Vertebroplasty is commonly used to treat painful, osteoporotic vertebral compression fractures. In this multicenter trial, we randomly assigned 131 patients who had one to three painful osteoporotic vertebral compression fractures to undergo either vertebroplasty or a simulated procedure without cement (control group). The primary outcomes were scores on the modified Roland–Morris Disability Questionnaire (RDQ) (on a scale of 0 to 23, with higher scores indicating greater disability) and patients' ratings of average pain intensity during the preceding 24 hours at 1 month (on a scale of 0 to 10, with higher scores indicating more severe pain). Patients were allowed to cross over to the other study group after 1 month. All patients underwent the assigned intervention (68 vertebroplasties and 63 simulated procedures). The baseline characteristics were similar in the two groups. At 1 month, there was no significant difference between the vertebroplasty group and the control group in either the RDQ score (difference, 0.7; 95% confidence interval [CI], −1.3 to 2.8; P=0.49) or the pain rating (difference, 0.7; 95% CI, −0.3 to 1.7; P=0.19). Both groups had immediate improvement in disability and pain scores after the intervention. Although the two groups did not differ significantly on any secondary outcome measure at 1 month, there was a trend toward a higher rate of clinically meaningful improvement in pain (a 30% decrease from baseline) in the vertebroplasty group (64% vs. 48%, P=0.06). At 3 months, there was a higher crossover rate in the control group than in the vertebroplasty group (51% vs. 13%, P<0.001). There was one serious adverse event in each group. Improvements in pain and pain-related disability associated with osteoporotic compression fractures in patients treated with vertebroplasty were similar to the improvements in a control group. (ClinicalTrials.gov number, NCT00068822.)

BACKGROUND AND PURPOSE: Imaging features of spine degeneration are common in symptomatic and asymptomatic individuals. We compared the prevalence of MR imaging features of lumbar spine degeneration in adults 50 years of age and younger with and without self-reported low back pain. MATERIALS AND METHODS: We performed a meta-analysis of studies reporting the prevalence of degenerative lumbar spine MR imaging findings in asymptomatic and symptomatic adults 50 years of age or younger. Symptomatic individuals had axial low back pain with or without radicular symptoms. Two reviewers evaluated each article for the following outcomes: disc bulge, disc degeneration, disc extrusion, disc protrusion, annular fissures, Modic 1 changes, any Modic changes, central canal stenosis, spondylolisthesis, and spondylolysis. The meta-analysis was performed by using a random-effects model. RESULTS: An initial search yielded 280 unique studies. Fourteen (5.0%) met the inclusion criteria (3097 individuals; 1193, 38.6%, asymptomatic; 1904, 61.4%, symptomatic). Imaging findings with a higher prevalence in symptomatic individuals 50 years of age or younger included disc bulge (OR, 7.54; 95% CI, 1.28–44.56; P = .03), spondylolysis (OR, 5.06; 95% CI, 1.65–15.53; P < .01), disc extrusion (OR, 4.38; 95% CI, 1.98–9.68; P < .01), Modic 1 changes (OR, 4.01; 95% CI, 1.10–14.55; P = .04), disc protrusion (OR, 2.65; 95% CI, 1.52–4.62; P < .01), and disc degeneration (OR, 2.24; 95% CI, 1.21–4.15, P = .01). Imaging findings not associated with low back pain included any Modic change (OR, 1.62; 95% CI, 0.48–5.41, P = .43), central canal stenosis (OR, 20.58; 95% CI, 0.05–798.77; P = .32), high-intensity zone (OR = 2.10; 95% CI, 0.73–6.02; P = .17), annular fissures (OR = 1.79; 95% CI, 0.97–3.31; P = .06), and spondylolisthesis (OR = 1.59; 95% CI, 0.78–3.24; P = .20). CONCLUSIONS: Meta-analysis demonstrates that MR imaging evidence of disc bulge, degeneration, extrusion, protrusion, Modic 1 changes, and spondylolysis are more prevalent in adults 50 years of age or younger with back pain compared with asymptomatic individuals.

BACKGROUND AND PURPOSE: Flow diverters are increasingly used in the endovascular treatment of intracranial aneurysms. Our aim was to determine neurologic complication rates following Pipeline Embolization Device placement for intracranial aneurysm treatment in a real-world setting. MATERIALS AND METHODS: We retrospectively evaluated all patients with intracranial aneurysms treated with the Pipeline Embolization Device between July 2008 and February 2013 in 17 centers worldwide. We defined 4 subgroups: internal carotid artery aneurysms of ≥10 mm, ICA aneurysms of <10 mm, other anterior circulation aneurysms, and posterior circulation aneurysms. Neurologic complications included spontaneous rupture, intracranial hemorrhage, ischemic stroke, permanent cranial neuropathy, and mortality. Comparisons were made with t tests or ANOVAs for continuous variables and the Pearson χ² or Fisher exact test for categoric variables. RESULTS: In total, 793 patients with 906 aneurysms were included. The neurologic morbidity and mortality rate was 8.4% (67/793), highest in the posterior circulation group (16.4%, 9/55) and lowest in the ICA <10-mm group (4.8%, 14/294) (P = .01). The spontaneous rupture rate was 0.6% (5/793). The intracranial hemorrhage rate was 2.4% (19/793). Ischemic stroke rates were 4.7% (37/793), highest in patients with posterior circulation aneurysms (7.3%, 4/55) and lowest in the ICA <10-mm group (2.7%, 8/294) (P = .16). Neurologic mortality was 3.8% (30/793), highest in the posterior circulation group (10.9%, 6/55) and lowest in the anterior circulation ICA <10-mm group (1.4%, 4/294) (P < .01). CONCLUSIONS: Aneurysm treatment with the Pipeline Embolization Device is associated with the lowest complication rates when used to treat small ICA aneurysms. Procedure-related morbidity and mortality are higher in the treatment of posterior circulation and giant aneurysms.

Background and Purpose— We report a preclinical study of a new endoluminal device for aneurysm occlusion to test the hypothesis that the device, even without use of intrasaccular coil placement, could occlude saccular aneurysms without causing substantial parent artery compromise or compromise of adjacent, small branch arteries. Methods— The Pipeline Neuroendovascular Device (Pipeline NED; Chestnut Medical Technologies, Inc) is a braided, tubular, bimetallic endoluminal implant aimed at occlusion of saccular aneurysms through flow disruption along the aneurysm neck. The device was implanted across the necks of 17 elastase-induced aneurysms in the New Zealand white rabbit model and followed for 1 month (n=6), 3 months (n=5), and 6 months (n=6). In each subject, a second device was implanted in the abdominal aorta to cover the origins of lumbar arteries. Aneurysm occlusion rates by angiography (grade 1, complete occlusion; grade 2, near-complete occlusion; and grade 3, incomplete occlusion) were documented. Percent area stenosis of the parent arteries was calculated. Presence of distal emboli in the downstream vessels in the parent artery and branch artery stenosis or occlusion was noted. Results— Grades 1, 2, and 3 occlusion rates were noted in 9 (53%), 6 (35%), and 2 (12%) of 17 aneurysms, respectively, indicating an 88% rate of complete or near complete occlusion. No cases of branch artery occlusion or distal emboli in the downstream vessels of the parent artery, specifically the subclavian artery, were seen. Parent artery compromise from neointimal hyperplasia was minimal in most cases. Conclusions— The Pipeline NED is a trackable, bio- and hemocompatible device able to occlude saccular aneurysms with preservation of the parent artery and small, adjacent branch vessels.

BACKGROUND AND PURPOSE: The use of stents for treatment of morphologically unfavorable, acutely ruptured aneurysms is avoided by most operators because of concerns about the risk of using dual antiplatelet therapy in the setting of acute SAH. Our aim was to review the literature regarding stent-assisted coil embolization of acutely ruptured intracranial aneurysms to determine the safety and efficacy of this treatment option. MATERIALS AND METHODS: Articles including ≥5 patients with ruptured aneurysms who were treated acutely with stent-assisted coiling or uncovered stent placement alone were identified. Data on clinical presentation, technical success, surgical crossover, intracranial complications, and clinical outcome were evaluated. RESULTS: A total of 17 articles were identified reporting 339 patients who met inclusion criteria. Among 212 patients with available data, technical success was noted in 198 (93%) patients. Three hundred twenty-six (96%) of 339 patients received both heparin during the procedure and dual-antiplatelet therapy during or immediately postprocedure. One hundred thirty (63%) of 207 aneurysms were completely occluded. Six (2%) of 339 patients required surgical crossover, usually for failure in stent placement or for intraprocedural aneurysm rupture. Clinically significant intracranial hemorrhagic complications occurred in 27 (8%) of 339 patients, including 9 (10%) of 90 patients known to have EVDs who had ventricular drain−related hemorrhages. Clinically significant thromboembolic events occurred in 16 (6%) of 288 patients. Sixty-seven percent of patients had favorable clinical outcomes, 14% had poor outcomes, and 19% died. CONCLUSIONS: Stent-assisted coiling in ruptured aneurysms can be performed with high degrees of technical success, but adverse events appear more common and clinical outcomes are likely worse than those achieved without stent assistance. Thromboembolic complications appear reasonably well-controlled. Reported EVD-related hemorrhagic complications were uncommon, though the total number of EVDs placed was unknown.

BACKGROUND AND PURPOSE: Understanding risk factors for intracranial aneurysm growth is important for patient management. We performed a meta-analysis examining risk factors for intracranial aneurysm growth in longitudinal studies and examined the association between aneurysm growth and rupture. MATERIALS AND METHODS: We searched the literature for longitudinal studies of patients with unruptured aneurysms. We examined the associations of demographics, multiple aneurysms, prior subarachnoid hemorrhage, family history of aneurysm or subarachnoid hemorrhage, smoking, and hypertension; and aneurysm shape, size, and location with aneurysm growth. We studied the association between aneurysm growth and rupture. A meta-analysis was performed by using a random-effects model by using summary statistics from included studies. RESULTS: Twenty-one studies including 3954 patients with 4990 aneurysms with 13,294 aneurysm-years of follow-up were included. The overall proportion of growing aneurysms was 3.0% per aneurysm-year (95% CI, 2.0%–4.0%). Patient risk factors for growth included age older than 50 years (3.8% per year versus 0.9% per year, P < .01), female sex (3.2% per year versus 1.3% per year, P < .01), and smoking history (5.5% per year versus 3.5% per year, P < .01). Characteristics associated with higher growth rates included cavernous carotid artery location (14.4% per year), nonsaccular shape (14.7% per year versus 5.2% per year for saccular, P < .01), and aneurysm size (P < .01). Aneurysm growth was associated with a rupture rate of 3.1% per year compared with 0.1% per year for stable aneurysms (P < .01). CONCLUSIONS: Observational evidence provided multiple clinical and anatomic risk factors for aneurysm growth, including age older than 50 years, female sex, smoking history, and nonsaccular shape. These findings should be considered when counseling patients regarding the natural history of unruptured intracranial aneurysms.