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
E-liac Stent Graft System
Study background Prospective, international, observational study 45 patients 11 centers 3 years follow-up Corelab
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
Demographic data Mean ± SD (n = 45) Age (years) 72 ± 7 Male 42 (93%) Smoking - yes 13 (29%) - unknown 4 (9%)
Femoral access Diameter of femoral artery (mm) Mean ± SD (n = 45) left 10 ± 2 right 11 ± 2
Femoral access % (n = 45) Surgical Percutaneous Femoral access (left) (69) (31) Femoral access (right) (69) (31)
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 ± 11 26 79 21 ± 4 10 32 Angle between CIA and IIA ( ) 38 ± 14 10 85 Diameter of internal iliac ostium (mm) Aneurysm in internal iliac artery (Ø 12mm) 8 ± 5 4-40 10 (21)
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.
Procedural results Mean ± SD Range Procedure times [min] (n = 45) Duration of intervention 188 ± 60 93-355 Duration of E-liac stent graft implantation* 61 ± 43 14-240 Total fluoroscopic time 38 ± 16 16-87 * 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.
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)
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)
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)
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
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.
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)
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
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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
Preliminary 1 Year Results 22 patients already achieved 1 year FU 1 patient lost to follow-up Data not cleaned
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
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
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
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
IDEA
Deployment of branched device
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)
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)
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