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4EVER results Koen Deloose, MD Marc Bosiers Koen Deloose

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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


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