Journal of neurointerventional surgeryJournal Article
10 Oct 2024
This study aimed to elucidate the safety and efficacy of mechanical thrombectomy using the Versi Retriever in patients with acute ischemic stroke (AIS).
This was a prospective, multicenter, single-arm study conducted at 10 institutes in Japan from December 2018 to March 2021 on mechanical thrombectomy using the Versi Retriever in patients with AIS. The primary efficacy outcome was the modified Rankin scale (mRS) 0-2 at 90 days after the procedure. The primary safety outcome was mortality within 90 days after the procedure.
Fifty-eight patients with a mean age of 72.7 years were enrolled in the study. The primary efficacy outcome of mRS 0-2 at 90 days was 62.0% (95% CI 47.2-75.3%) in patients within 8 hours of stroke onset. The rate of immediate reperfusion of Thrombolysis in Cerebral Infarction (TICI) grade 2b-3 using the Versi Retriever in three passes was 78.0% (64.0-88.5%). The rate of final reperfusion of TICI 2b-3 was 100% (92.9-100%). The primary safety outcome of mortality within 90 days was 8.0% (2.2-19.2%) in patients within 8 hours of AIS onset. The incidence of intracranial hemorrhage within 24 hours was 12.0% (4.5-24.3%) for symptomatic cases and 32.0% (19.5-46.7%) for asymptomatic cases.
The Versi Retriever proved to be a safe and effective option for mechanical thrombectomy in patients with AIS.
Competing interests: HI reports lecturer’s fees from Medtronic, Daiichi Sankyo, Terumo, Johnson & Johnson, Stryker, and Asahi Intec. TS reports a research grant from Canon Medical Systems, a lecturer’s fee from Medtronic, and a consulting fee from Kaneka Medix, outside of the submitted work. HiY reports research grants from Bristol-Myers Squibb and lecturer’s fees from Stryker, Medtronic, Johnson & Johnson, and Medico’s Hirata. SY reports research grants from Medico’s Hirata, Medtronic, and Terumo and lecturer fees from Medtronic, Kaneka Medix, Stryker, Daiichi Sankyo, Bristol-Meyers Squibb, and Johnson & Johnson. AI reports lecturer’s fees from Medtronic, Stryker, Terumo, Kaneka Medix, Johnson & Johnson, Asahi-Intec, Abbot Vascular, Medicos Hirata, and Daiichi-Sankyo; a research grant from Fuji Film; and consulting fees from Medtronic and Terumo. TF reports lecturer’s fees from Medtronic and Stryker. YM reports royalties from Sumitomo Bakelite and lecturer’s fees from Kaneka Medix, Medico’s Hirata, Nipro, Fuji Systems, GE Healthcare, Otsuka, Takeda, Century Medical, Terumo, Medtronic, and Stryker. TT reports lecturer’s fees from Terumo and Kaneka Medix. SK reports lecturer’s fees from Medtronic, Stryker, Terumo, Johnson & Johnson, and Kaneka Medix. YM reports lecturer’s fees from Medtronic, Stryker, Terumo, Johnson & Johnson, Kaneka Medix, and Jimro. NK reports lecturer’s fees from Medtronic and Kaneka Medix. TH reports lecturer’s fees from Dai-ichi Sankyo, Bayer, and Pfizer. YI reports lecturer’s fees from Medtronic Japan and Century Medical. KI reports research grants from Idorsia Pharmaceuticals Japan and Softbank Corp. NS reports research grants from Japan Lifeline, Kaneka Medix, Medtronic, Terumo, and TG Medical; lecturer’s fees from Asahi-Intec, Kaneka, Medtronic, Stryker, and Terumo; and membership on the advisory boards for Johnson & Johnson, Medtronic, and Terumo. Remaining authors (NO, NH, YN, HaY, and CS): no competing interests declared.
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