Duration of blood flow reversal during transcarotid artery revascularization does not affect outcome.

OBJECTIVE: Transcarotid artery revascularization (TCAR) has become an increasingly popular alternative for the treatment of carotid bifurcation stenosis. TCAR employs carotid blood flow reversal through an ex vivo common carotid artery to femoral vein shunt for neuroprotection during the placement and angioplasty of the carotid artery stent. There is a lack of data regarding an association between the duration of flow reversal and neurologic complications or other adverse events. We analyzed TCAR flow reversal time in relation to major adverse events. METHODS: There were 307 patients who underwent TCAR at four high-volume academic institutions. Patients were separated on the basis of the duration of carotid flow reversal as follows: group I, ≤8 minutes (n = 138); group II, 9-13 minutes (n = 105); group III, 14-20 minutes (n = 42); and group IV, >20 minutes (n = 22). Adverse events including stroke (assessed by a National Institute of Health Stroke Scale-certified examiner), myocardial infarction (MI), and death at discharge and 30 days were collected in all patients and were compared between groups using one-way analysis of variance and χ2 analysis. RESULTS: There were four strokes in the total cohort, yielding an overall stroke rate of 1.3%. All strokes were minor in nature; two were ipsilateral and two were contralateral. All patients demonstrated full recovery at 30 days. We found no significant difference in the stroke rate between any of the groups: I, 1.5% (2/138); II, 1.9% (2/105); III, 0% (0/42); and IV, 0% (0/22; P = .76). The four strokes occurred in patients with flow reversal time of 6, 7, 11, and 12 minutes. There was also no difference in the 30-day composite stroke/death or stroke/death/MI rates among the groups. CONCLUSIONS: The length of flow reversal during TCAR does not affect rates of stroke, MI, or death. These data suggest that operators should focus on the technical aspects of the procedure during flow reversal rather than on its duration.

The learning curve of transcarotid artery revascularization.

BACKGROUND: In the pivotal U.S. Food and Drug Administration approval trial, ROADSTER, transcarotid artery revascularization (TCAR) using the ENROUTE Transcarotid Neuroprotection System (Silk Road Medical Inc, Sunnyvale, Calif) was shown to have one of the lowest reported complication rates, not only for carotid artery stent placement, but also for any carotid intervention, including endarterectomy. The number of cases required for a surgeon to gain the proficiency to realize these outcomes has not been studied. Our objective was to determine the learning curve for vascular surgeons performing the TCAR procedure. We examined the effect of surgeon procedural experience on intraoperative data and postoperative outcome. METHODS: This retrospective review analyzed data from a prospectively maintained database of 188 consecutive patients from three large academic centers who underwent TCAR. Procedures were ordered chronologically for each surgeon and grouped into bins of five. Operative times and flow reversal times were analyzed by analysis of variance. Results led to comparison of surgeons' early experience (cases 1-15) with their later experience (cases 16-50). The primary outcome was postoperative stroke and death. RESULTS: The mean procedural time for all cases was 75.0 ± 23.8 minutes. When the procedural time of cases 1 through 15 (mean, 79.0 ± 28.3 minutes) were compared with cases 16 through 50 (mean, 71.8 ± 19.0 minutes), a significant difference was noted (P = .02). The mean flow reversal time was 10.6 ± 6.8 minutes. When flow reversal times were compared using analysis of variance testing, cases 1 through 15 were statistically similar and cases 11 through 50 were also similar, but the two groups differed from each other (P < .001). For flow reversal, cases 1 through 15 had mean reversal times of 13.3 ± 8.8 minutes compared with 8.5 ± 3.5 minutes for cases 16 through 50 (P < .001). Postoperative stroke rates were similar in the 1 through 15 and 16 through 50 case groups (2.4% vs 1.0%; P = .59), as were death rates (0.0% vs 1.0%; P > .99). The combined stroke/death rates were also comparable at 2.4% in the early cohort vs 1.9% in the late cohort (P > .99). CONCLUSIONS: There seems to be a relatively short learning curve for the TCAR procedure. After 15 cases, surgeons are able to reduce procedural decrease by 10% (from 79.0 to 71.8 minutes), and flow reversal times by an average of 40% (from 13.3 to 8.5 minutes). More important, the rates of stroke and death do not differ between early and late experience with TCAR. The TCAR procedure may be quickly and safely adopted by vascular surgeons for carotid intervention.

A multi-institutional analysis of transcarotid artery revascularization compared to carotid endarterectomy.

OBJECTIVE: Transcarotid artery revascularization (TCAR) is a novel approach to carotid intervention that uses a direct carotid cut-down approach coupled with cerebral blood flow reversal to minimize embolic potential. The initial positive data with TCAR indicates that it may be an attractive alternative to trans-femoral carotid artery stenting and possibly carotid endarterectomy (CEA) for high-risk patients. The purpose of this study was to present 30-day and 1-year outcomes after treatment by TCAR and to compare these outcomes against a matched control group undergoing CEA at the same institutions. METHODS: A retrospective review of all patients who underwent TCAR at four institutions between 2013 and 2017 was performed to evaluate the use of the ENROUTE Transcarotid Neuroprotection System (Silk Road Medical, Inc, Sunnyvale, Calif). TCAR patients had high-risk factors and were either enrolled in prospective trials or treated with a commercially available TCAR device after US Food and Drug Administration approval. Contemporaneous patients undergoing CEA at each institution were also reviewed. Patients were propensity matched in a 1:1 (CEA:TCAR) fashion with respect to preoperative comorbidities. Data were analyzed using statistical models with a P value of less than .05 considered significant. Individual and composite stroke, myocardial infarction, and death at 30 days and 1 year postoperatively were assessed. RESULTS: Consecutive patients undergoing TCAR or CEA were identified (n = 663) and compared. Patients undergoing the TCAR procedure (n = 292) had higher rates of diabetes (P = .01), hyperlipidemia (P = .02), coronary artery disease (P < .01), and renal insufficiency (P < .01) compared with unmatched CEA patients (n = 371). Stroke rates were similar at 30 days (1.0% TCAR vs 1.1% CEA) and 1 year (2.8% TCAR vs 3.0% CEA) in the unmatched groups. After propensity matching by baseline characteristics including gender, age, symptom status (36.3%, 35.3%) and diabetes, 292 TCAR patients were compared with 292 CEA patients. TCAR patients were more likely to be treated preoperative and postoperatively with clopidogrel (preoperatively, 82.2% vs 39.4% [P < .01]; postoperatively, 98.3% vs 36.0% [P < .01]) and statins (preoperatively, 88.0% vs 75.0% [P < .01]; postoperatively, 97.8% vs 78.8% [P < .01]). Stroke (1.0% TCAR vs 0.3% CEA; P = .62) and death (0.3% TCAR vs 0.7% CEA; P = NS) rates were similar at 30 days and comparable at 1 year (stroke, 2.8% vs 2.2% [P = .79]; death 1.8% vs 4.5% [P = .09]). The composite end point of stroke/death/myocardial infarction at 1 month postoperatively was 2.1% vs 1.7% (P = NS). TCAR was associated with a decreased rate of cranial nerve injury (0.3% vs 3.8%; P = .01). CONCLUSIONS: These early data suggest that patients undergoing TCAR, even those with high-risk comorbidities, achieve broadly similar outcomes compared with patients undergoing CEA while mitigating cranial nerve injury. Further comparative studies are warranted.

Initial experience in the treatment of thoracic aortic aneurysmal disease with a thoracic aortic endograft at Baylor University Medical Center.

A retrospective review of 27 patients who underwent endovascular repair of thoracic aneurysms and of other thoracic aortic pathology with the thoracic aortic endograft (Gore Medical, Flagstaff, AZ) from June 2005 to July 2007 was performed. The mean follow-up period was 13.5 months (range, 2-25 months). Indications for thoracic endografting included descending thoracic aneurysms (n = 18), thoracoabdominal aneurysms (n = 3), traumatic aortic injuries (n = 3), penetrating aortic ulcers (n = 2), and contained rupture of a type B dissection (n = 1). One patient died during the procedure, for an overall mortality rate of 3.7%. The average length of stay was 8.1 days, with an average stay in the intensive care unit of 4.2 days. If patients with traumatic aortic injuries were excluded, the average overall and intensive care unit length of stay were 5.6 and 1.8 days, respectively. There was one incident of spinal cord ischemia (3.7%). There were five type I or type III endoleaks, three of which required revision (11.1%). In conclusion, thoracic endografting is a safe and viable option for the repair of descending thoracic aneurysms and other aortic pathologies. We have found it to be less invasive, even in conjunction with preoperative debranching procedures, with a shorter recovery time, decreased perioperative morbidity and blood loss, and decreased peri-operative mortality compared with standard open repair.