Initial Experience with Neuroform EZ in the Treatment of Wide-neck Cerebral Aneurysms

PurposeStent-assisted coiling allows embolization and parent vessel reconstruction of wide-necked intracranial aneurysms. The Neuroform EZ (Boston Scientific, Fremont, CA, U.S.A.) stent delivery system offers deployment of a Neuroform stent with fewer steps and improved operator control. Initial experience, technical considerations, and treatment outcomes using the Neuroform EZ stent delivery system in combination with coil embolization are reported.Materials and MethodsSeventeen consecutive patients harboring 21 wide-necked saccular cerebral aneurysms were treated with stent reconstruction. Twenty aneurysms were unruptured; one was treated within 24 hours of diagnosis of rupture. Twenty aneurysms were located in the anterior circulation; one was in the posterior circulation. Immediate and six-month post-treatment angiography and clinical assessment were performed.ResultsIn all cases, the stents were delivered and positioned without difficulty in deployment. Technical complications occurred in 4 patients, but none were directly related to the stent delivery system. On immediate post-treatment angiography, 5 of 21 aneurysms showed complete occlusion, 5 of 21 showed residual neck, and 11 of 21 showed residual contrast filling of the aneurysm sac. At six month follow-up, all 17 patients were clinically stable. Angiography of 18 of the aneurysms showed total occlusion in 12, residual neck in 3, and residual aneurysm filling in 3. Retreatment was performed in the three with residual aneurysm.ConclusionThe Neuroform EZ stent system offers improved anchoring and support in stent delivery, which is particularly useful when multiple stents are overlapped to further protect the parent vessel and increase flow diversion away from the aneurysm sac. The only significant problem encountered was coil prolapse, which could be treated with a second stent when necessary. The ease of deployment improves upon the already clinically successful Neuroform design

Mobile Real-time Tracking of Acute Stroke Patients and Instant, Secure Inter-team Communication - the Join App

PurposeThe primary correlate to survival and preservation of neurologic function in patients suffering from an acute ischemic stroke is time from symptom onset to initiation of therapy and reperfusion. Communication and coordination among members of the stroke team are essential to maximizing efficiency and subsequently early reperfusion. In this work, we aim to describe our preliminary experience using the Join mobile application as a means to improve interdisciplinary team communication and efficiency.Materials and MethodsWe describe our pilot experience with the initiation of the Join mobile application between July 2015 and July 2016. With this application, a mobile beacon is transported with the patient on the ambulance. Transportation milestone timestamps and geographic coordinates are transmitted to the treating facility and instantly communicated to all treatment team members. The transport team / patient can be tracked en route to the treating facility.ResultsDuring our pilot study, 62 patients were triaged and managed using the Join application. Automated time-stamping of critical events, geographic tracking of patient transport and summary documents were obtained for all patients. Treatment team members had an overall favorable impression of the Join application and recommended its continued use.ConclusionThe Join application is one of several components of a multi-institutional, interdisciplinary effort to improve the treatment of patients with acute ischemic stroke. The ability of the treatment team to track patient transport and communicate with the transporting team may improve reperfusion time and, therefore, improve neurologic outcomes

Large vessel occlusion in the acute stroke patient: Identification, treatment, and management

Acute ischemic stroke is a major cause of death and disability in the United States. Historically, acute stroke patients were treated with intravenous (IV) thrombolysis. Patients with large vessel occlusions (LVOs) should be offered mechanical thrombectomy, with or without IV thrombolysis, in an extended window up to 24 hours of last known well. Both treatment options are the standard of care for a patient with an LVO. It is critical that the intensive care unit nurse understand new treatment indications for LVO strokes, and the priorities of nursing care with medical and endovascular intervention

Transvenous arteriovenous malformation embolization

Transvenous embolization of arteriovenous malformations has emerged as a safe and effective intervention. In carefully selected patients the transvenous approach has shown efficacy similar to that of conventional transarterial routes. The optimal lesions amenable to the transvenous approach have not been robustly delineated; however, the approach is reserved for small, deep seeded, single venous drainage lesions with poorly amenable arterial vascular supply. In this video we demonstrate a case of transvernous Onyx embolization of a Spetzler-Martin grade 3 (SM3) left hemispheric, ruptured arteriovenous malformation. The patient underwent successful, single session, complete embolization of the arteriovenous malformation through a venous route without further complications or repeat treatment

Thrombectomy with the pRESET vs solitaire stent retrievers as first-line large vessel occlusion stroke treatment: A randomized clinical trial

Importance:Stent retriever-based thrombectomy is highly beneficial in large vessel occlusion (LVO) strokes. Many stent retriever designs are currently available, but comparison of these technologies in well-conducted studies is lacking. Objective:To determine whether thrombectomy for LVO stroke with the pRESET stent retriever is noninferior to treatment with the Solitaire stent retriever. Design, setting, and participants:This study was a multicenter, prospective, randomized, controlled, open-label, adaptive, noninferiority trial with blinded primary end point evaluation. Between October 2019 and February 2022, multicenter participation occurred across 19 research hospitals and/or universities in the US and 5 in Germany. Patients with LVO stroke were enrolled and included up to 8 hours after symptom onset. Interventions:Patients underwent 1:1 randomization to thrombectomy with the pRESET or Solitaire stent retriever. Main outcomes and measures:The primary outcome was the difference in the rate of 90-day functional independence across the 2 devices, using a -12.5% noninferiority margin for the lower bound of the 1-sided 95% CI of the difference between pRESET and Solitaire retrievers. Results:Of 340 randomized patients, 170 (50.0%) were female, and the median (IQR) age was 73.0 (64.0-82.0) years. The study procedure was completed in 322 of the 340 randomized patients. The primary end point of 90-day functional independence was achieved by 95 patients (54.9%; 95% CI, 48.7-61.1) in the pRESET group and in 96 (57.5%; 95% CI, 51.2-63.8) in the Solitaire group (absolute difference, -2.57%; 95% CI, -11.42 to 6.28). As the lower bound of the 95% CI was greater than -12.5%, the pRESET retriever was deemed noninferior to the Solitaire retriever. The noninferiority of pRESET over Solitaire was also observed in the secondary clinical end point (90-day shift in modified Rankin Scale score) and in both angiographic end points (Expanded Treatment in Cerebral Infarction [eTICI] score of 2b50 or greater within 3 passes: 146 of 173 [84.4%] vs 149 of 167 [89.2%]; absolute difference, -4.83%; 95% CI, -10.84 to 1.19; eTICI of 2c or greater following the first pass: 76 of 173 [43.7%] vs 74 of 167 [44.3%]; absolute difference, -0.63%; 95% CI, -9.48 to 8.21). Symptomatic intracranial hemorrhage occurred in 0 patients in the pRESET group and 2 (1.2%) in the Solitaire group. Mortality occurred in 25 (14.5%) in the pRESET group and in 24 (14.4%) in the Solitaire group at 90 days. Findings of the per-protocol and as-treated analyses were in concordance with findings of the intention-to-treat analysis. Conclusions and relevance:In this study, among patients with LVO stroke, thrombectomy with the pRESET stent retriever was noninferior to thrombectomy with the Solitaire stent retriever. Findings suggest that pRESET offers a safe and effective option for flow restoration and disability reduction in patients with LVO stroke

Thrombectomy With the pRESET vs Solitaire Stent Retrievers as First-Line Large Vessel Occlusion Stroke Treatment A Randomized Clinical Trial

Importance Stent retriever–based thrombectomy is highly beneficial in large vessel occlusion (LVO) strokes. Many stent retriever designs are currently available, but comparison of these technologies in well-conducted studies is lacking. Objective To determine whether thrombectomy for LVO stroke with the pRESET stent retriever is noninferior to treatment with the Solitaire stent retriever. Design, Setting, and Participants This study was a multicenter, prospective, randomized, controlled, open-label, adaptive, noninferiority trial with blinded primary end point evaluation. Between October 2019 and February 2022, multicenter participation occurred across 19 research hospitals and/or universities in the US and 5 in Germany. Patients with LVO stroke were enrolled and included up to 8 hours after symptom onset. Interventions Patients underwent 1:1 randomization to thrombectomy with the pRESET or Solitaire stent retriever. Main Outcomes and Measures The primary outcome was the difference in the rate of 90-day functional independence across the 2 devices, using a −12.5% noninferiority margin for the lower bound of the 1-sided 95% CI of the difference between pRESET and Solitaire retrievers. Results Of 340 randomized patients, 170 (50.0%) were female, and the median (IQR) age was 73.0 (64.0-82.0) years. The study procedure was completed in 322 of the 340 randomized patients. The primary end point of 90-day functional independence was achieved by 95 patients (54.9%; 95% CI, 48.7-61.1) in the pRESET group and in 96 (57.5%; 95% CI, 51.2-63.8) in the Solitaire group (absolute difference, −2.57%; 95% CI, −11.42 to 6.28). As the lower bound of the 95% CI was greater than −12.5%, the pRESET retriever was deemed noninferior to the Solitaire retriever. The noninferiority of pRESET over Solitaire was also observed in the secondary clinical end point (90-day shift in modified Rankin Scale score) and in both angiographic end points (Expanded Treatment in Cerebral Infarction [eTICI] score of 2b50 or greater within 3 passes: 146 of 173 [84.4%] vs 149 of 167 [89.2%]; absolute difference, −4.83%; 95% CI, −10.84 to 1.19; eTICI of 2c or greater following the first pass: 76 of 173 [43.7%] vs 74 of 167 [44.3%]; absolute difference, −0.63%; 95% CI, −9.48 to 8.21). Symptomatic intracranial hemorrhage occurred in 0 patients in the pRESET group and 2 (1.2%) in the Solitaire group. Mortality occurred in 25 (14.5%) in the pRESET group and in 24 (14.4%) in the Solitaire group at 90 days. Findings of the per-protocol and as-treated analyses were in concordance with findings of the intention-to-treat analysis. Conclusions and Relevance In this study, among patients with LVO stroke, thrombectomy with the pRESET stent retriever was noninferior to thrombectomy with the Solitaire stent retriever. Findings suggest that pRESET offers a safe and effective option for flow restoration and disability reduction in patients with LVO stroke