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.

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.

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.

Treatment of an Infected, Bovine Pericardial Carotid Patch: Excision and Reconstruction with a Superficial Femoral Arterial Interposition Graft.

Carotid patch infection is a rare complication but one often associated with severe morbidity, including hemorrhage, stroke, cranial nerve injury, and mortality. We present a case of a gram-negative bacterial infection of a bovine pericardial carotid patch. Treatment ultimately required patch explantation and reconstruction with a femoral arterial interposition graft.

Stenting of a Retropharyngeal Internal Carotid Artery.

A retropharyngeal course of the carotid artery is an uncommon variant. Recognition of this anatomic anomaly is important in avoiding severe hemorrhage with endotracheal intubation and oropharyngeal procedures and for planning carotid interventions. We present a rare case of stenting for an asymptomatic, high-grade stenosis in a retropharyngeal internal carotid artery.

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.

Transcarotid Revascularization Results in Patients Over 70 Years of Age.

OBJECTIVE: Carotid endarterectomy is associated with fewer procedure-related strokes than transfemoral carotid artery stenting in older populations, based on the results from previous quality randomized controlled studies. Transcarotid artery revascularization (TCAR) is a hybrid procedure completed in the setting of cerebral flow reversal to deploy a stent, making it an appealing choice for older patients. This study was completed to elicit any age-related differences in outcomes after undergoing TCAR in patients 70 years of age and older. METHODS: A retrospective review was completed of a dual institutional database between December 2015 and April 2022 to capture demographics, comorbidities, and perioperative results. The geriatric cohort was defined at a cutoff of 70 years. Univariate statistical testing between groups were completed with Student's T-test or Fisher's exact test at an α of .05 for continuous and categorical variables, respectively. RESULTS: 851 procedures were captured for statistical analysis. With age cutoff of 70 years, we generated 567 geriatric (78.4 ± 5.7 years) and 284 young (63.2 ± 5.7 years) patients. The older patients tended to have more baseline illness, as measured by a higher rate Charlson Comorbidity Index (4.4 ± 2.2 vs 6.0 ± 2.1, P < .01). Younger patients tended to be actively smoking (42.3% vs 17.6%, P < .01). Intraoperative variables were grossly similar by age, including blood loss (43.0 ± 45.0 vs 45.7 ± 50.3 mLs, P = .45), reverse flow time (9.0 ± 7.4 vs 9.0 ± 6.7 mins, P = .98), and technical success (98.9% vs 98.6%, P = .76). While we observed an increased rate of stroke in the older patients, this did not reach statistical significance (1.4% vs 2.6%, P = .33). There were no differences between age groups with respect to myocardial infarction (0% vs .5%, P = .55) and death (1.1% vs 1.1%, P > .99) in the 30-day perioperative period. CONCLUSION: We found that TCAR was not associated with age-related increases in adverse outcomes and can be considered a viable option when treating carotid artery stenosis in patients older than 70 years of age.

Heparin-bonded versus standard polytetrafluoroethylene arteriovenous grafts: A Bayesian perspective on a randomized controlled trial for comparative effectiveness.

BACKGROUND: Heparin-bonded polytetrafluoroethylene grafts were marketed to improve hemodialysis access outcomes but are twice the cost of standard polytetrafluoroethylene. We launched a randomized trial of heparin-bonded polytetrafluoroethylene versus standard polytetrafluoroethylene for hemodialysis access to compare patency. Since the trial began, additional studies were published with heterogeneous findings. We performed an interim analysis by Bayesian methods using prior probability from meta-analysis of existing literature. METHODS: NCT01601873 is a randomized, blinded trial of heparin-bonded polytetrafluoroethylene versus standard polytetrafluoroethylene for dialysis access at 5 sites. Planned sample size was 200 with 1-year primary patency as the primary endpoint. At interim analysis (50% of sample size at 1 year), we also performed a meta-analysis for 1-year primary patency with a random effects model to compute summary rate ratio and standard-error estimates. Meta-analysis estimates formed a prior probability for a Bayesian Cox regression model, and trial data were reanalyzed to develop posterior probability of heparin-bonded polytetrafluoroethylene effectiveness at our hypothesized effect size. Futility analysis was conducted using posterior probability estimates. RESULTS: One hundred and five patients were enrolled at the time of interim analysis. One-year primary patency was 34.9% in the heparin-bonded-polytetrafluoroethylene group vs 32.7% in the standard-polytetrafluoroethylene group (P = .884). Summary rate ratio from the meta-analysis (1,209 patients) was 0.87 favoring heparin-bonded polytetrafluoroethylene (P = .33). Posterior hazard ratio from Cox regression was 0.90 (credible interval 0.70-1.13) favoring heparin-bonded polytetrafluoroethylene, which was not significant. Bayesian posterior probability of the a priori hypothesized 20% better patency with heparin-bonded polytetrafluoroethylene was 24%. Sample size to detect superiority with the small observed effect size would require about 3,800 subjects. CONCLUSION: Current evidence does not demonstrate sufficiently large benefit of heparin-bonded polytetrafluoroethylene over standard polytetrafluoroethylene for dialysis access to justify higher cost. Given similar 1-year patency rates, a conclusive finding of superiority was judged to be infeasible, and the trial was stopped for futility.