Peripheral Aneurysm Coiling Using Large Volume Ruby Coils Results from the ACE Study

Transcription

1 Peripheral Aneurysm Coiling Using Large Volume Ruby Coils Results from the ACE Study Corey Teigen, MD 1 1 Sanford Medical Center, Fargo, ND Blaise Baxter, MD 2 ; J. David Moskovitz, MD 3 ; Henry Moyle, MD 4 ; Ryan Hagino, MD 5 ; Richard Klucznik MD 6, Don Heck MD 7, Philippe Gailloud MD 8, Emily Luong BA 9, Vu N. Bach BS 9, Sophia S. Kuo PhD 9, Nam Nguyen MS 9, Arani Bose MD 9, Siu Po Sit PhD 9 for the Penumbra ACE Study Investigators 2 Erlanger Health System, Chattanooga, TN, 3 Florida Hospital, Orlando, FL, 4 Mount Sinai Medical Center, New York, NY, 5 Essentia Health, Duluth, MN, 6 The Methodist Hospital Research Institute, Houston, TX, 7 Forsyth Medical Center, Winston-Salem, NC, 8 Johns Hopkins University, Baltimore, MD, 9 Penumbra, Inc., Alameda, CA

2 Corey Teigen, MD Consultant/Advisory Board: Cordis

3 ACE Trial The Aneurysm Coiling Efficiency (ACE) multicenter post market prospective registry seeks to gather outcome data on the use of the Ruby Coil System in the embolization of peripheral aneurysms, malformations, as well as other peripheral vessels.

4 ACE Trial Outcome measures: Packing density with the number of coils deployed Time of fluoroscopic exposure Device-related serious adverse events (Immediate post-procedure) 6 month occlusion rate (optional 1 year follow-up)

5 Purpose Validate the efficacy of the Ruby Coil System in treatment of: Embolization of visceral aneurysms Vessel sacrifice AVMs

6 Ruby Coil System Large Volume Coil Longest length and largest diameter Fully detachable Multiple levels of softness Complex Soft 2 mm x 1 cm Complex Standard 32 mm x 60cm

7 Delivery Designed to be delivered through high flow Microcatheters

8 Ruby Volume Advantage One 30 cm Ruby Coil 28% Packing One 30 cm 018 conventional coil 7% Packing 7.5 mm glass aneurysm

9 Methods Retrospective analysis of the prospectively collected ACE registry was conducted to identify Ruby coil embolization from March 2012 to April cases, amongst 67 patients, across 15 centers were identified

10 Results Baseline Characteristics Age, median [IQR] 59 Years [IQR 48 71] Female, % (n/n) 44.8% (30/67) Total Patients, n 67 Total Events, N 78

11 Results Aneurysm/Malformations Angiographic Features Number of Aneurysms or Malformations, N 42 Volume, Median [IQR] Range Clinical Results Values 1025 mm 3 [IQR ] mm 3 Values Fluoroscopy Time, Median [IQR] 24.5 Minutes [IQR 17 36] Intra-procedure SAE 0 SAE within 24h Post-procedure* 2.4% (1/42) Retreatment at 6 months 6.3% (2/32) Retreatment at 1 year 5.6% (1/17) *Splenic infarction documented in 1 patient post embolization

12 Number of Events Locations of Aneurysms and Malformations Splenic Artery Aneurysms Renal Artery Aneurysm Mesenteric Aneurysms Iliac Aneurysm Hepatic Aneurysm Vertebral Artery Aneurysms AVMs Fistulae Varices Peripheral Aneurysms and Malformations

13 Results - Continued Clinical Outcome Number of Coils Deployed, Median [IQR] 5 [IQR 3-8] Packing Density, Median [IQR] 26.8% [IQR ] Recent publication indicated a packing density 24% is optimal 1 Protects against compaction or recanalization in long term follow-up ( 12 months). 5 Ruby Coils achieved 26.8% packing density 1. Yasumoto T, Osuga K, Yamamoto H, et al. Long-term outcomes of coil packing for visceral aneurysms: Correlation between packing density and incidence of coil compaction or recanalization. J Vasc Interv Radiol. 2013;24(12): doi: /j.jvir

14 Results - Continued Raymond Occlusion Classification* Post-procedure 6 Months 1 Year Class I 84.6% (22/26) 85.7% (18/21) 100% (15/15) Class II 7.7% (2/26) 9.5% (2/21) N/A Class III 7.7% (2/26) 4.8%(1/21) N/A *Class I: complete obliteration; Class II: residual neck; Class III: residual aneurysm

15 Illustrative Case 1 Splenic Artery Aneurysm Corey Teigen MD, Sanford Medical Center, ND 19 mm Splenic Artery Aneurysm

16 Case 1 Post-procedure 8 Ruby Coils deployed 33.8% packing density achieved Class I Raymond Occlusion at 6 months and 1 year follow-up

17 Case 2 Renal Artery Aneurysm Corey Teigen MD; Sanford Medical Center, ND 2cm aneurysm

18 Case 2 Post-procedure 3 Coils deployed 24.6% packing density Raymond Occlusion Class I

19 Clinical Outcomes Results Vessel Sacrifice Number of Cases, N 36 Value Number of Coils Deployed, Median [IQR] 3 [IQR 2 4] Fluoroscopy Time, Median [IQR] 21.0 Minutes [ ] Intra-procedural SAE 0 SAE within 24h Post-procedure* 5.6% (2/36) * 2 SAEs were recorded in 2 patients. 1 patient developed a splenic rupture, treated by splenectomy; the remaining patient had 2 embolizations; expired due to polytrauma complications (after family made decision to begin comfort care).

20 Results - Continued Occlusion Status from Index Procedure Progressive Occlusion Stable 6 months 5.3% (1/19) 94.7% (18/19) 0 1 year 0 100% (3/3) 0 Recanalized 100% of cases were either stable or better at both 6 months and 1 year follow-up

21 Case 3 Gastroduodenal Artery Sacrifice Henry Moyle MD; Mount Sinai, NY

22 Case 3 Post-procedure Intervention was pre Y90 mapping Complete cross sectional mechanical occlusion achieved with 1 Ruby Coil 4mm x 35cm Standard coil

23 Conclusion Current observation indicated that the Ruby Coil System exhibits safe and effective embolizations of peripheral aneurysms/malformations and vessel sacrifice. Complete obliteration immediate post-procedure 84.6% Class I occlusion in aneurysm/malformation cohort 100% stable embolization in all vessel sacrifice cases Persistent occlusion at follow-up 88.9% stable or progressive occlusion for the aneurysm/malformation cohort at 6 months, 100% at 1 year 100% stable or progressive occlusion at both 6 months and 1 year in vessel sacrifice patients Reduced overall: Number of coils needed Procedural time Fluoroscopy time/exposure Retreatment rate Additional data will help validate the current findings