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