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Outcomes of lower extremity revascularization among the hemodialysis-dependent.

ABSTRACT: Optimal patient selection for lower extremity revascularization remains a clinical challenge among the hemodialysis-dependent (HD). The purpose of this study was to examine contemporary real world open and endovascular outcomes of HD patients to better facilitate patient selection for intervention.A regional multicenter registry was queried between 2003 and 2013 for HD patients (N = 689) undergoing open surgical bypass (n = 295) or endovascular intervention (n = 394) for lower extremity revascularization. Patient demographics and comorbidities were recorded. The primary outcome was overall survival. Secondary outcomes included graft patency, freedom from major adverse limb events, and amputation-free survival (AFS). Multivariate analysis was performed to identify independent risk factors for death and amputation.Among the 689 HD patients undergoing lower extremity revascularization, 66% were male, and 83% were white. Ninety percent of revascularizations were performed for critical limb ischemia and 8% for claudication. Overall survival at 1, 2, and 5 years survival remained low at 60%, 43%, and 21%, respectively. Overall 1- and 2-year AFS was 40% and 17%. Mortality accounted for the primary mode of failure for both open bypass (78%) and endovascular interventions (80%) at two years. Survival, AFS, and freedom from major adverse limb event outcomes did not differ significantly between revascularization techniques. At 2 years, endovascular patency was higher than open bypass (76% vs 26%; 95% confidence interval [CI], 0.28-0.71; P = .02). Multivariate analysis identified age ?80 years (hazard ratio [HR], 1.9; 95% CI, 1.4-2.5; P < .01), indication of rest pain or tissue loss (HR, 1.8; 95% CI, 1.3-2.6; P < .01), preoperative wheelchair/bedridden status (HR, 1.5; 95% CI, 1.1-2.1; P < .01), coronary artery disease (HR, 1.5; 95% CI, 1.2-1.9; P < .01), and chronic obstructive pulmonary disease (HR, 1.4; 95% CI, 1.1-1.8; P = .01) as independent predictors of death. The presence of three or more risk factors resulted in predicted 1-year mortality of 64%.Overall survival and AFS among HD patients remains poor, irrespective of revascularization strategy. Mortality remains the primary driver for these findings and justifies a prudent approach to patient selection. Focus for improved results should emphasize predictors of survival to better identify those most likely to benefit from revascularization.

SUBMITTER: Fallon JM

PROVIDER: S-EPMC5315419 | biostudies-literature | 2015 Nov

REPOSITORIES: biostudies-literature

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Outcomes of lower extremity revascularization among the hemodialysis-dependent.

Fallon John M JM Goodney Philip P PP Stone David H DH Patel Virendra I VI Nolan Brian W BW Kalish Jeffrey A JA Zhao Yuanyuan Y Hamdan Allen D AD

Journal of vascular surgery 20150805 5

<h4>Objective</h4>Optimal patient selection for lower extremity revascularization remains a clinical challenge among the hemodialysis-dependent (HD). The purpose of this study was to examine contemporary real world open and endovascular outcomes of HD patients to better facilitate patient selection for intervention.<h4>Methods</h4>A regional multicenter registry was queried between 2003 and 2013 for HD patients (N = 689) undergoing open surgical bypass (n = 295) or endovascular intervention (n = ...[more]

PMID: 26254454

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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.

Project description:Background The long-term effectiveness of atherectomy treatment for peripheral arterial disease is unknown. We studied 5-year clinical outcomes by endovascular treatment type among patients with peripheral arterial disease. Methods and Results We queried the Medicare-linked VQI (Vascular Quality Initiative) registry for endovascular interventions from 2010 to 2015. The exposure was treatment type: atherectomy (with or without percutaneous transluminal angioplasty [ PTA] ), stent (with or without PTA ), or PTA alone. The outcomes were major amputation, any amputation, and major adverse limb event (major amputation or any reintervention). We used the center-specific proportions of atherectomy procedures performed in the 12 months before a patient's procedure as the instruments to perform an instrumental-variable Cox model analysis. Among 16 838 eligible patients (median follow-up: 1.3-1.5 years), 11% underwent atherectomy, 40% received PTA alone, and 49% underwent stenting. Patients receiving atherectomy commonly underwent femoropopliteal artery treatment (atherectomy: 65%; PTA : 49%; stenting: 43%; P<0.001) and had worse disease severity (Trans-Atlantic Inter-Society Consensus score [TASC] B and greater; atherectomy: 77%; PTA : 68%; stenting: 67%; P<0.001). The 5-year rate of major adverse limb events was 38% in patients receiving atherectomy versus 33% for PTA and 32% for stenting (log rank P<0.001). Controlling for unmeasured confounding using instrumental-variable analysis, patients treated with atherectomy experienced outcomes similar to those of patients treated with PTA , except for a higher risk of any amputation (hazard ratio: 1.51; 95% CI , 1.08-2.13). However, compared with stenting, atherectomy patients had a higher risk of major amputation (hazard ratio: 3.66; 95% CI , 1.72-7.81), any amputation (hazard ratio: 2.73; 95% CI , 1.60-4.76), and major adverse limb event (hazard ratio: 1.61; 95% CI , 1.10-2.38). Conclusions Atherectomy is used to treat severe femoropopliteal and tibial peripheral arterial disease even though long-term adverse outcomes occur more frequently after this treatment modality.

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.

Project description:ImportanceThe use of statins in patients with symptomatic peripheral artery disease remains suboptimal despite strong clinical practice guideline recommendations; however, it is unknown whether rates are associated with substantial improvements after lower extremity revascularization.ObjectiveTo report longitudinal trends of statin use in patients with peripheral artery disease undergoing lower extremity revascularization and to identify the clinical and procedural characteristics associated with prescriptions for new statin therapy at discharge.Design, setting, and participantsThis was a retrospective cross-sectional study using data from the Vascular Quality Initiative registry of patients who underwent lower extremity peripheral artery disease revascularization from January 1, 2014, through December 31, 2019. The Vascular Quality Initiative is a multicenter registry database including academic and community-based hospitals throughout the US. Patients aged 18 years or older undergoing lower extremity revascularization with available statin data (preprocedure and postprocedure) were included. Those not receiving statin therapy for medical reasons were excluded from final analyses.ExposuresPatients undergoing lower extremity revascularization for whom statin therapy is indicated.Main outcomes and measuresMultivariate logistic regression was used to determine the clinical and procedural characteristics associated with new statin prescription for patients not already taking a statin preprocedure. The overall rates of statin prescription as well as rates of new statin prescription at discharge were determined. In addition, the clinical, demographic, and procedural characteristics associated with new statin prescription were analyzed.ResultsThere were 172 025 procedures corresponding to 125 791 patients (mean [SD] age, 67.7 [11.0] years; 107 800 men [62.7%]; and 135 405 White [78.7%]) included in the analysis. Overall rates of statin prescription at discharge improved from 17 299 of 23 093 (75%) in 2014 to 29 804 of 34 231 (87%) in 2019. However, only 12 790 of 42 020 patients (30%) not already taking a statin at the time of revascularization during the study period were newly discharged with a statin medication. New statin prescription rates were substantially lower after endovascular intervention (7745 of 29 581 [26%]) than after lower extremity bypass (5045 of 12 439 [41%]). Body mass index of 30 or greater (odds ratio [OR], 1.13; 95% CI, 1.04-1.24; P < .001), diabetes (diet-controlled vs no diabetes, OR, 1.22; 95% CI, 1.05-1.41; P = .01), smoking (current vs never, OR, 1.32; 95% CI, 1.21-1.45; P < .001), hypertension (OR, 1.19; 95% CI, 1.09-1.29; P < .001), and coronary heart disease (OR, 1.26; 95% CI, 1.17-1.35; P < .001) were associated with an increased likelihood of new statin prescription after endovascular intervention, whereas female sex, older age, antiplatelet use, and prior peripheral revascularization were associated with a decreased likelihood.Conclusions and relevanceIn this cross-sectional study, although statin use was associated with a substantial improvement after lower extremity revascularization, more than two-thirds of patients not already taking a statin preprocedure remained not taking a statin at discharge. Further investigations to understand the clinical implications of these findings and develop clinician- and system-based interventions are needed.

Project description:IntroductionPatients with chronic kidney disease (CKD) have a high prevalence of peripheral artery disease. How best to manage lower extremity peripheral artery disease remains unclear in this patient population. We therefore sought to compare the outcomes after endovascular versus surgical lower extremity revascularization among patients with CKD.MethodsWe used data from Optum's de-identifed Clinformatics® Data Mart Database, a nationwide database of commercially insured persons in the United States to study patients with CKD who underwent lower extremity endovascular or surgical revascularization. We used inverse probability of treatment weighting to balance covariates. We employed proportional hazard regression to study the primary outcome of major adverse limb events (MALE), defined as a repeat revascularization or amputation. We also studied each of these events separately and death from any cause.ResultsIn our cohort, 60,057 patients underwent endovascular revascularization and 9,338 patients underwent surgical revascularization. Endovascular revascularization compared with surgical revascularization was associated with a higher adjusted hazard of MALE (hazard ratio (HR) 1.52; 95% confidence interval (CI) 1.46-1.59). Endovascular revascularization was also associated with a higher adjusted hazard of repeat revascularization (HR 1.65; 95% CI 1.57-1.72) but a lower adjusted risk of amputation (HR 0.71; CI 0.73-0.89). Patients undergoing endovascular revascularization also had a lower adjusted hazard for death from any cause (0.85; CI 0.82-0.88).ConclusionsIn this analysis of patients with CKD undergoing lower extremity revascularization, an endovascular approach was associated with a higher rate of repeated revascularization but a lower risk of subsequent amputation and death compared with surgical revascularization. Multiple factors must be considered when counseling patients with CKD, who have a high burden of comorbid conditions. Clinical trials should include more patients with kidney disease, who are often otherwise excluded from participation, to better understand the most effective treatment strategies for this vulnerable patient population.

Project description:BackgroundDual antiplatelet therapy (DAPT) after coronary stenting prolongs survival by preventing both in-stent thrombosis and other cardiovascular atherothrombotic events. Patients with peripheral artery disease (PAD) typically have a heavy burden of unrevascularized coronary artery disease and also stand to benefit from increased atherothrombotic protection with DAPT. The potential benefit of DAPT compared with aspirin alone in patients with PAD is not well described.MethodsWe identified all patients undergoing an initial elective lower extremity revascularization (bypass or endovascular) from 2003 to 2016 in the Vascular Quality Initiative registry discharged on aspirin or aspirin plus a thienopyridine antiplatelet agent (DAPT). We first estimated models predicting the likelihood of receiving DAPT and then used inverse probability weighting to account for baseline differences in the likelihood of receiving DAPT and compared late survival. For sensitivity analysis, we also performed Cox proportion hazard modeling on the unweighted cohorts and generated adjusted survival curves.ResultsWe identified 57,041 patients undergoing lower extremity revascularization (28% bypass). Of 15,985 bypasses (69% for critical limb ischemia [CLI]), 38% were discharged on DAPT. Of 41,056 endovascular interventions (39% for CLI), 69% were discharged on DAPT. Analyses using inverse probability weighting demonstrated a small survival benefit to DAPT at 1 year for bypass (93% vs 92% [P = .001]) and endovascular interventions (93% vs 92% [P = .005]) that was sustained through 5 years of follow-up (bypass, 80% vs 78% [P = .004]; endovascular, 76% vs 73% [P = .002]). When stratified by severity of PAD, DAPT had a survival benefit for patients with CLI undergoing bypass (5 years, 70% vs 66% [P = .04]) and endovascular intervention (5 years, 71% vs 67% [P = .01]) but not for patients with claudication (bypass, 89% vs 88% [P = .36]; endovascular, 87% vs 85% [P = .46]). The protective effect of DAPT was similar when using Cox proportional hazard models after bypass (hazard ratio, 0.81 [95% confidence interval, 0.72-0.90]) and endovascular intervention (hazard ratio, 0.89 [95% confidence interval, 0.83-0.95]).ConclusionsDAPT at time of discharge was associated with prolonged survival for patients with CLI undergoing lower extremity revascularization but not for those with claudication. Further research is needed to quantify the risks associated with DAPT and to identify subgroups at increased risk of thrombotic and bleeding complications to guide medical management of patients with PAD.

Dataset Information

Outcomes of lower extremity revascularization among the hemodialysis-dependent.

Publications

Outcomes of lower extremity revascularization among the hemodialysis-dependent.

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