Active control in EVAR: Orthogonal placement and 360 seal

using the angulation control

Marc van SambeekJenny Zwetsloot, Joep Teijink, Philippe Cuypers

Catharina Hospital Eindhoven

Eindhoven University of Technology

Disclosure

Speaker name:

Marc van Sambeek

I have the following potential conflicts of interest to report:

Consulting and speakersfee

WL Gore & Associates

Medtronic

Unrestricted research grants

Medtronic

W.L Gore & Associates

Philips Medical Systems

“Easy anatomy”

Liberalized interpretation of the instructions for use is

associated with increased risk of aneurysm sac

enlargement, which can lead to re-intervention and rupture

of the aneurysm. Schanzer A, et al. Circulation. 2011;123:2848-55

In a meta-analysis it was demonstrated that patients treated

with hostile neck anatomy were at significantly increased

risk

for operative morbidity, additional adjunctive procedures at

treatment, Type I endoleak at one year, and aneurysm

related

mortality at one year. Antoniou GA, et al. J Vasc Surg 2013;57:527-538

NEGATIVE

Complex anatomy

Emergency EVAR provides excellent results for

treatment of rAAA patients with both FNA and HNA.

EVAR in rAAAs with HNA is technically feasible and safe

in experienced endovascular centres.Broos PP, et al. EJVES 2015;50:313-319

Real-world, global experience shows promising results

and indicates that endovascular AAA repair is safe and

effective in patients with challenging aortic neck

anatomy. Broos PP, et al. J Vasc Surg 2015;62:312-318

POSITIVE

Complex anatomy

▪ Infrarenal neck: the most likely site of failure

– Angulation of the infrarenal aortic neck

– Length of the infrarenal aortic neck

– Presence of reverse taper

– Renal pathology

Infrerenal neck

There’s no univocal definition.

In general:

Neck length ≤ 15 mm?

Neck angulation ≥ 60°?

Double angled necks?

Irregular (thrombus, bulge, calcium)?

Wide (> 28 mm)?

Or outside instructions for use??

Endoleak

Migration

Rupture

Infrarenal neck

Solutions:

Improve accuracy

▪ Proper C-Arm angles

▪ Early fixation

▪ Repositioning of device after initial deployment

Infrarenal neck

Department of

Vascular Surgery

Department of

Cardiovascular Biomechanics

C-arm angles

Cranial/Caudal

RAO/LAO

Broeders and Blankensteijn, J Endovasc Ther, 2000:7:389-393

C-arm angles

Maximize sealing zone

Infrarenal neck

Solutions:

Improve accuracy

▪ Proper C-Arm angles

▪ Early fixation

▪ Repositioning of device after initial deployment

Maximize apposition zone

New devices which are specifically designed to perform

adequately across the spectrum of potential anatomic

presentations for infra-renal EVAR are needed.

Investigational device

Not approved in U.S.A

Gore ® Excluder ® Conformable AAA Endoprosthesis

GORE® EXCLUDER® Conformable AAA Endoprosthesis

The European IFU anatomic criteria:

• ≥15mm proximal neck length and ≤90˚ proximal neck

angulation

• ≥10mm proximal neck length and ≤60˚ proximal neck

angulation)

Investigational device

Not approved in U.S.A

Maximize apposition zone

Deployment in model

Deployment in patient

> 15 mm necklength

10-15 mm necklength

5-10 mm necklength

< 5 mm neck length

< 60° neckangulation

Inside IFU Inside IFU Challenginganatomy

Extreme anatomy

60-90° neckangulation

Inside IFU Challenginganatomy

Extreme anatomy

> 90° neckangulation

Challenginganatomy

Extreme anatomy

EXCeL Registry

150 consented subjects from 11

high-volume sites across Europe will

be included.

Follow-up 3 years

EXCeL Registry pre-operative

Rijstate Arnhem 20Catharina Hospital Eindhoven 17North Bristol NHS Trust 5Complexo Hospitalario de Orense 2San Carlos Hospital Madrid 3APHP Hospital Europeen Paris 3San Martino Hospital Genova 10Totaal 60

EXCeL Registry

Number of patients 46

Age 73 (56-87) years

AAA diameter 60 (46-90) mm

Neck length 34 (9-62) mm

Neck angulation 49 (12-94) degrees

EXCeL Registry pre-operative

EXCeL Registry

Number of patients 60

Percutaneous / open 55 / 5

Re-positioning main device 33 patients (range 0-9)

Active Control ® system used 22 patients (range 1-3)

Proximal extension used 3 patients

SAE 2 patients *

Type I endoleak 0 patients

Length of hospital stay 3.4 (2-28) days

*Renal artery stent

Covered stent for rCIA

EXCeL Registry intra operative

EXCeL Registry 30-days

Number of patients 39

Type Ia endoleak 0 patients

Type Ib endoleak 1 patient*

Secondary intervention 1 patient* (type Ib endoleak)

Type II endoleak 7 patients

Type endoleak undetermined 2 patients

New SAE 0 patients

EXCeL Registry 30 days

EXCeL Registry 1 year

Number of patients 11 patients

Type I endoleak (from 30-d) 0 patients

Secundary intervention (from 30-d) 0 patients

Death 2 patients*

*Cerebral hemorrhage after M

*Unknown yet

EXCeL Registry 1 year

EVAR continues to evolve as the treatment

option for AAA

New generation devices will extend the

applicability of EVAR

Gore ® Excluder ® Conformable AAA Endoprosthesis

Active control in EVAR: Orthogonal placement and 360 seal

using the angulation control

Marc van SambeekJenny Zwetsloot, Joep Teijink, Philippe Cuypers

Catharina Hospital Eindhoven

Eindhoven University of Technology