Zenith p-Branch Device Demonstrates Technical Success and Safety in Feasibility Study
November 26, 2019—Findings from a feasibility study of the Zenith p-Branch device (Cook Medical) for treating patients with asymptomatic juxtarenal or pararenal abdominal aortic aneurysms were published by Mark A. Farber, MD, et al in Journal of Vascular Surgery (JVS).
Zenith p-Branch is an off-the-shelf fenestrated device based on Cook’s Zenith platform, with two pivot renal fenestrations, a superior mesenteric artery (SMA) fenestration, and a celiac scallop.
The prospective, nonrandomized, multicenter, feasibility study was composed of 30 patients (93% men; mean age, 73 years; mean aneurysm diameter, 64.7 ± 11.4 mm) enrolled from January 2013 to June 2015. Eligible patients had an aneurysm that did not extend above the distal margin of the SMA, as well as renal and visceral artery anatomy compatible with one of the two p-Branch configurations. The mean follow-up period was 28.7 ± 12.5 months.
The p-Branch’s overall technical success rate was 93%. Technical failure occurred in the first two patients, although both patients survived the procedure and withdrew from the study. An updated physician training and proctoring program was then implemented, and no additional failures occurred.
As reported in JVS, there was no 30-day mortality. Three deaths occurred during follow-up, but these were unrelated to the device or procedure, as determined by clinical events committee adjudication.
Additionally, the investigators found:
No treated aneurysm rupture, conversion, core laboratory–adjudicated migration, or stent fracture
A primary renal artery patency rate of 88.6% ± 4.4% at 1 and 2 years
Renal insufficiency in two patients (7%)
No requirement for dialysis and no developed mesenteric ischemia
A 32% secondary intervention rate, with nine patients undergoing 13 secondary interventions
The investigators concluded that these results, which incorporated physician learning curves, support the safety and feasibility of the Zenith p-Branch device. Follow-up examinations through 5 years will assess the long-term results.