(CH-)EVAS mit Nellix. Jörg Heckenkamp Klinik für Gefäßchirurgie Niels-Stensen-Kliniken Marienhospital Osnabrück

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1 (CH-)EVAS mit Nellix Jörg Heckenkamp Klinik für Gefäßchirurgie Niels-Stensen-Kliniken Marienhospital Osnabrück

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. Seite 2 Allenberg, Deutsches Ärzteblatt, 1998 (57)

3 The Proximal Neck: The Remaining Barrier to a Complete EVAR World 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. Seite 3 De Vries JP, Semin Vasc Surg 25:182;2012

4 Unfavourable neck anatomy Keine eindeutige Definition Generell: Thrombus, Kalk Halslänge 15 mm Halswinkel 60 Doppelt gewinkelte Hälse Weite Hälse (> 28 mm) Seite 4

5 Aktuelle internationale Meinung (CX 2017) Seite 5

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7 NELLIX PLATFORM Complete aneurysm sealing for active sac management Seite 7

8 IFUs 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. Seite 8

9 Implantationsschritte Seite 9

10 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) 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. Seite 10

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12 1 Aortic Proximal Neck Diameter from 18-32mm diamete r to 18-28mm diamet er Potential Clinical Benefit 1A Endoleak Migration from to Aortic Neck 2 1A Diameter 10% 20% Endoleak Change Aortic Aneurysm Diameter <1. Max 3 4 Migration Aortic Blood Lumen Diameter ratio Max 4 Iliac Artery Luminal Diameter 9-35mm diameter No Change to Indication Proxi mal Seal Zone Aortic Aneurysm Diameter Aortic Max Blood Lumen Diameter Max Aortic Diamete r proximal istal Seal Zone Seite 12

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14 J Cardiovasc Surg: 2014,Oct;55: Use of the Nellix EVAS system to treat post-evar complications and to treat challenging infrarenal necks. Böckler D., et al. 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. Seite 14

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17 Complex aneurysms Complex revisions Seite 17

18 (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) Seite 18

19 (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 Seite 19

20 (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 Seite 20

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22 (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 Seite 22

23 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 Seite 23

24 1 Year Results CHEVAR PERICLES Donas 2015 CHEVAR 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 % 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) Seite 24 Target Vessel Patency 98%-100% 91.8% 95.7% 98%

25 Zusammenfassung Pararenale Aneurysmen selten Offene und endovaskuläre Verfahren möglich Fenestrierte Prothesen Gebranchte Prothesen Chimey Grafts CHEVAS Individuelle Therapieentscheidung Seite 25

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