Outcomes of endovascular treatment versus bypass surgery for critical limb ischemia in patients with thromboangiitis obliterans.
Ontology highlight
ABSTRACT:
SUBMITTER: Lee CY
PROVIDER: S-EPMC6177182 | biostudies-literature | 2018
REPOSITORIES: biostudies-literature
Publications
Outcomes of endovascular treatment versus bypass surgery for critical limb ischemia in patients with thromboangiitis obliterans.
Lee Chung Yeop CY Choi Kyunghak K Kwon Hyunwook H Ko Gi-Young GY Han Youngjin Y Kwon Tae-Won TW Cho Yong-Pil YP
PloS one 20181009 10
We aimed to compare the clinical outcomes between endovascular treatment and inframalleolar bypass surgery for critical limb ischemia (CLI) in patients with thromboangiitis obliterans (TAO) and to assess the role of bypass surgery in the era of innovative endovascular treatment. Between January 2007 and December 2017, a total of 33 consecutive patients with the diagnosis of TAO presenting with CLI who underwent endovascular treatment (endovascular group, n = 22) or bypass surgery to the pedal or ...[more]
Similar Datasets
Project description:OBJECTIVE:Lower extremity bypass (LEB) has traditionally been the "gold standard" in the treatment of critical limb ischemia (CLI). Infrainguinal endovascular intervention (IEI) has become more commonly performed than LEB, but comparative outcomes are limited. We sought to compare rates of major adverse limb events (MALEs) and major adverse cardiovascular events (MACEs) after LEB and IEI in a propensity score-matched, national cohort of patients with CLI. METHODS:The National Surgical Quality Improvement Program (NSQIP) vascular targeted files (2011-2014) for LEB and IEI were merged. CLI patients were identified by ischemic rest pain or tissue loss. Patients were matched on a 1:1 basis for propensity to undergo LEB or IEI. Primary outcomes were 30-day MALEs and MACEs. Within the propensity-matched cohort, multivariate logistic regression was used to identify independent predictors of MALEs and MACEs. RESULTS:A total of 13,294 LEBs and IEIs were identified, with 8066 cases performed for CLI. Propensity matching identified 3848 cases (1924 per group). There were no differences in preoperative variables between the propensity-matched LEB and IEI groups (all P > .05). At 30 days, rates of MALEs were significantly lower in the LEB group (9.2% LEB vs IEI 12.2%; P = .003). On multivariate logistic regression, bypass with single-segment saphenous vein vs IEI (odds ratio [OR], 0.7; 95% confidence interval [CI], 0.54-0.92; P = .01), bypass with alternative conduit (prosthetic, spliced vein, or composite) vs IEI (OR, 0.7; 95% CI, 0.56-0.98; P = .04), antiplatelet therapy (OR, 0.8; 95% CI, 0.58-1.00; P = .049), and statin therapy (OR, 0.8; 95% CI, 0.62-0.99; P = .04) were protective against MALEs, whereas infrageniculate intervention (OR, 1.4; 95% CI, 1.09-1.72; P = .01) and a history of prior bypass of the same arterial segment (OR, 1.8; 95% CI, 1.41-2.41; P <. 0001) were predictive. Rates of 30-day MACEs were not significantly different (4.9% LEB vs 3.7% IEI; P = .07) between the groups. Independent predictors of MACEs included age (OR, 1.02; 95% CI, 1.01-1.04; P = .01), steroid use (OR, 1.8; 95% CI, 1.08-2.99; P = .03), congestive heart failure (OR, 1.7; 95% CI, 1.00-1.96; P = .02), beta blocker use (OR, 1.6; 95% CI, 1.09-1.43; P = .01), dialysis (OR, 2.3; 95% CI, 1.55-3.45; P < .0001), totally dependent functional status (OR, 3.1; 95% CI, 1.25-7.58; P = .02), and suboptimal conduit for LEB compared with IEI (OR, 1.6; 95% CI, 1.08-2.36; P = .02). CONCLUSIONS:Within this large, propensity-matched, national cohort, LEB predicted lower risk-adjusted 30-day MALE rate compared with IEI. Furthermore, there was no difference in 30-day MACE rate between the groups despite higher inherent risk with open surgical procedures. Therefore, this study supports the effectiveness and primacy of LEB for revascularization in CLI.
| S-EPMC5612844 | biostudies-literature
Project description:Although open surgical bypass remains the standard revascularization strategy for patients with critical limb ischemia (CLI), many centers now perform peripheral endovascular intervention (PVI) as the first-line treatment for these patients. We sought to determine the effect of a prior ipsilateral PVI (iPVI) on the outcome of subsequent lower extremity bypass (LEB) in patients with CLI.A retrospective cohort analysis of all patients undergoing infrainguinal LEB between 2003 and 2009 within hospitals comprising the Vascular Study Group of New England (VSGNE) was performed. Primary study endpoints were major amputation and graft occlusion at 1 year postoperatively. Secondary outcomes included in-hospital major adverse events (MAE), 1-year mortality, and composite 1-year major adverse limb events (MALE). Event rates were determined using life table analyses and comparisons were performed using the log-rank test. Multivariate predictors were determined using a Cox proportional hazards model with multilevel hierarchical adjustment.Of 1880 LEBs performed, 32% (n = 603) had a prior infrainguinal revascularization procedure (iPVI, 7%; ipsilateral bypass, 15%; contralateral PVI, 3%; contralateral bypass, 17%). Patients with prior iPVI, compared with those without a prior iPVI, were more likely to be women (32 vs 41%; P = .04), less likely to have tissue loss (52% vs 63%; P = .02), more likely to require arm vein conduit (16% vs 5%; P = .001), and more likely to be on statin (71% vs 54%; P = .01) and beta blocker therapy (92% vs 81%; P = .01) at the time of their bypass procedure. Other demographic factors were similar between these groups. Prior PVI or bypass did not alter 30-day MAE and 1-year mortality after the index bypass. In contrast, 1-year major amputation and 1-year graft occlusion rates were significantly higher in patients who had prior iPVI than those without (31% vs 20%; P = .046 and 28% vs 18%; P = .009), similar to patients who had a prior ipsilateral bypass (1 year major amputation, 29% vs 20%; P = .022; 1 year graft occlusion, 33% vs 18%; P = .001). Independent multivariate predictors of higher 1-year amputation and graft occlusion rates were prior iPVI, prior ipsilateral bypass, dialysis dependence, prosthetic conduit and distal (tibial and pedal) bypass target.Prior iPVI is highly predictive for poor outcome in patients undergoing LEB for CLI with higher 1-year amputation and graft occlusion rates than those without prior revascularization, similar to prior ipsilateral bypass These findings provide information, which may help with the complex decisions surrounding revascularization options in patients with CLI.
| S-EPMC5292259 | biostudies-literature
Project description:ImportanceThe Bypass Versus Angioplasty for Severe Ischemia of the Leg randomized controlled trial showed comparable outcomes between endovascular revascularization (ER) and surgical revascularization (SR) for patients with critical limb ischemia (CLI). However, several observational studies showed mixed results. Most of these studies were conducted before advanced endovascular technologies were available.ObjectiveTo compare ER and SR treatment strategies for 6-month outcomes among patients with CLI.Design, setting, and participantsThis retrospective, population-based cohort study used the Nationwide Readmissions Database to identify 66 277 patients with CLI who underwent ER or SR from January 1, 2016, to December 31, 2018. Data analyses were conducted from January 1, 2022, to February 8, 2022. A propensity score with 1:1 matching was applied. Patients with CLI who underwent ER or SR were identified, and those with missing information on the length of stay and/or younger than 18 years were excluded.ExposuresEndovascular or surgical revascularization.Main outcomes and measuresThe primary outcome was a major amputation at 6 months. Significant secondary outcomes were in-hospital and 6-month mortality and an in-hospital safety composite of acute kidney injury, major bleeding, and vascular complication. Subgroup analysis was conducted for major amputation in high-volume centers.ResultsA total of 66 277 patients were identified between 2016 and 2018 who underwent ER or SR for CLI. The Nationwide Readmissions Database does not provide racial and ethnic categories. The mean (SD) age of the cohort was 69.3 (12) years, and 62.5% of patients were male. A total of 54 546 patients (82.3%) underwent ER and 11 731 (17.7%) underwent SR. After propensity score matching, 11 106 matched pairs were found. Endovascular revascularization was associated with an 18% higher risk of major amputation compared with SR (997 of 10 090 [9.9%] vs 869 of 10 318 [8.4%]; hazard ratio, 1.18; 95% CI, 1.08-1.29; P = .001). However, no difference was observed in major amputation risk when both procedures were performed in high-volume centers. Endovascular revascularization and SR had similar mortality rates (517 of 11 106 [4.7%] vs 490 of 11 106 [4.4%]; hazard ratio, 1.06; 95% CI, 0.93-1.20; P = .39). However, the ER group had a 17% lower risk of in-hospital safety outcomes compared with the SR group (2584 of 11 106 [23.3%] vs 2979 of 11 106 [26.8%]; odds ratio, 0.83; 95% CI, 0.78-0.88; P < .001).Conclusions and relevanceThe results of this study suggest that ER was safer, without any difference in mortality, but ER was associated with an increased risk of major amputation compared with SR. However, the risk of major amputation was similar when both procedures were performed at high-volume centers.
| S-EPMC9391961 | biostudies-literature
Project description:Although statin therapy has been linked to fewer short-term complications after infrainguinal bypass, its effect on long-term survival remains unclear. We therefore examined associations between statin use and long-term mortality, graft occlusion, and amputation after infrainguinal bypass.We used the Vascular Study Group of New England registry to study 2067 patients (71% male; mean age, 67 ± 11 years; 67% with critical limb ischemia [CLI]) who underwent infrainguinal bypass from 2003 to 2011. Of these, 1537 (74%) were on statins perioperatively and at 1-year follow-up, and 530 received no statin. We examined crude, adjusted, and propensity-matched rates of 5-year surviva1, 1-year amputation, graft occlusion, and perioperative myocardial infarction.Patients taking statins at the time of surgery and at the 1-year follow-up were more likely to have coronary disease (38% vs 22%; P < .001), diabetes (51% vs 36%; P < .001), hypertension (89% vs 77%; P < .001), and prior revascularization procedures (50% vs 38%; P < .001). Despite higher comorbidity burdens, long-term survival was better for patients taking statins in crude (risk ratio [RR], 0.7; P < .001), adjusted (hazard ratio, 0.7; P = .001), and propensity-matched analyses (hazard ratio, 0.7; P = .03). In subgroup analysis, a survival advantage was evident in patients on statins with CLI (5-year survival rate, 63% vs 54%; log-rank, P = .01) but not claudication (5-year survival rate, 84% vs 80%; log-rank, P = .59). Statin therapy was not associated with 1-year rates of major amputation (12% vs 11%; P = .84) or graft occlusion (20% vs 18%; P = .58) in CLI patients. Perioperative myocardial infarction occurred more frequently in patients on a statin in crude analysis (RR, 2.2; P = .01) but not in the matched cohort (RR, 1.9; P = .17).Statin therapy is associated with a 5-year survival benefit after infrainguinal bypass in patients with CLI. However, 1-year limb-related outcomes were not influenced by statin use in our large observational cohort of patients undergoing revascularization in New England.
| S-EPMC4283106 | biostudies-literature
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.
| S-EPMC7668154 | biostudies-literature
Project description:Preoperative 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.Patients 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.We 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).Mortality 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.
| S-EPMC5701845 | biostudies-literature
Project description:This study assessed the effectiveness and safety of bosentan when administered to thromboangiitis obliterans (Buerger's disease) patients.A clinical pilot study was designed in which patients with ulcer and/or pain at rest were treated with bosentan p.o. at a dose of 62.5 mg twice daily during the first month, which was thereafter up-titrated to 125 mg twice daily. The study endpoints were clinical improvement rate, major or minor amputation rate, haemodynamic changes, changes in endothelial function and angiographic changes.Seven out of 12 patients were male (58%). Median age was 39 years (range 29-49). The median follow-up was 20 months (range 11-40). All patients were smokers. With bosentan treatment, new ischaemic lesions were observed in only one patient. Overall, clinical improvement was observed in 12 of the 13 extremities (92%). Only two out of 13 extremities underwent amputation (one major and one minor) after bosentan treatment. After being assessed by digital arteriography with subtraction or angio-magnetic resonance imaging, an increase of distal flow was observed in 10 out of the 12 patients. All patients experienced a statistically significant improvement in their BAFMD values (mean: 1.8 at baseline; 6.6 at the end of the treatment; 12.7 three months after the end of the treatment; p < 0.01).Bosentan treatment may result in an improvement of clinical, angiographic and endothelial function outcomes. Bosentan should be investigated further in the management of TAO patients. Larger studies are required to confirm these results.ClinicalTrials.gov: NCT01447550.
| S-EPMC3306190 | biostudies-literature
Project description:Critical limb ischemia (CLI) is increasing in prevalence, and remains a significant source of mortality and limb loss. The decision to recommend surgical or endovascular revascularization for patients who are candidates for both varies significantly among providers and is driven more by individual preference than scientific evidence.The Best Endovascular Versus Best Surgical Therapy for Patients With Critical Limb Ischemia (BEST-CLI) Trial is a prospective, randomized, multidisciplinary, controlled, superiority trial designed to compare treatment efficacy, functional outcomes, quality of life, and cost in patients undergoing best endovascular or best open surgical revascularization. Approximately 140 clinical sites in the United States and Canada will enroll 2100 patients with CLI who are candidates for both treatment options. A pragmatic trial design requires consensus on patient eligibility by at least 2 investigators, but leaves the choice of specific procedural strategy within the assigned revascularization approach to the individual treating investigator. Patients with suitable single-segment of saphenous vein available for potential bypass will be randomized within Cohort 1 (n=1620), while patients without will be randomized within Cohort 2 (n=480). The primary efficacy end point of the trial is Major Adverse Limb Event-Free Survival. Key secondary end points include Re-intervention and Amputation-Free-Survival and Amputation Free-Survival.The BEST-CLI trial is the first randomized controlled trial comparing endovascular therapy to open surgical bypass in patients with CLI to be carried out in North America. This landmark comparative effectiveness trial aims to provide Level I data to clarify the appropriate role for both treatment strategies and help define an evidence-based standard of care for this challenging patient population.URL: https://www.clinicaltrials.gov/. Unique identifier: NCT02060630.
| S-EPMC5015366 | biostudies-literature
Project description:ObjectiveOur objective was to analyze periprocedural and 1-year outcomes of peripheral endovascular intervention (PVI) for critical limb ischemia (CLI).MethodsWe reviewed 1244 patients undergoing 1414 PVIs for CLI (rest pain, 29%; tissue loss, 71%) within the Vascular Study Group of New England (VSGNE) from January 2010 to December 2011. Overall survival (OS), amputation-free survival (AFS), and freedom from major amputation at 1 year were analyzed using the Kaplan-Meier method. Cox proportional hazards models were used to calculate hazard ratios (HRs) and 95% confidence intervals (CIs).ResultsThe number of arteries treated during each procedure were 1 (49%), 2 (35%), 3 (12%), and ≥4 (5%). Target arterial segments and TransAtlantic Inter-Society Consensus classifications were aortoiliac, 27% (A, 48%; B, 28%; C, 12%; and D, 12%); femoral-popliteal, 48% (A, 29%; B, 34%; C, 20%; and D, 17%); and infrapopliteal, 25% (A, 17%; B, 14%; C, 25%; D, 44%). Technical success was 92%. Complications included access site hematoma (5.0%), occlusion (0.3%), and distal embolization (2.4%). Mortality and major amputation rates were 2.8% and 2.2% at 30 days, respectively. Overall percutaneous or open reintervention rate was 8.0% during the first year. At 1-year, OS, AFS, and freedom from major amputation were 87%, 87%, and 94% for patients with rest pain and 80%, 71%, and 81% for patients with tissue loss. Independent predictors of reduced 1-year OS (C index = .74) included dialysis (HR, 3.8; 95% CI, 2.8-5.1; P < .01), emergency procedure (HR, 2.5; 95% CI, 1.0-6.2; P = .05), age >80 years (HR, 2.2; 95% CI, 1.7-2.8; P < .01), not living at home preoperatively (HR, 2.0; 95% CI, 1.4-2.8; P < .01), creatinine >1.8 mg/dL (HR, 1.9; 95% CI, 1.3-2.8; P < .01), congestive heart failure (HR, 1.7; 95% CI, 1.3-2.2; P < .01), and chronic β-blocker use (HR, 1.4; 95% CI, 1.0-1.9; P = .03), whereas independent preoperative ambulation (HR, 0.7; 95% CI, 0.6-0.9; P = .014) was protective. Independent predictors of major amputation (C index = .69) at 1 year included dialysis (HR, 2.7; 95% CI, 1.6-4.5; P < .01), tissue loss (HR, 2.0; 95% CI, 1.1-3.7; P = .02), prior major contralateral amputation (HR, 2.0; 95% CI, 1.1-3.5; P = .02), non-Caucasian race (HR, 1.7; 95% CI, 1.0-2.9; P = .045), and male gender (HR, 1.6; 95% CI, 1.1-2.6; P = .03), whereas smoking (HR, .60; 95% CI, 0.4-1.0; P = .042) was protective.ConclusionsSurvival and major amputation after PVI for CLI are associated with different patient characteristics. Dialysis dependence is a common predictor that portends especially poor outcomes. These data may facilitate efforts to improve patient selection and, after further validation, enable risk-adjusted outcome reporting for CLI patients undergoing PVI.
| S-EPMC5315445 | biostudies-literature
Project description:BackgroundHigh-risk patients with advanced peripheral artery disease (PAD), including critical limb ischemia (CLI), are often excluded from peripheral endovascular device intervention clinical trials, leading to difficulty in translating trial results into real-world practice. There is a need for prospectively assessed studies to evaluate peripheral endovascular device intervention outcomes in CLI patients.MethodsLIBERTY 360 is a prospective, observational, multi-center study designed to evaluate the procedural and long-term clinical outcomes of peripheral endovascular device intervention in real-world patients with symptomatic lower-extremity PAD. One thousand two hundred and four patients were enrolled and stratified based on Rutherford Classification (RC): RC2-3 (N=501), RC4-5 (N=603), and RC6 (N=100). For this sub-analysis, RC5 and RC6 patients (RC5-6; N=404) were pooled and 1-year outcomes were assessed.ResultsProcedural complications rarely (1.7%) resulted in post-procedural hospitalization and 89.1% of RC5-6 patients were discharged to home. Considering the advanced disease state in RC5-6 patients, there was a high freedom from 1-year major adverse event rate of 65.5% (defined as target vessel revascularization, death to 30 days, and major target limb amputation). At 1 year, freedom from major amputation was 89.6%. Wounds identified at baseline on the target limb had completely healed in 172/243 (70.8%) of the RC5-6 subjects by 1 year. Additionally, the overall quality of life, as measured by VascuQoL, improved from baseline to 1 year.ConclusionLIBERTY investigated real-world PAD patients with independent oversight of outcomes. This analysis of LIBERTY RC5-6 patients demonstrates that peripheral endovascular device intervention can be successful in CLI patients, with low rates of major amputation and improvement in wound healing and quality of life through 1-year follow-up.LIBERTY 360, https://clinicaltrials.gov/ct2/show/NCT01855412, ClinicalTrials.gov Identifier: NCT01855412.
| S-EPMC7020930 | biostudies-literature