Evaluate the safety and efficacy of dura sealant patch in reducing cerebrospinal fluid leakage following elective cranial surgery (ENCASE II): study protocol for a randomized, two-arm, multicenter trial.

BACKGROUND: Cerebrospinal fluid (CSF) leakage is a frequent and challenging complication in neurosurgery, especially in the posterior fossa, with a prevalence of 8%. It is associated with substantial morbidity and increased healthcare costs. A novel dural sealant patch (LIQOSEAL) was developed for watertight dural closure. The objective of this study is to clinically assess the safety and effectiveness of LIQOSEAL as a means of reducing intra- as well as postoperative CSF leakage in patients undergoing elective posterior fossa intradural surgery with a dural closure procedure compared to the best currently available dural sealants. METHODS: We will conduct a two-arm, randomized controlled, multicenter study with a 90-day follow-up. A total of 228 patients will be enrolled in 19 sites, of which 114 will receive LIQOSEAL and 114 an FDA-approved PEG sealant. The composite primary endpoint is defined as intraoperative CSF leakage at PEEP 20 cm H2O, percutaneous CSF leakage within 90 days of, wound infection within 90 days of or pseudomeningocele of more than 20cc on MRI or requiring intervention. We hypothesize that the primary endpoint will not be reached by more than 10 patients (9%) in the investigational arm, which will demonstrate non-inferiority of LIQOSEAL compared to control. DISCUSSION: This trial will evaluate whether LIQOSEAL is non-inferior to control as a means of reducing CSF leakage and safety TRIAL REGISTRATION: ClinicalTrials.gov NCT04086550 . Registered on 11 September 2019.

Treatment of wide-necked aneurysms with the Low-profile Visualized Intraluminal Support (LVIS Jr) device: a multicenter experience.

BACKGROUND: The Low-profile Visualized Intraluminal Support (LVIS) Junior stent is newly approved for the treatment of wide-necked intracranial aneurysms. OBJECTIVE: To report our multicenter experience with use of the LVIS Jr device. METHODS: The neurointerventional databases of the participating institutions were retrospectively reviewed for aneurysms treated with LVIS Jr from the time of Food and Drug Administration approval until February 2016. All patients in the study period were included. Clinical presentation, aneurysm location, aneurysm size, vessel size, procedural complications, clinical and imaging follow-up were included in the analysis. RESULTS: Eighty-five patients (54 female and 31 male) met the inclusion criteria for the study. Sixty-eight (80%) of the aneurysms were unruptured and the remainder were ruptured. The most common location of the treated aneurysms was anterior communicating artery (36%), middle cerebral artery bifurcation (22%), and basilar terminus (15%). The mean aneurysm size was 6.1 mm. The mean minimum parent vessel size was 2.3 mm. The LVIS Jr was successfully deployed in all but one case (99%). Initial angiographic results demonstrated Roy-Raymond class 1-2 occlusions in 61/84 patients (73%). At 6 months, 85% of the patients seen at follow-up had Roy-Raymond class 1-2 aneurysm occlusion. No procedure-related deaths occurred. Two cases of procedure-related complications (intraprocedural rupture and delayed rupture at day 2) were seen, leading to permanent neurologic morbidity. Both these cases were in patients with ruptured aneurysms. CONCLUSIONS: The LVIS Jr is a technically feasible, safe, and effective treatment for wide-necked intracranial aneurysms. Early results are promising but will need to be corroborated with longer-term follow-up.

Self-expanding versus balloon-mounted stents for vessel recanalization following embolic occlusion in the canine model: technical feasibility study.

BACKGROUND AND PURPOSE: Despite advances in mechanical thrombolysis for acute stroke, recanalization rates remain approximately 50%-60%. Technologic improvements allowed safe intracranial delivery of stents. To study the feasibility of stent-assisted recanalization for acute stroke, we deployed self-expanding or balloon-mounted stents in 2- to 3.5-mm canine vessels acutely occluded with clot emboli. METHODS: Six mongrel dogs were placed under general anesthesia. A guiding catheter was placed in the distal vertebral artery or an external carotid artery branch. A 7 x 3 mm (length x diameter) soft or hard clot was injected into the catheter and allowed to embolize distally; 20 vessels were successfully occluded. After systemic heparin anticoagulation, recanalization with a self-expanding stent was attempted in 11 vessels (5 occluded with soft clot; 6, with hard clot). Balloon-mounted stents were placed in an attempt to revascularize 9 vessels (4 occluded with soft clot; 5, with hard clot). Vessel recanalization was assessed as the primary end point. Side-branch occlusion and stent-induced vasospasm were also assessed. RESULTS: Thrombolysis in Myocardial Infarction/Thrombolysis in Cerebral Infarction flow for 11 vessels treated with self-expanding stents versus 9 treated with balloon-mounted stents was as follows: grade 3, 91% of vessels versus 78% of vessels; grade 2, 0% versus 11%; grade 1, 9% versus 0%; grade 0, 0% versus 11%. Lower rates of spasm and side-branch occlusion were noticed with self-expanding stents. Grade 2/3 flow was achieved in 18/20 vessels (90%). CONCLUSIONS: Excellent recanalization was demonstrated with both stents. Recanalization in self-expanding stents was achieved without pre- or post-balloon dilation. Stents may prove to be a useful adjunct for intra-arterial acute stroke treatment.