Diabetes mellitus was not associated with lower amputation-free survival after open revascularization for chronic limb-threatening ischemia - A nationwide propensity score adjusted analysis.
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SUBMITTER: Lilja E
PROVIDER: S-EPMC8493412 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:ObjectiveHistorically, open surgical bypass provided a durable repair among diabetic patients with chronic limb-threatening ischemia (CLTI). In the current endovascular era, however, the difference in long-term outcomes between first-time revascularization strategies among patients with insulin-dependent diabetes mellitus (IDDM) is poorly understood.MethodsWe reviewed the records of all patients with IDDM undergoing a first-time infrainguinal bypass graft (BPG) or percutaneous transluminal angioplasty with or without stenting (PTA/S) for CLTI at our institution from 2005 to 2014. We defined IDDM as use of chronic insulin administration at baseline to control blood glucose levels and recorded the most recent glycated hemoglobin value available within 3 months before the procedure and fasting blood glucose level on the day of the procedure. We compared rates of wound healing, restenosis, reintervention, major amputation, and mortality between BPG and PTA/S in our population using χ2, Kaplan-Meier, and Cox regression analyses. As a sensitivity analysis, we calculated propensity scores and employed inverse probability weighting to account for nonrandom assignment to BPG vs PTA/S.ResultsOf 2869 infrainguinal revascularizations from 2005 to 2014, 655 limbs (316 BPG, 339 PTA/S) in 580 patients fit our criteria and underwent a first-time revascularization for CLTI. Patients undergoing BPG, compared with PTA/S, were similar in age (69 vs 68 years; P = .55), had similar rates of tissue loss (87% vs 91%; P = .07) and dialysis dependence (26% vs 28%; P = .55), were less likely to be hypertensive (84% vs 92%; P < .001), and were more likely to be current smokers (21% vs 14%; P = .02). There were no differences between BPG and PTA/S patients in mean glycated hemoglobin levels (8.1% vs 8.0%; P = .51) or mean fasting blood glucose levels (158 vs 150 mg/dL; P = .18). Although total hospital length of stay was significantly longer among BPG patients (11 vs 8 days; P < .001), perioperative complications did not differ, including acute kidney injury (19% vs 23%; P = .24), hematoma (6.0% vs 3.8%; P = .20), acute myocardial infarction (1.3% vs 2.1%; P = .43), and mortality (3.8% vs 3.0%; P = .55). BPG-first patients had significantly lower unadjusted 6-month rates of incomplete wound healing (49% vs 57%) and 5-year rates of restenosis (53% vs 72%) and reintervention (47% vs 58%; all P < .05). After adjustment, multivariable analysis suggested PTA/S-first intervention to be significantly associated with higher risk of restenosis (hazard ratio, 1.9; 95% confidence interval, 1.3-2.7) and reintervention (1.9 [1.2-2.7]). These results remained robust after inverse probability weighting.ConclusionsAmong patients with IDDM and CLTI, a bypass-first strategy is associated with similar 30-day outcomes and lower restenosis and reintervention rates. These data suggest that a bypass-first approach may best serve appropriately selected, anatomically suitable patients with IDDM and pedal ischemia that requires revascularization.
| S-EPMC7106939 | biostudies-literature
Project description:Background and objectiveDiabetes mellitus associates with poor outcomes in chronic limb threatening ischemia but data on different hypoglycemic regimens and outcomes are lacking. We analyzed insulin-treated diabetes mellitus, non-insulin-treated diabetes mellitus, and patients without diabetes mellitus.MethodsAll patients with peripheral artery disease and/or diabetes mellitus and infrapopliteal revascularization in the Department of Vascular Surgery, Turku University Hospital during 2007-2015 were included. Tibial atherosclerosis was categorized into crural index classes of I-IV.ResultsOf the 497 patients, 180 were insulin-treated diabetes mellitus, 94 non-insulin-treated diabetes mellitus, and 223 patients without diabetes mellitus groups (diabetes mellitus 55.1%). Insulin-treated diabetes mellitus was the most ill, youngest (insulin-treated diabetes mellitus-median: 72.4, interquartile range: 64.0-79.5 versus non-insulin-treated diabetes mellitus-76.0, interquartile range: 67.9-83.6 versus patients without diabetes mellitus-77.3, interquartile range: 68.5-83.7, p < 0.001), had the highest body mass index (insulin-treated diabetes mellitus-median: 27.7, interquartile range: 24.0-31.8 versus non-insulin-treated diabetes mellitus-26.3, interquartile range: 23.2-30.3 versus patients without diabetes mellitus-23.9, interquartile range: 21.5-26.9, p < 0.001), and Charlson comorbidity index (insulin-treated diabetes mellitus-65.6% versus non-insulin-treated diabetes mellitus-46.8% versus patients without diabetes mellitus-10.8%, p < 0.001). After endovascular revascularization, limb salvage was poorer for insulin-treated diabetes mellitus (p = 0.046) and non-insulin-treated diabetes mellitus groups (p = 0.011) compared to surgery, but not for patients without diabetes mellitus (p = 0.15). Patients with crural index IV in insulin-treated diabetes mellitus (p = 0.001) and non-insulin-treated diabetes mellitus (p = 0.013) had higher mortality after revascularization. Crural index IV was a risk factor for limb loss (hazard ratio: 1.37, 95% confidence interval: 1.08-1.74, p = 0.008).ConclusionsLimb salvage after bypass is better for insulin and non-insulin diabetics, compared to the endovascular approach. Extensive tibial atherosclerosis is an independent risk factor for limb loss. It associates with increased mortality in both insulin and non-insulin diabetics.
| S-EPMC8688977 | biostudies-literature
Project description:Background:Lower limb amputation (LLA) is a complication of lower limb atherosclerosis, infection and tissue gangrene. Following ipsilateral LLA, the risk of major amputation of the contralateral limb or of death is unknown. The aim of this study was to determine the incidence of a contralateral major LLA, comparing those with a non-malignant/non-traumatic ipsilateral major vs. ipsilateral minor LLA. Methods:We used pre-existing linked administrative health databases for the study. Data were provided by the Institute for Clinical Evaluation Sciences (ICES), Toronto, Ontario. This is a retrospective population-based cohort study across Ontario, Canada, 2002-2012. Cause-specific Cox regression models were used to obtain hazard ratios. Cumulative incidence functions were used to calculate the risk of contralateral major LLA and the risk of the competing event death. Individuals who did not survive at least 30 days after their first ipsilateral LLA were excluded since they were ineligible to have a contralateral LLA. Results:5,816 adults underwent an ipsilateral major and 4,143 an ipsilateral minor LLA. The incidences of contralateral major LLA were 4.8 and 2.2 (adjusted HR 2.41, 95% CI 2.04-2.84) after ipsilateral major and minor LLA, respectively. Incidence of death was 18.9 and 11.4 (adjusted HR 1.22, 95% CI 1.13-1.31) following ipsilateral major and minor LLA, respectively. Conclusion:There is high incidence of a contralateral major LLA and even higher risk of death following the ipsilateral LLA. Healthcare professionals should develop strategies for contralateral limb preservation in individuals with existing ipsilateral LLA.
| S-EPMC6180416 | biostudies-literature
Project description:RNA-seq analysis of bone marrow derived macrophages stimulated with resolvin D1(RvD1)
2020-06-19 | GSE128679 | GEO
Project description:To determine whether diabetes mellitus has an independent impact on major limb outcomes at 1 year after endovascular treatment of lower extremity peripheral artery disease (PAD).The study involved 1906 consecutive patients (mean age 66 years; 1469 men) enrolled in the observational Excellence in Peripheral Artery Disease (XLPAD) registry ( ClinicalTrials.gov identifier NCT01904851) between January 2005 and October 2015 after undergoing index endovascular procedures in 2426 limbs for arterial occlusive disease. Patient outcomes included 12-month target limb amputation (above ankle) and target limb revascularization as well as all-cause death. Kaplan-Meier analysis and adjusted Cox proportional hazard models were used for time-to-event analysis of outcomes for the entire study sample as well as for the critical limb ischemia (CLI) and claudication subgroups. Results of the Cox regression models are reported as the hazard ratio (HR) and 95% confidence interval (CI).Diabetics undergoing endovascular procedures had higher rates of comorbid conditions (p<0.001), CLI (p<0.001), heavily calcified lesions (p=0.002), multivessel disease (p=0.030), and fewer infrapopliteal runoff vessels (p<0.001). Regression analysis after adjusting for confounders revealed significantly higher target limb major amputation in diabetics compared with nondiabetics (HR 5.02, 95% CI 1.44 to 17.56, p=0.011). However, repeat revascularization rates were similar. When considering CLI and claudication subgroups, diabetes was associated with a nonsignificant increased risk of 12-month major amputation only for patients presenting with CLI (HR 3.48, 95% CI 0.97 to 12.51, p=0.056). Diabetes was also associated with an increased risk of 12-month all-cause mortality in the overall study sample (HR 4.64, 95% CI 2.01 to 10.70, p<0.001) and in the CLI subgroup (HR 14.15, 95% CI 3.16 to 63.32, p<0.001) but not in the claudication subgroup (HR 1.42, 95% CI 0.45 to 4.54, p=0.552).Diabetes increases the risk of major amputation and all-cause death at 12 months following endovascular revascularization in patients with symptomatic PAD. These risks are especially heightened in patients presenting with CLI.
| S-EPMC5624231 | biostudies-literature
Project description:Patients with peripheral artery disease (PAD) are a heterogeneous population and differ in risk of mortality and low extremity amputation (LEA), which complicates clinical decision-making. This study aimed to develop a simple risk scale using decision tree methodology to guide physicians in managing critical limb ischemia (CLI) patients who will benefit from endovascular therapy (EVT).A total of 736 patients with CLI, Rutherford classification (RC) stage ≥4, and prior successful EVT were included. Variables significantly associated with LEA by univariate analysis (P < .05) were selected and put into classification tree analysis using the Classification and Regression Tree (CART) model with a dependent variable, amputation, and depth of tree = 3. Four risk groups were generated according to the order of amputation rate. The amputation-free survival (AFS) times between groups were compared using the Kaplan-Meier curve with the log-rank test.Patients were classified as high risk for amputation (G4) (WBC counts ≥10,000/μl, and platelet-lymphocyte ratio (PLR) ≥130.337); intermediate risk group 1 (G3) (WBC < 10,000/μl and RC stage before EVT > 5); intermediate risk group 2 (G2) (WBC count ≥ 10,000/μl, and PLR < 130.337) and low-risk group (G1) (WBC < 10,000/μl, RC before EVT ≤ 5). G2, G3, and G4 risk groups had shorter AFS time (range, 58.7 to 65.5 months) than the G1 risk group (100 months) (P < .05). Risk of LEA was significantly higher in the G4, G3, and G2 groups than in the G1 group (P ≤ .05). The G4 group had the highest risk of amputation (odds ratio = 6.84, P < .001).This simple risk scale model can help healthcare professionals more easily identify and appropriately treat patients with CLI who are at different levels of risk for LEA following endovascular revascularization.
| S-EPMC6831177 | biostudies-literature
Project description:BackgroundTo evaluate cycling participation and identify barriers and facilitators related to cycling participation in people with a lower limb amputation (LLA) in the Netherlands.MethodsA questionnaire was sent to adults with a LLA between March and August 2019 to obtain information regarding prosthesis, individual's characteristics, amputation, cycling barriers and facilitators, and prosthetic satisfaction. The questionnaires were distributed via 8 orthopedic workshops, post and were given directly. To find cycling predictors, variables associated with cycling (p < 0.1) were entered into a logistic regression analysis. Non-significant variables were removed manually.ResultsParticipants (n = 207, 71% males) had a mean age of 62.0 ± 13.0 years. The most frequent level of amputation was transtibial (42%), and trauma was the most frequent cause of amputation (43%). After the LLA, 141 participants (68%) cycled for recreation (80%), physical fitness (74%), and transport (50%). In the past six months, cyclists cycled for recreation (79%) and transport (66%). Most cycled less than once a day. Recreational cyclists cycled alone (75%) for a median duration of 45 min or 14 km per ride. Cyclists with a transportation purpose usually cycled to go shopping (80%) or to visit friends (68%), with a median duration of 20 min or five kilometers per ride. Cyclists reported more facilitators (median (IQR) = 5 (3, 7) than non-cyclists 0 (0, 3). The majority of cyclists reported a positive attitude toward cycling (89%) and cycled because of health benefits (81%). A dynamic foot (odds ratio: 5.2, 95% CI 2.0, 13.3) and a higher number of facilitators (odds ratio: 1.3, 95% CI 1.2, 1.5) positively predicted cycling, whereas the presence of other underlying diseases (odds ratio: 0.4, 95% CI 0.2, 0.9) negatively predicted cycling (R2: 40.2%).ConclusionIn the Netherlands, the majority of adults cycled after a LLA, mainly for recreational purposes. A dynamic foot, a higher number of facilitators, and no other underlying diseases increases the likelihood of cycling after a LLA. The results suggest that personal motivation and a higher mobility level could be the key to increasing cycling participation. Future research should determine the association between motivation, mobility levels, and cycling with a LLA.
| S-EPMC8272388 | biostudies-literature
Project description:The most severe type of peripheral arterial disease (PAD) is critical limb-threatening ischemia (CLI). In CLI, calcification of the vessel wall plays an important role in symptoms, amputation rate, and mortality. However, calcified arteries are also found in asymptomatic persons (non-PAD patients). We investigated whether the calcification pattern in CLI patients and non- PAD patients are different and could possibly explain the symptoms in CLI patients. 130 CLI and 204 non-PAD patients underwent a CT of the lower extremities. This resulted in 118 CLI patients (mean age 72 ± 12, 70.3% male) that were age-matched with 118 non-PAD patients (mean age 71 ± 11, 51.7% male). The characteristics severity, annularity, thickness, and continuity were assessed in the femoral and crural arteries and analyzed by binary multiple logistic regression. Nearly all CLI patients have calcifications and these are equally frequent in the femoropopliteal (98.3%) and crural arteries (97.5%), while the non-PAD patients had in just 67% any calcifications with more calcifications in the femoropopliteal (70.3%) than in the crural arteries (55.9%, p < 0.005). The crural arteries of CLI patients had significantly more complete annular calcifications (OR 2.92, p = 0.001), while in non-PAD patients dot-like calcifications dominated. In CLI patients, the femoropopliteal arteries had more severe, irregular/patchy, and thick calcifications (OR 2.40, 3.27, 1.81, p ≤ 0.05, respectively) while in non-PAD patients, thin continuous calcifications prevailed. Compared with non-PAD patients, arteries of the lower extremities of CLI patients are more frequently and extensively calcified. Annular calcifications were found in the crural arteries of CLI patients while dot-like calcifications were mostly present in non-PAD patients. These different patterns of calcifications in CLI point at different etiology and can have prognostic and eventually therapeutic consequences.
| S-EPMC8226835 | biostudies-literature
Project description:Participation in valued interpersonal and community activities is a key component of rehabilitation for Veterans with amputation. The purpose of this study was to identify specific factors that promote or inhibit participation to inform development of interventions that may facilitate participation in desired life activities. A convenience sample of 408 Veterans with at least one lower limb amputation and who had received outpatient care from the Regional Amputation Center (RAC) completed a mailed survey. Participation was measured using the Community Participation Indicators (CPI) Importance, Control, and Frequency scales and the Patient Reported Outcome Measurement Information System (PROMIS) Ability to Participate in Social Roles and Satisfaction with Social Participation scales. Multiple imputation procedures were used to address missing data. Correlates of participation were examined through multiple linear regression. A total of 235 participants completed the survey, a response rate of 58%. Levels of participation, measured with the PROMIS instruments, were 43.2 (SD = 8.1) for Ability and 46.4 (SD = 8.6) for Satisfaction. Regression analyses found robust amputation-specific correlates for participation, including body image and balance confidence. Generic (non-amputation specific) correlates for participation included depression and pain interference. Development of treatment approaches and devices that can address body image, balance confidence, pain, and mental health concerns such as depression have the potential to enhance the participation and rehabilitation of Veterans with lower limb amputation.
| S-EPMC9262244 | biostudies-literature
Project description:Background: Bone Marrow Mononuclear Cells (BM-MNC) constitute a promising alternative for the treatment of Chronic Limb-Threatening ischemia (CLTI), a disease characterized by extensive blockade of peripheral arteries, clinically presenting as excruciating pain at rest and ischemic ulcers which may lead to gangrene and amputation. BM-MNC implantation has shown to be efficient in promoting angiogenesis and ameliorating ischemic symptoms in CLTI patients. However, the variability seen between clinical trials makes necessary a further understanding of the mechanisms of action of BM-MNC, and moreover, to improve trial characteristics such as endpoints, inclusion/exclusion criteria or drug product compositions, in order to implement their use as stem-cell therapy. Materials: Herein, the effect of REX-001, a human-BM derived cell suspension enriched for mononuclear cells, granulocytes and CD34+ cells, has been assessed in a murine model of CLTI. In addition, a REX-001 placebo solution containing BM-derived red blood cells (BM-RBCs) was also tested. Thus, 24 h after double ligation of the femoral artery, REX-001 and placebo were administrated intramuscularly to Balb-c nude mice (n:51) and follow-up of ischemic symptoms (blood flow perfusion, motility, ulceration and necrosis) was carried out for 21 days. The number of vessels and vascular diameter sizes were measured within the ischemic tissues to evaluate neovascularization and arteriogenesis. Finally, several cell-tracking assays were performed to evaluate potential biodistribution of these cells. Results: REX-001 induced a significant recovery of blood flow by increasing vascular density within the ischemic limbs, with no cell translocation to other organs. Moreover, cell tracking assays confirmed a decrease in the number of infused cells after 2 weeks post-injection despite on-going revascularization, suggesting a paracrine mechanism of action. Conclusion: Overall, our data supported the role of REX-001 product to improve revascularization and ischemic reperfusion in CLTI.
| S-EPMC7755609 | biostudies-literature