Introduction/purpose Mechanical thrombectomy was shown superior to intravenous tissue-plasminogen activator (IV t-PA) in recently published clinical trials. The anecdotal data supports the use of conscious sedation over general anesthesia, as the preferred mode of sedation but no randomized trial exist to show the best practice. Therefore, the procedure is performed with wide spectrum of sedation practices with general anesthesia being the most common practice. The ideal sedation for stroke thrombectomy (ISST) registry will evaluate the feasibility of two sedation methods and delay in recanalization using general anesthesia.
Methods ISST is a prospective open-label consecutive enrollment registry. It was approved by Western Institutional Review Board (WIRB). The study compares the feasibility and time to recanalize using the two techniques of sedation. Being a pilot study, total 40 patients who received mechanical thrombectomy for anterior circulation ischemic stroke are enrolled. Total 30 patients have completed the study and therefore their results are being presented. Informed consent was obtained from each patient before enrollment. Primary endpoint includes time from arrival to interventional radiology (IR) room to recanalization time (RRT). Secondary endpoints are evaluated to estimate the effects on the outcome of patients between the two groups.
Results Total of 23 patients received thrombectomy under monitored anesthesia care (MAC)/conscious sedation arm referred as group 1 and 7 patients under general anesthesia arm referred as group 2. Male to female ratio was 14:9 (mean age: 73) in group 1 while 4:3 (mean age: 69) in group 2. The median duration RRT was 59 min in group 1 while it was 112 in group 2 (p-value 0.03). Good reperfusion (TICI ≥2 b) was achieved in all patients (100%) in group 1 and group 2 with TICI score of grade 2b in 10 patients (43.5%) and grade 3 in 13 patients (56.5%). While in group 2, grade 2b was achieved in 4 patients (57.1%) and grade 3 in 3 patients (42.9%). Median mRS score at 3 months was 1 in group 1 and 4 in group 2 (p-value 0.01). Two patients from each group developed asymptomatic SAH or ICH with Odds ratio 3.2 (95% CI: 0.38–27.78). 1 patient in each group developed aspiration pneumonia with Odds ratio 3.2 (95% CI: 0.18–59.60). Total 3 patients died in group 1 and 1 patient died of respiratory failure in group 2.
Conclusion Early findings from our pilot study showed statistically significant delay in time to recanalization with general anesthesia and better outcome in patients who underwent mechanical thrombectomy under MAC/conscious sedation.
Disclosure A financial research grant was provided by Stryker Neurovascular to support this study.
Disclosures M. Taqi: 1; C; Stryker Neurovascular. 2; C; Stryker Neurovascular. A. Sodhi: None. S. Suriya: 1; C; Stryker Neurovascular. F. Adl: None. M. Farooqi: None. S. Quadri: None. M. Mortazavi: 3; C; Haag-Streit Surgical, DePuy Synthes, American Surgical Company.
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