1. The Cook Fenestrated
Platform: Experiences and
Oncoming Technology
Krassi Ivancev
Department of Vascular & Endovascular Surgery,
Royal Free London NHS Foundation Trust,
London, United Kingdom

2. Disclosure
• Cook Medical Inc.
- Patent licenses/Royalties
- Research funds
- Travel expenses

3. Cook Zenith Fenestrated Device
Indication: Infrarenal Neck >4mm

4. Precision Design
Patient-Specific Fenestrations
Scallop
Small Fenestration
Large Fenestration
Scallops along the graft’s
proximal edge are 10 mm
wide and 6-12 mm high.
Small fenestrations
are 6 mm wide and
6 or 8 mm high.
Large fenestrations
range from 8-12 mm
in diameter.

5. Indications for fenestrated
stentgraft

Juxtarenal aneurysm
– Short neck
– Conical neck
– Thrombus-lined neck
•
15-20% of AAA will
have inadequate
neck for standard
infrarenal SG

6. Open vs F-EVAR vs Ch-EVAR
Cumulative Results for JAA

7. Study Design
• Systematic PubMed search
• English articles (January 2001-July 2012)
• JAA Management (Open surgery, F-EVAR, Ch-EVAR)
• Studies with ≥10 pts included

8. Study Cohorts

OPEN Surgery: 20 studies,1725 pts

F-EVAR: 10 studies, 931 pts

Ch-EVAR: 5 studies, 94 pts

9. Outcomes Comparison

10. Target Vessel Preservation
Excellent rates for F-EVAR, Ch-EVAR
Under-reported for Open

11. 30-Day Mortality

12. 30-Day Mortality (1)
→ F-EVAR ↓ Mortality vs Open but NS
However...
F-EVAR: ↑ Risk pts & Learning curve

13. 30-Day Mortality (2)
→ Reasonable due to acute cases in Ch-EVAR
But even with acute cases excluded…
Ch-EVAR: 5.1%
F-EVAR: 2.4%

14. Perioperative Complications
F-EVAR ↓ complications vs Open
Ch-EVAR ↓ pulmonary complications (only) vs Open

15. Operative Data
F-EVAR & Ch-EVAR : ↓ EBL, ICU & Hospital LOS vs Open

16. Proximal Type I Endoleak
Ch-EVAR: 5-31%, Cumulative 10%
F-EVAR: 0-5.9%, Cumulative 4.3%, (p=0.002)

18. TM Mastracci, MD, RK Greenberg, MD, MJ Eagleton et al, Durability of branches
in branched and fenestrated endografts, J Vasc Surg 2013;57:926-33

19. Secondary Interventions:
CCF Data
50% Endoleak
SMA Reintervention N=26 (4%)
50% Stenosis
9 Urgent
3 related deaths
Celiac Reintervention N=4 (0.6%)
LRA N=30 (5%) 32% Diagnostic
48% Endoleak
RRA N=41 (6%)
19% Stenosis
Device Migration
Time to any branch
stent intervention
N=7
5 req intervention,
4 branch related
237 days (SD 354 days)
TM Mastracci, MD, RK Greenberg, MD, MJ Eagleton et al, Durability of branches
in branched and fenestrated endografts, J Vasc Surg 2013;57:926-33

20. Freedom From Secondary Intervention
All Endo-Juxtarenal and TAAA Repairs
TM Mastracci, MD, RK Greenberg, MD, MJ Eagleton et al, Durability of branches
in branched and fenestrated endografts, J Vasc Surg 2013;57:926-33

21. Options in “short/no” Neck AAA
Conclusions

Open Surgery in short/no necks: good risk pts

Fenestrated EVAR: alternative to open,
especially in high risk patients

Chimney techniques: to be proven, therefore
only as bail-out and in acute patients

22. Problems with current
technology
 Planning
– Margin of Error
 Production
– 6-8 weeks
 Bilateral
Access
– LE perfusion
– Compromised access
 Precision
vivo
of graft in
Not for symptomatic/very large AAA?

23. Off The Shelf
•
-10
Retrospective analysis
of 353 patients
0
Methods/Assumptions
• Align SMA fenestration
• Device fits if renals are
within outer ring (15
mm diameter)
10
Distance to SMA
•
20
30
40
RRA
50
LRA
60
•
0
6
Results
• 80% coverage possible
2
8
4
10
6
12
8
2
Clock Position
J. Sobocinski, G. d’Utra, N. O’Brien et al. Off-the-Shelf Fenestrated Endografts: A Realistic Option for
More Than 70% of Patients With Juxtarenal Aneurysms ENDOVASC THER 2012;19:165–172
10
4
12
6

24. P-Branch device

25. Zenith® Preloaded Delivery System

26. Not available for sale.

27. 15mm
6mm

28. Not available for sale.

29. Current Status
 CE
marking trial on-going
– 4 sites (1 Europe, 3 US)
– 48 patients enrolled
» 6 ruptures
» 1 symptomatic

30. A Kitagawa, RK Greenberg, MJ Eagleton, TM Mastracci: Zenith pivot branch device (p-branch) standard endovascular
graft: Early experience on an innovative standard fenestrated endograft for juxtarenal abdominal aortic aneurysm
J Vasc Surg 2013;-:1-10

31. Current Status

32 patients:
• 2 renal artery stents occluded – succesfully
•
•
•
recanalized
1acute patient – SMA and renal artery stent
compression – succesfully re-stented
No type 1 and 3 endoleaks
30-day mortality = 0

32. P-Branch Limitations

Results of imperfect fit??
• Stress/strain on mating stents?
• Fenestrations more mobile?

New ancillary equipment
• Longer mating stents
• Longer sheaths/catheters

Balance of 3 vs. 2 target vessels

33. P-Branch Strengths

Base Technology works
– Based on Zenith Fenestrated Platform

Use for juxta, para and suprarenal AAA
– SMA fenestration

Unilateral Sheath
Preloaded Fenestrations

2 designs fit 70-80%


34. P Branch Conclusions
 Feasibility
 Valuable
addition to current
technology
– No complete replacement for CMD
 Use
AA
for wide range of paravisceral