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.
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.
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.
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.
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.
Physiologic assessment of lower limb peripheral artery occlusive disease is based on indirect physiologic measurement of ankle-brachial systolic pressure index (ABI) and recording ultrasound tibial ...artery waveforms. Duplex ultrasound testing affords direct tibial artery imaging and assessment of pulsed-Doppler tibial artery waveforms, which is more accurate then measurement of ABI for peripheral artery occlusive disease severity assessment. Tibial artery peak systolic velocity (PSV) is of particular value in the evaluation of patients with incompressible tibial arteries producing a falsely elevated ABI. Calculation of the ankle-profunda index (average tibial artery PSV/proximal profunda femoris artery PSV) also correlates with ABI reduction and can be used as an additional measure of peripheral artery occlusive disease. Tibial artery PSVs can be used to supplement ABI as an objective outcome measure after peripheral arterial interventions, and this aspect of duplex scanning warrants further clinical research.
PDF
