Prospective Study of the E-liac Stent Graft System in Patients with Common Iliac Artery Aneurysm: 30-Day Results
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1 Prospective Study of the E-liac Stent Graft System in Patients with Common Iliac Artery Aneurysm: 30-Day Results J. Brunkwall MD, Ph.D, FEBVS On behalf of the Pliant study groups
2 E-liac Stent Graft System
3 Study background Prospective, international, observational study 45 patients 11 centers 3 years follow-up Corelab
4
5 Study centers and patient numbers Study center Total patients (n = 45) Valladolid 7 Köln 6 Osnabrück 5 Kiel 5 Warszawa 5 San Sebastian 5 Chemnitz 4 Wien/Hietzing 4 Speyer 2 Wien 1 Berlin 1
6 Demographic data Mean ± SD (n = 45) Age (years) 72 ± 7 Male 42 (93%) Smoking - yes 13 (29%) - unknown 4 (9%)
7 Femoral access Diameter of femoral artery (mm) Mean ± SD (n = 45) left 10 ± 2 right 11 ± 2
8 Femoral access % (n = 45) Surgical Percutaneous Femoral access (left) (69) (31) Femoral access (right) (69) (31)
9 Morphology of iliac aneurysms Diameter of common iliac aneurysm (mm) Thrombus free lumen above native iliac bifurcation (mm) Mean ± SD Abs. (rel) frequency (n = 48) Range 38 ± ± Angle between CIA and IIA ( ) 38 ± Diameter of internal iliac ostium (mm) Aneurysm in internal iliac artery (Ø 12mm) 8 ± (21)
10 Details on intervention Details on intervention Abs. (rel) frequency (n = 45) Operation procedure E-liac + AAA Stent Graft 39 (87) Isolated E-liac 5 (11) E-liac in patient pretreated with AAA 1 (2) Stent Graft E-liac implantation side Right 28 (62) Left 14 (31) Both 3 (7) Contralateral internal iliac artery occluded* 10 (22) * Planned perioperative occlusion of contralateral iliac artery. Patient only treated unilaterally with an E-liac Stent Graft.
11 Procedural results Mean ± SD Range Procedure times [min] (n = 45) Duration of intervention 188 ± Duration of E-liac stent graft implantation* 61 ± Total fluoroscopic time 38 ± * Three patients were treated bilaterally with an E-liac Stent Graft ** The amount of non-iodinated contrast media was not documented. Therefore, minimum amount was 0 ml in some patients.
12 Peripheral covered stents Stent graft used Abs. (rel) frequency (n=48) E-ventus BX 36 (75) Advanta V12 10 (21) Bard LifeStream 1 (2) Bentley BeGraft 1 (2)
13 Landing area in IIA Distal landing area Abs. (rel) frequency (n = 48) Main IIA trunk 45 (94) Anterior IIA 1 (2) Posterior IIA 2 (4)
14 Abdominal stent grafts Abdominal stent graft used Abs. (rel) frequency (n = 45) E-vita abdominal XT (JOTEC) 8 (18) E-tegra Stent Graft (JOTEC) 23 (51) Endurant (Medtronic) 2 (4) Endurant AUI (Medtronic) 1 (2) Treovance (Bolton) 3 (7) Ovation (Endologix) 1 (2) Gore Excluder (Gore) 1 (2)
15 Technical success Definition: Aneurysm exclusion (no type I, III, IV endoleak) and primary patency of the arteria iliaca interna and the arteria iliaca externa on E-liac implantation side Abs. (rel) frequency (n = 45) Overall technical success 38 (84) Primary technical success 37 (82) without reintervention
16 Reasons why technical success was not achieved 7 endoleaks (except type II) 3 closed spontaneously until first post-op CT 4 persistent endoleaks type Ia 1 perioperative reintervention (24h): Embolization with transient or permanent ischemia contralateral to E-liac implantation side.
17 Clinical success after 30 days Definition: Aneurysm exclusion (no type I, III, IV endoleak) and primary patency of the arteria iliaca interna and the arteria iliaca externa on E-liac implantation side Overall clinical success Primary clinical success without reintervention Abs. (rel) frequency (n = 45) 43 (96) 39 (87)
18 Summary of 30 days results 96% clinical success at 30 days 4 successful reinterventions 1 lower limb claudicatio with relation to E- liac Stent Graft 3 without relation to E-liac Stent Graft 100% primary patency in IIA 98% primary patency in EIA
19 Thank you for your attention!
20 Reasons why clinical success was not achieved after 30 days 2 endoleaks type Ia 3 post-operative reinterventions: 1 infrarenal type Ia endoleak 1 type Ia endoleak in the common iliac artery Lower limb claudication due to severe iliac artery kinking on E- liac implantation side and on contralateral side
21 Preliminary 1 Year Results 22 patients already achieved 1 year FU 1 patient lost to follow-up Data not cleaned
22 Clinical success after 1 year Definition: Aneurysm exclusion (no type I, III, IV endoleak) and primary patency of the arteria iliaca interna and the arteria iliaca externa on E-liac implantation side Abs. (rel) frequency (n = 22) Overall clinical success 20 (91) Primary clinical success 16 (73) without reintervention Data not cleaned
23 Reasons why clinical success was not achieved at 1 year 1 endoleaks type Ib in IIA (Patient with AUI) AAA aneurysm Ø decreased CIA aneurysm Ø increased 1 endoleak type III in junction zone to peripheral covered stent (Patient with isolated E-liac) CIA aneurysm Ø stable
24 Reinterventions between 30 days and 1 year 3 reinterventions after 30 days: 1 patient with type Ia and Ic endoleak (AUI) Aortic cuff and occluders 1 patient with type Ia endoleak 2 aortic cuffs 1 patient with type Ia/II endoleak Balloon and Onyx used Misago stent in EIA contralateral to E-liac implantation side
25 Summary of preliminary 1 year results 1 year follow up: 91% clinical success at one year 3 successful reinterventions without relation to E-liac Stent Graft 100% primary patency in IIA 98% primary patency in EIA
26 IDEA
27
28
29
30
31 Deployment of branched device
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33 Medical history Abs. (%) frequency (n = 45) Arterial hypertension 37 (82) Cardiac Disease - yes 19 (42) - unknown 1 (2) Hyperlipidemia 24 (53) Pulmonary disease 10 (22) Renal Insufficiency 7 (16) Diabetes 9 (20) Dialysis 0 (0)
34 Morphology of access vessels Abs. (rel) frequency (n = 45) Access vessel None Mild Moderate Severe Calcification (left) 14 (31) 17 (38) 8 (18) 6 (13) Calcification (right) 14 (31) 14 (31) 12 (27) 5 (11) Angulatiion (left) 31 (69) 11 (24) 2 (4) 1 (2) Angulation (right) 31 (69) 9 (20) 4 (9) 1 (2)
35 Prospective Study of the E-liac Stent Graft System in Patients with Common Iliac Artery Aneurysm: 30-Day Results J. Brunkwall MD, Ph.D, FEBVS On behalf of the Pliant study groups
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