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IntroductionThe direct aspiration first pass technique (ADAPT) has been introduced as a rapid and safe endovascular treatment strategy in patients with ischemic stroke.ObjectiveTo determine the technical feasibility, safety, and functional outcome with ADAPT using the new large-bore 6F SOFIA Plus catheter.MethodsA retrospective analysis of prospectively collected data from six university hospitals was performed. The following parameters of all acute stroke procedures (June 2015– January 2016) using the SOFIA Plus catheter were analyzed: accessibility of the thrombus with the catheter, recanalization success (Thrombolysis in Cerebral Infarction ≥2b), time to recanalization, procedure-related complications. Furthermore, National Institutes of Health Stroke Scale (NIHSS) scores at presentation and discharge and the modified Rankin scale (mRS) score at 90 days were recorded.Results85 patients were treated using the SOFIA Plus catheter. The occlusion site was the anterior circulation in 94.1%. Median baseline NIHSS score was 18. In 64.7%, ADAPT alone was successful after a median procedure time of 21 min. With additional use of stent retrievers in the remaining cases, the recanalization rate was 96.5%. No catheter-related complications such as dissections were observed. Thrombus migration to a new vascular territory occurred in 4.7% and symptomatic hemorrhage in 4.7%. After 3 months, mRS 0–2 was achieved in 49.4%. Mortality rate was 20%.ConclusionsIn the majority of cases, thrombus aspiration using the SOFIA Plus catheter results in successful recanalization after a short procedure time. With additional use of stent retrievers, a high recanalization rate can be achieved (96.5%). The complication rate was in line with those of previous publications.

Introduction Five randomized controlled trials (RCTs) on endovascular therapy (EVT) of stroke have proven a clinical benefit over conservative treatment or IV-thrombolysis alone. Lesional clot aspiration with a dedicated system can achieve revascularization without an additional retriever (a direct-aspiration first-pass technique, ADAPT), and the SOFIA has been shown to be both safe and efficacious in a multicentric retrospective study. We have evaluated a subset of these data acquired in two major stroke centers with regard to using the SOFIA for first-line lesional aspiration.Methods Thirty patients with large-vessel occlusions treated with first-line lesional aspiration were identified. Procedural data, clot length, reperfusion success (mTICI), procedural timings, complications, and clinical status at admission, discharge and at 90 days were analyzed.Results The median baseline NIHSS was 16. IV thrombolysis was administered in 15/30 patients. Ninety-three percent of occlusions were in the anterior circulation. TICI ≥ 2b was achieved in 90% of multimodality treatments; lesional aspiration was successful in 67% within a median time of 20 minutes. The highest first-attempt success rate was in MCA occlusions (median time to recanalization 10 minutes). There were no device-related events. Symptomatic intracerebral hemorrhage (sICH) occurred in 10%, but never with sole lesional aspiration. Embolization to new territories was recorded in 1/30 (3%). Median discharge NIHSS was 7; 30% were mRS ≤ 2 at discharge and 43% at 90-day follow-up.Conclusions Lesional aspiration with SOFIA is in line with published data. The SOFIA may be used as a first-line device, aiming at fast recanalization by sole aspiration with good safety and efficacy. If unsuccessful, it converts into part of a stent retriever-based multimodality treatment.

IntroductionComplex, large, wide-neck aneurysms, but particularly partially thrombosed intracranial aneurysms (PTIAs), have a greater tendency to recanalize after coil occlusion. The Woven Endovascular Bridge (WEB) combines shape memory wires braided to a relatively uniform, dense surface, which may limit its compaction and its incorporation into an existing aneurysm clot and may thus reduce PTIA recurrence.ObjectiveTo carry out a retrospective analysis of our experience with the WEB as part of a complex treatment in conjunction with other implants to assess the efficacy and safety of this technique.MethodsAmong 43 aneurysms treated with the WEB in our center, eight complex, large, wide-neck aneurysms were treated in conjunction with other implants (additional WEBs, coils, stents, flow diverters). Six of these eight aneurysms were PTIAs. All patients were followed up by DSA between 3½ and 38 months.ResultsAll eight (100%) of the complex, large, wide-neck aneurysms were treated successfully and without periprocedural adverse events (0%). At follow-up, the two non-thrombosed aneurysms were completely occluded, but all six PTIAs recurred (75%) and were re-treated. There was no morbidity or mortality in these eight patients.ConclusionsTreatment of large, complex aneurysms with the WEB in conjunction with other implants was technically successful and safe but did not prevent recurrence of partially thrombosed aneurysms in our center. PTIA re-treatment was possible and not limited by the previously placed WEB.

Introduction/PurposeThe Pipeline™ Embolization Device (PED) is a flow-diverter available for treatment of intracranial aneurysms (IAs). We assessed the long-term safety and angiographic outcomes of a new generation of PED, Pipeline™ Flex Embolization Device with Shield Technology™ (Pipeline™ Shield). The Pipeline™ Shield device features the same implant and delivery system as the Pipeline™ Flex Embolization Device, but has been modified to include a surface synthetic biocompatible polymer to reduce the thrombogenicity of the braid surface.Materials and MethodsThe Pipeline Flex Embolization Device with Shield Technology (PFLEX) study is a prospective, single-arm, multicenter study for the treatment of unruptured IAs using Pipeline Shield. Patients with IA located in the internal carotid artery (ICA) up to the carotid terminus or vertebral artery segment up to and including the posterior inferior cerebellar artery were included. The primary study endpoint was the occurrence of major stroke in the territory supplied by the treated artery or neurological death at 1 year post-procedure. An independent Clinical Events Committee (CEC) adjudicated all adverse events. The study also assessed angiographic outcomes at 1 year post-procedure, and angiographic images in standard and working views that corresponded to the treatment angiograms were interpreted by an independent core radiology laboratory.ResultsFifty patients with 50 unruptured target IAs, 49 (98%) saccular and 1 (2%) fusiform, were treated. The mean age was 53.0±13.01 years, and 82% (41/50) of the patients were female. The mean target aneurysm diameter was 8.82±6.15 mm. Twenty-four aneurysms (48%) were small (<7 mm), 14 (28%) were medium (7–12 mm), 11 (22%) were large (13–24 mm), and 1 (2%) was giant (≥25 mm). Forty-seven (94%) aneurysms were located in the internal carotid artery, and 3 (6%) were located in the vertebral artery. Device deployment was successful in all patients. The mean number of Pipeline Shield utilized per aneurysm was 1.1±0.27. Complete wall apposition was achieved immediately post-procedure in 48 (96%) cases. No major strokes or neurological deaths were reported through 1 year post-procedure. There were 3 procedure-related, serious adverse events (headache, diplopia and retroperitoneal hematoma) and 1 device-related serious adverse event (intracranial arterythrombosis) observed through 1 year follow up. Complete aneurysm occlusion was achieved in 83.9% of target aneurysms at 1 year post-procedure. There were no reports of target aneurysm recurrence or retreatment.ConclusionsThe PFLEX study is the first prospective study to evaluate the use of the Pipeline Shield device. The results from the study are comparable to previously published results with the earlier generation devices, and demonstrate that the Pipeline Shield device is safe and effective for treatment of intracranial aneurysms.DisclosuresM. MartÍÁínez-galdÍÁíámez:2; C; Proctor and consultant for Medtronic. S. Lamin:2; C; Proctor and consultant for Medtronic. K. Lagios:None. T. Liebig:2; C; previously consulted and proctored for Covidien, Stryker, and MicroVention, and currently serves as a proctor and consultant for Sequent Medical.. E. Ciceri:None. R. Chapot:None. L. Stockx:None. S. Chavda:None. C. Kabbasch:None. G. Farago:None. H. Nordmeyer:None. T. Boulanger:None. M. Piano:None. E. Boccardi:2; C; receives honoraria from Medtronic and serves as a consultant for Medtronic.