Young Erben, Gustavo S. Oderich, Audra Duncan, Manju Kalra, Mark Fleming, Thanila Macedo, Peter Gloviczki, Thomas Bower
Division of Vascular and Endovascular Surgery, Mayo Clinic, Rochester, MN.
OBJECTIVES: To evaluate the impact of compliance with anatomic guidelines on outcomes of endovascular aortic aneurysm repair (EVAR) using "bell-bottom" stent grafts (BBSG).
METHODS: The clinical data of 1,087 patients from our EVAR database (1999-2012) was reviewed. The outcomes of 247 patients (234 male, 13 female; mean age, 76±7 years) treated with 376 BBSGs >18mm were analyzed. Computed tomography angiography (CTA) was utilized for compliance with anatomic guidelines as stated in each manufacturer's Instruction for Use (IFU), including length and diameter of common iliac artery (CIA), and presence of circumferential thrombus, calcium or angulation at the distal landing zone (DLZ). End-points were iliac limb events (type Ib endoleak, retrograde migration, component separation and stenosis), sac enlargement and re-interventions
RESULTS: Of the 376 BBSGs, only 56 (15%) in 27 patients met conservative anatomic guidelines recommended by IFU. Aneurysm exclusion was achieved in all patients. After a mean follow-up of 41±26 months, 27 patients (11%) had 29 iliac-limb events (13 type 1B endoleaks, 4 aneurysm growth, 3 retrograde migrations, 3 component separations, 3 stenosis, 2 ruptures and 1 limb occlusion), all among patients treated outside IFU criteria (p<0.04). Patients who did not meet anatomic guidelines for BBSGs had greater rates of sac enlargement (70% vs. 53%) and lower freedom from iliac limb events and re-interventions (89±5% vs. 100%) at 5-years (p<0.04). Larger CIA diameter was associated with higher rates of iliac limb events and re-interventions (HR 1.14, 95% CI 1.04-1.24; p<0.05), while length of DLZ >15mm was a protective factor (HR 0.65, 95% CI 0.46-0.91; p<.05).
CONCLUSIONS: BBSGs effectively seal ectatic CIAs and small aneurysms, but rates of iliac limb events, sac enlargement and re-interventions are higher among patients who do not meet anatomical criteria for BBSGs per IFU. The larger the CIA diameter, the higher the iliac limb and re-intervention rates. Length of DLZ >15mm was a protective factor.
AUTHOR DISCLOSURES: T. Bower: Nothing to disclose; A. Duncan: Nothing to disclose; Y. Erben: Nothing to disclose; M. Fleming: Nothing to disclose; P. Gloviczki: Nothing to disclose; M. Kalra: Nothing to disclose; T. Macedo: Nothing to disclose; G. S. Oderich: Cook Medical, Consulting fees or other remuneration (payment); W. L. Gore & Associates, Consulting fees or other remuneration (payment).
Posted April 2013