PULSERIDER-ASSISTED TREATMENT OF INTRACRANIAL ANEURYSMS IN THE STERLING REGISTRY

Introduction PulseRider (Cerenovus, Irvine, CA) is an adjunctive neck bridging device designed to aid in coiling of wide neck bifurcation intracranial aneurysms. We present outcomes of PulseRider assisted coil embolization of brain aneurysms in routine clinical practice included in the STERLING registry. Materials and Methods STERLING (NCT03642639) is a prospective, global registry of endovascular treatment of intracranial aneurysms with Galaxy and MicrusFrame coils (Cerenovus, Irvine, CA). PulseRider cases from STERLING were included in this interim analysis. Primary outcome measures were core-lab assessed modified Raymond-Roy (mRR) occlusion at final procedural angiogram, and where available, at 6 months (+/-3 months) or 1 year (COVID allowed window: -3 months/+1.5 years). Safety outcomes were procedureand device-related adverse events. Results Seventeen subjects (mean age 64.4 ± 8.69 years, 12 female) were treated with the PulseRider device. All cases were unruptured and two were retreatments of previously coiled aneurysms. All aneurysms had saccular morphology, 14/ 15 (93.3%) were wide neck and 13/15 (86.7%) were at a bifurcation. Target aneurysm locations included basilar artery (6/15, 40.0%), MCA bifurcation (4/15, 26.7%), ACA (3/15, 20%), ICA terminus (1/15, 6.7%), and M2 (distal to bifurcation, 1/15, 6.7%), with a mean parent vessel diameter of 2.65 ± 0.440mm. PulseRider was successfully implanted with the ability to retain the coil mass in all cases. Mean packing density was 29.7 ± 11.32%. Adequate occlusion (mRR I or II) was achieved in 86.7% (13/15) cases immediately post procedure, 100% (3/3) at 6 moths, and 75% (3/4) at 1 year. There were no intraprocedural ruptures, no symptomatic thromboembolic events, and no device related SAEs through the maximum follow up. 87.5% (7/8) subjects had mRS 0-2 at 1 year. There were no aneurysm retreatments. Conclusion In this interim analysis of the ongoing STERLING registry, treatment of intracranial aneurysms with the PulseRider device in conjunction with embolization using Galaxy and MicrusFrame coils showed excellent safety outcomes and high rates of adequate occlusion and good clinical outcome.

Impact of covid related restrictions on clinical trials-insights from the sterling registry

Introduction The STERLING registry is a prospective collection of aneurysms treated with endovascular techniques. The primary intention is to assess the efficacy and safety of Galaxy and MicrusFrame coils (Cerenovus, Irvine, CA). The Covid pandemic has the potential to alter the delivery of medical care or trial enrollment. Changes to regional or hospital specific research infrastructure will likely affect trials for the worse. Methods A retrospective review of STERLING sites and patients was undertaken to better understand regional variation in adapting to the pandemic and how enrollment was affected. Results 45 global sites currently take part in the STERLING registry. 28 sites began enrolling pre-Covid. 34% of U.S. sites were required to halt research, enrollment or elective surgery, whereas only 8% of EU and none of the Japanese sites were required to significantly change their research protocols respectively. At the 10 (9 US, 1 EU) sites required to put a hold on research, rates of enrollment dropped from an average of 0.6 subjects/month in the US (0.5 in EU) to 0 in the first month and 0.1 subjects/month in the second month of Covid-related restrictions. At the time of this analysis (1/ 2021), the average rate of enrollment across those sites partially recovered to 0.2 subjects/month in the US and 0.2 in EU, although 5 of the 10 sites (all US) had not enrolled any subjects post Covid. Overall, mean actual vs. projected enrollment rates decreased more in the U.S. than in the EU and Japan. The percent of ruptured aneurysms in the per-protocol analysis increased from 23% to 40%, while the percent of unruptured aneurysms decreased from 76% to 60%. There were no significant changes to occlusion rates or adverse events pre/ post Covid. Conclusion The Covid pandemic has the potential to dramatically alter how research is conducted worldwide. U.S. sites faced tougher restrictions than their EU and Japan counterparts. Particularly within the U.S., moratoriums on research and elective surgery may be the driving factor in reducing overall enrollment and increasing the percentage of ruptured aneurysm enrollment. Fortunately, these changes did not appear to negatively affect occlusion rates or adverse events.

Clot characteristics in mechanical thrombectomy: Interim analysis of the excellent registry

Introduction: Red blood cell (RBC) rich vs fibrin rich clots have different mechanical properties and greater knowledge about clot composition in the context of clinical, imaging, and procedural factors in mechanical thrombectomy (MT) may help with procedural optimization. The EXCELLENT Registry (NCT03685578) is a prospective, global, multi-center, observational registry of EmboTrap as the first line MT device for large vessel occlusion (LVO). We present an interim analysis of clot collected per pass in the registry. Methods: Five hundred thirty-three clot specimens from 376 subjects were collected by 20 sites and sent for analysis by independent Central Labs under standardized protocol. Analysis was interrupted by COVID-19, but the labs were fully operational as of June 2020 and on track to deliver results for 300 subjects in Q4. At the time of abstract submission, composition data for 234 clots from 163 subjects was available. All available data will be presented at the time of the conference. Results: Cardioembolic etiology (n=100) was associated with lower RBC (40.2 vs 47.2%) and higher fibrin content (31.7 vs 26.7%) compared to large artery disease (n=12). Hyperdense/vessel susceptibility sign (78+, 24-, per independent imaging core lab) corresponded to higher mean RBC content (44.4 vs 34.9%). Treatment with IV tPA (60+, 91-) had no clear impact on clot composition (42.3 vs 40.6% RBC;30.4 vs 30.0% fibrin). Notably, clots retrieved with the first 2 passes of were more RBC rich (42.1 vs 28.0%) and clots retrieved in higher passes had a higher average fibrin content (35.5 vs 29.6%) suggesting that higher fibrin content leads to greater refractoriness. Conclusions: Clot density/susceptibility on baseline imaging, stroke etiology and number ofthrombectomy passes were associated with differential clot composition. These findings may havepotential implications for the development of better MT strategies.

Initial real-world experience with VIZ LVO in transferred large vessel occlusion stroke patients

Background and Purpose: Randomized controlled trials have demonstrated the importance of time to endovascular therapy (EVT) on clinical outcomes in large vessel occlusion (LVO) acute ischemic stroke. Delays to treatment are particularly prevalent when patients require a transfer from hospitals without EVT capability onsite. A novel computer aided triage system, Viz LVO, has the potential to streamline workflows. This platform includes an image viewer, communication system, and an artificial intelligence (AI) algorithm that automatically identifies suspected LVO strokes on CTA imaging and rapidly triggers alerts. We hypothesize that the Viz application will decrease timeto- treatment. Methods: A prospective database was assessed for patients who presented to a stroke center utilizing Viz LVO in the Mount Sinai Health System in New York and underwent EVT following transfer for LVO stroke between July 2018 and March 2020. This time period was chosen due to the COVID-19 pandemic affecting stroke workflow after March 2020. Time intervals were compared for 55 patients divided into Pre- and Post-Viz cohorts. Results: The median initial door-to-neuroendovascular team (NT) notification time interval was significantly faster (25.0 minutes [IQR=12.0] vs 40.0 minutes [IQR=61.0];p=0.01) with significantly less variation (p<0.05). The median initial door-to-skin puncture time interval was 25 minutes shorter in the Post-Viz cohort, although not statistically significant (p=0.15). Post Viz LVO implementation, the Viz notification was the first NT notification 38% (10/26) of the time. Conclusions: Our preliminary results have shown that Viz LVO implementation is associated with earlier, more consistent NT notification times and potentially treatment times. This platform presents a novel application of AI that can serve as an early warning system and a failsafe to ensure that no LVO is left behind. Further studies are warranted.(Figure Presented).