Peripheral Aneurysm Coiling
Using Large Volume Ruby Coils –
Results from the ACE Study
Corey Teigen, MD1
1Sanford Medical Center, Fargo, ND
Blaise Baxter, MD2; J. David Moskovitz, MD3; Henry Moyle, MD4; Ryan
Hagino, MD5; Richard Klucznik MD6, Don Heck MD7, Philippe Gailloud
MD8, Emily Luong BA9, Vu N. Bach BS9, Sophia S. Kuo PhD9, Nam
Nguyen MS9, Arani Bose MD9, Siu Po Sit PhD9 for the Penumbra ACE
Study Investigators
2Erlanger
Health System, Chattanooga, TN, 3Florida Hospital, Orlando, FL, 4Mount
Sinai Medical Center, New York, NY, 5Essentia Health, Duluth, MN, 6The Methodist
Hospital Research Institute, Houston, TX, 7Forsyth Medical Center, Winston-Salem,
NC, 8Johns Hopkins University, Baltimore, MD, 9Penumbra, Inc., Alameda, CA
Corey Teigen, MD
•Consultant/Advisory Board: Cordis
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.
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)
Purpose
Validate the efficacy of the Ruby Coil System in
treatment of:
– Embolization of visceral aneurysms
– Vessel sacrifice
– AVMs
Ruby® Coil System
• Large Volume Coil
• Longest length and largest
diameter
• Fully detachable
Complex
Complex
Soft
Soft
2 mm x 1 cm
Complex
Complex
Standard
Standard
32 mm x 60cm
• Multiple levels of softness
Delivery
Designed to be delivered through high flow Microcatheters
Ruby Volume Advantage
One 30 cm Ruby Coil
28% Packing
One 30 cm 018 conventional coil
7% Packing
7.5 mm glass aneurysm
Methods
Retrospective analysis of the prospectively
collected ACE registry was conducted to identify
Ruby coil embolization from March 2012 to April
2016
78 cases, amongst 67 patients, across 15 centers
were identified
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
Results – Aneurysm/Malformations
Angiographic Features
Values
Number of Aneurysms or Malformations, N
42
Volume, Median [IQR]
Range
1025 mm3 [IQR 605–9873]
120 – 109653 mm3
Clinical Results
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
Locations of Aneurysms and Malformations
12
11
Number of Events
10
8
8
7
6
4
2
5
3
3
1
3
1
0
Splenic Renal Artery Mesenteric
Iliac
Artery
Aneurysm Aneurysms Aneurysm
Aneurysms
Hepatic
Aneurysm
Vertebral
Artery
Aneurysms
AVMs
Peripheral Aneurysms and Malformations
Fistulae
Varices
Results - Continued
Clinical Outcome
Number of Coils Deployed, Median [IQR]
5 [IQR 3-8]
Packing Density, Median [IQR]
26.8% [IQR 18.6 – 33]
Recent publication indicated a packing density ≥ 24% is optimal1
• 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):1798-1807. doi:10.1016/j.jvir.2013.04.030.
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
Illustrative Case 1
Splenic Artery Aneurysm
Corey Teigen MD, Sanford Medical Center, ND
19 mm Splenic Artery Aneurysm
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
Case 2
Renal Artery Aneurysm
Corey Teigen MD; Sanford Medical Center, ND
2cm aneurysm
Case 2 – Post-procedure
• 3 Coils deployed
• 24.6% packing density
• Raymond Occlusion
Class I
Results – Vessel Sacrifice
Clinical Outcomes
Value
Number of Cases, N
36
Number of Coils Deployed, Median [IQR]
3 [IQR 2 – 4]
Fluoroscopy Time, Median [IQR]
21.0 Minutes [11.5 – 29.0]
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).
Results - Continued
Occlusion Status
from Index
Procedure
Progressive
Occlusion
Stable
Recanalized
6 months
5.3% (1/19)
94.7% (18/19)
0
1 year
0
100% (3/3)
0
100% of cases were either stable or better at both
6 months and 1 year follow-up
Case 3
Gastroduodenal Artery Sacrifice
Henry Moyle MD; Mount Sinai, NY
Case 3 – Post-procedure
• Intervention was pre Y90 mapping
• Complete cross sectional mechanical occlusion
achieved with 1 Ruby Coil
• 4mm x 35cm Standard coil
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