Factors Associated with Urgent Amputation Status and Its Impact on Mortality.

BACKGROUND: Thirty-day mortality is higher after urgent major lower extremity amputations compared to elective lower extremity amputations. This study aims to identify factors associated with urgent amputations and to examine their impact on perioperative outcomes and long-term mortality. METHODS: Patients undergoing major lower limb amputation from 2013 to 2020 in the Vascular Quality Initiative were included. Urgent amputation was defined as occurring within 72 hr of admission. Associations with sociodemographic characteristics, comorbidities, and outcomes including postoperative complication, inpatient death, and long-term survival were compared using univariable tests and multivariable logistic regression. Long-term survival between groups was compared using Kaplan-Meier analysis. RESULTS: Of the 12,874 patients included, 4,850 (37.7%) had urgent and 8,024 (62.3%) had elective amputations. Non-White patients required urgent amputation more often than White patients (39.8% vs. 37.9%, P = 0.03). A higher proportion of Medicaid and self-pay patients presented urgently (Medicaid: 13.0% vs. 11.0%; self-pay: 3.4% vs. 2.5%, P < 0.001). Patients requiring urgent amputation were less often taking aspirin (55.6% vs. 60.1%, P < 0.001) or statin (62.2% vs. 67.2%, P < 0.001), had fewer prior revascularization procedures (41.0% vs. 48.8%, P < 0.001), and were of higher American Society of Anesthesiologists (ASA) class 4-5 (50.9% vs. 40.1%, P < 0.001). Urgent amputations were more commonly for uncontrolled infection (48.1% vs. 29.4%, P < 0.001) or acute limb ischemia (14.3% vs. 6.2%, P < 0.001). Postoperative complications were higher after urgent amputations (34.7% vs. 16.6%, P < 0.001), including need for return to operating room (23.8% vs. 8.4%, P < 0.001) and need for higher revision (15.2% vs. 4.5%, P < 0.001). Inpatient mortality was higher after urgent amputation (8.9% vs. 5.4%, P < 0.001). Multivariable analysis revealed non-White race, self-pay, homelessness, current smoking, ASA class 4-5, and amputations for uncontrolled infection or acute limb ischemia were associated with urgent status, whereas living in a nursing home or prior revascularization were protective. Furthermore, urgent amputation was associated with an increased odds of postoperative complication or death (odds ratio 1.86 [1.69-2.04], P < 0.001) as well as long-term mortality (odds ratio: 1.24 [1.13-1.35], P < 0.001). Kaplan-Meier analysis corroborated that elective status was associated with improvement of long-term survival. CONCLUSIONS: Patients requiring urgent amputations are more often non-White, uninsured, and less frequently had prior revascularization procedures, revealing disparities in access to care. Urgency was associated with a higher postoperative complication rate, as well as increased long-term mortality. Efforts should be directed toward reducing these disparities to improve outcomes following amputation.

A comparative effectiveness study of carotid intervention for long-term stroke prevention in patients with severe asymptomatic stenosis from a large integrated health system.

OBJECTIVE: The results of current prospective trials comparing the effectiveness of carotid endarterectomy (CEA) vs standard medical therapy for long-term stroke prevention in patients with asymptomatic carotid stenosis (ACS) will not be available for several years. In this study, we compared the observed effectiveness of CEA and standard medical therapy vs standard medical therapy alone to prevent ipsilateral stroke in a contemporary cohort of patients with ACS. METHODS: This cohort study was conducted in a large integrated health system in adult subjects with 70% to 99% ACS (no neurologic symptom within 6 months) with no prior ipsilateral carotid artery intervention. Causal inference methods were used to emulate a conceptual randomized trial using data from January 1, 2008, through December 31, 2017, for comparing the event-free survival over 96 months between two treatment strategies: (1) CEA within 12 months from cohort entry vs (2) no CEA (standard medical therapy alone). To account for both baseline and time-dependent confounding, inverse probability weighting estimation was used to derive adjusted hazard ratios, and cumulative risk differences were assessed based on two logistic marginal structural models for counterfactual hazards. Propensity scores were data-adaptively estimated using super learning. The primary outcome was ipsilateral anterior ischemic stroke. RESULTS: The cohort included 3824 eligible patients with ACS (mean age: 73.7 years, 57.9% male, 12.3% active smokers), of whom 1467 underwent CEA in the first year, whereas 2297 never underwent CEA. The median follow-up was 68 months. A total of 1760 participants (46%) died, 445 (12%) were lost to follow-up, and 158 (4%) experienced ipsilateral stroke. The cumulative risk differences for each year of follow-up showed a protective effect of CEA starting in year 2 (risk difference = 1.1%, 95% confidence interval: 0.5%-1.6%) and persisting to year 8 (2.6%, 95% confidence interval: 0.3%-4.8%) compared with patients not receiving CEA. CONCLUSIONS: In this contemporary cohort study of patients with ACS using rigorous analytic methodology, CEA appears to have a small but statistically significant effect on stroke prevention out to 8 years. Further study is needed to appropriately select the subset of patients most likely to benefit from intervention.

Simplifying Hospital Quality Comparisons for Vascular Surgery Using Center-Level Frailty Burden Rather Than Comorbidities.

BACKGROUND: Failure to rescue (FtR), or inpatient death following complication, is a publicly reported hospital quality measure. Previous work has demonstrated significant variation in the proportion of frail patients across hospitals. However, frailty is not incorporated into risk-adjustment algorithms for hospital quality comparisons and risk adjustment is made by comorbidity scores. Our aim was to assess the impact of frailty on FtR quality measurement and as a means of risk adjustment. METHODS: Patients undergoing open or endovascular aneurysm repair or lower extremity bypass in the Vascular Quality Initiative (VQI) at centers performing ≥ 25 vascular procedures annually (2003-2019) were included. Multivariable logistic regression evaluated in-hospital death using scaled hierarchical modeling clustering at the center level. Center FtR observed/expected ratios were compared with expected values adjusted for either standard comorbidity profiles or frailty as measured by the VQI Risk Analysis Index. Centers were divided into quartiles using VQI-linked American Hospital Association data to describe the hospital characteristics of centers whose ranks changed. RESULTS: A total of 63,143 patients (213 centers) were included; 1,630 patients (2.58%) were classified as FtR. After accounting for center-level variability, frailty was associated with FtR [scaled odds ratio 1.9 (1.8-2.0), P < 0.001]. The comorbidity-centric and frailty-based models performed similarly in predicting FtR with C-statistics of 0.85 (0.84-0.86) and 0.82 (0.82-0.84), respectively. Overall changes in ranking based on observed/expected ratios were not statistically significant (P = 0.48). High and low performing centers had similar ranking using comorbidity-centric and frailty-based methods; however, centers in the middle of the performance spectrum saw more variability in ranking alterations. Forty nine (23%) of hospitals improved their ranking by five or more positions when using frailty versus comorbidity risk adjustment. The centers in Quartile 4, those who performed the highest number of vascular procedures annually, experience on average a significant improvement in hospital ranking when frailty was used for risk adjustment, whereas centers performing the fewest number of vascular procedures and the lowest proportion of vascular surgery cases annually (Quartile 1) saw a significant worsening of ranking position (all P < 0.05). However, total number of surgical procedures annually, total hospital beds, for-profit status, and teaching hospital status were not significantly associated with changes in rank. CONCLUSIONS: A simple frailty-adjusted model has similar predictive abilities as a comorbidity-focused model for predicting a common quality metric that influences reimbursement. In addition to distilling the risk-adjustment algorithm to a few variables, frailty can be assessed preoperatively to develop quality improvement efforts for rescuing frail patients. Centers treating a greater proportion of frail patients and those who perform higher volumes of vascular surgery benefit from a risk adjustment strategy based on frailty.

Comparable Esophagectomy Outcomes by Surgeon Specialty: A NSQIP Analysis.

BACKGROUND: A few observational studies have found that outcomes after esophagectomies by thoracic surgeons are better than those by general surgeons. METHODS: Non-emergent esophagectomy cases were identified in the 2016-2017 American College of Surgeons NSQIP database. Associations between patient characteristics and outcomes by thoracic versus general surgeons were evaluated with univariate and multivariate logistic regression. RESULTS: Of 1,606 cases, 886 (55.2%) were performed by thoracic surgeons. Those patients differed from patients treated by general surgeons in race (other/unknown 19.3% vs 7.8%; P<.001) but not in other baseline characteristics (age, sex, BMI, and comorbidities). Thoracic surgeons performed an open approach more frequently (48.9% vs 30.8%, P<.001) and had operative times that were 30 minutes shorter (P<.001). General surgeons had lower rates of reoperation (11.8% vs 17.2%; P=.003) and were more likely to treat postoperative leak with interventional means (6.3% vs 3.4%, P=.01). Thoracic surgeons were more likely to treat postoperative leak with reoperation (5.9% vs 3.6%, P=.01). There were no other differences in univariate comparison of outcomes between the two groups, including leak, readmission, and death. General surgery specialty was associated with lower risk of reoperation. Our multivariable model also found no relationship between general surgeon and risk of any complication (odds ratio 1.10; 95% CI .86 to 1.42). DISCUSSION: In our large, national database study, we found that outcomes of esophagectomies by general surgeons were comparable with those by thoracic surgeons. General surgeons managed postoperative leaks differently than thoracic surgeons.

Gender-Affirming Mastectomy Trends and Surgical Outcomes in Adolescents.

Background: There are over 150,000 transgender adolescents in the United States, yet research on outcomes following gender-affirming mastectomy in this age group is limited. We evaluated gender-affirming mastectomy incidence, as well as postoperative complications, including regret, in adolescents within our integrated health care system. Methods: Gender-affirming mastectomies performed from January 1, 2013 - July 31, 2020 in adolescents 12-17 years of age at the time of referral were identified. The incidence of gender-affirming mastectomy was calculated by dividing the number of patients undergoing these procedures by the number of adolescents assigned female at birth ages 12-17 within our system at the beginning of each year and amount of follow-up time within that year. Demographic information, clinical characteristics (comorbidities, mental health history, testosterone use), surgical technique, and complications, including mention of regret, of patients who underwent surgery were summarized. Patients with and without complications were compared to evaluate for differences in demographic or clinical characteristics using chi-squared tests. Results: The incidence of gender-affirming mastectomy increased 13-fold (3.7 to 47.7 per 100,000 person-years) during the study period. Of the 209 patients who underwent surgery, the median age at referral was 16 years (range 12-17) and the most common technique was double-incision (85%). For patients with greater than 1-year follow-up (n=137, 65.6%), at least one complication was found in 7.3% (n=10), which included hematoma (3.6%), infection (2.9%), hypertrophic scars requiring steroid injection (2.9%), seroma (0.7%), and suture granuloma (0.7%); 10.9 % underwent revision (n=15). There were no statistically significant differences in patient demographics and clinical characteristics between those with and without complications (p>0.05). Two patients (0.95%) had documented postoperative regret but neither underwent reversal surgery at follow-up of 3 and 7 years postoperatively. Conclusion: Between 2013-2020, we observed a marked increase in gender-affirming mastectomies in adolescents. The prevalence of surgical complications was low and of over 200 adolescents who underwent surgery, only two expressed regret, neither of which underwent a reversal operation. Our study provides useful and positive guidance for adolescent patients, their families, and providers regarding favorable outcomes with gender-affirming mastectomy.

Natural History of Asymptomatic Moderate Carotid Artery Stenosis in a Large Community-Based Cohort.

BACKGROUND: Moderate carotid artery stenosis is a poorly defined risk factor for ischemic stroke. As such, practice recommendations are lacking. In this study, we describe the long-term risk of stroke in patients with moderate asymptomatic stenosis in an integrated health care system. METHODS: All adult patients with asymptomatic moderate (50%-69%) internal carotid artery stenosis between 2008 and 2012 were identified, with follow-up through 2017. The primary outcome was acute ischemic stroke attributed to the ipsilateral carotid artery. Stroke rates were calculated using competing risk analysis. Secondary outcomes included disease progression, ipsilateral intervention, and long-term survival. RESULTS: Overall, 11 614 arteries with moderate stenosis in 9803 patients were identified. Mean age was 74.2±9.9 years with 51.4% women. Mean follow-up was 5.1±2.9 years. There were 180 ipsilateral ischemic strokes (1.6%) identified (crude annual risk, 0.31% [95% CI, 0.21%-0.41%]), of which thirty-one (17.2%) underwent subsequent intervention. Controlling for death and intervention as competing risks, the cumulative incidence of stroke was 1.2% (95% CI, 1.0%-1.4%) at 5 years and 2.0% (95% CI, 1.7%-2.4%) at 10 years. Of identified strokes, 50 (27.8%) arteries had progressed to severe stenosis or occlusion. During follow-up, there were 17 029 carotid studies performed in 5951 patients, revealing stenosis progression in 1674 (14.4%) arteries, including 1614 (13.9%) progressing to severe stenosis and 60 (0.5%) to occlusion. The mean time to stenosis progression was 2.6±2.1 years. Carotid intervention occurred in 708 arteries (6.1%). Of these, 66.1% (468/708) had progressed to severe stenosis. The overall mortality rate was 44.5%, with 10.5% of patients lost to follow-up. CONCLUSIONS: In this community-based sample of patients with asymptomatic moderate internal carotid artery stenosis followed for an average of 5 years, the cumulative incidence of stroke is low out to 10 years. Future research is needed to optimize management strategies for this population.

Incidence of Ischemic Stroke in Patients With Asymptomatic Severe Carotid Stenosis Without Surgical Intervention.

Importance: Optimal management of patients with asymptomatic severe carotid stenosis is uncertain, due to advances in medical care and a lack of contemporary data comparing medical and surgical treatment. Objective: To estimate stroke outcomes among patients with medically treated asymptomatic severe carotid stenosis who did not undergo surgical intervention. Design, Setting, and Participants: Retrospective cohort study that included 3737 adult participants with asymptomatic severe (70%-99%) carotid stenosis diagnosed between 2008 and 2012 and no prior intervention or ipsilateral neurologic event in the prior 6 months. Participants received follow-up through 2019, and all were members of an integrated US regional health system serving 4.5 million members. Exposures: Imaging diagnosis of asymptomatic carotid stenosis of 70% to 99%. Main Outcomes and Measures: Occurrence of ipsilateral carotid-related acute ischemic stroke. Censoring occurred with death, disenrollment, or ipsilateral intervention. Results: Among 94 822 patients with qualifying imaging studies, 4230 arteries in 3737 (mean age, 73.8 [SD 9.5 years]; 57.4% male) patients met selection criteria including 2539 arteries in 2314 patients who never received intervention. The mean follow-up in this cohort was 4.1 years (SD 3.6 years). Prior to any intervention, there were 133 ipsilateral strokes with a mean annual stroke rate of 0.9% (95% confidence interval [CI], 0.7%-1.2%). The Kaplan-Meier estimate of ipsilateral stroke by 5 years was 4.7% (95% CI, 3.9%-5.7%). Conclusions and Relevance: In a community-based cohort of patients with asymptomatic severe carotid stenosis who did not undergo surgical intervention, the estimated rate of ipsilateral carotid-related acute ischemic stroke was 4.7% over 5 years. These findings may inform decision-making regarding surgical and medical treatment for patients with asymptomatic severe carotid artery stenosis.

Female sex is independently associated with in-hospital mortality after endovascular aortic repair for ruptured aortic aneurysm.

BACKGROUND: Endovascular aortic repair (EVAR) can treat anatomically compatible ruptured abdominal aortic aneurysms (rAAA), but registry data suggests that women undergo more open abdominal aneurysm repairs than men. We evaluate in-hospital outcomes of EVAR for rAAA by sex. METHODS: The Vascular Quality Initiative (VQI) registry was queried from 2013 to 2019 for rAAA patients treated with EVAR. Univariate analysis was performed with Student's t-test and chi-squared tests. Multivariable logistic regression was then performed to assess the association between female sex and inpatient mortality. RESULTS: A total of 1775 patients were included (23.8% female). Female rAAA patients were older (P< 0.01) and weighed less (P < 0.01). They were less likely to have smoked (P <.0 001) and had lower creatinine (1.29 vs. 1.43, P < 0.01) and hemoglobin (10.7 vs. 11.7, P < 0.01). Women had smaller maximum aortic diameters (74 vs. 66 mm, P < 0.01) and were less likely to have iliac aneurysms (P < 0.001). Women were more likely to have concomitant femoral endarterectomy (8.5% vs. 4.6%, P = 0.03). Despite having no significant difference in complication or reintervention rates, women had higher rates of in-hospital mortality (45.9% vs. 34.5%, P < 0.01). In a logistic regression model for predictors of in-hospital mortality (χ2 < .01), increased age (OR 1.08, P < 0.01), female sex (OR 1.7, P = 0.02), preoperative cardiac arrest (OR 5.29, P < 0.01), concurrent iliac stenting (OR 2.38, P = 0.02), postoperative mesenteric ischemia (OR 2.51, P < 0.01) and postoperative transfusion (OR 1.06, P < 0.01) were independently associated with in-hospital mortality. Increased preoperative hemoglobin was protective (OR 0.89, P < 0.01) CONCLUSIONS: Female sex is independently associated with in-hospital mortality after EVAR for rAAA, suggesting a relationship beyond anatomical, biochemical, and procedural covariates.

Establishing a carotid artery stenosis disease cohort for comparative effectiveness research using natural language processing.

OBJECTIVE: Investigation of asymptomatic carotid stenosis treatment is hindered by the lack of a contemporary population-based disease cohort. We describe the use of natural language processing (NLP) to identify stenosis in patients undergoing carotid imaging. METHODS: Adult patients with carotid imaging between 2008 and 2012 in a large integrated health care system were identified and followed through 2017. An NLP process was developed to characterize carotid stenosis according to the Society of Radiologists in Ultrasound (for ultrasounds) and North American Symptomatic Carotid Endarterectomy Trial (NASCET) (for axial imaging) guidelines. The resulting algorithm assessed text descriptors to categorize normal/non-hemodynamically significant stenosis, moderate or severe stenosis as well as occlusion in both carotid ultrasound (US) and axial imaging (computed tomography and magnetic resonance angiography [CTA/MRA]). For US reports, internal carotid artery systolic and diastolic velocities and velocity ratios were assessed and matched for laterality to supplement accuracy. To validate the NLP algorithm, positive predictive value (PPV or precision) and sensitivity (recall) were calculated from simple random samples from the population of all imaging studies. Lastly, all non-normal studies were manually reviewed for confirmation for prevalence estimates and disease cohort assembly. RESULTS: A total of 95,896 qualifying index studies (76,276 US and 19,620 CTA/MRA) were identified among 94,822 patients including 1059 patients who underwent multiple studies on the same day. For studies of normal/non-hemodynamically significant stenosis arteries, the NLP algorithm showed excellent performance with a PPV of 99% for US and 96.5% for CTA/MRA. PPV/sensitivity to identify a non-normal artery with correct laterality in the CTA/MRA and US samples were 76.9% (95% confidence interval [CI], 74.1%-79.5%)/93.1% (95% CI, 91.1%-94.8%) and 74.7% (95% CI, 69.3%-79.5%)/94% (95% CI, 90.2%-96.7%), respectively. Regarding cohort assembly, 15,522 patients were identified with diseased carotid artery, including 2674 exhibiting equal bilateral disease. This resulted in a laterality-specific cohort with 12,828 moderate, 5283 severe, and 1895 occluded arteries and 326 diseased arteries with unknown stenosis. During follow-up, 30.1% of these patients underwent 61,107 additional studies. CONCLUSIONS: Use of NLP to detect carotid stenosis or occlusion can result in accurate exclusion of normal/non-hemodynamically significant stenosis disease states with more moderate precision with lesion identification, which can substantially reduce the need for manual review. The resulting cohort allows for efficient research and holds promise for similar reporting in other vascular diseases.

Gender Disparity in Surgical Society Leadership and Annual Meeting Programs.

INTRODUCTION: Prior work suggests women surgical role models attract more female medical students into surgical training. We investigate recent trends of women in surgical society leadership and national conference moderator and plenary speaker roles. METHODS: Gender distribution was surveyed at 15 major surgical societies and 14 conferences from 2014 to 2018 using publicly reported data. Roles were categorized as leadership (executive council), moderator, or plenary speaker. Data were cross-checked from online profiles and by contacting societies. Logistic regression with Huber-White clustering by society was utilized to evaluate proportions of women in each role over time and determine associations between the proportion of women in executive leadership, and scientific session moderators and plenary speakers. RESULTS: The proportion of leadership positions held by women increased slightly from 2014 to 2018 (20.6%-26.6%, P = 0.23), as did the proportion of moderators (26.2%-30.6%, P = 0.027) and plenary speakers (26.2%-30.9%, P = 0.058). The proportion of women in each role varied significantly across societies (all P < 0.001): leaders (range 0.0%-52.0%), moderators (12.5%-58.8%), and plenary speakers (11.3%-60.0%). Three patterns of change were observed: eight societies (53.3%) demonstrated increases in representation of women over time, four societies (26.6%) showed stable moderate-to-good gender balance, and three societies (20.0%) had consistent underrepresentation of women. CONCLUSION: There is significant variability in the representation of women at the leadership level of national surgical societies and participating at national surgical conferences as moderators and plenary speakers. Over the past 5 years some societies have achieved advances in gender equity, but many societies still have substantial room for improvement.

Gender-Affirming Mastectomy in Transmasculine Patients: Does Obesity Increase Complications or Revisions?

BACKGROUND: Obesity can often be a barrier to gender-affirming top surgery in transmasculine patients because of concern for increased surgical site complications. STUDY DESIGN: All adult patients (N = 948) within an integrated health care system who underwent gender-affirming mastectomy from 2013 to 2018 were retrospectively reviewed to evaluate the relationship between obesity and surgical site complications or revisions. RESULTS: One third of patients (n = 295) had obese body mass index (BMI), and those patients were further stratified into obesity class I (BMI of 30-34.9 kg/m2, 9.4%), class II (BMI of 35-39.9 kg/m2, 8.9%), and class III (BMI of ≥40 kg/m2, 2.9%). A majority of patients across BMI categories underwent double incision surgery. There were no significant differences in complications or revisions between patients with obesity versus those with normal BMI, when BMI was treated as a categorical or continuous variable and when evaluating only patients who underwent double incision surgery. CONCLUSIONS: Obesity alone should not be considered a contraindication for gender-affirming mastectomy. Attention should be given to several modifiable risk factors identified in this study, including lesser incision surgical techniques, tobacco use, and testosterone use. Further research is needed to understand risks associated with the highest BMI (≥40 kg/m2) patients and to assess patient satisfaction with surgical outcome.

Midterm outcomes for 605 patients receiving Endologix AFX or AFX2 Endovascular AAA Systems in an integrated healthcare system.

BACKGROUND: Endologix issued important safety updates for the AFX Endovascular AAA System in 2016 and 2018 owing to the risk of type III endoleaks. Outcomes with these devices are limited to small case series with short-term follow-up. We describe the midterm outcomes for a large cohort of patients who received an Endologix AFX or AFX2 device. STUDY DESIGN: Data from an integrated healthcare system's implant registry, which prospectively monitors all patients after endovascular aortic repair, was used for this descriptive study. Patients undergoing endovascular aortic repair with three AFX System variations (Strata [AFX-S], Duraply [AFX-D], and AFX2 with Duraply [AFX2]) were identified (2011-2017). Crude cumulative event probabilities for endoleak (types I and III), major reintervention, conversion to open, rupture, and mortality (aneurysm related and all cause) were estimated. RESULTS: Among 605 patients, 375 received AFX-S, 197 received AFX-D, and 33 received AFX2. Median follow-up for the cohort was 3.9 (interquartile range, 2.5-5.1) years. The crude 2-year incidence of overall endoleak, any subsequent reintervention or conversion, and mortality was 8.8% (95% confidence interval [CI], 6.3-12.3), 12.0% (95% CI, 9.1-15.9), and 8.8% (95% CI, 6.3-12.2) for AFX-S. Respective estimates for AFX-D were 7.9% (95% CI, 4.8-13.0), 10.6% (95% CI, 6.9-16.1), and 9.7% (95% CI, 6.3-14.7); for AFX2, they were 14.1% (95% CI, 4.7-38.2), 16.2% (95% CI, 6.4-37.7), and 21.2% (95% CI, 10.7-39.4). CONCLUSIONS: The midterm outcomes of a large U.S. patient cohort with an Endologix AFX or AFX2 System demonstrate a concerning rate of adverse postoperative events. Patients with these devices should receive close clinical surveillance to prevent device-related adverse events.

Long-term stroke risk with carotid endarterectomy in patients with severe carotid stenosis.

OBJECTIVE: Informed debate regarding the optimal use of carotid endarterectomy (CEA) for stroke risk reduction requires contemporary assessment of both long-term risk and periprocedural risk. In this study, we report long-term stroke and death risk after CEA in a large integrated health care system. METHODS: All patients with documented severe (70%-99%) stenosis from 2008 to 2012 who underwent CEA were identified and stratified by asymptomatic or symptomatic indication. Those with prior ipsilateral interventions were excluded. Patients were followed up through 2017 for the primary outcomes of any stroke/death within 30 days of intervention and long-term ipsilateral ischemic stroke; secondary outcomes were any stroke and overall survival. RESULTS: Overall, 1949 patients (63.2% male; mean age, 71.3 ± 8.9 years) underwent 2078 primary CEAs, 1196 (58%) for asymptomatic stenosis and 882 (42%) for symptomatic stenosis. Mean follow-up was 5.5 ± 2.7 years. Median time to surgery was 72.0 (interquartile range, 38.5-198.0) days for asymptomatic patients and 21.0 (interquartile range, 5.0-55.0) days for symptomatic patients (P < .001). Most of the patients' demographics and characteristics were similar in both groups. Controlled blood pressure rates were similar at the time of CEA. Baseline statin use was seen in 60.5% of the asymptomatic group compared with 39.9% in the symptomatic group (P < .001), and statin adherence by 80% medication possession ratio was 19.3% asymptomatic vs 12.4% symptomatic (P < .001). The crude overall 30-day any stroke/death rates were 0.9% and 1.5% for the asymptomatic group and the symptomatic group, respectively. The 5-year risk of ipsilateral stroke and a combined end point of any stroke/death by Kaplan-Meier survival analysis were 2.5% and 28.7% for the asymptomatic group and 4.0% and 31.4% for the symptomatic group, respectively. Unadjusted cumulative all-cause survival was 74.2% for the asymptomatic group and 71.8% for the symptomatic group at 5 years. CONCLUSIONS: In a contemporary review of CEA, outcomes for either operative indication show low adverse events perioperatively and low long-term stroke risk up to 5 years. These results are well within consensus guidelines and published trial outcomes and should help inform the discussion around optimal CEA use for severe carotid stenosis.

Contemporary Practices and Complications of Surgery for Thoracic Outlet Syndrome in the United States.

BACKGROUND: Thoracic outlet syndrome (TOS) surgery is relatively rare and controversial, given the challenges in diagnosis as well as wide variation in symptomatic and functional recovery. Our aims were to measure trends in utilization of TOS surgery, complications, and mortality rates in a nationally representative cohort and compare higher versus lower volume centers. METHODS: The National Inpatient Sample was queried using International Classification of Diseases, Ninth Revision, codes for rib resection and scalenectomy paired with axillo-subclavian aneurysm (arterial [aTOS]), subclavian deep vein thrombosis (venous [vTOS]), or brachial plexus lesions (neurogenic [nTOS]). Basic descriptive statistics, nonparametric tests for trend, and multivariable hierarchical regression models with random intercept for center were used to compare outcomes for TOS types, trends over time, and higher and lower volume hospitals, respectively. RESULTS: There were 3,547 TOS operations (for an estimated 18,210 TOS operations nationally) performed between 2010 and 2015 (89.2% nTOS, 9.9% vTOS, and 0.9% aTOS) with annual case volume increasing significantly over time (P = 0.03). Higher volume centers (≥10 cases per year) represented 5.2% of hospitals and 37.0% of cases, and these centers achieved significantly lower overall major complication (defined as neurologic injury, arterial or venous injury, vascular graft complication, pneumothorax, hemorrhage/hematoma, or lymphatic leak) rates (adjusted odds ratio [OR] 0.71 [95% confidence interval 0.52-0.98]; P = 0.04], but no difference in neurologic complications such as brachial plexus injury (aOR 0.69 [0.20-2.43]; P = 0.56) or vascular injuries/graft complications (aOR 0.71 [0.0.33-1.54]; P = 0.39). Overall mortality was 0.6%, neurologic injury was rare (0.3%), and the proportion of patients experiencing complications decreased over time (P = 0.03). However, vTOS and aTOS had >2.5 times the odds of major complication compared with nTOS (OR 2.68 [1.88-3.82] and aOR 4.26 [1.78-10.17]; P < 0.001), and ∼10 times the odds of a vascular complication (aOR 10.37 [5.33-20.19] and aOR 12.93 [3.54-47.37]; P < 0.001], respectively. As the number of complications decreased, average hospital charges also significantly decreased over time (P < 0.001). Total hospital charges were on average higher when surgery was performed in lower volume centers (<10 cases per year) compared with higher volume centers (mean $65,634 [standard deviation 98,796] vs. $45,850 [59,285]; P < 0.001). CONCLUSIONS: The annual number of TOS operations has increased in the United States from 2010 to 2015, whereas complications and average hospital charges have decreased. Mortality and neurologic injury remain rare. Higher volume centers delivered higher value care: less or similar operative morbidity with lower total hospital charges.

Intraoperative heparin use is associated with reduced mortality without increasing hemorrhagic complications after thoracic endovascular aortic repair for blunt aortic injury.

OBJECTIVE: Thoracic endovascular aortic repair (TEVAR) is an effective treatment of blunt thoracic aortic injury (BTAI). However, the risks and benefits of administering intraoperative heparin in trauma patients are not well-defined, especially with regard to bleeding complications. METHODS: The Vascular Quality Initiative registry was queried from 2013 to 2019 to identify patients who had undergone TEVAR for BTAI with or without the administration of intraoperative heparin. Univariate analyses were performed with the Student t test, Fisher exact test, or χ2 test, as appropriate. Multivariable logistic regression was then performed to assess the association of heparin with inpatient mortality. RESULTS: A total of 655 patients were included, of whom most had presented with grade III (53.3%) or IV (20%) BTAI. Patients receiving heparin were less likely to have an injury severity score (ISS) of ≥15 (70.2% vs 90.5%; P < .0001) or major head or neck injury (39.6% vs 62.9%; P < .0001). Patients receiving heparin also had a lower incidence of inpatient death (5.1% vs 12.9%; P < .01). Across all injury grades, heparin use was not associated with the need for intraoperative transfusion or postoperative transfusion or the development of hematoma. In patients with grade III BTAI, the nonuse of heparin was associated with an increased risk of lower extremity embolization events (7.4% vs 1.8%; P < .05). On multivariable logistic regression analysis for inpatient mortality, intraoperative heparin use (odds ratio [OR], 0.31; 95% confidence interval [CI], 0.11-0.86; P < .05) and female gender (OR, 0.11; 95% CI, 0.11-0.86; P < .05) were associated with better survival, even after controlling for head and neck trauma and injury grade. In contrast, increased age (OR, 1.06; 95% CI, 1.03-1.1; P < .001), postoperative transfusion (OR, 1.06; 95% CI, 1.02-1.11; P < .01), higher ISS (OR, 1.04; 95% CI, 1.01-1.07; P < .05), postoperative dysrhythmia (OR, 4.48; 95% CI, 1.10-18.18; P < .05), and postoperative stroke or transient ischemic attack (OR, 5.54; 95% CI, 1.11-27.67; P < .05) were associated with increased odds of inpatient mortality. CONCLUSIONS: Intraoperative heparin use was associated with reduced inpatient mortality for patients undergoing TEVAR for BTAI, including those with major head or neck trauma and high ISSs. Heparin use did not increase the risk of hemorrhagic complications across all injury grades. Also, in patients with grade III BTAI, heparin use was associated with a reduced risk of lower extremity embolic events. Heparin appears to be safe during TEVAR for BTAI and should be administered when no specific contraindication exists.

Long-term Functional Outcomes Follow-up after 188 Rib Resections in Patients with TOS.

BACKGROUND: Short-term outcomes in patients with all forms of TOS have been widely reported in the literature and have established that rib resection can be beneficial in decompressing the thoracic outlet and relieving pressure on traversing structures. We sought to determine long-term functional outcomes using the Disability of the Arm, Shoulder, and Hand (QuickDASH) survey in patients with TOS who underwent rib resection. METHODS: Clinical records for patients who underwent rib resection for TOS at a single institution were retrospectively reviewed. All patients were contacted via telephone and long-term functional outcome was assessed at latest follow-up via the 11-item version of the QuickDASH questionnaire. Demographics, TOS type, preoperative QuickDASH score, and athletic status were recorded. Patients were asked if they returned to baseline activity since their surgery, would have the procedure again, and if they were subjectively better postoperatively. RESULTS: From 2000 to 2018, 261 patients underwent rib resection surgery. One hundred seventy patients (65.1%) were able to be contacted via telephone for long-term follow-up. A total of 188 surgeries (102 neurogenic thoracic outlet syndrome, 82 venous thoracic outlet syndrome, 4 arterial thoracic outlet syndrome) were performed in these 170 patients. The mean follow-up time for the cohort was 5.3 years (range 1-18). Overall, 167 (88.9%) patients returned to baseline activity postoperatively. Postop QuickDASH decreased to 12 from 44 preoperatively for the cohort. CONCLUSIONS: First rib resection and thoracic outlet decompression for all forms of TOS is a durable surgical treatment which results in excellent long-term functional outcomes as determined by both the QuickDASH score and subjective patient reporting.

Frailty as measured by the Risk Analysis Index is associated with long-term death after carotid endarterectomy.

OBJECTIVE: The role of carotid endarterectomy (CEA) continues to be debated in the age of optimal medical therapy, particularly for patients with limited life expectancy. The Risk Analysis Index (RAI) measures frailty, a syndrome of decreased physiologic reserve, which increases vulnerability to adverse outcomes. The RAI better predicts surgical complications, nonhome discharge, and death than age or comorbidities alone. We sought to measure the association of frailty, as measured by the RAI, with postoperative in-hospital stroke, long-term stroke, and long-term survival after CEA. We also sought to determine how postoperative stroke interacts with frailty to alter survival trajectory after CEA. METHODS: We queried the Vascular Quality Initiative CEA procedure and long-term data sets (2003-2017) for elective CEAs with complete RAI case information. For all analyses, the cohort was divided into asymptomatic and symptomatic carotid stenosis. Scoring was defined as not frail (RAI <30), frail (RAI 30-34), and very frail (RAI ≥35). Mortality information through December 2017 was obtained from the Social Security Death Index. Multivariable models (logistic and Cox proportional hazards regressions) were used to study the association of frail and very frail patients with the outcomes of interest. In a post hoc analysis, we created Kaplan-Meier curves to analyze patient mortality after CEA as well as after postoperative stroke. RESULTS: Of the 42,869 included patients, 17,092 (39.9%) were female, and 38,395 (89.6%) were white. There were 25,673 (59.9%) patients assigned to the asymptomatic stenosis group and 17,196 (40.1%) patients in the symptomatic stenosis group. Frailty was not associated with perioperative or long-term postoperative stroke. The risk of long-term mortality was significantly higher for frail (hazard ratio, 1.9 [1.7-2.3]) and very frail (hazard ratio, 3.1 [2.6-3.7]) asymptomatic patients; symptomatic frail and very frail patients also had a two to three times increased risk of long-term mortality. Frail and very frail patients had two to three times the risk for long-term mortality compared with patients who were not frail. Postoperative stroke negatively affected the mortality trajectory for all patients in the cohort, regardless of frailty status. CONCLUSIONS: RAI score is not associated with postoperative stroke; however, frail and very frail status is associated with decreased long-term survival in an incremental fashion based on increasing RAI. RAI assessment should be considered in the preoperative decision-making for patients undergoing CEA to ensure long-term survival and optimal surgical outcomes vs medical management.

Association of peripheral artery disease with life-space mobility restriction and mortality in community-dwelling older adults.

OBJECTIVE: Symptomatic peripheral artery disease (PAD) impairs walking, but data on the impact of PAD on community mobility is limited. Life-space mobility measures the distance, frequency, and assistance needed as older adults move through geographic areas extending from their bedroom (life-space mobility score: 0) to beyond their town (life-space mobility score: 120). We evaluated the association of PAD with longitudinal life-space mobility trajectory. METHODS: Participants were part of the University of Alabama at Birmingham Study of Aging, a longitudinal study of community-dwelling older adults who were observed from 2001 to 2009. We limited our analysis to those who survived at least 6 months (N = 981). PAD was based on self-report with verification by physician report and hospital records. Our primary outcome was life-space mobility score assessed every 6 months. A multilevel change model (mixed model) was used to determine the association between PAD and life-space mobility trajectory during a median 7.9 years of follow-up. RESULTS: Participants had a mean age of 75.7 (standard deviation, 6.7) years; 50.5% were female, and 50.4% were African American. PAD prevalence was 10.1%, and 57.1% of participants with PAD died. In participants with both PAD and life-space restriction, defined as life-space mobility score <60, we observed the highest mortality (73.1%). In a multivariable adjusted mixed effects model, participants with PAD had a more rapid decline in life-space mobility by -1.1 (95% confidence interval [CI], -1.9 to -0.24) points per year compared with those without PAD. At 5-year follow-up, model-adjusted mean life-space mobility was 48.1 (95% CI, 43.5-52.7) and 52.4 (95% CI, 50.9-53.8) among those with and without PAD, respectively, corresponding to a restriction in independent life-space mobility at the level of one's neighborhood. CONCLUSIONS: Life-space mobility is a novel patient-centered measure of community mobility, and PAD is associated with significant life-space mobility decline among community-dwelling older adults. Further study is needed to mechanistically confirm these findings and to determine whether better recognition and treatment of PAD alter the trajectory of life-space mobility.

Racial and Sex Disparities in Catheter Use and Dialysis Access in the United States Medicare Population.

BACKGROUND: Despite efforts to increase arteriovenous fistula and graft use, 80% of patients in the United States start hemodialysis on a central venous catheter (CVC). METHODS: To better understand in incident hemodialysis patients how sex and race/ethnicity are associated with time on a central venous catheter and transition to an arteriovenous fistula and graft, our observational cohort study analyzed US Renal Data System data for patients with incident ESKD aged ≥66 years who started hemodialysis on a CVC in July 2010 through 2013. RESULTS: At 1 year, 32.7% of 74,194 patients transitioned to an arteriovenous fistula, 10.8% transitioned to an arteriovenous graft, 32.1% stayed on a CVC, and 24.5% died. Women spent a significantly longer time on a CVC than men. Compared with white patients, patients who were black, Hispanic, or of another racial/ethnicity minority spent significantly more days on a CVC. In competing risk regression, women were significantly less likely than men to transition to a fistula and more likely to transition to a graft. Compared with white patients, blacks were significantly less likely to transition to a fistula but more likely to transition to a graft, Hispanics were significantly more likely to transition to a fistula, and other races/ethnicities were significantly more likely to transition to either a fistula or a graft. CONCLUSIONS: Female patients spend a longer time on a CVC and are less likely to transition to permanent access. Compared with white patients, minorities also spend longer time on a CVC, but are more likely to eventually transition to permanent access. Strategies to speed transition to permanent access should target groups that currently lag in this area.

Real-World Outcomes of EKOS Ultrasound-Enhanced Catheter-Directed Thrombolysis for Acute Limb Ischemia.

BACKGROUND: Ultrasound-enhanced catheter-directed thrombolysis (UET) using the Ekosonic® Endovascular System device for acute, peripheral arterial ischemia has been purported in clinical trials to accelerate the fibrinolytic process to reduce treatment time and lytic dosage. We aim to describe outcomes of UET in a real-world clinical setting. METHODS: We performed a retrospective review of all patients undergoing UET for acute limb ischemia at a single institution. Data collected included patient demographics, procedural details, and 30-day and 1-year outcomes. The primary endpoints for analysis were major adverse limb events (MALEs; reintervention and/or amputation) and mortality within 30-days and 1-year. Secondary endpoints included technical success, use of adjunctive therapies, and postoperative complications. RESULTS: A total of 32 patients (mean age 67.4 ± 14.9 years; 25% women) underwent UET for acute limb ischemia between 2014 and 2018. The Rutherford Acute Limb Ischemia Classification was Rutherford (R) 1 in 56.3%, R2a in 31.3%, and R2b in 12.5%. Etiology was thrombosis of native artery in 12.5% of patients, prosthetic bypass in 31.3%, autogenous bypass in 6.3%, and stented native vessel in 50.0%. Mean duration of thrombolytic therapy was 22.2 ± 11.3 hr, and mean tissue plasminogen activator dose was 24.5 ± 15.3 mg. MALEs occurred in 16.7% of patients within the first 30 days and 38.9% experienced a MALE by 1 year. Limb salvage at 30 days and 1 year was 93.8% and 87.5%, respectively. Ipsilateral reintervention was required in 12.5% of patients within 30 days and 37.5% of patients within 1 year. Overall mortality was 6.2% at 30 days and 13.5% at 1 year. In-line flow to the foot was re-established in 90.6% of patients, with a significant improvement in preoperative to postoperative ankle-brachial index (0.31 ± 0.29 vs. 0.78 ± 0.34, P < 0.001) and number of patent tibial runoff vessels (1.31 ± 1.20 vs. 1.96 ± 0.86, P < 0.001). There was no significant difference in revascularization success between occluded vessel types. All but one patient required adjunctive therapy such as further thromboaspiration, stenting, or balloon angioplasty. Major bleeding complications occurred in 3 patients (9.4%), including 1 intracranial hemorrhage (3.1%). CONCLUSIONS: UET with the EKOS device demonstrates acceptable real-world outcomes in the treatment of acute limb ischemia. UET is generally safe and effective at re-establishing in-line flow to yield high limb salvage rates. However, UET is associated with a high rate of reintervention. Further investigation is needed into specific predictors of limb salvage and need for reintervention, as well as cost-efficacy of this technology compared with that of traditional methods.