Evans, Avery J.

Abstract BACKGROUND Aneurysm recurrence after coiling has been associated with aneurysm growth, (re)hemorrhage, and a greater need for follow-up. The second-generation HydroCoil Embolic System (HES; MicroVention, Inc) consists of a platinum core with integrated hydrogel and was developed to reduce recurrence through enhancing packing density and healing within the aneurysm. OBJECTIVE To compare recurrence between the second-generation HES and bare platinum coil (BPC) in the new-generation Hydrogel Endovascular Aneurysm Treatment Trial (HEAT). METHODS HEAT is a randomized, controlled trial that enrolled subjects with ruptured or unruptured 3- to 14-mm intracranial aneurysms amenable to coiling. The primary endpoint was aneurysm recurrence using the Raymond-Roy scale. Secondary endpoints included minor and major recurrence, packing density, adverse events related to the procedure and/or device, mortality, initial complete occlusion, aneurysm retreatment, hemorrhage from target aneurysm during follow-up, aneurysm occlusion stability, and clinical outcome at final follow-up. RESULTS A total of 600 patients were randomized (HES, n = 297 and BPC, n = 303), including 28% with ruptured aneurysms. Recurrence occurred in 11 (4.4%) subjects in the HES arm and 44 (15.4%) subjects in the BPC arm ( P = .002). While the initial occlusion rate was higher with BPC, the packing density and both major and minor recurrence rates were in favor of HES. Secondary endpoints including adverse events, retreatment, hemorrhage, mortality, and clinical outcome did not differ between arms. CONCLUSION Coiling of small-to-medium aneurysms with second-generation HES resulted in less recurrence when compared to BPC, without increased harm. These data further support the use of the second-generation HES for the embolization of intracranial aneurysms. Video Abstract

Background and purpose The HydroSoft coil was developed as a finishing coil, ideally to be placed along the aneurysm neck to enhance intracranial aneurysm healing. The GEL THE NEC (Gaining Efficacy Long Term: Hydrosoft, an Emerging, New, Embolic Coil) multicenter registry was developed to assess the safety and efficacy of HydroSoft coils in treating intracranial aneurysms. We report angiographic and clinical results of this prospective registry. Materials and methods GEL THE NEC was performed at 27 centers in five countries. Patients aged 21–90 years with a ruptured or unruptured aneurysm 3–15 mm in size were eligible for enrollment. The following variables were obtained: demographics/comorbidities, aneurysm geometry, adjunctive devices used, proportion of patients in whom HydroSoft coils were successfully placed, and long-term angiographic outcomes (graded by an independent core laboratory using the Modified Raymond Scale), and procedure-related adverse events. Predictors of good angiographic outcome were studied using χ2 and t-tests. Results A total of 599 patients with 599 aneurysms were included in this study. HydroSoft coils were successfully deployed in 577 (96.4%) patients. Procedure-related major morbidity and mortality were 0.5% (3/599) and 1.3% (8/599), respectively. The most common perioperative complications were iatrogenic vasospasm (30/599, 5.0%), thromboemboli (27/599, 4.5%), and aneurysm perforation (16/599, 2.7%). At last angiographic follow-up (mean 9.0±6.3 months), the complete occlusion rate was 63.2% (280/442) and near complete occlusion rate was 25.2% (107/442). The core laboratory read recanalization rate was 10.8% (46/425) and the retreatment rate was 3.4% (20/599). Conclusions Endovascular treatment of intracranial aneurysms with HydroSoft coils resulted in complete/near complete occlusion rates of 88% and a major complication rate of 1.8%. Trial registration number NCT01000675.

Background and purpose Many studies demonstrate that both kyphoplasty and vertebroplasty are superior to conservative therapy in the treatment of osteoporotic vertebral body compression fractures. We performed a systematic review and meta-analysis of studies comparing the outcomes of vertebroplasty and kyphoplasty, which included prospective non-randomized, retrospective comparative, and randomized studies. Materials and methods We searched MEDLINE, EMBASE, and the Web of Science databases for studies of kyphoplasty versus vertebroplasty from 1 January 1990 to 30 November 2014 and compared the following outcomes: procedure characteristics, pain and disability improvement, complications and anatomic outcomes. A subgroup analysis was performed comparing pain outcomes based on the risk of bias. Results 29 studies enrolling 2838 patients (1384 kyphoplasty and 1454 vertebroplasty) were included. 16 prospective non-randomized studies, 10 retrospective comparative studies, and 3 randomized controlled studies were included. No significant differences were found in mean pain scores between the two groups postoperatively (2.9±1.5 kyphoplasty vs 2.9±1.7 vertebroplasty, p=0.39) and at 12 months (2.7±1.8 kyphoplasty vs 3.2±1.8 vertebroplasty, p=0.64). No significant differences were found in disability postoperatively (34.7±7.1 kyphoplasty group vs 36.3±7.8 vertebroplasty group, p=0.74) or at 12 months (28.3±16 kyphoplasty group vs 29.6±13.9 vertebroplasty group, p=0.70). Kyphoplasty was associated with lower odds of new fractures (p=0.06), less extraosseous cement leakage (p<0.01), and greater reduction in kyphotic angle (p<0.01). Conclusions No significant difference was found between vertebroplasty and kyphoplasty in short- and long-term pain and disability outcomes. Further studies are needed to better determine if any particular subgroups of patients would benefit more from vertebroplasty or kyphoplasty in the treatment of vertebral body compression fractures.