Fourteen-year outcomes of abdominal aortic endovascular repair with the Zenith stent graft.
Long-term results of abdominal aortic aneurysm (AAA) endovascular repair are affected by graft design renewals that tend to improve the performance of older generation prostheses but usually reset the follow-up times to zero. The present study investigated the long-term outcomes of endovascular AAA repair (EVAR) using the Zenith graft, still in use without major modification, in a single center experience.



Between 2000 and 2011, 610 patients underwent elective EVAR using the Zenith endograft (Cook Inc, Bloomington, Ind) and represent the study group. Primary outcomes were overall survival, freedom from AAA rupture, and freedom from AAA-related death. Secondary outcomes included freedom from late (>30 days) reintervention, freedom from late (>30 days) conversion to open repair, freedom from aneurysm sac enlargement >5.0 mm and freedom from EVAR failure, defined as a composite of AAA-related death, AAA rupture, AAA growth >5 mm, and any reintervention.



Mean age was 73.2 years. Mean aneurysm diameter was 55.3 mm. There were five perioperative deaths (0.8%) and three intraoperative conversions. At a mean follow-up of 99.2 (range, 0-175) months, seven AAA ruptures occurred, all fatal except one. Overall survival was 92.8% ± 1.1% at 1 year, 70.1% ± 1.9% at 5 years, 37.8% ± 2.9% at 10 years, and 24 ± 4% at 14 years. Freedom from AAA-rupture was 99.8% ± 0.02 at 1 year (one case), 99.4% ± 0.04 at 5 years (three cases), and 98.1% ± 0.07 at 10 and 14 years. Freedom from late reintervention and conversion was 98% ± 0.6 at 1 year, 87.7% ± 1.5 at 5 years, 75.7% ± 3.2 at 10 years, and 69.9% ± 5.2 at 14 years. Freedom from aneurysm sac growth >5.0 mm was 99.8% at 1 year, 96.6% ± 0.7 at 5 years, 81.0% ± 3.4 at 10 years, and 74.1% ± 5.8% at 14 years. EVAR failure occurred in 132 (21.6%) patients at 14 years. At multivariate analysis, independent predictors of EVAR failure resulted type I and III endoleak (hazard ratio [HR], 6.7; 95% confidence interval [CI], 4.6- 9.7; P < .001], type II endoleak (HR, 2.3; 95% CI, 1.6-3.4; P < .001), and American Society of Anesthesiologists grade 4 (HR, 1.6; 95% CI, 1.0-2.6; P = .034).



EVAR with Zenith graft represents a safe and durable repair. Risk of rupture and aneurysm-related death is low, whereas overall long-term survival remains poor. Novel endograft models should be tested and evaluated considering that one-fourth of the operated patients will still be alive after 14 years.
Vascular Surgery Unit, S. Maria della Misericordia Hospital, University of Perugia, Perugia, Italy. Electronic address: fabio.verzini@unipg.it.
Fabio
F
Verzini
Vascular Surgery Unit, S. Maria della Misericordia Hospital, University of Perugia, Perugia, Italy.
Lydia
L
Romano
Vascular Surgery Unit, S. Maria della Misericordia Hospital, University of Perugia, Perugia, Italy.
Gianbattista
G
Parlani
Vascular Surgery Unit, S. Maria della Misericordia Hospital, University of Perugia, Perugia, Italy.
Giacomo
G
Isernia
Vascular Surgery Unit, S. Maria della Misericordia Hospital, University of Perugia, Perugia, Italy.
Gioele
G
Simonte
Vascular Surgery Unit, S. Maria della Misericordia Hospital, University of Perugia, Perugia, Italy.
Diletta
D
Loschi
Vascular Surgery Unit, S. Maria della Misericordia Hospital, University of Perugia, Perugia, Italy.
Massimo
M
Lenti
Gruppo Villa Maria (GVM) Research and Care, Rome, Italy.
Piergiorgio
P
Cao
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D017544:Aortic Aneurysm, Abdominal / Q000150:complications / Q000000981:diagnostic imaging / Q000401:mortality / Q000601:surgery*; D001019:Aortic Rupture / Q000209:etiology / Q000401:mortality / Q000628:therapy; D001027:Aortography / Q000379:methods; D001807:Blood Vessel Prosthesis; D019917:Blood Vessel Prosthesis Implantation / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D016009:Chi-Square Distribution; D000072226:Computed Tomography Angiography; D016208:Databases, Factual; D018450:Disease Progression; D018572:Disease-Free Survival; D057867:Endoleak / Q000209:etiology / Q000401:mortality / Q000628:therapy; D057510:Endovascular Procedures / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D005260:Female; D006083:Graft Occlusion, Vascular / Q000209:etiology / Q000401:mortality / Q000628:therapy; D006801:Humans; D007558:Italy; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D016017:Odds Ratio; D016016:Proportional Hazards Models; D011474:Prosthesis Design; D019233:Retreatment; D012189:Retrospective Studies; D012307:Risk Factors; D015607:Stents; D013997:Time Factors; D016896:Treatment Outcome