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Objective: This study evaluated the effect of pedal arch quality on the amputation-free survival and patency rates of distal bypass grafts and its direct impact on the rate of healing and time to healing of tissue loss after direct angiosome revascularization in patients with critical limb ischemia (CLI). Methods: Between 2004 and 2011, patients undergoing distal bypass for CLI (Rutherford 4-6) were divided in groups taking into consideration the state of the pedal arch and direct angiosome revascularization (DAR) and non-DAR. Angiography was used to divide the pedal arch into three groups: complete pedal arch (CPA), incomplete pedal arch (IPA), and no pedal arch (NPA). The primary end points were patency rates at 12 months, amputation-free survival at 48 months, and the rate of healing and time to healing of foot tissue loss. Results: A total of 154 patients (75% men) with CLI underwent 167 infrapopliteal bypasses. Patients were a median age of 75 years (range, 46-96 years). Diabetic mellitus was present in 76%, chronic renal failure in 28%, and ischemic heart disease in 44%. The primary patency rates at 1 year in the CPA, IPA, and NPA groups were 58.4%, 54.6%, and 63.8%, respectively (P = .5168), the secondary patency rates were 86.0%, 84.7%, and 88.8%, respectively (P = .8940), and the amputation-free survival at 48 months was 67.2%, 69.7%, and 45.9%, respectively (P = .3883). Tissue loss was present in 141 of the 167 bypasses. In the CPA group, 83% of tissue loss with DAR healed compared with 92% in the non-DAR (median time to healing, 66 vs 74 days). Similarly in the IPA group, 90% with DAR healed compared with 81% in the non-DAR (median time to healing, 96 vs 86 days). In the NPA group, only 75% with DAR healed compared with 73% in the non-DAR (median time to healing, 90 vs 135 days). There was a significant difference in healing and time to healing between the CPA/IPA and NPA groups (P = .0264). Conclusions: The quality of the pedal arch did not influence the patency or the amputation-free survival rates. However, the rates for healing and time to healing were directly influenced by the quality of the pedal arch rather than the angiosome revascularized. [Copyright &y& Elsevier]

The Viabahn covered stent (W. L. Gore and Associates Inc, Flagstaff, Ariz) is made of expanded polytetrafluoroethylene attached to an external nitinol stent and is primarily used in the endovascular treatment of lower extremity arterial occlusive disease. The use of this device as an open conduit for lower extremity revascularization has been rarely reported. We expand on this experience by presenting a case of hybrid endovascular and open iliofemoral bypass in which we used the Viabahn endoprosthesis to recanalize an occluded iliac artery, followed by direct suturing of the distal portion of the Viabahn stent graft to the native common femoral artery bifurcation. [ABSTRACT FROM AUTHOR]

Objective: Lower extremity computed tomography angiography (CTA) is frequently used for anatomic assessment of lower extremity peripheral arterial disease. When lower extremity bypass is planned, duplex ultrasound (DUS) is routinely obtained to evaluate the great saphenous vein (GSV) for use as conduit. Although GSV can be visualized on CTA images, diameter assessment is not routinely included in formal study interpretation. We hypothesized that CTA images could be used to measure GSV diameters and that CTA-based diameters would correlate with measurements obtained using DUS. Methods: Consecutive patients undergoing lower extremity arterial bypass who were evaluated preoperatively with both CTA and DUS vein mapping were identified at a single hospital. Minimum above- and below-knee GSV diameters were measured from electronically archived CTA images by two independent observers. CTAs were performed using standard arterial phase protocol without additional venous phase imaging. Between-observer reproducibility of CTA-based diameter measurements was evaluated using intraclass correlation coefficients. Correlation between CTA and DUS-based GSV diameters was evaluated with Spearman correlation coefficients. CTA diameter cut-points for identification of adequate GSV bypass conduit, defined as DUS-based minimum GSV diameter ≥ 3 mm, were determined using receiver-operating characteristic curves. Results: Sixty-three lower extremities were evaluated in 36 patients. In the absence of previous surgical removal, GSV was visible on all CTAs reviewed. No instances of GSV thrombosis were identified on DUS. Minimum DUS-based above-knee GSV diameter was 2.9 ± 0.1 mm (range, 1.4-4.6 mm), and mean below-knee diameter was 2.6 ± 0.1 mm (range, 1.3-4.0 mm). When GSV was visible and exceeded the minimum diameter threshold for CTA measurement, correlation between CTA- and DUS-based diameters was both positive and highly significant (ρ = 0.595; P < .0001). CTA-based diameters also had excellent reliability between observers (r [95% CI]: 0.88 [0.85-0.91]). For identification of adequate bypass conduit using CTA, above-knee GSV diameter ≥ 3.9 mm was 67% sensitive and 73% specific; below-knee GSV diameter ≥3.0 mm was 75% sensitive and 84% specific. Conclusions: CTA-based GSV diameter measurements have good reproducibility and highly significant correlation with DUS-based diameters. CTA-based GSV diameter is a specific but relatively insensitive indicator of adequate bypass conduit. When CTA-based diameters indicate inadequate GSV bypass conduit, confirmatory DUS vein mapping is warranted. Confirmatory DUS vein mapping may be unnecessary when adequate vein diameter is identified on CTA. [Copyright &y& Elsevier]

Objective: The effect of diabetes type (noninsulin dependent vs insulin dependent) on outcomes after lower-extremity bypass (LEB) has not been clearly defined. Therefore, we analyzed associations between diabetes type and outcomes after LEB in patients with critical limb ischemia. Methods: We performed a retrospective analysis of 1977 infrainguinal LEB operations done for critical limb ischemia between 2003 and 2010 within the Vascular Study Group of New England. Patients were categorized as nondiabetic (ND), noninsulin-dependent diabetic (NIDD), or insulin-dependent diabetic (IDD) based on their preoperative medication regimen. Our main outcome measures were in-hospital mortality and major adverse events (MAEs) – a composite outcome, including myocardial infarction, dysrhythmia, congestive heart failure, wound infection, renal insufficiency, and major amputation. We compared crude and adjusted rates of mortality and MAEs using logistic regression across diabetes categories. Results: Overall, 41% of patients were ND, 28% were NIDD, and 31% were IDD. Crude rates of in-hospital mortality were similar across these groups (1.7% vs 3.1% vs 2.1%; P = .211). Adjusted analyses accounting for differences in patient characteristics showed that diabetes is not associated with increased risk of in-hospital mortality. However, type of diabetes was associated with a higher risk of MAEs in both crude (15.1% for ND; 21.1% for NIDD; and 25.2% for IDD; P < .001) and adjusted analyses (odds ratio for NIDD, 1.41; 95% confidence interval, 1.2-1.7; odds ratio for IDD, 1.53; 95% confidence interval, 1.3-1.8). Conclusions: Diabetes is a significant contributor to the risk of postoperative complications after LEB surgery, and insulin dependence is associated with higher risk. Quality measures aimed at limiting complications after LEB may have the most impact if these initiatives are focused on patients who are IDD. [ABSTRACT FROM AUTHOR]

The uncertainty continues over the best approach to patients with symptomatic peripheral arterial disease. Medical therapy and risk factor modification is part of any treatment regimen; with this there is little disagreement. However, with the introduction of lesser invasive percutaneous technologies, the discussion regarding surgical and endovascular therapies has become more and more complicated. Unfortunately, there is a relative shortage of robust outcomes data to support many of our specific treatment recommendations. Younger patients are an especially troublesome patient cohort. They have consistently shown poorer outcomes after any intervention compared with older patients and may represent a subset of more aggressive atherosclerotic disease. Our debaters will discuss their preferred approaches to these difficult patients in the context of the currently available supporting literature. [ABSTRACT FROM AUTHOR]

Background: Thrombolysis is a common method in the treatment of lower extremity bypass graft occlusion. The purpose of this study was to investigate the results of thrombolytic therapy in the management of acute bypass graft occlusion and to identify risk factors for technical failure and amputation. Methods: All patients at two tertiary referral centers undergoing thrombolysis for acute graft occlusion in the lower limb between January 1, 2000 and December 31, 2008 were retrospectively reviewed. Factors associated with technical failure of thrombolytic therapy, major amputation, and mortality were determined with multivariate analysis, and long-term outcomes were assessed with the Kaplan-Meier method and log-rank test. Results: During the study period, 123 patients underwent thrombolysis for acute bypass graft occlusion. Mean age was 69 years (range, 27-91 years); 38% were women. Sixty-seven percent had synthetic grafts. Acute critical leg ischemia (74%) was the dominating symptom preceding thrombolytic treatment. In 29% of cases, no adjunctive interventions were required, whereas 21% underwent open surgery, 39% endovascular intervention, and 11% underwent a hybrid procedure. Technical failure of thrombolysis occurred in 18 patients. Presence of ischemic heart disease (P = .013), older grafts (P = .014), and synthetic grafts (trend; P = .092) were associated with success of thrombolysis, and ischemic heart disease remained as an independent factor in the multivariate analysis for technical success of thrombolysis (P = .04; odds ratio 4.0; 95% confidence interval [CI; 1.1-15.1]), whereas there was a trend for older grafts (P = .089). Mean follow-up was 38 months (range, 0-119 months). The major amputation rate was 11% (14/123) at 1 month and 25% (31/122) at 1 year. In a Cox regression model, technical failure (P = .031; hazard ratio [HR] 2.58, 95% CI [1.0-6.08]), higher age (P = .004; HR 1.06, 95% CI [1.02-1.10]), and synthetic graft as opposed to vein graft (P = .050; HR 2.63, 95% CI [1.0-6.9]) remained as independent factors associated with major amputation. The amputation-free survival rate was 89% and 75% at 1 and 12 months, respectively. Higher age (P < .001; HR 1.06, 95% CI [1.03-1.09]) and acute limb ischemia (P = .007; HR 2.40, 95% CI [1.26-4.56]) remained as independent adverse factors associated with amputation-free survival. Conclusions: Our findings support the use of thrombolysis in the treatment of acute bypass graft occlusion in the lower limb given its acceptable short- and long-term amputation-free survival rates. Technical failure and higher age were factors associated with major amputation. Synthetic grafts appeared to have a somewhat increased likelihood of technically successful thrombolysis compared with vein grafts, but on the other hand, they exhibited an increased risk of amputation during follow-up. [ABSTRACT FROM AUTHOR]

Objective: Distal embolization (DE) during percutaneous lower extremity revascularization (LER) may cause severe clinical sequelae. To better define DE, we investigated which lesion types and treatment modalities increase the risk for embolization. Methods: A prospective registry of LER from 2004 to 2009 was reviewed. All cases with runoff evaluated before and after intervention were included. Angiograms and operative reports were reviewed for evidence of DE. Interventions included percutaneous transluminal angioplasty (PTA), with or without stent placement, and atherectomy with four different devices. Chi-square analysis and Fisher''s exact test were used to assess significance. Patency rates were calculated using Kaplan-Meier analysis and compared using log-rank analysis. Results: There were 2137 lesions treated in 1029 patients. The embolization rate was 1.6% (34 events). Jetstream (Pathway, Kirkland, Wash) and DiamondBack 360 (Cardiovascular Systems Inc, St Paul Minn) devices had a combined embolization rate of 22% (8 of 36), 4 of 18 (22%) in each group, which was significantly higher than with PTA alone (5 of 570, 0.9%), PTA and stent (5 of 740, 0.7%), SilverHawk (ev3, Plymouth, Minn) atherectomy (14 of 736, 1.9%), and laser atherectomy (2 of 55, 3.6%; P < .001). There was a significantly higher rate of embolization for in-stent restenosis (6 of 188, 3.2%) and chronic total occlusions (15 of 615, 2.4%) compared with stenotic lesions (13 of 1334, 0.9%; P = .01). The embolization rate was significantly higher in Transatlantic Inter-Society Consensus (TASC) II C and D lesions compared with TASC A and B lesions (P = .018). DE rates were not affected by preoperative runoff status (P = .152). Patency was restored at the completion of the procedure in 32 of 34 cases of DE. The 24-month primary patency, assisted primary patency, and secondary patency in the DE group was 54.0% ± 11.9%, 70.0% ± 10.3%, and 73.2% ± 10.3%, respectively, and was 44.4% ± 1.7%, 61.5% ± 1.7%, and 68.2% ± 1.6%, respectively, when embolization did not occur (P > .05). Limb salvage was 72.6% ± 3.1% in lesions in which no DE occurred vs 83.3% ± 15.2% in lesions in which DE occurred (P = .699). Conclusions: DE is a rare event that occurs more often with the Jetstream and DiamondBack 360 devices. In-stent and complex native lesions are at higher risk for DE. DE is typically reversible with endovascular techniques and has no effect on patency rates and limb salvage. [Copyright &y& Elsevier]

Background: Leg swelling in menopausal women is well known. Prevailing concept in primary care is that it is polycentric and a treatable cause may not be found. Patients are placed on empiric diuretics often without benefit. Our clinical experience indicates that iliac venous vein obstruction is the core cause; a variety of secondary factors common in postmenopausal women precipitate symptoms. Patients and Methods: A total of 163 limbs in 150 postmenopausal women (≥55 years of age) with leg swelling unresponsive to conservative therapy underwent intravascular ultrasound-guided iliac vein stenting over an 11-year period. Preoperative investigations included duplex, airplethysmography, venous pressure tests, contrast studies, and lymphangiography. The postmenopausal group constituted 9% of all limbs (n = 1760) stented for chronic venous disease (CVD) during the same period and 18% of those stented for swelling (n = 922). Median age was 67 (range, 55-92) and left-to-right ratio 2:1. Results: Iliac vein obstruction was “primary” (nonthrombotic) in 65% and postthrombotic in 35% of limbs; 35% of limbs had obstruction only and 65% combined obstruction/reflux. Lymphatic dysfunction was present in 21% of the limbs. Mean intravascular ultrasound area stenosis was 68% ± 22 SD. Mean follow-up was 22 months (±26 SD) (range, 1-113 months). Secondary stent patency (6 years) was 100% in primary and 91% in postthrombotic limbs; overall 98%. Swelling improved significantly (P < .0001) from preoperative grade 2.5 (±0.8 SD) to postoperative grade 1.2 (1.2 SD). Associated pain also improved significantly (P < .0001) from preoperative visual analog scale 3.5 (±3 SD) to postoperative 0.9 (2.1 ± SD). Quality-of-life (CIVQ) scores improved significantly in every category and overall (P < .0001). Conclusions: Patients with postmenopausal leg swelling often have obstructive venous pathology even though suggestive venous history and other signs are often absent. Morbidity arises from painful swelling that affects mobility, quality of life, and ability of self-care at later stages of life. Outpatient percutaneous iliac vein stenting affords substantial symptom relief and improvement in quality-of-life measures. Recognition of the clinical complex as a distinct entity of venous origin may lead to greater awareness and effective treatment. [Copyright &y& Elsevier]

Objective: Replacing heparin with bivalirudin has been beneficial in patients undergoing coronary intervention and coronary artery bypass. The use of this alternative anticoagulant during peripheral bypass operations has not been studied. Concerns over distal thrombosis using this direct thrombin inhibitor (DTI) prompted a single-arm, open-label, pilot prospective trial of bivalirudin in patients undergoing lower extremity bypass to assess perioperative safety and efficacy. Methods: Between 2006 and 2007, 18 patients met criteria for enrollment and underwent primary lower extremity bypass using bivalirudin. All patients had severe symptomatic atherosclerotic disease requiring lower extremity bypass. Bivalirudin at a bolus dose of 0.75 mg/kg and continuous infusion of 1.75 mg/kg/hr was used as the sole anticoagulant. Results: Patients (mean age, 67 years) underwent femoral-popliteal (n = 14) or femoral-tibial (n = 4) bypass preferentially using saphenous vein (83%). Mean operative time was 261 minutes, with bivalirudin infusion time of 95 ± 26 minutes (mean ± standard deviation). Reliable anticoagulation was achieved with weight-based dosing with activated clotting time values at baseline (systemic) of 131 ± 92 seconds, during infusion (systemic) of 347 ± 36 seconds, and from the distal vasculature (limb) of 345 ± 66 seconds. Distal limb bivalirudin levels were stable at 9755 ± 3860 ng/mL during clamp occlusion. Mean estimated blood loss was 332 ± 191 mL with four patients (22%) requiring blood products. One patient required revision of the proximal anastomosis during the initial hospitalization. At 30 days, all bypass operations were patent with improvement of mean ankle-brachial index from 0.57 to 0.81. There were no deaths, myocardial infarctions, or amputations in the 30-day postoperative period. Based on the Thrombolysis in Myocardial Infarction classification for bleeding, one patient had major bleeding (>2 units of packed red blood cells), and three patients had minor bleeding within the first 30 days. Conclusions: Bivalirudin is a safe and effective anticoagulant for lower extremity bypass operations. Thrombosis beyond the distal clamp was not seen. A comparative trial to standard anticoagulation is warranted. [Copyright &y& Elsevier]

Background: This study evaluated the durability of nitinol stent placement in high-risk patients with chronic critical limb ischemia (CLI) and infrapopliteal lesions after suboptimal balloon angioplasty. Methods: Between January 2006 and January 2009, 53 high-risk patients (24 women; mean age, 71.8 ± 5.1 years) with CLI underwent infragenicular stent placement with a 4F sheath-compatible self-expanding nitinol stent. Patients had three or more serious cardiopulmonary comorbidities, including chronic obstructive pulmonary disease, congestive heart failure, coronary artery occlusive disease, American Society of Anesthesiologists score ≥3, previous myocardial infarction, coronary stent or bypass, or infection after peripheral revascularization. Endovascular therapy was performed in 30 stenoses and 23 occlusions in 53 patients. The mean stenosis length was 5.5 ± 1.9 cm. The mean occlusion length was 6.5 ± 2.9 cm. The mean follow-up was 24.1 ± 7.3 months and consisted of clinical examination, ankle-brachial index (ABI) measurements, and duplex ultrasound imaging. Digital subtraction angiography was performed if restenosis or reocclusion was suspected. Results: The technical success rate was 98.1%. The 24-month cumulative primary patency rate was 75.5%. During the follow-up, two patients underwent successful repeat angioplasty, and four patients required crural bypass. The 24-month secondary patency and freedom from amputation rates were 88.7% and 88.7%, respectively. The mean ABI increased significantly at 12 and 24 months (P < .001). Risk stratification to detect predictors that influenced the patency rate showed that proximal lesions had significant better patency than distal crural lesions (83.3% vs 65.2%, P = .04). The morphology of the lesions (stenoses vs occlusions, P = .88) did not seem to influence primary patency. Four patients died from nonprocedure-related causes during the follow-up, including lung cancer, myocardial infarction, and glioblastoma multiforme. No procedure-related deaths were recorded. Conclusions: The 2-year outcome of our series underscores the value of infrapopliteal nitinol stent placement as a durable bailout treatment option in high-risk CLI patients with suboptimal angioplasty. [Copyright &y& Elsevier]

Background: Endovenous laser ablation (EVLA) is one of the most accepted treatment options for varicose veins. In previous studies conducted with a laser at 810 to 1320 nm, paresthesia, pain, and ecchymosis were common adverse effects. We hypothesized that a lower linear endovenous energy density (LEED), as used with 1470-nm diode laser fibers, would lead to a reduction in adverse events. Methods: We conducted a prospective, nonrandomized observational cohort study of 312 consecutively treated lower limbs legs in 286 patients. Of these, a bare laser fiber (ELVeS-plus kit) was used to treat 168 legs in 150 patients (group 1), and a radial fiber (ELVeS-radial kit) was used in 144 legs in 136 patients (group 2). Laser treatment was performed in the great saphenous vein. Follow-up for all patients was 3 months. The primary end point was the occurrence of ecchymosis and bruising. This was correlated to the reduced LEED needed with the 1470-nm diode laser. Results: Laser fiber (odds ratio [OR], 22.3; 95% confidence interval [CI], 20.2-24.5) and body mass index (OR, 0.35; 95% CI, 0.15-0.55) were identified as independent parameters for LEED. In group 2 compared with group 1, LEED in the great saphenous vein could be reduced from 79.4 ± 9.1 to 57.4 ± 10 J/cm (P < .0001). LEED was an independent parameter for skin bleeding (OR, 1.04; 95% CI, 1.017-1.058). Ecchymosis and bruising were significantly less frequent in group 2 than in group 1 (P < .0001). The need for analgesia was low, with 103.08 ± 15.34 mg diclofenac-sodium in group 1 vs 82.08 ± 18.86 mg in group 2 (P < .04). Occlusion with elimination of reflux was achieved in 100% of group 1 and group 2 (P < 1). No recanalization occurred at follow-up. Conclusion: Endovenous laser treatment of varicose veins in the great saphenous vein with the 1470-nm diode laser is safe and highly effective. The lower energy level needed using the radial laser fiber significantly minimized adverse effects compared with the bare laser fiber. [Copyright &y& Elsevier]

Objective: Studies of infrainguinal lower extremity bypass for critical limb ischemia (CLI) have traditionally emphasized outcomes of patency, limb salvage, and death. Because functional outcomes are equally important, our objectives were to describe the proportion of CLI patients who did not achieve symptomatic improvement 1 year after bypass, despite having patent grafts, and identify preoperative factors associated with this outcome. Methods: The prospectively collected Vascular Study Group of Northern New England database was used to identify all patients with elective infrainguinal lower extremity bypass for CLI (2003 to 2007) for whom long-term follow-up data were available. The primary composite study end point was clinical failure at 1 year after bypass, defined as amputation or persistent or worsened ischemic symptoms (rest pain or tissue loss), despite a patent graft. Variables identified on univariate screening (inclusion threshold, P < .20) were included in a multivariable logistic regression model to identify independent predictors. Results: Long-term follow-up data were available for 1012 patients who underwent infrainguinal bypasses for CLI, of which 788 (78%) remained patent at 1 year. Of these, 79 (10%) met criteria for the composite end point of clinical failure: 21 (2.7%) for major amputations and 58 (7.4%) for persistent rest pain or tissue loss. In multivariable analysis, significant predictors of clinical failure included dialysis dependence (odds ratio [OR], 3.74; 95% confidence interval [CI], 1.84-7.62; P < .001) and preoperative inability to ambulate independently (OR, 2.17; 95% CI, 1.26-3.73; P = .005). A history of coronary artery bypass graft or percutaneous coronary intervention was protective (OR, 0.52; 95% CI, 0.29-0.93; P = .03). Conclusions: After infrainguinal lower extremity bypass for CLI, 10% of patients with a patent graft did not achieve clinical improvement at 1 year. Preoperative identification of this specific patient subgroup remains challenging. To improve surgical decision making and the overall care of CLI patients, further emphasis needs to be placed on functional outcomes in addition to traditional surgical end points. [Copyright &y& Elsevier]

Introduction: Successful outcome after lower extremity revascularization is usually measured by physician-oriented terms such as graft patency and amputation-free survival. It has been increasingly appreciated that these criteria do not necessarily translate into success from the prospective of the patient. The purpose of this study, therefore, is to retrospectively examine success after lower extremity revascularization for tissue loss using patient-oriented measures and to include patients who underwent both open surgical bypass and endovascular therapy. Methods: Between 1998 and 2005, 677 patients (316 endovascular and 361 open surgery) underwent revascularization for ischemic tissue loss. The method of revascularization (endovascular or open surgery) was left to the discretion of the surgeon. Revascularization was considered to be clinically successful if each of the following occurred: reconstruction patency until wound healing, limb salvage for 1 year, maintenance of ambulation for 1 year, and survival for 6 months. The influence of 20 intrinsic patient factors, including type of revascularization (open vs endo) was examined using the χ2 test. Significant factors in bivariate analysis were included in a logistic regression model to determine independent predictors and probability of failure. Results: Overall clinical success was achieved in 277 (40.9%) patients. Success for open surgical and endovascular cohorts was 44.3% and 37.0%, respectively (P = .06). Type of intervention was not a significant factor in either bivariate or logistic regression analysis. Independent predictors of failure (odds ratio [OR]; 95% confidence interval [CI]) regardless of treatment type included impaired ambulatory status at the time of presentation (OR 3.24; CI 2.14, 4.90), diabetes (OR 1.62; CI 1.14, 2.32), endstage renal disease (ESRD) (OR 1.55; CI 1.07, 2.23), presence of gangrene (OR 2.0; CI 1.42, 2.82), and prior vascular intervention (OR 1.46; CI 1.02, 2.10). Paradoxically, hyperlipidemia (OR 0.70; CI 0.50, 0.98) was a predictor for success. Probability of failure was 35.4% (OR 1.0) if no independent predictors were present and increased with the addition of each adverse predictor. For instance, diabetic patients with impaired ambulatory status and gangrene had an 85.2% (OR 10.5) probability of failure. In the worst case scenario, a diabetic patient with ESRD, impaired ambulatory status, gangrene, and a prior vascular intervention was considered, probability of failure was a dismal 92.8% (OR 23.7). Conclusion: Clinical success after lower extremity revascularization for ischemic tissue loss is determined by intrinsic patient factors and not by method of revascularization. These data reiterate that future investigation efforts should be focused less on the method of revascularization and more on identification of patient cohorts at risk for failure regardless of treatment. [Copyright &y& Elsevier]

The proprietary heparin-bonded expanded polytetrafluoroethylene graft appears to be an attractive option for lower extremity revascularization in patients with compromised runoff and no autogenous vein. There is no detectable elution of heparin from the graft surface, but antithrombotic activity has been detected in devices implanted for >2 years. Although 15,000 Propaten (W. L. Gore and Associates, Flagstaff, Ariz) grafts have been implanted, to our knowledge, this is the first report of heparin-induced thrombocytopenia developing from this heparin-bonded graft. The heparin-induced thrombocytopenia responded promptly to graft explantation. A management plan is suggested for patients being considered for this graft. [Copyright &y& Elsevier]

Lower extremity revascularization is routinely performed for limb salvage purposes when critical limb ischemia has developed in a patient. Traditional reconstructions have been well described in the literature. We present a case of internal iliac artery endarterectomy with aortointernal iliac bypass for the treatment of limb ischemia. [Copyright &y& Elsevier]

Objective: Among individuals with peripheral artery disease (PAD), we compared annual change in 6-minute walk performance between participants who neither underwent lower extremity revascularization nor walked for exercise (group 1, reference), those who walked regularly for exercise (group 2), and those who underwent lower extremity revascularization (group 3). Methods: Participants were recruited from Chicago-area vascular laboratories and followed annually. Change in 6-minute walk was calculated beginning at the study visit preceding lower extremity revascularization or exercise behavior and continuing for 1 additional year after the therapy was reported. Results are adjusted for age, sex, race, comorbidities, and other confounders. Results: Of 348 PAD participants, 43 underwent revascularization during median follow-up of 84 months. Adjusted annual declines in 6-minute walk were ?96.6 feet/year for group 1, ?49.9 feet/year for group 2, and ?32.6 feet/year for group 3 (P < .001). Forty-one percent of revascularizations were not associated with ankle-brachial index (ABI) improvement. When group 3 was limited to participants with ABI improvement ?0.15 after revascularization, annual adjusted changes in 6-minute walk were ?97.7 feet/year for group 1, ?46.5 feet/year for group 2, and +68.1 feet/year for group 3 (P < .001). When group 3 was limited to participants without ABI improvement ?0.15 after revascularization, annual adjusted changes in 6-minute walk were ?99.2 feet/year for group 1, ?48.0 feet/year for group 2, and ?61.7 feet/year for group 3 (P < .001). Conclusions: A large proportion of PAD participants did not have ABI improvement of at least 0.15 at follow-up study visit after revascularization. The benefits of lower extremity revascularization in patients with PAD appear closely tied to improvements in the ABI after revascularization. [Copyright &y& Elsevier]

Objective: Aortoiliac arterial occlusive (AIOD) disease is common in India. The clinical presentation and etiology are different than in the West. Intervention is frequently required for advanced lower extremity ischemia, but the results have not been systemically evaluated. We studied the clinical profile and midterm results of patients undergoing aortobifemoral bypass for AIOD at a tertiary care center in south India. Methods: Clinical data of patients undergoing aortobifemoral bypass for AIOD over a 6-year period from January 1, 2005 to December 31, 2010 were retrospectively analyzed. Clinical presentation and factors affecting outcome were evaluated. Graft patency and mortality were included as study end points. Results: Ninety-nine patients (mean age, 52 years) with AIOD who underwent aortobifemoral bypass were included. Etiology included atherosclerosis in 79 patients, thromboangiitis obliterans in 15, Takayasu''s arteritis in two, and hematological conditions in 3. Smoking (82%), hypertension (40%), and diabetes (30%) were the most common risk factors; ischemic heart disease (4%), obesity (2%), and dyslipidemia (3%) were rare. Eighty-one percent of patients presented with critical limb ischemia. Mean duration of symptoms was 22 months (range, 4 months to 9 years). Concomitant infrainguinal arterial occlusive disease was identified in 81%, but intervened upon in only 2%. In-hospital mortality was 3%. Causes of death included myocardial infarction in two and colon ischemia in one. Major morbidity included nonfatal myocardial infarction (3%), pneumonia/atelectasis (5%), and renal dysfunction (2%). Groin wound complications occurred in 20%, seroma/lymph leak in 13%, infection in 7%, and anastomotic hemorrhage in 2%. Multidrug-resistant and polymicrobial infections were common. Early graft thrombosis (30 days) occurred in 15 patients; 8 of 11 reintervened grafts were salvaged. Four more grafts thrombosed during a mean follow-up of 2 years (range, 0-5 years) and two became infected. Overall study major limb loss rate was 10% (primary, 2%; secondary, 8%). Delayed presentation and smoking were more common in patients developing complications. There was no significant difference in overall complication rates between patients with thromboangiitis obliterans and atherosclerosis (P = .66). Conclusions: Despite earlier age at presentation, atherosclerosis remains the predominant etiology of aortoiliac arterial occlusive disease in Indian patients. Results of open revascularization are comparable to those in the Western literature. Thromboangiitis obliterans is the underlying pathology in a minority of patients with no significant difference in operative outcome. Patients frequently present late with critical limb ischemia, but this does not affect outcome. [Copyright &y& Elsevier]

Objective: This study assessed outcomes of revascularization strategies in young patients with premature arterial disease. Methods: Lower extremity revascularization outcomes from 2000 to 2008 were retrospectively compared among consecutive patients with comparable indications and procedures: age <50 years (group A) at the time of revascularization, 51 to 60 years (group B), and >60 years (control group C). Patency, limb salvage, and survival by limb or patient level were assessed by Kaplan-Meier and Cox proportional hazards analyses. Results: A total of 409 limbs in 298 patients were treated: 44% for claudication and 56% for critical limb ischemia (CLI). Group A patients were more likely to be smokers and have a hypercoagulable state but less likely to have diabetes and renal failure. Treatment indications were comparable among groups, and procedures were equally distributed between open surgical and endovascular interventions. Two perioperative deaths occurred in group C (2%). Mean follow-up was 29 months, and 16% of claudicant patients in group A progressed to CLI (B, 3%; C, 2%; P < .001). Overall, 2-year primary, primary assisted, and secondary patency were significantly lower in group A (50.5%, 65.2%, 68.2%; P = .045) vs B (65.7%, 81.4%, 86.8%; P = .01) and C (57.9%, 78.9%, 83.9%; P < .001). Claudicant patients in group A had an unexpectedly low 2-year freedom from major amputation after intervention of only 90%. Results were more comparable across groups for CLI. The 2-year freedom from reintervention was similar (A, 81.0%; B, 78.9%; C, 83.5%), irrespective of the indication for intervention (P = .60). Younger patients had a significantly higher 3-year survival (A, 89.5%; B, 85.3%) compared with patients aged >60 years (C, 71.4%; P = .005). The 2-year freedom from major amputation rate was significantly lower in claudicant patients in group A vs C undergoing endovascular revascularization (P = .002), but not in patients treated with open revascularization (P = .40). Predictors of loss of primary patency included age <50 years (P = .003), endovascular revascularization (P = .005), and progression from claudication to CLI (P < .001). Age <50 years was also an independent predictor of limb loss vs age >60 years (P = .05). Conclusions: Endovascular options are commonly being used in young patients, especially those with claudication, but patency rates and outcomes remain very poor. [Copyright &y& Elsevier]

Objective: Strict glucose control in patients undergoing coronary bypass grafting has been shown to decrease infectious complications, arrhythmias, and mortality. Our objective was to determine if strict glucose control reduced morbidity after lower extremity bypass (LEB). Methods: A prospective pilot study at a single institution within the Vascular Study Group of New England was conducted from January 2009 to December 2010. Patients with diabetes and without undergoing LEB were placed on an intravenous (IV) insulin infusion for 3 days after surgery with titration of blood glucose from 80 to 150 mg/dL. The IV insulin study group (n = 104) was compared to a historic control group (n = 189) that received standard insulin treatment from the preceding 3 years. The Fisher exact test, t-tests, Wilcoxon rank-sum tests, χ2, and logistic regression analyses were used to compare in-hospital morbidity. Stratified analyses were conducted to determine if findings differed based on the presence or absence of diabetes. Results: There was no difference in postoperative complications between the two groups with regard to graft infection, myocardial infarction, dysrhythmia, primary patency at discharge, or mortality. Patients in the IV insulin group had significantly fewer in-hospital wound infections (4% vs 11%; odds ratio [OR], 0.32; 95% confidence interval [CI], 0.11-0.96; P = .047). This association strengthened after adjusting for potentially confounding baseline differences in gender, body mass index, and smoking status (adjusted OR, 0.22; 95% CI, 0.05-0.84; P = .03). When stratified by presence of diabetes, wound infections were decreased in the IV insulin group (0/44 [0%] vs 9/90 [10%]; P = .03). In patients without diabetes treated with IV insulin, there was no significant difference in wound infections (7% vs 12%; P = .42). Conclusions: Strict glucose control with a postoperative insulin infusion protocol significantly decreased the incidence of postoperative in-hospital wound infection in the diabetic population. These previously unreported findings from this single-institution prospective study warrant further investigation. [Copyright &y& Elsevier]

Background: To develop standardized metrics for expected outcomes in lower extremity revascularization for critical limb ischemia (CLI), the Society for Vascular Surgery (SVS) has developed objective performance goals (OPGs) based on aggregate data from randomized trials of lower extremity bypass (LEB). It remains unknown, however, if these targets can be achieved in everyday vascular surgery practice. Methods: We applied SVS OPG criteria to 1039 patients undergoing 1039 LEB operations for CLI with autogenous vein (excluding patients on dialysis) within the Vascular Study Group of New England (VSGNE). Each of the individual OPGs was calculated within the VSGNE dataset, along with its surrounding 95% confidence intervals (CIs) and compared to published SVS OPGs using χ2 comparisons and survival analysis. Results: Across most risk strata, patients in the VSGNE and SVS OPG cohorts were similar (clinical high-risk [age >80 years and tissue loss]: 15.3% VSGNE; 16.2% SVS OPG; P = .58; anatomic high risk [infrapopliteal target artery]: 57.8% VSGNE; 60.2% SVS OPG; P = .32). However, the proportion of VSGNE patients designated as conduit high-risk (lack of single-segment great saphenous vein) was lower (10.2% VSGNE; 26.9% SVS OPG;P < .001). The primary safety endpoint, major adverse limb events (MALE) at 30 days, was lower in the VSGNE cohort (3.2%; 95% CI, 2.3-4.6) than the SVS OPG cohort (6.2%; 95% CI, 4.2-8.1; P = .05). The primary efficacy OPG endpoint, freedom from any MALE or postoperative death within the first year (MALE + postoperative death [POD]), was similar between VSGNE and SVS OPG cohorts (77%; 95% CI, 74%-80%) SVS OPG, 74% (95% CI, 71%-77%) VSGNE, P = .58). In the remaining safety and efficacy OPGs, the VSGNE cohort met or exceeded the benchmarks established by the SVS OPG cohort. Conclusion: Community and academic centers in everyday vascular surgery practice can meet OPGs derived from centers of excellence in LEB. Quality improvement initiatives, as well as clinical trials, should incorporate OPGs in their outcome measures to facilitate communication and comparison of risk-adjusted outcomes in the treatment of CLI. [Copyright &y& Elsevier]

A letter to the editor is presented in reponse to the four-study meta-analysis by Takagi and colleagues, which concludes that majority of sensitivity studies showed no statisticaly significant association between mortality and hospital number of lower extremity (LE) bypass graft procedures.

Objective: Hybrid reconstructions have been increasingly used for multilevel revascularization procedures as surgeons have embraced endovascular interventions. The goal of this study is to define the role of simple and complex hybrid techniques in patients who need multilevel revascularization. Methods: All patients undergoing arterial revascularization (endovascular [EV], open, hybrid) between June 2001 and May 2008 were included. Hybrid procedures were stratified as simple (sHYBRID group) when the endovascular-treated segment was TransAtlantic Society Consensus II (TASC) A/B, and complex (cHYBRID group), when TASC C/D. Results: Of the 654 patients, 770 limbs (67% critical limb ischemia), 226 (29%) had open, 436 (57%) had endovascular, and 108 (14%) had hybrid procedures (56 sHYBRID, 52 cHYBRID). The HYBRID group was more likely to have hypertension, chronic obstructive pulmonary disease, American Society of Anesthesia (ASA) 4, and aortoiliac reconstructions, with more ASA 4 in the cHYBRID than the sHYBRID group. Length of stay in the HYBRID group was significantly longer than the EV group, but less than open-treated groups. Endovascular intervention was performed for inflow in 85%, for runoff in 5%, and for both inflow and runoff in the remaining 10% of hybrid cases. Eleven (20%) sHYBRID cases were staged, while all cHYBRID cases were performed simultaneously. Femoral endarterectomy was more frequent in cHYBRID (75% vs 23% in sHYBRID), infrainguinal bypass (17% vs 55%) was more common in sHYBRID, the remainder being femoro-femoral bypasses (8% vs 21%). Endovascular procedures were primarily iliac interventions (91% in sHYBRID, 88% in cHYBRID). Thirty-day myocardial infarction/death rate was significantly higher in the HYBRID than the EV group, with no difference within the HYBRID group. The patency rates were similar in the sHYBRID and cHYBRID groups, and comparable to the endovascular and open treated patients with similar disease complexity. Limb salvage in patients who presented with critical limb ischemia was better in the cHYBRID group than other groups. Overall survival was similar in all groups. Conclusions: Complex and simple hybrid procedures enable multilevel revascularizations in high-risk patients with comparable patency and limb salvage. Femoral endarterectomy plays a central role, especially in complex hybrid repairs. An increase in perioperative morbidity and mortality was observed in the hybrid group, likely due to attempting revascularization in higher risk patients. [Copyright &y& Elsevier]

The Bypass versus Angioplasty in Severe Ischemia of the Leg (BASIL) trial is the only randomized controlled trial (RCT) to date comparing open surgical bypass with endovascular therapy for severe limb ischemia (SLI). In their initial 2005 publication, the BASIL investigators reported that the main clinical outcomes (overall survival and amputation-free survival) were no different at 2 years after randomization to angioplasty-first or bypass-first revascularization strategies. However, beyond 2 years there appeared to be a benefit for open bypass surgery, providing impetus for an extension study. The final analysis of the long-term outcomes from BASIL is now presented in a set of articles that are reviewed in this commentary. The benefit of initial randomization to open surgery for patients surviving ≥2 years (70% of the BASIL cohort) was confirmed. When outcomes were analyzed by treatment received, patients who had received prosthetic bypass grafts (25% of the surgical arm) fared much more poorly than those treated with a vein bypass. Patients who underwent surgical bypass after an initial failed angioplasty also fared significantly worse than those who were treated initially with bypass surgery. Health-related quality of life measures and costs were not significantly different overall. There are many controversies surrounding the BASIL trial and its interpretation, which are reviewed herein. These include the choice of study population, end points examined, and the nature of procedures performed. The BASIL trial confirms the primacy of open surgical bypass with vein for most patients with SLI and raises questions about the sequelae of failed endovascular interventions. Further multicenter trials are needed to address the large gap in evidence for treatment selection in this patient population. [Copyright &y& Elsevier]

Background: An intention-to-treat analysis of the Bypass versus Angioplasty in Severe Ischaemia of the Leg (BASIL) trial showed that in patients with severe lower limb ischemia (SLI) due to infrainguinal disease who survived for 2 years after intervention, initial randomization to a bypass surgery (BSX)-first vs balloon angioplasty (BAP)-first revascularization strategy was associated with improvements in subsequent overall survival (OS) and amputation-free survival (AFS) of about 7 and 6 months, respectively. This study explored the value of baseline factors to estimate the likelihood of survival to 2 years for the trial cohort (Cox model) and for individual BASIL trial patients (Weibull model) as an aid to clinical decision making. Methods: Of 452 patients presenting to 27 United Kingdom hospitals, 228 were randomly assigned to a BSX-first and 224 to a BAP-first revascularization strategy. Patients were monitored for at least 3 years. Baseline factors affecting the survival of the entire cohort were examined with a multivariate Cox model. The chances of survival at 1 and 2 years for patients with given baseline characteristics were estimated with a Weibull parametric model. Results: At the end of follow-up, 172 patients (38%) were alive without major limb amputation of the trial leg, and 202 (45%) were alive. Baseline factors that were significant in the Cox model were BASIL randomization stratification group, below knee Bollinger angiogram score, body mass index, age, diabetes, creatinine level, and smoking status. Using these factors to define five equally sized groups, we identified patients with 2-year survival rates of 50% to 90%. The factors that contributed to the Weibull predictive model were age, presence of tissue loss, serum creatinine, number of ankle pressure measurements detectable, maximum ankle pressure measured, a history of myocardial infarction or angina, a history of stroke or transient ischemia attack, below knee Bollinger angiogram score, body mass index, and smoking status. Conclusions: Patients in the BASIL trial were at high risk of amputation and death regardless of revascularization strategy. However, baseline factors can be used to stratify those risks. Furthermore, within a parametric Weibull model, certain of these factors can be used to help predict outcomes for individuals. It may thus be possible to define the clinical and anatomic (angiographic) characteristics of SLI patients who are likely—and not likely—to live for >2 years after intervention. Used appropriately in the context of the BASIL trial outcomes, this may aid clinical decision making regarding a BSX- or BAP-first revascularization strategy in SLI patients like those randomized in BASIL. [Copyright &y& Elsevier]

Background: The Bypass versus Angioplasty in Severe Ischaemia of the Leg (BASIL) trial showed that survival in patients with severe lower limb ischemia (rest pain, tissue loss) who survived postintervention for >2 years after initial randomization to bypass surgery (BSX) vs balloon angioplasty (BAP) was associated with an improvement in subsequent amputation-free and overall survival of about 6 and 7 months, respectively. We now compare the effect on hospital costs and health-related quality of life (HRQOL) of the BSX-first and BAP-first revascularization strategies using a within-trial cost-effectiveness analysis. Methods: We measured HRQOL using the Vascular Quality of Life Questionnaire (VascuQol), the Short Form 36 (SF-36), and the EuroQol (EQ-5D) health outcome measure up to 3 years from randomization. Hospital use was measured and valued using United Kingdom National Health Service hospital costs over 3 years. Analysis was by intention-to-treat. Incremental cost-effectiveness ratios were estimated for cost per quality-adjusted life-year (QALY) gained. Uncertainty was assessed using nonparametric bootstrapping of incremental costs and incremental effects. Results: No significant differences in HRQOL emerged when the two treatment strategies were compared. During the first year from randomization, the mean cost of inpatient hospital treatment in patients allocated to BSX ($34,378) was estimated to be about $8469 (95% confidence interval, $2,417-$14,522) greater than that of patients allocated to BAP ($25,909). Owing to increased costs subsequently incurred by the BAP patients, this difference decreased at the end of follow-up to $5521 ($45,322 for BSX vs $39,801 for BAP) and was no longer significant. The incremental cost-effectiveness ratio of a BSX-first strategy was $184,492 per QALY gained. The probability that BSX was more cost-effective than BAP was relatively low given the similar distributions in HRQOL, survival, and hospital costs. Conclusions: Adopting a BSX-first strategy for patients with severe limb ischemia does result in a modest increase in hospital costs, with a small positive but insignificant gain in disease-specific and generic HRQOL. However, the real-world choice between BSX-first and BAP-first revascularization strategies for severe limb ischemia due to infrainguinal disease cannot depend on costs alone and will require a more comprehensive consideration of individual patient preferences conditioned by expectations of survival and other health outcomes. [Copyright &y& Elsevier]

Background: The Bypass versus Angioplasty in Severe Ischaemia of the Leg (BASIL) trial showed in patients with severe lower limb ischemia (rest pain, tissue loss) who survive for 2 years after intervention that initial randomization to bypass surgery, compared with balloon angioplasty, was associated with an improvement in subsequent amputation-free survival and overall survival of about 6 and 7 months, respectively. The aim of this report is to describe the angiographic severity and extent of infrainguinal arterial disease in the BASIL trial cohort so that the trial outcomes can be appropriately generalized to other patient cohorts with similar anatomic (angiographic) patterns of disease. Methods: Preintervention angiograms were scored using the Bollinger method and the TransAtlantic Inter-Society Consensus (TASC) II classification system by three consultant interventional radiologists and two consultant vascular surgeons unaware of the treatment received or patient outcomes. Results: As was to be expected from the randomization process, patients in the two trial arms were well matched in terms of angiographic severity and extent of disease as documented by Bollinger and TASC II. In patients with the least overall disease, it tended to be concentrated in the superficial femoral and popliteal arteries, which were the commonest sites of disease overall. The below knee arteries became increasingly involved as the overall severity of disease increased, but the disease in the above knee arteries did not tend to worsen. The posterior tibial artery was the most diseased crural artery, whereas the peroneal appeared relatively spared. There was less interobserver disagreement with the Bollinger method than with the TASC II classification system, which also appears inherently less sensitive to clinically important differences in infrapopliteal disease among patients with severe leg ischemia. Conclusions: Anatomic (angiographic) disease description in patients with severe leg ischemia requires a reproducible scoring system that is sensitive to differences in crural artery disease. The Bollinger system appears well suited for this purpose, but the TASC II classification system less so. We hope this detailed analysis will facilitate appropriate generalization of the BASIL trial data to other groups of patients affected by similar anatomic (angiographic) patterns of disease. [Copyright &y& Elsevier]

Background: An intention-to-treat analysis of randomized Bypass versus Angioplasty in Severe Ischaemia of the Leg (BASIL) trial data showed that initial randomization to a bypass surgery (BSX)-first strategy was associated with improvements in subsequent overall survival (OS) and amputation-free survival (AFS) of about 7 and 6 months, respectively. We describe the nature and timing of first, crossover, and reinterventions and examine AFS and OS by first treatment received. We also compare vein with prosthetic BSX and transluminal with subintimal balloon angioplasty (BAP) and examine outcomes from BSX after failed BAP. Methods: We randomly assigned 452 patients with SLI due to infrainguinal disease in 27 United Kingdom hospitals to a BSX first (n = 228) or a BAP first (n = 224) revascularization strategy. All patients have been monitored for 3 years and more than half for >5 years. We prospectively collected data on every procedure, major amputation, and death. Results: Patients randomized to BAP were more likely to have their assigned treatment first (94% vs 85%, P = .01, χ2test). BAP had a higher immediate technical failure rate of 20% vs 2.6% (P = .01, χ2test). By 12 weeks after randomization 9 BAP (4%) vs 23 BSX (10%) patients had not undergone revascularization; 3 BAP (1.3%) vs 13 BSX (5.8%) had undergone the opposite treatment first; and 35 BAP (15.6%) and 2 (0.9%) BSX had received the assigned treatment and then undergone the opposite treatment. BSX distal anastomoses were divided approximately equally between the above and below knee popliteal and crural arteries; most originated from the common femoral artery. About 25% of the grafts were prosthetic and >90% of vein BSX used ipsilateral great saphenous vein. Most (80%) BAP patients underwent treatment of the SFA alone (38%) or combined with the popliteal artery (42%) and crural arteries (20%). Outcome of vein BSX was better for AFS (P = 0.003) but not OS (P = 0.38, log-rank tests) than prosthetic BSX. There were no differences in outcome between approximately equal numbers of transluminal and subintimal BAP. AFS (P = 0.006) but not OS (P = 0.06, log rank test) survival was significantly worse after BSX after failed BAP than after BSX as a first revascularization attempt. Conclusions: BAP was associated with a significantly higher early failure rate than BSX. Most BAP patients ultimately required surgery. BSX outcomes after failed BAP are significantly worse than for BSX performed as a first revascularization attempt. BSX with vein offers the best long term AFS and OS and, overall, BAP appears superior to prosthetic BSX. [Copyright &y& Elsevier]

Background: A 2005 interim analysis of the Bypass versus Angioplasty in Severe Ischaemia of the Leg (BASIL) trial showed that in patients with severe lower limb ischemia (SLI; rest pain, ulceration, gangrene) due to infrainguinal disease, bypass surgery (BSX)-first and balloon angioplasty (BAP)-first revascularization strategies led to similar short-term clinical outcomes, although BSX was about one-third more expensive and morbidity was higher. We have monitored patients for a further 2.5 years and now report a final intention-to-treat (ITT) analysis of amputation-free survival (AFS) and overall survival (OS). Methods: Of 452 enrolled patients in 27 United Kingdom hospitals, 228 were randomized to a BSX-first and 224 to a BAP-first revascularization strategy. All patients were monitored for 3 years and more than half for >5 years. Results: At the end of follow-up, 250 patients were dead (56%), 168 (38%) were alive without amputation, and 30 (7%) were alive with amputation. Four were lost to follow-up. AFS and OS did not differ between randomized treatments during the follow-up. For those patients surviving 2 years from randomization, however, BSX-first revascularization was associated with a reduced hazard ratio (HR) for subsequent AFS of 0.85 (95% confidence interval [CI], 0.5-1.07; P = .108) and for subsequent OS of 0.61 (95% CI, 0.50-0.75; P = .009) in an adjusted, time-dependent Cox proportional hazards model. For those patients who survived for 2 years after randomization, initial randomization to a BSX-first revascularization strategy was associated with an increase in subsequent restricted mean overall survival of 7.3 months (95% CI, 1.2-13.4 months, P = .02) and an increase in restricted mean AFS of 5.9 months (95% CI, 0.2-12.0 months, P = .06) during the subsequent mean follow-up of 3.1 years (range, 1-5.7 years). Conclusions: Overall, there was no significant difference in AFS or OS between the two strategies. However, for those patients who survived for at least 2 years after randomization, a BSX-first revascularization strategy was associated with a significant increase in subsequent OS and a trend towards improved AFS. [Copyright &y& Elsevier]

Background: Demographic and practice modality changes during the past decade have led to a substantial shift in the management of peripheral vascular disease. This study examined the effect of these changes using large national and regional data sets on procedure type, indications, morbidity, and on the primary target outcome: limb salvage. Methods: National Inpatient Sample (NIS) data sets and New York (NY) State inpatient hospitalizations and outpatient surgeries discharge databases from 1998 through 2007 were used to identify hospitalizations for lower extremity revascularization (LER) and major amputations. Patients were selected by cross-referencing diagnostic and procedural codes. Proportions were analyzed by χ2 analysis, continuous variables by t test, and trends by the Poisson regression. Results: The national per capita (100,000 population, age >40 years) volume of major amputations decreased by 38%. The volume for national and regional use of endovascular LER doubled. The volume of open LER decreased by 67% from 1998 through 2007. Ambulatory endovascular LER grew in NY State from 7 per capita in 1998 to 22 in 2007. Interventions declined by 20% (93 to 75) for critical limb ischemia (CLI) but increased by nearly 50% for claudication. Outpatient data analysis revealed a fivefold increase in vascular interventions for CLI and claudication. Nationally, endovascular LER interventions quadrupled (8% to 32%) for CLI and doubled (26% to 61%) for claudication. A parallel reduction occurred in major amputations for patients with CLI (42% to 30%), for other PAD diagnoses (18% to 14%), and for claudication (0.9% to 0.3%). Although surgical interventions for CLI declined significantly for octogenarians from 317 to 240, outpatient interventions increased for CLI, claudication, and other diagnoses in all age groups. Comorbidities for patients treated in 2006 were substantially greater than those of a decade ago. For most procedures, cardiac and bleeding complications have significantly decreased during the last decade. Length of stay (LOS) declined from 9.5 to 7.6 days and the percentage of short (1-2 day) hospitalizations increased from 16% to 35%. Conclusion: Although patients today, whether treated for claudication or CLI, have more comorbidities, the rates of amputation, the procedural morbidity and mortality, and LOS have all significantly decreased. Other variables, including changes in medical management and wound care, undoubtedly are important, but this change appears to be largely due to the widespread and successful use of endovascular LER or to earlier intervention, or both, driven by the safety of these techniques. [Copyright &y& Elsevier]

Objective: There are very few population-based studies of long-term outcomes after lower extremity (LE) bypass graft surgery. This study analyzes perioperative and long-term limb salvage and amputation-free survival outcomes for patients undergoing initial aortoiliac or femoropopliteal bypass graft surgery in California hospitals from 1996 to 1999. Methods: Administrative data with encrypted identifiers were used to identify a chronologically first, index admission of all patients undergoing LE bypass procedures for occlusive disease from 1996 to 1999. A 1993 to 1995 look-back period was used to exclude patients who had undergone prior bypass surgery or amputation procedures. Patients with incident procedures were then followed forward to determine subsequent hospitalizations and vital status through 2004. The study comprised 28,128 patients discharged from 345 California hospitals with a median 61.5-month follow-up. Risk factors included demographic characteristics, comorbid conditions, admission type, gangrene or ulceration, operation level, hospital LE bypass surgery volume, and year of discharge. Logistic regression was used to analyze 30-day outcomes, and Kaplan-Meier analysis and Cox proportional hazard models were used to analyze amputation-free survival. Results: Overall 30-day mortality was 4.3, and the 30-day major amputation rate was 2.6%. Limb salvage was 81.9% at 5 years and 76.4% at 9 years. Amputation-free survival was 51.5% at 5 years and 34.1% at 9 years. Risk factors were generally similar for both perioperative and late outcomes. Advanced age, higher comorbidity level, gangrene, and emergency or nursing home admission conferred significantly greater risk. Hospital volume was associated with both perioperative and late outcomes. African American and Hispanic patients had much higher amputation rates but did not have higher mortality risk after controlling for baseline severity of illness. Conclusions: Long-term outcomes of LE bypass surgery were superior for high-volume hospital patients. Graft surveillance and risk factor follow-up care provide a major opportunity for quality improvement efforts. The contrast between traditional limb salvage and amputation-free survival outcomes raises questions about the value of surgical treatment, particularly for patients with limited life expectancy and without coding of tissue loss or critical limb ischemia. [Copyright &y& Elsevier]

Introduction: Surgeons must weigh the morbidity of lower extremity bypass (LEB) with the likelihood of a functional outcome postoperatively. We developed a model to predict ambulation status 1 year after LEB. Methods: We analyzed a prospective registry of 1561 LEB procedures performed for occlusive disease (2003-2005) in 1400 patients (50 surgeons, 11 hospitals). Ambulation status was assessed preoperatively, at discharge, and at 1-year by life-table analysis. Cox proportional hazards models were used to determine predictors of ambulation status 1 year postoperatively. Results: The indication for surgery was claudication in 25% and critical limb ischemia (CLI) in 75%. Claudicant patients had higher primary (79% vs 73%, P < .001) and secondary (87% vs 81%, P < .001) graft patency rates and were more likely to be alive and ambulatory 1 year postoperatively (96% vs 81%, P < .001) than CLI patients. Amputation rates were 12% for CLI patients and 1% for claudicant patients (P < .001). All claudicant patients walked before surgery, and the 95% who survived 1 year postoperatively remained ambulatory. Preoperatively, 93% of CLI patients were ambulatory, and 88% of the survivors at 1 year remained ambulatory. The risk of dying or being nonambulatory 1 year postoperatively was increased in patients who were nonambulatory preoperatively (hazard ratio [HR], 1.5; 95% confidence interval [CI], 1.3-1.6; P < .0001), by increasing age of 70-79 (HR, 1.8; 95% CI, 1.2-2.6; P < .007) and 80-89 years (HR, 2.3; 95% CI, 1.5-3.7; P < .0001), by CLI (HR, 2.0; 95% CI, 1.2-3.4; P < .007), by postoperative myocardial infarction (HR, 2.5; 95% CI, 1.6-4.1; P < .001), and by major amputation (HR, 2.9; 95% CI, 2.1-4.1; P < .001). Graft thrombosis during follow-up (HR, 1.6; 95% CI, 1.1-1.8; P < .003) and living in a nursing home preoperatively (HR, 3.5; 95% CI, 1.5-7.8; P < .003) were independently associated with a higher risk of being nonambulatory at 1 year. Conclusions: Ambulatory and independent living status are well preserved after LEB. Risk factors of age, preoperative ambulatory ability, independent living status, CLI, graft patency, and amputation help to predict ambulatory status 1 year postoperatively. The likelihood of death or nonambulatory status at 1 year was <5% in patients with none of these risk factors to nearly 50% in patients with three or more risk factors. These variables can be used to inform decision making about whether patients should undergo LEB. [Copyright &y& Elsevier]

Objective: To examine the association between use of statin and nonstatin cholesterol-lowering medications and risk of nontraumatic major lower extremity amputations (LEAs) and treatment failure (LEA or death)., Methods: A retrospective cohort of patients with Type I and Type 2 diabetes mellitus (diabetes) was followed for 5 years between 2004 and 2008. The follow-up exposure duration was divided into 90-day periods. Use of cholesterol-lowering agents, diabetic medications, hemoglobin A1c, body mass index, and systolic and diastolic blood pressures were observed in each period. Demographic factors were observed at baseline. Major risk factors of LEA including peripheral neuropathy, peripheral artery disease, and foot ulcers were observed at baseline and were updated for each period. LEA and deaths were assessed in each period and their hazard ratios (HRs) were estimated. The study took place in the U.S. Department of Veterans Affairs Healthcare system, and the subjects consisted of cholesterol drug-naïve patients with Type I or II diabetes who were treated in the U.S. Department of Veterans Affairs Healthcare system in 2003 and were <65 years old at the end of follow-up., Results: Of 83,953 patients in the study cohort, 217 (0.3%) patients experienced a major LEA and 11,716 (14.0%) patients experienced an LEA or death (treatment failure) after a mean follow-up of 4.6 years. Compared with patients who did not use cholesterol-lowering agents, statin users were 35% to 43% less likely to experience an LEA (HR, 0.65; 95% confidence interval [CI], 0.42-0.99) and a treatment failure (HR, 0.57; 95% CI, 0.54-0.60). Users of other cholesterol-lowering medications were not significantly different in LEA risk (HR, 0.95; 95% CI, 0.35-2.60) but had a 41% lower risk of treatment failure (HR, 0.59; 95% CI, 0.51-0.68)., Conclusions: This is the first study to report a significant association between statin use and diminished amputation risk among patients with diabetes. In this nonrandomized cohort, beneficial effects of statin therapy were similar to that seen in large-scale clinical trial experience. For LEA risk, those given nonstatins did not have a statistically significant benefit and its effect on LEA risk was much smaller compared with statins. Unanswered questions to be explored in future studies include a comparison of statins of moderate vs high potency in those with high risk of coronary heart disease and an exploration of whether the effects seen in this study are simply effects of cholesterol-lowering or possibly pleiotropic effects., (Published by Mosby, Inc.)

Objective: Lower extremity amputation is often performed in patients where both lower extremities are at risk due to peripheral arterial disease or diabetes, yet the proportion of patients who progress to amputation of their contralateral limb is not well defined. We sought to determine the rate of subsequent amputation on both the ipsilateral and contralateral lower extremities following initial amputation., Methods: We conducted a retrospective review of all patients undergoing lower extremity amputation (exclusive of trauma or tumor) at our institution from 1998 to 2010. We used International Classification of Diseases-Ninth Revision codes to identify patients and procedures as well as comorbidities. Outcomes included the proportion of patients at 1 and 5 years undergoing contralateral and ipsilateral major and minor amputation stratified by initial major vs minor amputation. Cox proportional hazards regression analysis was performed to determine predictors of major contralateral amputation., Results: We identified 1715 patients. Mean age was 67.2 years, 63% were male, 77% were diabetic, and 34% underwent an initial major amputation. After major amputation, 5.7% and 11.5% have a contralateral major amputation at 1 and 5 years, respectively. After minor amputation, 3.2% and 8.4% have a contralateral major amputation at 1 and 5 years while 10.5% and 14.2% have an ipsilateral major amputation at 1 and 5 years, respectively. Cox proportional hazards regression analysis revealed end-stage renal disease (hazard ratio [HR], 3.9; 95% confidence interval [CI], 2.3-6.5), chronic renal insufficiency (HR, 2.2; 95% CI, 1.5-3.3), atherosclerosis without diabetic neuropathy (HR, 2.9; 95% CI, 1.5-5.7), atherosclerosis with diabetic neuropathy (HR, 9.1; 95% CI, 3.7-22.5), and initial major amputation (HR, 1.8; 95% CI, 1.3-2.6) were independently predictive of subsequent contralateral major amputation., Conclusions: Rates of contralateral limb amputation are high and predicted by renal disease, atherosclerosis, and atherosclerosis with diabetic neuropathy. Physicians and patients should be alert to the high risk of subsequent amputation in the contralateral leg. All patients, but particularly those at increased risk, should undergo close surveillance and counseling to help prevent subsequent amputations in their contralateral lower extremity., (Copyright © 2013 Society for Vascular Surgery. Published by Mosby, Inc. All rights reserved.)

Objective: Because patient-level differences do not fully explain the variation in lower extremity amputation rates across the United States, we hypothesized that variation in intensity of vascular care may also affect regional rates of amputation and examined the relationship between the intensity of vascular care and the population-based rate of major lower extremity amputation (above-knee or below-knee) from vascular disease., Methods: Intensity of vascular care was defined as the proportion of Medicare patients who underwent any vascular procedure in the year before amputation, calculated at the regional level (2003 to 2006), using the 306 hospital referral regions in the Dartmouth Atlas of Healthcare. The relationship between intensity of vascular care and major amputation rate, at the regional level, was examined between 2007 and 2009., Results: Amputation rates varied widely by region, from one to 27 per 10,000 Medicare patients. Compared with regions in the lowest quintile of amputation rate, patients in the highest quintile were commonly African American (50% vs 13%) and diabetic (38% vs 31%). Intensity of vascular care also varied across regions: <35% of patients underwent revascularization in the lowest quintile of intensity, whereas nearly 60% underwent revascularization in the highest quintile. Overall, an inverse correlation was found between intensity of vascular care and the amputation rate, ranging from R = -0.36 for outpatient diagnostic and therapeutic procedures to R = -0.87 for inpatient surgical revascularizations. Analyses adjusting for patient characteristics and socioeconomic status found patients in high-intensity vascular care regions were significantly less likely to undergo amputation without an antecedent attempt at revascularization (odds ratio, 0.37; 95% confidence interval, 0.34-0.37; P < .001)., Conclusions: The intensity of vascular care provided to patients at risk for amputation varies, and regions with the most intensive vascular care have the lowest amputation rate, although the observational nature of these associations do not impart causality. High-risk patients, especially African American diabetic patients residing in low-intensity vascular care regions, represent an important target for systematic efforts to reduce amputation risk., (Copyright © 2013 Society for Vascular Surgery. Published by Mosby, Inc. All rights reserved.)

Background: While endovascular (ENDO) therapy has increasingly become the initial intervention of choice to treat lower extremity peripheral arterial disease, reported outcomes for ENDO in patients with critical limb ischemia (CLI) and diabetes have been reported to be inferior compared to open bypass surgery (OPEN). Objective data assessing the hemodynamic success of ENDO compared to the established benchmark of OPEN are sparse. We therefore evaluated and compared early hemodynamic outcomes of ENDO and OPEN in patients with diabetes with CLI at a single academic center., Methods: We studied 85 consecutive patients with diabetes and CLI who underwent 109 interventions, either ENDO (n = 78) or OPEN (n = 31). The mean patient age was 69 years; 62% were men. All patients presented with either rest pain and/or ulcer/gangrene. Per protocol, all were assessed using ankle brachial index (ABI) and toe pressure (TP) determinations before and early postintervention., Results: Both ENDO (ΔABI = 0.36 ± 0.24, P < .0001; ΔTP = 35.6 ± 24.1, P < .0001) and OPEN (ΔABI = 0.39 ± 0.17, P < .0001; ΔTP = 34.3 ± 24.0, P < .0001) resulted in significant hemodynamic improvement. There was no statistically significant initial difference between the two types of intervention (ABI, P = .6; TP, P = .6)., Conclusions: These data suggest that with appropriate patient selection, each intervention is similarly efficacious in initially improving hemodynamics. If the intermediate or long-term results of ENDO for CLI in people with diabetes are inferior, the problem is not one of initial hemodynamic response, but more likely due to differing patient characteristics or durability of the intervention., (Copyright © 2012 Society for Vascular Surgery. Published by Mosby, Inc. All rights reserved.)

Purpose: To compare articulated and nonarticulated early walking aids (EWAs) for clinical and quality-of-life outcomes in transtibial amputees., Methods: Patients undergoing lower limb amputation in a tertiary-care vascular surgical unit were screened over a 4-year period. Recruited patients were randomized to receive articulated amputee mobility aid (AMA) or nonarticulated pneumatic postamputation mobility aid (PPAMA) during early rehabilitation. Primary (10-meter walking velocity) and secondary clinical (number and duration of physiotherapy treatments during EWA/prosthesis use) and quality-of-life (SF-36) outcome measures were recorded at five standardized assessment visits. Inter-group and intra-group analyses were performed., Results: Two hundred seventy-two patients were screened and 29 transtibial amputees (median age, 56 years) were recruited (14/treatment arm). No significant difference was seen in demographics and comorbidities at baseline. Inter-group analysis: Median 10-meter walking velocity was significantly (Mann-Whitney, P = .020) faster in the PPAMA group (0.245 m/s, interquartile range [IQR] 0.218-0.402 m/s) compared with the AMA group (0.165 m/s; IQR, 0.118-0.265 m/s) at visit 1. However, there was no difference between the groups at any other visit. Similarly, the number of treatments using EWA was significantly (P = .045) lower in the PPAMA group (5.0; IQR, 3.5-8.0) compared with the AMA group (6.0; IQR, 6.0-10.5). No difference was observed between the groups in duration of physiotherapy or SF-36 domain and summary scores. Intra-group analysis: Both treatment groups showed significant improvement in 10-meter walking velocity (Friedman test; AMA P = .001; PPAMA P = .007); however, other clinical outcomes did not show any statistically significant improvement. Only physical function domain of SF-36 demonstrated significant improvement (Friedman test; AMA P = .037; PPAMA P = .029)., Conclusions: There is no difference in clinical and QOL outcomes between articulated and nonarticulated EWAs in rehabilitation of transtibial amputees., (Copyright © 2010 Society for Vascular Surgery. Published by Mosby, Inc. All rights reserved.)

Objectives: Gender and ethnicity are factors affecting the incidence and severity of vascular disease as well as subsequent treatment outcomes. Although well studied in other fields, balanced enrollment of patients with relevant demographic characteristics in vascular surgery randomized controlled trials (RCTs) is not well known. This study describes the reporting of gender and ethnicity data in vascular surgery RCTs and analyzes whether these studies adequately represent our diverse patient population., Methods: We conducted a retrospective review of United States-based RCTs from 1983 through 2007 for three broadly defined vascular procedures: aortic aneurysm repair (AAR), carotid revascularization (CR), and lower extremity revascularization (LER). Included studies were examined for gender and ethnicity data, study parameters, funding source, and geographic region. The Nationwide Inpatient Sample (NIS) database was analyzed to obtain group-specific procedure frequency as an estimate of procedure frequency in the general population., Results: We reviewed 77 studies, and 52 met our inclusion criteria. Only 85% reported gender, and 21% reported ethnicity. Reporting of ethnicity was strongly associated with larger (>280 participants), multicenter, government-funded trials (P < .001 for all). Women are disproportionately under-represented in RCTs for all procedure categories (AAR, 9.0% vs 21.5%; CR, 30.0% vs 42.9%; LER, 22.4% vs 41.3%). Minorities are under-represented in AAR studies (6.0% vs 10.7%) and CR studies (6.9% vs 9.5%) but are over-represented in LER studies (26.0% vs 21.8%, P < .001 for all)., Conclusions: Minority ethnicity and female gender are under-reported and under-represented in vascular surgery RCTs, particularly in small, non-government-funded and single-center trials. The generalizability of some trial results may not be applicable to these populations. Greater effort to enroll a balanced study population in RCTs may yield more broadly applicable results.

Objective: Patients undergoing amputation of the lower limb due to peripheral arterial disease (PAD) are at risk of developing deep venous thrombosis (DVT). Few studies in the research literature report the incidence of DVT during the early postoperative period or the risk factors for the development of DVT in the amputation stump. This prospective study evaluated the incidence of DVT during the first 35 postoperative days in patients who had undergone amputation of the lower extremity due to PAD and its relation to comorbidities and death., Methods: Between September 2004 and March 2006, 56 patients (29 men), with a mean age of 67.25 years, underwent 62 amputations, comprising 36 below knee amputations (BKA) and 26 above knee amputations (AKA). Echo-Doppler scanning was performed preoperatively and on postoperative days 7 and 31 (approximately). All patients received acetylsalicylic acid (100 mg daily) preoperatively and postoperatively, but none received prophylactic anticoagulation., Results: DVT occurred in 25.8% of extremities with amputations (10 AKA and 6 BKA). The cumulative incidence in the 35-day postoperative period was 28% (Kaplan-Meier). There was a significant difference (P = .04) in the incidence of DVT between AKA (37.5%) and BKA (21.2%). Age >or=70 years (48.9% vs 16.8%, P = .021) was also a risk factor for DVT in the univariate analysis. Of the 16 cases, 14 (87.5%) were diagnosed during outpatient care. The time to discharge after amputation was averaged 6.11 days in-hospital stay (range, 1-56 days). One symptomatic nonfatal pulmonary embolism occurred in a patient already diagnosed with DVT. There was no relation between other comorbidities and DVT. The multivariate analysis showed no association between risk factors and the occurrence of DVT in the amputated extremity. DVT ipsilateral to the amputation did not influence the mortality rate (9.7%)., Conclusion: The incidence of DVT in the early postoperative period (or=70 years and for AKA. Patients with PAD who have recently undergone major amputations should be considered at high risk for DVT, even after hospital discharge. Given the high rate of postoperative DVT observed in this study, we now recommend prophylactic anticoagulation for these patients, but further study is needed to determine the optimal duration and efficacy of this treatment.

Background: Surgical approaches for forefoot osteomyelitis include amputation with immediate wound closure or resection followed by either staged re-resection and wound closure or local care of the open wound for secondary healing. This study evaluated the effectiveness of closed, staged, and open forefoot amputations in preventing major leg amputation and identified those variables that are associated with successful limb preservation., Methods: From July 2002 to June 2004, 208 patients with forefoot osteomyelitis or gangrene underwent minor amputation according to a standard treatment algorithm. Wounds with limited cellulitis underwent immediate wound closure (CLOSED), wounds with marginally viable soft tissue underwent open amputation followed by wound closure at 2 to 7 days (STAGED), and wounds with tenosynovitis or extensive necrosis underwent débridement with no attempt at wound closure (OPEN). Patient demographics, need for further operative interventions, time to complete healing, and progression to major amputation were recorded., Results: With four subjects lost to follow-up, 204 patients (98%) (94 CLOSED, 56 STAGED, and 54 OPEN) were monitored to complete healing, major amputation, or death. OPEN amputations had a significantly reduced initial healing rate (37%, P < .001) and a frequent need for repeat operative intervention (43%), although successful limb salvage was ultimately achieved in 70% of the cases. Initial healing in the CLOSED and STAGED amputation groups was similar (71% and 78%, respectively), leading to excellent early limb salvage (86% and 91%). The median time to healing for closed, staged, and open amputations was 1.2, 1.6, and 4.6 months, respectively (P < .001). Follow-up evaluation demonstrated the initial improvements in limb salvage with the CLOSED and STAGED groups were lost, resulting in similar amputation rates among the three groups of 30% to 35% over 36 months., Conclusions: Although open amputation of extensive forefoot infections frequently requires repeat operative interventions and a prolonged time to complete healing, this approach provides limb salvage rates approaching those observed for less invasive infections amenable to immediate closure. Staged closure offers an improved time to healing without negatively impacting the risk of major limb amputation. Independent of their initial operative approach, these patients frequently progress to early leg amputation.

Background: Wound complications after infrainguinal vein bypass remain a significant source of morbidity. Endoscopic saphenous vein harvest has emerged as a viable alternative to minimize vein harvest incisions., Methods: Infrainguinal bypass using endoscopic vein harvest was performed in 214 limbs in 197 consecutive patients between May 1998 and July 2004. The indication for bypass was limb salvage in 88.3%, claudication in 9.3%, and other in 2.4%. Atherosclerotic risk factors were prevalent, with diabetes mellitus in 68% and dialysis-dependent renal failure in 11.7%., Results: The procedure was successful in all but one patient. This patient was early in the series and had a friable varicose vein. Ipsilateral greater saphenous vein was used in 89.7%, contralateral greater saphenous vein in 8.4%, and lesser saphenous vein in 1.9%. Two injuries to the main trunk of the vein occurred early in the series. Assisted primary patency at a mean follow-up of 18 months (range, 1 to 48 months) is 77.2% by life-table analysis. For patients with claudication, rest pain, or minimal gangrene, the average length of stay was 3.15 days (range, 1 to 6 days). Wound complications occurred in 16 patients (7.5%), 10 of these required only local care (class I and II), and 6 had deep wounds threatening the leg or graft (class III). Only 5 patients, all with class III wounds, required readmission to the hospital for graft-related problems. There is no increase in operating room time once the learning curve is overcome. Patient satisfaction is very high., Conclusion: Endoscopic saphenous vein harvest is a useful adjunct to infrainguinal vein bypass, with short length-of-hospital stay, few wound complications, and low hospital readmission rates. Endoscopic vein harvest is recommended as the procedure of choice for vein procurement for infrainguinal bypass procedures.

Background: Despite being a major determinant of functional independence, ambulation after major limb amputation has not been well studied. The purpose, therefore, of this study was to investigate the relationship between a variety of preoperative clinical characteristics and postoperative functional outcomes in order to formulate treatment recommendations for patients requiring major lower limb amputation., Methods: From January 1998 through December 2003, 627 major limb amputations (37.6% below knee amputations, 4.3% through knee amputations, 34.5% above knee amputations, and 23.6% bilateral amputations) were performed on 553 patients. Their mean age was 63.7 years; 55% were men, 70.2% had diabetes mellitus, and 91.5% had peripheral vascular disease. A retrospective review was performed correlating various preoperative presenting factors such as age at presentation, race, medical comorbidities, preoperative ambulatory status, and preoperative independent living status, with postoperative functional endpoints of prosthetic usage, survival, maintenance of ambulation, and maintenance of independent living status. Kaplan-Meier survival curves were constructed and compared by using the log-rank test. Odds ratios (OR) and hazard ratios (HR) with 95% confidence intervals were constructed by using multiple logistic regressions and Cox proportional hazards models., Results: Statistically significant preoperative factors independently associated with not wearing a prosthesis in order of greatest to least risk were nonambulatory before amputation (OR, 9.5), above knee amputation (OR, 4.4), age > 60 years (OR, 2.7), homebound but ambulatory status (OR, 3.0), presence of dementia (OR, 2.4), end-stage renal disease (OR, 2.3), and coronary artery disease (OR, 2.0). Statistically significant preoperative factors independently associated with death in decreasing order of influence included age > or = 70 years (HR, 3.1), age 60 to 69 (HR, 2.5), and the presence of coronary artery disease (HR, 1.5). Statistically significant preoperative factors independently associated with failure of ambulation in decreasing order of influence included age > or = 70 years (HR, 2.3), age 60 to 69 (HR, 1.6), bilateral amputation (HR, 1.8), and end-stage renal disease (HR, 1.4). Statistically significant preoperative factors independently associated with failure to maintain independent living status in decreasing order of influence included age > or = 70 years (HR, 4.0), age 60 to 69 (HR, 2.7), level of amputation (HR, 1.8), homebound ambulatory status (HR, 1.6), and the presence of dementia (HR, 1.6)., Conclusions: Patients with limited preoperative ambulatory ability, age > or = 70, dementia, end-stage renal disease, and advanced coronary artery disease perform poorly and should probably be grouped with bedridden patients, who traditionally have been best served with a palliative above knee amputation. Conversely, younger healthy patients with below knee amputations achieved functional outcomes similar to what might be expected after successful lower extremity revascularization. Amputation in these instances should probably not be considered a failure of therapy but another treatment option capable of extending functionality and independent living.

Objective: African Americans have a much higher risk of major (above- or below-knee) lower extremity amputation and a lower rate of limb-preserving vascular surgery or angioplasty than white patients. This article analyzes two potential pathways for racial disparities: primary amputation, defined as a major amputation performed without any prior attempt at revascularization, and repeat amputation, defined as a major amputation subsequent to a previous through-foot or major amputation., Methods: Randomly selected medical records were reviewed for 248 African American, 30 Hispanic, and 235 white or other-race patients undergoing above- or below-knee amputation between 1995 and 2003 at three Chicago teaching hospitals. Chronic disease prevalence and severity, preadmission functional status, clinical presentation, and vascular history were used to test the risk-adjusted effect of race and ethnicity on rates of primary and repeat amputation., Results: Controlling for demographic, functional, chronic disease, and clinical characteristics, African American patients were 1.7 times more likely to have undergone both primary (P = .01) and repeat (P = .03) amputation than white or other-race amputees. Race remained a significant independent risk factor even after controlling for the higher severity of illness, greater disability, and more complex presentation of African American amputees., Conclusions: Higher rates of primary and repeat amputation for African American patients at study hospitals, which all have significant vascular surgery capacity and an aggressive policy of limb salvage, suggest that these rates may be even higher at less well equipped institutions. Improving access to primary and preventive care for lower-income patients could reduce amputation rates among African Americans.

The standard conduit in infrainguinal arterial bypass grafting, the great saphenous vein, is often unavailable. Arm and small saphenous veins are used as alternative conduits; yet both are deficient in length to accommodate femorocrural bypasses as a single conduit. In light of its high prevalence, the Giacomini vein harvested in continuity with the small saphenous vein may offer the latter extra length, promoting their combination into a single conduit able to meet the needs of infrainguinal reconstruction, particularly in lengthy infrainguinal bypass grafting. The Giacomini vein merits consideration when arterial reconstruction is performed in proximity to its anatomic course.

Endovascular aneurysm repair continues to become increasingly popular. As the number of implanted endografts increases, complications will increase as well. We report a new approach to endovascular treatment in two patients with acute iliac limb occlusions of a bifurcated aortic endograft with an endoskeleton. Neither patient required femoral-femoral bypass grafting because of unilateral limb ischemia. We believe this is the optimal primary approach in patients with a bifurcated stent graft with an endoskeleton.

Myositis, while uncommon, develops more frequently in patients with human immunodeficiency virus infection. We report a case of acute lower leg ischemia caused by myositis in such a patient. Urgent four-compartment fasciotomy of the lower leg was performed, which decompressed the compartmental hypertension and reversed the arterial ischemia. This case underscores the importance of recognizing compartment syndrome as a cause of acute limb ischemia.