Women are Not at Higher Risk for Reintervention or Major Amputation after Lower Extremity Atherectomy for Peripheral Artery Disease.

BACKGROUND: Our objective was to compare short-term and long-term differences in reintervention-free and major amputation-free survival between female and male patients undergoing lower extremity atherectomy for peripheral artery disease. METHODS: We analyzed lower extremity atherectomy procedures performed on 294 patients between January 2014 and September 2019. Reintervention was defined as either open bypass or endovascular procedure to the same region following the index operation. Kaplan-Meier (KM) survival analysis was performed to compare reintervention-free and major amputation-free survival between sexes. Multivariate logistic regression analyses were performed to determine the adjusted odds of reintervention and major amputation based on sex. We conducted subgroup analyses by anatomic region (femoropopliteal vs. tibial), indication (claudication vs. chronic limb-threatening ischemia (CLTI)), and balloon type (drug-coated balloon (DCB) versus plain balloon angioplasty (POBA)) across sexes. RESULTS: Of the 294 patients, 125 (42.5%) were female. Compared to men, women receiving atherectomy were more likely to be Black (28.0% vs. 16.6%; P = 0.018), a nonsmoker (44.8% vs. 21.3%; P < 0.001), and present with CLTI (55.2% vs. 43.2%; P = 0.042). There were no differences in atherectomy region, lesion type, or balloon type between sexes. KM analysis showed similar 4-year reintervention-free survival (68.8% vs. 75.1%; P = 0.88) and major amputation-free survival (97.6% vs. 97.6%; P = 0.41) between sexes. Women and men had similar reintervention-free survival when grouped by femoropopliteal (67.9% vs. 70.8%; P = 0.69) or tibial (76.2% vs. 83.9%; P = 0.68) atherectomy region. Indication (claudication versus CLTI) did not affect reintervention-free survival in either women (64.5% vs. 69.6%; P = 0.28) or men (68.5% vs. 76.7%; P = 0.84). KM curves for DCB versus POBA were also similar between sexes and showed an early benefit in reintervention rate favoring DCB, which dissipated in both women (65.4% vs. 72.7%; P = 0.61) and men (75.5% vs. 78.4%; P = 0.18) by 3 years. CONCLUSIONS: Compared to men, women demonstrate commensurate benefit from atherectomy for lower extremity revascularization. There were no differences seen in long-term reintervention or major amputation between sexes.

Follow-up after acute thrombotic events following COVID-19 infection.

OBJECTIVE: COVID-19 infection results in a hypercoagulable state predisposing patients to thrombotic events. We report the 3- and 6-month follow-up of 27 patients who experienced acute arterial thrombotic events in the setting of COVID-19 infection. METHODS: Data were prospectively collected and maintained for all vascular surgery consultations in the Mount Sinai Health System from patients who presented between March 16 and May 5, 2020. RESULTS: Twenty-seven patients experienced arterial thrombotic events. The average length of stay was 13.3 ± 15.4 days. Fourteen patients were treated with open surgical intervention, six were treated with endovascular intervention, and seven were treated with anticoagulation only. At 3-month follow-up, 11 patients (40.7%) were deceased. Nine patients who expired did so during the initial hospital stay. The 3-month cumulative primary patency rate for all interventions was 72.2%, and the 3-month primary patency rates for open surgical and endovascular interventions were 66.7 and 83.3, respectively. There were 9 (33.3%) readmissions within 3 months. Six-month follow-up was available in 25 (92.6%) patients. At 6-month follow-up, 12 (48.0%) patients were deceased, and the cumulative primary patency rate was 61.9%. The 6-month primary patency rates of open surgical and endovascular interventions were 66.7% and 55.6%, respectively. The limb-salvage rate at both 3 and 6 months was 89.2%. CONCLUSIONS: Patients with COVID-19 infections who experienced thrombotic events saw high complication and mortality rates with relatively low patency rates.

Trends, factors, and disparities associated with length of stay after lower extremity bypass for tissue loss.

OBJECTIVE: The objective of this study was to determine predictors of increased length of stay (LOS) in patients who underwent lower extremity bypass for tissue loss. METHODS: Using 2011 to 2016 National Surgical Quality Improvement Program vascular targeted databases, we compared demographics, comorbidities, procedural characteristics, and 30-day outcomes of patients who had expected LOS vs extended LOS (>75th percentile, 9 days) after nonemergent lower extremity bypass for tissue loss. We also compared factors associated with short LOS (<25th percentile, 4 days) and extended LOS (>75th percentile, 9 days) vs the interquartile range of LOS (4-9 days). Yearly trends and independent predictors were determined by linear and logistic regression. This study was exempt from Institutional Review Board approval. RESULTS: In 4964 analyzed patients, there were no significant yearly trends or changes in LOS in the recent 5 years (P > .05). Overall 30-day mortality, major amputation, and reintervention rates were 1.6%, 4.5%, and 4.8%, respectively, also with no significant yearly trends (all P > .05). On univariate analysis, nonwhite race, dependent functional status, transfers, dialysis, congestive heart failure, hypertension, beta blockers, distal bypass targets, and extended operative time were associated with extended LOS (P < .05). Extended LOS was also associated with higher rates of 30-day major adverse limb and cardiac events, additional procedures related to wound care, deep venous thrombosis, complications (pulmonary, renal, septic, bleeding, and wound), and discharge to facility but lower 30-day readmission rates. After adjustment for covariates, the independent factors for extended LOS included dialysis, beta blockers, prolonged operative time, reintervention, major amputation, additional procedures related to wound care, deep venous thrombosis, complications (pulmonary, renal, septic, bleeding, and wound), and discharge to facility (P < .05). On the other hand, multivariable analysis showed that patients with expected LOS were significantly more likely to have been of white race or readmitted postoperatively (P < .05). CONCLUSIONS: From 2011 to 2016, there were no significant changes in LOS. Efforts to decrease LOS without increasing readmission rates while focusing on some of the identified factors, including preventable postoperative complications and pre-existing socioeconomic factors, may improve the overall vascular care of these challenging patients.

Neutrophil-to-Lymphocyte Ratio Associated With Adverse Events After Endovascular Aneurysm Repair (EVAR).

BACKGROUND: The blood neutrophil-to-lymphocyte ratio (NLR) is a surrogate biomarker of systemic inflammation with important prognostic significance in multiple disease processes, including cardiovascular diseases. It is inexpensive, widely available, and may be related to the outcomes of patients after surgery. We aimed to investigate the possible association of NLR with the outcomes of patients following endovascular aneurysm repair (EVAR). METHODS: This single-center, retrospective study of a prospectively maintained database evaluated 777 patients with a diagnosed abdominal aortic aneurysm (AAA) who underwent EVAR and were longitudinally followed between 2001 and 2017. NLR was defined as the ratio of absolute neutrophil count to absolute lymphocyte count. The mortality and reinterventions were used to evaluate outcomes using the appropriate univariate models, and the effect of clinical variables on NLR was further investigated using multivariate modelling. RESULTS: The median NLR for all patients was 3 IQR [2.2 - 4.6]. A cut-off point of 3.6 was uncovered in a training set of 388 patients using the maximally ranked statistic method. Patients with NLR < 3.6 had significantly improved mortality rates (P< 0.0001) in the training set, and results were internally validated in a testing set of 389 patients (P = 0.042). Multivariate analysis revealed that high NLR (HR 1.4 95% CI [1.0 - 2.0]; P< 0.05) remained an independent predictor of mortality in a multivariate analysis controlling for characteristics such as comorbidities, age, and maximal aortic diameter. 5-year mortality and 30-day, 1-year and 5-year reinterventions were all higher in the high NLR group. CONCLUSION: High NLR was significantly associated with higher rates of death at 5 years as well as higher rates of reinterventions at 30 days, 1 year and 5 years. We also suggest that an internally validated cut-off point of NLR >3.6 may be clinically important to help segregate patients into high and low NLR categories. It remains unclear whether NLR is directly linked to adverse events post-EVAR or whether it is a surrogate for an inflammatory state that predisposes patients to higher risk of death or reinterventions.

Defining Types and Determining Risk Factors for Vascular Surgery Readmissions.

BACKGROUND: Vascular surgery patients typically have numerous comorbidities, which puts them at higher risk for postoperative readmissions. This study aims to investigate the risk factors for and appropriately categorize the various types of vascular surgery readmissions. METHODS: Nine hundred seventy-two patients were retrospectively reviewed. Readmissions were classified into 3 separate groups: readmissions that occurred between 0 and 30 days (30-day readmissions), 31-90 days (3-month readmissions), and 91-365 days (1-year readmissions). Each readmission was then assigned to 1 of the 4 categories based on whether they were related to the index procedure and whether they were planned. Univariate tests were performed for demographic variables based on their type of readmission, and logistic regressions were then performed to identify predictors of each unplanned, related readmissions. RESULTS: The overall 30-day readmission rate was 21.9% (n = 213). The unplanned, related readmission cohort (n = 83) had the highest readmission rate of 8.5%. The related, planned readmission rate was 5.9% (n = 58), while the unrelated, unplanned readmission rate was 5.6% (n = 55). In contrast, the overall 1-year readmission rate was 40.0% (n = 389), with the largest category being unplanned, unrelated readmissions at 19.7% (n = 191). The unplanned, related readmission rate was 8.7% (n = 85), whereas the planned, related readmission rate was 5.7% (n = 55). Compared with other types of readmissions, unplanned, related readmissions tended to affect patients who were younger, had poor glycemic control, and had higher body mass indexes (BMIs). Multivariate predictors of unplanned, related readmissions were poor glycemic control at 3 months (odds ratio [OR]: 2.16, P = 0.03), and BMI at 30 days (OR: 1.06, P = 0.04) and 1 year (OR: 1.05, P = 0.04). CONCLUSIONS: Readmissions have varying risk factors depending on their category; targeting glycemic control and obesity may reduce unplanned, related readmissions.

Black patients present with more severe vascular disease and a greater burden of risk factors than white patients at time of major vascular intervention.

BACKGROUND: Although many studies have demonstrated racial disparities after major vascular surgery, few have identified the reasons for these disparities, and those that did often lacked clinical granularity. Therefore, our aim was to evaluate differences in initial vascular intervention between black and white patients. METHODS: We identified black and white patients' initial carotid, abdominal aortic aneurysm (AAA), and infrainguinal peripheral artery disease (PAD) interventions in the Vascular Quality Initiative (VQI) registry from 2009 to 2014. We excluded nonblack or nonwhite patients as well as those with Hispanic ethnicity, asymptomatic PAD, or a history of prior ipsilateral interventions. We compared baseline characteristics and disease severity at time of intervention on a national and regional level. RESULTS: We identified 76,372 patients (9% black), including 35,265 carotid (5% black), 17,346 AAA (5% black), and 23,761 PAD interventions (18% black). For all operations, black patients were younger, more likely female, and had more insulin-dependent diabetes, hypertension, congestive heart failure, renal dysfunction, and dialysis dependence. Black patients were less likely to be on a statin before AAA (62% vs 69%; P < .001) or PAD intervention (61% vs 67%; P < .001) and also less likely to be discharged on an antiplatelet and statin regimen after these procedures (AAA, 60% vs 64% [P = .01]; PAD, 64% vs 67% [P < .001]). Black patients presented with more severe disease, including higher proportions of symptomatic carotid disease (36% vs 31%; P < .001), symptomatic or ruptured AAA (27% vs 16%; P < .001), and chronic limb-threatening ischemia (73% vs 62%; P < .001). Black patients more often presented with concurrent iliac artery aneurysms at the time of AAA repair (elective open AAA repair, 46% vs 26% [P < .001]; elective endovascular aneurysm repair, 38% vs 23% [P < .001]). CONCLUSIONS: Black patients present with more advanced disease at the time of initial major vascular operation. Efforts to control risk factors, identify and treat arterial disease in a timely fashion, and optimize medical management among black patients may provide opportunity to improve current disparities.

Regional variation in patient selection and treatment for lower extremity vascular disease in the Vascular Quality Initiative.

OBJECTIVE: Prior studies on the cause and effect of surgical variation have been limited by utilization of administrative data. The Vascular Quality Initiative (VQI), a robust national clinical registry, provides anatomic and perioperative details allowing a more robust analysis of variation in surgical practice. METHODS: The VQI was used to identify all patients undergoing infrainguinal open bypass or endovascular intervention from 2009 to 2014. Asymptomatic patients were excluded. The 16 regional groups of the VQI were used to compare variation in patient selection, operative indication, technical approach, and process measures. χ2 analysis was used to assess for differences across regions where appropriate. RESULTS: A total of 52,373 interventions were included (31%). Of the 16,145 bypasses, 5% were performed for asymptomatic disease, 26% for claudication, 56% for chronic limb-threatening ischemia (CLI) (61% of these for tissue loss), and 13% for acute limb-threatening ischemia. Of the 35,338 endovascular procedures, 4% were for asymptomatic disease, 40% for claudication, 46% for CLI (73% tissue loss), and 12% for acute limb-threatening ischemia. Potentially unwarranted variation included proportion of prosthetic conduit for infrapopliteal bypass in claudication (13%-41%, median, 29%; P < .001), isolated tibial endovascular intervention for claudication (0.0%-5.0%, median, 3.0%; P < .001), discharge on antiplatelet and statin (bypass: 62%-84%; P < .001; endovascular: 63%-89%; P < .001), and ultrasound guidance for percutaneous access (claudication: range, 7%-60%; P < .001; CLI: 5%-65%; P < .001). Notable areas needing further research with significant variation include proportion of CLI vs claudication treated by bypass (38%-71%; P < .001) and endovascular intervention (28%-63%; P < .001), and use of closure devices in percutaneous access (claudication; 26%-76%; P < .001; CLI: 30%-78%; P < .001). CONCLUSIONS: Significant variation exists both in areas where evidence exists for best practice and, therefore, potentially unwarranted variation, and in areas of clinical ambiguity. Quality improvement efforts should be focused on reducing unwarranted variation. Further research should be directed at identifying best practice where no established guidelines and high variation exists.

Regional variation in outcomes for lower extremity vascular disease in the Vascular Quality Initiative.

BACKGROUND: Increased focus has been placed on perioperative and long-term outcomes in the treatment of peripheral artery disease (PAD), both for purposes of quality improvement and for assessment of performance at a surgeon and institutional level. This study evaluates regional variation in outcomes after treatment for PAD within the Vascular Quality Initiative (VQI). By describing the variation in practice patterns and outcomes across regions, we hope that each regionally based quality group can select which areas are most important for them to focus on as they will have access to their regional data to compare. METHODS: We identified all patients in the VQI who had infrainguinal bypass or endovascular intervention from 2009 to 2014. We compared variation in perioperative and 1-year outcomes stratified by symptom status and revascularization type among the 16 regional groups of the VQI. We analyzed variation in perioperative end points using χ2 analysis, and 1-year end points were analyzed using Kaplan-Meier and life-table analysis. RESULTS: We identified 15,338 bypass procedures for symptomatic PAD: 27% for claudication, 59% for chronic limb-threatening ischemia (CLI; 61% of these for tissue loss), and 14% for acute limb ischemia. We identified 33,925 endovascular procedures for symptomatic PAD: 42% for claudication, 48% for CLI (73% of these for tissue loss), and 10% for acute limb ischemia. Thirty-day mortality varied significantly after endovascular intervention for CLI (0.5%-3%; P < .001) but not for claudication (0.0%-0.5%, P = .77) or for bypass for claudication (0.0%-2.6%; P = .37) or CLI (0.0%-5.0%; P = .08). After bypass, rates of >2 units transfused red blood cells (claudication, 0.0%-13% [P < .001]; CLI, 6.9%-27% [P < .001]) varied significantly. In-hospital major amputation was variable after bypass for CLI (0.0%-4.3%; P = .004) but not for claudication (0.0%-0.6%; P = .98), as was postoperative myocardial infarction (claudication, 0.0%-4% [P = .36]; CLI, 0.8%-6% [P = .001]). One-year survival varied significantly for endovascular interventions for claudication (92%-100%; P < .001), bypass for CLI (85%-94% [P < .001]), and endovascular interventions for CLI (77%-96%; P < .001) but not after bypass for claudication (95%-100%; P = .57). CONCLUSIONS: In this real-world comparison among VQI regions, we found significant variation in perioperative and 1-year end points for patients with PAD undergoing bypass or endovascular intervention. This study highlights opportunities for quality improvement efforts to reduce variation and to improve outcomes.

Preoperative inflammatory status as a predictor of primary patency after femoropopliteal stent implantation.

OBJECTIVE: The purpose of this study was to evaluate the impact of preoperative inflammatory status, as determined by complete blood count test parameters, on 12- and 24-month patency of femoropopliteal stenting for peripheral arterial disease. METHODS: We retrospectively analyzed baseline clinical and angiographic data among 138 patients (median age, 73 years; 46% female) from 2005 to 2014 at our institution with preoperative complete blood count test values and information of patency for at least 12 months after first-time femoropopliteal stenting. Patients were stratified into tertiles on the basis of preoperative blood counts to evaluate associations with in-stent restenosis (ISR) leading to loss of primary patency, defined by a Doppler velocity ratio ≥2.5:1, computed tomography angiography demonstrating ≥50% luminal narrowing within the stent, or reintervention. RESULTS: Univariate analysis determined that the 81 patients (59%) who experienced ISR within 12 months had significantly higher preoperative white blood cell (WBC), platelet, neutrophil, and lymphocyte counts than the 57 patients (41%) whose stents remained patent for longer than 12 months (8.7 vs 6.7 [P < .001], 246 vs 184 [P < .001], 5.7 vs 4.7 [P = .001], and 1.8 vs 1.2 [P = .004], respectively). Compared with patients in the lower WBC tertile (n = 45) who had a median patency of 19.4 months, those in the upper WBC tertile (n = 44) had a median patency of only 7.0 months and a 3.3-fold increased risk for ISR after adjusting for age, sex, lesion type, TransAtlantic Inter-Society Consensus II score, tibial vessel runoff, antiplatelet therapy, presence of diabetes, critical limb ischemia, adjunct procedures, hyperlipidemia, and end-stage renal disease in multivariate analysis (P < .001). Compared with patients in the lower platelet tertile (n = 45) who had a median patency of 16.9 months, those in the upper platelet tertile (n = 47) had a median patency of 7.1 months and a 2.7-fold increased adjusted risk (P = .001). Compared with patients in the lower neutrophil tertile (n = 33) who had a median patency of 14.3 months, those in the upper neutrophil tertile (n = 33) had a median patency of 6.2 months and a 3.2-fold increased adjusted risk (P = .001). After adjusting for covariates, patients divided into tertiles by lymphocyte counts exhibited no significant differences for ISR. CONCLUSIONS: Routine preoperative tests that determine baseline inflammatory status may provide strong clinical utility in assessing potential risk stratification of patients for ISR after femoropopliteal stenting. Circulating WBCs, platelets, and neutrophils may be important inflammatory mediators of ISR.

Vascular surgeon-hospitalist comanagement improves in-hospital mortality at the expense of increased in-hospital cost.

OBJECTIVE: We have shown that vascular surgeon- hospitalist co management resulted in improved in-hospital mortality rates. We now aim to assess the impact of the hospitalist co management service (HCS) on healthcare cost. METHODS: A total of 1558 patients were divided into three cohorts and compared: 516 in 2012, 525 in 2013, and 517 in 2014. The HCS began in January 2013. Data were standardized for six vascular surgeons that were present 2012-2014. New attendings were excluded. Ten hospitalists participated. Case mix index (CMI), contribution margin, total hospital charges (THCs), length of stay (LOS), actual direct costs (ADCs), and actual variable indirect costs (AVICs) were compared. Analysis of variance with post-hoc tests, t-tests, and linear regressions were performed. RESULTS: THC rose by a mean difference of $14,578.31 between 2012 and 2014 (P < .001) with a significant difference found between all groups during the study period (P = .0004). ADC increased more than AVIC; however, both significantly increased over time (P = .0002 and P = .014, respectively). A mean $3326.63 increase in ADC was observed from 2012 to 2014 (P < .0001). AVIC only increased by an average $392.86 during the study period (P = .01). This increased cost was observed in the context of a higher CMI and longer LOS. CMI increased from 2.25 in 2012 to 2.53 in 2014 (P = .006). LOS increased by a mean 1.02 days between 2012 and 2014 (P = .016), and significantly during the study period overall (P = .018). After adjusting for CMI, LOS increases by only 0.61 days between 2012 and 2014 (P = .07). In a final regression model, THC is independently predicted by comanagement, CMI, and LOS. After adjusting for CMI and LOS, the increase in THC because of comanagement (2012 vs 2014) accounts for only $4073.08 of the total increase (P < .001). During this time, 30-day readmission rates decreased by ∼7% (P = .005), while related 30-day readmission rates decreased by ∼2% (P = .32). Physician contribution margin remained unchanged over the 3-year period (P = .76). The most prevalent diagnosis-related group was consistent across all years. Variation in the principal diagnosis code was observed with the prevalence of circulatory disorders because of type II diabetes replacing atherosclerosis with gangrene as the most prevalent diagnosis in 2013 and 2014 compared with 2012. CONCLUSIONS: In-hospital cost is significantly higher since the start of the HCS. This surge may relate to increased CMI, LOS, and improved coding. This increase in cost may be justified as we have observed sustained reduction in in-hospital mortality and slightly improved readmission rates.

The Impact of Surgical Care Improvement Project Measures on In-Hospital Outcomes following Elective Vascular Procedures.

BACKGROUND: As part of the Surgical Care Improvement Project (SCIP), a national quality partnership of organizations including the Centers for Medicare and Medicaid Services and the Centers for Disease Control and Prevention implemented several perioperative guidelines regarding antibiotic, venous thromboembolism (VTE), and beta-blocker prophylaxis for surgical patients. We evaluated the effect of SCIP on in-hospital surgical site infections (SSI), graft infections, VTE, myocardial infarctions (MIs), cardiac complications, mortality, and length of stay following elective major vascular surgery. METHODS: Using International Classification of Diseases, Ninth Revision (ICD-9) diagnostic and procedure codes, we identified elective open abdominal aneurysm repair (OAR), endovascular aneurysm repair (EVAR), carotid endarterectomy (CEA), major lower extremity amputation, and lower extremity bypass (LEB) procedures in the National Inpatient Sample from 2000 to 2012. Logistic regression and generalized linear models controlling for covariates were used to compare postoperative in-hospital outcomes before and after SCIP implementation (pre-SCIP era 2000-2005 versus post-SCIP era 2009-2012). RESULTS: In the post-SCIP era, the rate of in-hospital SSI following OAR increased from 1.0% to 1.6% (P < 0.05). Nonetheless, there were improvements in in-hospital SSI (in EVAR and CEA), graft infections (in OAR, EVAR, and LEB for tissue loss), VTE (in CEA), MI (in EVAR and LEB for tissue loss), cardiac complication (in all procedures except OAR), mortality (in EVAR, CEA, major lower extremity amputation, and LEB for tissue loss), and length of stay (in all procedures except OAR) (all P < 0.05). However after adjusting for covariates, SCIP was only associated with reducing SSI in CEA and major lower extremity amputation, graft infections in OAR and LEB for tissue loss, VTE in LEB for claudication or rest pain, mortality in OAR, and length of stay in all procedures except EVAR and CEA. CONCLUSIONS: Implementation of SCIP measures was associated with slight improvements in a few in-hospital outcomes following vascular procedures. Additional measures that are more specific to the clinical and technical challenges of treating vascular disease may be more effective for improving the management of vascular patents.

The Protective Effects of Diabetes Mellitus on Post-EVAR AAA Growth and Reinterventions.

BACKGROUND: This study aims to investigate the effect of diabetes on post-endovascular aneurysm repairs (EVARs) of abdominal aortic aneurysms (AAAs). METHODS: A total of 1,479 consecutive patients who underwent AAA EVAR were reviewed. The cohorts were divided based on their diabetes status and compared. Preoperative demographic and comorbidity data were analyzed using the t-test and chi-squared test, whereas post-EVAR outcomes were analyzed using Probit multivariate model, followed by Kaplan-Meier survival curve and Cox regression. RESULTS: Of our 1,479 patients, 993 met inclusion criteria. One hundred eighty-three were diabetics (18.4%) compared with 810 nondiabetics (81.6%). Coronary artery disease (CAD; diabetics: 70.49%, nondiabetics: 60.76%, P = 0.014) and hypertension (HTN; diabetics: 90.16%, nondiabetics: 79.46%, P = 0.0008) were the only comorbidities analyzed, including follow-up length, which had any significant differences between the diabetic and nondiabetic groups. Probit multivariate analysis using a combined cohort follow-up mean of 51 months showed a significant decrease in aneurysm sac enlargement in diabetic patients (diabetics: 13.11%, nondiabetics: 19.43%, model estimate: 0.3058; 95% confidence interval [CI]: 0.0486-0.5629, Pr > ChiSq = 0.0198) and trended toward significantly fewer reinterventions (diabetics: 23.50%, nondiabetics: 28.41%, model estimate: 0.1990; 95% CI: -0.0262 to 0.4243, Pr > ChiSq = 0.0833). In the Cox regressions, diabetes had a significant protective factor on reinterventions (hazard ratio [HR]: 0.697, Pr > ChiSq = 0.0151), and was trending toward significance for aneurysm sac enlargement (HR: 0.750, Pr > ChiSq = 0.1961). There was no significant difference across diabetic status in any other outcomes, including mortality and endoleak occurrence. CONCLUSIONS: Although a higher proportion of diabetic patients present with HTN and CAD, they have decreased long-term rates of aneurysm sac enlargement after EVAR. As a result, this cohort trends toward a lower need for reintervention after EVAR.

Contemporary management of isolated chronic infrarenal abdominal aortic dissections.

OBJECTIVE: The purpose of this study was to report the presentation, treatment, and follow-up of isolated infrarenal aortic dissections. METHODS: A review of 37 patients with isolated infrarenal aortic dissections was performed. Computed tomography scans with intravenous administration of contrast material were examined for all patients; catheter-based angiography, magnetic resonance angiography, and duplex ultrasound were used selectively. In dissections associated with the development of abdominal aortic aneurysm (AAA), the aneurysm growth rate was determined by measuring the change in maximum aneurysm diameter over time and dividing that by the duration of observation. RESULTS: The majority of infrarenal abdominal aortic dissection patients were male (67.6%). Hypertension (77.1%) and hyperlipidemia (77.1%) were the most common comorbidities among these patients. Aortic atherosclerosis was present in the majority of patients (60.0%); 67.6% of dissections were discovered incidentally and were asymptomatic. The mean dissection length was 5.84 ± 4.23 cm. Concomitant AAAs were present in 48.6% of cases with an average maximum diameter of 4.38 ± 1.41 cm. The aneurysm growth rate was 1.2 mm/y. Aneurysms were significantly larger in men than in women (4.87 ± 1.31 vs 3.12 ± 0.67 cm; P = .001). Endovascular intervention was performed on 14 (37.8%) patients, open surgery was performed on 1 (2.7%) patient, and surveillance with conservative medical treatment was used for 22 (59.5%) patients. Ten patients were treated successfully with endovascular repair for progressive aneurysm expansion. At the time of intervention, the mean AAA diameter was 5.04 ± 1.39 cm. The mean growth rate for aneurysms that were intervened on was 2.3 mm/y. The mean diameter of AAAs that were not intervened on was 3.56 ± 1.04 cm. Type II endoleaks were observed in three (30%) patients who underwent endovascular repair. None of these were associated with aneurysm growth and none required reintervention. The mortality rate for endovascular intervention was 0%. The only open surgical repair performed was on a patient with a ruptured AAA, which the patient did not survive. Angioplasty with stent or stent graft placement was performed in four patients for the treatment of symptomatic arterial insufficiency resulting from aortic dissection. No patients experienced restenosis, and no reinterventions were performed. CONCLUSIONS: Isolated infrarenal aortic dissection is an uncommon vascular disease that is related to hypertension, hyperlipidemia, and atherosclerosis and may be associated with infrarenal AAA formation. The presence of dissection does not appear to increase the risk of complication or mortality for repair of concomitant aneurysm or for treatment of stenosis.

No major difference in outcomes for endovascular aneurysm repair stent grafts placed outside of instructions for use.

OBJECTIVE: Studies have shown that a sizable percentage of endovascular aneurysm repair (EVAR) for abdominal aortic aneurysms (AAAs) is performed outside the instructions for use (IFU). We report our long-term outcomes after EVAR with respect to device-specific IFU. METHODS: Computed tomography angiography data from a cohort of 566 patients meeting inclusion criteria who underwent elective EVAR between 2003 and 2014 were examined. Preoperative anatomic measurements for each patient were taken and compared with device-specific IFU. Primary outcomes included all-cause mortality and AAA-related mortality. Secondary outcomes were late-onset rupture, need for reintervention, endoleaks, aneurysm sac enlargement, and intraoperative and perioperative complications. RESULTS: Nine different stent grafts were placed in this set of patients with a mean follow-up of 3.54 ± 2.65 years. Most patients (465; 82.2%) were male, and the mean age was 74.8 ± 8.70 years. Overall, 176 patients (31.1%) fit all IFU anatomic criteria, and 535 patients (94.5%) fit at least half of IFU criteria. In patients, iliac artery diameter was most commonly outside of IFU (253; 44.7%). A total of 1114 iliac arteries were treated, with 463 (41.6%) treated outside of iliac artery diameter IFU; the majority of these (374; 80.7%) were larger than IFU. Demographics and comorbidities were comparable between the groups within and outside of IFU. AAA-related mortality and all-cause mortality were similar between these two groups, as was late-onset rupture, need for reintervention, rates of endoleak, aneurysm sac enlargement, and major intraoperative and perioperative complications. The sole statistically significant difference in secondary outcomes was increased perioperative blood transfusion needed in those treated outside the IFU, 13.2% vs 6.2% in those treated within IFU (P = .02); however, this was not associated with decreased access vessel diameter or iliac artery rupture. CONCLUSIONS: Despite most EVAR patients being treated outside of IFU, there was no difference in outcomes with respect to all-cause mortality or aneurysm-related mortality. In addition, with the exception of perioperative blood transfusions, there was no association between IFU adherence and late-onset rupture, need for reintervention, rates of endoleak, aneurysm sac enlargement, or most other major complications.

The Effect of Age on Post-EVAR Outcomes.

BACKGROUND: This study aims to investigate the relationship of increased age on post-endovascular aneurysm repair (EVAR) outcomes. METHODS: A total of 1,380 of 1,853 consecutive patients who underwent EVAR between 1992 and 2012 met our inclusion criteria and were reviewed. Five hundred of the 1,380 patients had computed tomography angiography data to characterize anatomic differences. Age <70 years and ≥70 years were compared. RESULTS: Older patients had higher Glasgow Aneurysm Scores (85.8 ± 8.2 vs. 70.9 ± 8.5, P < 0.0001), indicating higher preoperative risk in patients ≥70 years of age. Patients ≥70 years had increased tortuosity indices, angulation, and iliac calcification. Older patients required higher transfusion volumes (101.1 ± 266.8 vs. 57.6 ± 202.6 mL, P = 0.018). Overall comorbidities, blood loss, and procedure times were similar between groups. The older cohort had higher major and minor perioperative complication rates (10.7% vs. 7.0%, P = 0.007), with a trend toward more major perioperative complications (7.5% vs. 4.8%, P = 0.077). AAA-related perioperative mortality, all-cause perioperative mortality, and intraoperative complication rates were similar between the 2 cohorts. Patients <70 years were more likely to be discharged on postoperative day 1 (76.1% vs. 67.6%, P < 0.0001). Older patients were more likely to develop endoleaks (21.9% vs. 12.8%, P < 0.0001) and required more reinterventions (7.2% vs. 4.7%, P = 0.003). Freedom from AAA-related mortality was similar between the 2 groups (P = nonsignificant); however, patients <70 years had improved overall survival (P < 0.001). CONCLUSIONS: Older age is associated with more complex aneurysm morphology. These features likely resulted in more endoleaks, reinterventions, and complications observed in patients ≥70 years following EVAR.

Intermediate Outcomes of Femoropopliteal Stenting in Women: 3-Year Results of the DURABILITY II Trial.

BACKGROUND: This study investigated the effects of gender on the 3-year outcomes of the StuDy for EvalUating EndovasculaR TreAtments of Lesions in the Superficial Femoral Artery and Proximal Popliteal By usIng the Protege EverfLex NitInol STent System II (DURABILITY II) trial. METHODS: A total of 287 patients enrolled in the DURABILITY II trial (prospective and nonrandomized trial) were stratified by gender and evaluated for primary, primary assisted, and secondary patency at 3 years. Clinical scores including changes in ankle-brachial index (ABI) and walking impairment questionnaire (WIQ) scores were evaluated. RESULTS: Overall 190 male and 97 female patients were included for analysis. The 3-year primary, assisted primary, and secondary patency rates for women versus men were 62.5% vs. 58.8%, 68.5% vs. 64.9%, and 72.1% vs. 67.2%, respectively (P < 0.05). Although ABIs at presentation were similar between women versus men (0.64 vs. 0.65, P < 0.05), women had lower ABI scores at 3 years compared with men (0.85 vs. 0.92, P = 0.03). Women versus men had inferior walking distance scores at presentation (13.6 vs. 25.7, P < 0.001), scores were equalized by 2 years (51.6 vs. 60.8, P < 0.05); however, 3-year follow-up demonstrated less durable results for women versus men (37.3 vs. 58.8, P < 0.05). In addition, women had worse WIQ scores for pain, walking speed, and stair climbing. However, the relative change in scores between men and women were comparable, with both groups seeing similar improvements from baseline for these parameters. CONCLUSIONS: Women continue to see clinical improvement after intervention, achieving comparable ABIs and walking distance to men at 2 years. These benefits are diminished at 3-year follow-up with women achieving lower absolute ABI and WIQ parameters compared with men, but improved overall compared with scores at presentation.

Evolution of gender-related differences in outcomes from two decades of endovascular aneurysm repair.

OBJECTIVE: Women have been under-represented in trials that set guidelines for the management of aortic aneurysms. Several studies reported inferior outcomes in women compared with men after endovascular aneurysm repair (EVAR). We investigated the relationship between gender and outcomes after EVAR. METHODS: A total of 1380 consecutive patients underwent elective EVAR from 1992 to 2012. Baseline, intraoperative, and postoperative variables by gender were analyzed from a prospective database. RESULTS: The cohort comprised 214 women (15.5%) and 1166 men (84.5%). Women were older than men at repair (77.8 vs 74.5 years, P < .001) and had less cardiac disease (P = .005). They had shorter (19.8 ± 12.9 vs 26.3 ± 14.7 mm; P < .001) more angulated aortic necks (38.8° ± 16.1° vs 31.2° ± 14.7°; P < .001) and fewer iliac aneurysms (P = .002). Women had more arterial reconstructions (iliac conduits, P = .006; thrombolysis and thrombectomy, P = .013; patch angioplasty, P < .001; endarterectomy, P < .001), more perioperative complications (16.9% vs 9.1%; P = .001), and more in-hospital days (4.1 vs 3.4 days; P = .029). Perioperative mortality was equivalent (women: 2% vs men: 2.3%; P = .73). Mean follow-up was 30.9 months. Women and men experienced equivalent aneurysm-related deaths and overall survival. Survival curve analysis showed endoleaks were more likely to develop in women than men (P = .005); however, there was no difference in rates of arterial reinterventions required for each gender during the follow-up period. CONCLUSIONS: Female gender is associated with more periprocedural complications, adjunctive arterial procedures, and increased endoleaks but does not affect long-term reinterventions or survival. Further studies are warranted to elucidate the effect of gender on outcomes. These data should be considered when selecting EVAR for men and women.

The effect of a hospitalist comanagement service on vascular surgery inpatients.

OBJECTIVE: Vascular surgery patients have increased medical comorbidities that amplify the complexity of their care. We assessed the effect of a hospitalist comanagement service on inpatient vascular surgery outcomes. METHODS: We divided 1059 patients into two cohorts for comparison: 515 between January 2012 and December 2012, before the implementation of a hospitalist comanagement service, and 544 between January 2013 and October 2013, after the initiation of a hospitalist comanagement service. Nine vascular surgeons and 10 hospitalists participated in the hospitalist comanagement service. End points measured were in-hospital mortality, length of stay (LOS), 30-day readmission rates, visual analog scale pain scores (0-10), inpatient adult safety assessments using the Agency for Healthcare Research and Quality (AHRQ) Patient Safety Indicators, and resident perceptions assessed by survey. RESULTS: The in-hospital mortality rate decreased from 1.75% to 0.37% after the implementation of the hospitalist comanagement service (P = .016), with a decrease in the observed-to-expected ratio from 0.89 to 0.22. The risk-adjusted in-hospital mortality decreased from 1.56% to 0.0008% (P = .003). Mean LOS was lower in the base period, at 5.1 days vs 5.5 days (P < .001), with an observed-to-expected ratio of 0.83 and 0.78, respectively. The risk-adjusted LOS increased from 4.2 days to 4.3 days (P < .001). The overall 30-day readmission rate was unchanged, at 23.1% compared with 22.8% (P = .6). The related 30-day readmission rate was also similar, at 11.5% compared with 11.4% (P = .5). Patients reporting no pain during hospitalization increased from 72.8% before the hospitalist comanagement service to 77.8% after (P = .04). Reports of moderate pain decreased from 14% to 9.6% (P = .016). Mild and severe pain scores were similar between the two groups. Adult safety measured by AHRQ demonstrated a decrease from three to zero patients in the number of deaths among surgical patients with treatable complications (P = .04). Most house staff reported that the comanagement program had a positive effect on patient care and education. CONCLUSIONS: The hospitalist comanagement service has resulted in a significant decrease in in-hospital mortality rates, patient safety, as measured by AHRQ, and improved pain scores. Resident surveys demonstrated perceived improvement in patient care and education. Continued observation will be necessary to assess the long-term effect of the hospitalist comanagement service on quality metrics.

The impact of stent graft evolution on the results of endovascular abdominal aortic aneurysm repair.

OBJECTIVE: There have been four eras in the development of endovascular aneurysm repair (EVAR): physician-made grafts, early industry devices, intermediary commercial endografts, and modern stent grafts. This study analyzes differences in outcomes between these four groups and the impact of device evolution and increased physician experience. METHODS: From 1992 to 2012, 1380 patients underwent elective EVAR. Fourteen different devices were used during this time. The four generations were defined as follows: era 1, all physician-made devices; era 2, June 1994 to June 2003; era 3, June 2003 to January 2008; and era 4, January 2008 to July 2012. Grafts used in each era were the following: era 1, physician made; era 2, early industry, such as EVT, Talent, AneuRx, Excluder, Quantum LP, Vanguard, Ancure, and Teramed; era 3, Talent, Endologix, Excluder, AAAdvantage, Zenith, and Aptus; and era 4, Zenith, Endurant, and Excluder. RESULTS: Mean age was 75.2 years, and 84.5% were men. Adjunctive procedures decreased from era 1 to era 2 (P < .001) but rose again in eras 3 and 4 (P < .001). Procedure times (P < .001), blood loss (P < .001), and length of stay (P < .001) have decreased in eras 2, 3, and 4 compared with era 1. Major perioperative complications (era 1, 23%; era 2, 5.9%; era 3, 4.9%; and era 4, 4.7%; P < .001), abdominal aortic aneurysm-related perioperative mortality (era 1, 4.3%; era 2, 0.2%; era 3, 0.06%; and era 4, 0.5%; P < .001), and all-cause perioperative mortality (era 1, 7.7%; era 2, 1.9%; era 3, 1.5%; and era 4, 0.47%; P < .001) have also decreased in eras 2, 3, and 4 compared with era 1. Type I and type III endoleaks (P < .001) and the need for reintervention (P < .001) have decreased. Freedom from aneurysm-related mortality has significantly improved. CONCLUSIONS: EVAR has evolved during the last 20 years, resulting in an improvement in efficiency, outcomes, and procedural success. The most significant advance is seen in the transition from era 1 to the later eras.

The impact of sex on angioplasty and primary stenting for femoropopliteal occlusive disease: results of the DURABILITY II trial.

BACKGROUND: This study investigates the impact of sex on angioplasty and primary stenting for the treatment of claudicants with femoropopliteal occlusive disease (FPOD). METHODS: Two hundred eighty-seven patients enrolled in the Safety and Effectiveness Study of EverFlex Stent to Treat Symptomatic Femoral-popliteal Atherosclerosis (DURABILITY II) trial (a prospective, nonrandomized, core laboratory audited, and independently adjudicated investigational device exemption trial) were stratified by sex (190 men and 97 women) and reviewed. RESULTS: Women presented with FPOD at an older age than men (71.3 ± 11.2 vs. 65.9 ± 9.9 years; P < 0.001). Men were more likely to be hyperlipidemic (89.5% vs. 79.4%; P = 0.030). No other statistically significant differences were observed with regard to periprocedural comorbidities and demographics. Clinically, women presented more often with severe claudication (64.9% vs. 51.1%; P = 0.033) as compared with men that had more moderate claudication (44.2% vs. 29.9%; P = 0.022). The incidence of rest pain and tissue loss was low and did not vary between sexes. Angiographically, women had smaller reference vessels (4.4 ± 0.8 mm vs. 5.0 ± 0.9 mm; P < 0.001). Longer lesions (91.6 ± 46.8 mm vs. 87.8 ± 43.9 mm) and higher primary (79.0% vs. 76.5%), primary-assisted (90.6% vs. 85.1%), and secondary patency (90.6% vs. 85.7%) rates in women did not achieve statistical significance (P = NS). Mean percent stenosis and occlusion rates were similar between groups, but men were more likely to have severe calcification (47.9% vs. 34.0%; P = 0.020). Inter-Society Consensus for the Management of Peripheral Arterial Disease II classifications were similar between groups. The target lesion revascularization, major adverse event, and mortality rates were similar between groups. At baseline, the absolute claudication distance was 0.29 miles for men, while women only reached 0.14 miles (P < 0.0001). Walking improvement questionnaire scores were also compared; women had significantly lower scores at baseline and at 1 year. CONCLUSIONS: Despite presenting with FPOD at a later age, with more severe claudication, a shorter absolute claudication distance, and smaller vessels than men, women achieved equal patency rates using angioplasty and primary stenting with similar target lesion revascularization, major adverse event, and mortality rates. Despite these findings, women subjectively have worse symptoms at baseline and at 1 year.