The duration of carotid blood flow reversal during transcarotid artery revascularization (TCAR) for carotid bifurcation stenosis was not found to affect the rate of stroke, myocardial infarction, or death, according to a study published in the Journal of Vascular Surgery.
Transcarotid artery revascularization requires a temporary reversal of carotid blood flow during carotid artery stent placement through an ex vivo common carotid artery to femoral vein shunt. This procedure can be performed using the ENROUTE Transcarotid Neuroprotection System. Prospectively collected data was retrieved from 4 institutional databases on patients who were enrolled in the Safety and Efficacy Study for Reverse Flow Used During Carotid Artery Stenting Procedure, ROADSTER and ROADSTER 2 trials (Clinicaltrials.gov identifiers: NCT01685567 and NCT02536378, respectively), or the Vascular Quality Initiative TCAR Surveillance Project. The researchers retrospectively examined the records collected preprocedure, at discharge, and 30 days after discharge to identify neurologic deficits, myocardial infarction, and death. Patients (n=307) were grouped into 4 cohorts based on the duration of blood flow reversal: ≤8 minutes (n=138), 9 to 13 minutes (n=105), 14 to 20 minutes (n=42), and >20 minutes (n=22).
In this cohort, the average age was 71.2 years old, 63.5% of participants were men, 45.3% had diabetes, 53% had coronary artery disease, 85% had hyperlipidemia, and 40.1% were symptomatic. Baseline characteristics and comorbidities were comparable between the 4 groups. There were 4 strokes, 2 deaths, and 1 myocardial infarction in this cohort. The strokes occurred in patients with a blood flow reversal time of 6, 7, 11, and 12 minutes and were minor in nature, with full recovery observed after 30 days. There was not a significant difference in the 30-day stroke rate (P =.76), 30-day composite stroke and death rate (P =.59), or composite of stroke, death, and myocardial infarction rate (P =.60) between the groups.
Study limitations include the relatively small sample, the low number of neurological complications, the absence of data on contralateral carotid artery patency or intracranial circulation, and patients operated on by surgeons working at high-volume, academic institutions.
“[T]he duration of procedural cerebral blood flow reversal did not affect outcome measures of stroke, myocardial infarction, or death,” concluded the study authors.
Disclosure: This clinical trial was supported by Silk Road Medical. Several study authors declared affiliations with the pharmaceutical industry. Please see the original reference for a full list of authors’ disclosures.
Kumins NH, King AH, Jim J, et al. Duration of blood flow reversal during transcarotid artery revascularization does not affect outcome [published online December 31, 2019]. J Vasc Surg. doi: 10.1016/j.jvs.2019.10.092