Innovation forum EVAR
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- Kristian Powers
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1 Innovation forum EVAR Preliminary results of expanding indications for treatment with standard EVAR in patients with challenging anatomies, a multi-centric prospective evaluation (EXTREME) study Pasqualino Sirignano Vascular and Endovascular Surgery Division Department of Surgery Paride Stefanini Policlinico Umberto I Sapienza University of Rome Chief Prof Francesco Speziale
2 DISCLOSURE Speaker name:...pasqualino Sirignano... I have the following potential conflicts of interest to report: Consulting Employment in industry Stockholder of a healthcare company Owner of a healthcare company Other(s) X I do not have any potential conflict of interest
3 ESVS Guidelines Available guidelines recommend to perform EVAR in patient presenting at least a suitable Aortic Neck length >10mm Not reasonable, too restrictive
4 Sapienza Experience We strongly believe that challenging necks could be effectively managed by EVAR
5 Sapienza Experience Immediate and two-year outcomes after EVAR in "on-label" and "off-label" neck anatomies using different commercially available devices. Analysis of the experience of two Italian vascular centers Speziale F, Sirignano P, Setacci F, Menna D, Capoccia L, Mansour W, Galzerano G, Setacci C. Ann Vascular Surgery 2014 No significant difference in immediate results between patient treated in and out IFU Satisfactory outcomes were maintained during 2 years of follow-up
6 New Possibilities If conventional endografts guarantee satisfactory results could new devices further expand EVAR indications?
7 New Possibilities Pushing forward the limits of EVAR: new therapeutic solutions for extremely challenging AAAs using the Ovation Stent Graft Sirignano P, Capoccia L, Menna D, Mansour W, Speziale F Journal Cardiovascular Surgery 2016 Real life experience with Ovation stent-graft: lesson learned from first hundred-fifty treated patients Sirignano P, Mansour W, Pranteda C, Siani A, Accrocca F, d Adamo A, Capoccia L, Speziale F AVS 2017 Our experience suggests that EVAR by Ovation stent-graft can be performed with satisfactory immediate and mid-term outcomes in patients presenting severe challenging anatomies
8 A New Registry Moving from those promising experience, a new registry was developed aiming to demonstrate feasibility of EVAR by Ovation implantation in challenging anatomies
9 A New Registry Sirignano P, Speziale F et al. AMS 2017
10 Extreme Registry Objective 30-day and 12-month technical and clinical success with EVAR using the Ovation Stent-Graft in patients out of IFU for treatment by common endografts
11 Extreme Registry Study Design Prospective, consecutively enrolling, non-randomized multicenter post market registry. Study Population Minimum 60 patients
12 Extreme Registry Safety and Efficacy Clinical endpoints freedom from AAA-related mortality, AAA enlargement AAA rupture Technical endpoints Access-related vascular complications Technical Success Freedom from Type I & III endoleaks Migration Conversion to open repair Re-interventions
13 Extreme Registry Between march 2017 and march 2018, 122 patients were enrolled across 16 centers in Italy and Spain
14 Demographic Total Patients 122 Age (mean±sd) Male Sex (n;%) 111; Hypertension (n;%) 106; Dyslipidaemia (n;%) 85; Diabetes (n;%) 78; CAD (n;%) 69; Smoke (n;%) 83; COPD (n;%) 67; CRI (n;%) 45; PAOD (n;%) 37; ASA III/IV (n;%) 32; 26.22
15 Anatomical Features AAA Max Diameter (mean; SD; range) Total Patients mm (33-102) AAA Max Diameter <50mm (n;%) 38; AAA Max Diameter 50-60mm (n;%) 66; AAA Max Diameter >60mm (n;%) 18; IR Diameter (mean; SD; range) mm ( ) IR Diameter <25mm (n;%) 100; IR Diameter >25mm (n;%) 22; IR+13 Diameter (mean; SD; range) mm (18-30) IR+13 Diameter <25mm (n;%) 64; IR+13 Diameter >25mm (n;%) 58; Aortic Neck Length (mean; SD; range) mm (1-29.5) Aortic Neck Length <5mm (n;%) 35; 28.7 All graft were released according to IFU
16 Anatomical Features Total Patients 122 Right EIA Diameter (mean; SD; range) mm ( ) Right EIA Diameter <10mm (n;%) 106; Right EIA Diameter <7mm (n;%) 32; Left EIA Diameter (mean; SD; range) mm (2-11.1) Left EIA Diameter <10mm (n;%) 114; Left EIA Diameter <7mm (n;%) 42; Iliac Access Thrombosis/Calcification (n;%) 52; Right Iliac Access ITR (mean; SD; range) ( ) Left Iliac Access ITR (mean; SD; range) ( ) 72 patients out of 122 presented iliac access vessels <7mm
17 Intraoperative Results Technical success 98.36% 2 Type Ia endoleaks 15 Type II enndoleaks
18 Intraoperative Results Type Ia endoleaks were successfully treated by coils embolization
19 @ 1 month results No new Type Ia endoleaks 9 Type II endoleaks 2 limb occlusions
20 Thanks to all Collaborators PI: F Speziale F Accrocca, S Bartoli, S Camparini, L Capoccia, S Cuozzo, G de Donato, JM Gamez, A Ippoliti, G La Barbera, M Lenti, N Mangialardi, W Mansour, RG Medialdea, C Novali, G Pratesi, C Rivellini, MR Pinero, S Ronchey, C Setacci, A Siani, R Silingardi, P Sirignano, F Spinelli, F Talarico, M Taurino
21 Symposium Chairman Francesco Speziale Scientific Secretariat Laura Capoccia Wassim Mansour Pasqualino Sirignano
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