Detalle Publicación

The ENROUTE transcarotid neuroprotection system diffusion-weighted magnetic resonance imaging evaluation

Autores: Motaganahalli, R. L.; Leal Lorenzo, José ignacio; Kashyap, V. S.; Matouk, C.; Kallmayer, M.; Stoner, M.; Kwolek, C.
Título de la revista: JOURNAL OF VASCULAR SURGERY
ISSN: 0741-5214
Volumen: 75
Número: 6
Páginas: E81-82
Fecha de publicación: 2022
Resumen:
Objective The goal of this study is to evaluate the incidence and volume of diffusion-weighted magnetic resonance imaging (DW-MRI) new white lesions (NWLs) occurring within 30 days after transcarotid artery revascularization (TCAR). Methods This is a prospective, open-label, single-arm multicenter study. Between June 2019 and November 2021, 52 patients requiring carotid revascularization were enrolled in the DW-MRI protocol at five centers in the United States and two centers in the European Union and completed 30-day follow-up. Patients eligible for TCAR underwent serial DW-MRI of the brain before, after, and at 30 days after the procedure to assess the number, location, and volume of NWLs. All patients met at least one high-risk criterion for carotid endarterectomy. Aggregate data were pooled across sites, stratified by demographics, and analyzed using descriptive statistics. The primary end point was incidence of ipsilateral NWLs by DW-MRI after the procedure. Secondary end points were rates of stroke, neurological death, and rate of contralateral NWLs as well as the volume and location by DW-MRI. Results A total of 52 patients completed the 30-day follow-up as of November 1, 2021; 16 were symptomatic (30.8%) and 36 were asymptomatic (69.2%). There were no differences in the demographics or medical history by symptom status. At least one NWL was detected in the ipsilateral hemisphere in 11 of 52 (21.2%) patients at postprocedure DW-MRI. None of the patients experienced a clinical stroke by the National Institutes of Health Stroke Scale with no mortality. A summary of the NWLs after the procedure is shown in Table I, followed by NWLs stratified by symptom status in Table II. A total of 5 of 16 (31.2%) of symptomatic patients and 6 of 36 (16.7%) had NWLs. Symptomatic patients averaged 1.4 (7/5) NWLs, whereas asymptomatic patients averaged 7.2 (43/6) NWLs. The mean lesion volume was 0.11 cc. (symptomatic 0.02 cc and asymptomatic 0.03 cc). There were no predictive variables found for NWLs. Conclusions This multicenter evaluation suggests that DW-MRI NWLs are uncommon after TCAR, indicating the importance of high flow rate reversal. These imaging findings do not manifest as clinical neurological events. Furthermore, the outcomes of this analysis should serve as the benchmark for future comparisons evaluating carotid revascularization strategies on cerebral NWLs and the degree of neuroprotection offered by high flow rate flow reversal.
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