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

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

Treatment of Carotid Restenosis Using Transcarotid Revascularization.

OBJECTIVE: Transcarotid artery revascularization (TCAR) using the ENROUTE Neuroprotection System (Silk Road Medical) is a United States Food and Drug Administration-approved treatment modality for stroke risk reduction in the setting of carotid artery stenosis. The goal of this investigation was to define the real-world outcomes associated with the application of this technique to patients presenting with restenosis after previous carotid endarterectomy (CEA) or transfemoral carotid artery stenting (TF-CAS). METHODS: Retrospective review of prospectively maintained institutional databases capturing all nontrial TCARs performed between August 2013 and July 2018 using the ENROUTE Neuroprotection System was completed at 3 unaffiliated hospital systems and unified for descriptive outcomes analysis. RESULTS: During the study period, 237 combined TCARs were performed at our respective institutions. Of these procedures, 55 stents were implanted for the indication of restenosis after previous carotid revascularization (47 CEA, 8 TF-CAS). Within the 30-day perioperative period, we observed no ipsilateral strokes or deaths; one patient experienced perioperative myocardial infarction (MI; 1.8%). We noted a 4.8% incidence of postoperative hematoma, but none of these events were clinically significant as no reinterventions were performed in any of the 55 patients. Additionally, we did not observe any cases of stent thrombosis or pulmonary embolus. Mean length of stay was 2.2 ± 2.8 days. Our mean follow-up duration was 15.0 ± 9.2 months. Throughout the follow-up period, we did not observe any additional stroke or MI events. Additionally, there were no cases of in-stent restenosis, thrombosis, or reinterventions. CONCLUSION: Transcarotid artery revascularization can be performed in patients with restenotic carotid arteries with acceptable rates of ipsilateral stroke, MI, and death as demonstrated in this small multi-institutional series.

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

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

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

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

Novel Application of Transcarotid Artery Stenting With Dynamic Flow Reversal for Treatment of Symptomatic Tandem Carotid Artery Lesions Via an Ascending Aorta to Common Carotid Artery Bypass Graft.

The treatment of patients with symptomatic tandem lesions of their carotid artery is challenging. One solution is carotid endarterectomy with retrograde ipsilateral proximal endovascular intervention, but it is associated with a higher postoperative risk of stroke. Unfortunately, symptomatic patients with tandem lesions often present with stenotic, calcified supra-aortic arch vessels and require multiple modalities to adequately revascularize including staged approaches or hybrid procedures. Herein, we report the successful treatment of a symptomatic 76-year-old female with a calcific severe stenosis of her innominate artery treated by a prosthetic bypass graft from her ascending aorta to proximal common carotid artery, interval ligation, and use of TransCarotid artery revascularization with reverse-flow to treat her proximal internal carotid artery stenosis via this bypass graft.