(CH-)EVAS mit Nellix
Jörg Heckenkamp Klinik für Gefäßchirurgie
Niels-Stensen-Kliniken
Marienhospital Osnabrück
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Historie
Es ist wichtig festzuhalten, daß die offene und die
endovaskuläre chirurgische Therapie des infrarenalen
Aortenaneurysmas zur Zeit nicht vergleichbar
nebeneinanderstehen, da bislang für den
endovaskulären Behandlungsansatz äußerst strenge
Selektionskriterien verfolgt werden müssen, während
für die offene chirurgische Rekonstruktion keine
wesentliche morphologische Einschränkung besteht.
Allenberg, Deutsches Ärzteblatt, 1998 (57)
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The Proximal Neck: The Remaining
Barrier to a Complete EVAR World
De Vries JP, Semin Vasc Surg 25:182;2012
Migration
Endoleak Typ 1 (späte Ruptur)
Thrombembolische Komplikationen
Bildgebung, individuelle Planung, aktive aortale
Fixierung
In 95% der Fälle handelt es sich um Erweiterungen, die unterhalb der Nierenarterien
beginnen. Bei 3 % sind Nierenarterien und in 2 % alle Viszeralarterien in das Aneurysma
mit einbezogen.
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“Unfavourable neck anatomy”
Keine eindeutige Definition
Generell:
• Thrombus, Kalk
• Halslänge ≤ 15 mm
• Halswinkel ≥ 60°
• Doppelt gewinkelte Hälse
• Weite Hälse (> 28 mm)
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Aktuelle internationale Meinung (CX 2017)
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NELLIX® PLATFORM Complete aneurysm sealing for active sac management
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• Aortic proximal neck diameter range of 18 to 28mm.
• Minimum aortic proximal neck length ≥10mm
• Proximal aortic neck angulation of ≤60°.
• Aortic aneurysm with a blood lumen diameter ≤70mm.
• Iliac arteries luminal diameter range of 9 to 35mm.
IFUs
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Implantationsschritte
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“The ‘sealing the entire aneurysm’ idea of the Nellix system quite simply represents a very seductive concept that seems to lure the vascular surgeon beyond the IFU.” “Little to no neck?” Angulated necks? Large necks?....All not a problem, the endobags will take care of it….the sky seems the limit.”
Realistic patient selection
Precise placement of stents
Good endobag filling
Adequate proximal and distal seal in parallel sided artery
Refinement of IFU (28mm, 10% conicity)
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Aortic
Proximal Neck
Diameter
18-32mm
diameter
18-28mm diamet
er
from to
1
1A Endoleak
Migration
≤20%
from Aortic Neck
Diameter
Change
≤10%
to
2 1A Endoleak
Aortic Aneurysm DiameterMax
Aortic Blood Lumen DiameterMax 3 Migration
Potential Clinical Benefit
9-35mm diameter
Iliac Artery Luminal Diameter 4
Proximal Seal
Zone
Aortic Diameterproximal
Aortic Aneurysm Diameter
Max Aortic Blood Lumen
Diameter Max
istal Seal
Zone
No Change to Indication
<1.4
ratio
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CONCLUSION:
EVAS is an innovative, intriguing concept in the treatment of abdominal aortic
aneurysm (AAA). Short-term outcomes of the Nellix system is promising. Early
experience of Nellix out of IFU when treating patients with challenging proximal
infraenal necks, with post EVAR complications, short necks and chimney techniques
show technical feasibility and promising short-term results. Mid- and long-term data
are needed to validate device and procedure durability.
J Cardiovasc Surg: 2014,Oct;55:601-12.
Use of the Nellix EVAS system to treat post-EVAR
complications and to treat challenging infrarenal
necks.
Böckler D., et al.
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Complex aneurysms Complex revisions
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(CH-)EVAS in paravisceral aneurysms
Youssef et al.
Thorac Cardiovasc Surg 2017
N= 7 (four4 vessel chimneys)
One death, no reinterventions, graft thrombosis, no
endoleaks
Follow-Up 6 months
Conclusions: Alternative treatment (Acute
situations)
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(CH-)EVAS in paravisceral aneurysms
Dinkelmann et al.
J Cardiovasc Surg 2016
N= 16 (26 chimneys)
No deaths, 3 reinterventions (Type 1 endoleak, limb
occlusion, brachial dissection)
Follow-Up 1 month
Conclusions: Off-the-shelf solution
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(CH-)EVAS in paravisceral aneurysms
De Bruin et al.
Eur J Vasc Endovasc Surg, 2016
N= 28 (59 chimneys)
1 death (30 days), 3 reinterventions (Type 1
endoleak, limb occlusion, brachial dissection)
Conclusions: Off-the-shelf solution
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(CH-)EVAS after failed EVAR
Youssef et al.
J Endovasc Ther 2017
N= 15
No reinterventions, no graft thrombosis, no
endoleaks
Follow-Up 8 months
Conclusions: Feasible, Bailout, alternative
treatment
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Post-market registry of the Nellix System with Chimney Stents
Co-Principal Investigators: Andrew Holden and Matt Thompson
Open-label, single-arm, no prospective screening
200 patients, up to 10 international centers with 5y F/U
187 patients (154 primary, 9 rAAA, 25 Revision EVAR, 5 Revision EVAS)
Endpoints typical of EVAR therapy in complex AAA
Mean follow-up 5.6 m
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1 Year Results CHEVAR PERICLES Donas 2015
CHEVAR PROTAGORAS @ 3
YEARS Donas 2016
FEVAR Rao 2015
Mortality 30d 2.8% 3.7% 0.8% 4.1%
Mortality 1yr 10.2% 15% 17.2% (3 years) 2% - 28% (Globalstar, Circ 2012)
Stroke (Early) 1.9% 1.7% 1.6% n/r
(usually low, as they come from below)
Dialysis (permanent) 0.7% 1.5% 0.8% 1.9%
Type I (incident) 5% 3% - 13%
Katsargyris 2013, Linblad EJVES 2015
3.2% 16%
Type II (incident) 0% 6% (Donas 2013) NR 14%
Type III (incident) 0% nr 1.6% 3%
Type I (persistent) 0% 2.9% 0.8% 6%
Type II (persistent) 0% 6% (Donas 2013) NR 13%
Type III (persistent) 0% 1% 0% 3%
Secondary Intervention
9.7% 6.6% 14.8% (19/128) 17.6% (Di, 2013)
Target Vessel Patency 98%-100% 91.8% 95.7% 98%
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Zusammenfassung
Pararenale Aneurysmen selten
Offene und endovaskuläre Verfahren möglich
Fenestrierte Prothesen
Gebranchte Prothesen
Chimey Grafts
CHEVAS
Individuelle Therapieentscheidung
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