Early experience with the new endovascular aneurysm sealing system Nellix: First clinical results after 50 implantations.
OBJECTIVE
In the present study, 50 EVAS procedures were evaluated in regard to primary (survival and technical success) and secondary (device-related complications) events of interest.


METHODS
The single center study was conducted from July 2013 to August 2014 with prospective collection of the clinical data. The clinical results were controlled by CT angiography and contrast-enhanced ultrasound.


RESULTS
The technical success was 98% and the 30-day mortality 4%. One (2%) patient died from multisystem organ failure and another patient from an intracranial bleeding, respectively. One patient (2%) suffered from a device-related aneurysm rupture. During early follow-up, one (2%) patient developed an endoleak type II, while three (6%) patients suffered from a partial endograft limb thrombosis. Overall, a secondary intervention was necessary in six (12%) patients.


CONCLUSIONS
With the Nellix EVAS system, a high primary technical success of 98% was achieved; one (2%) patient developed an endoleak type II which did not require secondary intervention. Those promising results are contrasted by a substantial rate of endograft limb thromboses (8%) and one (2%) intraoperative aneurysm rupture. Further studies are needed to assess the durability of the Nellix stentgraft and the occurrence of device-related complications.
Klinikum Augsburg, Vascular surgery, Germany sebastian.zerwes@gmx.net.
Sebastian
S
Zerwes
Klinikum Augsburg, Vascular surgery, Germany.
Zmarai
Z
Nurzai
Klinikum Augsburg, Radiology, Germany.
Giesbert
G
Leissner
Klinikum Augsburg, Radiology, Germany.
Thomas
T
Kroencke
Klinikum Augsburg, Vascular surgery, Germany.
Hans-Kees
HK
Bruijnen
Klinikum Augsburg, Vascular surgery, Germany.
Rudolf
R
Jakob
Klinikum Augsburg, Vascular surgery, Germany.
Klaus
K
Woelfle
D000368:Aged; D000369:Aged, 80 and over; D017544:Aortic Aneurysm, Abdominal / Q000000981:diagnostic imaging / Q000401:mortality / Q000601:surgery*; D001027:Aortography / Q000379:methods; D001807:Blood Vessel Prosthesis; D019917:Blood Vessel Prosthesis Implantation / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D000072226:Computed Tomography Angiography; D057867:Endoleak / Q000209:etiology; D057510:Endovascular Procedures / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D005260:Female; D005858:Germany; D006083:Graft Occlusion, Vascular / Q000209:etiology; D006801:Humans; D008297:Male; D008875:Middle Aged; D019106:Postoperative Hemorrhage / Q000209:etiology; D011474:Prosthesis Design; D012189:Retrospective Studies; D015607:Stents; D013927:Thrombosis / Q000209:etiology; D013997:Time Factors; D016896:Treatment Outcome; D014463:Ultrasonography
AAA; EVAR; EVAS; Nellix; aneurysm sealing