Post on 30-Dec-2020
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