Purpose Aim of VOLCAN registry was to evaluate safety and effectiveness of the Penumbra Coil 400 (PC 400) System in a real-world population in the treatment of intracranial aneurysms per standard of care.
Methods This was a prospective, multi-center registry of patients with intracranial aneurysms, treated with the PC 400 System. Inclusion criteria included patients≥18 years; ruptured or unruptured intracranial aneurysms of >2 mm. Registry exclusion criteria included fusiform or dissecting aneurysms; aneurysms associated with cerebral AVMs; retreated aneurysms and use of endovascular embolization therapies other than the PC 400 System, whereas, adjunctive use of balloon and/or stent were acceptable. This per protocol analysis excluded five patients who used non-PC 400 endovascular embolization. Primary endpoints are packing density with number of coils implanted; time of fluoroscopic exposure; procedural device-related serious adverse events (SAE) at immediate post-procedure; aneurysm occlusion post-operatively and at 12±3 months post-procedure based on Raymond Roy Occlusion Classification (RROC). Secondary endpoints are acute occlusion of aneurysm sac at immediate post-procedure and adverse events occurring during procedure and 30±7 days following treatment. Patients followed up to 12±3 months post-procedure.
Results A total of 100 consecutive patients with intracranial aneurysms were enrolled in VOLCAN registry with 95 included in this per protocol analysis. The mean age was 56.1±12.1 years and 69.5% were female. Aneurysms were located in ACA (27.4%), ICA (42.1%), MCA (17.9%), posterior circulation (7.4%), and other vertebral locations (5.3%). At baseline, 37.9% were ruptured. The mean aneurysm size was 9.9±4.7 mm, with 72.6% small (<11 mm), 24.2% large, and 3.2% giant (>25 mm). Aneurysms were wide-neck in 64.5% (60/93) of patients. PC400 coils were deployed alone in 78.9% patients. Adjunctive therapy included stent-assisted coiling (6.3%), balloon-assisted coiling (12.6%), or both (2.1%). The mean number of coils implanted was 4.5±2.5. Median fluoroscopic exposure time was 25.0 min [IQR 18.0–35.0], and median coil deployment time was 20.0 min [IQR 15.0–32.0]. Median packing density was 39.5% [IQR 30.9–52.1]. Raymond Roy Occlusion Class I-II and III at one-year were achieved in 87.2% (75/86) and 12.8% (11/86) patients, respectively. Post procedure RROC Class I-II and III were achieved in 84.2% and 15.8% of patients, respectively. At one year compared to post-treatment, 77.9% (67/86) patients had stable or better occlusion per RROC. The retreatment rate at one year was 5.7% (5/87). mRS 0 to 2 was 94.2% (81/86) at 30 days and 97.8% (88/90) at one year. Procedural device-related SAE were observed in 2 subjects (2.1%; n=1 cerebrovascular accident prophylaxis; n=1 arterial thromboembolism). No death within 24 hours of procedure was reported. One-year mortality was 2.1%, with all deaths occurring in the ruptured aneurysm group. One device-related death at 176 days post procedure was due to intracranial hemorrhage ruptured aneurysm.
Conclusion Penumbra Coil 400 System achieves high packing density with quick and adequate embolization in the treatment of intracerebral aneurysms. Results from VOLCAN registry demonstrate safety and effectiveness of the PC 400 System in a real-world population in the treatment of intracranial aneurysms as standard of care.
Disclosures J. Berge: 2; C; Penumbra Inc.
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