The Association between Sex and Outcomes following Thoracic Endovascular Repair for Acute Type B Aortic Dissection.

OBJECTIVE: Prior literature has found worse outcomes for females following endovascular repair of AAA and mixed findings following TEVAR for TAA. However, the influence of sex on outcomes after TEVAR for acute Type B aortic dissection (aTBAD) is not fully elucidated. METHODS: We identified patients undergoing TEVAR for acute type B aortic dissection (<30 days) in the Vascular Quality Initiative (VQI) from 2014 to 2022. We excluded patients with an entry tear or stent seal within the ascending aorta or aortic arch and patients with an unknown proximal tear location. Included patients were stratified by biological sex, and we analyzed perioperative outcomes and 5-year mortality with multivariable logistic regression and Cox regression analysis, respectively. Furthermore, we analyzed adjusted variables for interaction with female sex. RESULTS: We included 1,626 patients, 33% of whom were female. At presentation, females were significantly older (65 [IQR: 54,75] years vs 56 [IQR: 49,68] years; p= 0.01). Regarding indications for repair, females had higher rates of pain (85% vs 80%; p=0.02), and lower rates of malperfusion (23% vs 35%; p<0.001): specifically mesenteric, renal, and lower limb malperfusion. Females had a lower proportion of proximal repairs in zone 2 (39% vs 48%; p< 0.01). Following TEVAR for aTBAD, female sex was associated with comparable odds of perioperative mortality compared with males (8.1 vs 9.2%; Adjusted Odds Ratio (aOR): 0.79 [95% CI: 0.51-1.20]). Regarding perioperative complications, female sex was associated with lower odds for cardiac complications (2.3% vs 4.7%; aOR: 0.52 [95%CI: 0.26-0.97]), but all other complications were comparable between sexes. Compared with male sex, female sex was associated with similar risk for 5-year mortality (26% vs 23%; Adjusted Hazard Ratio (aHR): 1.01 [95%CI: 0.77-1.32]). Upon testing variables for interaction with sex, female sex was associated with lower perioperative and 5-year mortality at older ages relative to males (aOR: 0.96 [0.93-0.99] | aHR: 0.97 [0.95-0.99]) and higher odds of perioperative mortality when mesenteric malperfusion was present (OR: 2.71 [1.04-6.96]). CONCLUSION: Female patients were older, less likely to have complicated dissection, and had more distal proximal landing zones. Following TEVAR for aTBAD, female sex was associated with similar perioperative and 5-year mortality compared with male sex, but lower odds of in-hospital cardiac complications. Interaction analysis showed females were at additional risk for perioperative mortality when mesenteric ischemia was present. These data suggest that TEVAR for aTBAD overall has a similar safety profile in females as it does for males.

Bailout Distal Internal Carotid Artery Stenting after Carotid Endarterectomy: Indications, Technique, and Outcomes.

BACKGROUND: Distal internal carotid artery (ICA) stenting may be employed as a bailout maneuver when an inadequate end point or clamp injury is encountered at the time of carotid endarterectomy (CEA) in a surgically inaccessible region of the distal ICA. We sought to characterize the indications, technique, and outcomes for this infrequently encountered clinical scenario. METHODS: We performed a retrospective review of all patients who underwent distal ICA stenting at the time of CEA at our institution between September 2008 and July 2022. Procedural details and postoperative follow-up were reviewed for each patient. RESULTS: Six patients were identified during the study period. All were male with an age range of 63 to 82 years. Five underwent carotid revascularization for asymptomatic carotid artery stenosis, and one patient was treated for amaurosis fugax. Three patients were on dual antiplatelet therapy preoperatively, whereas 2 were on aspirin monotherapy, and one was on aspirin and low-dose rivaroxaban. Five patients underwent CEA with patch angioplasty, and one underwent eversion CEA. The indication for stenting was distal ICA dissection due to clamp or shunt injury in 2 patients and an inadequate distal ICA end point in 4 patients. In all cases, access for stenting was obtained under direct visualization within the common carotid artery, and a standard carotid stent was deployed with its proximal aspect landing within the endarterectomized site. Embolic protection was typically achieved via proximal common carotid artery and external carotid artery clamping for flow arrest with aspiration of debris before restoration of antegrade flow. There was 100% technical success. Postoperatively, 2 patients were found to have a cranial nerve injury, likely occurring due to the need for high ICA exposure. Median length of stay was 2 days (range 1-7 days) with no instances of perioperative stroke or myocardial infarction. All patients were discharged on dual antiplatelet therapy with no further occurrence of stroke, carotid restenosis, or reintervention through a median follow-up of 17 months. CONCLUSIONS: Distal ICA stenting is a useful adjunct in the setting of CEA complicated by inadequate end point or vessel dissection in a surgically inaccessible region of the ICA and can minimize the need for high-risk extensive distal dissection of the ICA in this situation.

Discrepancies in clavicle-to-carotid bifurcation length measurements for transcarotid artery revascularization using different imaging modalities.

OBJECTIVE: Transcarotid artery revascularization (TCAR) has emerged as an effective method for carotid artery stenting. However, anatomic eligibility for TCAR is most often limited by an inadequate clavicle-to-carotid bifurcation length of <5 cm. Preoperative clavicle-to-carotid bifurcation distances may be underestimated when using conventional straight-line measurements on computed tomographic angiography (CTA) imaging. We therefore compared clavicle-to-carotid bifurcation lengths as measured by straight-line CTA, center-line CTA, and intraoperative duplex ultrasound (US), to assess potential differences. METHODS: We conducted a single-center, retrospective review of consecutive TCAR procedures performed between 2016 and 2019 for atherosclerotic carotid disease. For each patient, we compared clavicle-to-carotid bifurcation lengths measured by straight-line CTA, center-line CTA using TeraRecon image reconstruction, and intraoperative duplex US with neck extension and rotation. We further assessed patient and imaging characteristics in individuals with a ≥0.5 cm difference among the measurement methods. In particular, common carotid artery (CCA) tortuosity, defined as the inability to visualize the entire CCA from clavicle to carotid bifurcation on both a single coronal and sagittal imaging cut, was examined as a contributing factor for these discrepancies. RESULTS: Of the 70 TCAR procedures identified, 46 had all three imaging modalities available for review. The median clavicle-to-carotid bifurcation length was found to be 6.4 cm (interquartile range [IQR], 5.4-6.7 cm) on straight-line CTA, 7.0 cm (IQR, 6.0-7.5 cm) on intraoperative duplex US, and 7.2 cm (IQR, 6.5-7.5 cm) on center-line CTA (P < .001). Patients with a ≥0.5 cm difference between their straight-line CTA and either their intraoperative duplex US or center-line CTA measurements were more likely to have tortuous CCAs (60.0% vs 19.1%; P = .01; 51.4% vs 0.0%; P = .01). There were no notable differences in age, gender, prior neck/cervical spine surgery, or neck immobility among these individuals. In patients with tortuous CCAs, duplex US and center-line CTA measurements added 1.0 cm (IQR, 0.6-1.5 cm) and 1.1 cm (IQR, 0.9-1.6 cm) more in length than straight-line CTA measurements, respectively. There was a strong linear correlation between the additional lengths provided by duplex US measurements and those provided by center-line CTA measurements for each individual within the tortuous CCA group (r = 0.83). CONCLUSIONS: The use of straight-line CTA during preoperative planning can underestimate the clavicle-to-carotid bifurcation lengths in patients undergoing carotid revascularization, particularly in those with tortuous CCAs. Both duplex US performed with extended-neck surgical positioning and center-line CTA provide similar and longer carotid length measurements, and should be utilized in patients with tortuous carotid vessels to better determine TCAR anatomic eligibility.

Efficacy and safety of single versus dual antiplatelet therapy in carotid artery stenting.

OBJECTIVE: Current guidelines recommend dual antiplatelet (AP) therapy (DAPT) before carotid artery stenting (CAS); however, the true clinical effect of single AP therapy vs DAPT is unknown. We examined the efficacy and safety of preoperative single AP therapy vs DAPT in patients who had undergone transfemoral CAS (tfCAS) or transcarotid artery revascularization (TCAR). METHODS: We identified all patients who had undergone tfCAS or TCAR in the Vascular Quality Initiative database from 2016 to 2021. We stratified the patients by procedure and identified those who had received the following preoperative AP regimens: DAPT (acetylsalicylic acid [ASA] + P2Y12 inhibitor [P2Yi]), no AP therapy, ASA only, ASA + AP loading dose, P2Yi only, and P2Yi + AP loading dose. The AP loading dose was given within 4 hours of CAS. We generated propensity scores for each treatment regimen and assessed in-hospital outcomes using inverse probability weighted log binomial regression, with DAPT as the reference and adjusting for intraoperative protamine use. The primary efficacy outcome was a composite end point of stroke and death, and the primary safety outcome was access-related bleeding. RESULTS: Of the 18,570 tfCAS patients, 70% had received DAPT, 5.6% no AP therapy, 10% ASA only, 8.0% ASA + AP loading dose, 4.6% P2Yi only, and 2.9% P2Yi + AP loading dose. The corresponding unadjusted rates of stroke/death were 2.2%, 6.8%, 4.1%, 5.1%, 2.4%, and 2.3%. After adjustment, compared with DAPT, the incidence of stroke/death was higher with no AP therapy (relative risk [RR], 2.3; 95% confidence interval [CI], 1.7-3.2), ASA only (RR, 1.6; 95% CI, 1.2-2.1), and ASA + AP loading dose (RR, 2.0; 95% CI, 1.5-2.7) but was similar with P2Yi only (RR, 0.99; 95% CI, 0.58-1.7) and P2Yi + AP loading dose (RR, 1.1; 95% CI, 0.49-2.5). Of the 25,459 TCAR patients, 81% had received DAPT, 2.0% no AP therapy, 5.5% ASA only, 3.5% ASA + AP loading dose, 4.9% P2Yi only, and 2.4% P2Yi + AP loading dose. The corresponding unadjusted rates of stroke/death were 1.5%, 3.3%, 3.3%, 2.9%, 1.2%, and 1.1%. After adjustment, compared with DAPT, the incidence of stroke/death was higher with no AP therapy (RR, 2.0; 95% CI, 1.2-3.3) and ASA only (RR, 2.2; 95% CI, 1.5-3.1), with a trend toward a higher incidence with ASA + AP loading dose (RR, 1.6; 95% CI, 0.99-2.6), and was similar with P2Yi only (RR, 0.98; 95% CI, 0.54-1.8) and P2Yi + AP loading dose (RR, 0.66; 95% CI, 0.27-1.6). No differences were found in the incidence of access-related bleeding between the treatment groups after tfCAS or TCAR. CONCLUSIONS: Compared with DAPT, no AP therapy or ASA monotherapy was associated with higher rates of stroke/death after CAS and should be discouraged as unsafe practice. Meanwhile, P2Yi monotherapy was associated with similar rates of stroke/death. No differences were found in the incidence of bleeding complications, and adding an AP loading dose to ASA or P2Yi monotherapy within 4 hours of the procedure did not affect the outcomes. Overall, these findings support the current guidelines recommending DAPT before CAS but also suggest that P2Yi monotherapy might confer thromboembolic benefits similar to those with DAPT. However, an immediate preoperative AP loading dose might not provide additional thromboembolic benefits.

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

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

Racial and ethnic disparities in 3-year outcomes following infrainguinal bypass for chronic limb-threatening ischemia.

OBJECTIVE: Black and Hispanic patients have had higher rates of chronic limb-threatening ischemia (CLTI) and experienced worse perioperative outcomes after lower extremity bypass compared with White patients. The underlying reasons for these disparities have remained unclear, and data on 3-year outcomes are limited. Therefore, we examined the differences in 3-year outcomes after open infrainguinal bypass for CLTI stratified by race/ethnicity and explored the potential factors contributing to these differences. METHODS: We identified all CLTI patients who had undergone primary open infrainguinal bypass in the Vascular Quality Initiative registry from 2003 to 2017 with linkage to Medicare claims through 2018 for the 3-year outcomes. Our primary outcomes were the 3-year rates of major amputation, reintervention, and mortality. We also recorded the 30-day major adverse limb events (MALE) defined as major amputation or reintervention. We used Kaplan-Meier estimation methods and multivariable Cox regression analyses to evaluate the outcomes stratified by race/ethnicity and identify contributing factors. RESULTS: Of the 7108 patients with CLTI, 5599 (79%) were non-Hispanic White, 1053 (15%) were Black, 48 (1%) were Asian, and 408 (6%) were Hispanic patients. Compared with White patients, Black patients had higher rates of 3-year major amputation (Black vs White, 32% vs 19%; hazard ratio [HR], 1.9; 95% confidence interval [CI], 1.7-2.2), reintervention (Black vs White, 61% vs 57%; HR, 1.2; 95% CI, 1.1-1.3), and 30-day MALE (Black vs White, 8.1% vs 4.9%; HR, 1.3; 95% CI, 1.2-1.4) but lower mortality (Black vs White, 38% vs 42%; HR, 0.9; 95% CI, 0.8-0.99). Hispanic patients also experienced higher rates of amputation (Hispanic vs White, 27% vs 19%; HR, 1.6; 95% CI, 1.3-2.0), reintervention (Hispanic vs White, 70% vs 57%; HR, 1.4; 95% CI, 1.2-1.6), and MALE (Hispanic vs White, 8.7% vs 4.9%; HR, 1.5; 95% CI, 1.3-1.7. However, mortality was similar between the two groups (Hispanic vs White, 38% vs 42%; HR, 0.88; 95% CI, 0.76-1.0). The low number of Asian patients prevented a meaningful assessment of amputation (Asian vs White, 20% vs 19%; HR, 0.93; 95% CI, 0.44-2.0), reintervention (Asian vs White, 55% vs 57%; HR, 0.79; 95% CI, 0.51-1.2), MALE (Asian vs White, 8.5% vs 4.9%; HR, 0.71; 95% CI, 0.46-1.1), or mortality (Asian vs White, 36% vs 42%; HR, 0.83; 95% CI, 0.52-1.3). In the adjusted analyses, the association of Black race and Hispanic ethnicity with amputation and reintervention was explained by differences in the demographic characteristics (ie, age, sex) and baseline comorbidities (ie, tobacco use, diabetes, renal disease). CONCLUSIONS: Compared with White patients, Black and Hispanic patients had higher 3-year major amputation and reintervention rates. However, mortality was lower for Black patients than for the White patients and similar between Hispanic and White patients. Disparities in amputation and reintervention were partly attributable to differences in demographic characteristics and the higher prevalence of comorbidities in Black and Hispanic patients with CLTI. Future work is necessary to determine whether interventions to improve access to care and reduce the burden of comorbidities in these populations will confer limb salvage benefits.

Endovascular Snare Facilitates Difficult Transfemoral Target Vessel Cannulation During Fenestrated and Branched Endovascular Aortic Aneurysm Repair.

We developed a novel technique using an endovascular snare system to stabilize target vessel cannulation via transfemoral access during fenestrated and branched endovascular aortic aneurysm repair (FBEVAR) in patients with challenging target vessel anatomy. This technique uses a snare, an outer sheath, and an inner delivery sheath to facilitate target vessel cannulation and stenting during FBEVAR. With the outer sheath positioned in the lower end of the partially deployed aortic graft and the delivery sheath within, a large snare is advanced through the outer sheath and over the outside of the delivery sheath until it reaches the curved portion of the delivery sheath at the level of the target vessel. The snare is then tightened to provide stability and maintain proper curvature and alignment of the delivery sheath while the target vessel is selected and stented. Following successful passage, the snare is loosened and removed from the body via the outer sheath. This snare technique is a simple, effective, and inexpensive tool that can be used for difficult target vessel cannulation during FBEVAR.

A multicenter, prospective randomized trial of negative pressure wound therapy for infrainguinal revascularization with a groin incision.

BACKGROUND: Wound complications after open infrainguinal revascularization are a frequent cause of patient morbidity, resulting in increased healthcare costs. The purpose of the present study was to assess the effects of closed incision negative pressure therapy (ciNPT) on groin wound complications after infrainguinal bypass and femoral endarterectomy. METHODS: A total of 242 patients who had undergone infrainguinal bypass (n = 124) or femoral endarterectomy (n = 118) at five academic medical centers in New England from April 2015 to August 2019 were randomized to ciNPT (PREVENA; 3M KCI, St Paul, Minn; n = 118) or standard gauze (n = 124). The primary outcome measure was a composite endpoint of groin wound complications, including surgical site infections (SSIs), major noninfectious wound complications, or graft infections within 30 days after surgery. The secondary outcome measures included 30-day SSIs, 30-day noninfectious wound complications, readmission for wound complications, significant adverse events, and health-related quality of life using the EuroQoL 5D-3L survey. RESULTS: The ciNPT and control groups had similar demographics (age, 67 vs 67 years, P = .98; male gender, 71% vs 70%, P = .86; white race, 93% vs 93%, P = .97), comorbidities (previous or current smoking, 93% vs 94%, P = .46; diabetes, 41% vs 48%, P = .20; renal insufficiency, 4% vs 7%, P = .31), and operative characteristics, including procedure type, autogenous conduit, and operative time. No differences were found in the primary composite outcome at 30 days between the two groups (ciNPT vs control: 31% vs 28%; P = .55). The incidence of SSI at 30 days was similar between the two groups (ciNPT vs control: 11% vs 12%; P = .58). Infectious (13.9% vs 12.6%; P = .77) and noninfectious (20.9% vs 17.6%; P = .53) wound complications at 30 days were also similar for the ciNPT and control groups. Wound complications requiring readmission also similar between the two groups (ciNPT vs control: 9% vs 7%; P = .54). The significant adverse event rates were not different between the two groups (ciNPT vs control: 13% vs 16%; P = .53). The mean length of the initial hospitalization was the same for the ciNPT and control groups (5.2 vs 5.7 days; P = .63). The overall health-related quality of life was similar at baseline and at 14 and 30 days postoperatively for the two groups. Although not powered for stratification, we found no differences among the subgroups in gender, obesity, diabetes, smoking, claudication, chronic limb threatening ischemia, bypass, or endarterectomy. On multivariable analysis, no differences were found in wound complications at 30 days for the ciNPT vs gauze groups (odds ratio, 1.4; 95% confidence interval, 0.8-2.6; P = .234). CONCLUSIONS: In contrast to other randomized studies, our multicenter trial of infrainguinal revascularization found no differences in the 30-day groin wound complications for patients treated with ciNPT vs standard gauze dressings. However, the SSI rate was lower in the control group than reported in other studies, suggesting other practice patterns and processes of care might have reduced the rate of groin infections. Further study might identify the subsets of high-risk patients that could benefit from ciNPT.

Wound location is independently associated with adverse outcomes following first-time revascularization for tissue loss.

OBJECTIVE: Few studies adequately evaluate the impact of wound location on patient outcomes after lower extremity revascularization. Consequently, we evaluated the relationship between lower extremity wound location and long-term outcomes. METHODS: We reviewed all patients at our institution undergoing any first-time open surgical bypass or percutaneous transluminal angioplasty with or without stenting for tissue loss between 2005 and 2014. We categorized wounds into three distinct groups: forefoot (ie, toes and metatarsal heads), midfoot (ie, dorsal, plantar, lateral, medial surfaces excluding toes, metatarsal heads, or heel), and heel. Limbs with multiple wounds were excluded from analyses. We compared rates of perioperative complications, wound healing, reintervention, limb salvage, amputation-free survival, and survival using χ2, Kaplan-Meier, and Cox regression analyses. RESULTS: Of 2869 infrainguinal revascularizations from 2005 to 2014, 1126 underwent a first-time revascularization for tissue loss, of which 253 patients had multiple wounds, 197 had wounds proximal to the ankle, 100 had unreliable wound information, and 576 (forefoot, n = 397; midfoot, n = 61; heel, n = 118) fit our criteria and had a single foot wound with reliable information regarding wound specifics. Patients with forefoot, midfoot, and heel wounds had similar rates of coronary artery disease, hypertension, diabetes, and smoking history (all P > .05). Conversely, there were significant differences in patient age (71 vs 69 vs 70 years), prevalence of gangrene (41% vs 5% vs 21%), and dialysis dependence (18% vs 17% vs 30%) (all P < .05). There were no statistically significant differences in perioperative mortality (1.3% vs 4.9% vs 4.2%; P = .06) or postoperative complications among the three groups. Between forefoot, midfoot, and heel wounds, there were significant differences in unadjusted 6-month rates of complete wound healing (69% vs 64% vs 53%), 3-year rates of amputation-free survival (54% vs 57% vs 35%), and survival (61% vs 72% vs 41%) (all P < .05). After adjustment, compared with forefoot wounds, heel wounds were associated with higher rates of incomplete 6-month wound healing (hazard ratio [HR], 1.6; 95% confidence interval [CI], 1.1-2.]), major amputation or mortality (HR, 1.7; 95% CI, 1.1-2.7), and all-cause mortality (HR, 1.8; 95% CI, 1.1-3.0), but not major amputation alone (HR, 2.1; 95% CI, 0.9-4.5). In open surgical bypass-first patients, heel wounds were solely associated with an increased risk of all-cause mortality (HR, 1.7; 95% CI, 1.1-2.8), whereas heel wounds in percutaneous transluminal angioplasty-first patients were associated with an increased risk of incomplete wound healing (HR, 2.2; 95% CI, 1.3-3.7), major amputation or mortality (HR, 2.3; 95% CI, 1.1-5.4), and all-cause mortality (HR, 2.8; 95% CI, 1.1-7.2). CONCLUSIONS: Heel wounds confer considerably higher short- and long-term morbidity and mortality compared with midfoot or forefoot wounds in patients undergoing any first-time lower extremity revascularization.

Validation of the Global Limb Anatomic Staging System in first-time lower extremity revascularization.

OBJECTIVE: The Global Limb Anatomic Staging System (GLASS) was developed as a new anatomic classification scheme to grade the severity of chronic limb threatening ischemia. We evaluated the ability of this anatomic grading system to determine major adverse limb events after lower extremity revascularization. METHODS: We performed a single-institutional retrospective review of 1060 consecutive patients who had undergone 1180 first-time open or endovascular revascularization procedures for chronic limb threatening ischemia from 2005 to 2014. Using the review of angiographic images, the limbs were classified as GLASS stage 1, 2, or 3. The primary composite outcome was reintervention, major amputation (below- or above-the-knee amputation), and/or restenosis (>3.5× step-up by duplex criteria) events (RAS). The secondary outcomes included all-cause mortality, failure to cross the lesion by endovascular methods, and a comparison between bypass vs endovascular intervention. Kaplan-Meier estimates were used to determine the event rates at 1 and 5 years, and Cox regression analysis was used to adjust for baseline differences among the GLASS stages. RESULTS: Of all patients undergoing first-time revascularization, imaging studies were available for 1180 procedures (91%) for GLASS grading. Of these procedures, 552 were open bypass (47%) and 628 were endovascular intervention (53%). Compared with GLASS stage 1 disease (n = 267, 23%), stage 2 (n = 367; 31%) and stage 3 (n = 546; 42%) disease were associated with a greater risk of RAS at 1 year (stage 1, 33% vs stage 2, 48% vs stage 3, 53%) and 5 years (stage 1, 45% [reference]; stage 2, 65%; hazard ratio [HR], 1.7; 95% confidence interval [CI], 1.3-2.2; P < .001; stage 3, 69%; HR, 2.3; 95% CI, 1.7-2.9; P < .001). These differences were mainly driven by reintervention and restenosis rather than by major amputation. The 5-year mortality was similar for stage 2 and 3 compared with stage 1 disease (stage 1, 40% [reference]; stage 2, 45%; HR, 1.1; 95% CI, 0.8-1.4; P = .69; stage 3, 49%; HR, 1.2; 95% CI, 1.0-1.6; P = .11). For all attempted endovascular interventions, failure to cross a target lesion increased with advancing GLASS stage (stage 1, 4.5% vs stage 2, 6.3% vs stage 3, 13.3%; P < .01). Compared with open bypass (n = 552; 46.8%), endovascular intervention (n = 628; 53.3%) was associated with a higher rate of 5-year RAS for GLASS stage 1 (49% vs 34%; HR, 1.9; 95% CI, [1.1-3.5; P = .03), stage 2 (69% vs 52%; HR, 1.7; 95% CI, 1.2-2.5; P < .01), and stage 3 (83% vs 61%; HR, 1.5; 95% CI, 1.2-2.0; P < .01) disease. CONCLUSIONS: For patients undergoing first-time lower extremity revascularization, the GLASS can be used to predict for reintervention and restenosis. Bypass resulted in better long-term outcomes compared with endovascular intervention for all GLASS stages.

Surgical treatment patterns and clinical outcomes of patients treated for expanding aneurysm sacs with type II endoleaks after endovascular aneurysm repair.

OBJECTIVE: Persistent type II endoleaks (T2ELs) after endovascular aneurysm repair (EVAR) with sac growth have been associated with adverse events, including rupture. Whereas intervention in the presence of aneurysm growth has become an accepted treatment paradigm for T2ELs, the efficacy and clinical success of such interventions remain unclear. Therefore, we examined the treatment patterns and clinical outcomes of patients undergoing T2EL interventions after EVAR. METHODS: We performed a retrospective review of all patients treated for expanding aneurysm sacs with T2ELs after EVAR at an academic medical center between 2006 and 2017. The primary outcomes assessed were need for repeated intervention; intervention types; and achievement of clinical success, defined as stable aneurysm sac size on computed tomography angiography after treatment. RESULTS: Fifty-six patients underwent 119 interventions, of which 107 (90%) were technically successful. The median time from EVAR to index T2EL procedure was 37 months (interquartile range, 17-56 months), and the median follow-up time from first T2EL procedure was 27 months (interquartile range, 10-51 months). The most common index procedure was transarterial lumbar embolization (64%), followed by transarterial inferior mesenteric artery (20%), transcaval (14%), and translumbar embolization (1.8%). Thirty-three (59%) patients required further procedures for persistent aneurysm sac expansion. For subsequent T2EL interventions, the most common endovascular procedure was transarterial lumbar embolization (21%), followed by transcaval (21%), translumbar (11%), and transarterial inferior mesenteric artery embolization (8.6%). Twelve patients (21%) were found to have loss of proximal or distal seal on subsequent imaging and required graft extensions to stabilize aneurysm sac size. Ten patients (18%) ultimately underwent graft explantation or sacotomy with oversewing of the endoleak source. Freedom from any endoleak-related reintervention was 57% at 1 year and 36% at 3 years. Freedom from open treatment was 93% at 1 year and 82% at 3 years. Of the 44 patients with ≥6-month follow-up, 39 (89%) achieved clinical success. However, only 11 patients (25%) achieved clinical success without any further reintervention, and 29 patients (66%) achieved clinical success without open treatment. CONCLUSIONS: Despite high technical success, endoleak recurrence after T2EL treatment is common, and multiple interventions are often needed to stabilize aneurysm sac size in patients diagnosed with T2EL-associated sac growth. Notably, one in five patients treated for T2ELs was discovered, on further evaluation, to have proximal or distal seal zone loss that necessitated repair to achieve sac stability. Thus, thorough assessment of all endoleak types should be performed in patients with T2ELs associated with sac growth before T2EL treatment to ensure appropriate care and to minimize ineffective interventions.

The role of transfemoral carotid artery stenting with proximal balloon occlusion embolic protection in the contemporary endovascular management of carotid artery stenosis.

OBJECTIVE: Recent data have shown that transcarotid artery revascularization (TCAR) with flow reversal provides a superior method of embolic protection compared with transfemoral carotid artery stenting (tfCAS) with distal embolic protection. Flow reversal or flow arrest systems with proximal endovascular balloon occlusion can also be used through the transfemoral approach; however, their outcomes compared with TCAR with flow reversal and tfCAS with distal embolic protection are poorly described. METHODS: We performed a retrospective review of all patients undergoing tfCAS with proximal balloon occlusion, tfCAS with distal embolic protection, and TCAR with flow reversal in the Society for Vascular Surgery Vascular Quality Initiative from March 2005 to May 2019. We assessed in-hospital outcomes in propensity score-matched cohorts of patients using tfCAS with proximal balloon occlusion as the comparison cohort. The primary outcome was stroke or death. Secondary end points included the individual outcomes of stroke, death, transient ischemic attack (TIA), and myocardial infarction. RESULTS: Of the 24,232 patients undergoing carotid artery stenting, 561 (2.3%) procedures were performed through tfCAS with proximal balloon occlusion, 18,126 (74%) through tfCAS with distal embolic protection, and 5545 (22.9%) through TCAR with flow reversal. After matching, 463 pairs of patients undergoing tfCAS with proximal balloon occlusion and tfCAS with distal embolic protection were identified. There were no differences in stroke or death (proximal balloon, 3.2%; distal embolic protection, 3.7%; relative risk [RR], 0.88; 95% confidence interval [CI], 0.45-1.73; P = .73), stroke (2.4% vs 2.6%; RR, 0.92; 95% CI, 0.42-2.00; P = .83), death (1.1% vs 1.5%; RR, 0.71; 95% CI, 0.41-3.15; P = .80), TIA (1.7% vs 1.5%; RR, 1.14; 95% CI, 0.41-3.15; P = .80), or myocardial infarction (0.4% vs 0.6%; RR, 0.67; 95% CI, 0.11-3.99; P = .65). However, after matching 357 pairs of patients undergoing tfCAS with proximal balloon occlusion and TCAR with flow reversal, tfCAS with proximal balloon occlusion was associated with higher rates of stroke or death (3.1% vs 0.8%; RR, 3.67; 95% CI, 1.02-13.14; P = .03) and a trend toward higher rates of stroke (2.5% vs 0.8%; RR, 3.00; 95% CI, 0.81-11.08; P = .08) and death (0.8% vs 0.0%; P = .08), but no statistically significant differences in TIA (0.8% vs 0.8%; P > .99) or myocardial infarction (0.6% vs 0.3%; RR, 2.00; 95% CI, 0.18-22.06; P = .56). CONCLUSIONS: Compared with tfCAS with distal embolic protection, tfCAS with proximal balloon occlusion has similar major outcomes. However, tfCAS with proximal balloon occlusion does not offer the same degree of embolic protection compared with TCAR with flow reversal, given the significantly higher risk of perioperative stroke or death.

Contemporary outcomes after carotid endarterectomy in high-risk anatomic and physiologic patients.

OBJECTIVE: Current guidelines state that the acceptable 30-day postoperative stroke/death rate after carotid endarterectomy (CEA) is <3% for asymptomatic patients and <6% for symptomatic patients. The Centers for Medicare and Medicaid Services has identified certain high-risk characteristics used to define patients at highest risk for CEA for whom carotid artery stenting would be reimbursed. We evaluated the impact of the Centers for Medicare and Medicaid Services physiologic and anatomic high-risk criteria on major adverse event rates after CEA in asymptomatic and symptomatic patients. METHODS: We retrospectively reviewed all patients undergoing CEA from 2011 to 2017 in the American College of Surgeons National Surgical Quality Improvement Program vascular targeted database. Patients with high-risk anatomic or physiologic characteristics were identified by a predefined variable and were compared with normal-risk patients. The primary outcome was 30-day stroke/death, stratified by symptom status. RESULTS: We identified 25,788 patients undergoing CEA, of whom 60% were treated for asymptomatic carotid disease. Among all patients, high-risk physiology or anatomy was associated with higher rates of 30-day stroke/death compared with normal-risk patients (physiologic risk, 4.6% vs 2.3% [P < .001]; anatomic risk, 3.6% vs 2.3% [P < .001]). Patients who met criteria for high-risk physiology or anatomy also had higher rates of cardiac events (physiologic risk, 3.1% vs 1.6% [P < .001]; anatomic risk, 2.3% vs 1.6% [P < .01]), but only patients with high-risk anatomy had higher rates of cranial nerve injury (physiologic risk, 2.4% vs 2.5% [P = .81]; anatomic risk, 4.3% vs 2.5% [P < .001]). Asymptomatic patients with high-risk physiology or anatomy had higher rates of 30-day stroke/death, especially in the physiologic high-risk group (physiologic risk, 4.7% vs 1.5% [P < .001]; anatomic risk, 2.6% vs 1.5% [P < .01]), compared with normal-risk patients. However, among symptomatic patients, differences in stroke/death were seen only with high-risk anatomic patients and not with high-risk physiologic patients (physiologic risk, 4.6% vs 3.4% [P = .12]; anatomic risk, 4.8% vs 3.4% [P = .01]). CONCLUSIONS: As currently selected, contemporary real-world outcomes after CEA in asymptomatic carotid disease patients meeting high-risk physiologic criteria show an unacceptably high 30-day stroke/death rate, well above the 3% threshold. These results suggest the need for better selection of patients and preoperative optimization before elective CEA.

Thirty-Day Outcomes After Open Revascularization for Acute Mesenteric Ischemia From the American College of Surgeons National Surgical Quality Improvement Program.

BACKGROUND: Open revascularization for acute mesenteric ischemia (AMI) is associated with high perioperative morbidity and mortality; however, results from contemporary studies are varied. Therefore, we evaluated 30-day mortality after open revascularization for AMI and identified preoperative factors associated with mortality. METHODS: We performed a retrospective cohort study of patients in the American College of Surgeons National Surgical Quality Improvement Program database undergoing open mesenteric revascularization for AMI from 2005 to 2017. The primary outcome was 30-day mortality. We used multivariable logistic regression to identify preoperative factors independently associated with 30-day mortality. RESULTS: The study cohort included 918 patients; their median age was 70 years (interquartile range: 59-80 years), 62% were female, and 90% were white. Thirty-day mortality after open revascularization for AMI was 32%, specifically 35% after embolectomy, 31% after thromboendarterectomy, and 28% after mesenteric bypass. Mortality was higher in patients requiring concomitant bowel resection (38% vs. 29%, respectively, P < 0.01). The preoperative factor most strongly associated with 30-day mortality was disseminated cancer (odds ratio = 8.8, 95% confidence interval = 2.4-32, P = 0.001). Other factors independently associated with mortality were renal dysfunction, preoperative intubation, preoperative blood transfusion, diabetes, elevated preoperative international normalized ratio, elevated preoperative white blood cell count, and increasing age. CONCLUSIONS: In this retrospective cohort study using a real-world, nationwide cohort, open revascularization for AMI was associated with high mortality, with nearly one-third of patients dying within 30 days of their operation. The factors identified to be independently associated with 30-day mortality, particularly disseminated cancer, preoperative renal dysfunction, and elevated preoperative WBC count, are an important tool for preoperative risk stratification.

Intraoperative Unfractionated Heparin Unresponsiveness during Endovascular Repair of a Ruptured Abdominal Aortic Aneurysm following Administration of Andexanet Alfa for the Reversal of Rivaroxaban.

The authors describe a case of unfractionated heparin (UFH) unresponsiveness in the operating room secondary to reversal of rivaroxaban with coagulation factor Xa (recombinant) inactivated-zhzo (andexanet alfa). A 70-year-old man with a known 4.5- to 5.0-cm abdominal aortic aneurysm and atrial fibrillation managed with rivaroxaban presented with severe right-sided flank pain radiating to the left side of his abdomen. Computed tomography-angiography on arrival demonstrated a left retroperitoneal hematoma and a suspected ruptured abdominal aortic aneurysm. He received andexanet alfa to reverse rivaroxaban prior to an emergent endovascular aneurysm repair. During surgery, he received a total of 14,000 units (167 units/kg) of UFH with minimal changes in activated clotting time (132-144 sec; baseline 135 sec [reference range 74-137 sec]). This case highlights the potential complications of using UFH anticoagulation following reversal of factor Xa inhibitors with andexanet alfa and underscores the importance of peri-procedural anticoagulation planning. For patients who require intra-operative anticoagulation, providers should consider anticoagulation reversal with prothrombin complex concentrate instead of andexanet alfa or administration of a parenteral direct thrombin inhibitor, such as argatroban or bivalirudin during the surgical procedure.

Anatomic eligibility for transcarotid artery revascularization and transfemoral carotid artery stenting.

OBJECTIVE: Transcarotid artery revascularization (TCAR) has emerged as an alternative to transfemoral carotid artery stenting (tfCAS). We investigated the proportion of carotid arteries undergoing revascularization procedures that would be eligible for TCAR based on anatomic criteria and how many arteries at high anatomic risk for tfCAS would be amenable to TCAR. METHODS: We performed a retrospective review of consecutive patients who underwent carotid endarterectomy or carotid stenting between 2012 and 2015. Patients were excluded if computed tomography angiography of the neck was not performed within 6 months of the procedure. We assessed TCAR eligibility on the basis of the instructions for use of the ENROUTE Transcarotid Neuroprotection System (Silk Road Medical, Sunnyvale, Calif) and high anatomic risk for tfCAS on the basis of anatomic factors known to make carotid cannulation more difficult or hazardous. RESULTS: Of the 118 patients and 236 carotid arteries identified, 12 carotid arteries were excluded for presence of an occluded internal carotid artery (ICA). Of the remaining 224 carotid arteries, 72% were eligible for TCAR on the basis of the instructions for use criteria; 100% had 4- to 9-mm ICA diameters, 100% had ≥6-mm common carotid artery (CCA) diameter, 75% had ≥5-cm clavicle to carotid bifurcation distance, and 96% lacked significant CCA puncture site plaque. In addition, 7% of carotid arteries had bifurcation anatomy unfavorable for stenting; thus, of the entire cohort of arteries examined, 68% were eligible for TCAR. Hyperlipidemia (odds ratio [OR], 6.7; 95% confidence interval [CI], 1.7-26; P < .01), chronic obstructive pulmonary disease (OR, 3.5; 95% CI, 1.5-8.3; P < .01), and older age (OR, 1.1; 95% CI, 1.0-1.1; P < .01) were independently associated with TCAR ineligibility, whereas white race (OR, 0.2; 95% CI, 0.0-1.0; P = .048) and beta-blocker use (OR, 0.3; 95% CI, 0.1-0.7; P < .01) were independently associated with TCAR eligibility. In addition, 24% of carotid arteries were considered to be at high risk for tfCAS for the presence of a type III aortic arch (7.6%), severe aortic calcification (3.3%), tandem CCA lesions (7.1%), moderate to severe stenosis at the carotid ostium (8.9%), and tortuous distal ICA precluding embolic filter placement (4.5%). Active smoking (OR, 4.4; 95% CI, 1.9-10; P < .01), hyperlipidemia (OR, 4.0; 95% CI, 1.2-14; P = .03), and older age (OR, 1.1; 95% CI, 1.0-1.1; P = .02) were independently associated with tfCAS ineligibility, whereas preoperative aspirin (OR, 0.1; 95% CI, 0.0-0.4; P < .001) or clopidogrel (OR, 0.3; 95% CI, 0.1-0.8; P = .01) use was associated with tfCAS eligibility. Of the arteries that were considered to be at high risk for tfCAS, 69% were eligible for TCAR. CONCLUSIONS: The majority of carotid arteries in individuals selected for revascularization meet TCAR eligibility, making TCAR a viable treatment option for many patients.

Preoperative risk score for access site failure in ultrasound-guided percutaneous aortic procedures.

OBJECTIVE: The factors associated with access site failure after ultrasound-guided percutaneous access for aortic endograft procedures remain poorly characterized. We developed a prediction model to risk stratify patients for access site failure. METHODS: We performed a retrospective institutional review of consecutive patients who underwent endovascular aneurysm repair (EVAR), fenestrated EVAR (FEVAR), or thoracic endovascular aortic repair (TEVAR) from 2014 to 2016. We excluded patients undergoing direct aortic access through sternotomy and patients treated with physician-modified endografts, given reporting restrictions. Our primary outcome was groin access site failure, which included bleeding and thrombosis. An 8-point risk model was created for access site failure using multivariable fractional polynomials and internally validated using bootstrapping. RESULTS: We identified 469 femoral arteries from 247 patients undergoing endovascular aortic repair procedures (EVAR, 75%; FEVAR, 8.0%; TEVAR, 17%). Surgeons performed percutaneous access in 97.2% of the femoral arteries, with 99.6% ultrasound use. Twenty-seven (5.9%) access site failures occurred (17 bleeding, 10 thrombosis), all treated with groin cutdown, for a successful percutaneous femoral artery access rate of 94%. Of the 215 patients with attempted bilateral percutaneous access, 90% had successful bilateral access. However, FEVAR had lower rates of successful bilateral access (FEVAR, 78%; EVAR, 91%; TEVAR, 94%; P = .03). Factors independently associated with percutaneous access site failure were femoral artery outer wall diameter (per millimeter increase: odds ratio [OR], 0.003 [0.0002-0.1]; P < .001), femoral artery stenosis >50% (OR, 22.3 [2.7-183.2]; P < .01), and urgent/emergent intervention (OR, 3.6 [1.2-11.0]; P = .03). A risk prediction model based on these criteria produced a C statistic of 0.89, a Hosmer-Lemeshow goodness of fit of 0.99, and a Brier score of 0.04. Excluding treatment for ruptured aneurysms, cutdown for access failure and planned initial groin cutdown resulted in longer postoperative lengths of stay and higher rates of access-related readmission, return to operating room, groin infection, and myocardial infarction compared with successful percutaneous access. There was no difference in major adverse events between planned initial groin cutdown and cutdown after failure; however, the small number of patients in these two comparison groups limits the statistical power to detect a difference. CONCLUSIONS: Percutaneous ultrasound-guided access can be safely performed in almost all patients undergoing endovascular aortic procedures, but access site failures do occur. This risk score can help users select patients with high likelihood of success, identify patients who need close scrutiny with postclosure femoral duplex ultrasound, and provide patient guidance about risk of unplanned groin cutdown.

A Novel Quality of Life Instrument for Patients with an Abdominal Aortic Aneurysm.

OBJECTIVE: The surveillance and treatment of abdominal aortic aneurysms (AAAs) may impact patient quality of life (QOL). A novel AAA specific QOL instrument was developed and validated to quantify the impact of AAA surveillance on QOL. METHODS: The study was performed in two phases: development (2011-2013) and validation (2013-2014) of a survey instrument. Content was informed by focus groups at three centres (22 patients) and two multidisciplinary physician focus groups (6 vascular surgeons, 7 primary care providers). Cognitive interviews (17 patients) ensured questions were understood as intended. The final survey was mailed to AAA patients at six US institutions. Patients were scored on two AAA specific domains of QOL: emotional impact (EIS) and behavioural change (BCS), range 0-100 with higher scores indicating worse quality of life. Test retest reliability and internal consistency were assessed. Discriminant validity was determined by comparing scores between patients under surveillance vs. those who had undergone AAA repair. Scores were externally validated by correlation with the Short Form (SF)-12. RESULTS: A total of 1,008 (73%) of 1,373 patients returned surveys: 351 (35%) were under surveillance, 657 (65%) had undergone repair (endovascular, 414; open, 179; unsure, 64). Median EIS was 11 (range 0-95; IQR 7-26). Median BCS was 13 (range 0-100; IQR 9-47). To test reliability, 337 patients repeated the survey after four weeks with no significant differences between scores over time. EIS and BCS demonstrated good internal consistency (Cronbach's Alpha 0.85 and 0.75 respectively). There was strong correlation between scores (r = 0.53) and both related moderately to SF-12 scores (r = 0.45 and r = 0.39, respectively). Patients under AAA surveillance had worse EIS than repair patients (22 vs. 13; p < .001). Patients with a higher perceived rupture risk had a worse EIS (45 vs. 12; p < .001) and BCS (30 vs. 13; p < .001). CONCLUSIONS: An AAA specific QOL instrument was successfully created and validated. The range of impact on QOL by AAA surveillance is broad. For most patients the impact is minimal, but for some, especially those with a greater perceived rupture risk, it is severe.