Sex-related Outcomes after Thoracic Endovascular Repair for intact isolated Descending Thoracic Aortic Aneurysm: A Retrospective Cohort Study.

OBJECTIVE: To evaluate the association between sex and outcomes following TEVAR for intact isolated descending thoracic aortic aneurysms (iiDTAA). SUMMARY BACKGROUND DATA: Data regarding sex-related long-term outcomes after TEVAR for iiDTAA are limited and conflicting results regarding perioperative outcomes have been reported. METHODS: We included all TEVAR for iiDTAA between 2014-2019 in the Vascular Quality Initiative linked to Medicare claims, allowing reliable assessment of long-term outcome data. Primary outcomes included 5-year mortality, reinterventions, and ruptures of the thoracic aorta. Secondarily we assessed perioperative outcomes. RESULTS: We identified 685 patients, of which 54% were females. Females had higher aortic size index (females vs. males: 3.31 [IQR, 2.81-3.85] cm/m2 vs. 2.93 [IQR, 2.42-3.36] cm/m2; P<.001), were more frequently symptomatic (31% vs. 20%; P=.001), had longer procedure time (111 [IQR, 72-165] min vs. 97 [IQR, 70-146] min) and more iliac procedures (16% vs. 7.6%; P=.001). Compared with males, females had similar rates of 5-year mortality (58% vs. 53%; HR, 0.93; 95%CI 0.71-1.22; P=.61), reinterventions (39% vs. 30%; HR, 1.12; 95%CI 0.73-1.73; P=.60) and late ruptures (0.6% vs. 1.2%; HR, 0.87; 95%CI 0.12-6.18; P=.89). After adjustment, these outcomes remained similar through 5-years. Furthermore, perioperative mortality was not significantly different between sexes (4.1% vs. 2.2%; P=.25), as were rates of any complication as a composite outcome (16% vs. 21%; P=.16), as well as of individual complications (all P>.05). CONCLUSIONS: Our findings suggest that females who undergo TEVAR for iiDTAA have similar 5-year and perioperative outcomes as compared with males.

In-hospital outcomes after upper extremity versus transfemoral and transcarotid access for carotid stenting in the Vascular Quality Initiative.

OBJECTIVE: Carotid artery stenting (CAS) is frequently used for patients at high risk for carotid endarterectomy. However, there are limited data comparing transradial or transbrachial (tr/tbCAS) access with more established CAS approaches. Therefore, we examined the effect of a tr/tbCAS approach versus a transfemoral (tfCAS) or transcarotid (TCAR) approach on outcomes after CAS. METHODS: We identified all patients undergoing CAS in the Vascular Quality Initiative registry from January 2016 to December 2021. We compared outcomes across 1:3 propensity score-matched cohorts of patients who underwent tr/tbCAS versus tfCAS or tr/tbCAS versus TCAR. As a secondary analysis, we assessed outcomes stratified by carotid symptom status. Our primary outcome was a composite end point of in-hospital stroke/death. RESULTS: Among 40,835 CAS patients, 962 (2.4%) underwent tr/tbCAS, 18,840 (46%) underwent tfCAS, and 21,033 (52%) underwent TCAR. Among matched patients who underwent tr/tbCAS versus tfCAS, there was no significant difference in the risk of stroke/death (4.1% vs 2.9%; relative risk [RR] 1.4; 95% confidence interval [CI], 0.95-2.1), but tr/tbCAS was associated with a higher risk of death (2.4% vs 1.3%; RR, 1.8; 95% CI, 1.1-3.1). In the symptomatic subgroup, tr/tbCAS was associated with a higher risk of stroke/death (6.1% vs 3.9%; RR, 1.6; 95% CI, 1.0-2.4) and death (3.6% vs 1.7%; RR, 2.1; 95% CI, 1.2-3.7), but there were no differences in asymptomatic patients. After adjustment for mRS in patients with preoperative stroke, there were no significant differences in stroke/death (RR, 1.1; 95% CI, 0.66-1.9) or death (RR, 1.6; 95% CI, 0.81-3.3) between groups. In matched patients who underwent tr/tbCAS versus TCAR, tr/tbCAS was associated with a higher risk of stroke/death (4.2% vs 2.3%; RR, 1.8; 95% CI, 1.2-2.7) and death (2.4% vs 0.5%; RR, 4.8; 95% CI, 2.4-9.5). In the symptomatic subgroup, tr/tbCAS remained associated with a higher risk of stroke/death (6.2% vs 2.4%; RR, 2.6; 95% CI, 1.6-4.2) and death (3.7% vs 0.7%; RR, 5.6; 95% CI, 2.6-12), but there were no differences in asymptomatic patients. After adjustment for Modified Rankin Scale in patients with preoperative stroke, there were no significant differences in stroke/death (RR, 1.4; 95% CI, 0.79-2.6) or death (RR, 2.3; 95% CI, 0.95-5.7) between groups. CONCLUSIONS: Compared with tfCAS or TCAR, tr/tbCAS was associated with a higher risk of in-hospital stroke/death in symptomatic patients, which was driven primarily by a higher risk of death. These inferior outcomes were partly attributable to more severe preoperative neurologic disability in tr/tbCAS patients. In contrast, there were no differences in outcomes in asymptomatic patients. Overall, our findings highlight the importance of guideline-directed patient selection in tr/tbCAS.

Disparities in reporting and representation by sex, race, and ethnicity in endovascular aortic device trials.

OBJECTIVE: Vulnerable populations, including women and racial and ethnic minorities, have been historically underrepresented in clinical trials. We, therefore, studied the demographics of patients enrolled in pivotal endovascular aortic device trials in the United States. METHODS: We queried the Food and Drug Administration (FDA) medical devices database for all FDA-approved endografts for the treatment of aortic aneurysms, transections, and dissections from September 1999 to November 2021. These included abdominal endovascular aortic repair (EVAR), thoracic EVAR (TEVAR), fenestrated EVAR (FEVAR) devices, and dissection stents. Multiple cases of approval for expanded indications were included separately. The primary outcomes included the proportion of trials reporting participant sex, race, and ethnicity and the proportion of enrolled participants across sex, racial, and ethnic groups. RESULTS: The FDA provided 29 approvals from 29 trials of 24 devices: 15 EVAR devices (52%), 12 TEVAR devices (41%), 1 FEVAR device (3.4%), and 1 dissection stent (3.4%). These trials had included 4046 patients. Of the 29 trials, all had reported on the sex of the participants, and the median female enrollment was 21% (interquartile range [IQR], 11%-34%). The EVAR trials had the lowest female enrollment (11%; IQR, 8.7%-13%) compared with 41% (IQR, 27%-45%) in the TEVAR trials, 21% in the FEVAR trial, and 34% in the dissection stent trial (P < .01 for the difference). Only 52% of the trials had reported the three most common racial groups (White, Black, Asian), and only 48% had reported Hispanic ethnicity. The TEVAR trials were the most likely to report all three racial groups and Hispanic ethnicity (92% and 75%, respectively), while the EVAR trials had the lowest reporting rates (13% and 20%, respectively). Where reported, the median enrollment of racial and ethnic groups across the trials was as follows: Black patients, 9.8% (FEVAR, 0%; EVAR, 1.9%; TEVAR, 12%; dissection stent, 25%; P = .01); Asian patients, 2.4% (EVAR, 0.6%; FEVAR, 2.4%; TEVAR, 2.5%; dissection stent, 11%; P = .24); and Hispanic patients, 3.8% (EVAR, 1.3%; FEVAR, 2.4%; TEVAR, 3.9%; dissection stent, 4.1%; P = .75). CONCLUSIONS: Racial and ethnic minority groups were underrepresented and underreported in pivotal aortic device trials that led to FDA approval. Female patients were also underrepresented in these aortic trials, especially for EVAR. These data suggest the need for standardization of reporting practices and minimum thresholds for minority and female participation in pivotal trials to promote equitable representation.

In-hospital versus postdischarge major adverse events within 30 days following lower extremity revascularization.

OBJECTIVE: Studies using hospital discharge data likely underestimate postoperative morbidity and mortality after lower extremity revascularization because they fail to capture postdischarge events. However, the degree of underestimation and the timing of postdischarge complications are not well-characterized. METHODS: We used the American College of Surgeons National Surgical Quality Improvement Program procedure-targeted vascular databases from 2011 to 2015 to tabulate 30-day adverse events (in hospital and after discharge) for lower extremity bypass (LEB) and percutaneous vascular interventions (PVIs) performed for claudication and chronic limb-threatening ischemia (CLTI). RESULTS: A total of 14,125 patients underwent lower extremity revascularization, 8909 patients (63%) with LEB and 5216 (37%) with PVI. For CLTI, total 30-day mortality was similar between PVI and LEB (2.3% vs 2.1%; P = .61), but in-hospital deaths only accounted for 43% of PVI mortality and only 65% of LEB mortality (P ≤ .001). Major adverse cardiac events occurred in 2.9% of PVI patients and 4.6% of LEB patients (P < .001), with postdischarge events accounting for 37% of PVI events and 18% of LEB (P ≤ .001). Although the 30-day reoperation rates were 14% for PVI and 18% for LEB (P < .001), almost one-half occurred after discharge (PVI 46% vs LEB 44%; P = .55). Any postoperative major adverse events (MAEs) occurred in 22% of patients after PVI and 31% after LEB, with more than one-half occurring after discharge (PVI 56% vs LEB 53%; P = .17). For claudicants, total 30-day mortality was 0.4% for PVI and 0.7% for LEB (P = .32), with the vast majority of events occurring after discharge (PVI 90% vs LEB 50%; P = .049). The 30-day reoperation rates were 5.2% for PVI and 8.0% for LEB (P < .001), with more than one-half occurring after discharge (PVI 63% vs LEB 53%; P = .09). Any MAEs occurred in 7.0% of patients after PVI and 17% after bypass, with the majority occurring after discharge (PVI 65% vs LEB 63%; P = .66). CONCLUSIONS: Most MAEs occur less frequently after PVI than LEB. However, a significant number of major of adverse events after lower extremity revascularization occur after leaving the hospital, especially after PVI, which may overestimate its benefits compared with LEB if only in-hospital data are evaluated. These data demonstrate the importance of reporting 30-day rather than in-hospital outcomes when evaluating postoperative adverse events.

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.

Trends in Treatment and Mortality for Mesenteric Ischemia in the United States from 2000 to 2012.

BACKGROUND: It is unknown whether increased endovascular treatment of chronic mesenteric ischemia has led to decreases in open surgery, acute mesenteric ischemia, or overall mortality. The present study evaluates the trends in endovascular and open treatment over time for chronic and acute mesenteric ischemia. METHODS: We identified patients with chronic or acute mesenteric ischemia in the Nationwide Inpatient Sample and Center for Disease Control and Prevention database from 2000 to 2012. Trends in revascularization, mortality, and total deaths were evaluated over time. Data were adjusted to account for population growth. RESULTS: There were 14,810 revascularizations for chronic mesenteric ischemia (10,453 endovascular and 4,358 open) and 11,294 revascularizations for acute mesenteric ischemia (4,983 endovascular and 6,311 open). Endovascular treatment increased for both chronic (0.6-4.5/million, P < 0.01) and acute mesenteric ischemia (0.6-1.8/million, P < 0.01). However, concurrent declines in open surgery did not occur (chronic: 1-1.1/million, acute: 1.8-1.7/million). Among patients with acute mesenteric ischemia, the proportion with atrial fibrillation (18%) and frequency of embolectomy (1/million per year) remained stable. In-hospital mortality rates decreased for both endovascular (chronic: 8-3%, P < 0.01; acute: 28-17%, P < 0.01) and open treatment (chronic: 21-9%, P < 0.01; acute: 40-25%, P < 0.01). Annual population-based mortality remained stable for chronic mesenteric ischemia (0.7-0.6 deaths per million/year), but decreased for acute mesenteric ischemia (12.9-5.3 deaths per million/year, P < 0.01). CONCLUSIONS: Population mortality from acute mesenteric ischemia declined from 2000 to 2012, correlated with dramatic increases in endovascular intervention for chronic mesenteric ischemia, and in spite of a stable rate of embolization. However, open surgery for both chronic and acute ischemia remained stable.

Abdominal aortic aneurysms in women.

Abdominal aortic aneurysm (AAA) has long been recognized as a condition predominantly affecting males, with sex-associated differences described for almost every aspect of the disease from pathophysiology and epidemiology to morbidity and mortality. Women are generally spared from AAA formation by the immunomodulating effects of estrogen, but once they develop, the natural history of AAAs in women appears to be more aggressive, with more rapid expansion, a higher tendency to rupture at smaller diameters, and higher mortality following rupture. However, simply repairing AAAs at smaller diameters in women is a debatable solution, as even elective endovascular AAA repair is fraught with higher morbidity and mortality in women compared to men. The goal of this review is to summarize what is currently known about the effect of gender on AAA presentation, treatment, and outcomes. Additionally, we aim to review current controversies over screening recommendations and threshold for repair in women.

Risk factors and consequences of persistent type II endoleaks.

OBJECTIVE: Type II endoleaks are common after endovascular aneurysm repair (EVAR), but their clinical significance remains undefined and their management controversial. We determined risk factors for type II endoleaks and associations with adverse outcomes. METHODS: We identified all EVAR patients in the Vascular Study Group of New England abdominal aortic aneurysm database. Patients were subdivided into two groups: (1) those with no endoleak or transient type II endoleak and (2) persistent type II endoleak or new type II endoleak (no endoleak at completion of case). Patients with other endoleak types and follow-up shorter than 6 months were excluded. Multivariable analysis was used to evaluate predictors of persistent or new type II endoleaks. Kaplan-Meier and Cox regression analysis were used to evaluate predictors of reintervention and survival. RESULTS: Two thousand three hundred sixty-seven EVAR patients had information on endoleaks: 1977 (84%) were in group 1, of which 79% had no endoleaks at all, and 21% had transient endoleaks that resolved at follow-up. The other 390 (16%) were in group 2, of which 31% had a persistent leak, and 69% had a new leak at follow-up that was not seen at the time of surgery. Group 2 was older (mean age, 75 vs 73 years; P < .001) and less likely to have chronic obstructive pulmonary disease (COPD; 24% vs 34%; P < .001) or elevated creatinine levels (2.6% vs 5.3%; P = .027). Coil embolization of one or both hypogastric arteries was associated with a higher rate of persistent type II endoleaks (12 vs 8%; P = .024), as was distal graft extension (12% vs 8%; P = .008). In multivariable analysis, COPD (odds ratio [OR], 0.7; 95% confidence interval [CI], 0.5-0.9; P = .017) was protective against persistent type II endoleak, while hypogastric artery coil embolization (OR, 1.5; 95% CI, 1.0-2.2; P = .044), distal graft extension (OR, 1.6; 95% CI, 1.1-2.3; P = .025), and age ≥ 80 (OR, 2.7; 95% CI, 1.4-5.3; P = .004) were predictive. Graft type was also associated with endoleak development. Persistent type II endoleaks were predictive of postdischarge reintervention (OR, 15.3; 95% CI, 9.7-24.3; P < .001); however, they were not predictive of long-term survival (OR, 1.1; 95% CI, 0.9-1.6; P = .477). CONCLUSIONS: Persistent type II endoleak is associated with hypogastric artery coil embolization, distal graft extension, older age, the absence of COPD, and graft type, but not with aneurysm size. Persistent type II endoleaks are associated with an increased risk of reinterventions, but not rupture or survival. This reinforces the need for continued surveillance of patients with persistent type II endoleaks and the importance of follow-up to detect new type II endoleaks over time.

Routine use of ultrasound-guided access reduces access site-related complications after lower extremity percutaneous revascularization.

OBJECTIVE: We sought to elucidate the risks for access site-related complications (ASCs) after percutaneous lower extremity revascularization and to evaluate the benefit of routine ultrasound-guided access (RUS) in decreasing ASCs. METHODS: We reviewed all consecutive percutaneous revascularizations (percutaneous transluminal angioplasty or stent) performed for lower extremity atherosclerosis at our institution from 2002 to 2012. RUS began in September 2007. Primary outcome was any ASC (bleeding, groin or retroperitoneal hematoma, vessel rupture, or thrombosis). Multivariable logistic regression was used to determine predictors of ASC. RESULTS: A total of 1371 punctures were performed on 877 patients (43% women; median age, 69 [interquartile range, 60-78] years) for claudication (29%), critical limb ischemia (59%), or bypass graft stenosis (12%) with 4F to 8F sheaths. There were 72 ASCs (5%): 52 instances of bleeding or groin hematoma, nine pseudoaneurysms, eight retroperitoneal hematomas, two artery lacerations, and one thrombosis. ASCs were less frequent when RUS was used (4% vs 7%; P = .02). Multivariable predictors of ASC were age >75 years (odds ratio [OR], 2.0; 95% confidence interval [CI], 1.1-3.7; P = .03), congestive heart failure (OR, 1.9; 95% CI, 1.1-1.3; P = .02), preoperative warfarin use (OR, 2.0; 95% CI, 1.1-3.5; P = .02), and RUS (OR, 0.4; 95% CI, 0.2-0.7; P < .01). Vascular closure devices (VCDs) were not associated with lower rates of ASCs (OR, 1.1; 95% CI, 0.6-1.9; P = .79). RUS lowered ASCs in those >75 years (5% vs 12%; P < .01) but not in those taking warfarin preoperatively (10% vs 13%; P = .47). RUS did not decrease VCD failure (6% vs 4%; P = .79). CONCLUSIONS: We were able to decrease the rate of ASCs during lower extremity revascularization with the implementation of RUS. VCDs did not affect ASCs. Particular care should be taken with patients >75 years old, those with congestive heart failure, and those taking warfarin.

Relative importance of aneurysm diameter and body size for predicting abdominal aortic aneurysm rupture in men and women.

OBJECTIVE: Women have been shown to have up to a fourfold higher risk of abdominal aortic aneurysm (AAA) rupture at any given aneurysm diameter compared with men, leading to recommendations to offer repair to women at lower diameter thresholds. Although this higher risk of rupture may simply reflect greater relative aortic dilatation in women who have smaller aortas to begin with, this has never been quantified. Our objective was therefore to quantify the relationship between rupture and aneurysm diameter relative to body size and determine whether a differential association between aneurysm diameter, body size, and rupture risk exists for men and women. METHODS: We performed a retrospective review of all patients in the Vascular Study Group of New England (VSGNE) database who underwent endovascular or open AAA repair. Height and weight were used to calculate each patient's body mass index and body surface area (BSA). Next, indices of each measure of body size (height, weight, body mass index, BSA) relative to aneurysm diameter were calculated for each patient. To generate these indices, we divided aneurysm diameter (in cm) by the measure of body size; for example, aortic size index (ASI) = aneurysm diameter (cm)/BSA (m(2)). Along with other relevant clinical variables, we used these indices to construct different age-adjusted and multivariable-adjusted logistic regression models to determine predictors of ruptured repair vs elective repair. Models for men and women were developed separately, and different models were compared using the area under the curve. RESULTS: We identified 4045 patients (78% male) who underwent AAA repair (53% endovascular aortic aneurysm repairs). Women had significantly smaller diameter aneurysms, lower BSA, and higher BSA indices than men. For men, the variable that increased the odds of rupture the most was aneurysm diameter (area under the curve = 0.82). Men exhibited an increased rupture risk with increasing aneurysm diameter (<5.5 cm: odds ratio [OR], 1.0; 5.5-6.4 cm: OR, 0.9; 95% confidence interval [CI], 0.5-1.7; P = .771; 6.5-7.4 cm: OR, 3.9; 95% CI, 1.9-1.0; P < .001; ≥ 7.5 cm: OR, 11.3; 95% CI, 4.9-25.8; P < .001). In contrast, the variable most predictive of rupture in women was ASI (area under the curve = 0.81), with higher odds of rupture at a higher ASI (ASI >3.5-3.9: OR, 6.4; 95% CI, 1.7-24.1; P = .006; ASI ≥ 4.0: OR, 9.5; 95% CI, 2.3-39.4; P = .002). For women, aneurysm diameter was not a significant predictor of rupture after adjusting for ASI. CONCLUSIONS: Aneurysm diameter indexed to body size is the most important determinant of rupture for women, whereas aneurysm diameter alone is most predictive of rupture for men. Women with the largest diameter aneurysms and the smallest body sizes are at the greatest risk of rupture.

Carotid stenting versus endarterectomy in patients undergoing reintervention after prior carotid endarterectomy.

BACKGROUND: Outcomes for patients undergoing intervention for restenosis after prior ipsilateral carotid endarterectomy (CEA) in the era of carotid angioplasty and stenting (CAS) are unclear. We compared perioperative results and durability of CAS vs CEA in patients with symptomatic or asymptomatic restenosis after prior CEA and investigated the risk of reintervention compared with primary procedures. METHODS: Patients undergoing CAS and CEA for restenosis between January 2003 and March 2012 were identified within the Vascular Study Group of New England (VSGNE) database. End points included any stroke, death or myocardial infarction (MI) within 30 days, cranial nerve injury at discharge, and restenosis ≥ 70% at 1-year follow-up. Multivariable logistic regression was done to identify whether prior ipsilateral CEA was an independent predictor for adverse outcome. RESULTS: Out of 9305 CEA procedures, 212 patients (2.3%) underwent redo CEA (36% symptomatic). Of 663 CAS procedures, 220 patients (33%) underwent CAS after prior ipsilateral CEA (31% symptomatic). Demographics of patients undergoing redo CEA were comparable to patients undergoing CAS after prior CEA. Stroke/death/MI rates were statistically similar between redo CEA vs CAS after prior CEA in both asymptomatic (4.4% vs 3.3%; P = .8) and symptomatic patients (6.6% vs 5.8%; P = 1.0). No significant difference in restenosis ≥ 70% was identified between redo CEA and CAS after prior CEA (5.2% vs 3.0%; P = .5). Redo CEA vs primary CEA had increased stroke/death/MI rate in both symptomatic (6.6% vs 2.3%; P = .05) and asymptomatic patients 4.4% vs 1.7%; P = .03). Prior ipsilateral CEA was an independent predictor for stroke/death/MI among all patients undergoing CEA (odds ratio, 2.1; 95% confidence interval, 1.3-3.5). No difference in cranial nerve injury was identified between redo CEA and primary CEA (5.2% vs 4.7%; P = .8). CONCLUSIONS: In the VSGNE, CEA and CAS showed statistically equivalent outcomes in asymptomatic and symptomatic patients treated for restenosis after prior ipsilateral CEA. However, regardless of symptom status, the risk of reintervention was increased compared with patients undergoing primary CEA.

Presentation, treatment, and outcome differences between men and women undergoing revascularization or amputation for lower extremity peripheral arterial disease.

OBJECTIVE: Prior studies have suggested treatment and outcome disparities between men and women for lower extremity peripheral arterial disease after surgical bypass. Given the recent shift toward endovascular therapy, which has increasingly been used to treat claudication, we sought to analyze sex disparities in presentation, revascularization, amputation, and inpatient mortality. METHODS: We identified individuals with intermittent claudication and critical limb ischemia (CLI) using International Classification of Diseases, Ninth Revision codes in the Nationwide Inpatient Sample from 1998 to 2009. We compared presentation at time of intervention (intermittent claudication vs CLI), procedure (open surgery vs percutaneous transluminal angioplasty or stenting vs major amputation), and in-hospital mortality for men and women. Regional and ambulatory trends were evaluated by performing a separate analysis of the State Inpatient and Ambulatory Surgery Databases from four geographically diverse states: California, Florida, Maryland, and New Jersey. RESULTS: From the Nationwide Inpatient Sample, we identified 1,797,885 patients (56% male) with intermittent claudication (26%) and CLI (74%), who underwent 1,865,999 procedures (41% open surgery, 20% percutaneous transluminal angioplasty or stenting, and 24% amputation). Women were older at the time of intervention by 3.5 years on average and more likely to present with CLI (75.9% vs 72.3%; odds ratio [OR], 1.21; 95% confidence interval [CI], 1.21-1.23; P < .01). Women were more likely to undergo endovascular procedures for both intermittent claudication (47% vs 41%; OR, 1.27; 95% CI, 1.25-1.28; P < .01) and CLI (21% vs 19%; OR, 1.14; 95% CI, 1.13-1.15; P < .01). From 1998 to 2009, major amputations declined from 18 to 11 per 100,000 in men and 16 to 7 per 100,000 in women, predating an increase in total CLI revascularization procedures that was seen starting in 2005 for both men and women. In-hospital mortality was higher in women regardless of disease severity or procedure performed even after adjusting for age and baseline comorbidities (.5% vs .2% after percutaneous transluminal angioplasty or stenting for intermittent claudication; 1.0% vs .7% after open surgery for intermittent claudication; 2.3% vs 1.6% after percutaneous transluminal angioplasty or stenting for CLI; 2.7% vs 2.2% after open surgery for CLI; P < .01 for all comparisons). CONCLUSIONS: There appears to be a preference to perform endovascular over surgical revascularization among women, who are older and have more advanced disease at presentation. Percutaneous transluminal angioplasty or stenting continues to be popular and is increasingly being performed in the outpatient setting. Amputation and in-hospital mortality rates have been declining, and women now have lower amputation but higher mortality rates than men. Recent improvements in outcomes are likely the result of a combination of improved medical management and risk factor reduction.

Risk factors and indications for readmission after lower extremity amputation in the American College of Surgeons National Surgical Quality Improvement Program.

BACKGROUND: Postoperative readmission, recently identified as a marker of hospital quality in the Affordable Care Act, is associated with increased morbidity, mortality, and health care costs, yet data on readmission after lower extremity amputation (LEA) are limited. We evaluated risk factors for readmission and postdischarge adverse events after LEA in the American College of Surgeons National Surgical Quality Improvement Program (NSQIP). METHODS: All patients undergoing transmetatarsal (TMA), below-knee (BKA), or above-knee amputation (AKA) in the 2011-2012 NSQIP were identified. Independent predischarge predictors of 30-day readmission were determined by multivariable logistic regression. Readmission indication and reinterventions, available in the 2012 NSQIP only, were also evaluated. RESULTS: We identified 5732 patients undergoing amputation (TMA, 12%; BKA, 51%; AKA, 37%). Readmission rate was 18%. Postdischarge mortality rate was 5% (TMA, 2%; BKA, 3%; AKA, 8%; P < .001). Overall complication rate was 43% (in-hospital, 32%; postdischarge, 11%). Reoperation was for wound-related complication or additional amputation in 79% of cases. Independent predictors of readmission included chronic nursing home residence (odds ratio [OR], 1.3; 95% confidence interval [CI], 1.0-1.7), nonelective surgery (OR, 1.4; 95% CI, 1.1-1.7), prior revascularization/amputation (OR, 1.4; 95% CI, 1.1-1.7), preoperative congestive heart failure (OR, 1.7; 95% CI, 1.2-2.4), and preoperative dialysis (OR, 1.5; 95% CI, 1.2-1.9). Guillotine amputation (OR, 0.6; 95% CI, 0.4-0.9) and non-home discharge (OR, 0.7; 95% CI, 0.6-1.0) were protective of readmission. Wound-related complications accounted for 49% of readmissions. CONCLUSIONS: Postdischarge morbidity, mortality, and readmission are common after LEA. Closer follow-up of high-risk patients, optimization of medical comorbidities, and aggressive management of wound infection may play a role in decreasing readmission and postdischarge adverse events.

Accuracy of administrative data versus clinical data to evaluate carotid endarterectomy and carotid stenting.

OBJECTIVE: Administrative data have been used to compare carotid endarterectomy (CEA) and carotid artery stenting (CAS). However, there are limitations in defining symptom status, Centers for Medicare and Medicaid Services high-risk status, as well as complications. Therefore, we did a direct comparison between administrative data and physician chart review as well as between data collected for the National Surgical Quality Improvement Program (NSQIP) and physician chart review for CEA and CAS. METHODS: We performed an outcomes analysis on all CEA and CAS procedures from 2005 to 2011. We obtained International Classification of Diseases, Ninth Revision diagnosis codes from hospital discharge records regarding symptom status, high-risk status, and perioperative stroke. We also obtained data on all CEA patients submitted to NSQIP over the same time period. One of the study authors (R.B.) then performed a chart review of the same patients to determine symptom status, high-risk status, and perioperative strokes and the results were compared. RESULTS: We identified 1342 patients who underwent CEA or CAS between 2005 and 2011 and 392 patients who underwent CEA that were submitted to NSQIP. Administrative data identified fewer symptomatic patients (17.0% vs 34.0%), physiologic high-risk patients (9.3% vs 23.0%), and anatomic high-risk patients (0% vs 15.2%). Although administrative data identified a similar proportion of perioperative strokes (1.9% vs 2.0%), this was due to the fact that these data identified eight false positive and nine false negative perioperative strokes. NSQIP data identified more symptomatic patients compared with chart review (44.1% vs 30.3%), fewer physiologic high-risk patients (13.0% vs 18.6%), fewer anatomic high-risk patients (0% vs 6.6%), and a similar proportion of perioperative strokes (1.5% vs 1.8%, only one false negative stroke and no false positives). CONCLUSIONS: Administrative data are unreliable for determining symptom status, high-risk status, and perioperative stroke and should not be used to analyze CEA and CAS. NSQIP data do not adequately identify high-risk patients, but do accurately identify perioperative strokes and to a lesser degree, symptom status.

In-hospital versus postdischarge adverse events following carotid endarterectomy.

OBJECTIVE: Most studies based on state and nationwide registries evaluating perioperative outcome after carotid endarterectomy (CEA) rely on hospital discharge data only. Therefore, the true 30-day complication risk after carotid revascularization may be underestimated. METHODS: We used the National Surgical Quality Improvement Program database 2005-2010 to assess the in-hospital and postdischarge rate of any stroke, death, cardiac event (new Q-wave myocardial infarction or cardiac arrest), and combined stroke/death and combined adverse outcome (S/D/CE) at 30 days following CEA. Multivariable analyses were used to identify predictors for in-hospital and postdischarge events separately, and in particular, those that predict postdischarge events distinctly. RESULTS: A total of 35,916 patients who underwent CEA during 2005-2010 were identified in the National Surgical Quality Improvement Program database; 59% were male, median age was 72 years, and 44% had a previous neurologic event. Thirty-day stroke rate was 1.6% (n = 591), death rate was 0.8% (n = 272), cardiac event rate was 1.0% (n = 350), stroke or death rate was 2.2% (n = 794), and combined S/D/CE rate was 2.9% (n = 1043); 33% of strokes, 53% of deaths, 32% of cardiac events, 40% of combined stroke/death, and 38% of combined S/D/CE took place after hospital discharge. Patients with a prior stroke or transient ischemic attack had similar proportions of postdischarge events compared with patients without prior symptoms. Independent predictors for postdischarge events, but not for in-hospital events were female sex (stroke [odds ratio (OR), 1.6; 95% confidence interval (CI), 1.2-2.1] and stroke/death [OR, 1.4; 95% CI, 1.1-1.7]), renal failure (stroke [OR, 3.0; 95% CI, 1.4-6.2]) and chronic obstructive pulmonary disease (death [OR, 2.5; 95% CI, 1.6-3.7], stroke/death [OR, 1.8; 95% CI, 1.4-2.4], and S/D/CE [OR 1.8, 95% CI 1.4-2.3]). CONCLUSIONS: With 38% of perioperative adverse events after CEA happening posthospitalization, regardless of symptoms status, we need to be alert to the ongoing risks after discharge particularly in women, patients with renal failure, or chronic obstructive pulmonary disease. This emphasizes the need for reporting and comparing 30-day adverse event rates when evaluating outcomes for CEA, or comparing carotid stenting to CEA.

Gender differences in abdominal aortic aneurysm presentation, repair, and mortality in the Vascular Study Group of New England.

OBJECTIVE: Prior studies of gender differences in abdominal aortic aneurysm (AAA) repair suggest there may be differences in presentation, suitability for endovascular aneurysm repair (EVAR), and outcomes between men and women. METHODS: We used the Vascular Study Group of New England database to identify all patients undergoing EVAR or open AAA repair. We analyzed demographics, comorbidities, and procedural, and perioperative data. Results were compared using the Fisher exact test and the Student t-test. Multivariable logistic regression and Cox proportional hazards modeling were performed to identify predictors of mortality. RESULTS: We identified 4026 patients (78% men) who underwent AAA repair (54% EVAR). Women were less likely than men to undergo EVAR for intact aneurysms (50% vs 60% of intact AAA repair; P < .001) but not for ruptured aneurysms (26% vs 20%; P = .23). Women were older (median age, 75 vs 72 years for intact; P < .001; 78 vs 73 years for rupture; P < .001) with smaller aortic diameters (57 vs 59 mm for elective; P < .001; 71 vs 79 mm for rupture; P < .001). Arterial injury was more common in women (5.4% vs 2.7%; P = .013) among patients undergoing EVAR for intact aneurysms. Women stayed in the hospital longer (4.3 vs 2.7 days; P = .018) and had lower odds of being discharged home, even after adjusting for age. Among patients undergoing open repair for intact aneurysms, women more frequently experienced leg ischemia/emboli (4% vs 1%; P = .001) and bowel ischemia (5% vs 3%; P = .044). Women had higher 30-day mortality after OAR for intact (4% vs 2%; P = .03) and rupture (48% vs 34%; P = .03) repairs. However, 30-day mortality after EVAR was similar for intact (1% in men vs 1% in women; P = .57) and rupture (29% in men vs 27% in women; P > .99) repairs. Late survival was worse in women than men only for patients undergoing open repair of ruptured aneurysms (hazard ratio, 1.8; 95% confidence interval, 1.0-3.1; P = .04). After controlling for age, type of repair, urgency at presentation (ie, elective/intact vs ruptured), comorbidities, and other relevant risk factors, gender was not predictive of 30-day or 1-year mortality. CONCLUSIONS: Women with AAAs are being treated at older ages and smaller AAA diameters and are undergoing rupture repair at smaller diameters than men. Women are more likely to experience perioperative complications as a result of less favorable vascular anatomy. Age >80 years, comorbidity, presentation, and type of repair are more important predictors of mortality than gender.

Outcomes following infrapopliteal angioplasty for critical limb ischemia.

OBJECTIVE: Infrapopliteal angioplasty (percutaneous transluminal angioplasty [PTA]) is routinely used to treat critical limb ischemia (CLI) despite limited data on long-term outcomes. METHODS: We reviewed all patients undergoing infrapopliteal PTA for CLI from 2004 to 2012 stratified by TransAtlantic Inter-Society Consensus (TASC) class. Outcomes included restenosis, primary patency, reintervention (w/PTA or bypass), amputation, procedural complications, wound healing, and survival. RESULTS: Infrapopliteal PTA (stenting 14%, multilevel intervention 50%) was performed in 459 limbs of 413 patients (59% male) with a technical success of 93% and perioperative complications in 11%. TASC class was 16% A, 22% B, 27% C, and 34% D. Multilevel interventions were performed in 50% of limbs and were evenly distributed among all TASC classes. All technical failures were TASC D lesions. Mean follow-up was 15 months; 5-year survival was 49%. One- and 5-year primary patency was 57% and 38% and limb salvage was 84% and 81%, respectively. Restenosis was associated with TASC C (hazard ratio [HR], 2.2; 95% CI, 1.2-3.9; P = .010) and TASC D (HR, 2.4; 95% CI, 1.3-4.4; P = .004) lesions. Amputation rates were higher in patients who were not candidates for bypass (HR, 4.4; 95% CI, 2.6-7.5; P < .001) and with TASC D lesions (HR, 3.8; 95% CI, 1.1-12.5; P = .03). Unsuitability for bypass was also predictive of repeat PTA (HR, 1.8; 95% CI, 1.0-3.4; P = .047). Postoperative clopidogrel use was associated with lower rates of any revascularization (HR, 0.46; 95% CI, 0.25-0.83; P = .011). CONCLUSIONS: Infrapopliteal PTA is effective primary therapy for TASC A, B, and C lesions. Surgical bypass should be offered to patients with TASC D disease who are suitable candidates. Multilevel intervention does not adversely affect outcome.

Open repair of intact thoracoabdominal aortic aneurysms in the American College of Surgeons National Surgical Quality Improvement Program.

OBJECTIVE: Open surgical repair of thoracoabdominal aortic aneurysms (TAAAs) is uncommon. Mortality rates of 20% are reported in studies using national data and are 5% to 8% in single-institution studies. Clinical trials are currently evaluating branched and fenestrated endografts. The purpose of this study is to establish a benchmark for future comparisons with endovascular trials using open repair of TAAAs in the National Surgical Quality Improvement Program (NSQIP) database. METHODS: We identified all patients undergoing open elective and emergency surgical repair of intact TAAAs in NSQIP (2005 to 2010) using Current Procedural Terminology (American Medical Association, Chicago, Ill) and International Classification of Diseases, 9th Edition codes. We analyzed demographics, comorbidities, 30-day mortality, postoperative complications, and length of stay. Multivariable logistic regression was used to identify predictors of mortality. RESULTS: We identified 450 patients who underwent open surgical repair (418 elective, 32 emergent) of an intact TAAA. Mean age was 69.4 years, 60.7% were male, and 85.6% were white. Comorbidities included hypertension (87.1%), chronic obstructive pulmonary disease (27.3%), prior stroke or transient ischemic attack (16.7%), diabetes (11.6%), and peripheral vascular disease (9.6%). Thirty-day mortality was 10.0%. Pulmonary complications were the most common: failure to wean from ventilator (39.1%), pneumonia (23.1%), and reintubation (13.8%). Acute renal failure requiring dialysis occurred in 10.7% of patients. Multivariable analysis (odds ratio [95% confidence interval]) showed predictors of mortality were emergent repair (3.3 [1.03-10.83]; P = .04), age >70 years (3.5 [1.03-7.56], P = .001), preoperative dialysis (8.4 [1.90-37.29], P = .005), cardiac complication (2.9 [1.05-8.21], P = .04), and renal complications (8.4 [3.41-20.56], P < .001). CONCLUSIONS: In this study of NSQIP hospitals, the first to analyze open surgical repair of TAAAs, the 30-day mortality rate of 10.0% is similar to single-institution reports. However, morbidity and mortality after open TAAA repair remain high, confirming the need for less invasive procedures.