Abstract WP29: Early U.S. Experience with the Trevo Retriever Device: A Multi-Center Analysis
Introduction: The Trevo Retriever device (Stryker Neurovascular, Mountain View, CA) received FDA clearance as a 510K device in August 2012 for clot retrieval in acute ischemic stroke within eight hours of symptom onset. This study is an early look at the initial U.S. experience with the device following FDA clearance, examining the clinical results of the some of the first cases performed in the U.S.
Methods: This was a retrospective analysis of prospectively collected clinical data from the early U.S. experience using the Trevo Retriever device. All physician operators were in-serviced on the use of the device and technique prior to first clinical use. Of the first patients treated, 6 were MCA occlusions, and 1 ICA occlusion. Four of the patients received intravenous tPA prior to their intervention, the remaining three patients did not did not qualify for IV tPA. The mean NIHSS pre-procedure was 19.
Results: The Trevo device could be delivered across the intraluminal clot in all seven cases. There was a 100% success rate in revascularization of the target territory as judged by TICI score 2b or 3. One case resulted in an ACA embolus that was successfully revascularized. There was an average of 2.0 passes of the device to achieve this revascularization rate (range 1-4), with 71% of the cases needing 1 or 2 passes, and the remaining 3 or 4 passes. The mean time from femoral access to revascularization was 44 minutes (range 18-93 minutes, median 31 minutes). The average clot length was 11 mm. The clot was characterized as soft/friable in 2 cases, intermediate/rubbery in 3 cases, and hard/fibrous in 2 cases. The 24 hour post-procedure NIHSS was improved in 86% of the patients treated, and the mean NIHSS at 24 hours was 10 (range 0-27). Five of the seven patients had an improvement on the NIHSS of 9 points or greater.
Conclusions: The technical success rate, as measured by a TICI score of 2b or 3, was excellent (100%) in this initial U.S. experience. With a high revascularization rate and a few number of passes, this shortened the endovascular revascularization time, and resulted in improved clinical exam in 6 of the 7 patients within 24 hours post-procedure.
- © 2012 by American Heart Association, Inc.