Outcomes of Transcarotid Artery Revascularization Stratified by Institutional Designation: Academic Versus Community Hospitals.

BACKGROUND: The extent of practice setting's influence on transcarotid artery revascularization (TCAR) outcomes is not yet established. This study seeks to assess and compare TCAR outcomes in academic and community-based healthcare settings. METHODS: Retrospective review of prospectively maintained, systemwide TCAR databases from 2 institutions was performed between 2015 and 2022. Patients were stratified based on the setting of surgical intervention (i.e., academic or community-based hospitals). Relevant demographics, medical conditions, anatomic characteristics, intraoperative and postoperative courses, and adverse events were captured for multivariate analysis. RESULTS: We identified 973 patients who underwent TCAR, 570 (58.6%) were performed at academic and 403 (41.4%) at community-based hospitals. An academic facility was defined as a designated teaching hospital with 24/7 service-line coverage by a trainee-led surgical team. Baseline comorbidity between cohorts were similar but cases performed at academic institutions were associated with increased complexity, defined by high cervical stenosis (P < 0.001), prior dissection (P < 0.01), and prior neck radiation (P < 0.001). Intraoperatively, academic hospitals were associated with longer operative time (67 min vs. 58 min, P < 0.001), higher blood loss (55 mLs vs. 37 mLs, P < 0.001), and longer flow reversal time (9.5 min vs. 8.4 min, P < 0.05). Technical success rate was not statistically different. In the 30-day perioperative period, we observed no significant difference with respect to reintervention (1.5% vs. 1.5%, P ≥ 0.9) or ipsilateral stroke (2.7% vs. 2.0%, P = 0.51). Additionally, no difference in postoperative myocardial infarction (academic 0.7% vs. community 0.2%, P < 0.32), death (academic 1.9% vs. community 1.4%, P < 0.57), or length of stay (1 day vs. 1 day, P < 0.62) was seen between the cohorts. CONCLUSIONS: Cases performed at academic centers were characterized by more challenging anatomy, more frequent cardiovascular risk factors, and less efficient intraoperative variables, potentially attributable to case complexity and trainee involvement. However, there were no differences in perioperative outcomes and adverse events between the cohorts, suggesting TCAR can be safely performed regardless of practice setting.

Propensity-score-matched analysis of dual antiplatelet treatment and alternative antiplatelet regimens after transcarotid revascularizations.

OBJECTIVE: Dual antiplatelet therapy (DAPT) continues to be the preferred medication regimen after the placement of a carotid stent using the transcarotid revascularization (TCAR) technique despite a dearth of quality data. Therefore, this investigation was performed to define the risks associated with antiplatelet choice. METHODS: We queried all patients who underwent TCAR captured by the Vascular Quality Initiative from September 2016 to June 2022, to determine the association between antiplatelet choice and outcomes. Patients maintained on DAPT were compared with those receiving alternative regimens consisting of single antiplatelet, anticoagulation, or a combination of the two. A 1:1 propensity-score match was performed with respect to baseline comorbidities, functional status, anatomic/physiologic risk, medications, and intraoperative characteristics. In-hospital and 1-year outcomes were compared between the groups. RESULTS: During the study period, 29,802 procedures were included in our study population, with 24,651 (82.7%) receiving DAPT and 5151 (17.3%) receiving an alternative antiplatelet regimen. A propensity-score match with respect to 29 variables generated 4876 unique pairs. Compared with patients on DAPT, in-hospital ipsilateral stroke was significantly higher in patients receiving alternative antiplatelet regimens (1.7% vs 1.1%, odds ratio [95% confidence interval]: 1.54 [1.10-2.16], P = .01), whereas no statistically significant difference was noted with respect to mortality (0.6% vs 0.5%, 1.35 [0.72-2.54], P = .35). A composite of stroke/death was also more likely in patients receiving an alternative regimen (2.4% vs 1.7%, 1.47 [1.12-1.93], P = .01). Immediate stent thrombosis (2.75 [1.16-6.51]) and a nonsignificant trend toward increased return to the operating room were more common in the alternative patients. Conversely, the incidence of perioperative myocardial infarction was lower in the alternative regimen group (0.4% vs 0.7%, 0.53 [0.31-0.90], P = .02). At 1 year after the procedure, we observed an increased risk of mortality (hazard ratio [95% confidence interval]: 1.34 [1.11-1.63], P < .01) but not stroke (0.52 [0.27-0.99], P = .06) in patients treated with an alternative medication regimen. CONCLUSIONS: This propensity-score-matched analysis demonstrates an increased risk of in-hospital stroke and 1-year mortality after TCAR in patients treated with an alternative medication regimen instead of DAPT. Further studies are needed to elucidate the drivers of DAPT failure in patients undergoing TCAR to improve outcomes for carotid stenting patients.

Predictors of 30-Day Stroke and Death After Transcarotid Revascularization.

INTRODUCTION: Much of the previous robust analyses of the results associated with transcarotid revascularization (TCAR) derives from industry-sponsored trials or the Vascular Quality Initiative (VQI). This investigation was performed to identify preoperative predictors of 30-day stroke and death using institutional databases. METHODS: A retrospective analysis was performed of carotid revascularization databases created at two high-volume TCAR centers and maintained independently of the VQI carotid module between December 2015 and December 2021. The primary outcome of interest was a composite of perioperative (30-day) stroke and death. Univariate regression analyses, followed by multivariate regression analyses, were performed to identify potential predictors of adverse events. RESULTS: During the study period, 750 TCAR procedures were performed at our combined health systems, resulting in 24 (3.2%) individuals who experienced either stroke and/or death in the perioperative period. Of these, we observed nine (1.2%) mortality events and 18 (2.4%) strokes. On univariate analysis, candidate protectors of stroke/death were found to be coronary artery disease (odds ratio [OR], 0.43; 95% confidence interval [CI], 0.18-1.01; P = 0.05) and protamine reversal (0.51; 0.21-1.21; P = 0.15). Candidate predictors of the primary outcome were anticoagulant usage (3.03; 1.26-7.24; P = 0.01), postprocedural debris in the filter (2.30; 0.97-5.43; P = 0.06), symptomatic carotid lesion (2.03; 0.90-4.50), and cardiac arrhythmia (1.98; 0.80-4.03; P = 0.14). On multivariate analysis, two predictors remained, cardiac arrhythmia (4.21; 1.10-16.16; P = 0.04) and symptomatic carotid lesion (14.49; 1.80-116.94; P = 0.01). CONCLUSIONS: A symptomatic carotid lesion, and to a lesser extent cardiac arrhythmia, are strong predictors of 30-day stroke/death after TCAR. Surgeons should be cognizant of the increased risk of adverse events in the perioperative period in these patients.

Prediction of postprocedural filter debris after transcarotid revascularization.

OBJECTIVE: Transcarotid revascularization (TCAR) is a technique in which cerebral flow reversal is utilized as embolic protection during carotid stenting. The presence, or absence, of filter debris created during TCAR could potentially be a surrogate to characterize carotid lesions at high risk for embolization and, therefore, explored in this investigation. METHODS: A retrospective review of TCARs performed within the Indiana University and Memorial Hermann (McGovern Medical School at UTHealth) Health Systems to capture demographics and preoperative variables. A mixed effect multivariate logistic regression model was created to discern the best predictors of intraoperative filter debris. RESULTS: During the study period, from December 2015 to December 2021, we captured filter debris status in 693 of 750 patients containing 323 cases of filter embolization at case completion. With respect to demographics and indications, we found a higher incidence of neck radiation (2.7 vs. 7.1%, p = 0.01) and a more pronounced Charlson Comorbidity Index (CCI; 5.3 ± 0.3 vs 5.7 ± 0.3, p < 0.01) in the filter debris cohort while contralateral carotid occlusion (6.6 vs. 2.9%, p = 0.05) and clopidogrel usage (87.3 vs. 80.1%, p = 0.03) were less common. Longer intraoperative flow reversal (8.0 ± 1.2 vs 10.5 ± 1.2, p < 0.01) and fluoroscopy time (4.0 ± 0.6 vs 5.1 ± 0.6, p < 0.01) were also seen in those with filter debris. These findings remained when a mixed effect univariate logistic regression model was used to account for differences in filter debris reporting between locations. After multivariable modeling, we found that reverse flow time and CCI remained predictive of filter debris while the presence of a contralateral carotid occlusion was still protective. CONCLUSION: In our combined experience, the creation of visible filter debris after TCAR seems to be independently associated with extended reverse flow time and elevated CCI while a contralateral carotid occlusion was protective.

Transcarotid revascularization in obese patients.

OBJECTIVE: Transcarotid revascularization (TCAR) is a minimally invasive hybrid surgical carotid stenting technique which utilizes cerebral flow reversal as embolic protection during carotid lesion manipulation. This investigation was performed to define the perioperative risks associated with this operation in the obese patient. METHODS: A retrospective review of tandem carotid revascularization databases maintained at two high-volume health systems was performed to capture all TCARs performed between 2015 and 2022. A threshold of body mass index of 35 kg/m2 defined the "obese" patient. Demographics, intraoperative, perioperative, and follow-up characteristics were compared using univariate analysis. RESULTS: We performed 793 TCAR procedures that qualified for study inclusion within the prespecified time. After applying our obesity definition, 129 patients qualified as obese and were compared to the remainder. There were no significant differences in baseline demographics as comparable Charlson Comorbidity Indices were noted between groups; however, obese patients had a significantly higher prevalence of hypertension, hyperlipidemia, and diabetes. Intraoperative, case complexity in the obese patients did not seem to be increased, as measured by operative time (68.4 ± 23.0 vs 64.2 ± 25.8 min, p = 0.09), fluoroscopic time (4.9 ± 3.2 vs 4.6 ± 3.6 min, p = 0.38), and estimated blood loss (40.6 ± 49.0 vs 46.6 ± 49.4 min, p = 0.22). Similarly, no disparities were observed with respect to ipsilateral stroke (3.1 vs. 1.7%, p = 0.29), contralateral stroke (0 vs. 0.2%, p > 0.99), death (0 vs. 1.1%, p = 0.61), and stroke/death (3.1 vs. 3.0%, p > 0.99) in the 30-day perioperative period. Both cohorts were followed for approximately 1 year (12.0 ± 13.4 vs 11.6 ± 13.4 months, p = 0.76). During this period, rates of ipsilateral stroke (3.1% vs. 2.7%, p > 0.99), contralateral stroke (1.1 vs. 0.8%, p > 0.99), and death (4.7 vs. 6.2%, p = 0.68) were similar. CONCLUSIONS: TCAR performed in the obese population was not more challenging by intraoperative characteristics and did not result in a statistically higher incidence of adverse events in the perioperative phase.

Transcarotid artery revascularization is safe in necks with anatomy hostile for carotid endarterectomy.

OBJECTIVE: The outcomes associated with transcarotid revascularization (TCAR) have proved to be noninferior to the historical results established for carotid endarterectomy (CEA). Therefore, TCAR has been increasingly offered to patients with neck anatomy hostile for traditional CEA. The present investigation was completed to evaluate whether a difference exists for patients undergoing TCAR in de novo anatomy with unviolated surgical planes compared with those undergoing TCAR in necks with hostile anatomy. METHODS: The demographic data and outcomes were captured at two high-volume TCAR institutions from December 2015 to December 2021 via a query of two parallel, prospectively maintained, carotid intervention databases at these two health institutions. A hostile neck anatomy was defined as a history of previous ipsilateral neck radiation, oncologic dissection, or CEA. Univariate analysis was performed to compare the two cohorts at an α of 0.05. RESULTS: During the inclusion period, the data from 750 TCARs were captured, including 108 procedures in hostile neck anatomy and 642 in de novo necks. No significant differences were found in the baseline comorbidity burden using the Charlson comorbidity index or the indication for revascularization. Intraoperatively, no significant increase in case complexity was observed with respect to those with a hostile neck, except for the operative time, which was 10% longer (69.5 vs 63.4 minutes; P = .01). The flow reversal and fluoroscopic times, blood loss, radiation exposure, and contrast use were identical. Postoperatively, no differences were observed between the hostile and de novo necks with respect to stroke (0.9% vs 2.5%; P = .49), myocardial infarction (0.9% vs 0.2%; P = .27), and death (0% vs 1.5%; P = .37). Additionally, hematoma formation and the need for reintervention did not seem to vary between the two groups. Similarly, no differences in the two cohorts were noted during follow-up. CONCLUSIONS: According to the findings from our large, dual-institutional series, the performance of TCAR in surgical fields traditionally hostile for CEA was not associated with increased intraoperative complexity or postoperative morbidity.

Results associated with the health system-wide adoption of transcarotid revascularization.

BACKGROUND: In the present report, we have detailed the results derived from the adoption of transcarotid artery revascularization (TCAR) at a large health system based in the United States. METHODS: A retrospective review was performed of a prospectively maintained database capturing all carotid stents deployed using the ENROUTE neuroprotection device (Silk Road Medical, Sunnyvale, CA) and cerebral flow reversal. The demographics, intraoperative findings, and postoperative results were tabulated and reported. RESULTS: From September 2017 to December 2021, 429 TCAR procedures were attempted within the Memorial Hermann Health System. Preoperatively, all the patients were either asymptomatic with >70% stenosis (66.9%) or symptomatic with >50% stenosis (33.1%). The degree of stenosis was determined using computed tomography angiography and/or duplex ultrasound. We achieved a technical success rate of 99.1%, with the failures attributed to an inability to cross the lesion, an inability to track the stent, visualization of a flow-limiting dissection, and stent maldeployment for one patient each. During the 30-day perioperative period, nine strokes (2.3%) had occurred, three of which had occurred after discharge from the index operation and before the end of the 30-day period. No patient had experienced myocardial infarction. Five patients had died in the perioperative period. Three of the deaths were related to stroke, and two were attributed to cardiopulmonary events secondary to aspiration and likely pulmonary embolus. The mean follow-up after TCAR was 14.5 ± 12.0 months. During the follow-up period, two patients had required reintervention for in-stent stenosis. Ipsilateral to the implanted carotid stent, the overall (including perioperative) stroke incidence was 2.5%. Contralateral to the stent, the stroke incidence was 0.8%. The myocardial infarction rate was 0.8% during follow-up. Mortality in our study population was 5.1% during the follow-up period. CONCLUSIONS: After adoption of TCAR across the Memorial Hermann Health System, we found this procedure to be safe and efficacious with minimal perioperative risks comparable to the historically reported results associated with alternative carotid interventions.

Institutional Experiences with Transfemoral Compared to Transcarotid Stenting.

BACKGROUND: Transcarotid artery revascularization (TCAR) is a new surgical technique that is gaining popularity over the transfemoral method (TF-CAS) as the preferred strategy to deliver a carotid stent. This investigation was performed to evaluate the real-world perioperative and long-term outcomes of both techniques at the health system level. METHODS: A retrospective review of prospectively maintained carotid revascularization databases were performed at 2 high-volume TCAR centers in the United States to extract consecutive TF-CAS and TCAR procedures. The characteristics and outcomes associated with these 2 modalities were compared at the preoperative and perioperative points by univariate methods. The Kaplan-Meier methodology was utilized to calculate the long-term stroke and death trends. RESULTS: From 2008-2021, 1,058 carotid stents were implanted at our institutions, consisting of 750 TCARs and 308 TF-CAS procedures. Patients undergoing TF-CAS were older (68.2 ± 0.6 vs. 73.1 ± 0.3 years, P < 0.01) and unhealthier by Charlson Comorbidity Index (4.9 ± 0.1 vs. 5.5 ± 0.1, P < 0.01). Additionally, TF-CAS patients had more high-risk anatomic characteristics, such as restenosis after previous carotid surgery (27.0% vs. 9.5%, P < 0.01), previous ipsilateral neck surgery (38.8% vs. 11.5%, P < 0.01), irradiated ipsilateral field (20.4% vs. 4.5%, P < 0.01), and a contralateral carotid occlusion (10.4% vs. 4.6%, P < 0.01). The incidence of symptomatic lesions was the same (40.1% vs. 36.9%, P = 0.35). Within the operating room, TCAR outperformed TF-CAS with respect to operative time (83.2 ± 2.6 vs. 64.3 ± 0.9 min, P < 0.01), radiation exposure (769.9 ± 144.3 vs. 232.7 ± 19.1 mGys, P < 0.01), fluoroscopic time (17.8 ± 1.1 vs. 4.5 ± 0.1 min, P < 0.01), and contrast volume (75.2 ± 2.4 vs. 22.6 ± 0.4 mLs, P < 0.01). In the 30-day perioperative period, ipsilateral stroke (2.8% vs. 2.3%, P = 0.65), contralateral stroke (1.0% vs. 0.1%, P = 0.07), and death (1.0% vs. 1.2%, P > 0.99) were similar between modalities. None of these endpoints, including a composite of stroke and death (4.8% vs. 3.6%, P = 0.38), reached statistical significance. Additionally, we found no differences with respect to stroke-free survival between modalities during follow-up by Kaplan-Meier analysis (P = 0.30). CONCLUSIONS: In this combined experience from 2 large health systems, TCAR was associated with less intraoperative complexity, as measured by operative time, radiation exposure, and contrast volume. Although stroke and death seemed to be less frequent in patients undergoing transcervical stenting, this did not reach statistical significance.

Transcarotid Revascularization Associated Extended Reverse Flow Duration is Not a Harbinger of Poor Perioperative Outcomes.

BACKGROUND: Transcarotid revascularization (TCAR) is a carotid stenting technique in which an external shunt between the common carotid artery and femoral vein is created to induce cerebral flow reversal as protection against procedure-related plaque embolism. We completed this analysis to determine if prolonged cerebral flow reversal was associated with adverse perioperative outcomes. METHODS: A retrospective review of a combined carotid revascularization database separately maintained at 2 high-volume TCAR health systems was completed. Procedures with captured intraoperative reverse flow duration was included, stratified into two cohorts at a cut-off of 8 mi, and examined with univariate analysis. RESULTS: Within the predesignated study period, 800 patients received a carotid stent via the TCAR technique at Indiana University Health (n = 350) and Memorial Hermann Health Systems (n = 450). In 132 of these procedures, the duration of reverse flow time was not captured and, therefore, excluded from further analysis. Using our prespecified cutoff for extended reverse flow duration (ERFD), we generated 256 cases, leaving an additional 412 procedures completed with a short reverse flow duration. Baseline comorbidities were comparable with respect to individual diagnoses but the overall disease burden in ERFD patients was slightly higher by Charlson Comorbidity Index (5.3 ± 0.1 vs. 5.7 ± 0.1, P = 0.02). With respect to indications and high anatomic risk criteria, both groups were similar, with exception of the presence of a surgically inaccessible carotid bifurcation, which was more frequent in the ERFD procedures (5.3% vs. 10.2%, P = 0.02). Intraoperatively, more blood loss (40.9 ± 2.2 vs. 48.9 ± 2.9 mLs, P = 0.03), operative time (55.2 ± 0.8 vs. 76.3 ± 1.6 min, P < 0.01), radiation (126.3 ± 17.5 vs. 281.9 ± 28.5 mGys, P < 0.01), contrast volume (19.9 ± 0.4 vs. 26.9 ± 0.9 mLs, P < 0.01), and fluoroscopy time (3.3 ± 0.8 vs. 6.3 ± 0.3 min, P < 0.01) were noted in the patients with extended flow reversal. However, this did not increase the risk of stroke (2.7% vs. 2.0%, P = 0.61), myocardial infarction (0.5% vs. 0%, P = 0.53), or death (1.2% vs. 0.4%, P = 0.41) in the 30-day perioperative period. CONCLUSIONS: Extended cerebral flow reversal, defined here as greater than 8 min, was not associated with increased risk of stroke, myocardial infarction, or death in this institutionally derived series.

Fixed compared to mobile imaging arms for transcarotid artery revascularization.

OBJECTIVE: Transcarotid artery revascularization (TCAR) is a new surgical option for carotid artery stenosis. While this procedure is optimally performed in hybrid operating rooms (OR), it is currently unclear whether it could be safely performed using portable, C-arm fluoroscopy with equivalent results. The aim of this study is to determine whether there are differences in intraoperative and perioperative outcomes stratified by imaging modality. METHODS: A retrospective review of all TCAR procedures attempted within our health system was performed, capturing all cases between September 2017 and May 2022. Procedures were divided into 2 cohorts, based on whether they were performed in a hybrid OR or with portable, C-arm in a standard OR. Patient demographics, intraoperative results, and postoperative outcomes were compared using univariate strategies. RESULTS: A total of 503 patients were included for review, of which 422 were performed in a hybrid OR (84%) and 81 were performed using a portable C-arm (16%). Intraoperatively, an increased estimated blood loss (47.7 ± 54.7 vs 26.1 ± 26.9 mLs, p < 0.01) and operative time was found in the cases performed in a hybrid OR. However, the fluoroscopy time was lower (4.0 ± 2.6 vs 5.2 ± 5.8 min, p = 0.01) in the setting of advanced intraoperative imaging. Postoperatively, we found no differences with respect to myocardial infarction (0.2% vs. 0%, p > 0.99), stroke (2.4% vs. 2.5%, p = 0.96), or death (0.7% vs. 2.5%, p = 0.15) between groups. CONCLUSIONS: While there are some intraoperative variabilities between TCAR performed in hybrid versus standard ORs, postoperative outcomes are comparable. Therefore, the lack of a hybrid room should not be a deterrent to the adoption of TCAR.

Adverse events are not increased with trainee participation in transcarotid revascularization.

OBJECTIVE: To determine whether a vascular surgery trainee's participation in transcarotid revascularization (TCAR), a new technology, affects patient safety and outcomes. DESIGN: Retrospective, institutional review of our carotid database was performed. Patients who underwent TCAR were stratified based on whether a vascular trainee was present during the procedure. Relevant demographics, comorbidities, anatomical indication, perioperative courses, and adverse events in the postoperative period were captured for statistical analysis. SETTING: Data were obtained from affiliated Memorial Hermann Hospitals in Houston, Texas. PARTICIPANTS: All patients who underwent TCAR from September 2017 to January 2022 were included. RESULTS: Of 486 patients who underwent TCAR, 173 (35.6%) were performed in the presence of a trainee, and 313 (64.4%) were performed without a trainee. Subjects in the trainee cohort had more challenging anatomy, defined as a higher rate of carotid bifurcation above C2, restenotic disease, previous ipsilateral neck dissection, and neck radiation. The trainee cohort had higher rates of estimated blood loss (61.1 ± 66 vs. 35.5 ± 39 mL, p < 0.01), longer operative time (64.8 ± 30.3 vs. 57.9 ± 20.4 min, p < .01), longer cerebral blood flow reversal time (8.9 ± 6.1 vs. 7.9 ± 6.6 min, p = .01), and higher contrast administration (25.7 ± 12.0 vs. 21.1 ± 9.4 mL, p < .01). The ability to achieve technical success was similar between the two cohorts. There was no difference in the rates of cranial nerve palsy, ipsilateral stroke, hematoma, and stent thrombosis. Hospital length of stay, death (0% vs. 1.6%, p = .10), and stroke (1.1% vs. 2.8%, p = .22) were also similar between the two cohorts. CONCLUSION: Vascular surgery trainee's involvement during TCAR did not increase adverse outcomes, such as stroke and death, in the perioperative period. The results presented herein should encourage other teaching institutions to provide surgical trainees with supervised, hands-on experience during TCAR.

Perioperative and 1-year transcarotid revascularization outcomes in symptomatic patients.

OBJECTIVE: Previously published results of carotid revascularization with both transfemoral stenting and endarterectomy have demonstrated inferior perioperative stroke and death outcomes in neurologically symptomatic patients compared with those without symptoms. This study was completed to establish the real-world, symptom-based perioperative and follow-up outcomes for transcarotid artery revascularization (TCAR). METHODS: An institutional retrospective review of all TCARs performed outside of clinical trial regulations from 2016 to 2019 was completed. Eligible patients were classified as symptomatic or not based on a history of a unilateral neurologic deficit attributable to an extracranial carotid artery lesion within the previous 180 days. Univariate analysis consisting of Fisher's exact and Student t-tests, as appropriate, were performed between cohorts. Kaplan-Meier analysis was completed to estimate the stroke-free survival at 1 year postoperatively. RESULTS: Within the investigational period, 167 patients (85 symptomatic) qualified for study inclusion. Baseline demographics were roughly equivalent, although symptomatic patients were more likely to be female (28.0% vs 9.4%; P < .01). Procedures in symptomatic patients were associated with higher estimated blood loss (41 mL vs 58 mL; P = .04) and operative time (67 minutes vs 75 minutes; P = .06). We did not find an increased incidence of macroscopic debris in the filter of symptomatic patients after stent deployment. For symptomatic patients, we observed a perioperative (30-day) ipsilateral stroke risk of 1.2% (vs 2.4% in asymptomatic patients; P > .99), a myocardial infarction risk of 0% (vs 0%; P > .99), and a mortality risk of 4.9% (vs 0%; P = .06). Most deaths occurred after procedure-related discharge; as such, in-hospital (from index TCAR) mortality in symptomatic patients was 1.2%. The four perioperative deaths observed in our population were secondary to hemorrhagic stroke, acute on chronic congestive heart failure (n = 2), and unknown causes in the last patient. At 1 year after the procedure, 114 patients (54 symptomatic) had available data. In addition to the perioperative risks, in symptomatic patients we observed a rate of reintervention of 0% (vs 0%; P > .99), ipsilateral stroke of 3.7% (vs 0%; P = .22), >50% in-stent restenosis of 1.9% (vs 0%; P = .47), stent thrombosis of 3.7% (vs 0%; P = .22), and all-cause mortality of 13.0% (vs 10.0%; P = .77). Last, no difference was noted with respect to the 1-year stroke-free survival (P = .17) by Kaplan-Meier estimates. CONCLUSIONS: In this institutional series of patients undergoing TCAR, we found that symptomatic patients have a similar perioperative risk of stroke and myocardial infarction as asymptomatic patients. However, we did observe a strong statistical trend suggesting a higher mortality risk in symptomatic patients. There was no difference between cohorts with respect to 1-year stroke-free survival.

Propensity-Matched Outcomes of Transcarotid Artery Revascularization Versus Carotid Endarterectomy.

BACKGROUND: Transcarotid artery revascularization (TCAR) with cerebral flow reversal is an emerging treatment option for carotid artery stenosis in patients with high risk for traditional endarterectomy. The purpose of this study was to compare real-world, procedure-related outcomes in similarly comorbid patients undergoing TCAR or carotid endarterectomy (CEA). METHODS: A retrospective review of all patients receiving either TCAR or CEA outside of clinical trial regulations at our institution was performed. Participants were propensity-matched by age, gender, body mass index, smoking status, presence of restenosis, history of neck radiation, presence of contralateral carotid occlusion, history of previous neck dissection, and symptom status. Bivariate analysis was followed by a penalized Firth logistic regression to compare treatments. RESULTS: Between January 2011 and July 2018, 342 CEAs and 109 TCARs were captured for analysis. After matching, 87 distinct treatment pairs were created without evidence of variation in any of the prespecified variables. On multivariate analysis using maximum and penalized likelihood ratios, we found that TCAR was associated with an increased incidence of intraoperative hypertension (adjusted coefficient, 1.41; 95% confidence interval [0.53, 2.29], P < 0.01). TCAR was also associated with decreased reverse flow/clamp time (mins; -36.80; [-45.47, -27.93], P < 0.01) and estimated blood loss (mLs; -63.66; [-85.91, -41.42], P < 0.01). In the perioperative period, there were no differences between TCAR and CEA with respect to myocardial infarction (-0.04; [-3.68, 3.60], P = 0.98), stroke (-0.74; [-2.68, 1.19], P = 0.45), and all-cause mortality (1.09; [-1.76, 3.94], P = 0.11). Similarly, a composite incidence of stroke/death was the same between cohorts (2.42; [-0.57, 5.41], P = 0.11). CONCLUSIONS: This propensity-matched analysis of carotid artery revascularization modalities suggests that TCAR is equivalent to CEA in the perioperative period while incurring shorter operative time and less blood loss.

Perioperative and Long-term Results of Zenith Fenestrated Aortic Repair in Women.

BACKGROUND: Inferior perioperative outcomes for women receiving major vascular surgery are well established in the literature in multiple arterial distributions. Therefore, this study was completed to determine the perioperative and durability results associated with women undergoing complex aortic reconstruction using the Zenith Fenestrated platform (ZFEN; Cook Medical, Bloomington, IN). METHODS: A retrospective review of a fenestrated endovascular aortic repair (FEVAR) database capturing all ZFENs performed at our institution between October 2012 and March 2019 was completed. Preoperative, intraoperative, perioperative, and follow-up outcomes were tabulated for females and compared with their male counterparts. RESULTS: Within our study period, 136 total ZFEN procedures were performed; of which, 20 devices (14.7%) were implanted in women. Intraoperatively, we observed a higher rate of estimated blood loss (660.0 mL vs. 311.6 mL, P < 0.01) and resultant need for transfusion (1.4 vs. 0.3 units, P < 0.01) in women despite a similar frequency of brachial (5.0% vs. 7.8%, P > 0.99) and femoral artery cutdowns (55.0% vs. 49.1%, P = 0.81). Operative (295.7 min vs. 215.7 mins, P < 0.01) and fluoroscopy (84.3 vs. 58.7 min, P < 0.01) times were also significantly higher in females than those in their male counterparts. In the perioperative (30-day) period, we observed significantly longer length of stay (5.6 days vs. 3.3 days, P = 0.03) and continued need for transfusion (50% vs. 9.5%, P < 0.01) in women. Statistical trends favoring men were also noted with respect to all-cause mortality, reintervention, visceral stent thrombosis, renal failure, acute kidney injury, and respiratory failure. After a mean follow-up of nearly 2 years, we found no differences in late all-cause or aneurysm-related mortality, major adverse cardiovascular events, or need for reinterventions. CONCLUSIONS: The implantation of ZFEN in females is significantly more difficult than that in their male counterparts and may result in increased perioperative, but not necessarily long-term, complications.

Long-term outcomes after pediatric peripheral revascularization secondary to trauma at an urban level I center.

OBJECTIVE: The purpose of this investigation was to determine our limb-related contemporary pediatric revascularization perioperative and follow-up outcomes after major blunt and penetrating trauma. METHODS: A retrospective review was performed of a prospectively maintained pediatric trauma database spanning January 2010 to December 2017 to capture all level I trauma activations that resulted in a peripheral arterial revascularization procedure. All preoperative, intraoperative, and postoperative continuous variables are reported as a mean ± standard deviation; categorical variables are reported as a percentage of the population of interest. RESULTS: During the study period, 1399 level I trauma activations occurred at a large-volume, urban children's hospital. The vascular surgery service was consulted in 2.6% (n = 36) of these cases for suspected vascular injury based on imaging or physical examination. Our study population included only patients who received an arterial revascularization, which was performed in 23 of the 36 consultations (1.6% of total traumas; median age, 11 years). These injuries were localized to the upper extremity in 60.9% (n = 14), lower extremity in 30.4% (n = 7), and neck in 8.7% (n = 2). The mean Injury Severity Score in the revascularized cohort was 14.0 (±7.6). Bone fractures were associated with 39.1% of the vascular injuries (90% of blunt injuries). Restoration of in-line flow was achieved by an endovascular solution in one patient and open surgery in the remainder, consisting of arterial bypass in 59.1% and direct repair in 40.9%. Within 30 days of the operation, we observed no deaths, no infections of the arterial reconstruction, and no major amputations. One patient required perioperative reintervention by the vascular team secondary to the development of a superficial seroma without evidence of graft involvement. Mean follow-up in our cohort was 43.3 (±35.4) months. During this phase, no additional deaths, amputations, chronic wounds, or limb length discrepancies were observed. All vascular repairs were patent, and all but one patient reported normal function of the affected limb at the latest clinic visit. CONCLUSIONS: Traumatic peripheral vascular injury is rare in the pediatric population but is often observed secondary to a penetrating force or after long bone fracture. However, contemporary perioperative and long-term outcomes after surgical revascularization are excellent as demonstrated in this institutional case series.

Outcomes associated with a transcarotid artery revascularization-centered protocol in high-risk carotid revascularizations using the ENROUTE neuroprotection system.

OBJECTIVE: This investigation describes the perioperative and early follow-up results associated with transcarotid artery revascularization (TCAR) in patients not participating in the Safety and Efficacy Study for Reverse Flow Used During Carotid Artery Stenting Procedure II (ROADSTER-2) registry using the ENROUTE neuroprotection system (ENPS; Silk Road Medical, Sunnyvale, Calif). METHODS: A retrospective review was performed capturing all TCAR/ENPS procedures in patients deemed to be at high risk for complications after traditional carotid endarterectomy. All patients enrolled in the ROADSTER-2 registry were excluded, leaving only those treated outside trial regulations for analysis. Preoperative demographics, intraoperative variables, and perioperative and follow-up outcomes were abstracted and reported herein. RESULTS: From December 2015 to January 2018, there were 75 carotid arteries treated at our institution. All interventions were performed on carotid arteries that were symptomatic with ≥50% stenosis (46.7%) or asymptomatic with ≥80% stenosis (53.3%) by duplex ultrasound and computed tomography angiography. Technical success in our series was 97.3% (73/75), with treatment failures attributed to one case of common carotid artery dissection and another secondary to stent maldeployment in the external carotid artery. Perioperative (30-day) ipsilateral stroke rate was 2.7% (n = 2), myocardial infarction incidence was 0%, and mortality rate was 2.7% (n = 2). We did not observe any cranial nerve injuries. After a mean follow-up of 8.0 ± 6.7 months, no carotid stents required reintervention. However, we noted one instance of minor (<50%) in-stent stenosis and one asymptomatic stent thrombosis. One additional ipsilateral stroke was observed on follow-up, probably from a cardiac source. CONCLUSIONS: We report that dynamic reverse-flow TCAR using the ENPS continues to be safe, feasible, and efficacious with minimal risks of postoperative stroke, myocardial infarction, and mortality outside of ROADSTER-2 regulations.

Fenestrated endovascular aneurysm repair-induced acute kidney injury does not result in chronic renal dysfunction.

OBJECTIVE: Acute kidney injury (AKI) is a common physiologic complication after fenestrated endovascular aneurysm repair (FEVAR). This investigation was initiated to determine the unknown impact of post-FEVAR AKI on long-term renal function after index hospital discharge. METHODS: A retrospective review was performed of an institutional FEVAR database capturing preoperative, intraoperative, and postoperative variables related to the implantation of consecutive Zenith Fenestrated endografts (ZFEN; Cook Medical, Bloomington, Ind) between October 2012 and April 2018. AKI in this study was bimodally defined as qualification by either Risk, Injury, Failure, Loss of kidney function, and End-stage (RIFLE) criteria or a postoperative serum creatinine (sCr) concentration increase of 0.5 mg/dL from baseline. Glomerular filtration rate (GFR) was calculated using the validated Modification of Diet in Renal Disease (MDRD) study equation. RESULTS: During the study period, 120 FEVARs were performed at our institution. Twenty-four (20%) patients exhibited postoperative AKI by our established definitions. Two in-hospital deaths occurred in the AKI cohort compared with none in the remaining FEVARs (P = .04). Four (16.7%) AKI patients required perioperative (<30-day) renal replacement therapy, three of whom were successfully weaned before discharge. FEVARs uncomplicated by AKI exhibited no differences in sCr concentration from baseline to 1-month, 6-month, 1-year, and 2-year follow-up (mean, 1.8 ± 1.4 years). In contrast, patients exhibiting AKI experienced an sCr concentration increase of 57.1% (P = .01) at 1 month after the procedure. This elevation decreased to 14.3% (P = .35) at 6 months after the procedure and was maintained at baseline values at 1- and 2-year office visits (follow-up, 1.3 ± 1.5 years). A similar pattern of gradual recovery during follow-up was also observed with respect to calculated GFR. CONCLUSIONS: AKI is common after FEVAR but rarely results in permanent renal dysfunction as both sCr concentration and GFR return to baseline by 6 months after the procedure.

Procedural Complexity of TransCarotid Artery Revascularization Is Not Increased in Irradiated and Reoperative Necks.

BACKGROUND: TransCarotid Revascularization (TCAR) with dynamic flow reversal using the ENROUTE Neuroprotection System (ENPS) is a Food and Drug Administration-approved alternative carotid revascularization modality. The purpose of this investigation was to determine whether TCAR in a hostile (fibrotic) surgical field increases procedural complexity and postoperative complications. METHODS: Perioperative variables for all institutional TCARs performed between December 2015 and April 2019 were prospectively captured. Procedures performed as part of the ongoing ROADSTER-2 registry were excluded. Univariate analysis, consisting of Student's T and Fisher's exact testing, comparing virgin and hostile neck TCAR, was performed at an alpha of 0.05. RESULTS: During the study period, 149 total procedures (n = 30, hostile ipsilateral necks) qualified for inclusion. Both hostile and virgin neck groups were comparable with respect to preoperative comorbidities and medication profiles. The ipsilateral hostile neck cohort consisted of ten patients who underwent previous ipsilateral neck radiation and 23 who were status after neck dissection (3 had both). Intraoperatively, there were no differences with respect to estimated blood loss (47.2 vs. 44.8 mL, P = 0.81), operative time (69.5 vs. 74.5 min, P = 0.38), reverse flow time (12.4 vs. 10.4 min, P = 0.34), radiation exposure (217.7 vs. 226.2 mGy, P = 0.88), fluoroscopy time (5.4 vs. 5.0 min, P = 0.65), contrast usage (23.5 vs. 25.0 mL, P = 0.55), and ability to achieve technical success (96.7% vs. 100%, P = 0.58) between virgin and hostile necks, respectively. Perioperative (30-day) ipsilateral stroke and death rate was 2.5% vs. 0% (P = 1.0) and 2.5% vs. 0% (P = 1.0), respectively, between virgin and hostile necks. We observed one postoperative cranial nerve injury in any of our TCAR patients (hostile neck, P = 0.20). Finally, a total of 3 hematomas (requiring washout) occurred in our (2 in virgin necks and one in a hostile neck) surgical cohort (P = 0.49). CONCLUSIONS: Based on this limited, small series, TCAR in hostile surgical fields is not associated with an increase in case complexity and maintains a similar perioperative risk to virgin field procedures.

Rationale and design of the Clinical and Histologic Analysis of Mesenchymal Stromal Cells in AmPutations (CHAMP) trial investigating the therapeutic mechanism of mesenchymal stromal cells in the treatment of critical limb ischemia.

OBJECTIVE: Currently, there are no accepted nonsurgical therapies that improve the delivery of blood-derived nutrients to patients with critical limb ischemia. Here, we describe the ongoing phase 1/2 Clinical and Histologic Analysis of Mesenchymal Stromal Cells in AmPutations (CHAMP) trial, which will provide crucial evidence of the safety profile of mesenchymal stromal cells (MSCs) and explore their therapeutic mechanisms in the setting of critical limb ischemia requiring below-knee amputation (BKA). METHODS: In the CHAMP and the parallel marrowCHAMP trials (hereafter grouped together as CHAMP), a total of 32 extremities with rest pain or tissue loss requiring BKA will be enrolled to receive intramuscular injections of allogeneic MSCs (CHAMP; n = 16) or autogenous concentrated bone marrow aspirate (marrowCHAMP; n = 16) along the distribution of the BKA myocutaneous flap and proximal tibialis anterior. After treatment, subjects are randomized to BKA at four time points after injection (days 3, 7, 14, and 21). At the time of amputation, skeletal muscle is collected at 2-cm increments from the tibialis injection site and used to determine proangiogenic cytokine description, MSC retention, quantification of proangiogenic hematopoietic progenitor cells, and histologic description. Clinical limb perfusion before and after treatment will be quantified using transcutaneous oximetry, toe-brachial index, ankle-brachial index, and indocyanine angiography. Additional clinical end points include all-cause mortality, need for amputation revision, and gangrene incidence during the 6-month post-treatment follow-up. RESULTS: Enrollment is under way, with 10 patients treated per protocol thus far. We anticipate full conclusion of follow-up within the next 24 months. CONCLUSIONS: CHAMP will be pivotal in characterizing the safety, efficacy, and, most important, therapeutic mechanism of allogeneic MSCs and autogenous concentrated bone marrow aspirate in ischemic skeletal muscle.

Osteopontin may be a driver of abdominal aortic aneurysm formation.

OBJECTIVE: Previous in vitro and animal studies have suggested that osteopontin (OPN), an inflammatory extracellular matrix protein, is involved in the formation and growth of abdominal aortic aneurysms (AAAs). However, the mechanism by which this occurs continues to be nebulous. The relationship between OPN and inflammation-suppressing lymphocytes present in the human AAA condition was investigated and presented herein. METHODS: Serum OPN concentrations were measured in healthy, risk factor-matched non-AAA and AAA patients by enzyme-linked immunosorbent assay (ELISA). Immunohistochemistry was used to determine the source of OPN secretion using aortic tissue collected from multiorgan donors and AAA patients undergoing open surgical repair. Vascular smooth muscle cells (VSMCs) were exposed to various inflammatory mediators, and OPN expression was evaluated by quantitative reverse transcriptase-polymerase chain reaction and ELISA. The inflammatory nature of OPN and the aortic wall was determined using a TR1 suppressor cell induction assay as a surrogate and characterized by ELISA and fluorescence-activated cell sorting. RESULTS: OPN was found to be elevated in both the plasma and aortic homogenate of AAA patients compared with controls. On immunohistochemistry, OPN localized to the tunica media of the diseased aorta but was minimally expressed in healthy aorta. In vitro, cigarette smoke extract was the most potent stimulator of OPN secretion by VSMCs and increased both messenger RNA and supernatant concentrations. OPN demonstrated an ability to inhibit the induction of interleukin 10-secreting TR1 lymphocytes, a depleted population in the AAA patient, from naive precursors. Last, neutralizing receptor targets of OPN in the setting of AAA homogenate coincubation abrogated the inhibition of TR1 induction. CONCLUSIONS: OPN, secreted by the VSMCs of the tunica media, is elevated in the circulating plasma and aortic wall of patients with AAA. It can inhibit the induction of the TR1 suppressor cell, leading to an overall proinflammatory state contributing to progressive aortic wall breakdown and dilation.