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The Journal of Cardiovascular Surgery Jun 2004Subintimal angioplasty has been suggested as a treatment option for occlusive disease and has become an established practice in some centres, reducing their operative... (Comparative Study)
Comparative Study Review
Subintimal angioplasty has been suggested as a treatment option for occlusive disease and has become an established practice in some centres, reducing their operative workload considerably. Others have concerns about the safety and durability of the procedure. This review will focus on the evidence for the use of subintimal angioplasty in lower limb occlusive disease. A systematic review of the literature from a Medline search has been carried out. Despite a paucity of trial data, subintimal angioplasty is now an established technique for the treatment of lower limb occlusive disease. The results for femoro-popliteal disease are well documented, with excellent technical and clinical success rates and low complication rates. The results for iliac disease are less well documented and demand caution. For infra-popliteal disease with critical ischaemia, the technique is again safe with good short and long-term results in a group of patients in whom distal bypass surgery is often risky. Subintimal angioplasty has a definite learning curve and those wishing to take it up should visit an experienced centre first. To achieve widespread acceptance it is likely to require large scale randomised controlled trials.
Topics: Aged; Angiography; Angioplasty, Balloon; Arterial Occlusive Diseases; Female; Femoral Artery; Humans; Iliac Artery; Ischemia; Lower Extremity; Male; Middle Aged; Peripheral Vascular Diseases; Popliteal Artery; Prognosis; Risk Assessment; Severity of Illness Index; Treatment Outcome; Tunica Intima; Vascular Patency
PubMed: 15179334
DOI: No ID Found -
Cardiovascular Research Mar 2019Peripheral arterial disease (PAD) is the leading cause of lower limb amputation and estimated to affect over 202 million people worldwide. PAD is caused by... (Review)
Review
Peripheral arterial disease (PAD) is the leading cause of lower limb amputation and estimated to affect over 202 million people worldwide. PAD is caused by atherosclerotic lesions that occlude large arteries in the lower limbs, leading to insufficient blood perfusion of distal tissues. Given the severity of this clinical problem, there has been long-standing interest in both understanding how chronic arterial occlusions affect muscle tissue and vasculature and identifying therapeutic approaches capable of restoring tissue composition and vascular function to a healthy state. To date, the most widely utilized animal model for performing such studies has been the ischaemic mouse hindlimb. Despite not being a model of PAD per se, the ischaemic hindlimb model does recapitulate several key aspects of PAD. Further, it has served as a valuable platform upon which we have built much of our understanding of how chronic arterial occlusions affect muscle tissue composition, muscle regeneration and angiogenesis, and collateral arteriogenesis. Recently, there has been a global surge in research aimed at understanding how gene expression is regulated by epigenetic factors (i.e. non-coding RNAs, histone post-translational modifications, and DNA methylation). Thus, perhaps not unexpectedly, many recent studies have identified essential roles for epigenetic factors in regulating key responses to chronic arterial occlusion(s). In this review, we summarize the mechanisms of action of these epigenetic regulators and highlight several recent studies investigating the role of said regulators in the context of hindlimb ischaemia. In addition, we focus on how these recent advances in our understanding of the role of epigenetics in regulating responses to chronic arterial occlusion(s) can inform future therapeutic applications to promote revascularization and perfusion recovery in the setting of PAD.
Topics: Animals; Chronic Disease; Collateral Circulation; Disease Models, Animal; Epigenesis, Genetic; Hindlimb; Humans; Ischemia; Mice; Muscle, Skeletal; Neovascularization, Physiologic; Peripheral Arterial Disease; Rats; Regeneration; Regional Blood Flow
PubMed: 30629133
DOI: 10.1093/cvr/cvz001 -
VASA. Zeitschrift Fur Gefasskrankheiten Jan 2018Patients with critical limb ischaemia have a poor life expectancy. Aggressive revascularization is accepted in order to preserve their independence in the final phase of... (Review)
Review
Patients with critical limb ischaemia have a poor life expectancy. Aggressive revascularization is accepted in order to preserve their independence in the final phase of their lives. Bypass surgery and more recently endovascular interventions with angioplasty and stenting have become the treatment of choice to prevent amputation and to resolve pain. However, as many as 20 % of patients with critical limb ischaemia are unsuitable candidates for a vascular intervention because of extensive occlusions of outflow in the crural and pedal vessels. Such "no-option critical limb ischaemia" may be treated with venous arterialization. In the present review, we discuss the history of the venous arterialization procedure, the mechanisms, the different techniques, and complications of venous arterialization.
Topics: Humans; Ischemia; Limb Salvage; Lower Extremity; Peripheral Arterial Disease; Regional Blood Flow; Vascular Patency
PubMed: 29065790
DOI: 10.1024/0301-1526/a000669 -
Cardiovascular Journal of AfricaCritical limb ischaemia (CLI) is the most severe state of peripheral arterial disease and is one of the major causes of lower-limb amputations. One of the treatment...
OBJECTIVE
Critical limb ischaemia (CLI) is the most severe state of peripheral arterial disease and is one of the major causes of lower-limb amputations. One of the treatment choices is prosthetic vascular grafts. Despite treatment, CLI may lead to amputation owing to infection or progressive ischaemia. The aim of this study was to show that multidisciplinary planning and surgery for CLI patients with prosthetic grafts decreased the duration of hospital stay, costs, risk of infection and ascending conversion of the amputation level.
METHODS
Forty-two above-knee amputation patients with grafts were retrospectively evaluated. Group A patients ( = 24) had partial excision and group B patients ( = 18) total excision with or without saphenous patch-plasty, according to the patency of the deep femoral artery. Growth in wound culture, antibiotic therapy duration, conversion to hip disarticulation and hospitalisation periods were compared.
RESULTS
Differences in growth of wound culture ( = 0.007), antibiotic duration ( = 0.003), hip disarticulation ( = 0.029) and duration of hospital stay ( = 0.0001) between the two groups were found to be statistically significant ( < 0.05).
CONCLUSIONS
Management of CLI patients is a complex process, and a multidisciplinary approach is key to avoiding undesirable outcomes. Meticulous planning, including excision of the total graft, while ensuring the vascular supply, is essential.
Topics: Humans; Retrospective Studies; Vascular Patency; Blood Vessel Prosthesis; Peripheral Arterial Disease; Ischemia; Amputation, Surgical; Treatment Outcome
PubMed: 35211716
DOI: 10.5830/CVJA-2022-012 -
Atherosclerosis Mar 2013Critical limb ischaemia is a severe manifestation of peripheral arterial disease characterised by intractable pain and tissue gangrene. Conventional treatments include... (Review)
Review
Critical limb ischaemia is a severe manifestation of peripheral arterial disease characterised by intractable pain and tissue gangrene. Conventional treatments include percutaneous angioplasty and surgical bypass but up to one third of patients are not amenable to these interventions and will ultimately require amputation. Therapeutic neovascularisation has been proposed as an alternative treatment in these 'no option' patients and both cytokines and cells have shown impressive efficacy in the laboratory. Clinical trials in man, however, have had modest results. This discrepancy has put into question the relevance of the pre-clinical assays that are used to test potential agents. One of the most widely used of these assays is the hind limb ischaemia model that is often performed in young, healthy animals. This review critiques the techniques used to induce and assess ischaemia in this model and outlines the reasons why healthy rodents cannot fully recapitulate critical limb ischaemia in aged patients. Strategies that may produce a hind limb model that better simulates the human condition are proposed.
Topics: Animals; Disease Models, Animal; Femoral Artery; Hindlimb; Humans; Ischemia; Ligation; Mice; Neovascularization, Physiologic; Peripheral Vascular Diseases
PubMed: 23177969
DOI: 10.1016/j.atherosclerosis.2012.10.060 -
Journal of Vascular Surgery May 2010The Bypass versus Angioplasty in Severe Ischemia of the Leg (BASIL) trial is the only randomized controlled trial (RCT) to date comparing open surgical bypass with... (Review)
Review
The Bypass versus Angioplasty in Severe Ischemia of the Leg (BASIL) trial is the only randomized controlled trial (RCT) to date comparing open surgical bypass with endovascular therapy for severe limb ischemia (SLI). In their initial 2005 publication, the BASIL investigators reported that the main clinical outcomes (overall survival and amputation-free survival) were no different at 2 years after randomization to angioplasty-first or bypass-first revascularization strategies. However, beyond 2 years there appeared to be a benefit for open bypass surgery, providing impetus for an extension study. The final analysis of the long-term outcomes from BASIL is now presented in a set of articles that are reviewed in this commentary. The benefit of initial randomization to open surgery for patients surviving > or =2 years (70% of the BASIL cohort) was confirmed. When outcomes were analyzed by treatment received, patients who had received prosthetic bypass grafts (25% of the surgical arm) fared much more poorly than those treated with a vein bypass. Patients who underwent surgical bypass after an initial failed angioplasty also fared significantly worse than those who were treated initially with bypass surgery. Health-related quality of life measures and costs were not significantly different overall. There are many controversies surrounding the BASIL trial and its interpretation, which are reviewed herein. These include the choice of study population, end points examined, and the nature of procedures performed. The BASIL trial confirms the primacy of open surgical bypass with vein for most patients with SLI and raises questions about the sequelae of failed endovascular interventions. Further multicenter trials are needed to address the large gap in evidence for treatment selection in this patient population.
Topics: Aged; Aged, 80 and over; Amputation, Surgical; Angioplasty, Balloon; Blood Vessel Prosthesis Implantation; Constriction, Pathologic; Evidence-Based Medicine; Female; Humans; Ischemia; Lower Extremity; Male; Middle Aged; Multicenter Studies as Topic; Peripheral Vascular Diseases; Practice Guidelines as Topic; Prospective Studies; Quality of Life; Radiography; Randomized Controlled Trials as Topic; Reoperation; Research Design; Saphenous Vein; Severity of Illness Index; Time Factors; Treatment Outcome; United Kingdom; Vascular Surgical Procedures
PubMed: 20435263
DOI: 10.1016/j.jvs.2010.02.001 -
Acta Medica Scandinavica 1986Three hundred and twelve patients with peripheral arterial disease were followed up for 8 3/4 years or more (maximum 11 3/4 years) to assess the natural history of the...
Three hundred and twelve patients with peripheral arterial disease were followed up for 8 3/4 years or more (maximum 11 3/4 years) to assess the natural history of the disease and factors determining its outcome. Of the 312 patients, 188 (69%) died during the follow-up, 68% of the deaths having cardiovascular causes. The 10-year relative cumulative survival rate was 0.61 for males and 0.48 for females. The role of smoking as a risk factor could not be analysed without bias. In addition to known risk factors diabetes mellitus, cerebrovascular disease and coronary heart disease, the degree of peripheral arterial disease itself also proved to be a risk factor among men. The expected life lost for men with intermittent claudication was 20%, but 44.3% for men with advanced lower limb ischaemia (p less than 0.01). This difference could not be explained by the well-known association of advanced ischaemia and diabetes mellitus. The present results therefore suggest that the state of advanced ischaemia indicates larger involvement of the whole of the arterial tree and predicts fatal cardiovascular events among these patients.
Topics: Aged; Cardiovascular Diseases; Cerebrovascular Disorders; Diabetes Complications; Female; Follow-Up Studies; Humans; Intermittent Claudication; Ischemia; Leg; Male; Middle Aged; Prognosis; Retrospective Studies; Risk; Smoking
PubMed: 3799236
DOI: 10.1111/j.0954-6820.1986.tb02768.x -
The Cochrane Database of Systematic... Apr 2018Peripheral arterial disease (PAD) is a common circulatory problem that can lead to reduced blood flow to the limbs, which may result in critical limb ischaemia (CLI), a... (Review)
Review
BACKGROUND
Peripheral arterial disease (PAD) is a common circulatory problem that can lead to reduced blood flow to the limbs, which may result in critical limb ischaemia (CLI), a painful manifestation that occurs when a person is at rest. The mainstay of treatment for CLI is surgical or endovascular repair. However, when these means of treatment are not suitable, due to anatomical reasons or comorbidities, treatment for pain is limited. Lumbar sympathectomy and prostanoids have both been shown to reduce pain from CLI in people who suffer from non-reconstructable PAD, but there is currently insufficient evidence to determine if one treatment is superior. Due to the severity of the rest pain caused by CLI, and its impact on quality of life, it is important that people are receiving the best pain relief treatment available, therefore interest in this area of research is high.
OBJECTIVES
To compare the efficacy of lumbar sympathectomy with prostanoid infusion in improving symptoms and function and avoiding amputation in people with critical limb ischaemia (CLI) due to non-reconstructable peripheral arterial disease (PAD).
SEARCH METHODS
The Cochrane Vascular Information Specialist (CIS) searched the Specialised Register (last searched 29 March 2017) and CENTRAL (2017, Issue 2). The CIS also searched clinical trials databases for ongoing or unpublished studies.
SELECTION CRITERIA
Randomised controlled trials (RCTs), with parallel treatment groups, that compared lumbar sympathectomy (surgical or chemical) with prostanoids (any type and dosage) in people with CLI due to non-reconstructable PAD.
DATA COLLECTION AND ANALYSIS
Three review authors independently selected trials, extracted data and assessed risk of bias. Any disagreements were resolved by discussion. We performed fixed-effect model meta-analyses, when there was no overt sign of heterogeneity, with risk ratios (RRs) and 95% confidence intervals (CIs). We graded the quality of evidence according to GRADE.
MAIN RESULTS
We included a single study in this review comparing lumbar sympathectomy with prostanoids for the treatment of CLI in people with non-reconstructable PAD. The single study included 200 participants with Buerger's disease, a form of PAD, 100 in each treatment group, but only 162 were actually included in the analyses. The study compared an open surgical technique for lumbar sympathectomy with the prostanoid, iloprost, and followed participants for 24 weeks.Risk of bias was low for most evaluated domains. Due to the nature of the treatment, blinding of the participants and those providing the treatment would be impossible as a surgical procedure was compared with intravenous injections. It was not mentioned if blinded assessors evaluated the study outcomes, therefore, we judged subjective outcomes (i.e. pain reduction) to be at unclear risk of detection bias and objective outcomes (i.e. ulcer healing, amputation and mortality) at low risk of detection bias. We also rated the risk of attrition bias as unclear; 38 out of 200 (19%) participants were not included in the analysis without clear explanation (16 of 100 in the iloprost arm and 22 of 100 in the sympathectomy arm). The quality of evidence was low due to serious imprecision because the study numbers were low and there was only one study included.The single included study reported on the outcome of complete healing without pain or major amputation, which fell under three separate outcomes for our review: relief of rest pain, complete ulcer healing and avoidance of major amputation. We chose to keep the outcome as a singularly reported outcome in order to not introduce bias into the outcomes, which may have been the case if reported separately. The limited evidence suggests participants who received prostaglandins had improved complete ulcer healing without rest pain or major amputation when compared with those who received lumbar sympathectomy (RR 1.63, 95% CI 1.30 to 2.05), but as it was the only included study, we rated the data as low-quality and could not draw any overall conclusions. The study authors stated that more participants who received prostaglandins reported adverse effects, such as headache, flushing, nausea and abdominal discomfort, but only one participant experienced severe enough adverse effects to drop out. Five participants who underwent lumbar sympathectomy reported minor wound infection (low-quality evidence). There was no reported mortality in either of the treatment groups (low-quality evidence).The included study did not report on claudication distances, quality of life or functional status, ankle brachial pressure index (ABPI), tissue oxygenation or toe pressures, or progression to minor amputation, complications or provide any cost-effectiveness data.
AUTHORS' CONCLUSIONS
Low-quality evidence from a single study in a select group of participants (people with Buerger's disease) suggests that prostaglandins are superior to open surgical lumbar sympathectomy for complete ulcer healing without rest pain or major amputation, but possibly incur more adverse effects. Further studies are needed to better understand if prostaglandins truly are more efficacious than open surgical lumbar sympathectomy and if there are any concerns with adverse effects. It would be of great importance for future studies to include other forms of PAD (as Buerger's disease is a select type of PAD), other methods of sympathectomy as well as data on quality of life, complications and cost-effectiveness.
Topics: Humans; Iloprost; Ischemia; Leg Ulcer; Pain Management; Peripheral Arterial Disease; Prostaglandins; Sympathectomy; Thromboangiitis Obliterans; Vasodilator Agents
PubMed: 29658630
DOI: 10.1002/14651858.CD009366.pub2 -
European Journal of Vascular and... Dec 2011Recommendations stated in the TASC II guidelines for the treatment of peripheral arterial disease (PAD) regard a heterogeneous group of patients ranging from claudicants... (Review)
Review
Recommendations stated in the TASC II guidelines for the treatment of peripheral arterial disease (PAD) regard a heterogeneous group of patients ranging from claudicants to critical limb ischaemia (CLI) patients. However, specific considerations apply to CLI patients. An important problem regarding the majority of currently available literature that reports on revascularisation strategies for PAD is that it does not focus on CLI patients specifically and studies them as a minor part of the complete cohort. Besides the lack of data on CLI patients, studies use a variety of endpoints, and even similar endpoints are often differentially defined. These considerations result in the fact that most recommendations in this guideline are not of the highest recommendation grade. In the present chapter the treatment of CLI is not based on the TASC II classification of atherosclerotic lesions, since definitions of atherosclerotic lesions are changing along the fast development of endovascular techniques, and inter-individual differences in interpretation of the TASC classification are problematic. Therefore we propose a classification merely based on vascular area of the atherosclerotic disease and the lesion length, which is less complex and eases the interpretation. Lesions and their treatment are discussed from the aorta downwards to the infrapopliteal region. For a subset of lesions, surgical revascularisation is still the gold standard, such as in extensive aorto-iliac lesions, lesions of the common femoral artery and long lesions of the superficial femoral artery (>15 cm), especially when an applicable venous conduit is present, because of higher patency and limb salvage rates, even though the risk of complications is sometimes higher than for endovascular strategies. It is however more and more accepted that an endovascular first strategy is adapted in most iliac, superficial femoral, and in some infrapopliteal lesions. The newer endovascular techniques, i.e. drug-eluting stents and balloons, show promising results especially in infrapopliteal lesions. However, most of these results should still be confirmed in large RCTs focusing on CLI patients. At some point when there is no possibility of an endovascular nor a surgical procedure, some alternative non-reconstructive options have been proposed such as lumbar sympathectomy and spinal cord stimulation. But their effectiveness is limited especially when assessing the results on objective criteria. The additional value of cell-based therapies has still to be proven from large RCTs and should therefore still be confined to a research setting. Altogether this chapter summarises the best available evidence for the treatment of CLI, which is, from multiple perspectives, completely different from claudication. The latter also stresses the importance of well-designed RCTs focusing on CLI patients reporting standardised endpoints, both clinical as well as procedural.
Topics: Angioplasty; Arterial Occlusive Diseases; Critical Illness; Cryotherapy; Diabetic Foot; Humans; Ischemia; Laser Therapy; Limb Salvage; Lower Extremity; Peripheral Vascular Diseases; Practice Guidelines as Topic; Stents; Vascular Surgical Procedures
PubMed: 22172473
DOI: 10.1016/S1078-5884(11)60014-2 -
The Cochrane Database of Systematic... Jun 2013Peripheral arterial thrombolysis is technique used in the management of peripheral arterial ischaemia. Much is known about the indications, risks and benefits of... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Peripheral arterial thrombolysis is technique used in the management of peripheral arterial ischaemia. Much is known about the indications, risks and benefits of thrombolysis. However, it is not known whether thrombolysis works better than surgery in the initial treatment of acute limb ischaemia.
OBJECTIVES
To determine the preferred initial treatment, surgery or thrombolysis, for acute limb ischaemia.
SEARCH METHODS
For this update the Cochrane Peripheral Vascular Diseases Group Trials Search Co-ordinator searched the Specialised Register (last searched March 2013) and CENTRAL (2013, Issue 2).
SELECTION CRITERIA
All randomised studies comparing thrombolysis and surgery for the initial treatment of acute limb ischaemia.
DATA COLLECTION AND ANALYSIS
Each author independently assessed trial quality and extracted data. Agreement was reached by consensus.
MAIN RESULTS
Five trials with a total of 1283 participants were included. There was no significant difference in limb salvage or death at 30 days, six months or one year between initial surgery and initial thrombolysis. However, stroke was significantly more frequent at 30 days in thrombolysis participants (1.3%) compared to surgery participants (0%) (Odds ratio (OR) 6.41; 95% confidence interval (CI) 1.57 to 26.22). Major haemorrhage was more likely at 30 days in thrombolysis participants (8.8%) compared to surgery participants (3.3%) (OR 2.80; 95% CI 1.70 to 4.60); and distal embolization was more likely at 30 days in thrombolysis participants (12.4%) compared to surgery participants (0%) (OR 8.35; 95% CI 4.47 to 15.58).Participants treated by initial thrombolysis underwent a less severe degree of intervention (OR 5.37; 95% CI 3.99 to 7.22) and displayed equivalent overall survival compared to initial surgery (OR 0.87; 95% CI 0.61 to 1.25).
AUTHORS' CONCLUSIONS
Universal initial treatment with either surgery or thrombolysis cannot be advocated on the available evidence. There is no overall difference in limb salvage or death at one year between initial surgery and initial thrombolysis. Thrombolysis may be associated with a higher risk of ongoing limb ischaemia and haemorrhagic complications including stroke. The higher risk of complications must be balanced against risks of surgery in each person.
Topics: Hemorrhage; Humans; Ischemia; Leg; Outcome Assessment, Health Care; Postoperative Complications; Randomized Controlled Trials as Topic; Stroke; Thrombolytic Therapy; Time Factors
PubMed: 23744596
DOI: 10.1002/14651858.CD002784.pub2