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Objective: Reoperative carotid endarterectomy (CEA) can be technically challenging because of significant scarring as a consequence of the initial CEA procedure. There are limited data that describe outcomes after reoperative CEA, and as such, our goal was to determine the effect of reoperative CEA on perioperative outcomes., Methods: The American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP) database was queried for patients undergoing index and reoperative CEA between 2005 and 2014. Multivariate analysis was performed to assess the effect of reoperative CEA on outcomes including stroke, major adverse cardiovascular event, and procedure time., Results: There were 75,943 index and 140 reoperative CEAs identified. No differences were found in baseline demographics or comorbidities except that the reoperative group had a higher incidence of patients with end-stage renal disease (3.6% vs 1.1%; P = .004). Prior stroke with deficit (20.8% vs 15.4%; P = .137) and without deficit (11.5% vs 9.1%; P = .43) were similar between reoperative and index CEA groups. Both the reoperative and index initial CEA cohorts had comparable rates of surgical site infection (0.7% vs 0.3%; P = .462), return to the operating room (3.6% vs 4%; P = .816), readmission with 30 days (2.1% vs 6.9%; P = .810), myocardial infarction (2.1% vs 0.9%; P = .125), and perioperative death (0.7% vs 0.9%; P = .853). The reoperative cohort had a significantly higher rate of perioperative stroke (5.0% vs 1.6%; P = .002) and a longer operative duration (137 ± 54 vs 116 ± 49 minutes; P < .001). Multivariate analysis revealed that reoperative CEA was an independent factor for postoperative stroke (odds ratio, 3.71; 95% confidence interval [CI], 1.61-8.57; P = .002), major adverse cardiovascular event (odds ratio, 2.76; 95% CI, 1.32-5.78; P = .007), and longer procedure time (means ratio, 1.21; 95% CI, 1.12-1.30; P < .001)., Conclusions: Reoperative carotid surgery is associated with a longer operative time and higher risk for perioperative stroke compared with index CEA. This information informs the risk-benefit analysis for reoperation., (Copyright © 2017 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Objective: To identify the prevalence of monoclonal gammopathy of undetermined significance (MGUS) in patients with transthyretin (ATTR) amyloidosis., Patients and Methods: We performed a retrospective analysis of patients with biopsy-proven ATTRwt (wild-type transthyretin amyloid protein) and genopositive ATTR V122I (valine-to-isoleucine substitution at position 122 of the TTR gene) amyloidosis evaluated at the Amyloidosis Center at Boston University and Boston Medical Center between 1 January 2003 and 31 December 2016., Results: There were a total of 226 patients with ATTRwt and ATTR V122I amyloidosis evaluated during the specified time frame with 155 and 71 patients in each cohort, respectively. Those with complete medical records, 140 patients with ATTRwt and 57 V1221 ATTRm subjects, were included in the analyses. Fifty-five patients (39%) in the ATTRwt cohort and 28 patients (49%) in the ATTR V122I cohort had an MGUS, as indicated by an abnormality in the serum-free light-chain ratio and/or serum immunofixation electrophoresis., Conclusion: These data confirm the high prevalence of coexistent MGUS with ATTR amyloidosis in this patient population, with an MGUS rate that is higher than the general population. These findings also highlight the importance of a thorough diagnostic evaluation in patients with amyloidosis to determine the precursor protein, as the clinical course and treatment of AL (light-chain amyloid protein) and ATTR amyloidosis are distinct.

Background: Clinical trial data associate extended clopidogrel therapy with increased mortality and cancer. We sought to determine the impact of continued clopidogrel use on mortality and cancer within a patient-level meta-analysis of randomized clinical trials., Methods and Results: Meta-analytic clinical event rates for all-cause, cardiovascular, noncardiovascular, and cancer-related mortality; cancer; myocardial infarction; stroke; and fatal and major nonfatal bleeding were generated using patient-level data from 6 randomized trials comparing prolonged versus no or short-duration clopidogrel on a background of aspirin in patients with cardiovascular and cerebrovascular disease. Among 48 817 randomized patients (median follow-up 546 days), there was no difference in all-cause (7.23% versus 7.26%; P =0.97), cardiovascular (5.25% versus 5.22%; P =0.86), noncardiovascular (1.98% versus 2.03%; P =0.73), and cancer-related (0.93% versus 0.99%; P =0.59) mortality or in new cancer diagnoses (2.97% versus 2.96%; P >0.99). Rates of myocardial infarction (3.21% versus 4.05%; P <0.0001) and stroke (3.04% versus 3.75%; P <0.0001) were significantly lower in patients receiving continued clopidogrel. Fatal bleeding was more common with continued clopidogrel use (0.39% versus 0.27%; P =0.03), as were major nonfatal bleeding (4.06% versus 2.68%; P <0.0001) and intracranial hemorrhage (0.43% versus 0.30%; P =0.02)., Conclusions: Across trials of cardiovascular and cerebrovascular disease, extended-duration clopidogrel on a background of aspirin has no overall effect on mortality or cancer but does reduce rates of myocardial infarction and stroke and increase rates of bleeding. These findings emphasize the need for selective use of extended clopidogrel therapy in patients in whom the risks of ischemia are not fully counterbalanced by the risks of bleeding., (© 2018 American Heart Association, Inc.)

Background: It is poorly understood whether insurance type may be a major contributor to the underuse of oral anticoagulation (OAC) among patients with atrial fibrillation (AF), particularly for novel oral anticoagulants (NOACs)., Methods: We performed a retrospective cohort registry study of patients with insurance, AF, CHA 2 DS 2 -VASc ≥2, and at least one outpatient encounter recorded in the ACC NCDR's PINNACLE Registry between January 1, 2011 and December 31, 2014. We used hierarchical regression, adjusting for patient characteristics and clustering by physician, to evaluate the association of insurance type (Private, Military, Medicare, Medicaid, Other) with receipt of OAC (any OAC, warfarin, or NOAC)., Results: In 363,309 patients (age 75±10; 48% female), we found a significant difference in proportions of OAC and NOAC prescription across insurance types (OAC: Military 53%, Private 53%, Medicare 52%, Other 41%, Medicaid 41%, P<.001; NOAC: Military 24%, Private 19%, Medicare 17%, Other 17%, Medicaid 8%, P<.001). After adjustment for patient characteristics and facility, private, Medicaid, and other insurance were independently associated with a lower odds of OAC prescription relative to Medicare, but military insured patients were not significantly different. After adjustment, military and private insurance were independently associated with a higher odds of NOAC prescription relative to Medicare, while Medicaid and other insurance were associated with a lower odds of NOAC prescription., Conclusions: In a contemporary US AF population, there was significant variation of OAC prescription across insurance plans, with the highest among private and Medicare insured patients. These differences may indicate that insurance plan, and its associated pharmacy benefits, affect the pace of diffusion of new therapies., (Copyright © 2017. Published by Elsevier Inc.)

Objective: The purpose of this study is to externally validate a recently reported Vascular Study Group of New England (VSGNE) risk predictive model of postoperative mortality after elective abdominal aortic aneurysm (AAA) repair and to compare its predictive ability across different patients' risk categories and against the established risk predictive models using the Vascular Quality Initiative (VQI) AAA sample., Methods: The VQI AAA database (2010-2015) was queried for patients who underwent elective AAA repair. The VSGNE cases were excluded from the VQI sample. The external validation of a recently published VSGNE AAA risk predictive model, which includes only preoperative variables (age, gender, history of coronary artery disease, chronic obstructive pulmonary disease, cerebrovascular disease, creatinine levels, and aneurysm size) and planned type of repair, was performed using the VQI elective AAA repair sample. The predictive value of the model was assessed via the C-statistic. Hosmer-Lemeshow method was used to assess calibration and goodness of fit. This model was then compared with the Medicare, Vascular Governance Northwest model, and Glasgow Aneurysm Score for predicting mortality in VQI sample. The Vuong test was performed to compare the model fit between the models. Model discrimination was assessed in different risk group VQI quintiles., Results: Data from 4431 cases from the VSGNE sample with the overall mortality rate of 1.4% was used to develop the model. The internally validated VSGNE model showed a very high discriminating ability in predicting mortality (C = 0.822) and good model fit (Hosmer-Lemeshow P = .309) among the VSGNE elective AAA repair sample. External validation on 16,989 VQI cases with an overall 0.9% mortality rate showed very robust predictive ability of mortality (C = 0.802). Vuong tests yielded a significant fit difference favoring the VSGNE over then Medicare model (C = 0.780), Vascular Governance Northwest (0.774), and Glasgow Aneurysm Score (0.639). Across the 5 risk quintiles, the VSGNE model predicted observed mortality significantly with great accuracy., Conclusions: This simple VSGNE AAA risk predictive model showed very high discriminative ability in predicting mortality after elective AAA repair among a large external independent sample of AAA cases performed by a diverse array of physicians nationwide. The risk score based on this simple VSGNE model can reliably stratify patients according to their risk of mortality after elective AAA repair better than other established models., (Copyright © 2017 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Purpose: We investigated the effects of long-term testosterone therapy on urinary and sexual function, and quality of life in hypogonadal men., Materials and Methods: We performed an observational, prospective, cumulative registry study in 656 men with a mean ± SD age of 60.7 ± 7.2 years who had total testosterone 12.1 nmol/l or less and symptoms of hypogonadism. In the testosterone treated group 360 men received parenteral testosterone undecanoate 1,000 mg/12 weeks for up to 10 years. The 296 men who elected against testosterone therapy served as controls. From each group 82 patients were propensity matched by age, waist circumference and body mass index, resulting in 82 matched pairs of 164 men. Data were analyzed and estimated differences between the groups were adjusted for components of metabolic syndrome and quality of life., Results: We found significant decreases in I-PSS (International Prostate Symptom Score) and post-void bladder volume (each p <0.0001) in patients receiving testosterone therapy but not in the untreated group. We recorded a decrease in AMS (Aging Males' Symptoms Scale) in the testosterone treated group but not in the untreated group (p <0.0001). We also recorded significant improvement in the IIEF-EF (International Index of Erectile Function-Erectile Function) domain in the testosterone treated group but not in the untreated group (p <0.0001). The improvement was maintained throughout followup., Conclusions: Long-term testosterone therapy in hypogonadal men resulted in significant improvements in urinary and sexual function, and in quality of life. In untreated hypogonadal men voiding and erectile function deteriorated with continued followup., (Copyright © 2018 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.)

Background: The use of statin and antiplatelet medications has been advocated in patients with cerebrovascular disease as primary medical therapy and as an adjunct to carotid endarterectomy (CEA). Our goal was to assess the prevalence of preoperative statin and antiplatelet use and its effect on perioperative outcomes after CEA., Methods: The American College of Surgeons National Surgical Quality Improvement Program targeted CEA database was queried for patients undergoing CEA between 2011 and 2014. Multivariable analysis was used to assess the effect of preoperative statin and antiplatelet use on CEA., Results: There were 13,521 CEAs identified. The average age was 71 years, and 61.5% were male. More than half of patients (57.9%) were asymptomatic. Preoperative statin use was seen in 80.5% of patients, and antiplatelet use was seen in 89.3% of patients. Statin use was more common in patients with higher body mass index, independent functional status, diabetes, hypertension, bleeding disorders or anticoagulation, nonsmokers, and asymptomatic patients (P < 0.05). On univariate analysis, statin use was not associated with postoperative myocardial infarction (MI) (1.9% vs. 1.4%, P = 0.085), stroke (1.8% vs. 1.9%, P = 0.55), transient ischemic attack (TIA) (0.9% vs. 1.1%), or major adverse cardiovascular events (MACE) (4% vs. 3.6%). On multivariate analysis, preoperative statin use did not independently affect 30-day mortality (odds ratio [OR]: 0.94, 95% confidence interval [CI]: 0.55-1.6, P = 0.825), perioperative MI (OR 1.1, 95% CI 0.77-1.58, P = 0.573), stroke (OR: 0.891, 95% CI: 0.64-1.2, P = 0.42), or MACE (OR 1.03, 95% CI: 0.81-1.32, P = 0.806). Antiplatelet use was more common with male gender, nonsmoking, diabetes, hypertension, chronic obstructive pulmonary disease, dyspnea, and asymptomatic carotid disease. On univariate analysis, antiplatelet use showed no effect on 30-day mortality (0.7% vs. 1%, P = 0.28), MI (1.9% vs. 1.7%, P = 0.73), stroke (1.8% vs. 1.8%, P = 0.94), TIA (0.9% vs. 1%, P = 0.63), or MACE (3.9% vs. 4%, P = 0.8). On multivariate analysis, preoperative antiplatelet use did not independently affect 30-day mortality (OR: 0.67, 95% CI: 0.37-1.3, P = 0.19), perioperative MI (OR: 0.9, 95% CI: 0.59-1.38, P = 0.637), stroke (OR: 0.92, 95% CI: 0.61-1.4, P = 0.69), or MACE (OR: 0.88, 95% CI: 0.66-1.18, P = 0.39)., Conclusions: Preoperative statin and antiplatelet use in patients undergoing CEA was more often observed in patients with higher rates of comorbidities and asymptomatic disease, and this may represent closer follow-up and engagement with primary care physicians in this patient cohort. Preoperative statin and antiplatelet use did not affect perioperative outcomes suggesting that its short-term use is not essential. In patients who are not on statins or antiplatelet medications, CEA can safely be performed before consideration is given to their initiation., (Copyright © 2017 Elsevier Inc. All rights reserved.)

Introduction: Open aortic aneurysm repair (AAA) repair can be resource intensive and associated with a prolonged length of stay (LOS). We sought to examine patient and aneurysm predictors of prolonged LOS to better identify those at risk in the preoperative setting., Methods: Patient data were obtained from the targeted AAA American College of Surgery National Surgical Quality Improvement Program database from 2012 to 2014 of patients undergoing open AAA repair. Multivariable logistic regression was used to determine predictors of prolonged postoperative LOS defined as greater than 10 days (75th percentile)., Results: There were 1172 open AAA repairs identified. The majority (54%) of patients were older than 70 years and male (74%). Surgical approach was transperitoneal (70.9%) and retroperitoneal (29.1%). Aneurysms were 51.4% infrarenal, 33% juxtarenal, 5.7% pararenal, 7.4% suprarenal, and 2.5% type IV thoracoabdominal. Mean and median LOS were 9.1 ± 7.4 and 7 (0-72) days, respectively. Independently associated with extended LOS factors were visceral revascularization (odds ratio [OR]: 5.32, 95% confidence interval [CI]: 2.77-10.22, P < .001), type IV thoracoabdominal extent (OR: 3.09, 95% CI: 1.01-9.46, P = .048), suprarenal extent (OR: 1.89, 95% CI: 1.07-3.34, P = .029) and juxtarenal (OR: 1.43, 95% CI: 1.01-2.02, P = .004), non-Caucasian race (OR: 2.80, 95% CI: 1.77-4.41, P < .001), chronic obstructive pulmonary disease (OR: 1.76, 95% CI: 1.20-2.59, P = .004), not-from-home admission (OR: 1.91, 95% CI: 1.13-3.24), and age greater than 70 (OR: 1.49, 95% CI: 1.08-2.05, P = .014)., Conclusion: We identified patient and aneurysm characteristics independently associated with protracted LOS following open AAA repair. Prospective identification of high-risk patients may allow physicians and hospitals to engage in multidisciplinary collaborations preoperatively to try to improve LOS in this resource-intensive population.

Background: Timing of carotid endarterectomy (CEA) after onset of neurologic symptoms remains controversial. We assessed the association of CEA timing with postoperative outcomes., Methods: The Vascular Study Group of New England (VSGNE) database (2003-2014) was queried to identify CEA performed for symptomatic carotid stenosis during the same hospitalization. Cases were divided into four groups based on the time from onset of neurologic symptoms to CEA: group I, <2 days; group II, 2 to 5 days; group III, ≥6 days; and group IV, same-day CEA. The χ 2 test and t-test were used to compare demographics, medical history, modified Rankin scores, and outcomes (30-day postoperative death, stroke, myocardial infarction, and aggregate events [stroke/myocardial infarction]). Multivariable logistic regression was used to compare the association of time to surgery with outcomes while adjusting for confounding variables. Kaplan-Meier and Cox proportional hazards regression analyses were performed at 1 year to evaluate survival and stroke rates between the groups., Results: There were 989 of 14,864 VSGNE CEA cases that fit the inclusion criteria. The frequency of cases was highest in group II (36.6%), followed by groups I (31.9%), III (18.9%), and IV (12.4%). Age, gender, and comorbidity compositions were similar between groups, although group III had the highest rates of diabetes mellitus, coronary artery disease, coronary artery bypass graft procedures, congestive heart failure, and American Society of Anesthesiologists class 4 and the highest modified Rankin score (P < .05). Stroke rates were highest in group I (7.3%; P = .016), whereas group III had the highest rate of discharges to nursing facilities (37.2%; P < .001); other adverse outcomes were comparable among groups. CEAs in group I had significantly increased adjusted odds of stroke; adverse outcomes of CEAs in groups II and III were comparable to those in group IV., Conclusions: Our results suggest that CEAs performed 2 to 5 days after a neurologic event have similar outcomes to CEAs performed ≥6 days later. Early CEA should be considered an area for quality improvement among these patients., (Copyright © 2017 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Objective: Studies have shown that language discordance between treatment teams and patients leads to worse patient outcomes, including longer hospital stays, higher rates of readmission, impaired comprehension of discharge instructions, and lower treatment adherence. Yet, there is a paucity of data evaluating the effects of language discordance on postoperative outcomes among vascular surgery patients. This study compared 30-day postoperative complications and readmissions after nonemergent infrainguinal bypass between non-English-speaking (NES) and English-speaking (ES) patients., Methods: Consecutive patients who underwent nonemergent infrainguinal bypass for claudication, ischemic rest pain, and tissue loss at an urban, academic medical center between 2007 and 2014 were identified. Patients were stratified into NES or ES groups by their self-identified primary language. Crude comparisons and multivariable analyses were performed to assess the association of primary language status with 30-day wound infections, adverse graft events (wound infections, graft thromboses, or hematomas), readmissions, and Emergency Department return visits., Results: The study included 261 patients who underwent an infrainguinal bypass: 51 NES and 210 ES patients. The NES patients were older (67.4 ± 9.8 vs 63.1 ± 9.9 years; P = .005) and had a higher rate of diabetes (78.4% vs 58.6%; P = .009) and a lower rate of chronic obstructive pulmonary disease (5.9% vs 28.6%; P = .001). Other comorbidities were comparable between the two groups. The NES patients were more likely to be Medicaid beneficiaries (51.0% vs 21.4%; P < .001). Across all outcomes compared, crude analyses showed no significant difference between NES and ES patients. Adjusted analysis revealed that language discordance did not affect the odds of adverse outcomes of wound infections (odds ratio [OR], 1.87; 95% confidence interval [CI], 0.90-3.88; P = .095), adverse graft events (OR, 1.23; 95% CI, 0.62-2.45; P = .556), readmissions (OR, 1.51; 95% CI, 0.77-2.95; P = .478), or Emergency Department return visits (OR, 1.28; 95% CI, 0.58-2.83; P = .546)., Conclusions: Our study suggests that language discordance does not affect 30-day complication and readmission rates after infrainguinal bypass., (Copyright © 2017 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Background: Traditional study design submitted to the Food and Drug Administration to test newer drug-eluting stents (DES) for marketing approval is the prospective randomized controlled trial. However, several DES have extensive clinical data from trials conducted outside the United States that have led to utilization of a novel design using the Bayesian approach. This design was proposed for testing DES with bioresorbable polymer compared with DES most commonly in use today that use durable polymers for drug elution., Study Design and Objectives: This prospective, multicenter, randomized, controlled trial is designed to assess the safety and efficacy of the Orsiro bioresorbable polymer sirolimus-eluting stent (BP SES). Up to 1,334 subjects with up to 3 de novo or restenotic coronary artery lesions who qualify for percutaneous coronary intervention with stenting will be randomized 2:1 to the BP SES versus the Xience durable polymer everolimus-eluting stent (DP EES). Data from this trial will be combined with data from 2 similarly designed trials that also randomize subjects to BP SES and DP EES (BIOFLOW II, N=452 and BIOFLOW IV, N=579) by using a Bayesian approach. The primary end point is target lesion failure at 12 months post index procedure, defined as cardiac death, target vessel myocardial infarction, or clinically driven target lesion revascularization, and the primary analysis is a test of noninferiority of the BP SES versus DP EES on the primary end point according to a noninferiority delta of 3.85%. Secondary end points include stent thrombosis and the individual components of target lesion failure. Subjects will be followed for 5 years after randomization., Conclusions: The BIOFLOW V trial offers an opportunity to assess clinical outcomes in patients treated with coronary revascularization using the Orsiro BP SES relative to a commonly used DP EES. The use of a Bayesian analysis combines a large randomized cohort of patients 2 two smaller contributing randomized trials to augment the efficiency of the comparison., (Copyright © 2017 Elsevier Inc. All rights reserved.)

Background: The development of coronary drug-eluting stents has included use of new metal alloys, changes in stent architecture, and use of bioresorbable polymers. Whether these advancements improve clinical safety and efficacy has not been shown in previous randomised trials. We aimed to examine the clinical outcomes of a bioresorbable polymer sirolimus-eluting stent compared with a durable polymer everolimus-eluting stent in a broad patient population undergoing percutaneous coronary intervention., Methods: BIOFLOW V was an international, randomised trial done in patients undergoing elective and urgent percutaneous coronary intervention in 90 hospitals in 13 countries (Australia, Belgium, Canada, Denmark, Germany, Hungary, Israel, the Netherlands, New Zealand, South Korea, Spain, Switzerland, and the USA). Eligible patients were those aged 18 years or older with ischaemic heart disease undergoing planned stent implantation in de-novo, native coronary lesions. Patients were randomly assigned (2:1) to either an ultrathin strut (60 μm) bioresorbable polymer sirolimus-eluting stent or to a durable polymer everolimus-eluting stent. Randomisation was via a central web-based data capture system (mixed blocks of 3 and 6), and stratified by study site. The primary endpoint was 12-month target lesion failure. The primary non-inferiority comparison combined these data from two additional randomised trials of bioresorbable polymer sirolimus-eluting stent and durable polymer everolimus-eluting stent with Bayesian methods. Analysis was by intention to treat. The trial is registered with ClinicalTrials.gov, number NCT02389946., Findings: Between May 8, 2015, and March 31, 2016, 4772 patients were recruited into the study. 1334 patients met inclusion criteria and were randomly assigned to treatment with bioresorbable polymer sirolimus-eluting stents (n=884) or durable polymer everolimus-eluting stents (n=450). 52 (6%) of 883 patients in the bioresorbable polymer sirolimus-eluting stent group and 41 (10%) of 427 patients in the durable polymer everolimus-eluting stent group met the 12-month primary endpoint of target lesion failure (95% CI -6·84 to -0·29, p=0·0399), with differences in target vessel myocardial infarction (39 [5%] of 831 patients vs 35 [8%] of 424 patients, p=0·0155). The posterior probability that the bioresorbable polymer sirolimus-eluting stent is non-inferior to the durable polymer everolimus-eluting stent was 100% (Bayesian analysis, difference in target lesion failure frequency -2·6% [95% credible interval -5·5 to 0·1], non-inferiority margin 3·85%, n=2208)., Interpretation: The outperformance of the ultrathin, bioresorbable polymer sirolimus-eluting stent over the durable polymer everolimus-eluting stent in a complex patient population undergoing percutaneous coronary intervention suggests a new direction in improving next generation drug-eluting stent technology., Funding: BIOTRONIK., (Copyright © 2017 Elsevier Ltd. All rights reserved.)

Objectives: The objectives were to reassess use of amino-terminal pro B-type natriuretic peptide (NT-proBNP) concentrations for diagnosis and prognosis of acute heart failure (HF) in patients with acute dyspnea., Background: NT-proBNP facilitates diagnosis, prognosis, and treatment in patients with suspected or proven acute HF. As demographics of such patients are changing, previous diagnostic NT-proBNP thresholds may need updating. Additionally, value of in-hospital NT-proBNP prognostic monitoring for HF is less understood., Methods: In a prospective, multicenter study in the United States and Canada, patients presenting to emergency departments with acute dyspnea were enrolled, with demographic, medication, imaging, and clinical course information collected. NT-proBNP analysis will be performed using the Roche Diagnostics Elecsys proBNPII immunoassay in blood samples obtained at baseline and at discharge (if hospitalized). Primary end points include positive predictive value of previously established age-stratified NT-proBNP thresholds for the adjudicated diagnosis of acute HF and its negative predictive value to exclude acute HF. Secondary end points include sensitivity, specificity, and positive and negative likelihood ratios for acute HF and, among those with HF, the prognostic value of baseline and predischarge NT-proBNP for adjudicated clinical end points (including all-cause death and hospitalization) at 30 and 180days., Results: A total of 1,461 dyspneic subjects have been enrolled and are eligible for analysis. Follow-up for clinical outcome is ongoing., Conclusions: The International Collaborative of N-terminal pro-B-type Natriuretic Peptide Re-evaluation of Acute Diagnostic Cut-Offs in the Emergency Department study offers a contemporary opportunity to understand best diagnostic cutoff points for NT-proBNP in acute HF and validate in-hospital monitoring of HF using NT-proBNP., (Copyright © 2017 Elsevier Inc. All rights reserved.)

Objectives: In the absence of large, prospective, placebo-controlled studies of longer duration, substantial evidence regarding the safety and risk of testosterone (T) therapy (TTh) with regard to cardiovascular (CV) outcomes can only be gleaned from observational studies. To date, there are limited studies comparing the effects of long-term TTh in men with hypogonadism who were treated or remained untreated with T, for obvious reasons. We have established a registry to assess the long-term effectiveness and safety of T in men in a urological setting. Here, we sought to compare the effects of T on a host of parameters considered to contribute to CV risk in treated and untreated men with hypogonadism (control group)., Patients and Methods: Observational, prospective, cumulative registry study in 656 men (age: 60.7 ± 7.2 years) with total T levels ≤12.1 nmol/L and symptoms of hypogonadism. In the treatment group, men (n = 360) received parenteral T undecanoate (TU) 1000 mg/12 weeks following an initial 6-week interval for up to 10 years. Men (n = 296) who had opted against TTh served as controls. Median follow-up in both groups was 7 years. Measurements were taken at least twice a year, and 8-year data were analyzed. Mean changes over time between the 2 groups were compared by means of a mixed-effects model for repeated measures, with a random effect for intercept and fixed effects for time, group, and their interaction. To account for baseline differences between the 2 groups, changes were adjusted for age, weight, waist circumference, fasting glucose, blood pressure, and lipids., Results: There were 2 deaths in the T-treated group, none was related to CV events. There were 21 deaths in the untreated (control) group, 19 of which were related to CV events. The incidence of death in 10 patient-years was 0.1145 in the control group (95% confidence interval [CI]: 0.0746-0.1756; P < .000) and 0.0092 in the T-treated group (95% CI: 0.0023-0.0368; P < .000); the estimated difference between groups was 0.0804 (95% CI: 0.0189-0.3431; P < .001). The estimated reduction in mortality for the T-group was between 66% and 92%. There were also 30 nonfatal strokes and 26 nonfatal myocardial infarctions in the control group and none in the T-treated group., Conclusion: Long-term TU was well tolerated with excellent adherence suggesting a high level of patient satisfaction. Mortality related to CV disease was significantly reduced in the T-group.

Background: One of the main advantages of endovascular abdominal aortic aneurysm repair (EVAR) is shorter postoperative hospital length of stay (LOS) compared to open repair. However, patients with preexisting conditions may be predisposed to a protracted LOS. Our aim was to identify preoperative risk factors for prolonged postoperative LOS after elective EVAR., Methods: The American College of Surgeons National Surgical Quality Improvement Program database (2005-2013) was used to analyze all patients undergoing elective EVAR without adjunctive procedures. The upper quartile (≥3 days) was used to define protracted LOS. Preoperative risk factors with significant association (P < 0.2) were used to develop a logistic regression model for protracted postoperative LOS., Results: There were 21,769 patients that underwent elective EVAR with a median LOS of 2 days. The strongest independent preoperative predictors of LOS were chronic renal insufficiency (odds ratio [OR]: 3.0, 95% confidence interval [CI]: 1.7-5.2), admission from a facility (OR: 2.7, 95% CI: 2.2-3.2), dependent functional status (OR: 2.6, 95% CI: 2.2-3.1), recent weight loss (OR: 2.2, 95% CI: 1.7-2.9), the American Society of Anesthesiologists class IV (OR: 1.9, 95% CI: 1.6-2.3), congestive heart failure (OR: 1.8, 95% CI: 1.4-2.4), female gender (OR: 1.7, 95% CI: 1.6-1.9), non-Caucasian race (OR: 1.7, 95% CI: 1.5-1.9), and dyspnea at rest (OR: 1.5, 95% CI: 1.2-2.0). Patients with a protracted postoperative LOS were more likely to require discharge to a facility (21.8% vs. 2.1%, P < 0.001) and were more likely to be readmitted within 30 days (5.3% vs. 3.3%, P < 0.001)., Conclusions: Preoperative demographics and comorbidities represent significant risk factors for prolonged LOS after elective EVAR. These findings provide an important evidence basis for ongoing efforts to reduce health care spending by prospectively identifying high-risk patients. Preoperative targeting of these patients through multidisciplinary efforts may reduce costs and improve outcomes., (Copyright © 2017 Elsevier Inc. All rights reserved.)

Household contact studies, a mainstay of tuberculosis transmission research, often assume that tuberculosis-infected household contacts of an index case were infected within the household. However, strain genotyping has provided evidence against this assumption. Understanding the household versus community infection dynamic is essential for designing interventions. The misattribution of infection sources can also bias household transmission predictor estimates. We present a household-community transmission model that estimates the probability of community infection, that is, the probability that a household contact of an index case was actually infected from a source outside the home and simultaneously estimates transmission predictors. We show through simulation that our method accurately predicts the probability of community infection in several scenarios and that not accounting for community-acquired infection in household contact studies can bias risk factor estimates. Applying the model to data from Vitória, Brazil, produced household risk factor estimates similar to two other standard methods for age and sex. However, our model gave different estimates for sleeping proximity to index case and disease severity score. These results show that estimating both the probability of community infection and household transmission predictors is feasible and that standard tuberculosis transmission models likely underestimate the risk for two important transmission predictors. Copyright © 2017 John Wiley & Sons, Ltd., (Copyright © 2017 John Wiley & Sons, Ltd.)

Background: Despite higher thromboembolism risk, women with atrial fibrillation have lower oral anticoagulation (OAC) use compared to men. The influence of the CHA 2 DS 2 -VASc score or the introduction of non-vitamin K OACs on this relationship is not known., Methods and Results: Using the PINNACLE National Cardiovascular Data Registry from 2008 to 2014, we compared the association of sex with OAC use (warfarin or non-vitamin K OACs) overall and by CHA 2 DS 2 -VASc score and examined temporal trends in OAC use by sex. Multivariable regression models assessed the association between sex and OAC use in those with CHA 2 DS 2 -VASc scores ≥2. Temporal analyses assessed changes in OAC use by sex over time. Of the 691 906 atrial fibrillation patients, 48.5% were women. Women were significantly less likely than men to use any OAC overall (56.7% versus 61.3%; P <0.001) and at all levels of CHA 2 DS 2 -VASc score (adjusted risk ratio 9% to 33% lower, all P <0.001). Compared to other thromboembolic risk factors, female sex was associated with lower use of OAC (risk ratio 0.90, 95%CI 0.90-0.91). Over time, non-vitamin K OAC use increased at a slightly higher rate in women (56.2% increase per year, 95%CI 54.6% to 57.9%) compared to men (53.6% increase per year, 95%CI 52.0% to 55.2%), yet women remained less likely to receive any OAC at all time points ( P <0.001)., Conclusions: Among patients with atrial fibrillation, women were significantly less likely to receive OAC at all levels of the CHA 2 DS 2 -VASc score. Despite increasing non-vitamin K OAC use, women had persistently lower rates of OAC use compared to men over time., (© 2017 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley.)

Aim: Efficient start-up phase in clinical trials is crucial to execution. The goal was to determine factors contributing to delays., Materials & Methods: The start-up milestones were assessed for 38 studies and analyzed., Results: Total start-up time was shorter for following studies: device trials, no outsourcing, fewer ancillary services used and in interventional versus observational designs. The use of a centralized Institutional Review Board (IRB) versus a local IRB reduced time to approval. Studies that never enrolled took longer on average to finalize their budget/contract, and obtain IRB than ones that did enroll., Conclusion: Different features of clinical trials can affect timeline of start-up process. An understanding of the impact of each feature allows for optimization., Competing Interests: Financial & competing interests disclosure The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties. No writing assistance was utilized in the production of this manuscript.

Objective: The effect of preoperative malnutrition on outcomes in patients undergoing major vascular surgery is unclear. We investigated the effects of preoperative hypoalbuminemia, a marker for malnutrition, on outcomes after open abdominal aortic aneurysm repair (OAR) and endovascular abdominal aortic aneurysm repair (EVAR)., Methods: Patients undergoing OAR or EVAR were identified in the 2005 to 2012 American College of Surgeons National Surgical Quality Improvement Program database and stratified into three groups: normal albumin (serum albumin >3.5 g/dL), moderate hypoalbuminemia (2.8-3.5 g/dL), and severe hypoalbuminemia (<2.8 g/dL). Multivariable analyses were performed to assess the association of preoperative hypoalbuminemia with 30-day morbidity and mortality., Results: We identified 15,002 patients with a recorded preoperative serum albumin who underwent OAR (n = 4956) or EVAR (n = 10,046). Patients in both cohorts with hypoalbuminemia had a higher burden of comorbidity. In OAR patients, multivariable analyses demonstrated that moderate hypoalbuminemia was associated with an increased risk of 30-day mortality (odds ratio [OR], 1.32; 95% confidence interval [CI], 1.02-1.70) and postoperative length of stay (LOS; means ratio [MR], 1.10; 95% CI, 1.04-1.16), whereas severe hypoalbuminemia was associated with increased 30-day mortality (OR, 1.92; 95% CI, 1.37-2.70), reoperation ≤30 days (OR, 1.80; 95% CI, 1.32-2.48), pulmonary complications (OR, 1.40; 95% CI, 1.06-1.86), and postoperative LOS (MR, 1.33; 95% CI, 1.21-1.45). In EVAR patients, moderate hypoalbuminemia was associated with an increased risk of 30-day mortality (OR, 1.90; 95% CI, 1.38-2.62), pulmonary complications (OR, 1.61; 95% CI, 1.26-2.04), reoperation ≤30 days (OR, 1.39; 95% CI, 1.12-1.74), and postoperative LOS (MR, 1.23; 95% CI, 1.18-1.29), whereas severe hypoalbuminemia was associated with increased 30-day mortality (OR, 2.98; 95% CI, 1.96-4.53), pulmonary complications (OR, 1.88; 95% CI, 1.32-2.67), reoperation ≤30 days (OR, 1.54; 95% CI, 1.08-2.19), and postoperative LOS (MR, 1.52; 95% CI, 1.40-1.65)., Conclusions: Preoperative hypoalbuminemia is associated with increased postoperative morbidity and mortality in a severity-dependent manner among patients undergoing OAR or EVAR. Evaluation and optimization of nutritional status should be performed preoperatively in this high-risk population., (Copyright © 2016 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Objective: Since the 2004 approval by the United States Food and Drug Administration of carotid artery stenting (CAS), there have been two seminal publications about CAS reimbursement (Centers for Medicare and Medicaid Services guidelines; 2008) and clinical outcomes (Carotid Revascularization Endarterectomy versus Stent Trial [CREST]; 2010). We explored the association between these publications and national trends in CAS use among high-risk symptomatic patients., Methods: The most recent congruent data sets of the Nationwide Inpatient Sample (NIS) were queried for patients undergoing carotid revascularization. The sample was limited to include only patients who were defined as "high-risk" if they had a Charlson Comorbidity Score of ≥3.0. Subgroup analyses were performed of high-risk patients with symptomatic carotid stenosis. Utilization proportions of CAS were calculated quarterly from 2005 to 2011 for NIS. Three time intervals related to Centers for Medicare and Medicaid Services guidelines and CREST publication were selected: 2005 to 2008, 2008 to 2010, and after 2010. Logistic regression with piecewise linear trend for time was used to estimate different trends in CAS use for the overall high-risk sample and for neurologically asymptomatic and symptomatic cases. Multivariate logistic regression was used to compare odds of postoperative mortality and stroke between these two procedures at different time intervals independent of confounding variables., Results: During the study period, 20,079 carotid endarterectomies (CEAs) and 3447 CAS procedures were performed in high-risk patients in the NIS database. CAS utilization constituted 20.5% of carotid revascularization procedures among high-risk symptomatic patients, with a significant increase from 18.6% to 24.4% during the study period (P < .001). There was an initial increase during 2005 to 2008 in the rate of CAS compared with CEA, CAS utilization significantly decreased during 2008 to 2010 by a 3.3% decline in the odds ratio (OR) of CAS per quarter (OR, 0.967; 95% confidence interval [CI], 0.943-0.993; P = .002), and after CREST (after 2010), CAS utilization continued to increase significantly from the prepublication to the postpublication time interval. The odds of in-hospital mortality (OR, 2.56; 95% CI, 1.17-5.62; P = .019) and postoperative in-hospital stroke (OR, 1.53; 95% CI, 1.09-3.68; P = .024) were independently and significantly higher for CAS patients in the overall sample., Conclusions: The use of CAS for carotid revascularization in a high-risk cohort of patients has significantly increased from 2005 to 2011. Compared with CEA, CAS independently increased the odds of perioperative in-hospital stroke in all high-risk patients and of in-hospital mortality in symptomatic high-risk patients., (Copyright © 2017 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Background: Endovascular aneurysm repair (EVAR) is becoming the preferred treatment modality for patients with a ruptured abdominal aortic aneurysm (rAAA). Although the survival advantage of EVAR over open aortic repair (OAR) has been shown in some studies, it is unclear whether this benefit extends to elderly patients. We sought to evaluate the outcomes of rAAA repair in octogenarians., Methods: We reviewed the American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP) data set (2005-2014) to identify patients older than 80 years who were treated with EVAR and OAR for rAAA. Procedural trends were evaluated during the course of the study period. Perioperative outcomes including mortality, morbidity, and hospital length of stay (LOS) were compared. Multivariable regression models were used to identify predictors of perioperative mortality and morbidity., Results: Among 1048 elderly patients who underwent rAAA repair, 450 (43%) and 598 (57%) were treated with EVAR and OAR, respectively. The use of EVAR to treat rAAA had increased significantly in this population of patients (0% in 2005 vs 56% in 2014; P < .001). The overall 30-day mortality rate among octogenarians was 41%. The mortality rate was significantly higher among those treated with OAR compared with EVAR (47% vs 33%; P < .001). Pneumonia (21% vs 10%; P < .001), reintubation (14% vs 9%; P < .001), and >48-hour ventilator dependence (43% vs 21%; P < .001) were significantly higher in patients undergoing OAR. Hospital LOS (13 vs 10 days; P < .001) was also longer in the OAR cohort. Compared with EVAR, OAR was independently predictive of 30-day mortality (adjusted odds ratio [AOR], 1.7; 95% confidence interval [CI], 1.3-2.2; P < .001), pneumonia (AOR, 2.4; 95% CI, 1.7-3.6; P < .001), >48-hour ventilator dependence (AOR, 2.5; 95% CI, 1.8-3.3; P < .001), and longer LOS (adjusted mean ratio, 1.4; 95% CI, 1.2-1.6; P < .001)., Conclusions: Elderly patients have significant but acceptable perioperative mortality and morbidity after rAAA repair. Use of endovascular repair in the elderly population has increased and is associated with better perioperative survival and 30-day outcomes compared with traditional open repair in this study., (Copyright © 2016 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Background Dutasteride has been successfully used in treatment of lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH). However, dutasteride inhibits 5α-reductase type 1 and type 2 enzymes and may compromises glucocorticoids and androgen metabolism and alters metabolic function resulting in undesirable metabolic and sexual adverse side effects. Aim The aim of this study was to investigate the long-term adverse effects of dutasteride therapy in men with BPH on: i) blood glucose, ii) glycated hemoglobin (HbA1c), iii) low density lipoprotein-cholesterol (LDL-C); high density lipoprotein-cholesterol (HDL-C) and total cholesterol (TC), iv) testosterone (T), v) liver alanine and aspartate aminotransferases (ALT and AST) and vi) erectile dysfunction (ED). Methods A retrospective registry study, with a cohort of 230 men aged between 47 and 68 years (mean 57.78 ± 4.81) were treated with dutasteride (0.5 mg/day) for LUTS, secondary to BPH. A second cohort of 230 men aged between 52 and 72 years (mean 62.62 ± 4.65) were treated with tamsulosin (0.4 mg). All men were followed up for 36-42 months. At intervals of 3-6 months, and at each visit, plasma glucose, HbA1c, TC, LDL-cholesterol, T levels and liver alanine amino transferase (ALT) and aspartate aminotransferase (AST) were determined. Further patient assessment was made by the International Index of Erectile Function (IIEF-EF) questionnaire, the Aging Male Symptom (AMS) and International Prostate Symptom Scores (IPSS). Results Long-term treatment with dutasteride therapy is associated with significant improvements in LUTS, as assessed by reduction in prostate volume, IPSS and prostate specific antigen (PSA). Long-term dutasteride therapy, however, resulted in increased blood glucose, HbA1c, TC and LDL levels, ALT and AST activities, AMS Score and reduced T levels and worsened ED as assessed by the IIEF-EF scores. No worsening of ED, glucose, HbA1c, ALT, AST, AMS were observed in men treated with tamsulosin. Most importantly, long-term dutasteride therapy resulted in reduction in total T levels, contributing to a state of hypogonadism. Conclusion Our findings suggest that long-term dutasteride therapy produces worsening of ED, reduced T levels and increased glucose, HbA1c and alters lipid profiles, suggesting induced imbalance in metabolic function. We strongly recommend that physicians discuss with their patients these potential serious adverse effects of long-term dutasteride therapy prior to instituting this form of treatment.

Objective: Ambulatory status has been shown to be an important predictor of postoperative morbidity and mortality for a variety of surgical procedures. We sought to assess contemporary practice patterns in treating critical limb ischemia (CLI) and outcomes based on ambulatory status., Methods: The Vascular Quality Initiative (2010-2015) was queried for patients undergoing percutaneous vascular interventions (PVIs) or lower extremity bypass (LEB) for CLI. Ambulatory status was classified as ambulatory, ambulatory with assistance, and nonambulatory (composite of wheelchair bound and bedridden). Perioperative and postoperative outcomes were recorded. Multivariable analyses were performed to identify the effect of ambulatory status., Results: There were 11,522 ambulatory (PVI, 63%; LEB, 37%), 4443 ambulatory with assistance (PVI, 67%; LEB, 33%), and 1732 nonambulatory (PVI, 77%; LEB, 23%) patients with CLI treated (P < .01 across ambulatory status groups). Perioperative mortality for PVI and LEB for ambulatory, ambulatory with assistance, and nonambulatory status was 1.5% and 1.7%, 3.0% and 3.1%, and 4.7% and 4.9%, respectively (P < .01 across ambulatory status groups). Worsening ambulatory status was associated with higher perioperative complications with PVI and LEB. Multivariable analysis showed that worsening ambulatory status predicted higher postprocedural mortality, amputation or death, and major adverse limb events or death., Conclusions: In the Vascular Quality Initiative, as ambulatory status declines, perioperative morbidity and mortality increase. Impaired ambulatory patients are more likely to receive PVI than LEB for the treatment of CLI, although even among nonambulatory patients, there are still a significant number who receive LEB., (Copyright © 2017 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Background: Poor nutritional status has been associated with a higher risk of morbidity and mortality in general surgery patients; however, outcomes in vascular surgery patients are unclear. Our goal was to determine the effect of poor nutritional status on perioperative morbidity and mortality after lower extremity bypass (LEB)., Methods: The 2005-2012 National Surgical Quality Improvement Program was analyzed to determine associated complications, mortality, length of stay (LOS), and readmissions for patients with hypoalbuminemia (serum albumin <3.5 g/dL and <2.8 g/dL) undergoing infrainguinal lower extremity bypass for critical limb ischemia. Multivariable analyses were performed to assess associated risk factors while adjusting for possible confounders., Results: There were 5,110 LEB identified with an albumin level recorded. There were 2,327 (45.5%) patients with a low preoperative albumin. Patients with a low albumin were more likely to have diabetes, chronic obstructive pulmonary disease, congestive heart failure, previous myocardial infarction, renal failure, dialysis dependence, hypertension, history of transient ischemic attack or stroke, steroid use, impaired functional status, dyspnea at rest, anemia, prior operations within 30 days, preoperative wounds or infections, and a tibial target (P < 0.05). Multivariable analyses showed that low albumin was independently associated with increased mortality (odds ratio [OR]: 1.8, 95% confidence interval [95% CI]: 1.3-2.6, P = 0.001), return to the operating room (OR: 1.4, 95% CI: 1.2-1.6, P < 0.001), and increased LOS (MR: 1.2, 95% CI: 1.1-1.2, P < 0.001). When compared with patients with normal albumin, patients with more severe hypoalbuminemia, less than 2.8 g/dL, showed further increased risk of mortality (OR: 2.5, 95% CI: 1.6-3.8), return to the operating room (OR: 1.6, 95% CI: 1.3-2.0), and prolonged LOS (MR: 1.2, 95% CI: 1.2-1.3)., Conclusions: Poor preoperative hypoalbuminemia is associated with morbidity and mortality after infrainguinal lower extremity bypass for critical limb ischemia. Evaluation and optimization of nutritional status should be performed preoperatively in this high risk population., (Copyright © 2017 Elsevier Inc. All rights reserved.)

The six-minute walk test (6MWT) has been widely used as an objective evaluation of functional exercise capacity and response to medical intervention in cardiopulmonary diseases. However, little is known about the 6MWT in evaluating patients with AL amyloidosis. We performed a retrospective study of 120 adults with systemic AL amyloidosis (60 with cardiac involvement and 60 without cardiac involvement) who had their initial evaluation at the Amyloidosis Center between 2013 and 2015 and had undergone 6MWT as a measure of functional exercise capacity. Forty-seven patients with cardiac involvement and 41 patients without cardiac involvement were included in the final analysis. The six-minute walk distances (6MWD) were 368 ± 105 m and 420 ± 116 m (mean ± SD), respectively (P = 0·03). Among AL amyloidosis patients with cardiac involvement, the 6MWD was associated with New York Heart Association class (P < 0·001), B-type natriuretic peptide (P = 0·003) and overall survival (hazard ratio 0·381, 95% confidence interval 0·215-0·676, P = 0·001). In conclusion, the 6MWT is a valuable tool in assessing functional exercise capacity in patients with AL amyloidosis., (© 2017 John Wiley & Sons Ltd.)

Objective: Patients undergoing lower extremity bypass (LEB) are at high risk of perioperative complications that can lead to a cascade of secondary complications. Our goal was to understand the association of index complications with secondary complications after LEB., Methods: The American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP) database from 2005 to 2012 was used to analyze secondary complications after five index complications after LEB: deep/organ space surgical site infection, urinary tract infection (UTI), myocardial infarction (MI), pneumonia, and acute renal failure (ARF). Index cohorts were developed with 5:1 propensity matching for comparison. This score was based on preoperative variables and event-free days., Results: We evaluated 20,230 LEB patients. Postoperative index surgical site infection increased the risk of secondary ARF (odds ratio [OR], 4.0; 95% confidence interval [CI], 1.1-15.0), pneumonia (OR, 2.7; 95% CI, 1.0-7.4), UTI (OR, 3.1; 95% CI, 1.3-7.5), cardiac arrest (OR, 4.4; 95% CI, 1.6-12.2), wound disruption (OR, 10.5; 95% CI, 6.7-16.6), unplanned intubation (OR, 5.1; 95% CI, 2.0-12.8), prolonged ventilation (OR, 5.9; 95% CI, 2.0-17.6), sepsis (OR, 16.2; 95% CI, 10.2-25.6), and mortality (OR, 3.5; 95% CI, 1.7-7.1). Postoperative index UTI was associated with pneumonia (OR, 5.6; 95% CI, 2.7-11.6), sepsis (OR, 7.8; 95% CI, 5.1-11.8), and mortality (OR, 2.7; 95% CI, 1.3-5.3). Postoperative index MI was associated with secondary ARF (OR, 8.7; 95% CI, 3.8-20.1), pneumonia (OR, 4.9; 95% CI, 2.7-8.8), cardiac arrest (OR; 7.4; 95% CI; 4.0-13.5), deep venous thrombosis (OR, 3.9; 95% CI, 1.7-9.1), unplanned intubation (OR, 12.2; 95% CI, 7.3-20.3), prolonged intubation (OR, 12.2; 95% CI, 6.4-23.2), sepsis (OR, 2.2; 95% CI, 1.2-3.8), and mortality (OR, 5.6; 95% CI, 3.6-8.5). Postoperative index pneumonia was associated with secondary ARF (OR, 25.5; 95% CI, 3.0-219.3), MI (OR, 7.6; 95% CI, 3.2-18.0), UTI (OR, 4.3; 95% CI, 2.0-9.0), cardiac arrest (OR, 5.2; 95% CI, 2.0-13.2), deep venous thrombosis (OR, 7.7; 95% CI, 2.1-27.4), unplanned intubation (OR, 14.7; 95% CI, 8.3-26.1), prolonged ventilation (OR, 26.0; 95% CI, 11.8-56.9), sepsis (OR, 7.2; 95% CI, 4.0-12.8), and mortality (OR, 6.0; 95% CI, 3.7-10.0). Last, postoperative index ARF was associated with increased risk of secondary pneumonia (OR, 7.16; 95% CI, 2.6-20.0), cardiac arrest (OR, 15.5; 95% CI, 1.6-150.9), unplanned intubation (OR, 6.2; 95% CI, 2.3-16.8), prolonged ventilation (OR, 8.8; 95% CI, 3.4-22.4), and mortality (OR, 8.8; 95% CI, 3.4-22.4)., Conclusions: A postoperative index complication after LEB is significantly more likely to lead to serious secondary complications. Prevention and early identification of index complications and subsequent secondary complications could decrease morbidity and mortality., (Copyright © 2016 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Background: Use of the CHA 2 DS 2 -VASc score instead of the CHADS 2 score for thromboembolic risk stratification and initiation of oral anticoagulation (OAC) was recommended in the 2014 American Heart Association/American College of Cardiology/Heart Rhythm Society atrial fibrillation (AF) guidelines. We sought to define the proportion of patients with AF qualifying for and receiving OAC in contemporary practice by applying the CHA 2 DS 2 -VASc score to patients with a low CHADS 2 score., Methods and Results: Among patients with AF enrolled in the American College of Cardiology National Cardiovascular Data Registry's outpatient Practice Innovation and Clinical Excellence registry (2008-2014) CHADS 2 score of 0 or 1, we calculated the impact of adoption of the CHA 2 DS 2 -VASc score on the proportion of patients with an indication for OAC. We examined trends in prescription of OAC overall, direct OAC (dabigatran/rivaroxaban/apixaban), and multivariable associations between clinical characteristics and OAC use. Of 346 068 patients with AF aged 65±12 years, 61% were men and 65% were white. In total, 24% of those with CHADS 2 =0 and 81% of those with a CHADS 2 =1 were reclassified as having a definite indication for OAC (CHA 2 DS 2 -VASc score ≥2). OAC use increased from 37% to 48% during the study period, and direct OAC use increased from 5% to 30%. Increasing CHA 2 DS 2 -VASc score (odds ratio, 2.07; 95% confidence interval, 1.97-2.19 for score of 4 versus 0) and rhythm control strategy (odds ratio, 1.34; 95% confidence interval, 1.30-1.39) were associated with increased OAC use., Conclusions: Adoption of the CHA 2 DS 2 -VASc score reclassifies 64.5% of patients with AF with low CHADS 2 scores into a class I indication for OAC prescription. Overall OAC prescription increased between 2011 and 2014., (© 2017 American Heart Association, Inc.)

Background: Decisions to use rhythm control in atrial fibrillation (AF) should generally be dictated by patient factors, such as quality of life, heart failure, and other comorbidities. Whether or not other factors affect decisions about the use of rhythm control, and catheter ablation in particular, is unknown., Methods: A cohort of all patients diagnosed with nonvalvular AF were identified from the National Cardiovascular Data Registry's Practice Innovation and Clinical Excellence (PINNACLE) AF registry of US outpatient cardiology practices during the study period from May 1, 2008, to December 31, 2014. Overall and practice-specific rates of rhythm control (cardioversion, antiarrhythmic drug therapy, or catheter ablation) were assessed. We assessed patient and practice factors associated with rhythm control and determined the relative contribution of patient, practice, and unmeasured practice factors with its use., Results: Among 511,958 PINNACLE AF patients, 22.3% were treated with rhythm control and 2.9% underwent catheter ablation. Significant practice variation in rhythm control was present (median rate of rhythm control across practices 22.8%, range 0.2%-62.9%). Significant patient factors associated with rhythm control therapy included white (vs nonwhite) race (odds ratio [OR] 2.43, P<.001), private (vs nonprivate) insurance (OR 1.04, P<.001), and whether a patient was seen by an electrophysiologist (OR 1.77, P<.001). In an analysis of the relative contribution of patient, practice, and unmeasured practice factors with rhythm control, the contribution of unmeasured practice factors (95% range OR 0.29-3.44) exceeded that of either patient (95% range OR 0.46-2.30) or practice (95% range OR 0.15-2.77) factors., Conclusions: One in 5 AF patients in the PINNACLE registry received rhythm control, and 1 in 50 received catheter ablation, suggesting that rhythm control may be underused. A variety of measured and unmeasured practice factors unrelated to patient characteristics play a disproportionate role in the use of rhythm control treatment decisions. Understanding the drivers of these decisions may identify inappropriate treatment variation and better inform optimal use of these therapies., (Copyright © 2017 Elsevier Inc. All rights reserved.)

A 5-year, 16-site, randomized controlled trial enrolled 170 HNC survivors into active (estim + swallow exercise) or control (sham estim + swallowing exercise) arms. Primary analyses showed that estim did not enhance swallowing exercises. This secondary analysis determined if/how patient compliance impacted outcomes. A home program, performed 2 times/day, 6 days/week, for 12 weeks included stretches and 60 swallows paired with real or sham estim. Regular clinic visits ensured proper exercise execution, and detailed therapy checklists tracked patient compliance which was defined by mean number of sessions performed per week (0-12 times) over the 12-week intervention period. "Compliant" was defined as performing 10-12 sessions/week. Outcomes were changes in PAS, HNCI, PSS, OPSE, and hyoid excursion. ANCOVA analyses determined if outcomes differed between real/sham and compliant/noncompliant groups after 12 weeks of therapy. Of the 170 patients enrolled, 153 patients had compliance data. The mean number of sessions performed was 8.57/week (median = 10.25). Fifty-four percent of patients (n = 83) were considered "compliant." After 12 weeks of therapy, compliant patients in the sham estim group realized significantly better PAS scores than compliant patients in the active estim group (p = 0.0074). When pooling all patients together, there were no significant differences in outcomes between compliant and non-compliant patients. The addition of estim to swallowing exercises resulted in worse swallowing outcomes than exercises alone, which was more pronounced in compliant patients. Since neither compliant nor non-compliant patients benefitted from swallowing exercises, the proper dose and/or efficacy of swallowing exercises must also be questioned in this patient population.

Objective: Although endovascular repair of ruptured abdominal aortic aneurysms (rAAAs) is increasingly more prevalent and may yield better results, open repair of rAAAs is still commonly performed. Our goal was to assess the contemporary practice patterns and outcomes of open repair of rAAA., Methods: The 2011-2014 American College of Surgeons National Surgical Quality Improvement Program targeted open AAA database was queried for all rAAAs. Patient characteristics, presentation, aneurysm details, and operative details were analyzed to identify factors that may affect outcome in this population of patients., Results: We identified 404 patients who underwent open repair of rAAA. The average age was 72 ± 9.4 years, and 76.2% were male. There were 230 (56.9%) patients who presented with hypotension. The operative approach was retroperitoneal in 16.3% of cases. The proximal extents of the aneurysms were infrarenal (52.5%), juxtarenal (24.3%), pararenal (4.2%), and suprarenal (8.2%). The distal extents were aortic (38.6%), common iliac artery (34.2%), and external or internal iliac artery (8.9%). Renal, visceral, and lower extremity revascularization was performed in 6.4%, 2.2%, and 7.9% of patients, respectively. Thirty-day mortality was 35.6%, and postoperative complications included cardiac (18.3%), pulmonary (42.3%), wound complications (6.7%), acute renal failure (17.3%), and ischemic colitis (9.4%). Postoperative length of stay was 13.1 ± 12.7 days, and 30-day readmission was 4.5%. Predictors of 30-day mortality were transperitoneal approach (odds ratio [OR], 3.3; 95% confidence interval [CI], 1.38-7.89; P < .001), hypotension at presentation (OR, 2.03; 95% CI, 1.2-3.56; P = .007), and age (OR, 1.05; 95% CI, 1.02-1.09; P = .001). Transperitoneal approach also increased the risk of postoperative cardiac complications (OR, 3.25; 95% CI, 1.01-10.4; P = .047). Postoperative pulmonary complications were predicted by chronic obstructive pulmonary disease (OR, 2.06; 95% CI, 1.07-3.94; P = .03) and hypotension at presentation (OR, 1.77; 95% CI, 1.06-2.96; P = .03)., Conclusions: The majority of contemporary open rAAA repairs were performed for infrarenal aneurysms. Transperitoneal approach, hypotension, and chronic obstructive pulmonary disease were associated with higher mortality and postoperative complications. Thirty-day mortality after rAAA was lower compared with historical data., (Copyright © 2016 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Background: Clinical prediction rules (CPRs) represent a method of determining individual patient risk to help providers make more accurate decisions at the point of care. Well-validated CPRs are underutilized but may decrease antibiotic overuse for acute respiratory infections. The integrated clinical prediction rules (iCPR) study builds on a previous single clinic study to integrate two CPRs into the electronic health record and assess their impact on practice. This article discusses study design and implementation of a multicenter cluster randomized control trial of the iCPR clinical decision support system, including the tool adaptation, usability testing, staff training, and implementation study to disseminate iCPR at multiple clinical sites across two health care systems., Methods: The iCPR tool is based on two well-validated CPRs, one for strep pharyngitis and one for pneumonia. The iCPR tool uses the reason for visit to trigger a risk calculator. Provider completion of the risk calculator provides a risk score, which is linked to an order set. Order sets guide evidence-based care and include progress note documentation, tests, prescription medications, and patient instructions. The iCPR tool was refined based on interviews with providers, medical assistants, and clinic managers, and two rounds of usability testing. "Near live" usability testing with simulated patients was used to ensure that iCPR fit into providers' clinical workflows. Thirty-three Family Medicine and General Internal Medicine primary care clinics were recruited at two institutions. Clinics were randomized to academic detailing about strep pharyngitis and pneumonia diagnosis and treatment (control) or academic detailing plus use of the iCPR tool (intervention). The primary outcome is the difference in antibiotic prescribing rates between the intervention and control groups with secondary outcomes of difference in rapid strep and chest x-ray ordering. Use of the components of the iCPR will also be assessed., Discussion: The iCPR study uses a strong user-centered design and builds on the previous initial study, to assess whether CPRs integrated in the electronic health record can change provider behavior and improve evidence-based care in a broad range of primary care clinics., Trial Registration: Clinicaltrials.gov ( NCT02534987 ).

Objective: Emergency lower extremity embolectomy is a common vascular surgical procedure that has poorly defined outcomes. Our goal was to define the perioperative morbidity for emergency embolectomy and develop a risk prediction model for perioperative mortality., Methods: The American College of Surgeons National Surgical Quality Improvement database was queried to identify patients undergoing emergency unilateral and lower extremity embolectomy. Patients with previous critical limb ischemia, bilateral embolectomy, nonemergency indication, and those undergoing concurrent bypass were excluded. Patient characteristics and postoperative morbidity and mortality were analyzed. Multivariate analysis for predictors of mortality was performed, and from this, a risk prediction model was developed to identify preoperative predictors of mortality., Results: There were 1749 patients (47.9% male) who met the inclusion criteria. The average age was 68.2 ± 14.8 years. Iliofemoral-popliteal embolectomy was performed in 1231 patients (70.4%), popliteal-tibioperoneal embolectomy in 303 (17.3%), and at both levels in 215 (12.3%). Fasciotomies were performed concurrently with embolectomy in 308 patients (17.6%). The 30-day postoperative mortality was 13.9%. Postoperative complications included myocardial infarction or cardiac arrest (4.7%), pulmonary complications (16.0%), and wound complications (8.2%). The rate of return to the operating room ≤30 days was 25.7%. Hospital length of stay was 9.8 ± 11.5 days, and the 30-day readmission rate was 16.3%. A perioperative mortality risk prediction model based on factors identified in multivariate analysis included age >70 years, male gender, functional dependence, history of chronic obstructive pulmonary disease, congestive heart failure, recent myocardial infarction/angina, chronic renal insufficiency, and steroid use. The model showed good discrimination (C = 0.769; 95% confidence interval, 0733-0.806) and calibrated well., Conclusions: Emergency lower extremity embolectomy has high morbidity, mortality, and resource utilization. These data provide a benchmark for this complex patient population and may assist in risk stratifying patients, allowing for improved informed consent and goals of care at the time of presentation., (Copyright © 2016 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Objective: Despite vast improvement in the field of vascular surgery, elective abdominal aortic aneurysm (AAA) repair still leads to perioperative death. Patients with asymptomatic AAAs, therefore, would benefit from an individual risk assessment to help with decisions regarding operative intervention. The purpose of this study was to describe such a 30-day postoperative (POD) risk prediction model using American College of Surgeons National Surgical Quality Improvement Project (NSQIP) data., Methods: The NSQIP database (2005-2011) was queried for patients undergoing elective AAA repair using open or endovascular techniques. Clinical variables and known predictors of mortality were included in a full prediction model. These variables included procedure type, patient's age, functional dependence and comorbidities, and surgeon's specialty. Backward elimination with alpha-level of 0.2 was used to construct a parsimonious model. Model discrimination was evaluated in equally sized risk quintiles., Results: The overall mortality rate for 18,917 elective AAA patients was 1.7%. In this model, surgeon's specialty was not predictive of POD. The most significant factors affecting POD included open repair (odds ratio [OR], 2.712; 95% confidence interval [CI], 2.119-3.469; P < .001), age >70 (OR, 2.243; 95% CI, 1.695-3.033; P < .001), functional dependency (OR, 2.290; 95% CI, 1.442-3.637; P < .001), creatinine above 2.0 mg/dL (OR, 2.1; 95% CI, 1.403-3.142; P < .001) and low hematocrit levels (OR, 2.157; 95% CI, 1.365-3.408; P = .001).The discriminating ability of the NSQIP model was reasonable (C-statistic = 0.751) and corrected to 0.736 after internal validation. The NSQIP model performed well predicting mortality among risk-group quintiles., Conclusions: The NSQIP risk prediction model is a robust vehicle to predict POD among patient undergoing elective AAA repair. This model can be used for risk stratification of patients undergoing elective AAA repair., (Copyright © 2016 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Dose finding Phase I oncology designs can be broadly categorized as rule based, such as the 3 + 3 and the accelerated titration designs, or model based, such as the CRM and Eff-Tox designs. This paper systematically reviews and compares through simulations several statistical operating characteristics, including the accuracy of maximum tolerated dose (MTD) selection, the percentage of patients assigned to the MTD, over-dosing, under-dosing, and the trial dose-limiting toxicity (DLT) rate, of eleven rule-based and model-based Phase I oncology designs that target or pre-specify a DLT rate of ∼0.2, for three sets of true DLT probabilities. These DLT probabilities are generated at common dosages from specific linear, logistic, and log-logistic dose-toxicity curves. We find that all the designs examined select the MTD much more accurately when there is a clear separation between the true DLT rate at the MTD and the rates at the dose level immediately above and below it, such as for the DLT rates generated using the chosen logistic dose-toxicity curve; the separations in these true DLT rates depend, in turn, not only on the functional form of the dose-toxicity curve but also on the investigated dose levels and the parameter set-up. The model based mTPI, TEQR, BOIN, CRM and EWOC designs perform well and assign the greatest percentages of patients to the MTD, and also have a reasonably high probability of picking the true MTD across the three dose-toxicity curves examined. Among the rule-based designs studied, the 5 + 5 a design picks the MTD as accurately as the model based designs for the true DLT rates generated using the chosen log-logistic and linear dose-toxicity curves, but requires enrolling a higher number of patients than the other designs. We also find that it is critical to pick a design that is aligned with the true DLT rate of interest. Further, we note that Phase I trials are very small in general and hence may not provide accurate estimates of the MTD. Thus our work provides a map for planning Phase I oncology trials or developing new ones.

Purpose: Magnetic resonance imaging (MRI) is a high-cost imaging modality, and an optimized encounter ideally provides high-quality care, patient satisfaction, and capacity utilization. Our purpose was to assess the effectiveness of team training and its impact on patient show-up and completion rates for their MRI examinations., Materials and Methods: A total of 97,712 patient visits from three tertiary academic medical centers over 1-year intervals were evaluated, totaling 49,733 visits at baseline and 47,979 after training. Each center's MRI team received team training skill training including advanced communication and team training techniques training. This training included onsite instruction including case simulation with scenarios requiring appropriate behavioral and communicative interventions. Orientation and training also utilized customized online tools and proctoring. The study completion rate and patient show-up rate during consecutive year-long intervals before and after team training were compared to assess its effectiveness. Two-sided chi-square tests for proportions using were applied at a 0.05 significance level., Results: Despite differing no-show rates (5-22.2%) and study incompletion rates (0.7-3.7%) at the three academic centers, the combined patients' data showed significant (P < 0.0001) improvement in the patients' no-show rates (combined decreases from 11.2% to 8.7%) and incompletion rates (combined decreases from 2.3% to 1.4%)., Conclusion: Our preliminary results suggest training of the imaging team can improve the no-show and incompletion rates of the MRI service, positively affecting throughput and utilization. Team training can be readily implemented and may help address the needs of the current cost-conscious and consumer-sensitive healthcare environment. J. MAGN. RESON. IMAGING 2016;44:1040-1047., (© 2016 International Society for Magnetic Resonance in Medicine.)

Background: Proton-pump inhibitors (PPIs) have been demonstrated to reduce rates of gastrointestinal events in patients requiring dual antiplatelet therapy (DAPT). Data are limited regarding the efficacy and safety of PPIs in high-risk cardiovascular subsets after acute coronary syndrome or percutaneous coronary intervention., Methods: All patients enrolled in COGENT (Clopidogrel and the Optimization of Gastrointestinal Events Trial) were initiated on DAPT (with aspirin and clopidogrel) for various indications within the prior 21 days. These post hoc analyses of the COGENT trial evaluated the efficacy and safety of omeprazole compared with placebo in subsets of patients requiring DAPT for the 2 most frequent indications: 1) patients undergoing percutaneous coronary intervention (for any indication) within 14 days of randomization (n = 2676; 71.2%); and 2) patients presenting with acute coronary syndrome managed with or without percutaneous coronary intervention (n = 1573; 41.8%). Unadjusted Cox proportional hazards models were used to estimate effect sizes through final follow-up., Results: Median follow-up duration was 110 days (interquartile range 55-167). In percutaneous coronary intervention-treated patients, omeprazole significantly reduced rates of composite gastrointestinal events at 180 days (1.2% vs 2.7%; hazard ratio [HR] 0.43; 95% confidence interval [CI], 0.22-0.85; P = .02) without increasing composite cardiovascular events (5.4% vs 6.3%; HR 1.00; 95% CI, 0.67-1.50; P = 1.00). Similarly, omeprazole lowered risk of the primary gastrointestinal endpoint at 180 days in patients presenting with acute coronary syndrome (1.1% vs 2.7%; HR 0.37; 95% CI, 0.13-1.01; P = .05) without a significant excess in cardiovascular events (5.6% vs 4.5%; HR 1.40; 95% CI, 0.77-2.53; P = .27)., Conclusions: PPI therapy attenuates gastrointestinal bleeding risk without significant excess in major cardiovascular events in high-risk cardiovascular subsets, regardless of indication for DAPT. Future studies will be needed to clarify optimal gastroprotective strategies for higher-intensity and longer durations of DAPT., (Copyright © 2016 Elsevier Inc. All rights reserved.)

Objectives: The Model of End-Stage Liver Disease (MELD) score has been traditionally utilized to prioritize for liver transplantation; however, recent literature has shown its value in predicting surgical outcomes for patients with hepatic dysfunction. The benefit of carotid endarterectomy in asymptomatic patients is dependent on low perioperative morbidity. Our objective was to use MELD score to predict outcomes in asymptomatic patients undergoing carotid endarterectomy., Methods: Patients undergoing carotid endarterectomy were identified in the National Surgical Quality Improvement Program data sets from 2005 to 2012. The Model of End-Stage Liver Disease score was calculated using serum bilirubin, creatinine, and the international normalized ratio (INR). Patients were grouped into low (<9), moderate (9-14), and high (15+) MELD classifications. The effect of the MELD score on postoperative morbidity and mortality was assessed by multivariable logistic and gamma regressions and propensity matching., Results: There were 7966 patients with asymptomatic carotid endarterectomy identified. The majority 5556 (70%) had a low MELD score, 1952 (25%) had a moderate MELD score, and 458 (5%) had a high MELD score. High MELD score was independently predictive of postoperative death, increased length of stay, need for transfusion, pulmonary complications, and a statistical trend toward increased cardiac arrest/myocardial infarction. The Model of End-Stage Liver Disease score did not affect postoperative stroke, wound complications, or operative time., Conclusion: High MELD score places asymptomatic patients undergoing carotid endarterectomy at a higher risk of adverse outcomes in the 30 days following surgery. This provides further empirical evidence for risk stratification when considering treatment for these patients. Outcomes of medical management or carotid stenting should be investigated in high-risk patients., (© The Author(s) 2016.)

Objectives: To update the imaging literature regarding spleen appearances in young patients with sickle cell disease (SCD)., Methods: We conducted a retrospective study and included 112 patients age 0 to 21 years with SCD who had at least 1 abdominal sonogram at our institution between 1999 and 2011. Radiologic findings were compared between risk groups by χ(2) analysis. Findings were correlated with other imaging modalities when available., Results: In our cohort, 35.7% of patients had autosplenectomy, and 8.0% had undergone surgical splenectomy. Only 5.0% of individuals age 0 to 5 years had autosplenectomy. In those who had not undergone surgical splenectomy or autosplenectomy, 76.2% had echogenic spleens, heterogeneous-appearing spleens, or both, and patients with the homozygous sickle cell anemia (HbSS) genotype were more likely to have an abnormal spleen echo texture. Patients treated with transfusions had echogenic spleens and had a higher frequency of splenic regeneration nodules. Most patients (80%) with splenomegaly did not require surgical splenectomy after 5.7 years of follow-up., Conclusions: Twenty years ago, children with HbSS SCD were expected to have autosplenectomy by age 5 years. There have been changes in the radiologic appearance of the spleen in patients with SDC, likely due to improved supportive care and the use of acute and chronic transfusion therapy. We found that autosplenectomy is rare by age 5 years, and during childhood and adolescence, the spleen typically appears echogenic, heterogeneous, or both, depending on disease severity.

Background: Native arteriovenous fistulas (AVFs) have a high 1 year failure rate leading to a need for secondary procedures. We set out to create a predictive model of early failure in patients undergoing first-time AVF creation, to identify failure-associated factors and stratify initial failure risk., Methods: The Vascular Study Group of New England (VSGNE) (2010-2014) was queried to identify patients undergoing first-time AVF creation. Patients with early (within 3 months postoperation) AVF failure (EF) or no failure (NF) were compared, failure being defined as any AVF that could not be used for dialysis. A multivariate logistic regression predictive model of EF based on perioperative clinical variables was created. Backward elimination with alpha level of 0.2 was used to create a parsimonious model., Results: We identified 376 first-time AVF patients with follow-up data available in VSGNE. EF rate was 17.5%. Patients in the EF group had lower rates of hypertension (80.3% vs. 93.2%, P = 0.003) and diabetes (47.0% vs. 61.3%, P = 0.039). EF patients were also more likely to have radial artery inflow (57.6% vs. 38.4%, P = 0.011) and have forearm cephalic vein outflow (57.6% vs. 36.5%, P = 0.008). Additionally, the EF group was noted to have significantly smaller mean diameters of target artery (3.1 ± 0.9 vs. 3.6 ± 1.1, P = 0.002) and vein (3.1 ± 0.7 vs. 3.6 ± 0.9, P < 0.001). Multivariate analyses revealed that hypertension, diabetes, and vein larger than 3 mm were protective of EF (P < 0.05). The discriminating ability of this model was good (C-statistic = 0.731) and the model fits the data well (Hosmer-Lemeshow P = 0.149). β-estimates of significant factors were used to create a point system and assign probabilities of EF., Conclusions: We developed a simple model that robustly predicts first-time AVF EF and suggests that anatomical and clinical factors directly affect early AVF outcomes. The risk score has the potential to be used in clinical settings to stratify risk and make informed follow-up plans for AVF patients., (Copyright © 2016 Elsevier Inc. All rights reserved.)

Although the concept of equivalence for drugs (generics) and biologics (biosimilars) has been readily adopted, the concept of equivalence or indistinguishable characteristics for class III medical devices has yet to be specifically addressed regarding a defined regulatory approval process in the US. In September 2015, GenVisc 850® (sodium hyaluronate), a hyaluronic acid approved for the treatment of knee osteoarthritis, was approved by the US Food and Drug Administration (FDA) based upon indistinguishable characteristics in comparison to an approved branded hyaluronic acid (Supartz®/Supartz FX™). The purpose of this paper is to review the methodology and report the main outcomes used to demonstrate clinical comparability of GenVisc 850 with Supartz/Supartz FX. The FDA approval was collectively attained using prospectively defined methods for preclinical, physical, and chemical testing, as well as noninferiority in clinical performance comparisons. Evidence from five randomized controlled studies of Supartz/Supartz FX vs saline control injections (used for Supartz approval), two randomized controlled trials of GenVisc 850 vs saline control injections, and one randomized controlled study of GenVisc 850 vs Supartz/Supartz FX provided evidence of safety for GenVisc 850. Efficacy was further assessed based on assessment of the same Supartz studies and three prospectively identified GenVisc 850 studies. A Bayesian network meta-analysis was used to demonstrate that the clinical efficacy of GenVisc 850 was noninferior to Supartz/Supartz FX and superior to saline control. Overall, safety of GenVisc 850 was similar to that of Supartz/Supartz FX and saline control injections, while efficacy of GenVisc 850 was noninferior to that of Supartz/Supartz FX and superior to saline control injections.

Objective: The Model for End-Stage Liver Disease (MELD) score has traditionally been used to prioritize liver transplantation. However, its use has been extended to predict overall and postoperative outcomes in patients with hepatic and renal dysfunction. Our objective was to use the MELD score to predict outcomes in patients undergoing lower extremity bypass., Methods: Patients undergoing infrainguinal bypass were identified in the American College of Surgeons National Surgical Quality Improvement Program data sets from 2005 to 2012. The MELD score was calculated using serum bilirubin and creatinine values and the international normalized ratio. Patients were grouped into low (<9), moderate (9-14), and high (15+) MELD classifications. The associations of the MELD score on postoperative morbidity and mortality were assessed by multivariable logistic and gamma regressions and by propensity matching., Results: There were 5967 patients who underwent infrainguinal bypass with the following MELD score distribution: <9, 3795 (64%); 9 to 14, 1819 (30%); and 15+, 353 (6%). Matched analysis in comparing low, moderate, and high MELD scores showed a higher risk for cardiac complications (2.8% vs 3.2% vs 5.4%; P < .001), bleeding complications (9.3% vs 11.1% vs 13.9%; P = .048), and increased postoperative length of stay (median [range], 5 [0-93] vs 6 [0-73] vs 6 [0-86]; P < .001). The MELD score had no association with early bypass failure, wound complications, or operative time. Moderate and high MELD scores were independent predictors of postoperative myocardial infarction/cardiac arrest (odds ratio [OR], 2.4; 95% confidence interval [CI], 1.6-3.6; P < .001; and OR, 4.1; 95% CI, 2.3-7.3; P < .01), bleeding complications (OR, 1.3; 95% CI, 1.1-1.6; P < .01; and OR, 1.8; 95% CI, 1.3-2.5; P < .01), return to the operating room (OR, 1.3; 95% CI, 1.1-1.5; P < .01; and OR, 1.4; 95% CI, 1.03-1.8; P = .03), extended postoperative length of stay (means ratio, 1.2; 95% CI, 1.1-1.2; P < .01; and means ratio, 1.2; 95% CI, 1.2-1.3; P < .01), and perioperative mortality (OR, 1.6; 95% CI, 1.02-2.5; P = .04; and OR, 2.9; 95% CI, 1.6-5.4; P = .01), respectively. Propensity matching between low, moderate, and high MELD score groups confirmed an increased risk of postoperative myocardial infarction/cardiac arrest (P < .01), bleeding complications (P = .05), and extended postoperative length of stay (P < .01) with a trend toward increased mortality and return to operating room., Conclusions: An elevated MELD score places patients undergoing infrainguinal bypass at higher risk of perioperative morbidity and mortality. This provides an evidence base for risk stratification and informed consent for these patients. Alternative treatment may be considered in these patients; however, the overall morbidity and mortality rates may still be acceptable, even in high-risk patients., (Copyright © 2016 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Background: Autologous great saphenous vein (GSV) has always been considered the gold standard conduit for infrainguinal revascularization. When GSV is inadequate or unavailable, alternative conduits have been used. In this study, we compared modern outcomes of different conduit types used in lower extremity bypass (LEB) for patients with critical limb ischemia (CLI)., Methods: The Vascular Study Group of New England database (2003-2014) was queried for patients who underwent infrageniculate bypass originating from the femoral arteries. Conduit types were categorized as single-segment GSV, alternative autologous conduit (AAC), and nonautologous conduit (NAC). Primary outcomes were 1-year freedom from major adverse limb event (MALE), MALE-free survival, and primary graft patency. Multivariable Cox regression was used to adjust for demographics and comorbidities., Results: LEB was performed in 2148 patients, of which 1125 were to below-knee popliteal (BK-Pop) and 1023 to infrapopliteal artery (IPA) targets. The baseline characteristics differed among the conduit groups: Patients in the GSV group were younger and had fewer comorbidities than in the AAC groups. Patients undergoing BK-Pop bypass with NAC had higher rates of postoperative myocardial infarction (7.1%) and postoperative (5.8%) and 1-year death (40.8%) than in those with GSV (3.1%, 2%, and 31.7%, respectively) and AAC (0%, 0%, and 25%, respectively). In multivariable analysis, conduit type did not make a difference in 1-year MALE, MALE-free survival, or primary graft patency for BK-Pop bypasses. For IPA bypasses, NAC use was associated with higher rates of postoperative (6.4%) and in-hospital death (4.5%) compared with GSV (2.5% and 1.4%, respectively) and AAC (2.9% and 1.9%, respectively). In adjusted analysis, NAC was associated with higher risk of MALE (hazard ratio [HR], 1.50; 95% confidence interval [CI], 1.03-2.20; P = .036) and primary patency loss (HR, 1.3; 95% CI, 0.91-1.89), and lower MALE-free survival (HR, 1.47; 95% CI, 1.03-2.09; P = .035) compared with GSV. There was no difference between the NAC and AAC groups., Conclusions: Conduit type does not affect outcomes in BK-Pop bypass. In the absence of single-segment GSV, the use of AAC for IPA bypass does not appear to confer any additional benefit of MALE, MALE-free survival, or graft patency compared with prosthetic grafts at 1-year follow-up., (Copyright © 2016. Published by Elsevier Inc.)

Background: In randomized trials endovascular aortic aneurysm repair (EVAR) has been shown to have superior perioperative outcomes compared with open aneurysm repair (OAR). However, outcomes in patients at low risk of complications are unclear and many surgeons still prefer OAR in this cohort. The objective was to analyse perioperative and longer-term outcomes of OAR and EVAR in this low-risk group of patients., Methods: All elective infrarenal EVARs and OARs in the Vascular Study Group of New England database were reviewed from 2003 to 2014. The Medicare scoring system was used to identity patients at low risk of perioperative complications and death. Perioperative and longer-term outcomes were analysed in this cohort. A Kaplan-Meier plot was constructed for evaluation of longer-term survival. Further propensity matching and multivariable analysis were performed to analyse additional differences between the two groups., Results: Some 1070 patients who underwent EVAR and 476 who had OAR were identified. Mean(s.d.) age was 67·3(5·7) and 65·1(6·3) years respectively (P < 0·001). EVAR was associated with a lower overall perioperative complication rate (4·2 versus 26·5 per cent; P < 0·001). There was no difference in 30-day mortality (0·4 versus 0·6 per cent; P = 0·446). Overall survival at 3 years was similar after EVAR and OAR (92·5 versus 92·1 per cent respectively; P = 0·592). In multivariable analyses there was no difference in freedom from reintervention (odds ratio 1·69, 95 per cent c.i. 0·73 to 3·90; P = 0·220) or survival (hazard ratio 0·85, 0·61 to 1·20; P = 0·353)., Conclusion: In patients predicted to be at low risk of perioperative death following aneurysm repair, EVAR resulted in fewer perioperative complications than OAR. However, perioperative mortality, reinterventions and survival rates in the longer term appeared similar between endovascular and open repair., (© 2016 BJS Society Ltd Published by John Wiley & Sons Ltd.)

Background/objectives: Long-term testosterone therapy (TTh) in men with hypogonadism has been shown to improve all components of the metabolic syndrome. In this study, we investigated the effects of long-term TTh up to 8 years in hypogonadal men with a history of cardiovascular disease (CVD)., Patients and Methods: In two urological clinics observational registries, we identified 77 hypogonadal men receiving TTh who also had a history of CVD. The effects of TTh on anthropometric and metabolic parameters were investigated for a maximum duration of 8 years. Any occurrence of major adverse cardiovascular events was reported. All men received long-acting injections of testosterone undecanoate at 3-monthly intervals., Results: In 77 hypogonadal men with a history of CVD who received TTh, we observed a significant weight loss and a decrease in waist circumference and body mass index. Mean weight decreased from 114±13 kg to 91±9 kg, change from baseline: -24±1 kg and -20.2%±0.5%. Waist circumference decreased from 112±8 cm to 99±6 cm, change from baseline: -13±0.3 cm. Body mass index decreased from 37±4 to 29±3, change from baseline: -8±0.2 kg/m(2). Cardio-metabolic parameters such as lipid pattern, glycemic control, blood pressure, heart rate, and pulse pressure all improved significantly and sustainably. No patient suffered a major adverse cardiovascular event during the full observation time., Conclusion: In men with hypogonadism, TTh appears to be effective in achieving sustained improvements in all cardiometabolic risk factors and may be effective as an add-on measure in the secondary prevention of cardiovascular events in hypogonadal men with a history of CVD.