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Endovascular experience in thetreatment of CFA with Supera
Koen Deloose, MD
Head Vascular Surgery, AZ Sint Blasius,
Dendermonde, Belgium
2ID3 Medical – 2017 |
Disclosure slide
I have the following potential conflicts of interest to report:
Consulting: Medtronic, Spectranetics, Biotronik, Abbott, Bard
iVascular, Bentley, Cook, GE Healthcare, Terumo, Boston
Scientific, Contego Medical, B Braun
Employment in industry
Stockholder of a healthcare company
Owner of a healthcare company
Other(s)
I do not have any potential conflict of interest
Speaker name: Koen Deloose, MD
3ID3 Medical – 2017 |
The CFA-area is ripe for (tailored) endovascular penetration…
Gouëffic Y et al. JACC Cardiovasc Interv 2017 Jul 10(13):1344-1354
4ID3 Medical – 2017 |
VMI-CFAPhysician initiated, prospective, multicenter, single arm trial toevaluate the Supera Peripheral Vascular Mimetic Implant Device (Abbott Vascular) for symptomatic (RB 2-4) CFA disease treatment
1
13
5
3
4
27
47
0 10 20 30 40 50
CHU, Clermont-Ferrand
Clinique Rhône-Durance, Avignon
CHU, Nantes
Imelda, Bonheiden
ZNA, Antwerp
AZ Sint-Blasius, Dendermonde
OLV Hospital, Aalst
The CFA-area is ripe for (tailored) endovascular penetration…
5ID3 Medical – 2017 |
VMI-CFA trial : Endpoints
• Primary endpointEfficacy endpoint : Primary patency @12 months (DUS PSVR < 2,5)
(Core lab adjudicated) in CFA, SFA & DFA with no reintervention
Safety endpoint : periprocedural adverse events up to 30 days post procedure
• Secondary endpointsTechnical success rate (angiographical RS<30%)
Primary patency @ 6 months (same definition)
Freedom from TLR @ 6 & 12 months
Clinical success : defined as improvement in RB classification
6ID3 Medical – 2017 |
• RB 5-6 classification
• In-stent lesions CFA
• Previous surgery CFA
• occluded DFA/SFA
• Non treatable inflow lesion
• thrombus
• Debulking, DE technologies…
Inclusion Exclusion• RB 2-4 classification
• De novo/post POBA lesions
• stenosis >50%/occlusions
• Patent DFA
• Good SFA run off
Azéma L. et al. EJVEVS, 41, 6 : June 2011 ; 787-793
VMI-CFA trial : In/Ex-clusion criteria
7ID3 Medical – 2017 |
1 M 6 M 12 Mproc
Patient informed consent
In- / exclusion criteria check
Medical / clinical history
Medication
Physical examination
Rutherford
ABI
Regular Angiography
Regular Duplex UltrasoundCore Lab Duplex Ultrasound
Adverse Events
dischscreen
VMI-CFA trial : Timeline
8ID3 Medical – 2017 |
N = 100 out of 100
Male (%) 81 (81%)
Age (min-max ± SD) 72,72 (46,87 - 95,76 ± 8,59)
Nicotine (%) 29 (29%)
Hypertension (%) 78 (78%)
Diabetes (%) 35 (35%)
Renal insufficiency (%) 14 (14%)
Hypercholesterolemia (%) 62 (62%)
Obesity (%) 25 (25%)
Claudicant 79 (79%)
CLI patient 21 (21%)
21
58
20
1
Rutherford Classification
2 3 4 5
* Protocol deviation
*
VMI-CFA trial : demographics
9ID3 Medical – 2017 |
N = 100 out of 100
Lesion length (min-max ± SD) 44,17mm (15mm – 80mm ± 15,67)
Ref vessel diameter (min-max ± SD) 7,29mm (5mm – 9mm ± 0,93mm)
Degree of stenosis (min-max ± SD) 82,6% (60% - 100% ± 10,65%)
Occlusion (%) 11 (11%)
Calcified lesion (%) 82 (82%)
Azéma classification II (%) 52%
Azéma classification III (%) 47%
VMI-CFA trial : lesion characteristics
10ID3 Medical – 2017 |
N = 100 out of 100
Procedure time (min-max ± SD) 55,68min (15min – 150min ± 29,59min)
Scopy time (min-max ± SD) 14,64min (4min – 55min ± 9,93min)
Contrast (min-max ± SD) 82,54ml (10ml – 353ml ± 75,08ml)
Femoral access (%) 92 (92%)
Cross-over performed (%) 82 (89,13%)
Inflow lesion (%) 23 (23%)
Outflow lesion (%) 62 (62%)
VMI-CFA trial : Procedure
11ID3 Medical – 2017 |
N = 100 out of 100
Predilatation performed (%) 100 (100%)
Diameter predilatation balloon (min-max ± SD) 7,10mm (3mm – 9mm ± 1,22mm)
Length predilatation balloon (min-max ± SD) 50,53mm (20mm – 200mm ± 31,65mm)
# supera used 102
1 stent received (%) 98 (98%)
2 stents received (%) 2 (2%)
Diameter stent (min-max ± SD) 6,48mm (5mm – 8mm ± 0,79mm)
Length stent (min-max ± SD) 49,02mm (20mm – 100mm ± 16,32mm)
Postdilatation performed (%) 83 (83%)
Diameter postdilatation balloon (min-max ± SD) 7,43mm (5mm – 10mm ± 1,06mm)
Length postdilatation balloon (min-max ± SD) 50mm (20mm – 200mm ± 25,79mm)
VMI-CFA trial : Procedure
7,29mm
12ID3 Medical – 2017 |
time baseline 1MFU(30 days)
6MFU*(180 days)
6MFU*(210 days)
at risk 100 100 94 58
% 100 100 100 100
100%
* Data from 1 patient missing
VMI-CFA trial : primary patency
13ID3 Medical – 2017 |* Data from 1 patient missing
VMI-CFA trial : f-TLR
100%
time baseline 1MFU(30 days)
6MFU*(180 days)
6MFU*(210 days)
at risk 100 100 94 58
% 100 100 100 100
14ID3 Medical – 2017 |* Data from 1 patient missing
VMI-CFA trial : Survival Rate
96,9%
95,9%
time baseline 1MFU(30 days)
6MFU*(180 days)
6MFU*(210 days)
at risk 100 100 94 58
% 100 100 96,9% 95,9%
15ID3 Medical – 2017 |
0102030405060708090
100
Screening 1MFU 6MFU
5 1 0 0
4 20 1 0
3 58 0 1
2 21 2 2
1 0 4 6
0 0 83 79
Rutherford category
0 1 2 3 4 5
* Protocol deviation
**
*
** Data from 1 patient missing
VMI-CFA trial : clinical success
16ID3 Medical – 2017 |
VMI-CFA trial : Safety outcomes
MAEs 180 days 210 days
Death (N) 3 4
CD-TVR (N) 0 0
Target limb major amputation (N) 0 0
Thrombosis (N) 0 0
Primary safety endpoint 30 days
Device or procedure related death (N) 0
CD-TVR (N) 0
Target limb major amputation (N) 0
17ID3 Medical – 2017 |
Case 1
18ID3 Medical – 2017 |
Case 2
19ID3 Medical – 2017 |
Case 2
20ID3 Medical – 2017 |
Case 3
21ID3 Medical – 2017 |
Case 3
22ID3 Medical – 2017 |
Conclusion
• In 2018, although CFE still remains the golden standard, thehistorical “no endovascular for this baby”-statement is wrong.
• There are some indicative papers, the randomized TECCO trial included, that there is definitely a place for safer andas-efficient endovascular therapy in CFA treatment.
• Newer generation of devices, like the high crush resistant, repuncturable Supera stent are facilitating this treatment
• With this particular device, the VMI-CFA trial shows excellent short term results (6m) with 100% PP- and f-TLR rates, clear clinical benefit & a 100% safety profile
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