Andres Schanzer

Predictors of Abdominal Aortic Aneurysm Sac Enlargement After Endovascular Repair

Background— The majority of infrarenal abdominal aortic aneurysm (AAA) repairs in the United States are performed with endovascular methods. Baseline aortoiliac arterial anatomic characteristics are fundamental criteria for appropriate patient selection for endovascular aortic repair (EVAR) and key determinants of long-term success. We evaluated compliance with anatomic guidelines for EVAR and the relationship between baseline aortoiliac arterial anatomy and post-EVAR AAA sac enlargement. Methods and Results— Patients with pre-EVAR and at least 1 post-EVAR computed tomography scan were identified from the M2S, Inc. imaging database (1999 to 2008). Preoperative baseline aortoiliac anatomic characteristics were reviewed for each patient. Data relating to the specific AAA endovascular device implanted were not available. Therefore, morphological measurements were compared with the most liberal and the most conservative published anatomic guidelines as stated in each manufacturers instructions for use. The primary study outcome was post-EVAR AAA sac enlargement (>5-mm diameter increase). In 10 228 patients undergoing EVAR, 59% had a maximum AAA diameter below the 55-mm threshold at which intervention is recommended over surveillance. Only 42% of patients had anatomy that met the most conservative definition of device instructions for use; 69% met the most liberal definition of device instructions for use. The 5-year post-EVAR rate of AAA sac enlargement was 41%. Independent predictors of AAA sac enlargement included endoleak, age ≥80 years, aortic neck diameter ≥28 mm, aortic neck angle >60°, and common iliac artery diameter >20 mm. Conclusion— In this multicenter observational study, compliance with EVAR device guidelines was low and post-EVAR aneurysm sac enlargement was high, raising concern for long-term risk of aneurysm rupture.

The Society for Vascular Surgery Lower Extremity Threatened Limb Classification System: Risk stratification based on Wound, Ischemia, and foot Infection (WIfI)

Critical limb ischemia, first defined in 1982, was intended to delineate a subgroup of patients with a threatened lower extremity primarily because of chronic ischemia. It was the intent of the original authors that patients with diabetes be excluded or analyzed separately. The Fontaine and Rutherford Systems have been used to classify risk of amputation and likelihood of benefit from revascularization by subcategorizing patients into two groups: ischemic rest pain and tissue loss. Due to demographic shifts over the last 40 years, especially a dramatic rise in the incidence of diabetes mellitus and rapidly expanding techniques of revascularization, it has become increasingly difficult to perform meaningful outcomes analysis for patients with threatened limbs using these existing classification systems. Particularly in patients with diabetes, limb threat is part of a broad disease spectrum. Perfusion is only one determinant of outcome; wound extent and the presence and severity of infection also greatly impact the threat to a limb. Therefore, the Society for Vascular Surgery Lower Extremity Guidelines Committee undertook the task of creating a new classification of the threatened lower extremity that reflects these important considerations. We term this new framework, the Society for Vascular Surgery Lower Extremity Threatened Limb Classification System. Risk stratification is based on three major factors that impact amputation risk and clinical management: Wound, Ischemia, and foot Infection (WIfI). The implementation of this classification system is intended to permit more meaningful analysis of outcomes for various forms of therapy in this challenging, but heterogeneous population.

2016 AHA/ACC Guideline on the Management of Patients With Lower Extremity Peripheral Artery Disease: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines

Jonathan L. Halperin, MD, FACC, FAHA, Chair Glenn N. Levine, MD, FACC, FAHA, Chair-Elect Sana M. Al-Khatib, MD, MHS, FACC, FAHA Kim K. Birtcher, PharmD, MS, AACC Biykem Bozkurt, MD, PhD, FACC, FAHA Ralph G. Brindis, MD, MPH, MACC Joaquin E. Cigarroa, MD, FACC Lesley H. Curtis, PhD, FAHA

Society for Vascular Surgery practice guidelines for atherosclerotic occlusive disease of the lower extremities: Management of asymptomatic disease and claudication

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.

The Vascular Study Group of New England Cardiac Risk Index (VSG-CRI) predicts cardiac complications more accurately than the Revised Cardiac Risk Index in vascular surgery patients

OBJECTIVE The Revised Cardiac Risk Index (RCRI) is a widely used model for predicting cardiac events after noncardiac surgery. We compared the accuracy of the RCRI with a new, vascular surgery-specific model developed from patients within the Vascular Study Group of New England (VSGNE). METHODS We studied 10,081 patients who underwent nonemergent carotid endarterectomy (CEA; n = 5293), lower extremity bypass (LEB; n = 2673), endovascular abdominal aortic aneurysm repair (EVAR; n = 1005), and open infrarenal abdominal aortic aneurysm repair (OAAA; n = 1,110) within the VSGNE from 2003 to 2008. First, we analyzed the ability of the RCRI to predict in-hospital major adverse cardiac events, including myocardial infarction (MI), arrhythmia, or congestive heart failure (CHF) in the VSGNE cohort. Second, we used a derivation cohort of 8208 to develop a new cardiac risk prediction model specifically for vascular surgery patients. Chi-square analysis identified univariate predictors, and multivariate logistic regression was used to develop an aggregate and four procedure-specific risk prediction models for cardiac complications. Calibration and model discrimination were assessed using Pearson correlation coefficient and receiver operating characteristic (ROC) curves. The ability of the model to predict cardiac complications was assessed within a validation cohort of 1873. Significant predictors were converted to an integer score to create a practical cardiac risk prediction formula. RESULTS The overall incidence of major cardiac events in the VSGNE cohort was 6.3% (2.5% MI, 3.9% arrhythmia, 1.8% CHF). The RCRI predicted risk after CEA reasonably well but substantially underestimated risk after LEB, EVAR, and OAAA for low- and higher-risk patients. Across all VSGNE patients, the RCRI underestimated cardiac complications by 1.7- to 7.4-fold based on actual event rates of 2.6%, 6.7%, 11.6%, and 18.4% for patients with 0, 1, 2, and >or=3 risk factors. In multivariate analysis of the VSGNE cohort, independent predictors of adverse cardiac events were (odds ratio [OR]) increasing age (1.7-2.8), smoking (1.3), insulin-dependent diabetes (1.4), coronary artery disease (1.4), CHF (1.9), abnormal cardiac stress test (1.2), long-term beta-blocker therapy (1.4), chronic obstructive pulmonary disease (1.6), and creatinine >or=1.8 mg/dL (1.7). Prior cardiac revascularization was protective (OR, 0.8). Our aggregate model was well calibrated (r = 0.99, P < .001), demonstrating moderate discriminative ability (ROC curve = 0.71), which differed only slightly from the procedure-specific models (ROC curves: CEA, 0.74; LEB, 0.72; EVAR, 0.74; OAAA, 0.68). Rates of cardiac complications for patients with 0 to 3, 4, 5, and >or=6 VSG risk factors were 3.1%, 5.0%, 6.8%, and 11.6% in the derivation cohort and 3.8%, 5.2%, 8.1%, and 10.1% in the validation cohort. The VSGNE cardiac risk model more accurately predicted the actual risk of cardiac complications across the four procedures for low- and higher-risk patients than the RCRI. When the VSG Cardiac Risk Index (VSG-CRI) was used to score patients, six categories of risk ranging from 2.6% to 14.3% (score of 0-3 to 8) were discernible. CONCLUSIONS The RCRI substantially underestimates in-hospital cardiac events in patients undergoing elective or urgent vascular surgery, especially after LEB, EVAR, and OAAA. The VSG-CRI more accurately predicts in-hospital cardiac events after vascular surgery and represents an important tool for clinical decision making.

Endovascular treatment of ruptured abdominal aortic aneurysms in the United States (2001-2006): A significant survival benefit over open repair is independently associated with increased institutional volume

OBJECTIVE Endovascular aortic repair (EVAR) has gained wide acceptance for the elective treatment of abdominal aortic aneurysms (AAA), leading to interest in similar treatment of ruptured abdominal aortic aneurysms (RAAA). The purpose of this study was to evaluate national outcomes after EVAR for RAAA and to assess the effect of institutional volume metrics. METHODS The Nationwide Inpatient Sample was used to identify patients treated with open or EVAR for RAAA, 2001-2006. Procedure volume was determined for each institution categorizing hospitals as low-, medium-, and high-volume. The primary outcome was in-hospital mortality. Secondary outcomes related to resource utilization. Multivariable logistic regression models were used to determine independent predictors of EVAR usage and mortality. RESULTS From 2001 to 2006, an estimated 27,750 hospital discharges for RAAA occurred; 11.5% were treated with EVAR. EVAR utilization increased over time (5.9% in 2001 to 18.9% in 2006, P < .0001) while overall RAAA rates remained constant. EVAR had a lower overall in-hospital mortality than open repair (31.7% vs 40.7%, P < .0001), an effect which amplified when stratified by institutional volume. On multivariable regression, open repair independently predicted mortality (odds ratio [OR] 1.56; 95% confidence interval [CI] 1.29-1.89). EVAR usage for RAAA increased with age (>80 years) (OR 1.58; 95% CI 1.30-1.93), high elective EVAR volume (>40/y) vs medium (19-40/y) (OR 2.65; 95% CI 1.86-3.78) and low (<19/y) (OR 5.37; 95% CI 3.60-8.0). EVAR had a shorter length of stay (11.1 vs 13.8 days, P < .0001), higher discharges to home (65.1% vs 53.9%, P < .0001), and lower charges (

Statins are independently associated with reduced mortality in patients undergoing infrainguinal bypass graft surgery for critical limb ischemia

108,672 vs

Carotid artery stenting has increased rates of postprocedure stroke, death, and resource utilization than does carotid endarterectomy in the United States, 2005

114,784, P < .0001). CONCLUSIONS In the United States, for RAAA, EVAR had a lower postoperative mortality than open repair. Higher elective open repair as well as RAAA volume increased this mortality advantage for EVAR. These results support regionalization of RAAA repair to high volume centers whenever possible and a wider adoption of endovascular repair of RAAA nationwide.

Prior failed ipsilateral percutaneous endovascular intervention in patients with critical limb ischemia predicts poor outcome after lower extremity bypass

OBJECTIVE Evidence suggesting a beneficial effect of cardioprotective medications in patients with lower extremity atherosclerosis derives largely from secondary prevention studies of heterogeneous populations. Patients with critical limb ischemia (CLI) have a large atherosclerotic burden with related high mortality. The effect of such therapies in this population is largely inferred and unproven. METHODS The Project of Ex-Vivo vein graft Engineering via Transfection III (PREVENT III) cohort comprised 1404 patients with CLI who underwent lower extremity bypass grafting in a multicenter, randomized prospective trial testing the efficacy of edifoligide for the prevention of graft failure. Propensity scores were used to evaluate the influence of statins, beta-blockers, and antiplatelet agents on outcomes while adjusting for demographics, comorbidities, medications, and surgical variables that may influence drug use. Primary outcomes were major adverse cardiovascular events < or =30 days, vein graft patency, and 1-year survival assessed by Kaplan-Meier method. Potential determinants of 1-year survival were modeled using a multivariate Cox regression. RESULTS In this cohort, 636 patients (45%) were taking statins, 835 (59%) were taking beta-blockers, and 1121 (80%) were taking antiplatelet drugs. Perioperative major adverse cardiovascular events (7.8%) and early mortality (2.7%) were not measurably affected by the use of any drug class. Statin use was associated with a significant survival advantage at 1 year of 86% vs 81% (hazard ratio [HR], 0.71; 95% confidence interval [CI], 0.52-0.98; P = .03) by analysis of both unweighted and propensity score-weighted data. Use of beta-blockers and antiplatelet drugs had no appreciable impact on survival. None of the drug classes were associated with graft patency measures at 1 year. Significant predictors of 1-year mortality by Cox regression modeling were statin use (HR, 0.67; 95% CI, 0.51-0.90; P = .001), age >75 (HR, 2.1; 95% CI, 1.60-2.82; P = .001), coronary artery disease (HR, 1.5; 95% CI, 1.15-2.01; P = .001), chronic kidney disease stages 4 (HR, 2.0; 95% CI, 1.17-3.55; P = .001) and 5 (HR, 3.4; 95% CI, 2.39-4.73; P < .001), and tissue loss (HR, 1.9; 95% CI, 1.23-2.80; P = .003). CONCLUSIONS Statin use is associated with improved survival in CLI patients 1 year after surgical revascularization. Further studies are indicated to determine optimal dosing in this population and to definitively address the question of relationship to graft patency. These data add to the growing literature supporting statin use in patients with advanced peripheral arterial disease.

Validation of the PIII CLI risk score for the prediction of amputation-free survival in patients undergoing infrainguinal autogenous vein bypass for critical limb ischemia.

OBJECTIVE Carotid endarterectomy (CEA) remains the procedure of choice for treatment of patients with severe carotid artery stenosis. The role of carotid artery stenting (CAS) in this patient group is still being defined. Prior single and multicenter studies have demonstrated economic savings associated with CEA compared with CAS. The purpose of this study was to compare surgical outcomes and resource utilization associated with these two procedures at the national level in 2005, the first year in which a specific ICD-9 procedure code for CAS was available. METHODS All patient discharges for carotid revascularization for the year 2005 were identified in the Nationwide Inpatient Sample based on ICD9-CM procedure codes for CEA (38.12) and CAS (00.63). The primary outcome measures of interest were in-hospital mortality and postoperative stroke; secondary outcome measures included total hospital charges and length of stay (LOS). All statistical analyses were performed using SAS version 9.1 (Cary, NC), and data are weighted according to the Nationwide Inpatient Sample (NIS) design to draw national estimates. Univariate analyses of categorical variables were performed using Rao-Scott chi(2), and continuous variables were analyzed by survey weighted analysis of variance (ANOVA). Multivariate logistic regression was performed to evaluate independent predictors of postoperative stroke and mortality. RESULTS During 2005, an estimated 135,701 patients underwent either CEA or CAS nationally. Overall, 91% of patients underwent CEA. The mean age overall was 71 years. Postoperative stroke rates were increased for CAS compared with CEA (1.8% vs 1.1%, P < .05), odds ratio (OR) 1.7; (95% confidence interval [CI] 1.2-2.3). Overall, mortality rates were higher for CAS compared with CEA (1.1% vs 0.57%, P < .05) this difference was substantially increased in regard to patients with symptomatic disease (4.6% vs 1.4%, P < .05). By logistic regression, CAS trended toward increased mortality, OR 1.5; (95% CI .96-2.5). Overall, the median total hospital charges for patients that underwent CAS were significantly greater than those that underwent CEA (