POTENTIAL TREATMENT FOR PERIPAPILLARY PACHYCHOROID SYNDROME.

PURPOSE: The purpose of this study was to describe the effect of topical prednisolone on intraretinal fluid in patients with peripapillary pachychoroid syndrome. METHODS: We selected 11 consecutive patients (17 eyes) with a diagnosis of peripapillary pachychoroid syndrome, who were treated with topical prednisolone (Pred Forte [PF] 10 mg/mL) three times daily for 4 weeks. We tapered off PF among patients who demonstrated a reduction of intraretinal fluid. RESULTS: Of the included 17 eyes, the average follow-up before PF treatment ranged from 6 to 192 months, during which patients experienced no apparent reduction of intraretinal fluid. The baseline mean best-corrected VA (BCVA) was 0.6 (20/33) Snellen. The median subfoveal and peripapillary choroidal thickness were 430 µm and 202 µm, respectively. All patients showed an initial reduction of intraretinal fluid after 4 weeks of topical prednisolone. Six patients (35%) experienced a prolonged reduction of intraretinal fluid when the dosage was reduced to once daily. On tapering off PF, four eyes (24%) experienced a recurrence of intraretinal fluid. Four eyes (24%) experienced elevated intraocular pressure above 26 mmHg. In two eyes, PF was discontinued, on which intraretinal fluid reappeared. The BCVA seemed to be improved in 9 eyes (53%) and remained equal in 4 eyes (24%). CONCLUSION: In this case series of patients with peripapillary pachychoroid syndrome, we observed a reduction of peripapillary intraretinal fluid after treatment with topical prednisolone for 4 weeks in all 17 eyes. The disappearance of intraretinal fluid seemed to concede with a slight improvement in BCVA for some cases. Thus, topical prednisolone may prove to be a viable treatment option in peripapillary pachychoroid syndrome.

Clinical impact of sex on carotid revascularization.

BACKGROUND: The impact of sex in the management of carotid disease is unclear in the current literature. Therefore, we evaluated the effect of sex on perioperative outcomes following carotid endarterectomy (CEA) and carotid artery stenting (CAS). METHODS: We included patients who underwent CEA or CAS between 2012 and 2017 in the Vascular Quality Initiative database. Our primary outcome was perioperative stroke/death. Secondary outcomes were in-hospital stroke, 30-day mortality, and in-hospital MI. We compared perioperative outcomes between female and male patients, stratified by treatment modality and symptom status, and used multivariable regression to account for differences in baseline characteristics. RESULTS: A total of 83,436 patients underwent either a CEA (71,383) or CAS (12,053). Asymptomatic and symptomatic CEA females were less likely to be on a preoperative antiplatelet agent, when compared to males. Females overall, were less likely to be on a preoperative statin and more likely to have chronic obstructive pulmonary disease. Within the CAS cohort, females were more likely to have a previous ipsilateral CEA. There were no differences between males and females in major adverse events following CEA for asymptomatic disease. Following CEA for symptomatic disease, there was no difference in stroke/death rate or in-hospital stroke. However, females experienced a higher 30-mortality after adjustment (univariate: 1.0% vs 0.7%, P = .04; adjusted: odds ratio [OR], 1.4:1.02-1.94). Following CAS for asymptomatic disease, females experienced a higher rate of perioperative stroke/death (2.9% vs 1.9% P = .02; OR, 1.5: 1.05-2.03) and in-hospital stroke (2.1% vs 1.2% P = .01; OR, 1.8: 1.20-2.60). There were no differences in outcomes for symptomatic females vs males undergoing CAS. CONCLUSIONS: Females with carotid disease less frequently receive optimal medical treatment with antiplatelet agents and statins. This is an important target area for quality improvement issue in both females and males. Furthermore, among symptomatic CEA patients the female sex is associated with higher mortality and among asymptomatic CAS patients, females experience higher rates of stroke/death. These findings suggest that careful patient selection is necessary in the treatment of female patients. Quality improvement projects should be created to further investigate and eliminate the disparities of optimal medical management between the sexes.

The Weekend Effect in AAA Repair.

BACKGROUND: Conflicting reports exist regarding whether patients undergoing surgery on the weekend or later in the week experience worse outcomes. METHODS: We identified patients undergoing abdominal aortic aneurysm (AAA) repair in the Vascular Quality Initiative between 2009 and 2017 [n = 38,498; 30,537 endovascular aneurysm repair (EVAR) and 7961 open repair]. We utilized mixed effects logistic regression to compare adjusted rates of perioperative mortality based on the day of repair. RESULTS: Tuesday was the most common day for elective repair (22%), Friday for symptomatic repairs (20%), and ruptured aneurysms were evenly distributed. Patients with ruptured aneurysms experienced similar adjusted mortality whether they underwent repair during the week or on weekends. Transfers of ruptured AAA were more common over the weekend. However, patients transferred on the weekend experienced higher adjusted mortality than those transferred during the week (28% vs 21%, P = 0.02), despite the fact that during the week, transferred patients actually experienced lower adjusted mortality than patients treated at the index hospital (21% vs 31%, P < 0.01). Among symptomatic patients, adjusted mortality was higher for those undergoing repair over the weekend than those whose surgeries were delayed until a weekday (7.9% vs 3.1%, P = 0.02). Adjusted mortality in elective cases did not vary across the days of the week. Results were consistent between open and EVAR patients. CONCLUSION: We found no evidence of a weekend effect for ruptured or symptomatic AAA repair. However, patients with ruptured AAA transferred on the weekend experienced higher mortality than those transferred during the week, suggesting a need for improvement in weekend transfer processes.

Risk of insulin-dependent diabetes mellitus in patients undergoing carotid endarterectomy.

OBJECTIVE: There is conflicting evidence regarding the association of diabetes mellitus (DM) and insulin use with outcomes after carotid endarterectomy (CEA). Therefore, we sought to evaluate the risk of insulin-dependent DM (IDDM) and noninsulin-dependent DM (NIDDM) on 30-day outcomes after CEA. METHODS: We identified patients undergoing CEA from the Targeted Vascular module of the National Surgical Quality Improvement Program (2011-2015) and stratified patients on the basis of their preprocedural symptom status. We compared 30-day outcomes between nondiabetics and patients with NIDDM or IDDM, with 30-day stroke/death as the primary end point. RESULTS: Of 16,739 CEA patients, 9784 (58%) were asymptomatic, of whom 6720 (69%) had no diagnosis of DM, 1109 (11%) had IDDM, and 1955 (20%) had NIDDM. Of the 6955 symptomatic patients, 4982 (72%) had no diagnosis of DM, 810 (12%) had IDDM, and 1163 (17%) had NIDDM. Among asymptomatic patients, patients with IDDM experienced higher rates of 30-day stroke/death compared with those without DM (3.4% vs 1.5%; P < .001), whereas those with NIDDM experienced rates similar to those of patients without DM (2.1% vs 1.5%; P = .1). Moreover, asymptomatic patients with IDDM and an anatomic high-risk criterion experienced a 30-day stroke/death rate of 6.6%. After adjustment, IDDM was associated with 30-day stroke/death in asymptomatic patients compared with patients without DM (odds ratio, 2.3; 95% confidence interval, 1.5-3.4; P < .001), but NIDDM was not (odds ratio, 1.4; 95% confidence interval, 1.0-2.1; P = .1). In comparison, among symptomatic patients, those with IDDM and NIDDM experienced similar rates of 30-day stroke/death as patients without DM (4.9% vs 3.6% and 4.0% vs 3.6%; both P > .1). After adjustment, neither IDDM nor NIDDM was associated with 30-day stroke/death in symptomatic patients compared with symptomatic patients without DM. CONCLUSIONS: Rates of 30-day stroke/death after CEA in asymptomatic patients with IDDM exceed international vascular societies' guideline thresholds for acceptable outcomes in asymptomatic patients, especially those with anatomic high-risk criteria. Thus, asymptomatic patients with IDDM may not benefit from CEA, although more data are needed about the natural history of carotid disease in this population.

Three-dimensional image fusion is associated with lower radiation exposure and shorter time to carotid cannulation during carotid artery stenting.

OBJECTIVE: Three-dimensional (3D) image fusion is associated with lower radiation exposure, contrast agent dose, and operative time during endovascular abdominal aortic aneurysm repair. Therefore, we evaluated the impact of this technology on carotid artery stenting (CAS). METHODS: We identified consecutive CAS procedures from 2009 to 2017 and compared those performed with and without 3D image fusion. For image fusion, we created a 3D reconstruction of the aortic arch anatomy based on preoperative computed tomography or magnetic resonance angiography that we merged with two-dimensional fluoroscopy, allowing 3D image overlay. We compared radiation exposure, fluoroscopy time, contrast agent dose, time to common carotid artery (CCA) cannulation, time from CCA cannulation to completion angiography, and total procedure time in procedures with and without image fusion. We also assessed rates of 30-day stroke/death, in-hospital and 30-day stroke, and acute kidney injury. We used multivariable linear regression to adjust for patient and procedural characteristics and used these models to compute the marginal effects of image fusion compared with no image fusion. RESULTS: There were 46 patients who underwent CAS with a 3D image fusion system and 70 patients without. Patients undergoing CAS with image fusion experienced 31% lower radiation exposure compared with the control group (207 ± 23 mGy vs 300 ± 26 mGy, respectively; P < .01), shorter fluoroscopy time (21 ± 6 minutes vs 24 ± 8 minutes; P = .02), shorter time to carotid cannulation (21 ± 9 minutes vs 31 ± 8 minutes; P < .001), and shorter total procedure time (47 ± 13 minutes vs 54 ± 18 minutes; P = .03). There was no difference in contrast material volume, time from CCA cannulation to completion angiography, or total in-room time. After multivariable adjustment, 3D image fusion remained associated with lower radiation dose, shorter fluoroscopy time, and shorter time to carotid cannulation (all P < .05). The rate of 30-day stroke/death was 2.7% (three strokes and no deaths at 30 days), and the rate of acute kidney injury was 1.8%. CONCLUSIONS: CAS with 3D image fusion was associated with lower radiation exposure and shorter time to CCA cannulation. These results represent the potential technical advantage gained with image fusion and add to the growing body of evidence demonstrating its impact on radiation exposure and operative times during complex endovascular procedures.

Fenestrated endovascular aneurysm repair is associated with lower perioperative morbidity and mortality compared with open repair for complex abdominal aortic aneurysms.

OBJECTIVE: The Zenith Fenestrated Endovascular Graft (ZFEN; Cook Medical, Bloomington, Ind) has expanded the anatomic eligibility of endovascular aneurysm repair (EVAR) for complex abdominal aortic aneurysms (AAAs). Current data on ZFEN mainly consist of single-institution experiences and show conflicting results. Therefore, we compared perioperative outcomes after repair using ZFEN with open complex AAA repair and infrarenal EVAR in a nationwide multicenter registry. METHODS: We identified all patients undergoing elective AAA repair using ZFEN, open complex AAA repair, and standard infrarenal EVAR between 2012 and 2016 within the American College of Surgeons National Surgical Quality Improvement Program targeted vascular module. Open complex AAA repairs were defined as those with a juxtarenal or suprarenal proximal AAA extent in combination with an aortic cross-clamping position that was above at least one renal artery. The primary outcome was perioperative mortality, defined as death within 30 days or within the index hospitalization. Secondary outcomes included postoperative renal dysfunction (creatinine concentration increase of >2 mg/dL from preoperative value or new dialysis), occurrence of any complication, procedure times, blood transfusion rates, and length of stay. To account for baseline differences, we calculated propensity scores and employed inverse probability-weighted logistic regression. RESULTS: We identified 6825 AAA repairs-220 ZFENs, 181 open complex AAA repairs, and 6424 infrarenal EVARs. Univariate analysis of ZFEN compared with open complex AAA repair demonstrated lower rates of perioperative mortality (1.8% vs 8.8%; P = .001), postoperative renal dysfunction (1.4% vs 7.7%; P = .002), and overall complications (11% vs 33%; P < .001). In addition, fewer patients undergoing ZFEN received blood transfusions (22% vs 73%; P < .001), and median length of stay was shorter (2 vs 7 days; P < .001). After adjustment, open complex AAA repair was associated with higher odds of perioperative mortality (odds ratio [OR], 4.9; 95% confidence interval [CI], 1.4-18), postoperative renal dysfunction (OR, 13; 95% CI, 3.6-49), and overall complication rates (OR, 4.2; 95% CI, 2.3-7.5) compared with ZFEN. Compared with infrarenal EVAR, ZFEN presented comparable rates of perioperative mortality (1.8% vs 0.8%; P = .084), renal dysfunction (1.4% vs 0.7%; P = .19), and any complication (11% vs 7.7%; P = .09). Furthermore, after adjustment, there was no significant difference between the odds of perioperative mortality, postoperative renal dysfunction, or any complication between infrarenal EVAR and ZFEN. CONCLUSIONS: ZFEN is associated with lower perioperative morbidity and mortality compared with open complex AAA repair, and outcomes are comparable to those of infrarenal EVAR. Long-term durability of ZFEN compared with open complex AAA repair warrants future research.

Timing of Carotid Endarterectomy After Stroke: Retrospective Review of Prospectively Collected National Database.

OBJECTIVE: Our objective was to identify the postoperative risk associated with different timing intervals of repair. BACKGROUND: Timing of carotid intervention in poststroke patients is widely debated with the scales balanced between increased periprocedural risk and recurrent neurologic event. National database reviews show increased risk to patients treated within the first 2 days of a neurologic event compared to those treated after 6 days. METHODS: Utilizing Vascular Quality Initiative data, all carotid interventions performed on stroke patients between the years 2012 and 2017 were queried. Patients were then stratified based on the timing of surgery from their stroke (<48 hours, 3-7 days, 8-14 days, >15 days). Major outcomes included postoperative stroke, death, and myocardial infarction. RESULTS: A total of 8404 patients were included being predominantly men (5281, 62.8%), with an average age of 69 (±10). Patients treated at greater than 8 days showed significantly less risk of postoperative combined stroke/death and postoperative stroke. There were no significant differences in postoperative stroke or death between the 8 to 14 and greater than 15 days groups.Multivariate regression analysis showed that delayed timing of surgery between 3 and 7 days was protective for postoperative stroke/death (P = 0.003) and any postoperative complication (P = 0.028). Delaying surgery to more than 8 days after stroke was protective for postoperative stroke/death (P < 0.001), postoperative stroke (P < 0.001), and any postoperative complication (P < 0.001). CONCLUSIONS: Carotid revascularization should occur no sooner than 48 hours after index stroke event. Surgeons should strive to operate between 8 and 14 days to protect against postoperative stroke/death.

Three-Year Results of the Endurant Stent Graft System Post Approval Study.

BACKGROUND: Long-term data following endovascular aneurysm repair (EVAR) exist but are limited to endografts that are no longer in use. The aim of the ENGAGE Post Approval Study is to describe the long-term safety and effectiveness data following EVAR using the Endurant stent graft system. METHODS: From August 2011 to June 2012, 178 patients were enrolled and treated with the Endurant stent graft system. Clinical and radiologic data were prospectively collected and analyzed. The primary end point was abdominal aortic aneurysm (AAA)-related mortality, and secondary end points were overall mortality, endoleak, secondary interventions, and device-related complications. Kaplan-Meier estimates were used for late outcomes. RESULTS: A total of 178 patients underwent EVAR with the Endurant stent graft across 24 centers (82% men; median age 71, interquartile range [IQR] 66-79). Median aortic diameter was 55 mm (IQR 51-58 mm). There was a 98.9% technical success rate. Three-year clinical and radiographic follow-up data were available for 87% and 74% of patients, respectively. Median follow-up was 37 months (IQR 30-38 months). Three-year aneurysm-related mortality rate was 1.1%, with 2 deceased patients in the perioperative period. All-cause mortality rate at 3 years was 13%. No patients suffered from aneurysm rupture or underwent conversion to open repair through 3 years of follow-up. Only 11 patients (6.2%) had undergone reintervention at 3 years. Younger age was associated with reintervention (HR 3.3 per younger decade, 95% confidence interval 1.3-7.6, P < 0.01), but neck diameter, length, and angulation were not significantly associated with reintervention. CONCLUSIONS: The Endurant stent graft system provides a safe, durable approach to treating infrarenal AAA. No patients experienced late rupture or aneurysm-related mortality, and only 1 in 16 patients underwent reintervention by 3 years. The rate of reintervention with the Endurant graft appears to be lower than other contemporary grafts, despite more liberal "Instructions For Use" parameters, but further research including direct graft comparisons will be necessary to guide appropriate graft selection.

Regional variation in patient outcomes in carotid artery disease treatment in the Vascular Quality Initiative.

OBJECTIVE: Quality metrics were developed to improve outcomes after carotid artery revascularization; however, few studies have evaluated regional differences in perioperative outcomes. This study aimed to evaluate regional variation in mortality and perioperative outcomes after carotid endarterectomy (CEA) and carotid artery stenting (CAS). METHODS: We identified all patients who underwent CEA or CAS from 2009 to 2016 in the Vascular Quality Initiative. Patients were analyzed on the basis of their symptom status. We assessed variation in perioperative outcomes using χ2 analysis, Fisher exact test, and t-test, where appropriate. RESULTS: A total of 78,467 carotid interventions were identified; 85% were CEAs, with 69% of those asymptomatic. Within CAS, 39% were asymptomatic. Perioperative stroke/death varied across regions within both CAS groups (asymptomatic, 0%-5.8% [P = .03]; symptomatic, 2.4%-8.1% [P = .1]), and several regions did not meet the American Heart Association (AHA) guidelines of 3% for asymptomatic patients and 6% for symptomatic patients, which persisted after risk adjustment. For CEA, the stroke/death rates fell within the standards set by the AHA guidelines in all regions for both the unadjusted and risk-adjusted models; however, there was significant regional variation in the cohorts (asymptomatic, 0.9%-3.1% [P < .01]; symptomatic, 1.3%-4.9% [P < .01]). Variation in 30-day mortality was significant in symptomatic patients (asymptomatic: CEA, 0%-1.3% [P = .2], CAS, 0%-2.4% [P = .2]; symptomatic: CEA, 0%-1.8% [P < .01], CAS, 0%-4.6% [P = .01]). Rates of in-hospital stroke, postoperative myocardial infarction, prolonged length of stay (>2 days), and use of intravenous blood pressure medications all varied significantly across the regions. After CEA, there was significant variation in the rates of cranial nerve injuries (asymptomatic, 0.9%-4.9% [P < .01]; symptomatic, 1.5%-7.7% [P < .01]), return to the operating room (asymptomatic, 0.9%-3.4% [P < .01]; symptomatic, 0.6%-3.4% [P = .02]), and discharge on antiplatelet and statin (asymptomatic, 75%-87% [P < .01]; symptomatic, 78%-91% [P < .01]). After CAS, significant variation was found in the rates of access site complications (asymptomatic, 2.3%-18.2% [P < .01]; symptomatic, 1.4%-16.9% [P < .01]) and discharge on dual antiplatelet therapy (asymptomatic, 79%-94% [P < .01]; symptomatic, 83%-93% [P < .01]). CONCLUSIONS: Unwarranted regional variation exists in outcomes after carotid artery revascularization across the regions of the VQI. Significant variation was seen in a number of outcomes for which quality metrics currently exist, such as length of stay and discharge medications. In addition, after CAS, several regions failed to meet the AHA guidelines for stroke and death. Given these results, quality improvement projects should be targeted to improve adherence to current guidelines to promote best practices.

The impact of race on outcomes after carotid endarterectomy in the United States.

OBJECTIVE: Black patients undergoing carotid endarterectomy (CEA) in the United States are more often symptomatic at presentation and have more comorbidities compared with white patients. However, the impact of race on outcomes after CEA is largely unknown. METHODS: We identified CEA patients in the Vascular Quality Initiative registry (2012-2017) and compared them by race (black vs white). All other nonwhite races (891 [1.4%]) and Hispanics (2222 [3.4%]) were excluded. We used multilevel logistic regression to account for differences in demographics and comorbidities. We assessed long-term survival using multivariable Cox regression. The primary outcome was perioperative stroke/death, with long-term survival as a secondary outcome. RESULTS: We included 57,622 CEA patients; 2909 (5.0%) were black, of whom 983 (34%) were symptomatic. Of the 54,713 white patients, 16,132 (30%) were symptomatic. Black patients, compared with white patients, had a higher vascular disease burden and were less likely to be operated on in a high-volume hospital or by a high-volume surgeon. In addition, black symptomatic patients, compared with white symptomatic patients, were more often operated on <2 weeks after the index neurologic symptom (47% vs 40%; P < .001). Perioperative stroke/death was comparable between black and white patients (symptomatic, 2.8% vs 2.2% [P = .2]; asymptomatic, 1.6% vs 1.3% [P = .2]), as was unadjusted survival at 3 years (93% vs 93%; P = .7). However, after adjustment, black patients did experience better long-term survival compared with white patients (hazard ratio, 0.8; 95% confidence interval, 0.7-0.9; P = .01). On multilevel logistic regression, race was not associated with perioperative stroke/death (odds ratio, 1.0; 95% confidence interval, 0.8-1.3; P = .98). CONCLUSIONS: Despite the greater prevalence of vascular risk factors in black patients and racial inequalities in surgical treatment, rates of perioperative stroke/death and unadjusted survival were similar between white and black patients. Moreover, black patients experienced better adjusted long-term survival after CEA.

Early reintervention after open and endovascular abdominal aortic aneurysm repair is associated with high mortality.

OBJECTIVE: Although reinterventions are generally considered more common after endovascular aneurysm repair (EVAR) than after open surgical repair (OSR), less is known about reintervention in the early postoperative period. Furthermore, there are few data regarding the impact of early reintervention on 30-day mortality. We sought to evaluate the rates and types of reintervention after abdominal aortic aneurysm (AAA) repair and the impact of reintervention on postoperative mortality. METHODS: The American College of Surgeons National Surgical Quality Improvement Program (NSQIP) was queried from 2012 to 2014 for all intact, infrarenal AAA repairs. The 30-day reintervention was classified by Current Procedural Terminology (CPT) codes. Univariate analysis comparing patients with and without reintervention was performed with the Fisher exact test and Mann-Whitney U test. Logistic regression was used to identify predictors of reintervention and to assess the association between 30-day reintervention and mortality. RESULTS: We identified 5877 patients (OSR, 658 [11%]; EVAR, 5219 [89%]), of whom 261 underwent reintervention (OSR, 7.1%; EVAR, 4.1%; P < .01). Patients who underwent reintervention had larger aortic diameter (median, 5.7 cm vs 5.5 cm; P < .01), were more often symptomatic at presentation (16% vs 9.1%; P < .01), and were more likely to have renal insufficiency (7.7% vs 3.6%; P < .01) and history of prior abdominal operations (32% vs 26%; P = .04). Patients who underwent reintervention had higher 30-day mortality (OSR, 28% vs 2.8% [P < .001]; EVAR, 12% vs 1.0% [P < .001]) and major complications. Factors significantly associated with reintervention included open repair, diameter, symptom status, hypertension, and renal insufficiency. After adjusting for demographics, comorbidities, and type of repair, reintervention was independently associated with 30-day mortality after EVAR and OSR (odds ratio, 13; 95% confidence interval, 8-22; P < .001). CONCLUSIONS: Compared with EVAR, patients undergoing open infrarenal AAA repair were significantly more likely to undergo 30-day reintervention, which could be related to higher open anatomic complexity and lower experience of the surgeon with open repair. Reintervention after both EVAR and OSR was associated with a >10-fold increase in postoperative mortality, emphasizing the need to minimize the complications associated with reintervention.

Patient selection and perioperative outcomes of bypass and endovascular intervention as first revascularization strategy for infrainguinal arterial disease.

OBJECTIVE: The optimal initial revascularization strategy remains uncertain for patients with peripheral arterial disease. The purpose of this study was to evaluate current nationwide selection and perioperative outcomes of patients undergoing bypass or endovascular intervention for infrainguinal disease in those with no prior ipsilateral revascularization. METHODS: Patients undergoing nonemergent first-time infrainguinal revascularization were identified in the Targeted Vascular module of the National Surgical Quality Improvement Program (NSQIP) for 2011 to 2014 and stratified by symptom status (chronic limb-threatening ischemia [CLTI] or claudication). Patients treated with endovascular intervention were compared with those who underwent bypass. Multivariable logistic regression was used to evaluate current selection of patients and to establish independent associations between first-time procedures and postoperative outcomes. RESULTS: Of 5998 first-time infrainguinal revascularizations performed, 3193 were bypass procedures (63% for CLTI) and 2805 were endovascular interventions (64% for CLTI). Current patient characteristics associated with an endovascular-first approach as opposed to bypass-first in CLTI patients were age ≥80 years, tissue loss, nonsmoking, functional dependence, diabetes, dialysis, and tibial lesions, whereas age ≥80 years, nonwhite race, nonsmoking, diabetes, and tibial lesions were associated with an endovascular approach for claudication. In comparing first-time endovascular intervention with bypass, there was no difference in 30-day mortality in CLTI patients (univariate: 2.1% vs 2.2%; adjusted: odds ratio [OR], 0.7; 95% confidence interval [CI], 0.4-1.1) or claudication patients (0.3% vs 0.6%). Among CLTI patients, endovascular-first intervention was associated with lower rates of major adverse cardiovascular event (3.6% vs 4.7%; OR, 0.6; 95% CI, 0.4-0.9), surgical site infection (0.9% vs 7.7%; OR, 0.1; 95% CI, 0.1-0.2), bleeding (8.5% vs 17%; OR, 0.4; 95% CI, 0.3-0.5), unplanned reoperation (13% vs 17%; OR, 0.7; 95% CI, 0.5-0.8), and unplanned readmission (17% vs 18%; OR, 0.8; 95% CI, 0.7-0.9). Patients with claudication undergoing endovascular-first intervention also had lower rates of major adverse cardiovascular event (0.8% vs 1.6%; OR, 0.4; 95% CI, 0.2-0.95), surgical site infection (0.7% vs 6.6%; OR, 0.1; 95% CI, 0.04-0.2), bleeding (2.3% vs 6.0%; OR, 0.3; 95% CI, 0.2-0.5), unplanned reoperation (4.3% vs 6.6%; OR, 0.6; 95% CI, 0.4-0.9), and unplanned readmission (5.9% vs 9.0%; OR, 0.6; 95% CI, 0.4-0.8). Conversely, endovascular-first intervention was associated with a higher rate of secondary revascularizations within 30 days for CLTI (4.3% vs 3.1%; OR, 1.6; 95% CI, 1.04-2.3) but not for claudication (2.6% vs 1.9%; OR, 1.7; 95% CI, 0.9-3.4). CONCLUSIONS: An endovascular-first approach as a revascularization strategy for infrainguinal disease was associated with substantially lower early morbidity but not mortality, at the cost of higher rates of postoperative secondary revascularizations. As a national representation of first-time revascularizations, this study highlights the early endovascular perioperative benefit, although more robust long-term data are needed to adopt either one strategy or the other in select patients with peripheral arterial disease.

Preoperative anemia is associated with mortality after carotid endarterectomy in symptomatic patients.

OBJECTIVE: Preoperative anemia and blood transfusions are associated with worse outcomes after surgery. However, the impact of preoperative anemia and transfusions on outcomes after carotid endarterectomy (CEA) is unknown. METHODS: CEA patients from 2011 to 2015 in the American College of Surgeons National Surgical Quality Improvement Program Targeted Vascular module were compared by the presence of preoperative anemia (hematocrit <36%) after stratification by symptom status. Multivariable analysis accounted for differences in baseline characteristics. We included an interaction term in our multivariable model to assess whether the effect of anemia differed significantly between patients who received a perioperative transfusion and those who did not, with 30-day mortality as our primary outcome. RESULTS: Of 16,068 patients, 6734 (42%) were symptomatic, of whom 1500 (22%) had anemia. Of the 9334 asymptomatic patients, 1935 (21%) had anemia. Both symptomatic and asymptomatic anemic patients were more likely to be transfused perioperatively compared with nonanemic patients, with 7.0% vs 0.4%, and 5.8% vs 0.7% (both P < .001). Among symptomatic patients, those with anemia compared with those without had a higher rate of 30-day mortality (2.5% vs 0.7%; P < .001). After adjustment, anemic symptomatic patients had a higher 30-day mortality risk (odds ratio [OR], 3.1; 95% confidence interval [CI], 1.9-5.0; P < .001) compared with nonanemic symptomatic patients. In addition, in symptomatic patients, we found a significant interaction between anemia and perioperative transfusion on the outcome of 30-day mortality (P = .004), with a higher risk in perioperatively transfused symptomatic patients with anemia (OR, 7.8; 95% CI, 3.4-18.0; P < .001) than in symptomatic patients with anemia who did not receive a perioperative transfusion (OR, 2.3; 95% CI, 1.4-3.9; P = .002). In asymptomatic patients, anemic and nonanemic patients had comparable 30-day mortality rates (0.9% vs 0.6%; P = .2). After adjustment, anemia was not associated with 30-day mortality in asymptomatic patients (OR, 1.0; 95% CI, 0.5-2.0; P = .9), nor did we identify an interaction between anemia and perioperative transfusion in asymptomatic patients (P = .1). Patients who received a preoperative transfusion had a higher 30-day mortality rate than anemic patients not receiving preoperative transfusion in both symptomatic (n = 31, 9.7% vs 2.5%; P = .04) and asymptomatic patients (n = 21, 9.5% vs 0.9%; P = .02). CONCLUSIONS: Preoperative anemia is a risk factor for 30-day mortality after CEA in symptomatic patients but not in asymptomatic patients. These results should be factored into the selection of symptomatic patients for CEA and dissuade treatment of asymptomatic patients scheduled for CEA who need a preoperative transfusion.

An update on the incidence of perioperative outcomes after carotid endarterectomy, stratified by type of preprocedural neurologic symptom.

OBJECTIVE: Perioperative complications after carotid endarterectomy (CEA) have decreased over time. Therefore, we aimed to provide an update on 30-day outcomes after CEA, stratified by type of preprocedural neurologic symptom. METHODS: We included all CEAs from the Targeted Vascular module of the American College of Surgeons National Surgical Quality Improvement Program (ACS-NSQIP, 2011-2015) and stratified patients based on type of preprocedural neurologic symptom, that is, asymptomatic, ocular transient ischemic attack (TIA), hemispheric TIA, and stroke. We compared 30-day outcomes across the groups, with 30-day stroke/death as our primary endpoint. RESULTS: Of 16,739 CEA patients, 9784 were asymptomatic (58%). Among the 6955 symptomatic patients, 1216 (17%) had a preprocedural ocular TIA, 2635 (38%) a preprocedural hemispheric TIA, and 3104 (45%) a preprocedural stroke. Preprocedural stroke patients had higher 30-day stroke/death rates compared with those with a preprocedural hemispheric TIA, or ocular TIA, or asymptomatic patients (5.0% vs 3.3%, 1.9%, and 1.8%, respectively; all P < .001), primarily owing to differences in perioperative 30-day stroke rates, with 4.1% vs 2.5%, 1.4%, and 1.3%, respectively (all P < .001). CONCLUSIONS: Among symptomatic CEA patients, those with a preprocedural stroke had a high perioperative 30-day stroke/death rate, compared with those patients with either a preprocedural hemispheric or ocular TIA. Therefore, the common stratification applied to CEA patients, which groups all symptomatic patients, should be avoided, especially as the relative proportion of symptomatic patients with a preprocedural stroke vs those with a hemispheric or ocular TIA will affect the overall outcome for all symptomatic patients after CEA.

Preoperative anemia associated with adverse outcomes after infrainguinal bypass surgery in patients with chronic limb-threatening ischemia.

OBJECTIVE: Preoperative anemia in elderly patients undergoing surgery is prevalent and associated with adverse events; however, the interaction with other risk factors in patients with chronic limb-threatening ischemia (CLTI) is not well described. The purpose of this study was to assess the association between lower hematocrit (HCT) levels on admission and postoperative outcomes after infrainguinal bypass surgery. METHODS: Patients with CLTI undergoing nonemergent infrainguinal bypass were identified in the targeted vascular module of National Surgical Quality Improvement Program (NSQIP; 2011-2014). The 30-day outcomes were compared across preoperative HCT levels: severe (≤29%), moderate (29.1%-34%), mild (34.1%-39%), or no anemia (>39%), with no anemia serving as the reference group for all analyses. Independent associations between levels of anemia and postoperative outcomes were established using multivariable logistic regression. A sensitivity analysis was performed to assess interactions between preoperative anemia and blood transfusions. RESULTS: We identified 5081 patients undergoing bypass, of which 741 (15%) had severe, 1317 (26%) moderate, 1516 (30%) mild, and 1507 (30%) no anemia. Anemic patients were older and more commonly suffered from tissue loss and comorbidities (eg, hypertension, diabetes, and renal insufficiency; all P < .001). After adjustment for baseline conditions, mortality was higher in those with severe anemia (3.1%; odds ratio [OR], 2.8; 95% confidence interval [CI], 1.3-6.3) and moderate anemia (3.0%; OR, 2.6; 95% CI, 1.2-5.5) compared with those without anemia (0.7%). Severe anemia was independently associated with major amputation (6.9% vs 3.3%; OR, 1.6; 95% CI, 1.01-2.6) compared with no anemia. Anemia on admission was additionally associated with several other adverse outcomes, such as major adverse cardiovascular event (MACE; severe: OR, 1.9; 95% CI, 1.1-3.0; moderate: OR, 1.9; 95% CI, 1.3-2.9; mild: OR, 1.6; 95% CI, 1.1-2.4) and unplanned return to the operating room (severe: OR, 1.6; 95% CI, 1.2-2.1; moderate: OR, 1.5; 95% CI, 1.2-1.8; mild, OR: 1.3; 95% CI, 1.03-1.6). Moreover, mortality associated with preoperative anemia was not different in patients receiving postoperative blood transfusions compared with those who did not, whereas MACE was significantly higher in patients with preoperative anemia and blood transfusions (interaction; P < .001). CONCLUSIONS: Mortality and major adverse events in CLTI patients undergoing infrainguinal bypass are inversely associated with preoperative HCT levels, with the highest event rates in the most severely anemic patients. The correlation between anemia and MACE-but not mortality-was stronger in those patients receiving postoperative blood transfusions. Further research is needed to define an appropriate transfusion threshold, and attention should be focused on how to best optimize anemic CLTI patients before intervention.

The impact of contralateral carotid artery stenosis on outcomes after carotid endarterectomy.

OBJECTIVE: Patients with contralateral carotid occlusion (CCO) have been excluded from randomized clinical trials because of a deemed high risk for adverse neurologic outcomes with carotid endarterectomy (CEA). Evidence for this rationale is limited and conflicting. Therefore, we aimed to compare outcomes after CEA between patients with and without CCO and varying degrees of contralateral carotid stenosis (CCS). METHODS: We identified patients undergoing CEA from 2003 to 2015 in the Vascular Study Group of New England (VSGNE) registry. Patients were stratified by preoperative symptom status and presence of CCO. Multivariable analysis was used to account for differences in demographics and comorbidities. Our primary outcome was 30-day stroke/death risk. RESULTS: Of 15,487 patients we identified who underwent CEA, 10,377 (67%) were asymptomatic. CCO was present in 914 patients, of whom 681 (75%) were asymptomatic. Overall, the 30-day stroke/death was 2.0% for symptomatic patients (CCO: 2.6%) and 1.1% for asymptomatic patients (CCO: 2.3%). After adjustment, including symptom status, CCO was associated with higher 30-day stroke/death (odds ratio [OR], 2.1; 95% confidence interval [CI], 1.4-3.3; P = .001), any in-hospital stroke (OR, 2.8; 95% CI, 1.7-4.6; P < .001), in-hospital ipsilateral stroke (OR, 2.2; 95% CI, 1.2-4.0; P = .02), in-hospital contralateral stroke (OR, 5.1; 95% CI, 2.2-11.4; P < .001), and prolonged length of stay (OR, 1.6; 95% CI, 1.3-1.9; P < .001). CCS of 80% to 99% was only associated with a prolonged length of stay (OR, 1.3; 95% CI, 1.1-1.6; P = .01), not with in-hospital stroke. Neither CCO nor CCS was associated with 30-day mortality. CONCLUSIONS: Although CCO increases the risk of 30-day stroke/death, in-hospital strokes, and prolonged length of stay after CEA, the 30-day stroke/death rates in symptomatic and asymptomatic patients with CCO remain within the recommended thresholds set by the 14 societies' guideline document. Thus, CCO should not qualify as a high-risk criterion for CEA. Moreover, there is no evidence that patients with CCO have lower stroke/death rates after carotid artery stenting than after CEA. We believe that CEA remains a valid and safe option for patients with CCO and that CCO should not be applied as a criterion to promote carotid artery stenting per se.

External validity of randomized controlled trials in older adults, a systematic review.

BACKGROUND: To critically assess the external validity of randomized controlled trials (RCTs) it is important to know what older adults have been enrolled in the trials. The aim of this systematic review is to study what proportion of trials specifically designed for older patients report on somatic status, physical and mental functioning, social environment and frailty in the patient characteristics. METHODS: PubMed was searched for articles published in 2012 and only RCTs were included. Articles were further excluded if not conducted with humans or only secondary analyses were reported. A random sample of 10% was drawn. The current review analyzed this random sample and further selected trials when the reported mean age was ≥ 60 years. We extracted geriatric assessments from the population descriptives or the in- and exclusion criteria. RESULTS: In total 1396 trials were analyzed and 300 trials included. The median of the reported mean age was 66 (IQR 63-70) and the median percentage of men in the trials was 60 (IQR 45-72). In 34% of the RCTs specifically designed for older patients somatic status, physical and mental functioning, social environment or frailty were reported in the population descriptives or the in- and exclusion criteria. Physical and mental functioning was reported most frequently (22% and 14%). When selecting RCTs on a mean age of 70 or 80 years the report of geriatric assessments in the patient characteristics was 46% and 85% respectively but represent only 5% and 1% of the trials. CONCLUSION: Somatic status, physical and mental functioning, social environment and frailty are underreported even in RCTs specifically designed for older patients published in 2012. Therefore, it is unclear for clinicians to which older patients the results can be applied. We recommend systematic to transparently report these relevant characteristics of older participants included in RCTs.

Risk factors for 30-day unplanned readmission following infrainguinal endovascular interventions.

OBJECTIVE: Unplanned hospital readmissions following surgical interventions are associated with adverse events and contribute to increasing health care costs. Despite numerous studies defining risk factors following lower extremity bypass surgery, evidence regarding readmission after endovascular interventions is limited. This study aimed to identify predictors of 30-day unplanned readmission following infrainguinal endovascular interventions. METHODS: We identified all patients undergoing an infrainguinal endovascular intervention in the targeted vascular module of the American College of Surgeons National Surgical Quality Improvement Program between 2012 and 2014. Perioperative outcomes were stratified by symptom status (chronic limb-threatening ischemia [CLI] vs claudication). Patients who died during index admission and those who remained in the hospital after 30 days were excluded. Indications for unplanned readmission related to the index procedure were evaluated. Multivariable logistic regression was used to identify preoperative and in-hospital (during index admission) risk factors of 30-day unplanned readmission. RESULTS: There were 4449 patients who underwent infrainguinal endovascular intervention, of whom 2802 (63%) had CLI (66% tissue loss) and 1647 (37%) had claudication. The unplanned readmission rates for CLI and claudication patients were 16% (n = 447) and 6.5% (n = 107), respectively. Mortality after index admission was higher for readmitted patients compared with those not readmitted (CLI, 3.4% vs 0.7% [P < .001]; claudication, 2.8% vs 0.1% [P < .01]). Approximately 50% of all unplanned readmissions were related to the index procedure. Among CLI patients, the most common indication for readmission related to the index procedure was wound or infection related (42%), whereas patients with claudication were mainly readmitted for recurrent symptoms of peripheral vascular disease (28%). In patients with CLI, predictors of unplanned readmission included diabetes (odds ratio, 1.3; 95% confidence interval, 1.01-1.6), congestive heart failure (1.6; 1.1-2.5), renal insufficiency (1.7; 1.3-2.2), preoperative dialysis (1.4; 1.02-1.9), tibial angioplasty/stenting (1.3; 1.04-1.6), in-hospital bleeding (1.9; 1.04-3.5), in-hospital unplanned return to the operating room (1.9; 1.1-3.5), and discharge other than to home (1.5; 1.1-2.0). Risk factors for those with claudication were dependent functional status (3.5; 1.4-8.7), smoking (1.6; 1.02-2.5), diabetes (1.5; 1.01-2.3), preoperative dialysis (3.6; 1.6-8.3), procedure time exceeding 120 minutes (1.8; 1.1-2.7), in-hospital bleeding (2.9; 1.2-7.4), and in-hospital unplanned return to the operating room (3.4; 1.2-9.4). CONCLUSIONS: Unplanned readmission after endovascular treatment is relatively common, especially in patients with CLI, and is associated with substantially increased mortality. Awareness of these risk factors will help providers identify patients at high risk who may benefit from early surveillance, and prophylactic measures focused on decreasing postoperative complications may reduce the rate of readmission.

Sex differences in mortality and morbidity following repair of intact abdominal aortic aneurysms.

OBJECTIVE: Medicare studies have shown increased perioperative mortality in women compared with men following endovascular and open abdominal aortic aneurysm (AAA) repair. However, a recent regional study of high-volume centers, adjusting for anatomy but limited in sample size, did not show sex to be predictive of worse outcomes. This study aimed to evaluate sex differences after intact AAA repair in a national clinical registry. METHODS: The targeted vascular module of the National Surgical Quality Improvement Program was queried to identify patients undergoing endovascular aneurysm repair (EVAR) or open repair for intact, infrarenal AAA from 2011 to 2014. Univariate analysis was performed using the Fisher exact test and Mann-Whitney test. Multivariable logistic regression was used to account for differences in comorbidities, aneurysm details, and operative characteristics. RESULTS: We identified 6611 patients (19% women) who underwent intact AAA repair (87% EVAR; 83% women vs 88% men; P < .001). Women were older (median age, 76 vs 73 years; P < .001), had smaller aneurysms (median, 5.4 vs 5.5 cm; P < .001), and had more chronic obstructive pulmonary disease (22% vs 17%; P < .001). Among patients undergoing EVAR, women had longer operative times (median, 138 [interquartile range, 103-170] vs 131 [106-181] minutes; P < .01) and more often underwent renal (6.3% vs 4.1%; P < .01) and lower extremity (6.6% vs 3.8%; P < .01) revascularization. After open repair, women had shorter operative time (215 [177-304] vs 226 [165-264] minutes; P = .02), but women less frequently underwent lower extremity revascularization (3.1% vs 8.2%; P = .03). Thirty-day mortality was higher in women after EVAR (3.2% vs 1.2%; P < .001) and open repair (8.0% vs 4.0%; P = .04). After adjusting for repair type, age, aneurysm diameter, and comorbidities, female sex was independently associated with mortality (odds ratio [OR], 1.7; 95% confidence interval [CI], 1.1-2.6; P = .02) and major complications (OR, 1.4; CI, 1.1-1.7; P < .01) after intact AAA repair. However, after adjusting for aortic size index rather than for aortic diameter, the association between female sex and mortality (OR, 1.5; CI, 0.98-2.4; P = .06) and major complications (OR, 1.1; CI, 0.9-1.4; P = .24) was reduced. CONCLUSIONS: Women were at higher risk for 30-day death and major complications after intact AAA repair. Some of this disparity may be explained by differences in aortic size index, which should be further evaluated to determine the ideal threshold for repair.