Clopidogrel versus ticagrelor for antiplatelet therapy in transcarotid artery revascularization in the Society for Vascular Surgery Vascular Quality Initiative.

OBJECTIVE: Transcarotid artery revascularization (TCAR) with dynamic flow reversal is a hybrid technique for operative management of carotid artery stenosis. Dual antiplatelet therapy is recommended for patients undergoing TCAR; however, nonresponders to these medications may be predisposed to perioperative thromboembolic complications. Prevalent in up to 44% to 66% of patients taking clopidogrel, high on-treatment platelet reactivity may thus be responsible for a portion of adverse cerebrovascular events in TCAR. A previous single-institution study has demonstrated the use of ticagrelor as a viable alternative to clopidogrel for antiplatelet therapy in patients undergoing TCAR; however, large-scale comparisons between clopidogrel and ticagrelor are needed to confirm the safety of ticagrelor outside of highly selected patients and providers. METHODS: Data from patients enrolled in the Society for Vascular Surgery Vascular Quality Initiative undergoing TCAR with a perioperative antiplatelet therapy regimen including either clopidogrel or ticagrelor from January 2015 to March 2021 were analyzed and compared. Multivariable logistic regression and propensity score matching were used to evaluate the primary 30-day outcomes of stroke, major bleeding event, and combined stroke/myocardial infarction (MI)/death rate while adjusting for baseline characteristics of the patients. RESULTS: A total of 11,973 patients underwent TCAR with a dual antiplatelet therapy regimen that included clopidogrel vs 426 patients with ticagrelor. Compared with patients on clopidogrel, patients on ticagrelor were significantly more likely to have coronary artery disease (51% vs 66%; P < .001), particularly unstable angina or MI within 6 months (3% vs 9%; P < .001), and more likely to have insulin-dependent diabetes mellitus (14% vs 19%; P < .001). The unadjusted 30-day rates of stroke, major bleeding, and combined stroke/MI/death were not statistically significant among both groups (1.3% vs 0.5%; P = .14, 2.4% vs 1.4%; P = .18, and 1.9% vs 1.6%; P = .71], respectively). After multivariable adjustment and propensity matching, these remained statistically insignificant. CONCLUSIONS: Despite a substantially higher medical risk in patients undergoing TCAR with ticagrelor, 30-day rates of stroke, major bleeding events, and combined stroke/MI/death were similar between patients on ticagrelor and clopidogrel as part of adjunctive antiplatelet therapy. Randomized prospective trials, and studies with larger sample sizes and longer follow-up will be needed to better examine the outcome differences in TCAR between these two medications.

Cerebral monitoring during transcarotid artery revascularization with flow reversal via transcranial doppler ultrasound examination.

OBJECTIVE: Transcarotid artery revascularization (TCAR) is a hybrid technique for carotid artery revascularization that relies on proximal carotid occlusion with flow reversal for distal embolic protection. The hemodynamic response of the intracranial circulation to flow reversal is unknown. In addition, the rate and pattern of cerebral embolization during flow reversal has yet to be investigated. The aim of this study was to characterize cerebral hemodynamic and embolization patterns during TCAR. METHODS: A single-institution retrospective study of patients with carotid artery stenosis undergoing TCAR with intraoperative transcranial Doppler (TCD) monitoring of the middle cerebral artery (MCA) was performed. Primary outcomes included changes in MCA velocity and MCA embolic signals observed throughout TCAR. RESULTS: Eleven patients underwent TCAR with TCD monitoring of the ipsilateral MCA. The average MCA velocity at baseline was 50.6 ± 16.4 cm/s. MCA flow decreased significantly upon initiation of flow reversal (50.5 ± 16.4 cm/s vs 19.1 ± 18.4 cm/s; P = .02). The reinitiation of antegrade flow resulted in a significant increase in the number of embolic events compared with baseline (P = .003), and embolic events were observed in two patients during flow reversal. CONCLUSIONS: TCD monitoring of patients undergoing TCAR revealed that the initiation of flow reversal results in a decrement in ipsilateral MCA velocity. Furthermore, embolic events can occur during flow reversal and are significantly associated with the reinitiation of antegrade flow in the internal carotid artery. However, both of these hemodynamic events were well-tolerated in our cohort. These findings suggest that TCAR remains a safe neuroprotective strategy for carotid revascularization.

Outcomes and strategy of tailored antiplatelet therapy with ticagrelor in patients undergoing transcarotid artery revascularization.

OBJECTIVE: Antiplatelet drug resistance is associated with periprocedural ischemic complications in patients undergoing intravascular stent implantation. Nonresponders are subject to increased risk of stent thrombosis and in-stent stenosis, and high on-treatment platelet reactivity (HTPR) is present in up to 44% of patients taking clopidogrel, a widely used component of dual antiplatelet therapy (DAPT). Evidence points to ticagrelor as a viable alternative to overcome HTPR on clopidogrel. Studies have shown fewer thromboembolic events with ticagrelor therapy; however, results on bleeding risk are mixed, and its safety and efficacy in hybrid operative techniques have yet to be established. Transcarotid artery revascularization (TCAR) is a hybrid procedure to treat severe carotid stenosis. The objective of this study was to establish the safety and efficacy of ticagrelor as part of DAPT in patients undergoing TCAR and to develop a protocol to ensure adequate antithrombotic protection throughout the operative course. METHODS: Data were collected retrospectively for patients undergoing TCAR on DAPT of aspirin and ticagrelor for symptomatic (≥50%) or asymptomatic (≥80%) carotid stenosis. Preoperative platelet reactivity was determined using Thromboelastography with Platelet Mapping (Haemonetics Corporation, Braintree, Mass), with adequate platelet reactivity defined as maximal amplitude produced by adenosine diphosphate <50 mm. The primary safety end point was 30-day major bleeding event rate. Primary efficacy end points were 30-day incidence of ipsilateral cerebrovascular ischemic event (stroke or transient ischemic attack), myocardial infarction, and death. Secondary end points were postoperative length of hospital stay, procedure time, and clamp/flow reversal time. RESULTS: Sixty-seven TCAR procedures with patients receiving periprocedural DAPT of ticagrelor and aspirin were performed during the study period. Patients had an average age of 79 years, and 28 (42%) were symptomatic. The mean procedure time was 45.8 ± 9.2 minutes, with a mean clamp/flow reversal time of 4.8 ± 1.5 minutes, and mean postoperative length of hospital stay of 3.1 ± 2.2 days for inpatients and 1.3 ± 0.8 days for outpatients. Technical success was achieved in all cases, with no 30-day major bleeding events and no occurrence of ipsilateral cerebrovascular ischemic event, myocardial infarction, or death. CONCLUSIONS: Initial experience with ticagrelor as part of DAPT in patients undergoing TCAR demonstrated its safety and efficacy in both symptomatic and asymptomatic disease. No bleeding events or thromboembolic complications occurred. Furthermore, a protocol to administer ticagrelor to assay for HTPR on ticagrelor and consequent medication and patient management is proposed. Ticagrelor may represent a safe and effective alternative to overcome clopidogrel nonresponsiveness in DAPT regimens for TCAR.

Risk factors and impact of postoperative hypotension after carotid artery stenting in the Vascular Quality Initiative.

OBJECTIVE: Hypotension is a frequent complication of carotid artery stenting (CAS). Although common, its occurrence is unpredictable, and association with adverse events has not been well defined. The aim of this study was to identify predictors of postoperative hypotension after CAS and the association with stroke/transient ischemic attack (TIA), major adverse cardiac events (MACEs), increased length of stay (LOS), and in-hospital mortality. METHODS: This is a retrospective analysis of all CAS procedures, including transfemoral CAS (TF-CAS) and transcarotid artery revascularization (TCAR), performed in the Vascular Quality Initiative between 2003 and 2018. The primary study end point was postoperative hypotension, defined as hypotension treated with continuous infusion of a vasoactive agent for ≥15 minutes. Secondary end points included any postoperative neurologic events (stroke/TIA), MACEs (myocardial infarction, congestive heart failure, and dysrhythmias), prolonged LOS (>1 day), and in-hospital mortality. Patients' demographics predictive of hypotension were determined by multivariable logistic regression, and a risk score was developed for correlation with outcomes. RESULTS: During the time period of study, 24,699 patients underwent CAS; 19,716 (80%) were TF-CAS, 3879 (16%) were TCAR, and 1104 (4%) were not defined. Fifty-six percent were for symptomatic disease, 75% were for a primary atherosclerotic lesion, and 72% were performed under local or regional anesthesia. Postoperative hypotension occurred in 15% of TF-CAS and 14% of TCAR patients (P = .50). Patients with hypotension (vs no hypotension) had higher rates of stroke/TIA (7.3% vs 2.6%; P < .001), MACEs (9.6% vs 2.1%; P < .001), prolonged LOS (65% vs 28%; P < .001), and in-hospital mortality (2.9% vs 0.7%; P < .001). By multivariable analysis, risk factors associated with hypotension included an atherosclerotic (vs restenotic) lesion (odds ratio, 2.2; 95% confidence interval, 2.0-2.4; P < .001), female sex (1.3 [1.2-1.4]; P < .001), positive stress test result (1.3 [1.2-1.4]; P < .001), age 70 to 79 years (1.1 [1.1-1.3]; P < .002), age >80 years (1.2 [1.1-1.4]; P < .001), history of myocardial infarction or angina (1.3 [1.2-1.4]; P < .001), and an urgent (vs elective) procedure (1.1 [1.0-1.2]; P < .01). A history of hypertension was protective (0.9 [0.8-0.9]; P < .02). A normalized risk score for hypotension was created from the multivariable model. Increasing risk scores correlated directly with rates of adverse events, including postoperative stroke/TIA, MACEs, increased LOS, and increased in-hospital mortality. CONCLUSIONS: Hypotension after CAS is associated with adverse neurologic and cardiac events as well as with prolonged LOS and in-hospital mortality. A scoring tool may be valuable in stratifying patients at risk. Interventions aimed at preventing postoperative hypotension may improve outcomes with CAS.

Endovascular stenting of supra-aortic lesions using a transcarotid retrograde approach and flow reversal: A multicenter case series.

OBJECTIVE: Endovascular treatment has largely replaced open reconstruction of proximal brachiocephalic and left common carotid ostial arterial stenoses. The objective of this study was to report the technical feasibility and safety of a flow-based embolic protection system in stenting of single and tandem stenotic lesions of supra-aortic arch vessels. METHODS: All cases used flow-based neuroprotection by the ENROUTE Transcarotid Neuroprotection System (Silk Road Medical, Sunnyvale, Calif). Case specifics, such as the stents used, the details of flow-based neuroprotection, the order in which lesions were treated, and the case-specific exceptions, are detailed in the body of the publication. The primary end point of this study was the occurrence of stroke or transient ischemic attack. RESULTS: Sixteen patients (12 women) with an average age of 68 years (range, 54-83 years) underwent endovascular stenting to treat single (11 patients) or tandem (5 patients) stenotic lesions of supra-aortic arch vessels. A total of 21 lesions were treated: 7 in the innominate artery, 1 in the right common carotid artery, 8 in the left common carotid artery, and 5 in the internal carotid artery (tandem cases). Eleven patients (69%) were symptomatic, and the stenoses of the five asymptomatic patients were identified during routine workup for comorbidities. Technical success was obtained in all cases. There were no strokes or transient ischemic attacks during the 30 days after the procedure. Minor complications included a minor wound dehiscence that healed secondarily without sequelae and a hematoma at the neck incision that resolved spontaneously without further intervention. CONCLUSIONS: The use of a transcarotid retrograde approach with flow-based neuroprotection is technically feasible for the endovascular stenting of single and tandem stenotic lesions of the supra-aortic arch vessels. These data further support the advantages of a transcarotid approach and flow-based neuroprotection to minimize the risk of intraoperative complications and embolic events during and after the procedure.

Transcarotid Artery Revascularization (TCAR): The Best Surgical Intervention Option in an Unusual Presentation of Carotid Dissection in a 37-Year-Old Pregnant Female.

Carotid artery dissection (CAD) is a condition that compromises blood flow and leads to serious complications such as a stroke or cerebrovascular accident (CVA). This case report demonstrates an unusual case of right internal carotid artery dissection, stenosis of >70%, and an intraluminal thrombus. The patient presented to the emergency department with complaints of right-sided neck pain and severe headache status-post a complicated pregnancy. A computed tomography (CT) angiogram of the right carotid was conducted and showed a right internal carotid artery dissection with 70% luminal stenosis and thrombosis. Carotid endarterectomy (CEA), transfemoral carotid angioplasty with stenting (CAS), or transcarotid artery revascularization (TCAR) were all surgical intervention options that were explored. Risks and benefits were compared between the three surgical intervention options, and transcarotid artery revascularization was deemed the best surgical option in this patient's case.

Rescue of immediate post-transcarotid artery revascularization carotid stent thrombosis due to clopidogrel resistance using flow-reversal and aspiration thrombectomy.

An 84-year-old patient developed immediate thrombosis of his carotid stent in recovery after transcarotid artery revascularization. In the present report, the technical details about intraoperative management for neurovascular rescue using the transcarotid artery revascularization flow-reversal system are described. The patient was determined to have clopidogrel resistance. Intraoperative medical management is also discussed. The current alternative intravenous and oral antiplatelet therapies such as glycoprotein IIb/IIIa and P2Y12 inhibitors are explored. The debate regarding preoperative antiplatelet resistance testing remains ambiguous, and increasing studies have demonstrated the safety and efficacy of alternatives to clopidogrel. Despite an unpredictable and devastating complication, the patient's outcome was successful using contemporary strategies.

Update on Management of Symptomatic Carotid Stenosis.

Carotid artery stenosis (CAS) is one of the leading causes of cerebral ischemia and stroke.7 When plaque builds up in the internal carotid artery, it blocks blood flow to the brain. Oftentimes, this condition only comes to light after a patient experiences a stroke or stroke-like symptoms. When this occurs, cholesterol-lowering medications and blood thinners can help to increase blood flow to the brain. However, if the plaque is so large that it severely narrows the lumen of the artery, surgery may be required to restore blood flow to the brain. Patients with severe stenosis can undergo procedures such as carotid endarterectomies (CEA), stenting, and transcarotid artery revascularization (TCAR) for this purpose. In this review, we discuss these procedures and which patients warrant which type of intervention. We look at the pathophysiology of internal carotid artery stenosis and current treatment options, while highlighting emerging treatment options. This review aims to increase understanding of the management of symptomatic carotid artery stenosis as well as provide a groundwork for more innovative treatments.

Estimated Cost of Transcarotid Arterial Revascularization Compared With Carotid Endarterectomy and Transfemoral Carotid Stenting.

Objectives Transcarotid arterial revascularization (TCAR) is associated with a lower risk of stroke or death than transfemoral carotid artery stenting (TF-CAS). TCAR infers a lower risk of cranial nerve injury and a similar risk of myocardial infarction (MI) than carotid endarterectomy (CEA). There have been no comparative studies on the cost of TCAR, TF-CAS, and CEA, which may have important implications for institutional support for the new modality to address carotid artery stenosis. Our aim was to compare the estimated cost profiles of TCAR, TF-CAS, and CEA. Methods A review was performed on Medicare patients who underwent TCAR, TF-CAS, or CEA between January 1, 2020, and December 31, 2020. Demographics, comorbidities, operative details, and postoperative complications were reviewed. Acute stroke presentations and elective procedures were included. Cost data were obtained from the hospital's finance department. Quantitative variables were compared using analysis of variance, and categorical variables were compared using the chi-square analysis. Results In total, 21 TCAR, 97 TF-CAS, and 26 CEA patients were initially identified. After removing the non-Medicare patients, 17 TCAR, 57 TF-CAS, and 13 CEA patients were included in the analysis. In-hospital stroke, MI, and mortality included three deaths in TF-CAS patients. At 30 days, the stroke rates for TCAR, TF-CAS, and CEA groups were 0%, 1.8%, and 0%, respectively. The payments for TCAR, TF-CAS, and CEA were $15,400 ± 2,100, $23,400 ± 11,800 and $14,300 ± 5,700 (p=0.001), respectively. The estimated costs for TCAR, TF-CAS, and CEA were $10,500 ± 3,300, $13,800 ± 14,300, and $12,400 ± 6,000 (p=0.575), respectively. The profit margins for TCAR, TF-CAS, and CEA were $5,100 ± 3,100, $9,600 ± 12,100, and $1,900 ± 6,400 (p=0.032), respectively. There was no significant difference in American Society of Anesthesiologists (ASA) scores (p=0.635) or age (p=0.485) among the three groups. The length of hospital stay was not significantly different (p=0.107). The TF-CAS maintained the highest profit margin (p<0.001) when matched for the same diagnosis-related code (without complications or comorbidities). Urgency classification within the TF-CAS group included 45 elective, four urgent, and eight emergent cases. The profit margin was significantly higher for the elective group than for the emergent group (p=0.002) but not different for elective versus urgent (p=0.503) or urgent versus emergent (p=0.102). All patients who underwent TCAR and CEA were elective. Conclusion The hospital reimbursement and profit margins are higher for TF-CAS than for TCAR. With the increasing data now demonstrating similar outcomes with TF-CAS and CEA, further research is required to examine the long-term cost-effectiveness of TCAR and how this will compare to TF-CAS.

The Efficacy of Transcarotid Artery Revascularization With Flow Reversal System Compared to Carotid Endarterectomy: A Systematic Review and Meta-Analysis.

Background: Carotid artery stenosis has long been a critical cause of stroke and death, and it can seriously affect the life quality. Transcarotid artery revascularization (TCAR) and carotid endarterectomy (CEA) are both feasible therapies for this disease. This systematic review and meta-analysis aim to evaluate if the efficacy of the two approaches is comparable. Methods: Clinical studies up to March 2021 were searched through PubMed, Embase, and Scopus from a computer. The screening process was designed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) statement. Newcastle-Ottawa Scale (NOS) was used for methodological quality assessment of works of literature meeting the inclusion criteria, and Review Manager 5.4 was used for data synthesis. The I2 statistic was performed to measure the heterogeneity, and M-H/I-V fixed or random model was utilized depending on the I2 value. The evidence evaluation was accomplished based on grades of recommendation, assessment, development, and evaluation (GRADE) online tool. Results: A total of 14,200 subjects (six comparative studies) were finally included in this pooled study. There is no statistical discrepancy between the two treatments on reducing stroke/death/myocardial infarction (odds ratio [OR] 0.85, 95% CI 0.67-1.07), stroke (OR 1.03, 95% CI 0.77-1.37), or death (OR 1.14, 95% CI 0.67-1.94). Besides, TCAR is associated with a lower incidence of myocardial infarction (P = 0.004), cranial nerve injury (P < 0.00001), and shorter procedure time (P < 0.00001) than CEA among the overall cohort. Conclusions: TCAR is a rapidly developing treatment that reaches a comparable prognosis to CEA and significantly reduces the risk of myocardial infarction under the well-matched condition, which is a dependable choice for patients with carotid stenosis.

Anesthetic Considerations for Transcarotid Artery Revascularization: Experience and Review of Forty Cases From a Single Medical Center.

Transcarotid artery revascularization (TCAR) procedure is a novel hybrid surgical modality in treating carotid stenosis. Understanding the various steps of the TCAR and the unique challenges involved in the anesthetic management is essential for the successful conduct of anesthesia. In this article, we discuss the overview of the key issues relevant to the anesthetic management and strategies from our experience. We present the data on anesthetic management and outcomes of 40 patients who underwent TCAR procedure at our institute between June 2018 and February 2020. Electronic medical records were retrospectively reviewed and relevant demographic, clinical, and laboratory data were collected. All our patients had general anesthesia with an endotracheal tube utilizing standard American Society of Anesthesiology (ASA) monitoring along with intra-arterial blood pressure monitoring and cerebral oximetry. The mean age of our patients was 73.6 ± 7.58 years. Fifteen (37.5 %) patients had significant co-morbidities, thus classified as ASA 4 and 10 (25%) patients were on at least three antihypertensives (beta-blockers, calcium channel blockers, angiotensin-converting enzyme inhibitors, loop diuretics, thiazides). Thirty-four (85%) patients were considered to have symptomatic carotid stenosis which was the predominant indication for the TCAR procedure. Patients who had episodes of transient ischemic attack (TIA) or a cerebrovascular accident (CVA) documented by a computerized tomography (CT) scan of the brain and/or residual weakness are considered symptomatic. Thirty-six (90%) of our patients received a bolus dose of 0.2 - 0.4 mg of glycopyrrolate for maintaining heart rate of around 70 beats per minute (BPM) and 38 (95%) received phenylephrine infusion during the carotid clamp to maintain blood pressure between 140 and 160 mm Hg systolic or at patients' baseline. Twenty-one (52.5%) patients needed antihypertensives such as hydralazine ( 10-20 mg) or beta-blockers such as labetalol (10-20 mg) at the time of emergence from anesthesia to mitigate hemodynamic response during extubation. The mean blood loss was 74 ml ± 33.19 ml, and none of our patients received blood transfusion during the perioperative period. The mean duration of anesthesia was 202.6 ± 27.85 minutes, and the mean length of hospital stay was 1.5 ± 0.97 days. A thorough preoperative examination with specific attention to the preoperative neurological deficits and cardiopulmonary reserve is important for the meticulous management of intraoperative hemodynamics. Intraoperative administration of glycopyrrolate and the use of vasopressors to maintain optimal hemodynamics to ensure cerebral perfusion during the perioperative period should be considered. The anesthetic goals of carotid revascularization (TCAR) are perioperative hemodynamic stability and early evaluation of neurological status in the immediate postoperative period.

Safety and Feasibility of Simultaneous Transcarotid Revascularization With Flow Reversal and Coronary Artery Bypass Grafting for Concomitant Carotid Artery Stenosis and Coronary Artery Disease.

OBJECTIVE: The management of patients with combined severe carotid artery and coronary artery disease (CAD) is controversial. Transcarotid stenting with flow reversal (TCAR) is a novel hybrid technique for carotid revascularization. We sought to investigate the safety and feasibility of simultaneous TCAR and coronary artery bypass grafting (CABG) for concomitant carotid and CAD. METHODS: A single-institution, retrospective study of patients with critical carotid artery stenosis and symptomatic CAD who underwent simultaneous TCAR-CABG was completed. The primary outcomes were technical success, perioperative stroke, death, and hemorrhage. RESULTS: Four patients underwent TCAR-CABG. All patients were male with a mean age of 64. Technical success was achieved in all cases. There were no perioperative strokes or deaths. There were no reexplorations for hemorrhage. CONCLUSIONS: Transcarotid stenting with flow reversal-CABG is a technically feasible hybrid approach for simultaneous carotid and coronary revascularization. It should be part of the vascular surgeon's armamentarium for coexisting carotid and coronary disease. Further research focused on patient selection and perioperative antiplatelet management is warranted prior to the widespread adoption of this technique.

Simultaneous transcarotid artery revascularization with flow reversal and coronary artery bypass grafting: A novel hybrid technique.

Optimal management of concomitant coronary artery disease and carotid artery stenosis remains unknown. Current treatment strategies for patients with significant dual disease burden include simultaneous carotid endarterectomy and coronary artery bypass grafting (CABG) or staged carotid endarterectomy and CABG. Herein we present the case of a patient with severe coronary artery disease and carotid artery stenosis and discuss a novel hybrid approach to management of concomitant coronary and carotid disease using transcarotid artery revascularization with flow reversal before CABG.

Endovascular Stenting of Tandem Carotid Artery Origin and Bifurcation Stenotic Lesions Using Flow Reversal.

BACKGROUND: The treatment of tandem lesions involving severe stenosis of the internal carotid artery with concomitant stenosis of the ipsilateral common carotid artery (CCA) origin represents an ongoing challenge. Current options for the treatment of tandem carotid artery origin and bifurcation stenotic lesions include open surgical endarterectomy, endovascular stenting, balloon angioplasty, and hybrid procedures combining both modalities. However, these options are either associated with high peri-operative risks or not always anatomically feasible. CASE DESCRIPTION: We report, for the first time in North America (to the best of our knowledge), an alternative treatment modality that involves obtaining access through a direct carotid cut-down, with serial treatment of the tandem lesions through a combination of retrograde and anterograde endovascular stenting. CONCLUSION: This technique obviates the need for navigating the aortic arch in patients with difficult arch anatomy and permits the use of distal embolic protection devices, thus decreasing the risk of peri-operative ischemic events.