Bypass surgery for chronic lower limb ischaemia.
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ABSTRACT:
SUBMITTER: Antoniou GA
PROVIDER: S-EPMC6478298 | biostudies-literature | 2017 Apr
REPOSITORIES: biostudies-literature
Publications
Bypass surgery for chronic lower limb ischaemia.
Antoniou George A GA Georgiadis George S GS Antoniou Stavros A SA Makar Ragai R RR Smout Jonathan D JD Torella Francesco F
The Cochrane database of systematic reviews 20170403
<h4>Background</h4>Bypass surgery is one of the mainstay treatments for patients with critical lower limb ischaemia (CLI). This is the second update of the review first published in 2000.<h4>Objectives</h4>To assess the effects of bypass surgery in patients with chronic lower limb ischaemia.<h4>Search methods</h4>For this update, the Cochrane Vascular Group searched its trials register (last searched October 2016) and the Cochrane Central Register of Controlled Trials (CENTRAL) in the Cochrane L ...[more]
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Project description:BackgroundPeripheral arterial disease is a major health problem, and in about 1% to 2% of patients the disease progresses to critical limb ischaemia (CLI). In a substantial number of patients with CLI, no effective treatment option other than amputation is available and around a quarter of these patients will require a major amputation during the following year. This is an update of the review first published in 2011.ObjectivesTo determine the effectiveness and safety of local intramuscular transplantation of autologous adult bone marrow mononuclear cells (BMMNCs) as a treatment for critical limb ischaemia (CLI).Search methodsFor this update the Cochrane Peripheral Vascular Diseases Group Trials Search Co-ordinator searched the Specialised Register (last searched February 2014) and the Cochrane Central Register of Controlled Trials (CENTRAL; 2014, Issue 1).Selection criteriaWe included all randomised controlled trials of CLI in which participants were randomly allocated to intramuscular administration of autologous adult BMMNCs or control (either no intervention or conventional conservative therapy). We excluded studies on patients with intermittent claudication.Data collection and analysisTwo authors independently selected trials, assessed trials for eligibility and methodological quality, and extracted data. Disagreements were resolved by consensus or by the third author.Main resultsOnly two small studies, with a combined total of 57 participants, met our inclusion criteria and were finally included. They were classified as having a moderate risk of bias with unclear issues regarding their methods, and according to the GRADE approach, the overall quality of the evidence would be considered as moderate. In one study the effects of intramuscular injections of BMMNCs in the ischaemic lower limbs of patients with CLI were compared with control (standard conservative treatment). No deaths were reported and no significant difference was observed between the two groups for either pain (P = 0.37) or the ankle brachial index (ABI) parameter. However, the treatment group showed a significantly smaller proportion of participants undergoing amputation compared with the control group (P = 0.026).In the other study, following subcutaneous injections of granulocyte colony-stimulating factor (G-CSF) for five days, peripheral blood derived mononuclear cells were collected and then transplanted by intramuscular injections into ischaemic lower limbs. The effects were compared with daily intravenous prostaglandin E1 injections (control group). No deaths were reported. Pain reduction was greater in the treatment group than in the control group (P < 0.001) as was increase in ABI (mean increase 0.13 versus 0.02, P < 0.01). The treatment group experienced a statistically significant increase in pain-free walking distance (PFWD) compared with the control group (mean increase 306.4 m versus 78.6 m, P = 0.007). A smaller proportion of participants underwent amputation in the treatment group compared with the control group (0% versus 36%, P = 0.007).Authors' conclusionsThe data from the published trials suggest that there is insufficient evidence to support this treatment. These results were based on only two trials which had a very small number of participants. Therefore evidence from larger randomised controlled trials is needed in order to provide adequate statistical power to assess the role of intramuscular mononuclear cell implantation in patients with CLI.
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Project description:BackgroundConsensus is lacking regarding intervention for patients with acute lower limb ischaemia (ALI). The aim was to study amputation-free survival in patients treated for ALI by either primary open or endovascular revascularization.MethodsThe Swedish Vascular Registry (Swedvasc) was combined with the Population Registry and National Patient Registry to determine follow-up on mortality and amputation rates. Revascularization techniques were compared by propensity score matching 1 : 1.ResultsOf 9736 patients who underwent open surgery and 6493 who had endovascular treatment between 1994 and 2014, 3365 remained in each group after propensity score matching. Results are from the matched cohort only. Mean age of the patients was 74·7 years; 47·5 per cent were women and mean follow-up was 4·3 years. At 30-day follow-up, the endovascular group had better patency (83·0 versus 78·6 per cent; P < 0·001). Amputation rates were similar at 30 days (7·0 per cent in the endovascular group versus 8·2 per cent in the open group; P = 0·113) and at 1 year (13·8 versus 14·8 per cent; P = 0·320). The mortality rate was lower after endovascular treatment, at 30 days (6·7 versus 11·1 per cent; P < 0·001) and after 1 year (20·2 versus 28·6 per cent; P < 0·001). Accordingly, endovascular treatment had better amputation-free survival at 30 days (87·5 versus 82·1 per cent; P < 0·001) and 1 year (69·9 versus 61·1 per cent; P < 0·001). The number needed to treat to prevent one death within the first year was 12 with an endovascular compared with an open approach. Five years after surgery, endovascular treatment still had improved survival (HR 0·78, 99 per cent c.i. 0·70 to 0·86) but the difference between the treatment groups occurred mainly in the first year.ConclusionPrimary endovascular treatment for ALI appeared to reduce mortality compared with open surgery, without any difference in the risk of amputation.
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Project description:The aim of this meta-analysis was to evaluate the mortality, amputation and complication rates in patients with peripheral lower limb arterial disease undergoing bypass surgery with or without a prior history of endovascular operation. A systematic literature screen was performed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines on four academic databases, Medline, Scopus, Embase and Cochrane Central Register of Controlled Trials. Out of 1,072 records, six articles involving 11,420 patients (mean age, 68.1±2.0 years) met the inclusion criteria. The findings presented a 2b level of evidence (i.e. overall evidence represents data from individual cohort study or low quality randomized controlled trials) and suggested lower mortality, amputation and complication rates for patients undergoing bypass surgery without any history of endovascular operation, compared with those with a history of prior endovascular operation. Moreover, a random-effect meta-analysis suggested a small, positive reduction in mortality (Hedge's g=0.08), amputation (Hedge's g=0.18) and complication rates (Hedge's g=0.05) for patients undergoing bypass surgery without any history of endovascular operation. Nevertheless, owing to the scarcity of high-quality data, further studies and randomized clinical trials are needed to confirm these effects.
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Project description:The anatomical location of cutaneous melanoma is a relevant independent prognostic factor in melanoma. The aim of the study is to know the prognosis of lower limb cutaneous melanoma related to their location within the limb, regardless of the histological type, and if there are any other influencing variables. A real-world data observational study was developed. The lesions were divided depending on the location of the melanoma (thigh, leg and foot). Bivariate and multivariate analysis were performed, and melanoma-specific survival and disease-free survival rates were calculated. When these analysis were done, the results showed that, in melanomas of the lower limb, location on the foot presented a lower melanoma-specific survival rate compared to more proximal locations, and only the anatomical location presents statistical significance to discriminate cases with a higher mortality risk and a lower disease-free survival rate among distal melanomas (mainly on the foot). In conclusion, this study confirms that a more distal location of lower limb cutaneous melanoma is a relevant prognostic factor.Trial registration number NCT04625491 retrospectively registered.
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Project description:ObjectivePreoperative anemia in elderly patients undergoing surgery is prevalent and associated with adverse events; however, the interaction with other risk factors in patients with chronic limb-threatening ischemia (CLTI) is not well described. The purpose of this study was to assess the association between lower hematocrit (HCT) levels on admission and postoperative outcomes after infrainguinal bypass surgery.MethodsPatients with CLTI undergoing nonemergent infrainguinal bypass were identified in the targeted vascular module of National Surgical Quality Improvement Program (NSQIP; 2011-2014). The 30-day outcomes were compared across preoperative HCT levels: severe (≤29%), moderate (29.1%-34%), mild (34.1%-39%), or no anemia (>39%), with no anemia serving as the reference group for all analyses. Independent associations between levels of anemia and postoperative outcomes were established using multivariable logistic regression. A sensitivity analysis was performed to assess interactions between preoperative anemia and blood transfusions.ResultsWe identified 5081 patients undergoing bypass, of which 741 (15%) had severe, 1317 (26%) moderate, 1516 (30%) mild, and 1507 (30%) no anemia. Anemic patients were older and more commonly suffered from tissue loss and comorbidities (eg, hypertension, diabetes, and renal insufficiency; all P < .001). After adjustment for baseline conditions, mortality was higher in those with severe anemia (3.1%; odds ratio [OR], 2.8; 95% confidence interval [CI], 1.3-6.3) and moderate anemia (3.0%; OR, 2.6; 95% CI, 1.2-5.5) compared with those without anemia (0.7%). Severe anemia was independently associated with major amputation (6.9% vs 3.3%; OR, 1.6; 95% CI, 1.01-2.6) compared with no anemia. Anemia on admission was additionally associated with several other adverse outcomes, such as major adverse cardiovascular event (MACE; severe: OR, 1.9; 95% CI, 1.1-3.0; moderate: OR, 1.9; 95% CI, 1.3-2.9; mild: OR, 1.6; 95% CI, 1.1-2.4) and unplanned return to the operating room (severe: OR, 1.6; 95% CI, 1.2-2.1; moderate: OR, 1.5; 95% CI, 1.2-1.8; mild, OR: 1.3; 95% CI, 1.03-1.6). Moreover, mortality associated with preoperative anemia was not different in patients receiving postoperative blood transfusions compared with those who did not, whereas MACE was significantly higher in patients with preoperative anemia and blood transfusions (interaction; P < .001).ConclusionsMortality and major adverse events in CLTI patients undergoing infrainguinal bypass are inversely associated with preoperative HCT levels, with the highest event rates in the most severely anemic patients. The correlation between anemia and MACE-but not mortality-was stronger in those patients receiving postoperative blood transfusions. Further research is needed to define an appropriate transfusion threshold, and attention should be focused on how to best optimize anemic CLTI patients before intervention.
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| S-EPMC10178874 | biostudies-literature