Introduction: The purpose of this study was to evaluate the safety and efficacy of the pREset stent retriever in a real-world clinical setting.
Methods: Patients treated with pREset were selected from a prospectively maintained single-center database. A TICI score ≥2b after ≤3 passes was regarded as successful recanalization. All device-related complications and their clinical significance were reported. Parenchymal hematomas (PH) were classified according to ECASS, adding focal and diffuse subarachnoid hemorrhage (SAH) as categories. A 90-day mRS of 0-2 was defined as favorable outcome. In addition, we separately analyzed patients treated with >3 pREset passes and patients receiving other rescue maneuvers.
Results: We included 271 patients. Successful recanalization was achieved in 76.4 %. Device-related complications occurred in 9.2 % of which 2.2 % were clinically significant. PH I, PH II, focal SAH, and diffuse SAH was observed in 5.2, 4.8, 12.2, and 2.2 %, respectively. A total of 39.5 % of patients had favorable clinical outcome. Considering treatments with >3 pREset passes or other rescue procedures, an additional 8.5 and 9.3 % of target vessels were recanalized. The chance of favorable clinical outcome decreased significantly with any kind of rescue therapy. In addition, the rate of PH I was significantly higher in patients treated with >3 pREset passes, whereas all other types of hemorrhage showed no difference.
Conclusion: In terms of safety and effectiveness, pREset performed comparably to other stent retriever devices. To avoid futile recanalization and potential additional harm, escalation of therapy beyond three thrombectomy passes should only be performed after careful individual consideration of each case.