Results from a Prospective Multicenter Feasibility Study of Zenith p-Branch Stent Graft
Mark A. Farber, MD1, Gustavo Oderich, MD2, Carlos Timaran, MD3, Luis Sanchez, MD4, Feiyi Jia, PhD5.
1University of North Carolina, Chqpel Hil, NC, USA, 2Mayo Clinic, Rochester, MN, USA, 3UT Southwestern, Dallas, TX, USA, 4Washington University, St. Louis, MO, USA, 5Cook Incorporated, Bloomington, IN, USA.
OBJECTIVES: To evaluate the results from a prospective, non-randomized, multicenter feasibility study conducted in the United States on Cook Zenith p-Branch Stent Graft for the treatment of patients with asymptomatic juxtarenal or pararenal abdominal aortic aneurysms.
METHODS: The off-the-shelf p-Branch endograft incorporates a celiac scallop, a superior mesenteric artery (SMA) fenestration, and 2 conical-shaped pivot renal fenestrations. Patients were eligible if the aneurysm did not extend above the distal margin of the SMA and the anatomy of renal and visceral arteries was compatible with the two p-Branch configurations. A total of 30 patients (93% male; mean age 73 years; mean aneurysm diameter 64.7±11.4 mm) were enrolled between January 2013 and June 2015. Mean follow-up was 14.8±8 months (data as of June 2016).
RESULTS: Seventeen patients (56.7%) were implanted with device configuration A (renal fenestrations at same longitudinal position), and 13 patients (43.3%) with configuration B (offset renal fenestrations). Technical success was achieved in 96.7% (29/30). In one patient, the p-Branch device was deliberately repositioned below the renal arteries due to difficulty in cannulating the renal arteries. In total, 57/60 renal arteries and 29/30 SMAs were stented during the index procedure; no stents were placed for celiac arteries. There was no 30-day mortality. Two deaths occurred within 1 year (due to a cerebral aneurysm and a dissecting ruptured pre-existing proximal thoracic aortic aneurysm, respectively), neither related to device/procedure by CEC adjudication. There was no rupture, conversion, or core lab reported migration, stent fracture, or aneurysm growth. Eleven patients required secondary interventions (SI) and included proximal type I endoleak (n=2; both without renal stent placement during the index procedure), type III endoleak (n=1; between p-Branch and renal stent), renal artery occlusion (n=2), SMA occlusion (n=1), renal or SMA stenosis (n=4; one also treated for lower extremity claudication), and renal stent kink (n=1). There was no bowel ischemia. One patient developed renal insufficiency secondary to a right renal artery stenosis, and one patient with a history of chronic renal insufficiency experienced renal failure. No patients in the study required dialysis to date.
CONCLUSIONS: These early results, which incorporate physician learning curves, appeared to support the safety and feasibility of the off-the-shelf Zenith p-Branch device. Follow-up through 5 years is ongoing to assess long-term results.
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