R. L. Motaganahalli1, M. Malas2, J. Jim3, I. Leal4, H. H. Eckstein5, P. Schneider6, C. J. Kwolek7, R. Cambria8, V. Kashyap9 1Indiana University School Of Medicine, Vascular Surgery, Indianapolis, IN, USA 2University Of California – San Diego, Vascular Surgery, San Diego, CA, USA 3Abbott Northwestern Hospital, Vascular Surgery, Minneapolis, MN, USA 4Clinica Universidad de Navarra, Vascular Surgery, Toledo, Spain 5Technical University of Munich, Munich, Germany, Vascular Surgery, Munich, Germany 6University Of California – San Francisco, Vascular Surgery, San Francisco, CA, USA 7Massachusetts General Hospital, Vascular Surgery, Boston, MA, USA 8Steward Health, Vascular Surgery, Massachussets, MA, USA 9University Hospitals Cleveland Medical Center, Vascular Surgery, Cleveland, OH, USA
INTRODUCTION : Transcarotid artery revascularization (TCAR) can be performed with either General (GA) or Local /Regional (LA) anesthesia. Roadster 1&2 clinical trials concluded excellent early outcomes for patients undergoing carotid revascularization using TCAR. It is not clear if procedure outcomes vary depending on the type of anesthesia utilized for TCAR. Using the combined trial cohorts, we compare and report the peri-operative 30-day outcome differences in patients undergoing TCAR with either GA or LA.
METHODS :The ROADSTER 1& 2 trial is a prospective, open label, single arm, multicenter pre & post-approval registries respectively for evaluating safety and efficacy of ENROUTE™ Neuroprotection system in patients undergoing TCAR. Patients considered at high risk for complications from carotid endarterectomy (CEA) with symptomatic stenosis ≥50% or asymptomatic stenosis ≥80% with intention to treat were included. Demographic data and hierarchical analyses for any Major adverse events (MAE), death, stroke and MI for the pooled data (ROADSTER 1 & 2, combined), along with the intra-study results by general anesthesia vs. Local /Regional anesthesia was compared. Probability values were calculated using two-tailed Fisher’s exact test and 1-factor analysis of variance model.
Results: This study enrolled 833 patients who underwent TCAR, with 565 procedures (67%) completed using GA. There was no differences in the age range (p=0.1520), Gender (66.4 %v/s 69.4% Male p=0.429), asymptomatic status (72.9% v/s 76.5% p=0.309) between GA and LA patients respectively. There was no differences in the 30 day MAE (3.4% v/s 3.0%), Death (0.7% v/s 0.4%), Stroke (1.6% v/s2.2 %), MI (1.1% v/s 0.4%) between GA and LA groups. Summary of statistical analyses based on hierarchical presentation is presented in table. There was no differences in the length of stay (p=0.2532), Cranial nerve injury (1.4% v/s 1.1% p=1.000) between two groups. Total procedure time (73.51 +/- 29.385 min [mean +/- SD] v/s 84.05 +/- 34.021 min), total flow reversal time (10.74 +/- 6.601 min v/s 12.43 +/- 9.123 min) favored GA
CONCLUSIONS :Pooled analysis of patients from ROADSTER trials suggests no differences in the MAE, Death, Stroke, and MI irrespective of the type of anesthesia used for Transcarotid revascularization. This study adds to our ongoing understanding of procedure time and flow reversal time as it favors use of GA for TCAR. As Experience continues to increase with TCAR, choice of anesthetic technique should be dependent on the patient & physician preferences
