A national census for the off-label treatment of complex aortic aneurysms.

OBJECTIVE: Despite regulatory challenges, device availability, and rapidly expanding techniques, off-label endovascular repair of complex aortic aneurysms (cAAs) has expanded in the past decade. Given the lack of United States Food and Drug Administration-approved endovascular technology to treat cAAs, we performed a national census to better understand volume and current practice patterns in the United States. METHODS: Targeted sampling identified vascular surgeons with experience in off-label endovascular repair of cAAs. An electronic survey was distributed with institutional review board approval from the University of Rochester to 261 individuals with a response rate of 38% (n = 98). RESULTS: A total of 93 respondents (95%) reported off-label endovascular repair of cAAs. Mean age was 45.7 ± 8.3 years, and 84% were male. Most respondents (59%) were within the first 10 years of practice, and 69% trained at institutions with a high-volume of off-label endovascular procedures for complex aortic aneurysms with or without a physician-sponsored investigational device exemption (PS-IDE). Twelve respondents from 11 institutions reported institutional PS-IDEs for physician-modified endografts (PMEGs), in-situ laser fenestration (ISLF), or parallel grafting technique (PGT), including sites with PS-IDEs for custom-manufactured devices. Eighty-nine unique institutions reported elective off-label endovascular repair with a mean of 20.2 ± 16.5 cases/year and ∼1757 total cases/year nationally. Eighty reported urgent/emergent off-label endovascular repair with a mean of 5.7 ± 5.4 cases/year and ∼499 total cases/year nationally. There was no correlation between high-volume endovascular institutions (>15 cases/year) and institutions with high volumes of open surgical repair for cAAs (>15 cases/year; odds ratio, 0.7; 95% confidence interval, 0.3-1.5; P = .34). Elective techniques included PMEG (70%), ISLF (30%), hybrid PMEG/ISLF (18%), and PGT (14%), with PMEG being the preferred technique for 63% of respondents. Techniques for emergent endovascular treatment of complex aortic disease included PMEG (52%), ISLF (40%), PGT (20%), and hybrid-PMEG/ISLF (14%), with PMEG being the preferred technique for 41% of respondents. Thirty-nine percent of respondents always or frequently offer referrals to institutions with PS-IDEs for custom-manufactured devices. The most common barrier for referral to PS-IDE centers included geographic distance (48%), longitudinal relationship with patient (45%), and costs associated with travel (33%). Only 61% of respondents participate in the Vascular Quality Initiative for complex endovascular aneurysm repair, and only 57% maintain a prospective institutional database. Eighty-six percent reported interest in a national collaborative database for off-label endovascular repair of cAA. CONCLUSIONS: Estimates of off-label endovascular repair of cAAs are likely underrepresented in the literature based on this national census. PMEG was the most common technique for elective and emergent procedures. Under-reported off-label endovascular repair of cAA outcomes data appears to be limited by non-standardized PS-IDE reporting to the United States Food and Drug Administration, and the lack of Vascular Quality Initiative participation and prospective institutional data collection. Most participants are interested in a national collaborative database for endovascular repair of cAAs.

Implementation of a vascular acute care surgery service model is associated with decreased surgeon burnout.

OBJECTIVE: Vascular surgeons have one of the highest rates of burnout among surgical specialties, often attributed to high patient acuity and clinical workload. Acute Care Surgery models are a potential solution used among general and trauma surgeons. METHODS: This is a retrospective analysis of prospectively collected Accreditation Council for Graduate Medical Education survey results from faculty and residents before and after implementation of a vascular Acute Care Surgery (VACS) model. The VACS model assigns a weekly rotation of an attending surgeon with no elective cases or clinic responsibilities and a monthly rotating resident team. Residents and attendings are in-house to cover all urgent and emergent vascular daytime consultations and procedures, whereas nights and weekend coverage remain a typical rotating schedule. Survey question results were binned into domains consistent with the Maslach Burnout Inventory. RESULTS: Both residents and faculty reported an increase in median scores in Maslach Burnout Inventory domains of emotional exhaustion (Faculty: 2.9 vs 3.4; P < .001; Residents: 3.1 vs 3.6; P < .001) and faculty reported higher personal accomplishment scores (Faculty: 3.3 vs 3.8; P = .005) after the VACS model implementation. CONCLUSIONS: A VACS model is a tangible practice change that can address a major problem for current vascular surgeons, as it is associated with decreased burnout for faculty and residents through improvement in both emotional exhaustion and personal accomplishment. Improved longitudinal assessment of resident and faculty burnout is needed and future work should identify specific practice patterns related to decreased burnout.

Implementation of a Vascular Acute Care Surgery Model is Associated with Improved Surgeon Efficiency and Two-Year Mortality After Lower Extremity Intervention.

OBJECTIVE: Vascular surgeons work long, unpredictable hours with repeated exposure to high-stress situations. Inspired by general surgery acute care surgery models, we sought to organize the care of vascular emergencies with the implementation of a vascular acute care surgery (VACS) model. Within this model, a surgeon is in-house without elective cases and assigned for consultations and urgent operative cases on a weekly basis. This study examined the impact of a VACS model on postoperative mortality and surgeon efficiency. METHODS: This was a retrospective cohort analysis of institutional Vascular Quality Initiative data from July 2014 - July 2023. Patients undergoing lower extremity bypass, peripheral vascular intervention, or amputation were included. There was a washout period from January 2020 - January 2022 to account for COVID-19 pandemic practice abnormalities. Patients were separated into pre- or post-VACS groups. The primary clinical outcomes were 30-day and 2-year mortality. Secondary clinical outcomes included 30-day complications and 30-day and 1-year major adverse limb events (MALE). Separate analyses of operating room data from July 2017 - February 2024 and fiscal data from fiscal year 2019 - fiscal year 2024 were conducted. A washout period from January 2020 - January 2022 was applied. Efficiency outcomes included monthly relative value units (RVUs) per clinical fraction full-time equivalent (cFTE) and daytime (0730-1700, Monday-Friday) operating room minutes. Patient factors and operative efficiency were compared using appropriate statistical tests. Regression modeling was performed for the primary outcomes. RESULTS: There were 972 and 257 patients in the pre- and post-VACS groups, respectively. Pre-VACS patients were younger (66.8±12.0 vs 68.7±12.7 years, p=0.03) with higher rates of coronary artery disease (34.6% vs 14.8%, p<0.01), hypertension (88.4% vs 82.2%, p=0.01), and tobacco history (84.4% vs 78.2%, p=0.02). 30-day mortality (2.4% pre- vs 0.8% post-VACS, p=0.18) and Kaplan-Meier estimation of 2-year mortality remained stable after VACS (p=0.07). VACS implementation was not associated with 30-day mortality but was associated with lower 2-year mortality hazard on multivariable Cox regression (hazard ratio: 0.5, 95% confidence interval: 0.3-0.9, p=0.01). Operative efficiency improved post-VACS (850.0 [765.7, 916.3] vs 918.0 [881.0, 951.1] RVU/cFTE-month, median [inter-quartile range], p=0.03). Daytime operating minutes increased (469.1±287.5 vs 908.2±386.2 minutes, p<0.01), while non-daytime minutes (420.0 [266.0, 654.0] vs 469.5 [242.0, 738.3] minutes, p=0.40) and weekend minutes (129.0 [0.0, 298.0] vs 113.5 [0.0, 279.5] minutes, p=0.59) remained stable. CONCLUSIONS: A VACS model leads to improvement in surgeon operative efficiency while maintaining patient safety. The adoption of a vascular acute care model has a positive impact on the delivery of comprehensive vascular care.

A registry-based study of paclitaxel drug-coated balloon angioplasty for the treatment of in-stent restenosis of the femoral-popliteal artery.

OBJECTIVE: The aim of this study was to report the results of a prospective, single-arm, registry-based study assessing the safety and performance of a paclitaxel drug-coated balloon (DCB) for the treatment of superficial femoral artery (SFA) or popliteal artery in-stent restenosis (ISR) in a United States population. METHODS: We conducted a prospective, non-randomized, multi-center, single-arm, post-market registry of the IN.PACT Admiral DCB for the treatment of ISR lesions in the SFA or popliteal artery at 43 sites within the Society for Vascular Surgery (SVS) Vascular Quality Initiative (VQI) Registry from December 2016 to January 2020. Clinical outcomes were assessed at 12, 24, and 36 months. The primary endpoint was target lesion revascularization at 12 months. Secondary endpoints included technical success, target vessel revascularization, major limb amputation, and all-cause mortality. Results are presented as survival probabilities based on Kaplan-Meier survival estimates. RESULTS: Patients (N = 300) were 58% male, with a mean age of 68 ± 10 years. Diabetes was present in 56%, 80% presented with claudication, and 20% with rest pain. Lesions included ISR of the SFA in 68%, SFA-popliteal in 26%, and popliteal arteries in 7%. The mean lesion length was 17.8 ± 11.8 cm. Lesions were categorized as occlusions in 43% (mean occluded length, 16 ± 10 cm). TASC type was A (17%), B (29%), C (38%), and D (15%). Technical success was 99%. Re-stenting was performed in 5% and thrombolysis in 0.6% of patients. Kaplan-Meier estimates for freedom from target lesion revascularization were 90%, 72%, and 62% at 12, 24, and 36 months. Freedom from target vessel revascularization was 88%, 68%, and 59% and freedom from major target limb amputation was 99.6%, 98.9%, and 98.9%, respectively, at 12, 24, and 36 months. Survival was 95%, 89%, and 85% at 12, 24, and 36 months. CONCLUSIONS: This post-market registry-based study shows promising results in treating femoral-popliteal ISR with paclitaxel DCB in comparison to the results of plain balloon angioplasty reported in the literature. These results demonstrate the ability of the SVS VQI to conduct post-market evaluation of peripheral devices in partnership with industry and federal regulators.

Early Financial Outcomes of Physician Modified Endograft Programs Are Dictated by Device Cost.

INTRODUCTION: Physician-modified endografts (PMEGs) have been used for repair of thoracoabdominal aortic aneurysms (TAAAs) for 2 decades with good outcomes but limited financial data. This study compared the financial and clinical outcomes of PMEGs to the Cook Zenith-Fenestrated (ZFEN) graft and open surgical repair (OSR). METHODS: A retrospective review of financial and clinical data was performed for all patients who underwent endovascular or OSR of juxtarenal aortic aneurysms and TAAAs from January 2018 to December 2022 at an academic medical center. Clinical presentation, demographics, operative details, and outcomes were reviewed. Financial data was obtained through the institution's finance department. The primary end point was contribution margin (CM). RESULTS: Thirty patients met inclusion criteria, consisting of twelve PMEG, seven ZFEN, and eleven open repairs. PMEG repairs had a total CM of -$110,000 compared to $18,000 for ZFEN and $290,000 for OSR. Aortic and branch artery implants were major cost-drivers for endovascular procedures. Extent II TAAA repairs were the costliest PMEG procedure, with a total device cost of $59,000 per case. PMEG repairs had 30-d and 1-y mortality rates of 8.3% which was not significantly different from ZFEN (0.0%, P = 0.46; 0.0%, P = 0.46) or OSR (9.1%, P = 0.95; 18%, P = 0.51). Average intensive care unit and hospital stay after PMEG repairs were comparable to ZFEN and shorter than OSR. CONCLUSIONS: Our study suggests that PMEG repairs yield a negative CM. To make these cases financially viable for hospital systems, device costs will need to be reduced or reimbursement rates increased by approximately $8800.

Locoregional Anesthesia's Association With Reduced Intensive Care Unit Stay After Elective Endovascular Aneurysm Repair: Impact of Temporal Changes in Practice Patterns.

BACKGROUND: Elective endovascular aneurysm repair (EVAR) can be performed via local anesthetics and/or regional (epidural or spinal) anesthesia (locoregional [LR]), versus general anesthesia (GA), conferring reduced intensive care unit (ICU) and hospital stays. Current analyses fail to account for temporal changes in vascular practice. Therefore, this study aimed to confirm reductions in ICU and hospital stays among LR patients while accounting for changes in practice patterns. MATERIALS AND METHODS: Using the Society for Vascular Surgery's Vascular Quality Initiative, elective EVARs from August 2003 to June 2021 were grouped into LR or GA. Outcomes included ICU admission and prolonged hospital stay (>2 d). Procedures were stratified into groups of 2 y periods, and outcomes were analyzed within each time period. Univariable and multivariate analyses were used to assess outcomes. RESULTS: LR was associated with reduced ICU admissions (22.3% versus 32.1%, P < 0.001) and prolonged hospital stays (14.3% versus 7.9%, P < 0.001) overall. When stratified by year, LR maintained its association with reduced ICU admissions in 2014-2015 (21.8% versus 34.0%, P < 0.001), 2016-2017 (23.6% versus 31.6%, P < 0.001), 2018-2019 (18.5% versus 30.2%, P < 0.001), and 2020-2021 (15.8% versus 28.8%, P < 0.001), although this was highly facility dependent. LR was associated with fewer prolonged hospital stays in 2014-2015 (15.6% versus 20.4%, P = 0.001) and 2016-2017 (13.3% versus 16.6%, P = 0.006) but not after 2017. CONCLUSIONS: GA and LR have similar rates of prolonged hospital stays after 2017, while LR anesthesia was associated with reduced rates of ICU admissions, although this is facility-dependent, providing a potential avenue for resource preservation in patients suitable for LR.

Preoperative Risk Factors Impacting Length of Stay After Transcarotid Artery Revascularization.

BACKGROUND: Transcarotid artery revascularization (TCAR), using interoperative flow reversal is a unique, hybrid operation utilized in treating critical carotid artery stenosis. Over the past decade, TCAR has been increasingly used to treat asymptomatic carotid artery disease and has a similar risk profile to traditional carotid endarterectomy. Postoperative length of stay (LOS) has a significant impact on cost-effectiveness and quality outcomes in this expanded setting. The objective of this study is to develop a multivariate regression model to identify key preoperative variables and their impact factor on LOS after TCAR for asymptomatic carotid artery stenosis. We hypothesized that high-risk preoperative patient factors historically identified in carotid endarterectomy would similarly impact LOS after TCAR. METHODS: A multi-institution, retrospective study of all adult patients undergoing TCAR with flow-reversal for intraoperative neuroprotection was performed using the Society for Vascular Surgery Vascular Quality Initiative (VQI) from January 2016 to August 2021. Patients with prolonged preoperative hospitalization (preoperative LOS ≥1 day) were excluded to enhance the capture of carotid artery stenosis as the index admission. Univariate analysis was done on preoperative factors against LOS using nonparametric statistical tests. A multivariate model was then constructed using a negative binomial regression. The study population was split into 80% "training" data for model formulation and 20% "test" data for model validation. RESULTS: Thirteen thousand four hundred eighty-three patients undergoing TCAR for asymptomatic carotid stenosis met the study's inclusion criteria with a median postoperative LOS of 1.82 days. Factors in VQI found to have a significant effect on LOS and retained in the multivariate model were lesion type (restenosis versus atherosclerotic), age, gender, chronic obstructive pulmonary disease, preoperative beta blocker, calcific lesion burden, hypertension status, and race (P < 0.05). The model accurately predicted LOS after TCAR within 1 day for 86.04% and within 2 days for 94.51% of patients in the test population. CONCLUSIONS: This large-scale analysis from 2016 to 2021 spans a considerable expansion in the practice of TCAR for asymptomatic carotid disease. All preoperative variables shown to significantly increase the postoperative LOS were derived from the VQI data set. As LOS is a measure of health-care efficiency and cost-effectiveness, this model can be used to identify patients at risk for increased postoperative LOS. It has the potential to be incorporated into a patient/physician decision support tool to optimize resource planning and patient selection for elective TCAR.

Females are less likely to receive best medical therapy for stroke prevention before and after carotid revascularization than males.

BACKGROUND: Current professional guidelines recommend best medical therapy (BMT) with statin agents and antiplatelet therapy for primary and secondary stroke prevention in patients with carotid artery stenosis. We aimed to assess the association of patient sex with preoperative BMT in patients undergoing carotid revascularization. METHODS: We performed a retrospective review of Vascular Quality Initiative patients who underwent carotid endarterectomy or carotid artery stenting between January 2003 and February 2022. Multivariable logistic regression models were used to assess the association of patient sex with preoperative BMT after adjusting for sociodemographic, comorbidity, and disease severity characteristics. In-hospital outcomes were assessed by sex and preoperative BMT status. RESULTS: Of 214,008 patients who underwent carotid revascularization, 38.7% (n = 82,855) were female and 61.3% (n = 131,153) were male. Overall, 77.2% (n = 63,922) of females were on preoperative BMT, compared with 80.4% (n = 105,375) of males (P < .001). After adjusting for baseline differences, females had 11% lower odds of being on BMT compared with males (adjusted odds ratio, 0.89; 95% confidence interval, 0.86-0.91). Postoperatively, females had 18% lower odds of being prescribed BMT than males (adjusted odds ratio, 0.82; 95% confidence interval, 0.79-0.84). In-hospital stroke (1.20% vs 1.51%), death (0.37% vs 0.66%), and stroke/death (1.46% vs 1.98%) were all significantly lower for patients on BMT (all P < .001). CONCLUSIONS: There is a significant discrepancy in the proportion of females versus males receiving preoperative BMT for stroke prevention before carotid artery revascularization. In-hospital outcomes are worse in patients without BMT, highlighting the importance of raising awareness and implementing targeted interventions to improve preoperative adherence to stroke prevention guidelines.

Locoregional anesthesia is associated with reduced hospital stay and need for intensive care unit care of elective endovascular aneurysm repair patients in the Vascular Quality Initiative.

OBJECTIVE: It has been shown local or regional anesthetic techniques are a feasible alternative to general anesthesia for endovascular aortic aneurysm repair (EVAR). However, studies to date have shown controversial findings with respect to the benefit of locoregional anesthesia (LR) in the elective setting. The objective of this study is to compare postoperative outcomes between LR and general anesthesia (GA) in the setting of elective EVAR, using a large, multicenter database. METHODS: Using the Society for Vascular Surgery Vascular Quality Initiative database, we retrospectively analyzed all patients who underwent elective EVAR from August 2003 to June 2021. Patients were grouped by anesthetic type based on the level of consciousness afforded by the anesthetic: local or regional anesthesia (LR) vs GA. Primary outcomes were total postoperative hospital length-of-stay (LOS) and intensive care unit (ICU) LOS. Propensity score matching was used for risk adjustment and to analyze the primary outcomes with confirmatory analysis using logistic or linear regression, as appropriate, in single and multilevel models. Secondary outcomes were 30-day mortality, 1-year mortality, postoperative outcomes, operative time, fluoroscopy time, and reoperation rate. These were analyzed following propensity score matching as well as using logistic regression and Cox proportional hazard regression in single and multilevel models, as appropriate. RESULTS: A total of 50,809 patients underwent elective EVAR from 2003 to 2021. Of these, 4302 repairs used LR (8.5%) and 46,507 (91.5%) were performed under GA. After employing propensity score matching, two groups of 3027 patients were produced. These showed no significant difference in 30-day mortality (odds ratio, 1.22; P = .53), 1-year mortality (hazard ratio, 1.06; P = .62), or any postoperative outcomes. LR was found to be significantly associated with shorter hospital stays (≤2 days) (12.5% vs 14.8%; P = .01), decreased ICU utilization (19.3% vs 30.6%; P < .001), decreased operative time (110.8 vs 117.3 minutes; P < .001), decreased fluoroscopy time (21.0 vs 22.7 minutes; P < .001), and a slight reduction in reoperation rate (1.2% vs 1.9%; P = .02), which all remained significant following single-level and multilevel multivariate analyses accounting for hospital and physician random effects. CONCLUSIONS: These data suggest that LR anesthesia is safe and may offer advantages in reducing resource utilization for patients undergoing elective EVAR, primarily based on associations with reduced ICU care and reduced hospital stay. Given these findings, LR may prove an advantageous technique in appropriately selected patient populations.

Impact of calcified plaque volume on technical and 3-year outcomes after transcarotid artery revascularization.

OBJECTIVE: We sought to quantify the percent calcification within carotid artery plaques and assess its impact on percent residual stenosis and rate of restenosis in patients undergoing transcarotid artery revascularization for symptomatic and asymptomatic carotid artery stenosis. METHODS: A retrospective review of prospectively collected institutional Vascular Quality Initiative data was performed to identify all patients undergoing transcarotid artery revascularization from December 2015 to June 2021 (n = 210). Patient and lesion characteristics were extracted. Using a semiautomated workflow, preoperative computed tomography head and neck angiograms were analyzed to determine the calcified plaque volume in distal common carotid artery and internal carotid artery plaques. Intraoperative digital subtraction angiograms were reviewed to calculate the percent residual stenosis post-intervention according to North American Symptomatic Carotid Endarterectomy Trial criteria. Peak systolic velocity and end-diastolic velocity were extracted from outpatient carotid duplex ultrasound examinations. Univariate logistic regression was performed to analyze the relationship of calcium volume percent and Vascular Quality Initiative lesion calcification to percent residual stenosis in completion angiograms. Kaplan-Meier analysis examined the relationship between calcium volume percent and in-stent stenosis over 36 months. RESULTS: One hundred ninety-seven carotid arteries were preliminarily examined. Predilation was performed in 87.4% of cases with a mean balloon diameter of 5.1 ± 0.7 mm and a mean stent diameter was 8.8 ± 1.1 mm. The mean calcium volume percent was 11.9 ± 12.4% and the mean percent residual stenosis was 16.1 ± 15.6%. Univariate logistic regression demonstrated a statistically significant difference between calcium volume percent and percent residual stenosis (odds ratio [OR], 1.324; 95% confidence interval [CI], 1.005-1.746; P = .046). Stratified by quartile, only the top 25% of calcified plaques (>18.7% calcification) demonstrated a statistically significant association with higher percent residual stenosis (OR, 2.532; 95% CI, 1.049-6.115; P =.039). There was no statistical significance with lesion calcification (OR, 1.298; 95% C,: 0.980-1.718; P = .069). A Kaplan-Meier analysis demonstrated a statistically significant increase in the rate of in-stent stenosis during a 36-month follow-up for lesions containing >8.2% calcium volume (P = .0069). CONCLUSIONS: A calcium volume percent of >18.7% was associated with a higher percent residual stenosis, and a calcium volume percent of >8.2% was associated with higher in-stent stenosis at 36 months. There was one clinically diagnosed stroke during the follow-up period, demonstrating the overall safety of the procedure.

Opioid-Sparing Effects of the Bupivacaine Pleural Catheter in Surgical Decompression of the Thoracic Outlet.

BACKGROUND: Rib resection in thoracic outlet decompression can result in significant postoperative pain requiring high levels of opioid medications. We evaluated the impact of a bupivacaine infusing pleural catheter on postoperative pain and opioid usage in patients undergoing rib resection for thoracic outlet syndrome. We hypothesized that delivery of local anesthetic via the pleural catheter would improve postoperative pain control compared to standard multimodal analgesia, and that the use of the catheter would decrease opioid use during the index hospitalization and prescriptions for opioid pain medications at discharge. METHODS: We conducted a single-center retrospective cohort study of 26 patients who underwent rib resection for thoracic outlet decompression. Primary outcome was opioid consumption during the index hospitalization, measured in morphine milligram equivalents (MME). Secondary outcomes were MME prescribed at discharge and pain scores during the index hospitalization before and after the pleural drain and pleural catheter were removed. RESULTS: Patients in the bupivacaine infusion pleural catheter group (n = 11) had significantly lower MME usage during the index hospitalization (22.5 [1.9, 65.6] vs. 119.8 [76.5, 167.4]), and significantly lower MME prescribed at discharge (0 [0, 37.5] vs. 225 [183, 315]), compared to standard multimodal analgesia in controls (n = 15). Only 3 patients in the bupivacaine pleural catheter group were discharged with any opioid prescriptions (27%), compared to 14 patients in the control group (93%). There was no difference in postoperative pain scores between groups before or after removal of the pleural drain, which was placed in all cases (P = 0.31 and P = 0.76, respectively). CONCLUSIONS: Intraoperative placement of a bupivacaine infusion pleural catheter significantly reduced opioid use during the index hospitalization and opioid prescribing at discharge. Anesthetic infusion pleural catheters should be the treatment modality of choice for postoperative pain management in patients undergoing thoracic outlet decompression.

Survival, Reintervention, and Value of Open and Endovascular Repair for Chronic Mesenteric Ischemia.

BACKGROUND: There are limited analyses of survival and postoperative outcomes in chronic mesenteric ischemia (CMI) using data from large cohorts. Current guidelines recommend open repair (OR) for younger, healthier patients when long-term benefits outweigh increased perioperative risks or for poor endovascular repair (ER) candidates. This study investigates whether long-term survival, reintervention, and value differ between these treatment modalities. METHODS: A retrospective cohort analysis was performed on data extracted from the Statewide Planning and Research Cooperative System, the New York statewide all-payer database containing demographics, diagnoses, treatments, and charges. Patients were selected for CMI and subsequent ER or OR using International Classification of Diseases, Ninth Revision codes. Patients with peripheral arterial disease were excluded to account for ambiguity in the International Classification of Diseases, Ninth Revision procedure code for angioplasty of noncoronary vessels, which includes angioplasty of upper and lower extremity vessels. Kaplan-Meier analysis was used to compare 1-year and 5-year survival and reintervention between treatment modalities using a propensity-matched cohort. Cox proportional hazards testing was performed to find factors associated with 1-year and 5-year survival and reintervention. Analysis of procedural value was performed using linear regression. RESULTS: From 2000 to 2014, 744 patients met inclusion criteria. Of these, 209 (28.1%) underwent OR and 535 (71.9%) ER. No difference between propensity-matched groups was found in 1-year (P = 0.46) or 5-year (P = 0.91) survival. Congestive heart failure (hazard ratio [HR]: 2.8, 95% confidence interval [CI]: 1.7-4.4; P < 0.01), cancer (HR: 2.8, 95% CI: 1.3-5.8; P < 0.01), and dysrhythmia (HR: 1.8, 95% CI: 1.1-2.8; P = 0.02) correlated with 1-year mortality. Cancer (HR: 2.9, 95% CI: 1.6-5.5; P < 0.01), congestive heart failure (HR: 2.2, 95% CI: 1.5-3.2; P < 0.01), chronic pulmonary disease (HR: 1.4, 95% CI: 1.0-2.0; P = 0.04), and age (HR: 1.03, 95% CI: 1.01-1.05; P < 0.01) correlated with 5-year mortality. Treatment modality was not associated with reintervention at 1 year on Kaplan-Meier analysis (P = 0.29). However, ER showed increased instances of reintervention at 5 years (P < 0.01). Additionally, ER was associated with an increased 5-year value (0.7 ± 0.9 vs. 0.5 ± 0.5 life years/charges at index admission [$10k], P < 0.01; b coefficient: 0.2, 95% CI: 0.1-0.4, P < 0.01). CONCLUSIONS: This is the largest retrospective propensity-matched single-study cohort to analyze long-term survival outcomes after intervention for CMI. Long-term mortality was independent of treatment modality and rather was associated with patient comorbidities. Therefore, treatment selection should depend on anatomic considerations and long-term value. ER should be considered over OR in patients with amenable anatomy based on the superior procedural value.

Long-term anticoagulation is associated with type II endoleaks and failure of sac regression after endovascular aneurysm repair.

OBJECTIVE: Within the context of endovascular aneurysm repair (EVAR), the role of anticoagulation therapy on endoleak development and subsequent reintervention is unclear with conflicting data in the literature. The hypothesis of this study is that long-term anticoagulation is associated with persistent type II endoleaks and failure of sac regression in patients undergoing endoluminal repair of intact infrarenal aortic aneurysm. METHODS: Retrospective cohort abstracted from the Vascular Quality Initiative index hospitalization and long-term follow-up datasets for EVAR (2003-2017) were included in the analysis. Patients not taking aspirin preoperatively and postoperatively were excluded. Patients taking anticoagulation and aspirin concomitantly (treatment) after the index procedure were compared against patients taking aspirin alone (control). Anticoagulation included warfarin and novel oral anticoagulants, including factor Xa inhibitors and direct thrombin inhibitors. One-to-one greedy matching using propensity scores was implemented to match patients. The primary end points were failure of aneurysm sac regression, sac expansion, risk of endoleak, and reintervention rate for endoleak at follow-up. Sac regression was defined as a decrease of at least 5 mm and sac expansion was defined as an increase of at least 5 mm. RESULTS: There were 9004 patients who received ASA alone and 332 patients who received ASA and anticoagulation. Propensity scores were used to create 301 matching pairs to account for differences in baseline characteristics and comorbidities, including but not limited to age, sex, smoking, coronary artery disease, heart failure, and chronic kidney disease between the treatment and control groups. After adjusting for covariables anticoagulation use was independently associated with a significantly decreased abdominal aortic aneurysm sac regression (41.59% vs 58.41%; P = .001), but no statistically significant difference in sac expansion with long-term anticoagulation use (9.7% vs 4.9%; P = .056). There was increased risk of type II endoleaks (11.96% vs 6.31%; P = .023; relative risk, 1.89; 95% confidence interval, 1.11-3.23; P = .016), but no significant differences in type I, III, or indeterminate endoleaks. There was no statistical difference in 2-year reintervention rates (4.32% vs 2.66%; hazard ratio, 1.43; 95% confidence interval, 0.55-3.77; P = .461). There were no differences in any primary outcome between warfarin and novel oral anticoagulants. CONCLUSIONS: These data demonstrate that long-term aspirin plus anticoagulation use is associated with a lack of aortic sac reduction and persistent type II endoleak, but not an increased risk for subsequent reintervention. Because prior studies have demonstrated that sac regression is a correlate of survival, these findings associating regression failure suggest a potential therapeutic failure for patients undergoing EVAR who also require long-term anticoagulation therapy. Although not a contraindication, long-term anticoagulation should be considered when counseling patients with a surgical indication aortic aneurysm.

Balloon dilation strategy does not affect outcomes for transcarotid artery revascularization in prospective trials.

OBJECTIVES: Strategies of balloon dilation during transfemoral carotid artery stenting include prestent dilation only (PRE), post-stent dilation only (POST), or both predilation and postdilation (PRE+POST). Concerns over higher neurological risk have been raised with POST and PRE+POST during transfemoral carotid artery stenting. Whether these concerns are applicable to transcarotid artery revascularization (TCAR), which uses proximal clamping and cerebral blood flow reversal during stent deployment and balloon angioplasty remains unknown. Our aim is to analyze outcomes of PRE, POST, or PRE+POST balloon dilation strategies during TCAR. METHODS: We analyzed the prospectively collected data from the ROADSTER1 (pivotal), ROADSTER2 (US Food and Drug Administration indicated postmarket), and ROADSTER Extended Access TCAR trials. All trial patients had a high risk anatomic or clinical factors for carotid endarterectomy and were included, unless they did not undergo stent deployment or balloon dilation. For trial inclusion, asymptomatic patients had a carotid stenosis of more than 80%, and symptomatic patients had stenosis of more than 50%. Primary outcome measures were stroke, death, and myocardial infarction (MI) at 30 days. Data were statistically analyzed with χ2, analysis of variance, and multivariable analysis, as appropriate. RESULTS: There were 851 patients (566 male) who underwent dilation by PRE (n = 216), POST (n = 249), or PRE+POST (n = 386). Patients had carotid stenosis of greater than 70% (n = 828, 97%), and 207 (24%) were symptomatic. Flow reversal times were longer in the PRE+POST group (PRE 10.2 minutes, POST 9.8 minutes, and PRE+POST 13.3 minutes; P < .001). The 30-day stroke rate for the whole cohort was 1.9%, mortality was 0.5%, and MI rate was 0.94%. Stroke rates for the PRE cohort (1.9%), POST cohort (2.0%), and PRE+POST cohort (1.8%; P = .98) were similar. Also, death rates at 30 days, and composite stroke, death, and MI rates were similar in the three cohorts. No significant differences in adverse outcomes were noted among the various dilation strategies for both symptomatic and asymptomatic patients. CONCLUSIONS: Based on these prospective trial data, there is no difference in neurological complications owing to balloon dilation strategy during TCAR. The balloon dilation technique best suited to the patient's specific lesion morphology should be used. Further studies are needed to evaluate the relationship of these dilation strategies to long-term outcomes, including stent patency, restenosis, and reintervention.

Left Subclavian Artery Coverage is Not Associated with Neurological Deficits in Trauma Patients Undergoing Thoracic Endovascular Repair.

BACKGROUND: Endovascular repair of the thoracic aorta (TEVAR) outcomes have been studied with an interest in complications related to left subclavian artery (LSA) coverage in patients with atherosclerotic pathologies; however, specific data on the management of the LSA in a trauma population are lacking. The objective of this study is to evaluate outcomes following TEVAR for traumatic aortic injury based on LSA coverage. METHODS: The Vascular Quality Initiative thoracic endovascular aortic repair module (2010-2017) was analyzed. Patients were included if they had a traumatic aortic injury requiring TEVAR. Patients were placed in 2 groups based on coverage of the LSA. Patients were propensity score matched and the primary outcomes were cerebrovascular symptoms and spinal cord ischemia. Additional clinical and resource utilization outcomes were analyzed. RESULTS: Four hundred and fifty one patients were included in the analysis. There were 268 patients in the LSA not-covered group and 183 patients in the LSA covered group. The mean aortic injury grade was 2.88 ± 0.056 vs. 2.88 ± 0.049 in the covered versus not-covered group (P = 0.957). Glasgow coma scale and injury severity score were not different between the groups. There was no difference between groups for cerebrovascular symptoms or spinal cord ischemia, 1.4% vs. 2.8%, P = 0.684 and 0% vs. 2.1%, P = 0.247, after propensity score matching. Significant differences in access site complications and resource utilization were identified between groups. CONCLUSIONS: This is the largest series to evaluate complications based on LSA coverage following TEVAR in trauma patients. Our data demonstrate that coverage of the LSA during TEVAR following blunt trauma is associated with no difference in central nervous system outcomes. As such, LSA revascularization strategies, while possible, are not directly supported by these data and should be individualized based on each patient's specific clinical scenario.

Multi-institutional patterns of clopidogrel response among patients undergoing transcarotid artery revascularization.

OBJECTIVE: Current guidelines recommend dual antiplatelet therapy (DAPT) in patients undergoing carotid artery stenting. The most common DAPT regimen is aspirin and clopidogrel, a P2Y12 receptor antagonist; however, the prevalence of clopidogrel resistance (CR) in patients undergoing percutaneous coronary interventions may exceed 60%. Few studies have investigated the prevalence and impact of CR in patients undergoing extracranial carotid artery stenting, particularly transcarotid artery revascularization (TCAR). METHODS: Consecutive high-risk patients ≥ 18 years who underwent TCAR for high grade (≥70%) and/or symptomatic (≥50%) carotid stenosis with preoperative P2Y12 testing between August 2019 and December 2021 were identified across five institutions. Preoperative platelet reactivity was measured with the VerifyNow P2Y12 Reaction Unit (PRU) Test (Instrumentation Laboratory, Bedford, MA), with CR defined as PRU ≥ 194 and hyper-response as PRU <70. Patients without preoperative P2Y12 testing within 30 days prior to TCAR or those on a non-clopidogrel P2Y12 inhibitor preoperatively were excluded. The primary outcome of interest was prevalence of CR. Secondary outcomes of interest included the incidence of ischemic and hemorrhagic complications. RESULTS: Of 92 patients identified, the majority were male (59%) and Caucasian (75%) with a mean age of 75 years (±8, range 56-92). Preoperatively, 93% of patients were on aspirin, 100% on clopidogrel, and 13% on therapeutic anticoagulation. At presentation, 36% were symptomatic. The mean preoperative P2Y12 was 156 PRU (±76, range 6-349). In total, 30 (33%) patients met criteria for CR (mean PRU 240 ± 37; range 197-349), and 15 (16%) met criteria for hyper-responder (mean PRU 38 ± 20; range 6-68). There was no significant difference by clopidogrel response phenotype in terms of sex (p = 0.246), race (p = 0.384), or symptomatic presentation (p = 0.956). Postoperatively, the cumulative incidence of stroke and MI was 2.1%, with no statistically significant difference in the incidence of in-hospital stroke (PRU 238, p = 0.489) or MI (PRU 168, p = 1) between clopidogrel phenotypes. Three (3.3%) patients, one CR (PRU 240) and two responders (PRU 119 and PRU 189), experienced postoperative access site hematomas that required no subsequent intervention. No other index hospitalization hemorrhagic complications occurred. CONCLUSIONS: Using preoperative P2Y12 testing with a threshold PRU ≥ 194 to define CR, we identified a high prevalence of CR in patients undergoing TCAR similar to that in the pre-existing coronary literature. We found no significant differences in postoperative ischemic or hemorrhagic complications by clopidogrel response phenotype, although complication rates in the overall study cohort were low. CR may be a spectrum from responder to partial responder to complete non-responder, and this may account for the differences in our CR cohort compared to the ROADSTER 2 protocol deviation cohort. Further investigation is warranted to determine if a quantitative assessment of CR is sufficient to identify patients at risk of developing secondary cerebrovascular ischemic events in this patient population.

Association Between the Atherosclerotic Disease Risk Score and Carotid Artery Stenosis.

BACKGROUND: Carotid artery stenosis (CAS) is the most frequently detected treatable cause of ischemic stroke. However, there are no recommendations to screen asymptomatic patients. The atherosclerotic cardiovascular disease (ASCVD) risk score estimates individuals' 10-year risk for developing cardiovascular disease. The objective of this study is to identify a relationship between the ASCVD risk score and moderate/severe CAS based on ultrasound findings. MATERIALS AND METHODS: We performed a single-institution retrospective review of patients who underwent a surveillance ultrasound for CAS between 2015 and 2018. We used Strandness velocity criteria to separate patients into two cohorts: none to mild CAS (<50%) and moderate/severe CAS (≥50%). We performed Student's t-test, multivariate analysis, and receiver operator characteristic (ROC) curve analysis to determine a relationship between the ASCVD risk score and degree of CAS. We evaluated a new risk score model based on stepwise logistic regression of significant variables on univariate analysis. RESULTS: Two thousand eight hundred and fifty-six patients with carotid ultrasounds (1623 with none to mild, 1161 with moderate, and 72 with severe disease) were included in the study. The ASCVD risk score significantly predicted moderate/severe CAS in an adjusted multivariate analysis. Each 10% increase in the ASCVD risk score corresponded to an additional 11% likelihood of moderate/severe stenosis (OR: 1.11 [1.04-1.20], P = 0.004). The ROC area under the curve for predicting moderate/severe CAS based on the ASCVD risk score was 0.59 (Youden index (J) = 0.14); the optimized ASCVD cutoff point was 28.4%. Our new atherosclerotic disease model demonstrated increased odds of moderate/severe CAS with scores greater than zero (ROC area under the curve = 0.57). CONCLUSIONS: This is the first study to demonstrate an association between atherosclerotic disease risk factors as measured by the ASCVD risk score and moderate/severe CAS. However, this tool is not sensitive or specific for using the ASCVD risk score as a screening mechanism for moderate/severe CAS.

A Reappraisal of CT Angiography Derived Duplex Ultrasound Velocity Criteria With a Comparison to Digital Subtraction Angiography in Patients With Carotid Artery Stenosis.

BACKGROUND: Traditionally, carotid duplex ultrasound (CDUS) velocity criteria have been derived from angiography. Recent studies support a shift toward computed tomography angiography (CTA) derived velocity criteria; however, they lack a comparison to angiography. The purposes of this study are to validate CTA derived measurements with digital subtraction angiography (DSA) and to update our previous CTA-derived velocity criteria for 50% and 80% stenosis. METHODS: All patients between 2010 and 2019 who underwent CDUS and a neck CTA within 6 months were identified for a retrospective review. Vessel diameter and corresponding CDUS data were recorded. Additional DSA measurements were recorded for a subset of patients. Data from this cohort were added to a previously reported deidentified data set from patients between 2000 and 2009. Receiver operating characteristic (ROC) curves were generated to determine optimal velocity thresholds. Spearman rank correlation was used to correlate measurements obtained by CTA to those obtained by DSA. RESULTS: A total of 1139 vessels from 636 patients were analyzed. ROC analysis to identify ≥ 50% stenosis resulted in optimized thresholds of 143 cm/sec, 46.2 cm/sec, and 2.15 for peak systolic velocity (PSV), end-diastolic velocity (EDV), and PSV to common carotid artery PSV ratio (PSVR), respectively. ROC analysis to identify ≥ 80% stenosis resulted in optimized thresholds of 319 cm/sec, 87.2 cm/sec, and 3.49 for PSV, EDV, and PSVR, respectively. The degree of carotid artery stenosis for a subset of 124 vessels on CTA correlated well with that of DSA (ρ = 0.89, P< 0.0001). CONCLUSIONS: These data demonstrate a high correlation between measurements obtained on CTA and DSA while forming reliable CTA-derived CDUS velocity criteria.

Regional Variation in Usage of Ultrasound-Guided Femoral Access in the Vascular Quality Initiative.

BACKGROUND: Access site complications are among the most common complications following peripheral vascular interventions. Previous studies have demonstrated a reduced rate of complications with ultrasound-guided vascular access (UGVA). The objective of this study is to evaluate the regional use of UGVA within the Vascular Quality Initiative (VQI). METHODS: The VQI peripheral intervention module between 2010 and 2018 was evaluated. Regional ID was used to compare distribution of ultrasound usage. Regions were grouped into terciles based on the rate of ultrasound use. Patients were categorized based on type of access. Primary outcome was use of ultrasound across regions. Secondary outcomes were access site complications. RESULTS: Over 43,000 cases across the 18 VQI regions were evaluated. The average rate of ultrasound usage was 71% across the regions with a wide variation (range 38-97%). There is a significant difference in utilization among the top third (87%), middle third (79%), and bottom third (58%) (P < 0.001). Average sheath size was similar across all 3 groups. A higher use of ultrasound-guided access was associated with significantly fewer access site complications (top third 1.96% vs. bottom third 3.04%, P < 0.001), the most significant of which was a decreased rate of access site hematoma (top third 1.37% vs. bottom third 2.35%, P < 0.001). CONCLUSIONS: This is the first study to evaluate ultrasound-guided access across VQI regions. Our results demonstrate that despite strong evidence supporting the utilization of UGVA, there remains a wide variation in ultrasound usage across VQI regions. This is also the first study to show that the prevalence of ultrasound use in peripheral vascular interventions (PVI) is inversely related to access site complications. Given all of the data supporting the usage of UGVA across numerous specialties, our findings encourage the consideration of an ultrasound-first approach for vascular access in PVI and the implementation of targeted strategies and evidence-based guidelines to enhance UGVA utilization in PVI.

Evaluation of Opioid Prescription and Consumption Habits Following Endovascular Aortic Aneurysm Repair.

BACKGROUND: There has been a dramatic rise in opioid-related deaths over the past decade. Most of the reduction strategies have focused on outpatient use; however, recent studies have demonstrated an association between inpatient opioid use and consumption following discharge across a variety of surgical procedures. The objective of this study is to evaluate the association of inpatient use of opioids as well as the consumption of opioids after discharge following endovascular aortic aneurysm repair (EVAR). METHODS: A prospectively maintained database was reviewed for cases between 2015 and 2018. Patients were included in the study if they underwent an elective EVAR, had an intensive care unit stay less than 1 day and total length of stay less than 3 days. Patients were contacted to participate in a survey of opioid use if they received a prescription at discharge. The primary outcome was percent of prescribed opioids consumed following discharge. Multivariate analyses were performed to determine predictors of receiving an opioid prescription. RESULTS: One hundred seventy-one patients were included in the analysis; 95% patients were white and 85% male. 59% of patients responded to the survey. Seventy-one (42%) received an opioid prescription at discharge. Patients that received a discharge prescription tended to be younger (71 vs. 75 years, P = 0.005) and more likely to have received opioids while in the hospital (79% vs. 45%, P < 0.001). Additionally, patients who received opioids at discharge received a significantly greater amount of milligram oral morphine equivalents (OME) while in the hospital (27.76 ± 38.91 vs. 10.05 ±29.43, P < 0.001). Multivariate analysis demonstrated age, estimated blood loss (EBL), and OME per day to be significant inpatient predictors of requiring an outpatient opioid prescription. Open femoral access (27%) was not a predictor of opioid prescription at discharge. A total of 1185 pills were prescribed (29.6 ± 2.06 per patient), but only 208 pills consumed (5.2 ± 1.27 per patient). Around 82% of total pills prescribed were not consumed. CONCLUSIONS: This study evaluates inpatient opioid use and postdischarge consumption following EVAR. These data identify key factors associated with receiving an opioid prescription at discharge and demonstrate that patients consume far fewer opioids than prescribed. These findings provide insight as to which patients may not require an outpatient prescription following EVAR, leading to potential practice-changing opioid reduction strategies.