Aneurysm Sac Shrinkage at 1 Year after Fenestrated-Branched Endovascular Aortic Repair of Complex Aortic Aneurysms Offers Mid-Term Survival Advantage.

OBJECTIVES: To investigate the impact of 1-year changes in aneurysm sac diameter on patient survival after fenestrated-branched endovascular aortic repair (FB-EVAR) of complex abdominal (CAAA) or thoracoabdominal aortic aneurysms (TAAA). METHODS: We reviewed the clinical data of patients enrolled in a prospective non-randomized study investigating FB-EVAR (2013-2022). Patients with sequential follow up computed tomography (CT) scans at baseline and 6 to 18 months after FB-EVAR were included in the analysis. Aneurysm sac diameter change was defined as the difference in maximum aortic diameter (MAD) from baseline measurements obtained in centerline of flow. Patients were classified as those with sac shrinkage (≥5mm) or failure to regress (<5mm or expansion) according to sac diameter change. Primary endpoint was all-cause mortality. Secondary endpoints were aortic-related mortality (ARM), aortic aneurysm rupture (AAR) and aorta-related secondary intervention. RESULTS: There were 549 patients treated by FB-EVAR. Of these, 463 patients (71% male, mean 74±8 years-old) with sequential CT imaging were investigated. Aneurysm extent was TAAA in 328 (71%) patients and CAAA in 135 (29%). Sac shrinkage occurred in 270 (58%) patients and failure to regress in 193 (42%) patients, including 19 (4%) patients with sac expansion at 1-year. Patients from both groups had similar cardiovascular risk factors, except for younger age among patients with sac shrinkage (73±8 vs. 75±8 years-old; P<.001). Median follow-up was 38 months (interquartile range, 18-51 months). Five-year survival estimate was 69%±4.1% for sac shrinkage and 46%±6.2% for failure to regress group. Survival estimates adjusted for confounders (age, chronic pulmonary obstructive disease, chronic kidney disease, congestive heart failure, and aneurysm extent) revealed a higher hazard of late mortality in patients with failure to regress (adjusted hazard ratio, 1.72; 95% confidence interval, 1.18-2.52; P=.005). Five-year cumulative incidences of ARM (1.1% vs. 3.1%, P=.30), AAR (0.6% vs. 2.6%, P=.20) and aorta-related secondary intervention (17±2.8% vs. 19±3.8%) were both comparable between the groups. CONCLUSIONS: Aneurysm sac shrinkage at 1 year is frequent after FB-EVAR and is associated with improved patient survival, while sac enlargement affects only a minority of patients. The low incidences of ARM and AAR indicate that failure to regress may serve as a surrogate marker for non-aortic-related death.

Using Machine Learning to Predict Outcomes of Patients with Blunt Traumatic Aortic Injuries.

INTRODUCTION: The optimal management of blunt thoracic aortic injury (BTAI) remains controversial, with experienced centers offering therapy ranging from medical management to TEVAR. We investigated the utility of a machine learning (ML) algorithm to develop a prognostic model of risk factors on mortality in patients with BTAI. METHODS: The Aortic Trauma Foundation registry was utilized to examine demographics, injury characteristics, management and outcomes of patients with BTAI. A STREAMLINE (A Simple, Transparent, End-To-End Automated Machine Learning Pipeline Facilitating Data Analysis and Algorithm Comparison) model as well as logistic regression (LR) analysis with imputation using chained equations was developed and compared. RESULTS: From a total of 1018 patients in the registry, 702 patients were included in the final analysis. Of the 258 (37%) patients who were medically managed, 44 (17%) died during admission, 14 (5.4%) of which were aortic related deaths. 444 (63%) patients underwent TEVAR and 343 of which underwent TEVAR within 24 hours of admission. Amongst TEVAR patients, 39 (8.8%) patients died and 7 (1.6%) had aortic related deaths. (Table 1) Comparison of the STREAMLINE and LR model showed no significant difference in ROC curves and high AUCs of 0.869 (95% CI, 0.813 - 0.925) and 0.840 (95% CI, 0.779 - 0.900) respectively in predicting in-hospital mortality. Unexpectedly, however, the variables prioritized in each model differed between models (Figure 1A-B). The top three variables identified from the LR model were similar to that from existing literature. The STREAMLINE model, however, prioritized location of the injury along the lesser curve, age and aortic injury grade (Figure 1A). CONCLUSIONS: Machine learning provides insight on prioritization of variables not typically identified in standard multivariable logistic regression. Further investigation and validation in other aortic injury cohorts are needed to delineate the utility of ML models. LEVEL OF EVIDENCE: Level IIIStudy TypeOriginal research (prognostic/epidemiological).

Prospective evaluation of upper extremity access and total transfemoral approach during fenestrated and branched endovascular repair.

OBJECTIVE: Total transfemoral (TF) access has been increasingly used during fenestrated-branched endovascular aortic repair (FB-EVAR). However, it is unclear whether the potential decrease in the risk of cerebrovascular events is offset by increased procedural difficulties and other complications. The aim of this study was to compare outcomes of FB-EVAR using a TF vs upper extremity (UE) approach for target artery incorporation. METHODS: We analyzed the clinical data of consecutive patients enrolled in a prospective, nonrandomized clinical trial in two centers to investigate the use of FB-EVAR for treatment of complex abdominal aortic aneurysms (CAAA) and thoracoabdominal aortic aneurysms (TAAA) between 2013 and 2022. Patients were classified into TF or UE access group with a subset analysis of patients treated using designs with directional branches. End points were technical success, procedural metrics, 30-day cerebrovascular events defined as stroke or transient ischemic attack, and any major adverse events (MAEs). RESULTS: There were 541 patients (70% males; mean age, 74 ± 8 years) treated by FB-EVAR with 2107 renal-mesenteric TAs incorporated. TF was used in175 patients (32%) and UE in 366 patients (68%) including 146 (83%) TF and 314 (86%) UE access patients who had four or more TAs incorporated. The use of a TF approach increased from 8% between 2013 and 2017 to 31% between 2018 and 2020 and 96% between 2021 and 2022. Compared with UE access patients, TF access patients were more likely to have CAAAs (37% vs 24%; P = .002) as opposed to TAAAs. Technical success rate was 96% in both groups (P = .96). The use of the TF approach was associated with reduced fluoroscopy time and procedural time (each P < .05). The 30-day mortality rate was 0.6% for TF and 1.4% for UE (P = .67). There was no early cerebrovascular event in the TF group, but the incidence was 2.7% for UE patients (P = .035). The incidence of MAEs was also lower in the TF group (9% vs 18%; P = .006). Among 237 patients treated using devices with directional branches, there were no significant differences in outcomes except for a reduced procedural time for TF compared with UE access patients (P < .001). CONCLUSIONS: TF access was associated with a decreased incidence of early cerebrovascular events and MAEs compared with UE access for target artery incorporation. Procedural time was decreased in TF access patients irrespective of the type of stent graft design.

Transcarotid stenting of extracranial carotid artery aneurysm with covered stents and flow reversal.

Introduction: An extracranial carotid artery aneurysm (ECAA) is a rare pathology comprising <1% of all arterial aneurysms. The etiology includes trauma, previous surgery, radiation, and infection. Treatment of ECAAs has evolved from open repair to endovascular repair with stenting. Reports of endovascular repair describe the transfemoral approach; however, little more than case reports are available describing the transcarotid approach for ECAAs. In this study, we describe a cohort of patients who safely underwent transcarotid repair of ECAAs. Methods: We performed a retrospective medical record review of all cases of transcarotid stenting using covered stents for a carotid aneurysm within 11 different hospitals within the Memorial Hermann Health System from December 2019 through December 2022. Technical success is defined as coverage of the aneurysm with no endoleak. We report the patient demographics, clinical presentation, intraoperative metrics, and outcomes. Results: Seven patients underwent transcarotid covered stent placement using flow reversal for neurologic protection. Their average age was 65 years, and four of the seven patients were men. Three patients presented with pain, two with transient ischemic attack, one with stroke, and one with a pulsatile mass. Technical success was 100%. All the patients were treated with transcarotid stenting, and the average aneurysm size was 13 mm. The average operative time was 69 minutes, and the flow reversal time was 9 minutes. No postoperative stroke, myocardial infarction, or death occurred. The average length of hospital stay was 2.7 days. Conclusions: A transcarotid approach for endovascular treatment of ECAAs was safe for this cohort of patients, with no postoperative death, stroke, or myocardial infarction. Also, the technical success was 100%.

Outcomes of fenestrated-branched endovascular aortic repair in patients with or without prior history of abdominal endovascular or open surgical repair.

OBJECTIVE: The aim of this study was to compare outcomes of fenestrated-branched endovascular aortic repair (FB-EVAR) of complex abdominal (CAAAs) and thoracoabdominal aortic aneurysms (TAAAs) in patients with or without prior history of abdominal open surgical (OSR) or endovascular aortic repair (EVAR). METHODS: The clinical data of consecutive patients enrolled in a prospective, non-randomized study to evaluate FB-EVAR for treatment of CAAAs and TAAAs was reviewed. Clinical outcomes were analyzed in patients with no previous aortic repair (Controls), prior EVAR (Group 1), and prior abdominal OSR (Group 2), including 30-day mortality and major adverse events (MAEs), patient survival and freedom from aortic-related mortality (ARM), secondary interventions, any type II endoleak, sac enlargement (≥5 mm), and new-onset permanent dialysis. RESULTS: There were 506 patients (69% male; mean age, 72 ± 9 years) treated by FB-EVAR, including 380 controls, 54 patients in Group 1 (EVAR), and 72 patients in Group 2 (abdominal OSR). FB-EVAR was performed on average 7 ± 4 and 12 ± 6 years after the index EVAR and abdominal OSR, respectively (P < .001). All three groups had similar clinical characteristics, except for less coronary artery disease in controls and more TAAAs and branch stent graft designs in Group 2 (P < .05). Aneurysm extent was CAAA in 144 patients (28%) and TAAA in 362 patients (72%). Overall technical success, mortality, and MAE rate were 96%, 1%, and 14%, respectively, with no difference between groups. Mean follow up was 30 ± 21 months. Patient survival was significantly lower in Group 2 (P = .03), but there was no difference in freedom from ARM and secondary interventions at 5 years between groups. Group 1 patients had lower freedom from any type II endoleak (P = .02) and sac enlargement (P < .001), whereas Group 2 patients had lower freedom from new-onset permanent dialysis (P = .03). CONCLUSIONS: FB-EVAR was performed with high technical success, low mortality, and similar risk of MAEs, regardless of prior history of abdominal aortic repair. Patient survival was significantly lower in patients who had previous abdominal OSR, but freedom from ARM and secondary interventions were similar among groups. Patients with prior EVAR had lower freedom from type II endoleak and sac enlargement. Patients with prior OSR had lower freedom from new-onset dialysis.

Technical Pitfalls for Fenestrated-Branched Endovascular Aortic Repair Following PETTICOAT.

PURPOSE: The Provisional Extension to Induce Complete Attachment Technique (PETTICOAT) uses a bare-metal stent to scaffold the true lumen in patients with acute or subacute aortic dissections. While it is designed to facilitate remodeling, some patients with chronic post-dissection thoracoabdominal aortic aneurysms (TAAAs) require repair. This study describes the technical pitfalls of fenestrated-branched endovascular aortic repair (FB-EVAR) in patients who underwent prior PETTICOAT repair. TECHNIQUE: We report 3 patients with extent II TAAAs who had prior bare-metal dissection stents treated by FB-EVAR. Two patients required maneuvers to reroute the aortic guidewire, which was initially placed in-between stent struts. This was recognized before the deployment of the fenestrated-branched device. A third patient had difficult advancement of the celiac bridging stent due to a conflict of the tip of the stent delivery system into one of the stent struts, requiring to redo catheterization and pre-stenting with a balloon-expandable stent. There were no mortalities and target-related events after a follow-up of 12 to 27 months. CONCLUSION: FB-EVAR following the PETTICOAT is infrequent, but technical difficulties should be recognized to prevent complications from the inadvertent deployment of the fenestrated-branched stent-graft component in-between stent struts. CLINICAL IMPACT: The present study highlights a few maneuvers to prevent or overcome possible complications during endovascular repair of chronic post-dissection thoracoabdominal aortic aneurysm following PETTICOAT. The main problem to be recognized is the placement of the aortic wire beyond one of the struts of the existing bare-metal stent. Moreover, encroachment of catheters or the bridging stent delivery system into the stent struts may potentially cause difficulties.

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.

Cover with caution: Management of the Left Subclavian Artery in TEVAR for trauma.

BACKGROUND: Elective Thoracic Endovascular Aortic Repair (TEVAR) with left subclavian artery coverage (LSA-C) without revascularization is associated with increased rates of ischemic stroke. In patients with blunt thoracic aortic injury (BTAI) requiring TEVAR, LSA-C is frequently required in over one-third of patients. This study aimed to evaluate outcomes of TEVAR in BTAI patients with and without LSA-C. METHODS: The largest existing international multicenter prospective registry of BTAI, developed and implemented by the Aortic Trauma Foundation, was utilized to evaluate all BTAI patients undergoing TEVAR from March 2016 to January 2021. Patients with uncovered left subclavian artery (LSA-U) were compared with patients who had left subclavian artery coverage with (LSA-R) and without (LSA-NR) revascularization. RESULTS: Of the 364 patients with BTAI who underwent TEVAR, 97 (26.6%) underwent LSA-C without revascularization, 10 (2.7%) underwent LSA-C with revascularization (LSA-R). Late and all ischemic strokes were more common in LSA-NR patients than LSA-U patients ( p = 0.006, p = 0.0007). There was no difference in rate of early, late, or overall incidence of paralysis/paraplegia between LSA-NR and LSA-U. When compiled as composite central nervous system ischemic sequelae, there was an increased rate in early, late, and overall events in LSA-NR compared with LSA-U ( p = 0.04, p = 0.01, p = 0.001). CONCLUSION: While prior studies have suggested the relative safety of LSA-C in BTAI, preliminary multicenter prospective data suggests there is a significant increase in ischemic events when the left subclavian artery is covered and not revascularized. Additional prospective study and more highly powered analysis is necessary. LEVEL OF EVIDENCE: Therapeutic/Care Management; Level III.

Characterization of Secondary Interventions After Fenestrated-branched Endovascular Repair of Complex Aortic Aneurysms and Its Effect on Quality of Life and Patient Survival.

OBJECTIVE: To assess the impact of secondary intervention (SI) on health-related quality of life (HR-QOL) after fenestrated-branched endovascular aortic repair (FB-EVAR) for complex abdominal aortic aneurysms and thoracoabdominal aortic aneurysms. BACKGROUND: The effect of SI after FB-EVAR on physical and mental HR-QOL has not been described. METHODS: A cohort of 430 consecutive patients enrolled in a prospective, nonrandomized study to evaluate FB-EVAR (2013-2020) was assessed with 1325 short-form 36 HR-QOL questionnaires preoperatively and during follow-up visits. SIs were classified as major or minor procedures. Endpoints included patient survival, freedom from aortic-related mortality (ARM), freedom from SIs, and changes in HR-QOL physical component score (PCS) and mental component score. RESULTS: There were 302 male with mean age 74±8 years treated by FB-EVAR for 133 complex abdominal aortic aneurysms and 297 thoracoabdominal aortic aneurysms. After a mean follow up of 26±20 months, 97 patients (23%) required 137 SIs. At 5 years, freedom from any SI was 64%±4%, including freedom from minor SIs of 77%±4% and major SIs of 87%±3%. There was no difference in patient survival and freedom from ARM at same interval. On adjusted analysis, minor SIs correlated with improved survival. SIs had a negative correlation with PCS ( r =-0.8). There were no significant changes in mental component score with SIs. Predictors for SIs were fluoroscopy time, graft design, and aneurysm sac change. CONCLUSION: SIs were needed in nearly 1 out of 4 patients treated by FB-EVAR with no effect on patient survival or ARM. SI resulted in decline in PCS.

Transcarotid Revascularization Timing and Early Postoperative Outcomes in Symptomatic Patients.

OBJECTIVE: Carotid endarterectomy (CEA) performed several days after onset of symptoms has been shown to be optimal in preventing procedure-related stroke. Transcarotid artery revascularization (TCAR) is an alternative hybrid procedure to treat high-risk for CEA patients. In this investigation, our aim is to determine the effect of timing of TCAR in symptomatic patients. METHODS: Procedures were captured prospectively at 2 independent health systems from 2016-2022 within a carotid intervention database. A retrospective analysis of this database was performed to generate cohorts by time to revascularization from onset of symptoms, with the short-interval revascularization (SIR) group defined as having a time to revascularization between 2-5 days; and long-interval revascularization (LIR) group having a time to revascularization of 6-180 days. Univariate analysis was performed comparing the cohorts at an α of .05. RESULTS: During the study period, 875 TCARs were captured, including 321 procedures performed in symptomatic patients. Of these, 84 had revascularization performed within 6 days after onset of symptoms (SIR) while 237 additional cases were completed 6 or more days after onset of symptoms (LIR). Baseline comorbidities were grossly similar between cohorts. Intraoperatively, SIR patients were less likely to develop bradycardia (4.8% vs 22.2%, P = .01) and experienced a shorter operative time (58 minutes vs 65 minutes, P = .02). Estimated blood loss, flow reversal time, radiation exposure, fluoroscopic time and contrast volume were identical between the groups. Length of stay in SIR patients was longer (1, IQR [1-3] vs 1, IQR [1-2] days, P < .01). Additionally, SIR patients seemed to trend toward a higher rate of reinterventions (3.6% vs .4%, P = .06). The incidence of ipsilateral or contralateral stroke, cranial nerve palsy, myocardial infarction, hematoma, stent thrombosis and death were statistically identical between the 2 groups. CONCLUSION: Like the previous results established for CEA, symptomatic patients undergoing TCAR demonstrate similar outcomes if the procedure is performed 48 hours after the neurologic event.

Fate of Hemodialysis Patients Undergoing Transcarotid Revascularization.

INTRODUCTION: Carotid revascularization in patients with end-stage renal disease (ESRD) continues to be a controversial topic, as life expectancy is poor, thus, preventing the recouperation of cumulative stroke-risk reduction in the postoperative period. We performed this primarily descriptive analysis of the results of transcarotid revascularization (TCAR) in renal failure patients. METHODS: A retrospective review of two independent carotid revascularization databases maintained at two large health systems were performed to capture all consecutive TCAR procedures. Patients were classified as either (1) ESRD or (2) preserved renal function (PRF) and compared with standard univariate techniques, where appropriate. RESULTS: From December 2015 to April 2022, 851 consecutive TCARs were attempted at our participating facilities. Of these, 27 were performed in ESRD patients (all hemodialysis). These patients were younger and presented with a higher Charlson Comorbidity Index. The incidence of a high anatomic risk criterion as defined for the Centers for Medicare and Medicaid Services (CMS) were similar between groups, as was the incidence of a symptomatic carotid lesion. There were no differences between the groups in terms of intraoperative characteristics and the postoperative medication management were grossly similar by renal function. In the 30-day perioperative period, there were no stroke, death, or myocardial infarction in the 27 ESRD patients treated with TCAR. The mean duration of follow-up in the ESRD cohort was 15.0 months. During this time, there was no ipsilateral stroke events, one contralateral stroke, and one MI. All 27 carotid stents remained patent during this period. Six patients perished after TCAR at a mean interval of 12.2 months after TCAR. CONCLUSION: Survival is poor after carotid revascularization via the TCAR technique on intermediate follow-up. Careful patient selection is required to identify those who will survive to collect on the cumulative stroke-risk reduction afforded by carotid intervention.

Outcomes of iliofemoral conduits during fenestrated-branched endovascular repair of complex abdominal and thoracoabdominal aortic aneurysms.

OBJECTIVE: To describe the technical pitfalls and outcomes of iliofemoral conduits during fenestrated-branched endovascular repair (FB-EVAR) of complex abdominal aortic aneurysms (CAAAs) and thoracoabdominal aortic aneurysms (TAAAs). METHODS: We retrospectively reviewed the clinical data of 466 consecutive patients enrolled in a previous prospective nonrandomized study to investigate FB-EVAR for CAAAs/TAAAs (2013-2021). Iliofemoral conduits were performed through open surgical technique (temporary or permanent) in patients with patent internal iliac arteries or endovascular technique among those with occluded internal iliac arteries. End points were assessed in patients who had any iliac conduit or no conduits, and in patients who had conduits performed prior or during the index FB-EVAR, including procedural metrics, technical success, and major adverse events (MAE). RESULTS: There were 138 CAAAs, 141 extent IV, and 187 extent I-III TAAAs treated by FB-EVAR with an average of 3.89 ± 0.52 vessels incorporated per patient. Any iliac conduit was required in 35 patients (7.5%), including 24 patients (10.4%) treated between 2013 and 2017 and 11 (4.7%) who had procedures between 2018 and 2021 (P = .019). Nineteen patients had permanent conduits using iliofemoral bypass, 11 had temporary iliac conduits, and 5 had endoconduits. Iliofemoral conduits were necessary in 12% of patients with extent I to III TAAA, in 6% with extent IV TAAA, and in 3% with CAAA (P = .009). The use of iliofemoral conduit was more frequent among women (74% vs 27%; P < .001) and in patients with chronic obstructive pulmonary disease (49% vs 28%; P = .013), peripheral artery disease (31% vs 15%; P = .009), and American Society of Anesthesiologists classification of III or higher (74% vs 51%; P = .009). There were no inadvertent iliac artery disruptions in the entire study. The 30-day mortality and MAE were 1% and 19%, respectively, for all patients. An iliofemoral conduit using retroperitoneal exposure during the index FB-EVAR was associated with longer operative time (322 ± 97 minutes vs 323 ± 110 minutes vs 215 ± 90 minutes; P < .001), higher estimated blood loss (425 ± 620 mL vs 580 ± 1050 mL vs 250 ± 400 mL; P < .001), and rate of red blood transfusion (92% vs 78% vs 32%; P < .001) and lower technical success (83% vs 87% vs 98%; P < .001), but no difference in intraoperative access complications and MAEs, compared with iliofemoral conduits without retroperitoneal exposure during the index FB-EVAR and control patients who had FB-EVAR without iliofemoral conduits, respectively. There were no differences in mortality or in other specific MAE among the three groups. CONCLUSIONS: FB-EVAR with selective use of iliofemoral conduits was safe with low mortality and no occurrence of inadvertent iliac artery disruption or conversion. A staged approach is associated with shorter operating time, less blood loss, and lower transfusion requirements in the index procedure.

Dual Antiplatelet Alternatives are Associated With Increased Stroke and Death After Transcarotid Revascularization.

OBJECTIVE: To define the risks associated with the replacement of dual antiplatelets for alternate medication regimens. BACKGROUND: Patients undergoing transcarotid artery revascularization (TCAR) for atherosclerotic disease in the Vascular Quality Initiative database from September 2016 to June 2022 were included. In all, 29,802 TCAR procedures were captured between 2016 and 2022, consisting of 24,651 (82.7%) maintained on dual antiplatelet therapy (DAPT) and 5151 (17.3%) on alternative regimens. METHODS: Patients maintained on DAPT were compared with those on alternative regimens consisting of any combination of single antiplatelet monotherapy and/or anticoagulation. RESULTS: On univariable analysis, patients on alternative medications were more likely to experience in-hospital death, ipsilateral stroke, any stroke, and transient ischemic attacks compared with patients in the DAPT group. The mortality rate was higher at 1 year in the alternative cohort (4.7% vs 7.0%, P <0.01). The use of alternate medication regimens was associated with increased odds of stroke and the composite outcome of in-hospital stroke/death compared with DAPT. There was also a significant association between alternative medication use and increased odds of in-hospital transient ischemic attack, immediate stent occlusion, and return to the operating room. At 1 year, there was no significant difference in the incidence of stroke between the 2 groups. However, the use of alternate regimens was associated with higher 1-year of mortality after multivariable adjustment. CONCLUSIONS: Patients not maintained on DAPT after TCAR experienced an increased risk of stroke and death in the perioperative and follow-up periods. Increased surgeon vigilance is required to ensure compliance with dual antiplatelets as recommended.

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.

Single-Center Experience with the Femoral-to-Brachial Preloaded Delivery System for Fenestrated-Branched Endovascular Repair of Complex Aortic Aneurysms.

PURPOSE: To assess technical aspects and outcomes of fenestrated-branched endovascular aortic repair (FB-EVAR) using a femoral-to-brachial (FTB) preloaded delivery system (PDS) with two separate configurations. METHODS: Clinical data of all consecutive patients enrolled in a prospective study to evaluate FB-EVAR for complex abdominal and thoracoabdominal aortic aneurysms (CAAAs & TAAA) between 2013 and 2020 were reviewed. Patients treated with FTB-PDS were included. The two configurations included 4 trans-brachial preloaded wires (4BR) or 2 trans-brachial and 2 transfemoral preloaded wires (2BR-2FE). Outcome measures included technical success, procedural metrics, 30-day or in-hospital mortality, major adverse events (MAEs), and target-vessel outcomes. RESULTS: There were 115 patients with a mean age of 73.8 ± 8 years, treated with FTB-PDS. Of these, 62 patients (54%) had 4BR and 53 patients (46%) had 2BR-2FE FTB-PDS. There were 106 TAAA (92%) and 9 CAAAs (8%). Technical success, defined as successful implantation of the stent-graft and all intended target-vessel stents without type I or III endoleak, was 97%, with no differences in total operating time, endovascular time, and radiation dose between groups. There were 3 deaths (3%) at 30 days. MAEs were noticed in 21 patients (18%) with no difference between groups, including new-onset dialysis (2% vs. 4%, P = 0.59), and paraplegia (7% vs. 11%, P = 0.51), for 4BR and 2BR-2FE, respectively. Patient survival and freedom from aortic-related mortality at 2-years were 79 ± 5% and 97 ± 1.7%, respectively, with no difference between groups. CONCLUSION: The use of FTB-PDS for FB-EVAR is safe with high technical success and a reasonable rate of MAEs. Each configuration provides specific benefits based on patient anatomy, while having similar procedural metrics and clinical outcomes.

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.

Outcomes of low- and standard-profile fenestrated and branched stent grafts for treatment of complex abdominal and thoracoabdominal aortic aneurysms.

OBJECTIVE: We compared the outcomes of fenestrated-branched (FB) endovascular abdominal aortic aneurysm repair (EVAR) using low-profile (LP) and standard-profile (SP) stent grafts for the treatment of complex abdominal aortic aneurysms (CAAAs) and thoracoabdominal aortic aneurysms (TAAAs). METHODS: We reviewed the clinical data of 466 consecutive patients (70% male; mean age, 74 ± 8 years) enrolled in a prospective nonrandomized study to investigate FB-EVAR for the treatment of CAAAs and TAAAs (2013-2021). The endpoints compared between the patients treated with LP (18F-20F) and SP (20F-22F) devices included procedural metrics, access-related complications, major adverse events (MAE), patient survival, freedom from secondary intervention, thromboembolic events, stent graft integrity issues, aneurysm sac enlargement, and the rate of sac shrinkage. RESULTS: Of the 466 aneurysms treated by FB-EVAR, 138 were CAAAs and 141 were extent IV and 187 extent I to III TAAAs, with a mean number of 3.9 ± 0.5 vessels stented per patient. LP devices had been used in 239 patients (51%) and SP devices in 227 patients (49%). LP devices had been used more frequently for chronic dissections (12% vs 7%; P = .041) and with preloaded systems (77% vs 65%; P = .005) and bilateral percutaneous femoral access (83% vs 74%; P = .020) and less frequently with upper extremity access (67% vs 88%; P < .001) and iliac conduits (2% vs 6%; P = .020). The patients treated using LP devices had experienced similar technical success (96% vs 97%; P = .527), with a shorter total operating time (225 ± 81 minutes vs 243 ± 78 minutes; P = .018), lower radiation exposure (median, 0.93 Gy; interquartile range [IQR], 0.94; vs median, 1.01 Gy; IQR, 0.91 Gy; P < .001), and less use of contrast (median, 135 mL; IQR, 68 mL; vs median, 144 mL; IQR, 80 mL; P = .008). No differences were found in the rates of iliofemoral access complications between the LP and SP device groups (1.3% vs 3.5%; P = .107). At 30 days, 5 patients had died (1%) and MAEs had occurred in 89 patients (19%), with no differences between the two groups. The mean follow-up was 28 months (95% confidence interval, 25-30 months). At 4 years, the patients treated with LP devices had had similar freedom from all-cause mortality (69% ± 6% vs 68% ± 4%; P = .199), freedom from aortic-related mortality (97% ± 1% vs 98% ± 1%; P = .488), freedom from any secondary intervention (65% ± 6% vs 70% ± 4%; P = .433), freedom from thromboembolic events (98% ± 1% vs 99% ± 1%; P = .364) and aneurysm sac enlargement (93% ± 3% vs 91% ± 3%; P = .293). However, the LP group had had less freedom from any integrity-related issues (92% ± 5% vs 100%; P < .001). The cumulative risk of sac shrinkage was greater for patients treated with LP devices (adjusted hazard ratio, 2.040; 95% confidence interval, 1.516-2.744; P < .001). CONCLUSIONS: FB-EVAR was performed with low rates of mortality and MAEs, irrespective of the device profile. However, the procedures performed with LP devices had had less need for iliac conduits and had had better procedural metrics. The use of LP devices resulted in higher rates of sac shrinkage. However, the results on stent graft integrity require future investigation.

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.

Outcomes and practice patterns of medical management of blunt thoracic aortic injury from the Aortic Trauma Foundation global registry.

OBJECTIVE: Blunt thoracic aortic injury (BTAI) is the second leading cause of death from blunt trauma. In the present study, we aimed to determine the outcomes of medical management (MM) for BTAI. We hypothesized from the results of several previously reported studies, that patients with a minimal aortic injury (BTAI grades 1 and 2) could safely be treated with definitive MM alone. METHODS: The Aortic Trauma Foundation international prospective multicenter registry was used to examine the demographics, injury characteristics, management, and outcomes of patients with BTAI. We analyzed a subset of patients for whom MM was initiated as definitive therapy. RESULTS: From November 2016 to April 2020, 432 patients (median age, 41 years; 76% male; median injury severity score, 34) with BTAI (Society for Vascular Surgery grade 1, 23.6%; grade 2, 14.4%; grade 3, 51.2%; grade 4, 10.9%) were evaluated. Of the 432 patients, 245 (57%) had received MM in the initial period and 114 (26.4%) had received MM as the planned definitive therapy (grade 1, 59.6%; grade 2, 23.7%; grade 3, 15.8%; grade 4, 0.9%). The most common mechanism of BTAI was a motor vehicle collision (60.4%). Hypotension was present on arrival in 74 patients (17.2%). Continuous titratable infusion of antihypertensive medication was used for 49.1%, followed by intermittent bolus administration (29.8%), with beta-blockers (74.6%) the most common agent used. Treatments were targeted to a goal systolic blood pressure for 83.3%, most often to a target goal systolic blood pressure <120 mm Hg (66.3%). The MM goals based on blood pressure control were attained in 64.0% (73 of 114). Twelve patients (10.5%; grade 1, 1; grade 2, 0; grade 3, 10; grade 4, 1) had required subsequent intervention after MM. Eleven patients (9.6%) had undergone thoracic endovascular aortic repair and one (0.9%) had required open repair for a grade 4 injury. The overall in-hospital mortality for patients selected for definitive MM was 7.9%. No aortic-related deaths had occurred in the patients receiving definitive MM. CONCLUSIONS: Approximately one in four patients with BTAI will receive MM as definitive therapy. The variation in the pharmacologic therapies used is considerable. MM for patients with minimal aortic injury (BTAI grades 1 and 2) is safe and effective, with a low overall intervention rate and no aortic-related deaths. These findings support the use of definitive MM for grade 2 BTAI.

Initial experience and early outcomes of the management of acute pulmonary embolism using the FlowTriever mechanical thrombectomy device.

BACKGROUND: Submassive and massive pulmonary embolism is associated with a high risk of complications. We aimed to evaluate our initial experience with a mechanical thrombectomy device in the management of these patients. METHODS: A single-center, retrospective study was performed in patients with acute submassive and massive pulmonary embolism treated with the FlowTriever device (Inari Medical, Irvine, CA, USA) between June 2019 and November 2020. Clinical and technical parameters were analyzed during the hospitalization and at 30- and 180-days after the procedure. RESULTS: Fourteen patients were evaluated with a median (IQR) age of 60 (50-69) years and 64% were male. All had right heart strain as the main indication for thrombectomy. The procedure duration and fluoroscopic time was 52 (37-89) and 13 (9-24) minutes, respectively. There was 100% technical success, and the pulmonary arterial pressure went from 60 (48-65) mmHg to 40 (34-47) mmHg. Thrombolysis was used in two patients and nine patients required intensive care. 100% experienced improvement in symptoms at the time of discharge. There were no device-related complications, major bleeding events, myocardial infarctions, or deaths. Preprocedural hemoglobin was 13 (12-15) g/dL, and predischarge was 12 (10-13) g/dL. Overall postprocedural length of stay was three (2-6) days. All the patients were discharged with oral anticoagulation. There were no device-related complications or recurrence of embolism at 30 and 180 days. CONCLUSIONS: The mechanical thrombectomy device for submassive and massive pulmonary embolism is promising and appears a safe and effective procedure with 100% technical success, no complications, short intensive care requirement/stay, and good early clinical outcomes.