1. 4EVER results Koen Deloose, MD Marc Bosiers Koen Deloose
A.Z. Sint-Blasius, Dendermonde
Marc Bosiers
Koen Deloose
Joren Callaert
4EVER results
Imelda Hospital, Bonheiden
Patrick Peeters
Jürgen Verbist
OLV Hospital, Aalst
Lieven Maene
Roel Beelen
R.Z. Heilig Hart, Tienen
Koen Deloose, MD
Koen Keirse

2. What is the ideal world?

3. 1. Performing all procedures with ES access
Lesion passages
Balloons (6mm – 28cm)
DEB (5mm – 12cm)
Coronary stents
DES
Nitinol stents (7mm – 20cm)
Rotablator
Atherectomy (Silverhawk, Laser, Jetstream,..)
Outback/Front runner
“Kissing” bifurcation
treatment
Thrombo-aspiration
Coral reef lesions

4. 2. Without access complications
Hematoma
Pseudo-aneurysm
Arterio-venous fistula
Acute arterial occlusion
Dissection
Acute thrombosis
Neural damage

5. 3. Without the use of closure devices…

6. … and their related complications…
Stenosis
Laceration
Inadequate adventitial closure
Infection
Femoral neuralgic syndrome
Periarterial fibrosis
Intraluminal Thrombosis

7. BUT …from the ideal world…

8. …Back to daily-life reality!!!

9. Does a 4F system really functions in our daily endovascular practice?
Astron Pulsar
Fortress Sheath
Pulsar-18 9

10. 1. Performing all procedures with 4F access?
What we CAN DO with 4F approach :
Lesion passages
Balloons (6mm – 28cm)
DEB (5mm – 12cm)
Coronary stents
DES
Nitinol stents (7mm – 20cm)
Rotablator
What we CAN’T DO with 4F approach :
Atherectomy (Silverhawk, Laser, Jetstream,..)
Outback/Front runner
“Kissing” bifurcation
treatment
Thrombo-aspiration
Coral reef lesions

11. 1. Performing all procedures with 4F access?
What we CAN DO with 4F approach :
Lesion passages
Balloons (6mm – 28cm)
DEB (5mm – 12cm)
DES
Coronary stents
Nitinol stents (7mm – 20cm)
Rotablator
Sufficient for the vast majority of endovascular treatments

12. 2. Safety and effectiveness ?
4EVER study
Physician-Initiated Trial Investigating the Safety of the Full 4F EndoVascular TrEatement AppRoach of Infra-Inguinal Arterial Stenotic Disease 12

13. Study design Prospective, non-randomized, multi-center study
A total of 120 enrollments
Main inclusion criteria:
Rutherford category 2-4
SFA stenosis >50% or occlusion
Lesion length ≤200mm
At least one-vessel run-off to the foot

14. One of the secondary endpoints
Primary endpoint
Primary patency at 12 months, defined as :
No binary re-stenosis (>50%) on duplex ultrasound (PSV<2.5)
No TLR performed within 12 months
One of the secondary endpoints
Number of puncture site complications in the absence of a closure device after intervention 14

15. Lesion description (N=120)
Left/Right limb (%) (59.17%) /49 (40.83%)
Lesion length in mm (min – max) (10 – 200)
Popliteal involvement (%) (4.17%)
Occlusions (%) (20.83%)
Ulcerated lesion (%) 3 (2.50%)
Calcified lesion (%) (30.83%)
Presence of trombus (%) 2 (1.67%)

16. SAFETY : Complications access site
A total of 4 patients (3,34%) presented with important haematoma at puncture site
3 major haematoma requiring transfusion, 1 minor haematoma
2 at right groin - 2 at left groin
No surgical repair required
Subanalysis : access complication rate
*Coumarin patients (n = 17) : 17.7%
*Non Coumarin patients : 0.97%
p =

17. SAFETY : Manual compression time
Mean manual compression time: 8,12 minutes
Min – max: 2 minutes – 15 minutes

18. SAFETY : Compared to 6F manual compression time in literature
Puncture
site hole
Mean manual compression time
SANBORN, J Am Coll Cardiol Nov 1;22(5):1273-9 6F
9,2 minutes
BOGART, Am J Crit Care April 1, 1995 vol. 4 (2)
22 minutes
SIMON, Am J Crit Care August 1, 1998 vol. 7 (4)
14,93 minutes
UPPONI, Eur J Radiol Feb;61(2): Epub 2006 Oct 30.
10,6 minutes

19. EFFECTIVENESS : 12-month survival
93,0 %
time
baseline
6MFU
12MFU
at risk
120
112
106 %
100%
98.3%
93.0%

20. EFFECTIVENESS : 12-m primary patency
81,4 %
time
baseline
6MFU
12MFU
at risk
120
103 89 %
100%
90.4%
81.4%

21. EFFECTIVENESS : 12-m freedom of TLR
89,3 %
time
baseline
6MFU
12MFU
at risk
120
109 97 %
100%
96.5%
89.3%

22. EFFECTIVENESS : 12-month primary patency: Astron Pulsar vs. Pulsar-18
Mean lesion length
43.50 mm mm
85,2 %
73,4 %
p=0.236
time
baseline
6MFU
12MFU
Astron Pulsar 70 64 56
Mixed stent use 4
Pulsar-18 46 35 29

23. EFFECTIVENESS : 12-month primary patency: Stenosis vs. occlusion
83,5 %
73,2 %
p=0.384
time
baseline
6MFU
12MFU
occlusion 25 21 16
stenosis 95 82 73

24. EFFECTIVENESS : 12-month primary patency: Calcification vs
EFFECTIVENESS : 12-month primary patency: Calcification vs. No calcification
82,0 %
80,2 %
p=0.659
time
baseline
6MFU
12MFU
No calcification 83 69 62
Calicification 37 34 27

25. Lessons we learned from 4 Ever
Use of 4F devices is feasable for the majority of endovascular treatments, with equal technical success rate, primary patency and freedom from TLR as 6F devices over 1 year, even in calcified lesions.
Less access complications
(cave Coumarines)
No need for expensive
closure devices
time for manual compression