(ch-)evas mit nellix - heidelberger heisses eisen · evas is an innovative, intriguing concept in...

(CH-)EVAS mit Nellix

Jörg Heckenkamp Klinik für Gefäßchirurgie

Niels-Stensen-Kliniken

Marienhospital Osnabrück

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J. Heckenkamp, Heisses Eisen 2017 Seite 2

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.



“Unfavourable neck anatomy”

Keine eindeutige Definition

Generell:

• Thrombus, Kalk

• Halslänge ≤ 15 mm

• Halswinkel ≥ 60°

• Doppelt gewinkelte Hälse

• Weite Hälse (> 28 mm)



Aktuelle internationale Meinung (CX 2017)



NELLIX® PLATFORM Complete aneurysm sealing for active sac management



• 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



Implantationsschritte



“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)



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



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.



Complex aneurysms Complex revisions



(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)




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




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



(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



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



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%



Zusammenfassung

Pararenale Aneurysmen selten

Offene und endovaskuläre Verfahren möglich

Fenestrierte Prothesen

Gebranchte Prothesen

Chimey Grafts

CHEVAS

Individuelle Therapieentscheidung


(ch-)evas mit nellix - heidelberger heisses eisen · evas is an innovative, intriguing concept in...

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