Clinical outcomes for endovascular repair of abdominal aortic aneurysm with the Seal stent graft

Objective Since 2007, the availability of the Seal (S & G Biotech Inc, Seong-nam, Gyeonggi-do, Korea) stent graft for endovascular aneurysm repair (EVAR) has improved short-term outcomes in Korea. However, midterm outcome data are lacking. This retrospective study evaluated the midterm outcomes...

Full description

Saved in:
Bibliographic Details
Published in:Journal of vascular surgery 2016-11, Vol.64 (5), p.1270-1277
Main Authors: Kim, Jeong Ho, MD, Cho, Young Kwon, MD, Seo, Tae-Seok, MD, Song, Myung Gyu, MD, Jeon, Yong Sun, MD, Han, Young Min, MD, Kang, Min Ho, MD, Lim, Hyoung Gun, MD
Format: Article
Language:English
Subjects:
Aged
Aged, 80 and over
Aortic Aneurysm, Abdominal - diagnostic imaging
Aortic Aneurysm, Abdominal - mortality
Aortic Aneurysm, Abdominal - surgery
Aortic Rupture - diagnostic imaging
Aortic Rupture - mortality
Aortic Rupture - surgery
Blood Vessel Prosthesis
Blood Vessel Prosthesis Implantation - adverse effects
Blood Vessel Prosthesis Implantation - instrumentation
Blood Vessel Prosthesis Implantation - mortality
Endoleak - etiology
Endoleak - therapy
Endovascular Procedures - adverse effects
Endovascular Procedures - instrumentation
Endovascular Procedures - mortality
Female
Foreign-Body Migration - etiology
Foreign-Body Migration - therapy
Humans
Kaplan-Meier Estimate
Male
Middle Aged
Multivariate Analysis
Odds Ratio
Proportional Hazards Models
Prosthesis Design
Prosthesis Failure
Republic of Korea
Retreatment
Retrospective Studies
Risk Factors
Stents
Surgery
Time Factors
Treatment Outcome
Citations: Items that this one cites
Items that cite this one
Online Access:Get full text
Tags: Add Tag
No Tags, Be the first to tag this record!
Description
Summary:Objective Since 2007, the availability of the Seal (S & G Biotech Inc, Seong-nam, Gyeonggi-do, Korea) stent graft for endovascular aneurysm repair (EVAR) has improved short-term outcomes in Korea. However, midterm outcome data are lacking. This retrospective study evaluated the midterm outcomes of 126 patients who underwent EVAR using the Seal stent graft between 2007 and 2010. Methods Data regarding use of the Seal stent graft for EVAR were collected from 16 Korean centers, and were analyzed retrospectively using Kaplan-Meier and Cox univariate and multivariate analyses. Results The mean patient age was 71 ± 8 years (median, 70; range, 49-87 years). Patients who were treated using a bifurcated graft (113; 90%) were generally symptomatic (56; 44%, which included 13 ruptured abdominal aortic aneurysms [10%]) and male (105; 83%). The primary technical success rate was 99%. Four patients (3%) died within 30 days, 5 patients (4%) died after 30 days, and 12 patients (9%) were lost to follow-up. The survival rates were 97% ± 2% (1 month), 97% ± 2% (3 months), 96% ± 2% (6 months), 96% ± 2% (1 year), 94% ± 3% (3 years), and 81% ± 10% (5 years). During a mean follow-up of 55 ± 22 months (median, 40; range, 0.03-91.2 months), 18 reinterventions were performed for 16 patients (13%). The freedom from reintervention rates were 96% ± 2% (1 month), 96% ± 2% (3 months), 94% ± 2% (6 months), 89% ± 3% (1 year), 84% ± 4% (3 years), and 57% ± 17% (5 years). The mean aneurysm diameter significantly decreased from 69.6 to 46.6 mm during the follow-up ( P  < .0001). A proximal neck of less than 15 mm, different simultaneous endoleaks, and insufficient bilateral coverage of the iliac aneurysm were associated with significantly higher rates of increased or unchanged aneurysm diameters (all P  < .0001). Significantly higher rates of clinical failure were observed in patients who were less than 70 years old ( P  = .04), had a neck length of less than 15 mm ( P  = .02), and had a neck diameter of greater than 28 mm ( P  = .02). Conclusions Most Seal stent grafts were implanted successfully (even in cases with a physical status of grade IV or higher or a ruptured abdominal aortic aneurysm), had an appropriate reintervention rate, and were stable during the midterm follow-up. However, there was a high rate of type I endoleak, which may be related to the early device model that we used. Therefore, long-term radiologic follow-up is recommended for the early detection of stent graft migra
ISSN:0741-5214
1097-6809
DOI:10.1016/j.jvs.2016.02.057