Safety and effectiveness of the Woven EndoBridge (WEB) system for the treatment of wide necked bifurcation aneurysms: final 5 year results of the pivotal WEB Intra-saccular Therapy study (WEB-IT).

INTRODUCTION: The US Woven EndoBridge Intra-saccular Therapy (WEB-IT) study is a pivotal, prospective, single arm, investigational device exemption study to evaluate the safety and effectiveness of the WEB device for the treatment of wide neck bifurcation aneurysms (WNBAs). We present complete 5 year data for the cohort of 150 patients. METHODS: 150 patients with WNBAs were enrolled at 21 US and six international centers. Imaging from the index procedure, 6 month, 1 year, 3 year, and 5 year follow-up were reviewed by a core laboratory. Adverse events were reviewed and adjudicated by a clinical events adjudicator. RESULTS: 83 patients had 5 year follow-up imaging and 123 had clinical follow-up. No ruptured (0/9) or unruptured aneurysm (0/141) rebled or bled during follow-up. No new device or procedure related adverse events or serious adverse events were reported after 1 year. At 5 years, using the LOCF method, complete occlusion was observed in 58.1% and adequate occlusion in 87.2% of patients. For patients with both 1 year and 5 year occlusion statuses available, 76.8% (63/82) of aneurysms remained stable or improved with no retreatment. After 1 year, 18 aneurysms were retreated, 11 of which were adequately occluded at 1 year, and 15 of which were retreated in the absence of any deterioration in occlusion grade. CONCLUSIONS: Five year follow-up data from the WEB-IT study demonstrated that the WEB device was safe and effective when used in the treatment of WNBAs. Aneurysm occlusion rates achieved at 1 year follow-up were durable, with rates of progressive thrombosis far exceeding rates of recurrence over time.

Adult Cranioplasty Reconstruction With Customized Cranial Implants: Preferred Technique, Timing, and Biomaterials.

INTRODUCTION: Complex cranial defects requiring delayed reconstruction present numerous challenges. Delayed cranioplasties accompany frequent complications approaching an incidence of 35 to 40%. Therefore, the authors sought to collate their experience in hopes of sharing their perspective on several topics including technique, timing, and preferred biomaterials. METHODS: The authors' 5-year consecutive experience over 430 customized cranial implants is described herein. Since its inception in 2012, the authors' team has employed the pericranial-onlay cranioplasty technique instead of the standard epidural approach. Optimal timing for cranioplasty is determined using objective criteria such as scalp healing and parenchymal edema, close collaboration with neuroplastic surgery, conversion from autologous bone to sterile implant in instances of questionable viability/storage, and the first-line use of solid poly(methylmethacrylate) implants for uncomplicated, delayed cases, first-line porous polyethylene (MEDPOR) implants for single-stage cranioplasty, and first-line polyether-ether-ketone implants for cases with short notice. Furthermore, the use of the pterional design algorithm with temporal bulking for all customized implants has helped to correct and/or prevent temporal hollowing deformities. RESULTS: The authors' team has observed a three-fold reduction in reported complications as compared with the existing literature, with a major complication rate of 11%. The multidisciplinary center has provided an optimal stage for synergy and improved outcomes versus standard cranioplasty techniques. CONCLUSION: Secondary cranial reconstruction, or cranioplasty, can be challenging due to numerous reasons. These best practices, developed in collaboration with neuroplastic surgery and neurosurgery, appear to encompass the largest published experience to date. The authors find this approach to be both safe and reliable.

Intercostal aneurysm causing spinal cord compression in an NF1 patient.

PURPOSE: The authors illustrate a case where an intercostal aneurysm was observed in a patient with type 1 neurofibromatosis. METHODS: A 32-year-old man with NF1 presented with thoracic back pain. The patient's symptoms progressed to include myelopathic symptoms, including difficulty urinating, numbness in the lower extremities, and increased weakness. Imaging revealed what appeared to be a neurofibroma at the T4-T5 level and a plan to resect the mass was formulated. Upon initial limited hemilaminotomy, significant arterial blood was encountered. The patient was then taken to the interventional suite and angiography was performed, revealing a left T4 intercostal aneurysm. The aneurysm was coil-embolized with no residual filling. RESULTS: By 6 months post-surgery, the patient had regained full strength and sensation in his lower extremities and no longer had difficulty urinating. There has been no recurrence of symptoms 3 years postoperatively. CONCLUSIONS: Intercostal artery lesions must be considered as a possible diagnosis in NF1.

Independent predictors of morbidity after image-guided stereotactic brain biopsy: a risk assessment of 270 cases.

OBJECT: Image-guided stereotactic brain biopsy is associated with transient and permanent incidences of morbidity in 9 and 4.5% of patients, respectively. The goal of this study was to perform a critical analysis of risk factors predictive of an enhanced operative risk in frame-based and frameless stereotactic brain biopsy. METHODS: The authors reviewed the clinical and neuroimaging records of 270 patients who underwent consecutive frame-based and frameless image-guided stereotactic brain biopsies. The association between preoperative variables and biopsy-related morbidity was assessed by performing a multivariate logistic regression analysis. Transient and permanent stereotactic biopsy-related morbidity was observed in 23 (9%) and 13 (5%) patients, respectively. A hematoma occurred at the biopsy site in 25 patients (9%); 10 patients (4%) were symptomatic. Diabetes mellitus (odds ratio [OR] 3.73, 95% confidence interval [CI] 1.37-10.17, p = 0.01), thalamic lesions (OR 4.06, 95% CI 1.63-10.11, p = 0.002), and basal ganglia lesions (OR 3.29, 95% CI 1.05-10.25, p = 0.04) were in'dependent risk factors for morbidity. In diabetic patients, a serum level of glucose that was greater than 200 mg/dl on the day of biopsy had a 100% positive predictive value and a glucose level lower than 200 mg/dl on the same day had a 95% negative predictive value for biopsy-related morbidity. Pontine biopsy was not a risk factor for morbidity. Only two (4%) of 45 patients who had epilepsy before the biopsy experienced seizures postoperatively. The creation of more than one needle trajectory increased the incidence of neurological deficits from 17 to 44% when associated with the treatment of deep lesions (those in the basal ganglia or thalamus; p = 0.05), but was not associated with morbidity when associated with the treatment of cortex lesions. CONCLUSIONS: Basal ganglia lesions, thalamic lesions, and patients with diabetes were independent risk factors for biopsy-associated morbidity. Hyperglycemia on the day of biopsy predicted morbidity in the diabetic population. Epilepsy did not predispose to biopsy-associated seizure. For deep-seated lesions, increasing the number of biopsy samples along an established track rather than performing a second trajectory may minimize the incidence of morbidity. Close perioperative observation of glucose levels may be warranted.