title: Clinical outcomes for endovascular repair of abdominal aortic aneurysm with the Seal stent graft.
abstract: 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 migration or endoleaks.
authors.affiliation: Department of Radiology, Gachon University Gil Hospital, Gachon University College of Medicine, Incheon, Korea.
authors.forename: Jeong Ho
authors.initials: JH
authors.lastname: Kim
authors.affiliation: Department of Radiology, Kangdong Seong-Sim Hospital, Hallym University College of Medicine, Seoul, Korea. Electronic address: ykchoman@naver.com.
authors.forename: Young Kwon
authors.initials: YK
authors.lastname: Cho
authors.affiliation: Department of Radiology, Korea University Guro Hospital, Korea University College of Medicine, Seoul, Korea.
authors.forename: Tae-Seok
authors.initials: TS
authors.lastname: Seo
authors.affiliation: Department of Radiology, Korea University Guro Hospital, Korea University College of Medicine, Seoul, Korea.
authors.forename: Myung Gyu
authors.initials: MG
authors.lastname: Song
authors.affiliation: Department of Radiology, Inha University Hospital, Inha University College of Medicine, Incheon, Korea.
authors.forename: Yong Sun
authors.initials: YS
authors.lastname: Jeon
authors.affiliation: Department of Radiology, Chonbuk National University Hospital, Chonbuk National University College of Medicine, Jeonju-si, Korea.
authors.forename: Young Min
authors.initials: YM
authors.lastname: Han
authors.affiliation: Department of Radiology, Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheongju-si, Korea.
authors.forename: Min Ho
authors.initials: MH
authors.lastname: Kang
authors.affiliation: Department of Radiology, KEPCO Medical Center, Seoul, Korea.
authors.forename: Hyoung Gun
authors.initials: HG
authors.lastname: Lim
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D017544:Aortic Aneurysm, Abdominal / Q000000981:diagnostic imaging / Q000401:mortality / Q000601:surgery*; D001019:Aortic Rupture / Q000000981:diagnostic imaging / Q000401:mortality / Q000601:surgery*; D001807:Blood Vessel Prosthesis; D019917:Blood Vessel Prosthesis Implantation / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D057867:Endoleak / Q000209:etiology / Q000628:therapy; D057510:Endovascular Procedures / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D005260:Female; D005548:Foreign-Body Migration / Q000209:etiology / Q000628:therapy; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D016017:Odds Ratio; D016016:Proportional Hazards Models; D011474:Prosthesis Design; D011475:Prosthesis Failure; D056910:Republic of Korea; D019233:Retreatment; D012189:Retrospective Studies; D012307:Risk Factors; D015607:Stents; D013997:Time Factors; D016896:Treatment Outcome