Long-term results of balloon-expandable LifePath endografts in abdominal aortic aneurysm: A single-center experience
Received 22 February 2009; accepted 8 April 2009. published online 29 June 2009.
Objective
This retrospective single-center study analyzed long-term results after LifePath (Edwards Lifesciences LLC, Irvine, Calif) endoprosthesis implantation for abdominal aortic aneurysm (AAA), primarily focusing on the wire form fracture issue and consecutive endoleak rate.
Methods
Between 1999 and 2004, all consecutive patients with LifePath AAA devices in our institution were included in the retrospective analysis. All patients had computed tomography angiography (CTA) imaging preoperatively and image postprocessing. The follow-up using CTA imaging specifically addressed material fatigue (wire form fractures) resulting in migrations and type I endoleaks.
Results
During the 6-year study period, which included the 1-year withdrawal and redesign of the device, 51 patients were treated with LifePath AAA endografts. The 30-day mortality was 0%. The perioperative 30-day morbidity was 9.8%. One patient required a primary conversion due to misdeployment of the iliac limbs within the graft main body. The primary endoleak rate was 20.56% (type I, 2%; type II, 19.6%). During the mean follow-up of 40.7 months, 12 patients died, six were lost to follow-up, and 32 underwent subsequent CTA imaging. Eight patients (25%) demonstrated a proximal type I endoleak, seven (22%) had a type II endoleak, and three had a type III endoleak (9%). In nine patients (28.1%), wire form fractures could be detected at image postprocessing. Four patients required a secondary conversion due to endoleak and aneurysm growth (2 type I endoleaks and 2 type III endoleaks).
Conclusion
Wire form fracture is the major structural problem in the LifePath balloon-expandable endograft device, resulting in a significant endoleak rate. We must caution those patients with a LifePath device in-situ that careful follow-up must be performed due to material fatigue and they should consider secondary conversion.
aDepartment of Vascular Surgery, Klinikum rechts der Isar, Technische Universität München, München, Germany
bDepartment of Radiology, German Cancer Research Center Heidelberg, Heidelberg, Germany
cDepartment of Vascular and Endovascular Surgery, University of Heidelberg, Heidelberg, Germany
dDepartment of Diagnostics and Interventional Radiology, University of Heidelberg, Heidelberg, Germany
Correspondence: Stefan Ockert, MD, Department of Vascular Surgery, Klinikum rechts der Isar, Technische Universität München, Ismaninger Str 22, D-81675 Munich, Germany
ABSTRACT