Peripheral arterial disease (PAD) continues to grow in global prevalence and consumes an increasing amount of resources in the United States health care system. Overall rates of intervention for PAD ...have been rising steadily in recent years. Changing demographics, evolution of technologies, and an expanding database of outcomes studies are primary forces influencing clinical decision making in PAD. The management of PAD is multidisciplinary, involving primary care physicians and vascular specialists with varying expertise in diagnostic and treatment modalities. PAD represents a broad spectrum of disease from asymptomatic through severe limb ischemia. The Society for Vascular Surgery Lower Extremity Practice Guidelines committee reviewed the evidence supporting clinical care in the treatment of asymptomatic PAD and intermittent claudication (IC). The committee made specific practice recommendations using the GRADE (Grades of Recommendation Assessment, Development and Evaluation) system. There are limited Level I data available for many of the critical questions in the field, demonstrating the urgent need for comparative effectiveness research in PAD. Emphasis is placed on risk factor modification, medical therapies, and broader use of exercise programs to improve cardiovascular health and functional performance. Screening for PAD appears of unproven benefit at present. Revascularization for IC is an appropriate therapy for selected patients with disabling symptoms, after a careful risk-benefit analysis. Treatment should be individualized based on comorbid conditions, degree of functional impairment, and anatomic factors. Invasive treatments for IC should provide predictable functional improvements with reasonable durability. A minimum threshold of a >50% likelihood of sustained efficacy for at least 2 years is suggested as a benchmark. Anatomic patency (freedom from restenosis) is considered a prerequisite for sustained efficacy of revascularization in IC. Endovascular approaches are favored for most candidates with aortoiliac disease and for selected patients with femoropopliteal disease in whom anatomic durability is expected to meet this minimum threshold. Conversely, caution is warranted in the use of interventions for IC in anatomic settings where durability is limited (extensive calcification, small-caliber arteries, diffuse infrainguinal disease, poor runoff). Surgical bypass may be a preferred strategy in good-risk patients with these disease patterns or in those with prior endovascular failures. Common femoral artery disease should be treated surgically, and saphenous vein is the preferred conduit for infrainguinal bypass grafting. Patients who undergo invasive treatments for IC should be monitored regularly in a surveillance program to record subjective improvements, assess risk factors, optimize compliance with cardioprotective medications, and monitor hemodynamic and patency status.
Objective To develop a set of suggested objective performance goals (OPG) for evaluating new catheter-based treatments in critical limb ischemia (CLI), based on evidence from historical controls. ...Methods Randomized, controlled trials of surgical, endovascular, and pharmacologic/biologic treatments for CLI were reviewed according to specified criteria regarding study population and data quality. Line-item data were obtained for selected studies from the sponsor/funding agency. A set of specific outcome measures was defined in accordance with the treatment goals for the CLI population. Risk factors were examined for their influence on key endpoints, and models of stratification based on specific clinical and anatomic variables developed. Sample size estimates were made for single-arm trial designs based on comparison to the suggested OPG. Results Bypass with autogenous vein was considered the established standard, and data compiled from three individual randomized, controlled trials (N = 838) was analyzed. The primary efficacy endpoint was defined as perioperative (30-day) death or any major adverse limb event (amputation or major reintervention) occurring within one year. Results of open surgery controls demonstrated freedom from the primary endpoint in 76.9% (95% confidence interval CI 74.0%-79.9%) of patients at one year, with amputation-free survival (AFS) of 76.5% (95% CI 73.7%-79.5). An additional 3% non-inferiority margin was suggested in generating OPG for catheter-based therapies. Defined clinical (age > 80 years and tissue loss) and anatomic (infra-popliteal anatomy or lack of good quality saphenous vein) risk subgroups provided significantly different point estimates and OPG threshold values. Conclusions For new catheter-based therapies in CLI, OPGs offer a feasible approach for pre-market evaluation using non-randomized trial designs. Such studies should incorporate risk stratification in design and reporting as the CLI population is heterogeneous with respect to baseline variables and expected outcomes. Guidelines for CLI trial design to address consistency in study cohorts, methods of assessment, and endpoint definitions are provided.
Major lower extremity amputations (MLEAs) remain a significant source of disability. It is unknown whether postamputation functional outcomes and outcome predictability have changed with a population ...of increasingly aging and obese patients. Accordingly, we sought to evaluate contemporary trends.
A retrospective chart review was performed to identify patients undergoing MLEA using Current Procedural Terminology codes in a university hospital. Demographics, comorbidities, perioperative variables, and outcomes were obtained. Descriptive statistics, t-tests, and χ2 and multivariate logistic regression modeling were used where appropriate. Survival analyses were performed with the Kaplan-Meier method.
From October 2005 to November 2016, 206 patients (147 male; mean age, 63 ± 13.5 years) underwent 256 MLEAs (90.9% below-knee amputations, 1.3% through-knee amputations, and 7.8% above-knee amputations AKAs) related to acute and critical limb ischemia, infection, or other causes. Mean follow-up was 178.7 ± 266.9 days. Conversion from below-knee amputation to AKA was 3.5%. Estimated 1-year survival was 83%, and it was 15% lower in nonambulatory patients (75% vs 90%; P = .04). Overall 1-year postamputation ambulatory rate was 46.1%. Nonambulatory patients had a higher body mass index (30.9 ± 8.0 vs 25.6 ± 5.4; P < .001), lower preoperative hematocrit (31.0% ± 7.4% vs 33.3% ± 8.1%; P < .05), higher modified frailty index (mFI; 8.4 ± 1.0 vs 5.4 ± 1.2; P < .0001), higher chronic alcohol use (9% vs 1%; P = .01), dependent preoperative functional status (29% vs 2.1%; P < .01), and lack of family support (66.3% vs 17.9%; P < .01); they were less likely to be married (83.2% vs 35.8%; P < .01) and more likely to have an AKA (20% vs 52.6%; P = .004). There were no patients with dementia, on dialysis, or with bilateral MLEAs who were ambulatory after amputation. Factors predictive of nonambulatory status after MLEA with multivariate logistic regression analysis included increased body mass index (odds ratio OR, 0.88; 95% confidence interval CI, 0.81-0.98; P = .017) and an increased mFI (OR, 0.23; 95% CI, 0.16-0.34; P < .0001); a higher hemoglobin level was protective (OR, 1.3; 95% CI, 1.03-1.62; P = .019).
Patients should be counseled that <50% of patients receiving MLEAs are ambulatory after amputation. Educating patients about the deleterious effects of obesity on ambulatory status after MLEA may motivate patients to improve their level of fitness to achieve successful ambulation. Patients with an elevated mFI, patients with dementia, and those on dialysis should be considered for AKAs.
The CEAP classification for chronic venous disorders (CVD) was developed in 1994 by an international ad hoc committee of the American Venous Forum, endorsed by the Society for Vascular Surgery, and ...incorporated into “Reporting Standards in Venous Disease” in 1995. Today most published clinical papers on CVD use all or portions of CEAP.
Rather than have it stand as a static classification system, an ad hoc committee of the American Venous Forum, working with an international liaison committee, has recommended a number of practical changes, detailed in this consensus report. These include refinement of several definitions used in describing CVD; refinement of the C classes of CEAP; addition of the descriptor n (no venous abnormality identified); elaboration of the date of classification and level of investigation; and as a simpler alternative to the full (advanced) CEAP classification, introduction of a basic CEAP version. It is important to stress that CEAP is a descriptive classification, whereas venous severity scoring and quality of life scores are instruments for longitudinal research to assess outcomes.
Objective Both runoff scores and direct (DR) vs indirect revascularization (IR) according to pedal angiosomes have unclear impact on outcome for patients with critical limb ischemia (CLI). We ...compared DR vs IR and runoff scores in CLI patients undergoing infrapopliteal bypass for foot wounds. Methods Patients who had tibial/pedal bypass for a foot/ankle wound from 2005-2011 were identified and operations classified as DR or IR based on wound location and bypass target. A blinded observer reviewed angiograms for an intact pedal arch and calculated standard Society for Vascular Surgery (single tibial) and modified (composite tibial) runoff scores. Comorbidities, wound characteristics, wound healing, major amputation, and overall survival were determined. Results A total of 106 limbs were revascularized in 97 patients; 54 limbs had DR and 52 had IR, although only 36% of wounds corresponded to a single, distinct angiosome. Wound characteristics and comorbidities were similar between groups. Mean standard (7.9 vs 7.2; P = .001) and modified (22.2 vs 20.0; P = .02) runoff scores were worse (higher number indicates worse runoff) in the IR vs DR groups; 33% had a complete pedal arch. Complete wound healing (78% vs 46%; P = .001) and time to complete healing (99 vs 195 days; P = .002) were superior with DR vs IR but were not influenced by runoff score, modified runoff score or presence of complete plantar arch. In multivariate models controlling for runoff score, DR remained a significant predictor for wound healing (odds ratio, 2.9; 95% confidence interval, 1.1-7.4; P = .028) and reduced healing time (hazard ratio, 2.1; 95% confidence interval, 1.2-3.7; P = .012). Mean amputation-free survival (75 vs 71 months for DR vs IR; P = .82) and median survival (36 vs 33 months DR vs IR; P = .22) were not different for DR vs IR. Conclusions DR according to pedal angiosomes provides more efficient wound healing, but is possible in only one-half of the patients and does not affect amputation-free or overall survival. DR is associated with improved runoff scores, but current runoff scores have little clinical utility in predicting outcomes in CLI patients.
Objectives Peripherally inserted central catheters (PICCs) may be complicated by upper extremity (UE) superficial (SVT) or deep venous thrombosis (DVT). The purpose of this study was to determine ...current PICC insertion patterns and if any PICC or patient characteristics were associated with venous thrombotic complications. Methods All UE venous duplex scans during a 12-month period were reviewed, selecting patients with isolated SVT or DVT and PICCs placed ≤30 days. All UE PICC procedures during the same period were identified from an electronic medical record query. PICC-associated DVTs, categorized by insertion site, were compared with all first-time UE PICCs to determine the rate of UE DVT and isolated UE SVT. Technical and clinical variables in patients with PICC-associated UE DVT also were compared with 172 patients who received a PICC without developing DVT (univariable and multivariable analysis). Results We identified 219 isolated UE SVTs and 154 UE DVTs, with 2056 first-time UE PICCs placed during the same period. A PICC was associated with 44 of 219 (20%) isolated UE SVTs and 54 of 154 UE DVTs (35%). The rates of PICC-associated symptomatic UE SVT were 1.9% for basilic, 7.2% for cephalic, and 0% for brachial vein PICCs. The rates of PICC-associated symptomatic UE DVT were 3.1% for basilic, 2.2% for brachial, and 0% for cephalic vein PICCs (χ 2 P < .001). Univariate analysis of technical and patient variables demonstrated that larger PICC diameter, noncephalic insertion, smoking, concurrent malignancy, diabetes, and older age were associated with UE DVT ( P < .05). Multivariable analysis showed larger catheter diameter and malignancy were the only variables associated with UE DVT ( P < .05). Conclusions The incidence of symptomatic PICC-associated UE DVT is low, but given the number of PICCs placed each year, they account for up to 35% of all diagnosed UE DVTs. Larger-diameter PICCs and malignancy increase the risk for DVT, and further studies are needed to evaluate the optimal vein of first choice for PICC insertion.
The PREVENT III study was a prospective, randomized, double-blinded, multicenter phase III trial of a novel molecular therapy (edifoligide; E2F decoy) for the prevention of vein graft failure in ...patients undergoing infrainguinal revascularization for critical limb ischemia (CLI).
From November 2001 through October 2003, 1404 patients with CLI were randomized to a single intraoperative ex vivo vein graft treatment with edifoligide or placebo. After surgery, patients underwent graft surveillance by duplex ultrasonography and were followed up for index graft and limb end points to 1 year. A blinded Clinical Events Classification committee reviewed all index graft end points. The primary study end point was the time to nontechnical index graft reintervention or major amputation due to index graft failure. Secondary end points included all-cause graft failure, clinically significant graft stenosis (>70% by angiography or severe stenosis by ultrasonography), amputation/reintervention-free survival, and nontechnical primary graft patency. Event rates were based on Kaplan-Meier estimates. Time-to-event end points were compared by using the log-rank test.
Demographics, comorbidities, and procedural details reflected a population with CLI and diffuse atherosclerosis. Tissue loss was the presenting symptom in 75% of patients. High-risk conduits were used in 24% of cases, including an alternative vein in 20% (15% spliced vein and 5% non–great saphenous vein) and 6% less than 3 mm in diameter; 14% of the cases were reoperative bypass grafts. Most (65%) grafts were placed to infrapopliteal targets. Perioperative (30-day) mortality occurred in 2.7% of patients. Major morbidity included myocardial infarction in 4.7% and early graft occlusion in 5.2% of patients. Ex vivo treatment with edifoligide was well tolerated. There was no significant difference between the treatment groups in the primary or secondary trial end points, primary graft patency, or limb salvage. A statistically significant improvement was observed in secondary graft patency (estimated Kaplan-Meier rates were 83% edifoligide and 78% placebo; P = .016) within 1 year. The reduction in secondary patency events was manifest within 30 days of surgery (the relative risk for a 30-day event for edifoligide was 0.45; 95% confidence interval, 0.27-0.76; P = .005). For the overall cohort at 1 year, the estimated Kaplan-Meier rate for survival was 84%, that for primary patency was 61%, that for primary assisted patency was 77%, that for secondary patency was 80%, and that for limb salvage was 88%.
In this prospective, randomized, placebo-controlled clinical trial, ex vivo treatment of lower extremity vein grafts with edifoligide did not confer protection from reintervention for graft failure.
The Society of Radiologists in Ultrasound convened a multidisciplinary panel of experts in the field of vascular ultrasonography (US) to come to a consensus regarding Doppler US for assistance in the ...diagnosis of carotid artery stenosis. The panel's consensus statement is believed to represent a reasonable position on the basis of analysis of available literature and panelists' experience. Key elements of the statement include the following: (a) All internal carotid artery (ICA) examinations should be performed with gray-scale, color Doppler, and spectral Doppler US. (b) The degree of stenosis determined at gray-scale and Doppler US should be stratified into the categories of normal (no stenosis), <50% stenosis, 50%-69% stenosis, > or =70% stenosis to near occlusion, near occlusion, and total occlusion. (c) ICA peak systolic velocity (PSV) and presence of plaque on gray-scale and/or color Doppler images are primarily used in diagnosis and grading of ICA stenosis; two additional parameters, ICA-to-common carotid artery PSV ratio and ICA end-diastolic velocity may also be used when clinical or technical factors raise concern that ICA PSV may not be representative of the extent of disease. (d) ICA should be diagnosed as (i) normal when ICA PSV is less than 125 cm/sec and no plaque or intimal thickening is visible; (ii) <50% stenosis when ICA PSV is less than 125 cm/sec and plaque or intimal thickening is visible; (iii) 50%-69% stenosis when ICA PSV is 125-230 cm/sec and plaque is visible; (iv) > or =70% stenosis to near occlusion when ICA PSV is greater than 230 cm/sec and visible plaque and lumen narrowing are seen; (v) near occlusion when there is a markedly narrowed lumen at color Doppler US; and (vi) total occlusion when there is no detectable patent lumen at gray-scale US and no flow at spectral, power, and color Doppler US. (e) The final report should discuss velocity measurements and gray-scale and color Doppler findings. Study limitations should be noted when they exist. The conclusion should state an estimated degree of ICA stenosis as reflected in the above categories. The panel also considered various technical aspects of carotid US and methods for quality assessment and identified several important unanswered questions meriting future research.
Objective The influence of operator-dependent variables on the outcomes of lower extremity bypass (LEB) surgery have primarily been reported in single-institution, retrospective studies. We utilized ...data from a prospective, multicenter trial to identify technical variables that were significantly associated with early and midterm results of autogenous LEB for limb salvage. Methods The PREVENT III trial database includes 1404 North American patients with critical limb ischemia (CLI) who underwent LEB using excised autogenous vein. The study protocol excluded claudicants and in situ reconstructions. Technical factors analyzed included vein diameter, conduit type, graft length, vein orientation, location of proximal and distal anastomoses, and performance of completion imaging. Univariate analysis was used to determine the effect of these factors on 30 day and 1-year outcomes. Multivariate Cox regression models evaluated the influence of these factors while adjusting for age, sex, race, tobacco, diabetes, dialysis-dependency, previous index limb bypass, and study drug (edifoligide) administration. The primary outcomes were primary patency (PP), primary assisted patency (PAP), and secondary patency (SP) assessed by Kaplan-Meier method. Results Univariate analysis revealed that vein diameter <3.5 mm and composite graft type were significantly associated with early (30 day) graft failure. At 1 year, multivariate analysis revealed that patency rates were negatively associated with diameter <3.5 mm (PP, PAP, SP), non-great saphenous vein (GSV) type (PP, SP), and graft lengths >50 cm (PP only). Limb salvage and survival at 1 year were not significantly impacted by technical variables. Employing a prespecified trial definition of high-risk conduits (diameter <3mm or nonsingle segment GSV; 24% of entire cohort) revealed that use of such conduits was associated with a 2.1-fold increased risk of 30 day graft failure ( P < .05), as well as reduced PP, PAP, and SP at 1 year. Use of a high-risk conduit was also associated with an increased index length of stay (mean 9.37 vs 8.71 days, P = .03) and a greater number of reinterventions (mean 0.67 vs 0.42, P < .0001) over the ensuing year. Conclusions In this large, multicenter cohort of patients undergoing LEB for CLI, vein diameter and conduit type were the dominant technical determinants of early and late graft failure. High-risk conduits and longer grafts may benefit from aggressive postoperative graft surveillance.
Abstract Objective The neutrophil-to-lymphocyte ratio (NLR) has been used as a surrogate marker of systemic inflammation. We sought to investigate the association between NLR and wound healing in ...diabetic wounds. Methods The outcomes of 120 diabetic foot ulcers in 101 patients referred from August 2011 to December 2014 were examined retrospectively. Demographic, patient-specific, and wound-specific variables as well as NLR at baseline visit were assessed. Outcomes were classified as ulcer healing, minor amputation, major amputation, and chronic ulcer. Results The subjects' mean age was 59.4 ± 13.0 years, and 67 (66%) were male. Final outcome was complete healing in 24 ulcers (20%), minor amputation in 58 (48%) and major amputation in 16 (13%), and 22 chronic ulcers (18%) at the last follow-up (median follow-up time, 6.8 months). In multivariate analysis, higher NLR (odds ratio, 13.61; P = .01) was associated with higher odds of nonhealing. Conclusions NLR can predict odds of complete healing in diabetic foot ulcers independent of wound infection and other factors.
PDF
