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Critical limb ischemia (CLI) is a frequent and major vascular problem and can lead to amputation and death despite surgical revascularization. Women have been shown to have 3 to 4 per cent lower revascularization rates for CLI compared with men as well as inferior outcomes. We hypothesize that this difference is a result of women being more likely admitted to low-volume hospitals, which in turn perform fewer revascularizations. Prospective cohort study. Data from the Nationwide Inpatient Sample 2007 to 2010 were used to identify admissions with primary International Classification of Diseases-9 codes for CLI (International Classification of Diseases-9 codes: 440.22, 440.23, 440.24, 707.1, 707.10-707.15, or 707.19). Hospitals were grouped in quintiles by annual revascularization procedures. Bivariate analyses were performed and multivariable logistic regression was used to analyze the odds of revascularization, amputation, and mortality while controlling for patient and hospital-level factors. Of 113,631 admissions, 54,370 (47.8%) were women, who were more likely admitted to low-volume hospitals (very low: 49.6% vs very high: 47.1%; P < 0.001). Revascularization rates were lower in women (31.6% vs 35.1%, P < 0.001) across all volume quintiles, whereas the difference was greatest in the use of open surgical revascularization (12.5% vs 16.0%, P < 0.001). In multivariable analysis, female gender [odds ratio (OR) 0.87, 95% confidence interval (CI) 0.83-0.92, P < 0.001] and very-low hospital volume (OR 0.21, 95% CI 0.17-0.26, P < 0.001) were both significantly associated with lower rates of revascularization. Women had lower odds of major amputation compared with men (OR 0.75, 95% CI 0.69-0.82, P < 0.001), whereas treatment in a very high-volume hospital was associated with increased odds for amputation (OR 1.37, 95% CI 1.09-1.73, P = 0.008). Neither gender nor hospital volume were independently associated with in-hospital mortality in the multivariable regression model. Women are more likely to be admitted to low-volume hospitals for treatment of CLI. Because of this, they are less likely to undergo revascularization, although they also had lower rates of major amputation.

Objective: Wound complications (WCs) after lower extremity arterial surgery (LEAS) are common, resulting in readmissions and reinterventions. Whereas diabetes and obesity are known risk factors for WCs, gender-specific variability in body fat distribution (android vs gynoid) may drive differential risks of WCs after LEAS. We analyzed the independent and synergistic effects of gender and body mass index (BMI) on WCs., Methods: We performed a retrospective review of prospectively collected data from a published, randomized, multicenter trial assessing the incidence of WCs (dehiscence, surgical site infections, seroma, and hematoma) after LEAS. Postoperative outcomes were compared between genders. A multivariable regression model assessed the impact of gender and BMI on WCs. Subanalysis focused on the synergy of gender and body habitus, groin-only incisions, and clinical outcomes., Results: There were 502 patients who underwent LEAS between October 2010 and September 2013. The cohort was elderly (67.6 ± 10.5 years), mostly male (72%), and overweight (BMI, 27.6 ± 5.7); 225 (45%) patients had a groin-only incision. In 171 patients (37.9%), a WC developed within 30 days, 85% of which were infectious in etiology. On multivariable regression, obesity (odds ratio [OR], 2.10; 95% confidence interval [CI], 1.17-3.77), morbid obesity (OR, 2.87; 95% CI, 1.32-6.23), and female gender (OR, 1.17; 95% CI, 1.06-2.75) were independent predictors of infectious WCs at 30 days. When stratified by groin-only incision, BMI was no longer significant, but female gender (OR, 2.70; 95% CI, 1.24-5.87) was predictive of infectious WCs at 30 days. There was no synergistic effect of BMI and gender on WCs., Conclusions: WCs are common after LEAS. BMI is an independent risk factor for the development of any WC. Female gender, a potential surrogate for high hip to waist ratio body habitus, is also an independent predictor of groin WCs, suggesting the clinical importance of gynoid vs android fat distribution., (Copyright © 2017 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Objective: Historically, edge stenosis and late thrombosis limited the effectiveness of adjunctive endovascular brachytherapy (EVBT) for in-stent restenosis (ISR) after percutaneous transluminal angioplasty (PTA) and stenting. We evaluated an updated protocol of PTA and EVBT for ISR among patients with lower extremity occlusive disease., Methods: This is a retrospective, single-center review of patients treated with PTA and EVBT for ISR in the iliac and femoropopliteal segments between 2004 and 2012. A dose of 20 Gy was given at a depth of 0.5 mm beyond the radius of the largest PTA balloon using iridium 192, with at least 2-cm-long margins of radiation coverage proximal and distal to the injured area. Stents were assessed for patency by duplex ultrasound imaging at 1, 3, 6, 9, 12, and 18 months and then yearly. The primary end point was freedom from ≥50% restenosis in the treated segment at 6 months, 1 year, and 2 years. Patency data were estimated using the Kaplan-Meier method. Secondary end points were early and late thrombotic occlusion., Results: Among 42 consecutive cases in 35 patients of EVBT for ISR in common or external iliac (9 [20.8%]) and superficial femoral or popliteal (33 [76.7%]) arteries, or both, 21 patients (50%) had claudication, asymptomatic hemodynamically significant stenoses were identified on duplex ultrasound imaging in 16 (38.1%), and 4 (9.8%) had critical limb ischemia. Mean treated length was 23.5 ± 12.3 cm over a mean duration of 16.1 ± 9.6 minutes. There was one technical failure (2.3%). Median post-EVBT follow-up time was 682 days (range, 1-2262 days). There were two (4.9%) and five (11.9%) cases of early and late thrombotic occlusions, respectively. There was one death, believed to be secondary to acute coronary syndrome. Primary, assisted primary, and secondary patency in the entire cohort was 75.2%, 89.1%, and 89.1%, respectively, at 1 year and 63.7%, 80.6%, and 85.6%, respectively, at 2 years., Conclusions: This contemporary protocol of PTA and adjunctive EVBT for lower extremity ISR, which is updated from those used in prior trials and includes a surveillance strategy that identifies at-risk stents for reintervention before occlusion, may be a promising treatment for lower extremity ISR at institutions where a close collaboration between vascular surgeons and radiation oncologists is feasible., (Copyright © 2016 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Objective: Despite patent vein bypass grafts, some patients with critical limb ischemia (CLI) receive major amputations. We analyzed the predictive factors leading to major amputation in the presence of patent lower extremity bypass (LEB) grafts., Methods: Data from the Project of Ex-Vivo vein graft Engineering via Transfection III (PREVENT III), a large prospective randomized trial of 1404 patients who underwent LEB with vein graft for CLI, were queried for outcomes. The primary outcome was major amputation with patent (PMA) LEB compared with patients with patent LEB who achieved limb salvage (PLS). The population excluded those who received amputation for occluded grafts. A Cox proportional hazard model identified independent predictors., Results: Of 1404 LEB patients, 162 (11.5%) had major amputation: 89 (6.3%) with patent and 73 (5.2%) with occluded LEB. For PMA, 21 of 89 (23.6%) developed critical stenosis and 11 of 21 (52.4%) were revised. For PLS, 460 of 1242 (37.0%) developed critical stenosis and 351 of 460 (76.3%) were revised. Predictive patient factors included having preoperative gangrene (vs rest pain; hazard ratio [HR], 3.504; 95% confidence interval [CI], 1.533-8.007; P = .0029), diabetes (HR, 1.800; 95% CI, 1.006-3.219; P = .0477), black (vs white) race (HR, 1.779; 95% CI, 1.051-3.011; P = .0321), baseline creatinine clearance <25 mL/min (vs >65 mL/min; HR, 1.759; 95% CI, 1.016-3.048; P = .0439), prior history of coronary artery bypass grafting (HR, 1.702; 95% CI, 1.080-2.683; P = .0221), and lower baseline activity quality of life score (HR, 1.401; 95% CI, 1.105-1.778; P = .0054). Postoperative wound factors included gangrenous changes (HR, 5.830; 95% CI, 1.647-20.635; P = .0063), surgical wound necrosis (HR, 5.319; 95% CI, 1.478-19.146; P = .0105), deep (vs superficial) wound infection (HR, 3.815; 95% CI, 1.220-11.927; P = .0213), and wound healing abnormally (HR, 3.754; 95% CI, 1.061-13.278; P = .0402). Associated postoperative consequences leading to PMA included having recurrent CLI symptoms (HR, 2.915; 95% CI, 1.816-4.681; P < .0001), a severe (vs mild) adverse event (HR, 2.751; 95% CI, 1.391-5.443; P = .0036), fewer percutaneous revisions (HR, 2.425; 95% CI, 1.573-3.740; P < .0001), discharge on low-molecular-weight heparin (HR, 2.087; 95% CI, 1.309-3.326; P = .0020), and decreasing days to critical stenosis/occlusion/revision/amputation (HR, 1.010; 95% CI, 1.007-1.012; P < .0001)., Conclusions: Whereas a patent vein graft is important to all vascular surgeons, additional factors should be considered in trying to attain limb salvage for patients with CLI. These factors include intervening surgically before CLI has progressed to a state of gangrene or limited activity and optimizing nutrition, diabetes control, cardiac conditions, and activity level. Revision offers hope for clinical improvement but may be delayed when there is no graft lesion identified. The absence of a graft lesion to revise may also portend amputation despite a patent graft because of nongraft-related factors such as infection. Finally, the experience of a severe (vs mild) adverse event may also result in limb loss despite a patent graft. Systematic efforts to reduce severe adverse events among patients may also lead to increased limb salvage., (Copyright © 2016 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Objective: Major lower extremity (MLE) amputation is a common procedure that results in a profound change in a patient's life. We sought to determine the association between social support and outcomes after amputation. We hypothesized that patients with greater social support will have better post amputation outcomes., Methods: From November 2011 to May 2013, we conducted a cross-sectional, observational, multicenter study. Social integration was measured by the social integration subset of the Short Form Craig Handicap Assessment and Reporting Technique. Systemic social support was assessed by comparing a United States and Tanzanian population. Walking function was measured using the 6-minute walk test and quality of life (QoL) was measured using the EuroQol-5D., Results: We recruited 102 MLE amputees. Sixty-three patients were enrolled in the United States with a mean age of 58.0. Forty-two (67%) were male. Patients with low social integration were more likely to be unable to ambulate (no walk 39% vs slow walk 23% vs fast walk 10%; P = .01) and those with high social integration were more likely to be fast walkers (no walk 10% vs slow walk 59% vs fast walk 74%; P = .01). This relationship persisted in a multivariable analysis. Increasing social integration scores were also positively associated with increasing QoL scores in a multivariable analysis (β, .002; standard error, 0.0008; P = .02). In comparing the United States population with the Tanzanian cohort (39 subjects), there were no differences between functional or QoL outcomes in the systemic social support analysis., Conclusions: In the United States population, increased social integration is associated with both improved function and QoL outcomes among MLE amputees. Systemic social support, as measured by comparing the United States population with a Tanzanian population, was not associated with improved function or QoL outcomes. In the United States, steps should be taken to identify and aid amputees with poor social integration., (Copyright © 2016 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Objective: Recent initiatives to improve health care quality have focused attention on length of stay (LOS) and readmission rates for surgical patients, yet these two outcomes may be inversely related. This study was designed to elucidate the risk factors for both outcomes and to clarify the relationship between them in patients undergoing lower extremity bypass (LEB)., Methods: Peripheral arterial disease (PAD) patients who underwent LEB were identified from the 2007-2010 California State Inpatient Database. LOS and risk factors were analyzed using Poisson regression. Risk factors for 30-day readmission were analyzed using logistic regression., Results: There were 6307 patients who underwent LEB, and 1291 (20%) were readmitted. The average index LOS was 8.3 days for those who were readmitted and 5.5 days for those who were not (P < .0001) and was an independent risk factor for 30-day readmission. The significant factors with the largest effect estimates for increased LOS reflected disease severity and postoperative complications: emergency department admission; advanced PAD; postoperative pneumonia, respiratory failure, urinary tract infection, wound/graft infection, graft complication, and discharge to a nursing facility. Independent predictors of readmission, other than LOS, reflected underlying patient factors: advanced PAD, chronic lung disease, diabetes, renal failure, postoperative congestive heart failure, and discharge status. Age, Medicaid or private insurance, and low income were protective. Of the 1291 readmissions, 453 (35%) were for definitive complications., Conclusions: In patients undergoing LEB, LOS is primarily associated with the occurrence of postoperative complications, whereas 30-day readmission is largely explained by underlying patient illness. Additionally, increased LOS is an independent risk factor for readmission. These findings suggest that efforts to reduce both LOS and readmission will be complementary. Furthermore, they support the notion that both LOS and 30-day readmission rates should be risk-adjusted., (Published by Elsevier Inc.)

Objective: Wound complications negatively affect outcomes of lower extremity arterial reconstruction. By way of an investigator initiated clinical trial, we tested the hypothesis that a silver-eluting alginate topical surgical dressing would lower wound complication rates in patients undergoing open arterial procedures in the lower extremity., Methods: The study block-randomized 500 patients at three institutions to standard gauze or silver alginate dressings placed over incisions after leg arterial surgery. This original operating room dressing remained until gross soiling, clinical need to remove, or postoperative day 3, whichever was first. Subsequent care was at the provider's discretion. The primary end point was 30-day wound complication incidence generally based on National Surgical Quality Improvement Program guidelines. Demographic, clinical, quality of life, and economic end points were also collected. Wound closure was at the surgeon's discretion., Results: Participants (72% male) were 84% white, 45% were diabetic, 41% had critical limb ischemia, and 32% had claudication (with aneurysm, bypass revision, other). The overall 30-day wound complication incidence was 30%, with superficial surgical site infection as the most common. In intent-to-treat analysis, silver alginate had no effect on wound complications. Multivariable analysis showed that Coumadin (Bristol-Myers Squibb, Princeton, NJ; odds ratio [OR], 1.72; 95% confidence interval [CI], 1.03-2.87; P = .03), higher body mass index (OR, 1.05; 95% CI, 1.01-1.09; P = .01), and the use of no conduit/material (OR, 0.12; 95% CI, 0.82-3.59; P < .001) were independently associated with wound complications., Conclusions: The incidence of wound complications remains high in contemporary open lower extremity arterial surgery. Under the study conditions, a silver-eluting alginate dressing showed no effect on the incidence of wound complications., (Copyright © 2015 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Background: When judging the success or failure of major lower extremity (MLE) amputation, the assessment of appropriate functional and quality of life (QOL) outcomes is paramount. The heterogeneity of the scales and tests in the current literature is confusing and makes it difficult to compare results. We provide a primer for outcome assessment after amputation and assess the need for the additional development of novel instruments., Methods: MEDLINE, EMBASE, and Google Scholar were searched for all studies using functional and QOL instruments after MLE amputation. Assessment instruments were divided into functional and QOL categories. Within each category, they were subdivided into global and amputation-specific instruments. An overall assessment of instrument quality was obtained., Results: The initial search revealed 746 potential studies. After a review of abstracts, 102 were selected for full review, and 40 studies were then included in this review. From the studies, 21 different assessment instruments were used 63 times. There were 14 (67%) functional measures and 7 (33%) QOL measures identified. Five (36%) of the functional instruments and 3 (43%) of the QOL measures were specific for MLE amputees. Sixteen instruments were used >1 time, but only 5 instruments were used >3 times. An additional 5 instruments were included that were deemed important by expert opinion. The 26 assessment instruments were rated. Fourteen of the best-rated instruments were then described., Conclusions: The heterogeneity of instruments used to measure both functional and QOL outcomes make it difficult to compare MLE amputation outcome studies. Future researchers should seek to use high-quality instruments. Clinical and research societies should endorse the best validated instruments for future use in order to strengthen overall research in the field., (Copyright © 2014 Elsevier Inc. All rights reserved.)

Background: Patients with critical limb ischemia (CLI) often undergo revascularization before amputation. The exact relationship between multiple procedures and increased risk of amputation is unclear. We sought to determine the increased risk of amputation for each additional revascularization., Methods: The 2007-2009 California State Inpatient Database (SID) was used to identify a cohort of CLI patients undergoing revascularization and conduct a time-to-event analysis for patients undergoing one or more revascularization procedures. One-year estimates were generated with Kaplan-Meier curves and compared with the log-rank test. The Wei-Lin-Weissfeld (WLW) marginal proportional hazards model was used to assess independent effects of number of revascularization procedures on amputation and death., Results: A total of 11,190 patients with CLI underwent revascularization between July 2007 and December 2009. Their mean age was 71.0 years (interquartile range 62-80 years) and 6255 (55.9%) were male. Over half the subjects (55.2%) were smokers and there was a high burden of comorbidities in the cohort. One-year estimates of amputation by number of revascularizations (1: 23.3%; 2: 27.1%; 3: 30.3%; 4: 26.7%; 5(+): 28.6%; P < 0.001) and death (1: 18.7%; 2: 21.1%; 3: 26.3%; 4: 23.6%; 5+: 32.1%; P = 0.012) increased significantly as procedures increased. In the WLW model for amputation, the hazard increased significantly for patients with 2 revascularization versus 1 (HR = 1.22; 95% CI 1.09-1.37; P = 0.001) and 3 revascularizations versus 2 (HR = 1.33; 95% CI 1.10-1.62; P = 0.004). In the multivariable WLW models for death, the increase in revascularization procedures for 2 compared with 1 (HR = 1.18; 95% CI 1.04-1.34; P = 0.010) was significant., Conclusions: The risk of amputation increases with each additional revascularization procedure. These findings hold true for both percutaneous transluminal angioplasty only and lower extremity bypass only subsets. In addition, increased revascularization procedures appear to result in an increased risk of death. We advocate for continued communication between clinicians and patients on the true risks and benefits of additional revascularization procedures., (Copyright © 2014 Elsevier Inc. All rights reserved.)

Background: Thirty-day unplanned readmission after lower extremity bypass represents a large cost burden and is a logical target for cost-containment strategies. We undertook this study to evaluate factors associated with unplanned readmission after lower extremity bypass., Methods: This is a retrospective analysis from a prospective institutional registry. All lower extremity bypasses for occlusive disease from January 1995 to July 2011 were included. The primary end point was 30-day unplanned readmission. Secondary end points included graft patency and limb salvage., Results: Of 1543 lower extremity bypasses performed, 84.5% were for critical limb ischemia and 15.5% were patients with intermittent claudication. Twenty-seven patients (1.7%) died in-house and were excluded from further analysis. Of 1516 lower extremity bypasses analyzed, 42 (2.8%) were in patients with a planned readmission within 30 days, and 349 (23.0%), in patients with an unplanned readmission. Most unplanned readmissions were wound related (62.9%). By multivariable analysis, preoperative predictive factors for unplanned readmission were dialysis dependence (odds ratio [OR], 1.73; P = .004), tissue loss indication (OR, 1.62; P = .0004), and history of congestive heart failure (OR, 1.43; P = .03). Postoperative predictors included distal inflow source (OR, 1.38; P = .016), in-hospital wound infection (OR, 8.30; P < .0001), in-hospital graft failure (OR, 3.20; P < .0001), and myocardial infarction (OR, 1.96; P < .04). Neither index length of stay nor discharge disposition independently predicted unplanned readmission. Unplanned readmission was associated with loss of assisted primary patency (hazard ratio, 1.39; 95% confidence interval, 1.08-1.80; P = .01) and long-term limb loss (hazard ratio, 1.68; 95% confidence interval, 1.23-2.29; P = .001)., Conclusions: Thirty-day unplanned readmission is a frequent occurrence after lower extremity bypass (23.0%). Stratifying patients by risk factors associated with unplanned readmission is essential for quality improvement and equitable resource allocation when disease-specific bundling strategies are being derived., (Copyright © 2013 Society for Vascular Surgery. Published by Mosby, Inc. All rights reserved.)

Background: Single-segment great saphenous vein (SSGSV) remains the conduit of choice for femoral to below-knee popliteal (F-BK) surgical revascularization. The purpose of this study was to determine the optimal conduit in patients with inadequate SSGSV., Methods: This was a retrospective review of a prospectively maintained vascular registry. Patients underwent F-BK bypass with alternative vein (AV; arm vein, spliced GSV, or composite vein) or prosthetic conduit (PC)., Results: From January 1995 to June 2010, 83 patients had unusable SSGSV for F-BK popliteal reconstruction. Thirty-three patients had an AV conduit and 50 had PC. The AV group was a lower median age than the PC group (69 vs 75 years). The two groups were otherwise similar in comorbid conditions of diabetes mellitus (57.6% vs 58.0%; P > .99), smoking (15.2% vs 32.0%; P = .12), and hemodialysis (3% vs 12%; P = .23). The groups were similar in baseline characteristics such as limb salvage as indication (93.9% vs 86.0%; P = .31), mean runoff score (5.2 vs 4.6; P = .39), and prior ipsilateral bypass attempts (18.2% vs 18.0%; P > .99). The AV and PC groups were also similar in 30-day mortality (6.1% vs 4.0%; P > .99) and wound infection rates (6.1% vs 6.0%; P > .99). PC patients were more likely to be discharged on Coumadin (Bristol-Myers Squibb, Princeton, NJ) than AV patients (62.0% vs 27.3%; P = .002). Seventeen of the 50 PC patients (34%) had a distal anastomotic vein cuff. A log-rank test comparison of 5-year outcomes for the AV and PC groups found no significant difference in primary patency (55.3% ± 9.9% vs 51.9% ± 10.8%; P = .82), assisted primary patency (68.8% ± 9.6% vs 54.0% ± 11.0%; P = .45), secondary patency (68.4% ± 9.6% vs 63.7% ± 10.4% for PC; P = .82), or limb salvage rates (96.2% ± 3.8% vs 81.1% ± 8.1%; P = .19). Multivariable analysis demonstrated no association between conduit type and loss of patency or limb. The factors most predictive of primary patency loss were limb salvage as the indication for surgery (hazard ratio [HR], 4.23; 95% confidence interval [CI], 1.65-10.9; P = .003) and current hemodialysis (HR, 3.51; 95% CI, 1.08-11.4; P = .037). The most predictive factor of limb loss was current hemodialysis (HR, 7.02; 95% CI, 1.13-43.4; P = .036)., Conclusions: For patients with inadequate SSGSV, PCs, with varying degrees of medical and surgical adjuncts, appear comparable to AV sources in graft patency for below-knee popliteal bypass targets. This observation is tempered by the small cohort sample size of this single-institutional analysis. Critical limb ischemia as the operative indication and current hemodialysis predict impaired patency, and hemodialysis is associated with limb loss., (Copyright © 2012 Society for Vascular Surgery. Published by Mosby, Inc. All rights reserved.)

Objective: Disparities in limb salvage procedures may be driven by socioeconomic status (SES) and access to high-volume hospitals. We sought to identify SES factors associated with major amputation in the setting of critical limb ischemia (CLI)., Methods: The 2003-2007 Nationwide Inpatient Sample was queried for discharges containing lower extremity revascularization (LER) or major amputation and chronic CLI (N = 958,120). The Elixhauser method was used to adjust for comorbidities. Significant predictors in bivariate logistic regression were entered into a multivariate logistic regression for the dependent variable of amputation vs LER., Results: Overall, 24.2% of CLI patients underwent amputation. Significant differences were seen between both groups in bivariate and multivariate analysis of SES factors, including race, income, and insurance status. Lower-income patients were more likely to be treated at low-LER-volume institutions (odds ratio [OR], 1.74; P < .001). Patients at higher-LER-volume centers (OR, 15.16; P <.001) admitted electively (OR, 2.19; P < .001) and evaluated with diagnostic imaging (OR, 10.63; P < .001) were more likely to receive LER., Conclusions: After controlling for comorbidities, minority patients, those with lower SES, and patients with Medicaid were more likely receive amputation for CLI in low-volume hospitals. Addressing SES and hospital factors may reduce amputation rates for CLI., (Copyright © 2011 Society for Vascular Surgery. Published by Mosby, Inc. All rights reserved.)

Limb salvage, operative mortality and short and long term graft patency have long been important variables for assessment of infrainguinal arterial reconstructions. More recently it is now appreciated that patient and society oriented measures of outcomes in determining the effectiveness of any surgical procedure are also important. In particular, the impact of an intervention on a patient's overall quality of life (QOL) and whether it is cost effective in achieving improvement of QOL are questions of increasing importance from the patient's perspective and from the perspective of those who must make difficult health policy decisions. This chapter reviews the cost effectiveness and impact of infrainguinal bypass on patient perceived quality of life in patients with intermittent claudication and patients with critical limb ischemia. The data are not robust but suggest favorable impact of infrainguinal bypass in terms of both QOL and cost effectiveness in both patients with intermittent claudication and critical limb ischemia.