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Transcript of Preliminary results of expanding indications for treatment with ...€¦ · Sirignano P, Capoccia...
Vascular and Endovascular Surgery Division - “Sapienza” University of Rome
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 SirignanoVascular and Endovascular
Surgery Division Department of Surgery “Paride Stefanini”
Policlinico Umberto I“Sapienza” University of RomeChief Prof Francesco Speziale
Vascular and Endovascular Surgery Division - “Sapienza” University of Rome
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
DISCLOSURE
Vascular and Endovascular Surgery Division - “Sapienza” University of Rome
Available guidelines recommend to perform EVAR in patient
presenting at least a suitable Aortic Neck length >10mm
Not reasonable, too restrictive
ESVS Guidelines
Vascular and Endovascular Surgery Division - “Sapienza” University of Rome
We strongly believe that challenging necks
could be effectively managed by EVAR
“Sapienza” Experience
Vascular and Endovascular Surgery Division - “Sapienza” University of Rome
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
“Sapienza” Experience
Vascular and Endovascular Surgery Division - “Sapienza” University of Rome
If conventional endografts guarantee satisfactory results…
could new devices further expand EVAR indications?
New Possibilities
Vascular and Endovascular Surgery Division - “Sapienza” University of Rome
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
New Possibilities
Vascular and Endovascular Surgery Division - “Sapienza” University of Rome
Moving from those promising
experience, a new registry
was developed aiming to
demonstrate feasibility of
EVAR by Ovation implantation
in challenging anatomies
A New Registry
Vascular and Endovascular Surgery Division - “Sapienza” University of Rome
Sirignano P, Speziale F et al. AMS 2017
A New Registry
Vascular and Endovascular Surgery Division - “Sapienza” University of Rome
Objective30-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
Extreme Registry
Vascular and Endovascular Surgery Division - “Sapienza” University of Rome
Study DesignProspective, consecutively enrolling, non-randomized
multicenter post market registry.
Study PopulationMinimum 60 patients
Extreme Registry
Vascular and Endovascular Surgery Division - “Sapienza” University of Rome
Safety and Efficacy
Clinical endpointsfreedom from AAA-related mortality,
AAA enlargement
AAA rupture
Technical endpointsAccess-related vascular complications
Technical Success
Freedom from Type I & III endoleaks
Migration
Conversion to open repair
Re-interventions
Extreme Registry
Vascular and Endovascular Surgery Division - “Sapienza” University of Rome
Between march 2017 and march 2018, 122
patients
were enrolled across 16 centers in Italy and
Spain
Extreme Registry
Vascular and Endovascular Surgery Division - “Sapienza” University of Rome
Total Patients 122
Age (mean±SD) 78.657.67Male Sex (n;%) 111; 90.98
Hypertension (n;%) 106; 86.88Dyslipidaemia (n;%) 85; 69.67
Diabetes (n;%) 78; 63.93CAD (n;%) 69; 56.55
Smoke (n;%) 83; 68.03COPD (n;%) 67; 54.91
CRI (n;%) 45; 36.88PAOD (n;%) 37; 30.32
ASA III/IV (n;%) 32; 26.22
Demographic
Vascular and Endovascular Surgery Division - “Sapienza” University of Rome
Total Patients 122AAA Max Diameter (mean; SD; range)
52.9610.1mm (33-102)
AAA Max Diameter <50mm (n;%) 38; 31.14
AAA Max Diameter 50-60mm (n;%) 66; 54.09
AAA Max Diameter >60mm (n;%) 18; 14.77
IR Diameter (mean; SD; range) 21.963.46mm (15.9-32)IR Diameter <25mm (n;%) 100; 81.96
IR Diameter >25mm (n;%) 22; 18.04
IR+13 Diameter (mean; SD; range) 24.243.31mm (18-30)IR+13 Diameter <25mm (n;%) 64; 52.45
IR+13 Diameter >25mm (n;%) 58; 47.55
Aortic Neck Length (mean; SD; range) 7.756.05mm (1-29.5)Aortic Neck Length <5mm (n;%) 35; 28.7
All graft were released according to IFU
Anatomical Features
Vascular and Endovascular Surgery Division - “Sapienza” University of Rome
Total Patients 122Right EIA Diameter (mean; SD; range) 7.82.07mm (4.1-7.7)Right EIA Diameter <10mm (n;%) 106; 86.88
Right EIA Diameter <7mm (n;%) 32; 26.22Left EIA Diameter (mean; SD; range) 7.331.59mm (2-11.1)Left EIA Diameter <10mm (n;%) 114; 93.44
Left EIA Diameter <7mm (n;%) 42; 34.42Iliac Access Thrombosis/Calcification (n;%) 52; 42.66Right Iliac Access ITR (mean; SD; range) 0.760.09 (0.5-0.96)Left Iliac Access ITR (mean; SD; range) 0.80.1 (0.5-0.98)
72 patients out of 122 presented iliac access vessels
<7mm
Anatomical Features
Vascular and Endovascular Surgery Division - “Sapienza” University of Rome
2 Type Ia endoleaks
15 Type II enndoleaks
Technical success
98.36%
Intraoperative Results
Vascular and Endovascular Surgery Division - “Sapienza” University of Rome
Type Ia endoleaks were successfully treated by coils embolization
Intraoperative Results
Vascular and Endovascular Surgery Division - “Sapienza” University of Rome
No new Type Ia endoleaks
9 Type II endoleaks
2 limb occlusions
@ 1 month results
Vascular and Endovascular Surgery Division - “Sapienza” University of Rome
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
Thanks to all Collaborators
Vascular and Endovascular Surgery Division - “Sapienza” University of Rome
Symposium Chairman
Francesco Speziale
Scientific Secretariat
Laura Capoccia
Wassim Mansour
Pasqualino Sirignano