complications