BACKGROUND AND PURPOSE: Flow diverters have been increasingly used lately in off-label, distal intracranial aneurysm treatments. Our aim was to evaluate the effectiveness of flow diverters in the treatment of middle cerebral artery bifurcation aneurysms and to analyze midterm angiographic patterns of regional flow modifications for safety and clinical outcomes. MATERIALS AND METHODS: Consecutive patients treated from January 2010 to December 2014 by the authors by using endovascular flow-diverting stents for MCA bifurcation aneurysms were evaluated retrospectively with prospectively maintained data. All patients had been followed for at least 12 months after treatment, with at least 2 control angiograms; regional flow-related angiographic modifications were registered by using a new angiographic outcome scale for flow diverters. Data were analyzed with emphasis on procedure-related events, angiographic results, and clinical outcome. RESULTS: Fifty-eight patients were included in the study, with 63 MCA bifurcation aneurysms; 13 of these were large and giant. Pretreatment mRS was 0 for 12 patients (20.7%), 1 for 41 (70.7%), and 2 for 5 patients (8.6%). Six-month control revealed mRS 0–2 for 57 (98.3%) patients and 3 for 1 (1.7%) patient. Procedure-related morbidity and mortality were 8.6% (5/58) and 0%, respectively. From 95% of still circulating immediate postprocedure angiographic outcomes, 68% progressed to aneurysm occlusion at 6 months and 95%, to occlusion at 12 months, with a 0% aneurysm rupture rate. CONCLUSIONS: Flow diverters seem to be an effective treatment alternative for complex MCA bifurcation aneurysms, with reasonable complication rates. Longer angiographic follow-ups are needed to assess the morphologic outcome; immediate subtotal occlusions do not seem to be related to rupture.

The goal of endovascular treatment of cerebral bifurcation aneurysms is to achieve safe coiling of the sac along with preserving patency of the diverging branches. Our purpose was evaluate procedural safety and efficacy as well as the long-term durability of endovascular treatment of bifurcation aneurysms with double stent-assisted coiling. One hundred ninety-one consecutive patients with bifurcation aneurysms were included in this series. Technical failure occurred in 3 aneurysms (1.5%); 188 patients with 193 aneurysms treated with double stent-assisted coiling were retrospectively evaluated; 113 aneurysms were located at middle cerebral artery bifurcation, 42 at the anterior communicating artery, 22 at the basilar artery bifurcation, and the remaining 16 at the internal carotid artery bifurcation; 132 were small (25 mm). The technical success rate of double-stent application was 98.5% (193 aneurysms). In total, there were 5 procedural complications with an associated rate of 2.7%, one of which led to death (0.5%). Delayed ischemic stroke occurred in 2 patients (1.1%). Overall, permanent morbidity occurred in 2 patients, with associated rate of 1.1%. Follow-up was obtained in 186 aneurysms (96.4%), and recanalization occurred in 4 aneurysms (2.2%). In subgroup analysis, the recanalization rate was 3.8% for large aneurysms and 40% for giant aneurysms. No recanalization occurred in small aneurysms. Dual stent-assisted coiling of cerebral aneurysms is a feasible and safe procedure. It may offer a curative solution with long-term durability for treatment of wide-neck small and large aneurysms.

SUMMARY: Incomplete initial occlusion rates and relatively less long-term durability remain as major problems of endovascular treatment of cerebral aneurysms. Stent-assisted coiling is a well-established current solution to overcome these problems. Double-stent treatment with a Y-configuration has been previously reported to improve the application of coiling to wide-neck bifurcation aneurysms. Herein, a novel technique of X-configured stent-assisted coiling for treatment of wide-neck and complex AcomA aneurysms is described.

Background Challenges to revascularization of large vessel occlusions (LVOs) persist. Current stent retrievers have limited effectiveness for removing organized thrombi. The NeVa device is a novel stent retriever designed to capture organized thrombi within the scaffold during retrieval. Objective To evaluate the safety and effectiveness of revascularization of acute LVOs with the NeVa device. Methods Prospective, international, multicenter, single-arm, Investigational Device Exemption study to evaluate the performance of the NeVa device in recanalizing LVOs including internal carotid artery, M1/M2 middle cerebral artery, and vertebrobasilar arteries, within 8 hours of onset. Primary endpoint was rate of expanded Treatment in Cerebral Ischemia (eTICI) score 2b–3 within 3 NeVa passes, tested for non-inferiority against a performance goal of 72% with a −10% margin. Additional endpoints included first pass success and 90-day modified Rankin Scale (mRS) score 0–2. Primary composite safety endpoint was 90-day mortality and/or 24-hour symptomatic intracranial hemorrhage (sICH). Results From April 2021 to April 2022, 139 subjects were enrolled at 25 centers. Median National Institutes of Health Stroke Scale (NIHSS) score was 16 (IQR 12–20). In the primary analysis population (n=107), eTICI 2b–3 within 3 NeVa passes occurred in 90.7% (97/107; non-inferiority P<0.0001; post hoc superiority P<0.0001). First pass eTICI 2b–3 was observed in 73.8% (79/107), with first pass eTICI 2b67–3 in 69.2% (74/107) and eTICI 2c–3 in 48.6% (52/107). Median number of passes was 1 (IQR 1–2). Final eTICI 2b–3 rate was 99.1% (106/107); final eTICI 2b67–3 rate was 91.6% (98/107); final eTICI 2c–3 rate was 72.9% (78/107). Good outcome (90-day mRS score 0–2) was seen in 65.1% (69/106). Mortality was 9.4% (13/138) with sICH in 5.0% (7/139). Conclusions The NeVa device is highly effective and safe for revascularization of LVO strokes and demonstrates superior first pass success compared with a predicate performance goal. Trial registration number NCT04514562.

Background: The best strategy to achieve optimal reperfusion outcomes during mechanical thrombectomy remains to be defined. The RapidPulse^TM Cyclic Aspiration System is a novel technology, delivering high-frequency pulsed vacuum forces to increase the efficiency of aspiration thrombectomy. Methods: Prospective, multicenter, open-label, core lab-adjudicated, two-arm study comparing safety and efficacy of a feasibility version of the RapidPulse^TM system compared with contemporary controls. Primary endpoint was the rate of mTICI ≥ 2c after first-pass effect (FPE). Additional efficacy endpoints were the rates of mTICI [ ] 2b after first pass (modified FPE (mFPE)), last pass with study device defined as frontline technical success, and after all passes including rescue therapy. The primary safety endpoints included symptomatic ICH (sICH) within 24 h post-procedure. Results: Between February 2022 to December 2022, 80 subjects were consented and enrolled in the study (n = 40 treatment arm, n = 40 control arm). In the intent to treat (ITT) population, mean age was 67.8 ± 11.5 years; 19 (47.5%) were male. Median NIHSS score was 16 (IQR: 13–22). Median ASPECTS score was 9 (IQR: 8–10). The rate of mTICI ≥ 2c after first pass was 53.9% in ITT population (60.0% in per-protocol population) versus 38.5% in the corresponding control population. Functional independence (mRS 0-2) at 90 days was achieved in 61.1% (22/36) in the RapidPulse^TM arm and 52.8% (19/36) in the control arm. In the RapidPulse^TM arm, no sICH within 24 h and no device-related morbidity or mortality occurred. Conclusion: Preliminary data suggests RapidPulse^TM Aspiration System is highly effective and safe for recanalization of large vessel occlusions.