Primary results from the CLEAR study of a novel stent retriever with drop zone technology.

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.

Bilateral carotid-cavernous fistula after trauma presenting as hemorrhagic shock: Case report.

Bilateral carotid-cavernous fistula (CCF) is a rare complication associated with severe head injury and skull base fractures. Initial presentation with hemodynamically relevant epistaxis is unusual. We report a case of a 27-year-old male presenting with severe craniocerebral injury associated with massive epistaxis. To stabilize the patient hemodynamically, the bleeding was stopped by embolization of left internal carotid artery with coils, after checking that the Willis circle is well compensated. The left CCF was embolized later with flow diverter stent when it was safe to use platelet aggregation inhibitors. Reporting this case enlighten the management of bilateral CCF with hemorrhagic shock.

ADC measurement relevance to predict hemorrhage transformation after mechanical thrombectomy.

BACKGROUND: ADC (apparent coefficient diffusion) value has been known to predict hemorrhage transformation (HT) after thrombolysis and recently, after mechanical thrombectomy (MT). We aimed to evaluate that utility separately in basal ganglia and superficial territory. We used HT occurrence with or without NIHSS change as primary outcome measures. METHODS: This single-center retrospective study included consecutive stroke patients receiving MT for internal carotid artery (ICA) or middle cerebral artery (M1 or M2) occlusion. In patient with or without HT, using the Heidelberg Bleeding Classification, on follow-up CT scan at 24-48 h, we assessed the ADC value separately in basal ganglia and superficial territory on MRI before MT to search for the correlation. Multivariable analysis was performed using variables with significant differences between the HT group and non-HT group. RESULTS: One hundred seventeen patients were included in the final analysis. HT distribution was as follows: 9 patients (7.69%) HI1 or 2; 14 patients (11.97%) PH1; 21 patients (17.95%) PH2; 29 patients (24.79%) subarachnoid hemorrhage; and 21 patients (17.95%) symptomatic intracranial hemorrhage (sICH). Mean ADC minimal value in basal ganglia in the HT group was significantly lower than in the non-HT group (377.6 × 10-6 mm2/s [± 52.4] vs 413.3 × 10-6 mm2/s [± 72.5]; p = 0.0229) with an area under the curve (AUC) of 0.6622 (95% CI: 0.5-0.8; p = 0.014). MRI-MT time was significantly longer in the HT group (p = 0.0002), but there was no association between ADC value and onset-MRI or MRI-MT times (Spearman's coefficients <0.7, p > 0.05). Glycemia at admission (>1.5 g/L) (OR = 4.2; 95% CI [1.611; 10.961]) and carotid occlusion (OR = 2.835; 95% CI [1.134; 7.091]) were independently associated with HT. CONCLUSIONS: ADC value in basal ganglia, unlike brain superficial territory, are correlated to HT risk after MT.

Intracranial aneurysm treatment with WEB and adjunctive stent: preliminary evaluation in a single-center series.

BACKGROUND: Intrasaccular flow disruption with WEB is a safe and efficacious technique that has significantly changed endovascular management of wide-neck bifurcation aneurysms (WNBAs). Use of stent in combination with WEB is occasionally required. We analyzed the frequency of use, indications, safety, and efficacy of the WEB-stent combination. METHODS: All aneurysms treated with WEB and stent were extracted from a prospectively maintained database. Patient and aneurysm characteristics, complications, and anatomical results were independently analyzed by a physician independent of the procedures. RESULTS: From June 2011 to January 2020, 152 patients with 157 aneurysms were treated with WEB. Of these, 17/152 patients (11.2%) with 19/157 aneurysms (12.1%) were treated with WEB device and stent. Indications were very wide neck with a branch emerging from the neck in 1/19 (5.2%) aneurysms and WEB protrusion in 18/19 (94.7%). At 1 month, no morbimortality was reported. At 6 months, anatomical results were complete aneurysm occlusion in 15/17 aneurysms (88.2%), neck remnant in 1/17 (5.9%), and aneurysm remnant in 1/17 (5.9%). At 12 months, there was complete aneurysm occlusion in 13/14 aneurysms (92.9%) and neck remnant in 1/14 (7.1%). CONCLUSIONS: Combining WEB and stent is a therapeutic strategy to manage WNBA. In our series, this combination was used in 11.2% of patients treated with WEB, resulting in no morbidity or mortality with a high efficacy at 6 and 12 months (complete aneurysm occlusion in 88.2% and 92.9%, respectively).