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 LB5. One Year Results from the Zenith® Low Profile Pivotal AAA Endovascular Graft Clinical Study

Ronald M. Fairman MD1, Cherrie Abraham MD2, Stephan Haulon MD3, Satish C. Muluk MD4, Takao Ohki MD5, Michael J. Singh MD6, Benjamin W. Starnes MD7, Edward Y. Woo MD1, and Alan Saunders8 for the Zenith Low Profile Investigators
1Hospital of the University of Pennsylvania, 2Jewish General Hospital, 3HôpitalCardiologique, CHRU de Lille, 4Allegheny General Hospital, 5Jikei University Hospital, 6University of Rochester, 7University of Washington, 8MED Institute, Inc.

OBJECTIVES: This prospective, nonrandomized global study is intended to evaluate the safety and effectiveness of the Zenith® Low Profile AAA Endovascular Graft in the treatment of patients with abdominal aortic, aortoiliac, or iliac aneurysms suitable for endovascular repair.

METHODS: The Zenith® LP AAA Graft is a modular system composed of nitinol stents and denser, thinner polyester graft material delivered in a 16 Fr sheath. 5-year follow-up of study patients is ongoing. The primary study endpoints are 30-day freedom from major adverse events (MAE) and 12-month device success.

RESULTS: Of the 120 patients enrolled (86.7% male, mean age 71.8 years), 27 (22.5%) would have been excluded from the previous Zenith® AAA study due to narrow common iliac artery lumen diameter. The mean maximum aneurysm diameter was 55.0 ± 7.7 mm. All devices were deployed successfully, using a percutaneous approach in 30.0% (36/120) of cases. Freedom from MAE was 99.2% (119/120) at 30 days, with re-intubation in 1 patient. MAEs reported between 1 and 12 months included 1 case of renal failure requiring dialysis (only MAE related to AAA repair), 1 stroke, and 5 deaths. Device success was achieved in 97.3% (110/113) of patients at 12 months, with 2 cases of aneurysm growth and 1 conversion; there have been no Type I or III endoleaks requiring re-intervention and no ruptures. Freedom from graft limb occlusion at 12 months was 92.3%, with predictive pre-procedure clinical/anatomical factors in most occlusion patients. There have been no migrations at 12 months and only 1 case (1.1%, 1/95) of CEC-confirmed stent fracture, which did not result in clinical sequelae.

CONCLUSIONS: These 12-month results confirm the safety and effectiveness of the Zenith® Low Profile AAA Endovascular Graft. With this system, more patients will be amenable to EVAR, although those with diseased and/or narrowed aortic bifurcations and iliac arteries may require adjunctive strategies to ensure graft patency is maintained.

AUTHOR DISCLOSURES: R. Fairman MD, Nothing to Disclose; C. Abraham MD, Consulting Fees or Other Remuneration (Payment): Cook; S. Haulon MD, Research Grants: Cook; Honoraria: Cook; Scientific Advisory Committee: Cook; Consulting Fees or Other Remuneration (Payment): Cook; S. Muluk MD, Nothing to Disclose; T. Ohki MD, Research Grants: Cook; Speakers Bureau: Cook; M. Singh MD, Consulting Fees or Other Remuneration (Payment): Cook, Covidien; B. Starnes MD, Other: Intellectual Property: Cook; E. Woo MD, Research Grants: Gore, Medtronic; Speakers Bureau: Medtronic; Scientific Advisory Committee: Endospan; Consulting Fees or Other Remuneration (Payment): Cook, Endologix; A. Saunders, Employment (Full- or Part-time): MED Institute (Cook).

Updated May 2012

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