Experience Using the Penumbra Ruby Coil in the Peripheral Vasculature: ACE Multicenter Study Preliminary Results

Abstract

Purpose The Penumbra Ruby TM Coil system (Penumbra Inc., Alameda, California) is a new generation of larger (0.020 inch) platinum detachable coils that are designed for arterial and venous embolization in the peripheral vasculature. Recent literature has been published indicating the importance of higher packing density and its impact on occlusion stability and decreased recanalization rates. (1) The Aneurysm Coiling Efficiency (ACE) registry offers a unique opportunity to study the demographics and long-term outcomes of a multicenter cohort of patients with peripheral vasculature embolizations, reported herein. Material and Methods Between March 2012 and September 2014, data were collected at 12 centers. There were 63 cases of peripheral aneurysms/malformations or vessel sacrifices (11 splenic artery aneurysms, 9 renal artery aneurysms, 1 hepatic artery aneurysm, 2 mesenteric artery aneurysms, 7 AVMs, 6 fistulae, 3 varices, and 23 vessel sacrifices) treated with the Ruby Coils. The follow-up period was 6 months. Results The mean number of coils placed per aneurysm was 9 with mean packing density of 26% in the aneurysms/malformations cases (N = 39). Aneurysms identified at the splenic and renal arteries had volumes from 110 to 21,500 mm 3 and neck diameters ranging from 4 to 16 mm. Mean fluoroscopy time was 29 minutes. No procedural serious adverse events (SAEs) were noted. Among the cases of aneurysms with post-treatment occlusion data, 21/21 (100%) were graded as post-treatment Raymond Scale Class I occlusion. Of the 10 patients with 6-month follow up data, 10 (100%) displayed stable complete Class I occlusion with 0% recanalization. Of the peripheral vessel sacrifices, 23/23 patients (100%) were reported to have had successful coil embolization by the treating physician. The mean number of coils placed was 4 with a mean fluoroscopy time of 22 minutes. No procedural SAEs were recorded. All of the 11 patients with 6-month follow-up data displayed stable occlusion. Conclusions Using Ruby in the peripheral vasculature resulted in a high mean packing density and complete occlusion post-procedure which remained stable at 6-month follow-up. The long lengths and large volume of the coil allowed the use of fewer devices to achieve high packing densities. Due to the small cohort of cases, a larger sample size is needed to validate these data.