Female and male patients have similar outcomes after transcarotid artery revascularization in prospective trials.

OBJECTIVE: Sex disparities in outcomes after carotid revascularization have long been a concern, with several studies demonstrating increased postoperative death and stroke for female patients after either carotid endarterectomy or transfemoral stenting. Adverse events after transfemoral stenting are higher in female patients, particularly in symptomatic cases. Our objective was to investigate outcomes after transcarotid artery revascularization (TCAR) stratified by patient sex hypothesizing that the results would be similar between males and females. METHODS: We analyzed prospectively collected data from the Safety and Efficacy Study for Reverse Flow Used During Carotid Artery Stenting Procedure (ROADSTER)1 (pivotal), ROADSTER2 (US Food and Drug Administration indicated postmarket), and ROADSTER Extended Access TCAR trials. All patients had verified carotid stenosis meeting criteria for intervention (≥80% for asymptomatic patients and ≥50% in patient with symptomatic disease), and were included based on anatomical or clinical high-risk criteria for carotid stenting. Neurological assessments (National Institutes of Health Stroke Scale, Modified Rankin Scale) were obtained before and within 24 hours from procedure end by an independent neurologist or National Institutes of Health Stroke Scale-certified nurse. Patients were stratified by sex (male vs female). Baseline demographics were compared using χ2 and Fisher's exact tests where appropriate; primary outcomes were combination stroke/death (S/D) and S/D/myocardial infarction (S/D/M) at 30 days, and secondary outcomes were the individual components of S/D/M. Univariate logistic regression was conducted. RESULTS: We included 910 patients for analysis (306 female [33.6%], 604 male [66.4%]). Female patients were more often <65 years old (20.6% vs 15%) or ≥80 years old (22.6% vs 20.2%) compared with males, and were more often of Black/African American ethnicity (7.5% vs 4.3%). There were no differences by sex in term of comorbidities, current or prior smoking status, prior stroke, symptomatic status, or prevalence of anatomical and/or clinical high-risk criteria. General anesthetic use, stent brands used, and procedure times did not differ by sex, although flow reversal times were longer in female patients (10.9 minutes male vs 12.4 minutes female; P = .01), as was more contrast used in procedures for female patients (43 mL male vs 48.9 mL female; P = .049). The 30-day S/D and S/D/M rates were similar between male and female patients (S/D, 2.7% male vs 1.6% female [P = .34]; S/D/M, 3.6% male vs 2.6% female [P = .41]), which did not differ when stratified by symptom status. Secondary outcomes did not differ by sex, including stroke rates at 30 days (2.2% male vs 1.6% female; P = .80), nor were differences seen with stratification by symptom status. Univariate analysis demonstrated that history of a prior ipsilateral stroke was associated with increased odds of S/D (odds ratio [OR], 4.19; P = .001) and S/D/M (OR, 2.78; P = .01), as was symptomatic presentation with increased odds for S/D (OR, 2.78; P = .02). CONCLUSIONS: Prospective TCAR trial data demonstrate exceptionally low rates of S/D/MI, which do not differ by patient sex.

Intravascular Ultrasound Use in Peripheral Arterial and Deep Venous Interventions: Multidisciplinary Expert Opinion From SCAI/AVF/AVLS/SIR/SVM/SVS.

Percutaneous revascularization is the primary strategy for treating lower extremity venous and arterial disease. Angiography is limited by its ability to accurately size vessels, precisely determine the degree of stenosis and length of lesions, characterize lesion morphology, or correctly diagnose postintervention complications. These limitations are overcome with use of intravascular ultrasound (IVUS). IVUS has demonstrated the ability to improve outcomes following percutaneous coronary intervention, and there is increasing evidence to support its benefits in the setting of peripheral vascular intervention. At this stage in its evolution, there remains a need to standardize the use and approach to peripheral vascular IVUS imaging. This manuscript represents considerations and consensus perspectives that emerged from a roundtable discussion including 15 physicians with expertise in interventional cardiology, interventional radiology, and vascular surgery, representing 6 cardiovascular specialty societies, held on February 3, 2023. The roundtable's aims were to assess the current state of lower extremity revascularization, identify knowledge gaps and need for evidence, and determine how IVUS can improve care and outcomes for patients with peripheral arterial and deep venous pathology.

Physiologic risk factors increase risk of myocardial infarction with transcarotid artery revascularization in prospective trials.

OBJECTIVE: Patients can be considered at high risk for carotid endarterectomy (CEA) because of either anatomic or physiologic factors and will often undergo transcarotid artery revascularization (TCAR). Patients with physiologic criteria will be considered to have a higher overall surgical risk because of more significant comorbidities. Our aim was to study the incidence of stroke, myocardial infarction (MI), death, and combined end points for patients who had undergone TCAR stratified by the risk factors (anatomic vs physiologic). METHODS: An analysis of prospectively collected data from the ROADSTER (pivotal; safety and efficacy study for reverse flow used during carotid artery stenting procedure), ROADSTER 2 (Food and Drug Administration indicated postmarket trial; postapproval study of transcarotid artery revascularization in patients with significant carotid artery disease), and ROADSTER extended access TCAR trials was performed. All 851 patients were considered to be at high risk for CEA and were included and stratified using high-risk anatomic criteria (ie, contralateral occlusion, tandem stenosis, high cervical artery stenosis, restenosis after previous endarterectomy, bilateral carotid stenting, hostile neck anatomy with previous neck irradiation, neck dissection, cervical spine immobility) or high-risk physiologic criteria (ie, age >75 years, multivessel coronary artery disease, history of angina, congestive heart failure New York Heart Association class III/IV, left ventricular ejection fraction <30%, recent MI, severe chronic obstructive pulmonary disease, permanent contralateral cranial nerve injury, chronic renal insufficiency). For trial inclusion, asymptomatic patients were required to have had ≥80% carotid stenosis and symptomatic patients to have had ≥50% stenosis. The primary outcome measures were stroke, death, and MI at 30 days. The data were statistically analyzed using the χ2 test, as appropriate. RESULTS: A total of 851 high surgical risk patients were categorized into two groups: those with anatomic-only risk factors (n = 372) or at least one physiologic risk factor present (n = 479). Of the 851 patients, 74.5% of those in the anatomic subset were asymptomatic, and 76.6% in the physiologic subset were asymptomatic. General anesthesia was used similarly in both groups (67.7% anatomic vs 68.1% physiologic). MI had occurred in eight patients in the physiologic group (1.7%), all of whom had been asymptomatic and in none of the anatomic patients (P = .01). The combined stroke, death, and MI rate was 2.1% in the anatomic cohort and 4.2% in the physiologic cohort (P = .10). Stratification of each group into asymptomatic and symptomatic patients did not yield any further differences. CONCLUSIONS: The patients who had undergone TCAR in the present prospective, neurologically adjudicated trial because of high-risk physiologic factors had had a higher rate of MI compared with the patients who had qualified for TCAR using anatomic criteria only. These patients had experienced comparable rates of combined stroke, death, and MI rates. The anatomic patients represented a healthier and younger subset of patients, with notably low overall event rates.

Five-year results of the LEOPARD trial of commercially available endografts.

OBJECTIVE: The LEOPARD (Looking at EVAR Outcomes by Primary Analysis of Randomized Data) trial is a randomized controlled trial comparing the outcomes of endovascular aneurysm repair (EVAR) using commercially available devices in a real-world population. METHODS: A prospective, randomized, multi-center trial was performed to compare the anatomically fixated (AF) AFX/AFX2 endograft system (Endologix) with endografts with proximal fixation (PF) (Cook Medical Zenith Flex; Gore Excluder; and Medtronic Endurant II) in patients with infrarenal abdominal aortic aneurysms. The primary endpoint was freedom from aneurysm-related complications (ARCs), a composite endpoint consisting of perioperative death (≤30 days), aneurysm rupture, conversion to open surgical repair, postoperative endoleaks, endograft migration (≥10 mm), aneurysm enlargement (≥5 mm), endograft limb occlusion, and device- or aneurysm-related reintervention. RESULTS: The study population was 455 patients enrolled at 56 United States centers: 235 patients were treated with AF devices and 220 with PF devices. The primary endpoint supported noninferiority of the AF cohort at 1 year. The 5-year freedom from ARC Kaplan-Meier estimates were 63.8% for AF patients and 55.5% for PF patients (P = .10). Kaplan-Meier estimates for freedom from aneurysm-related mortality were 98.7% and 97.0% in the AF group and 99.5% and 98.5% in the PF group at 1 and 5 years. There was no difference in aneurysm-related mortality, all-cause mortality, rupture, secondary interventions, and type I and type III endoleak between the two cohorts. The type III endoleak rate at 5 years for the AFX cohort was 1.5% and 0.0% for the comparator cohort (P = .11). There was a lower type II endoleak rate in the AF group at 5 years (78.8% vs 68.4%; P = .037). There were zero open surgical conversions (0.0%) in the AF group and four (2.0%) in the PF group. CONCLUSIONS: The 5-year results from the LEOPARD study demonstrated that there was no clinically significant difference in overall aneurysm-related outcomes between patients randomized to the AFX endograft system or commercially available endografts with proximal fixation.

Partial and complete explantation of aortic endografts in the modern era.

OBJECTIVE: Despite the progressive advancement of devices for endovascular aortic repair (EVAR), endografts continue to fail, requiring explant. We present a single-institutional experience of EVAR explants, characterizing modern failure modes, presentation, and outcomes for partial and complete EVAR explantation. METHODS: A retrospective analysis was performed of all EVARs explanted at an urban quaternary center from 2001 to 2020, with one infected endograft excluded. Patient and graft characteristics, indications, and perioperative and long-term outcomes were analyzed. Partial versus complete explants were performed per surgeon discretion without a predefined protocol. This process was informed by patient risk factors; asymptomatic, symptomatic, or ruptured aneurysm presentation; and anatomical or intraoperative factors, including endoleak type. RESULTS: From 2001 to 2020, 52 explants met the inclusion and exclusion criteria. More than one-half (57.7%) were explants of EVAR devices placed at outside institutions, designated nonindex explants. Most patients were male (86.5%), the median age was 74 years (interquartile range, 70-78 years). More than one-half (61.5%) were performed in the second decade of the study period. The most commonly explanted grafts were Gore Excluder (n = 9 grafts), Cook Zenith (n = 8), Endologix AFX (n = 7), Medtronic Endurant (n = 5), and Medtronic Talent (n = 5). Most grafts (78.8%) were explanted for neck degeneration or sac expansion. Five were explanted for initial seal failure, five for symptomatic expansion, and seven for rupture. The median implant duration was 4.2 years, although ranging widely (interquartile range, 2.6-5.1 years), but similar between index and nonindex explants (4.2 years vs 4.1 years). Partial explantation was performed in 61.5%, with implant duration slightly lower, 3.2 years versus 4.4 years for complete explants. Partial explantation was more frequent in index explants (68.2% vs 56.7%). The median length of stay was 8 days. The median intensive care unit length of stay was 3 days, without significant differences in nonindex explants (4 days vs 3 days) and partial explants (4 days vs 3 days). Thirty-day mortality occurred in two nonindex explants (one partial and one complete explant). Thirty-day readmission was similar between partial and complete explants (9.7% vs 5.0%), without accounting for nonindex readmissions. Long-term survival was comparable between partial and complete explants in Cox regression (hazard ratio, 2.45; 95% confidence interval, 0.79-7.56; P = .12). CONCLUSIONS: Explants of EVAR devices have increased over time at our institution. Partial explant was performed in more than one-half of cases, per operating surgeon discretion, demonstrating higher blood loss, more frequent acute kidney injury, and longer intensive care unit stays, however with comparable short-term mortality and long-term survival.

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

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

Late Type 1A Endoleaks: Associated Factors, Prognosis and Management Strategies.

BACKGROUND: Unlike periprocedural Type 1A endoleaks, late appearing proximal endoleaks have been poorly described. METHODS: We studied all elective EVAR from 2010 -2018 in a single institution. Late endoleaks were defined as those appearing after 1 year. We used Cox regression to study factors associated with late Type 1A endoleaks and survival. RESULTS: Of 477 EVAR during the study period, 411 (86%) had follow-up imaging, revealing 24 Type 1A endoleaks; 4 early and 20 late. Freedom from Type 1A endoleaks was 99%, 92-81% at 1, 5 and 8 years with a median time to occurrence of 2.5 years (.01-8.2 years). On completion angiogram, only 10% of patients with a late Type 1A had a proximal endoleak, and 60% had no endoleak. Only 21% of late Type 1As were diagnosed on routine 1-year CT angiogram, but 79% had stable or expanding sacs. Two thirds (65%) of the patients eventually diagnosed with late Type 1A endoleaks had previously been treated for other endoleaks, mostly Type 2 (10/13). Age (HR 1.07/year [1.02-1.12], P = 0.01), neck diameter >28mm (HR 3.5 [1.2-10.3], P = 0.02), neck length <20mm (HR 3.0 [1.1-8.6], P = 0.04), and neck angle>60 degrees (HR 3.4 [1.5-7.9], P = 0.004) were associated with higher rates of Type 1A endoleak, but not female sex, endograft, or the use of suprarenal fixation. 2 patients had proximal degeneration and 5 experienced graft migration. There were 2 ruptures (10%), and 13 patients underwent repair with 5 open conversions. Median survival after late Type 1A repair was 6.6 years (0-8.4 years). CONCLUSION: Late appearing Type 1A endoleaks have a high rate of rupture and present significant diagnostic and management challenges. Careful surveillance is needed in patients with hostile neck anatomy and those who undergo intervention for other endoleaks. Adverse neck anatomy may be better suited for open repair or fenestrated/branched devices rather than conventional EVAR.

Comparison of treatment options for aortic necks outside standard endovascular aneurysm repair instructions for use.

OBJECTIVE/BACKGROUND: Endovascular aneurysm repair (EVAR) is associated with worse outcomes in patients whose anatomy does not meet the device instructions for use (IFU). However, whether open surgical repair (OSR) and commercially available fenestrated EVAR (Zenith Fenestrated [ZFEN]) represent better options for these patients is unknown. METHODS: We identified all patients without prior aortic surgery undergoing elective repair of abdominal aortic aneurysms with neck length ≥4 mm at a single institution with EVAR, OSR, and ZFEN. We applied device-specific aneurysm neck-related IFU to EVAR patients, and a generic EVAR IFU to ZFEN and OSR patients. Long-term outcomes were studied using propensity scores with inverse probability weighting. We compared outcomes in patients undergoing EVAR by adherence to IFU and outcomes by repair types in the subset of patients not meeting IFU. RESULTS: Of 652 patients (474 EVAR, 34 ZFEN, 143 OSR), 211 had measurements outside of standard EVAR IFU (109 EVAR [23%], 27 ZFEN [80%], and 74 OSR [52%]). Perioperative mortality was 0.5% overall. For EVAR, treatment outside the IFU was associated with significantly higher adjusted rates of long-term type IA endoleak (22% at 5 years compared to 2% within IFU, hazard ratio [HR]: 5.8 [3.1-10.9], P < .001), and lower survival (5- and 10-year survival: 56% and 34% vs 81% and 53%, HR: 2.3 [1.2-4.3], P = .01). There was no difference in reinterventions or open conversion. In patients not meeting IFU, ZFEN was associated with higher adjusted rates of reinterventions (EVAR as referent: HR: 2.6 [1.5-4.4, P < .001), whereas OSR and EVAR patients experienced similar reintervention rates (HR: 0.7 [0.4-1.1], P = .13). Patients outside the IFU experienced lower mortality with OSR compared with either EVAR (HR: 0.4 [0.2-0.9], P = .005) or ZFEN (HR: 0.3 [0.1-0.7], P = .002). When restricted to patients outside the IFU deemed fit for open repair, OSR patients remained associated with lower adjusted mortality compared with ZFEN (HR: 0.2 [0.1-0.5], P < .001), but statistical significance was lost in the comparison to EVAR (HR: 0.6 [0.3-1.1], P = .1). CONCLUSIONS: Treatment outside device-specific IFU is associated with adverse long-term outcomes. Open surgical repair is associated with higher long-term survival in patients who fall outside of the EVAR IFU and should be favored over EVAR or ZFEN in suitable patients. A three-vessel-based fenestrated strategy may not be a durable solution for difficult aortic necks, but more data are needed to evaluate the performance of newer, four-vessel devices.

Clinical competence statement of the Society for Vascular Surgery on training and credentialing for transcarotid artery revascularization.

As the practice of medicine grows in complexity, the process of defining the expertise required for the competent execution of specific procedures has also become complex. The Society for Vascular Surgery therefore constituted a task force to provide informed recommendations on the knowledge, technical skills, resources, and infrastructure required to obtain and to maintain privileges for the safe and effective performance of transcarotid artery revascularization (TCAR). The TCAR procedure is being adopted rapidly, and it is therefore important that informed guidance be available expeditiously. Formal training in the pathophysiology and diagnosis of carotid occlusive disease and all management options is essential. Appropriate diagnostic, imaging, endovascular, surgical, and monitoring infrastructure is required, as are resources to maintain quality control. Credentialing and privileging require a combination of both open surgical and endovascular skills. As such, physicians must have hospital privileges to perform carotid endarterectomy. They should attend an appropriate program for education and simulated training in TCAR. In addition, physicians must have performed ≥25 endovascular procedures as the primary operator using low-profile rapid-exchange platforms plus ≥5 TCAR procedures as the primary operator (pathway 1); or they may have acquired ≥25 endovascular procedures as the primary operator using low-profile rapid-exchange platforms and a supplement of 5 TCAR procedures under proctored guidance if they have not performed sufficient TCAR procedures (pathway 2); or a team of two physicians can collaborate, combining the endovascular and surgical requirements plus at least 5 TCAR procedures under proctored guidance (pathway 3).

Open Tacking of a Migrated Thoracic Endovascular Aortic Graft.

Complications of thoracic endovascular aortic repair (TEVAR) are beginning to emerge as novel vascular issues. While endovascular solutions exist for most, some graft complications require a more traditional open solution. These operations are most commonly performed for endoleak or disease progression. Much less frequently observed is the migration of the endograft requiring open reintervention. Herein we present a case of a proximally migrated TEVAR graft, which required open fixation under deep hypothermic circulatory arrest (DHCA).

Analysis of the ROADSTER pivotal and extended-access cohorts shows excellent 1-year durability of transcarotid stenting with dynamic flow reversal.

OBJECTIVE: We report the 1-year outcomes of the Safety and Efficacy Study for Reverse Flow Used During Carotid Artery Stenting Procedure (ROADSTER) multicenter trial. This trial introduced a novel transcarotid neuroprotection system (NPS), the ENROUTE transcarotid NPS (Silk Road Medical Inc, Sunnyvale, Calif). Postoperative results demonstrated that the use of the ENROUTE transcarotid NPS is safe and effective. The aim of this study was to evaluate the safety of transcarotid artery revascularization (TCAR) and to present the 1-year outcomes. METHODS: This study is a prospective, single-arm clinical trial. Current enrollment occurs in 14 centers. Primary end points were incidence rates of ipsilateral stroke at 1 year after TCAR. Occurrence of stroke was ascertained by an independent Clinical Events Committee. Patients with anatomic or medical high-risk factors for carotid endarterectomy (CEA) were eligible to be enrolled in the ROADSTER trial. RESULTS: Overall, 165 patients were included in the long-term follow-up (112 of 141 patients from the pivotal phase and 53 of 78 patients from the extended access). Mean age was 73.9 years (range, 42.1-91.3 years). Patients aged 75 years and older were 43.3% of the cohort. The majority of patients were white (92.7%) and male (75.2%). Most patients were asymptomatic (79.9%). Anatomic risk factors were distributed as follows: contralateral carotid artery occlusion (11.0%), tandem stenosis of >70% (1.8%), high cervical carotid artery stenosis (25.0%), restenosis after CEA (25.6%), bilateral stenosis requiring treatment (4.3%), and hostile neck (14.6%). Medical high-risk criteria included two-vessel coronary artery disease (14.0%) and severe left ventricular dysfunction with ejection fraction <30% (1.8%). In general, 43.3% of patients had at least one anatomic high-risk factor, whereas 29.9% of patients had medical high-risk factors. Both subsets of factors were present simultaneously in 26.8% of the cohort. At 1-year follow-up, ipsilateral stroke incidence rate was 0.6%, and seven patients (4.2%) died. None of the deaths were neurologic in origin. CONCLUSIONS: TCAR with dynamic flow reversal had previously shown favorable 30-day perioperative outcomes. This excellent performance seems to extend to 1 year after TCAR as illustrated in this analysis. The promising results from the ROADSTER trial likely stem from the novel cerebral protection provided through the ENROUTE transcarotid NPS in comparison to distal embolic protection devices as well as the transcarotid approach's circumventing diseased aortic arch manipulation and minimizing embolization. TCAR offers a safe and durable revascularization option for patients who are deemed to be at high risk for CEA.

Severe contralateral carotid stenosis or occlusion does not have an impact on risk of ipsilateral stroke after carotid endarterectomy.

OBJECTIVE: This study evaluates the impact of severe (>70%) contralateral carotid stenosis or occlusion (SCSO) on outcomes after carotid endarterectomy (CEA). METHODS: Clinical data for all patients undergoing CEA at a single center were prospectively gathered and retrospectively reviewed, with the sample population stratified according to the presence of SCSO. Perioperative outcomes of CEA in the presence of SCSO were analyzed using univariate and multivariate methods. RESULTS: During a 17-year study period, 2945 CEAs were performed on 1843 patients, including 736 (25%) patients with SCSO. Patients identified with SCSO had a higher rate of positive intraoperative electroencephalographic changes (30% vs 16%; P < .0001) and use of an intraoperative shunt (40% vs 28%; P < .0001). Univariate analysis identified SCSO as a risk factor for any stroke (2.8% vs 1.5%; P = .02), death (2.2% vs 1.1%; P = .02), and any stroke/death (4.3% vs 2.4%; P < .0079) but not ipsilateral stroke (1.5% vs 1.2%; P = .38). Multivariable regression demonstrated SCSO as an independent predictor of any stroke (odds ratio [OR], 1.8; 95% confidence interval [CI], 1.0-3.3; P = .05) and any stroke/death (OR, 1.7; 95% CI, 1.1-2.7; P = .02), without increasing risk of ipsilateral stroke (OR, 1.3; 95% CI, 0.6-2.7; P = .54). The presence of SCSO was also associated with a higher risk of late mortality (hazard ratio, 1.3; 95% CI, 1.1-1.4; P < .01). CONCLUSIONS: Although the presence of SCSO is a risk factor for any stroke/death with CEA, it does not increase the risk of ipsilateral stroke. These data suggest that increased attention to perioperative medical and hemodynamic management should be especially considered in this cohort of patients as the observed strokes do not occur in the territory at risk from the surgical procedure.

Early Experience with Fenestrated Endovascular Compared to Open Repair of Complex Abdominal Aortic Aneurysms in a High-Volume Open Aortic Center.

BACKGROUND: Early data suggest that fenestrated endovascular aneurysm repair (FEVAR) is feasible but may have higher morbidity and unclear durability compared to open surgical repair (OSR) of complex abdominal aortic aneurysms (CAAAs). We compared the early experience following elective FEVAR to traditional OSR of CAAA in a high-volume open aortic center. METHODS: All patients undergoing FEVAR and OSR for elective CAAA from 1/2010-7/2015 were identified. Univariate, multivariable logistic, and Cox hazards modeling were used to compare perioperative and intermediate outcomes. RESULTS: We identified 116 patients who underwent CAAA repair (18 FEVAR) with a median follow-up of 26 months. FEVAR patients had higher rates of congestive heart failure (22% vs. 5.1%; P = 0.03). Operative time was slightly longer following FEVAR (282 vs. 240 min, P = 0.02). There was no difference in 30-day operative mortality (0% in both) or major complications. Median intensive care unit (0 vs. 3 days; P < 0.001) and hospital length of stay (2.5 vs. 7 days; P < 0.001) were shorter after FEVAR. Rates of 30-day graft complications (5.6% FEVAR vs. 5.1% OSR, P = 1.0) were similar, and there was no statistically significant difference in rates of graft complications in follow-up (17% vs. 8.2%, P = 0.37). After multivariable modeling, FEVAR patients were more likely to develop late graft-related complications (hazard ratio [HR]; 5.0, 95% confidence interval [CI]: 0.98-25). Kaplan-Meier 1-year survival was similar (100% vs. 92%), even after multivariable adjustment (HR, 0.6; 95% CI: 0.1-5.0). CONCLUSIONS: Early experience in FEVAR at a high-volume open aortic center shows that FEVAR can be performed safely with comparable perioperative risk to OSR. FEVAR may be associated with graft complications during follow-up, which should be considered in clinical decision-making. Further study is warranted to better elucidate late durability of FEVAR and the impact of the learning curve on outcomes.

Technical aspects of transcarotid artery revascularization using the ENROUTE transcarotid neuroprotection and stent system.

Transcarotid artery revascularization (TCAR) with the ENROUTE transcarotid neuroprotection and stent system (Silk Road Medical, Inc, Sunnyvale, Calif) combines surgical principles of neuroprotection with less invasive endovascular techniques to treat high grade stenosis in the carotid artery. The ENROUTE Neuroprotection System allows the surgeon to directly access the common carotid artery to initiate high rate temporary blood flow reversal to protect the brain while performing carotid angioplasty and stenting. Unprotected catheterization of the arch and lesion is, thus, avoided. Pivotal data from the Safety and Efficacy Study for Reverse Flow Used During Carotid Artery Stenting Procedure (ROADSTER) study of high-risk patients undergoing TCAR have showed a low stroke rate compared with other prospective trials of endovascular carotid intervention. The aim of this article is to provide specific technical details of TCAR.

Initial and midterm results of the Bolton Relay Thoracic Aortic Endovascular Pivotal Trial.

OBJECTIVE: To report the initial and midterm results of the Bolton Relay Thoracic Stent Graft for the endovascular treatment of thoracic aortic lesions [thoracic endovascular aortic repair (TEVAR)]. METHODS: The Bolton Relay Thoracic Aortic Endovascular Pivotal Trial was a prospective, nonrandomized, multicenter, U.S. Investigational Device Exemption study conducted at 27 U.S. investigational sites. One hundred twenty TEVAR subjects were treated with the Relay device between January 2007 and May 2010, with 13 patients enrolled during the continued access phase through September 2012. TEVAR outcomes were compared with a prospectively and retrospectively enrolled surgical cohort consisting of 60 patients enrolled under similar inclusion/exclusion criteria. Follow-up examinations were prescribed at 1 month, 6 months, and yearly thereafter for 5 years. Major adverse events (MAEs) included stroke, paralysis/paraplegia, myocardial infarction, procedural bleeding, respiratory failure, renal failure, wound healing complications, and aneurysm-related mortality. RESULTS: Stent grafts were successfully delivered and deployed in 129 of 133 patients (97.0%). At 30 days, a lower rate of mortality was observed in the TEVAR arm (5.3% vs 10.0%; P = .230), and TEVAR was associated with a significantly lower rate of MAEs (20.3% vs 48.3%; P < .001), primarily driven by a lower frequency of respiratory failure in the cohort (5.5% vs 21.6%; P = .007) and procedural bleeding. Freedom from aneurysm-related mortality through 5 years was similar at 91.3% for the TEVAR cohort and 89.4% for the surgical cohort (P = .406); with 5-year freedom from all-cause mortality at 57.1% and 50.2% (P = .289), respectively. Freedom from MAEs through 5 years was significantly higher in the TEVAR cohort (65.7% vs 44.7%; P = .001). Six TEVAR patients (4.5%) experienced core laboratory-reported type I or III endoleaks, and secondary procedures were performed in 10 patients (7.5%), with seven procedures to correct endoleak and one surgical conversion. Endograft migration occurred in three patients (2.3%) and wireform fractures were assessed in two patients (1.5%). Aneurysm sac size decreased or remained stable in 113 patients (85.0%) over 5-year follow-up. There were no instances of rupture or endograft occlusion. A 38-subject subset treated with the newer Relay Plus Delivery System had a significantly reduced MAE rate (15.8% vs 35.8%; P = .035), and fewer perioperative strokes (2.6% vs 12.6%; P = .108). CONCLUSIONS: Data from the Relay TEVAR clinical trial demonstrate safety and effectiveness of the Relay device compared with surgical controls, indicating continued device durability with a low rate of device-related complications through 5 years.

Chronic Kidney Disease Class Predicts Mortality After Abdominal Aortic Aneurysm Repair in Propensity-matched Cohorts From the Medicare Population.

INTRODUCTION: Chronic kidney disease (CKD) predicts mortality after abdominal aortic aneurysm (AAA) repair. Few studies are adequately powered to stratify outcomes by CKD severity. This study assesses the effect of CKD severity on survival after AAA repair. METHODS: Patients who underwent AAA repair from 2006 to 2007 were retrospectively identified in the Medicare database and stratified by CKD class as follows: normal (CKD class 1 and 2), moderate (CKD class 3), and severe (CKD class 4 and 5). Propensity matching (30:1) by clinical factors and procedure type was performed to derive well-matched comparative cohorts. Primary outcomes were 30-day and long-term mortality; secondary outcomes included hospital length of stay and cost. RESULTS: A total of 47,715 patients were included (96.7% normal, 1.88% moderate, and 1.65% severe). Propensity matching was corrected for differences between cohorts. Thirty-day mortality was higher in moderate (5.7% vs normal 2.5%; P < 0.01) and severe (9.9% vs normal 1.8%; P < 0.01) groups. Hospital length of stay increased with CKD severity (4.4 ±â€Š3.7 days normal vs 6.5 ±â€Š4.2 days moderate CKD; P < 0.01/4.7 ±â€Š3.8 days normal vs 9.1 ±â€Š4.5 days severe CKD; P < 0.01) as did cost ($23 ±â€Š14K normal vs $25 ±â€Š16K moderate; P < 0.01 /$22 ±â€Š11K normal vs $29 ±â€Š22K severe; P < 0.01). Three-year survival favored the normal cohort (80% vs 64% moderate; log rank P < 0.01 /82% normal vs 44% severe; log rank P < 0.01). CONCLUSIONS: CKD severity is an important predictor of perioperative mortality and long-term survival after AAA repair in propensity-matched cohorts. The 5-fold increase in 30-day mortality and 44% in 3-year survival suggest that elective AAA repair is contraindicated in most severe CKD patients.

Retrograde stenting of proximal lesions with carotid endarterectomy increases risk.

OBJECTIVE: Concomitant carotid bifurcation and proximal ipsilateral arch branch disease is uncommon. A combined approach using carotid endarterectomy (CEA) with ipsilateral proximal endovascular (IPE) intervention (CEA+IPE) has been proposed as safe and durable, with similar results to isolated CEA. This study was conducted to identify diagnostic modalities and outcomes of this uncommon procedure at our institution. METHODS: Operative records were used to identify patients who underwent CEA+IPE between May 2003 and July 2014. Patients were excluded if they underwent open retrograde access for endovascular intervention only, without CEA. The primary end points were freedom from neurologic event and need for reintervention. RESULTS: Twenty-three patients (15 women [65%]) underwent CEA+IPE. Mean clinical follow-up was 44 ± 35 months. Average age was 69 ± 9 years. Most patients (22 [96%]) were taking a statin and at least one antiplatelet agent. Bilateral internal carotid stenosis (>50%) was present in 12 patients (52%), and eight (35%) were symptomatic. Seven patients (30%) had prior ipsilateral CEA. All patients underwent preoperative carotid duplex and axial imaging. Computed tomography angiography was the initial imaging assessment in 10 patients (43%). The proximal lesion was identified in 19 (83%) by blunted waveforms on carotid duplex. Most bifurcation operations were CEA with patch (20 [87%]), and 21 (91%) underwent the bifurcation procedure first, followed by IPE. All IPE included balloon-expandable stenting (22 of 23 [96%] bare-metal, 7 [30%] innominate artery, 16 [70%] left common carotid artery). Electroencephalographic changes occurred in two patients (9%). Shunting was used in three (13%). Three vessel dissections (13%) occurred at the IPE site; two required further stenting and one was complicated by stroke and death. There were two perioperative strokes (9%) and one death (4%). Mean imaging follow-up was 30.6. ± 27.2 months, with restenosis identified in five patients (23%; four bifurcation, one IPE in-stent). One patient required open reintervention with subclavian-carotid bypass at 13 months for recurrent transient ischemic attack. The 4-year actuarial survival was 85%. Stroke-free survival and freedom from reintervention were 80% and 90% at 36 months, respectively. CONCLUSIONS: The stroke and death rate for CEA+IPE is higher than that of isolated CEA at our institution. Duplex findings can suggest proximal stenosis; however, confirmation with physical examination in conjunction with axial imaging are integral. This combined treatment strategy should be reserved for those with evident hemodynamically significant proximal stenosis and approached with caution in asymptomatic patients.

The natural history of splanchnic artery aneurysms and outcomes after operative intervention.

OBJECTIVE: Splanchnic artery aneurysms (SAAs) are uncommon, and standards for surveillance and intervention are lacking. The goal of this study was to review our 20-year experience with managing SAAs. METHODS: The Research Patient Data Registry at the Massachusetts General Hospital was queried, and all patients with SAAs identified by axial imaging from 1994 to 2014 were included. Aneurysms were stratified into two cohorts: those that underwent early intervention (<6 months after lesion discovery) and those that received surveillance. Primary study end points included aneurysm growth or rupture during surveillance and patient 30-day morbidity or mortality after aneurysm repair. RESULTS: There were 264 SAAs identified in 250 patients. In 166 patients, 176 SAAs (66.6%) were placed into the surveillance cohort; 38 SAAs (21.6%) did not have subsequent axial imaging and were considered lost to follow-up. Mean aneurysm size in the surveillance cohort at first imaging study was 16.28 mm (8-41 mm), and mean surveillance time was 36.1 months (2-155 months); 126 SAAs (91.3%) remained stable in size over time, and 8 SAAs (5.8%) required intervention for aneurysm growth after a mean of 24 months. There were no ruptures in the surveillance cohort. There were 88 SAAs (33.3%) repaired early. Mean size of SAAs that were repaired early was 31.1 mm (10-140 mm). For intact SAAs, 30-day morbidity and mortality rates after repair were 13% and 3%, respectively. In the early repair cohort, 13 SAAs (14.7%) were ruptured at presentation. The 30-day morbidity and mortality rates after rupture were 54% and 8%, respectively. Five ruptured SAAs (38%) were anatomically located in the pancreaticoduodenal arcade. On univariate analysis, pancreaticoduodenal aneurysms were strongly associated with rupture (P = .0002). CONCLUSIONS: Small SAAs (≤25 mm) are not prone to significant expansion and do not require frequent surveillance imaging. Imaging every 3 years for small SAAs is adequate. Aneurysms of the pancreaticoduodenal arcade and gastroduodenal aneurysms are more likely to rupture and therefore warrant a more aggressive interventional approach.

The presentation and management of aneurysms of the pancreaticoduodenal arcade.

OBJECTIVE: Gastroduodenal artery aneurysms (GDAAs) and pancreaticoduodenal artery aneurysms (PDAAs) are uncommon lesions associated, however, with a significant risk of rupture. This study describes the clinical presentation, associated imaging findings, and operative strategies for these aneurysms. METHODS: The records of all patients with GDAAs or PDAAs identified through an institutional database by axial imaging between 1994 and 2014 were retrospectively reviewed. Data on presenting symptoms, comorbid conditions, imaging findings, and outcomes after operative intervention were collected and examined. RESULTS: We identified 11 GDAAs and 25 PDAAs in 35 patients. Mean size of the GDAAs was 31.1 mm (range, 10-60 mm) and mean size of the PDAAs was 19.1 mm (range, 10-48 mm). At presentation, 13 aneurysms (36%) were symptomatic and seven aneurysms (19.4%) were ruptured. Median size of ruptured aneurysms was 20 mm (range, 10-60 mm). On axial imaging, 24 aneurysms (67%) were associated with a severe stenosis or occlusion of the celiac axis origin, and 11 aneurysms (31%) were thought to be associated with compression of the celiac axis in the setting of median arcuate ligament syndrome. Twenty-four aneurysms (67%) underwent repair. Of these aneurysms, 18 (75%) were successfully managed with primary endovascular repair (coil embolization with or without celiac stent), whereas endovascular therapy failed in two (8%) and required open repair. Four aneurysms (17%) were treated with primary open repair. Overall 30-day morbidity and mortality after aneurysm repair were 29% and 4%, respectively. CONCLUSIONS: GDAAs and PDAAs are uncommon lesions that are often associated with a celiac axis stenosis/occlusion leading to altered hemodynamics in the pancreaticoduodenal arcade. These aneurysms are prone to rupture regardless of size, and intervention is accordingly recommended for all aneurysms upon recognition. Despite the concordant celiac axis obstruction and concern for maintenance of hepatic circulation, endovascular repair of these aneurysms is generally successful and should be considered as the initial operative approach.

Results of the ROADSTER multicenter trial of transcarotid stenting with dynamic flow reversal.

OBJECTIVE: This report presents the 30-day results of the Safety and Efficacy Study for Reverse Flow Used During Carotid Artery Stenting Procedure (ROADSTER) multicenter trial and evaluates the safety and efficacy of ENROUTE Transcarotid NPS (Silk Road Medical Inc, Sunnyvale, Calif), a novel transcarotid neuroprotection system that provides direct surgical common carotid access and cerebral embolic protection via high-rate flow reversal during carotid artery stenting (CAS). METHODS: A prospective, single-arm, multicenter clinical trial was performed to evaluate the use of the ENROUTE Transcarotid NPS during CAS procedures performed in patients considered to be at high risk for complications from carotid endarterectomy. Symptomatic patients with ≥50% stenosis and asymptomatic patients with ≥70% stenosis were eligible to be treated with any U.S. Food and Drug Administration-approved carotid artery stent. The primary end point was the composite of all stroke, myocardial infarction (MI), and death at 30 days postprocedure as defined in the Food and Drug Administration-approved study protocol. Secondary end points included cranial nerve injury; 30-day stroke, death, stroke/death, and MI; acute device, technical, and procedural success; and access site complications. All major adverse events were adjudicated by an independent clinical events committee. RESULTS: Between November 2012 and July 2014, 208 patients were enrolled at 18 sites. Sixty-seven patients were enrolled as lead-in cases, and 141 were enrolled in the pivotal phase. In the pivotal cohort, 26% were symptomatic and 75% were asymptomatic. Acute device and technical success were 99% (140 of 141). By hierarchical analysis, the all-stroke rate in the pivotal group was 1.4% (2 of 141), stroke and death was 2.8% (4 of 141), and stroke, death and MI was 3.5% (5 of 141). One patient (0.7%) experienced postoperative hoarseness from potential Xth cranial nerve injury, which completely resolved at the 6-month follow-up visit. CONCLUSIONS: The results of the ROADSTER trial demonstrate that the use of the ENROUTE Transcarotid NPS is safe and effective at preventing stroke during CAS. The overall stroke rate of 1.4% is the lowest reported to date for any prospective, multicenter clinical trial of CAS.