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Defining utility and predicting outcome of cadaveric lower extremity bypass grafts in patients with critical limb ischemia.

ABSTRACT: Despite poor long-term patency, acceptable limb salvage has been reported with cryopreserved saphenous vein bypass (CVB) for various indications. However, utility of CVB in patients with critical limb ischemia (CLI) remains undefined. The purpose of this analysis was to determine the role of CVB in CLI patients and to identify predictors of successful outcomes.A retrospective review of all lower extremity bypass (LEB) procedures at a single institution was completed, and CVB in CLI patients were further analyzed. The primary end point was amputation-free survival. Secondary end points included primary patency and limb salvage. Life tables were used to estimate occurrence of end points. Cox regression analysis was used to determine predictors of limb salvage.From 2000 to 2012, 1059 patients underwent LEB for various indications, of whom 81 received CVB for either ischemic rest pain or tissue loss. Mean age (± standard deviation) was 66 ± 10 years (male, 51%; diabetes, 51%; hemodialysis dependence, 12%), and 73% (n = 59) had history of failed ipsilateral LEB or endovascular intervention. None had sufficient autogenous conduit for even composite vein bypass. Infrainguinal CVB (infrapopliteal target, 96%; n = 78) was completed for multiple indications including Rutherford class 4 (42%; n = 34), class 5 (40%; n = 32), and class 6 (18%; n = 15). Eleven (14%) had CLI and concomitant graft infection (n = 8) or acute on chronic ischemia (n = 3). Intraoperative adjuncts (eg, profundaplasty, suprainguinal stent or bypass) were completed in 49% (n = 40) of cases. Complications occurred in 36% (n = 29), with 30-day mortality of 4% (n = 3). Median follow-up for CLI patients was 11.8 (interquartile range, 0.4-28.4) months with corresponding 1- and 3-year actuarial estimated survival (± standard error mean) of 84% ± 4% and 62% ± 6%. Primary patency of CVB for CLI was 27% ± 6% and 17% ± 6% at 1 and 3 years, respectively. Amputation-free survival was 43% ± 6% and 23% ± 6% at 1 and 3 years, respectively, and significantly higher for rest pain (59% ± 9%, 36% ± 10%) compared with tissue loss (31% ± 7%, 14% ± 7%; log-rank, P = .04). Freedom from major amputation after CVB for CLI was 57% ± 6% and 43% ± 7% at 1 and 3 years. Multivariable predictors of limb salvage for the CVB CLI cohort included postoperative warfarin (hazard ratio [HR], 0.4; 95% confidence interval [CI], 0.2-0.8), dyslipidemia (HR, 0.4; 95% CI, 0.2-0.9), and rest pain (HR, 0.4; 95% CI, 0.2-0.9). Predictors of major amputation included graft infection (HR, 3.1; 95% CI, 1.1-9.0).In CLI patients with no autologous conduit and prior failed infrainguinal bypass, CVB outcomes are disappointing. CVB performs best in patients with rest pain, particularly those who can be anticoagulated with warfarin. However, it may be an acceptable option in patients with minor tissue loss or concurrent graft infection, but consideration should be weighed against the known natural history of nonrevascularized CLI and nonbiologic conduit alternatives, given potential cost implications.

SUBMITTER: Chang CK

PROVIDER: S-EPMC5548462 | biostudies-literature | 2014 Dec

REPOSITORIES: biostudies-literature

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Defining utility and predicting outcome of cadaveric lower extremity bypass grafts in patients with critical limb ischemia.

Chang Catherine K CK Scali Salvatore T ST Feezor Robert J RJ Beck Adam W AW Waterman Alyson L AL Huber Thomas S TS Berceli Scott A SA

Journal of vascular surgery 20140716 6

<h4>Objective</h4>Despite poor long-term patency, acceptable limb salvage has been reported with cryopreserved saphenous vein bypass (CVB) for various indications. However, utility of CVB in patients with critical limb ischemia (CLI) remains undefined. The purpose of this analysis was to determine the role of CVB in CLI patients and to identify predictors of successful outcomes.<h4>Methods</h4>A retrospective review of all lower extremity bypass (LEB) procedures at a single institution was compl ...[more]

PMID: 25043889

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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.

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.

Project description:BackgroundMany believe that variation in vascular practice may affect limb salvage rates in patients with severe peripheral arterial disease. However, the extent of variation in procedural vascular care obtained by patients with critical limb ischemia (CLI) remains unknown.Methods and resultsBy using Medicare 2003 to 2006 data, we identified all patients with CLI who underwent major lower extremity amputation in the 306 hospital referral regions described in the Dartmouth Atlas of Healthcare. For each patient, we studied the use of lower extremity vascular procedures (open surgery or endovascular intervention) in the year before amputation. Our main outcome measure was the intensity of vascular care, defined as the proportion of patients in the hospital referral region undergoing a vascular procedure in the year before amputation. Overall, 20,464 patients with CLI underwent major lower extremity amputations during the study period, and collectively underwent 25,800 vascular procedures in the year before undergoing amputation. However, these procedures were not distributed evenly: 54% of patients had no vascular procedures performed in the year before amputation, 14% underwent 1 vascular procedure, and 32% underwent >1 vascular procedure. In the regions in the lowest quintile of vascular intensity, vascular procedures were performed in 32% of patients. Conversely, in the regions in the highest quintile of vascular intensity, revascularization was performed in 58% of patients in the year before amputation (P<0.0001). In analyses accounting for differences in age, sex, race, and comorbidities, patients in high-intensity regions were 2.4 times as likely to undergo revascularization in the year before amputation than patients in low-intensity regions (adjusted odds ratio, 2.4; 95% CI, 2.1-2.6; P<0.001).ConclusionsSignificant variation exists in the intensity of vascular care provided to patients in the year before major amputation. In some regions, patients receive intensive care, whereas in other regions, far less vascular care is provided. Future work is needed to determine the association between intensity of vascular care and limb salvage.

Project description:BackgroundInfrainguinal bypass (IB) surgery is an effective means of improving arterial circulation to the lower extremity for patients with critical limb ischemia (CLI). However, wound complications (WC) of the surgical incision following IB can impart significant morbidity.MethodsA retrospective analysis of WC from the 1404 patients enrolled in a multicenter clinical trial of vein bypass grafting for CLI was performed. Univariate and multivariable regression models were used to determine WC predictors and associated outcomes, including graft patency, limb salvage, quality of life (QoL), resource utilization (RU), and mortality.ResultsA total of 543 (39%) patients developed a reported WC within 30 days of surgery, with infections (284, 52%) and hematoma/hemorrhage (121, 22%) being the most common type. Postoperative anticoagulation (odds ratio [OR], 1.554; 95% confidence interval [CI] 1.202 to 2.009; P = .0008) and female gender (OR, 1.376; 95% CI, 1.076 to 1.757; P = .0108) were independent factors associated with WC. Primary, primary-assisted, and secondary graft patency rates were not influenced by the presence of WC; though, patients with WC were at increased risk for limb loss (hazard ratio [HR], 1.511; 95% CI 1.096 to 2.079; P = .0116) and higher mortality (HR, 1.449; 95% CI 1.098 to 1.912; P = .0089). WC was not significantly associated with lower QoL at 3 months (4.67 vs 4.79, P = .1947) and 12 months (5.02 vs 5.13, P = .2806). However, the subset of patients with serious WC (SWC) demonstrated significantly lower QoL at 3 months compared with patients without WC, (4.43 vs 4.79, respectively, P = .0166), though this difference was not seen at 12 months (4.94 vs 5.13, P = .2411). Patients with WC had higher RU than patients who did not have WC. Mean index length of hospital stay (LOS) was 2.3 days longer, mean cumulative 1-year LOS was 8.1 days longer, and mean number of hospitalizations was 0.5 occurrences greater for patients with WC compared with patients without WC (all P < .0001).ConclusionsWC is a frequent complication of IB for CLI, associated with increased risk for major amputation, mortality, and greater RU. Further detailed investigation into the link between female gender and oral anticoagulation use with WC may help identify causes of WC and perhaps prevent or lessen their occurrence.

Project description:Factors responsible for the variability in outcomes after lower extremity vein bypass grafting (LEVBG) are poorly understood. Recent evidence has suggested that a single nucleotide polymorphism (SNP) in the promoter region of the p27(Kip1) gene, a cell-cycle regulator, is associated with coronary in-stent restenosis. We hypothesized an association with vein graft patency.This was a retrospective genetic association study nested within a prospective cohort of 204 patients from three referral centers undergoing LEVBG for claudication or critical ischemia. The main outcome measure was primary vein graft patency.All patients were followed up for a minimum of 1 year with duplex graft surveillance (median follow-up, 893 days; interquartile range, 539-1315). Genomic DNA was isolated and SNP analysis for the p27(Kip1)-838C>A variants was performed. Allele frequencies were correlated with graft outcome using survival analysis and Cox proportional hazards modeling. The p27(Kip1)-838C>A allele frequencies observed were CA, 53%; CC, 30%; and AA, 17%, satisfying Hardy-Weinberg equilibrium. Race (P = .025) and history of coronary artery disease (P = .027) were different across the genotypes; all other baseline variables were similar. Primary graft patency was greater among patients with the -838AA genotype (75% AA vs 55% CA/CC at 3 years; P = .029). In a Cox proportional hazards model including age, sex, race, diabetes, critical limb ischemia, redo (vs primary) bypass, vein type, and baseline C-reactive protein level, the p27(Kip1)-838AA genotype was significantly associated with higher graft patency (hazard ratio for failure, 0.4; 95% confidence interval, 0.17-0.93). Genotype was also associated with early (0-1 month) changes in graft lumen diameter by ultrasound imaging.These data suggest that the p27(Kip1)-838C>A SNP is associated with LEVBG patency and, together with previous reports, underscore a central role for p27(Kip1) in the generic response to vascular injury.

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.

Dataset Information

Defining utility and predicting outcome of cadaveric lower extremity bypass grafts in patients with critical limb ischemia.

Publications

Defining utility and predicting outcome of cadaveric lower extremity bypass grafts in patients with critical limb ischemia.

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