Repositioning the future of evar real life experience with the gore excluder featuring c3 delivery system and one year results of the european registry

1. XV. ULUSALVASKULER
CERRAHI KONGRESI
Mr. Paul Bachoo
Consultant Vascular Surgeon
Aberdeen
Scotland

3. WHY REPOSITIONABLE ?

5.  Proximal aortic neck diameter
> 28mm
 Length <15mm
 11-15mm
 <10mm
• Angle >60
• Reverse taper / bulging neck
• Thrombus lining
• Calcification
Neck 10mm
Angle 94
Aberdeen case

6. Stent graft
attributes
ACCURATE
DEPLOYMENT

7. Aberdeen: 3mensio Vascular Tera-recon

9. Trans renal Infra renal
Top downBottom up
Repositionable

10. Device Manufacturer Stent Graft Delivery Special feature
Talent Medtronic Nitinol Woven
Polyester
Integrated
sheath
Pararenal bare
stent
Zenith Flex Cook Stainless
steel
Woven
Polyester
Integrated
sheath
Uncovered
stent,
suprarenal
fixation
Powerlink Endologix Cobalt
chromium
ePTFE Integrated
sheath
Sits on
bifurcation

11. Device Manufacturer Stent Graft Delivery Special feature
Anaconda Vascutek Nitinol Woven
Polyester
Integrated
sheath
Repositionable
Magnetic
guidance
Aorfix Lombard Nitinol Woven
Polyester
Integrated
sheath
Crumple zone
Endurant Medtronic Nitinol Woven
Polester
Integrated
sheath
Pararenal bare
stent,
suprarenal
hooks

13. Endoframes Endobags

14. Infrarenal
hooks
Nitinol
ePTFE
RepositionableTop
down
Infra
renal

17. Deploy the trunk to the contra gate. This allows distal
perfusion and prevents wind sock effect

18. Repositioning is not mandatory

19. Point of no return

20. Step 3: deploying the ispi legDeploying the ipsi-lateral leg

21. However if repositioning is required

22. Constraining the trunk will disengage the anchoring
pins and allow re-positioning of the device

23. After repositioning

27. Deploy Trunk
Attempt Cannulation
Remove
Constraining
Mechanism
Deploy ipsi
Balloon Trunk-ipsi
Reposition
Reposition
Happy
With
Position?
Success?
NoYes
Yes
No
Deploy Contra

28. Confidence
 Take on challenging aortic neck anatomy
 Angulated long
 Angulated short
 Straight short
 Train future endovascular surgeons
 Introduce surgeons experienced in open AAA surgeons to EVAR
 Allow experienced endovascular surgeons to take on challenging
anatomy

29. Short straight neck
Courtesy of Professor Eric Vorhoeven

32. C3 ADDRESSESTHE INABILITYOF BEING ABLETO RELIABLY PREDICT
THE EXACT LANDING SITE OF A GRAFTWITHIN A CURVED SEGMENT

36. Site
Number Site Name
Procedure Date
Range
C3 Deployment
System
203 Klinikum Nürnberg Süd 08/10 - 10/11 40(24.2%)
209 University of Cologne University Clinics 09/10 - 09/11 17(10.3%)
215 Klinikum der Universität Regensburg 08/10 - 08/11 12(7.3%)
218 University of Heidelberg 03/11 – 8/11 8(4.8%)
263 Hospital Clinic I Provincial de Barcelona 09/10 – 6/11 5(3.0%)
264 Orebro University Hopsital 9/10 – 6/11 16(9.5%)
278 Aberdeen Royal Infirmary 9/10 – 10/11 32(19.0%)
279 Cambridge University Hospitals NHS Trust 09/10 - 09/11 13(7.9%)
280 Royal Liverpool University Hospital 09/10 – 10/11 16(9.7%)
283 Weißeritztal Kliniken GmbH 08/10 - 05/11 9(9.5%)
Total Subjects Enrolled 08/10 - 10/11 168

37. C3 Device
N (C3) / N (ABD) =168(%)
%Male 85 / 87
Age (yrs)
Mean (Std Dev) 73.7 / 74 (7.7)
Median 75.0
Range (51.0-90.0)
Patient demographics & surgical risk factors
ASA Classification NYHA Classification
Number Responding 162 Number Responding 161
I 3 / (1.9) I 28(18.0)
II 52(32.1 / 10) II 89(55.3)
III 100(61.7 / 70) III 29(18.0)
IV 7(4.3 / 10) IV 0(0.0)
V 0(0.0) No Cardiac Disease 14(8.7)

38. N=161(%)
Aortic Pathology
Abdominal aortic aneurysm 157(97.5 / 100)
Common iliac aneurysm 3(1.9)
Abdominal aortic aneurysm rupture 1(0.6)
Reason for Treatment
Primary Procedure for Endovascular Treatment 155(96.3 / 100)
Reintervention of an Open Surgical Procedure 3(1.9)
Reintervention of a Prior Endovascular Procedure 2(1.2)

39. Aneurysm Diameter (mm)
n 155
Mean (Std Dev) 58.4(60)
Median 56.0
Range (35.0,95.0)
Proximal Neck Length (cm)
n 154
Mean (Std Dev) 2.9 (2.1)
Median 2.5
Range (0.3,21.0)
Infrarenal Neck Angle
n 147
Mean (Std Dev) 27.7(24.4)
Median 22.0
Range (0.0,100.0)
Case Planning
Information
Neck Length < 1.5 cm 13(8.1%)
Neck Angulation ≥ 60 15(9.3%)
Significant Calcification at
Landing Zones
28(17.4%)
Significant Thrombus at
Landing Zones
18(11.2%)

40. Anesthesia Method n (%)
General 149 (92.5 / 100)
Regional 11(6.8)
Local 0
Procedure Survival 161(100 / 100)
Procedure Time (skin-to-skin)
Mean (Std Dev) 126.7(65.4 / 70)
Median 110.0
Range (60.0,477.0)
Hospital Stay (Days)
Mean (Std Dev) 6.6(8.1 / 3)
Median 5.0
Range (1.0,93.0)

41. Number of Enrolled Subjects n=168(%)
Number of Cases Requiring Trunk Repositioning 91/8(57)
Reasons for Repositioning
Positioning Closer to Renal Arteries 67 / 7(42)
Contralateral Gate Positioning 27(17)
Other 16(10)

42. Number of cases requiring repositioning n=95
Number of Repositions per Case
1 61 (7)
2 24(1)
3 5
4 1
Missing 4

43. Number of Enrolled Subjects 168 (%)
95% CI1
Device Deployed Where Planned 150(93 / 100) (88.2%,96.1%)
Deployed ≥5mm from intended location 4(2.5%) (1.0%,6.2%)

44. Number of Enrolled Subjects n=168 (%)
Subjects with Aortic Extender(s) Implanted 8 / 2 (5.0)
Subjects with unplanned Aortic Extender(s) 7 (4.3)
Reasons for Unplanned Extender Use
Increase Seal 1 (0.6)
Extend Landing Zone 1 (0.6)
Type I Endoleak 5 (3.1)

45. Number of Enrolled Subjects n=168 (%)
Any In-Hospital Serious Event 4 / 0 (2.4)
Iliac artery occlusion 2 (1.2)
Device Dislocation 1 (0.6)
Renal haemorrhage 1 (0.6)
Surgical mortality = 0
30 day mortality = 0
Death reported at day 35 due to renal sepsis from dialysis
Death reported at day 173 due to subdural hematoma

46. Why repositionable ?

47.  Controlled delivery
 Controlled and precise adjustments in a vertical plane
 Controlled orientation of contra-lateral limb in a horizontal
plane
 Controlled proximal landing at preferred site avoiding
calcium plaques / thrombus/preserving accessory renals
 Controlled proximal landing within a angled neck
 Controlled and safe training
 Controlled constraint and disengagement of hooks
 Controlled use of aortic cuffs / expenses

48. If not the first time certainly by the third repositioning you will
achieve your intended proximal landing site