First-in-Human Use of the Cook Hybrid Frozen Elephant Trunk Graft: The Canadian Experience.

Abstract

Advancements in technology have changed the treatment of aortic arch pathologies. Specifically, the introduction of the frozen elephant trunk technique has allowed one-stage treatment of pathologies that would have otherwise required a two-stage procedure. We present the early outcomes of a novel frozen elephant hybrid stent graft. Between August 2015 and July 2019, 39 patients (56% male; mean age 67 ± 11years) underwent an arch reconstruction with a novel hybrid stent graft in four different Canadian centers. The most common indication for surgery was arch aneurysm (31%) followed by acute dissection (28%). All patients were prospectively followed with clinical and imaging assessments. The device was successfully implanted in all patients. There were 3 perioperative deaths (8%). Transient spinal cord injury occurred in 5 patients (13%); all had complete neurologic recovery before discharge. Seven patients had a perioperative stroke/transient ischemic attack; 3 of them initially presented with cerebral malperfusion caused by acute dissection. One patient died during the study follow-up. Survival at 30 days and at 1 and 3 years was 92% ± 5%, 89% ± 5%, and 89% ± 5%, respectively. At a median follow-up of 16 months, 3 patients required a reintervention to address a type I distal endoleak and 1 patient was treated for a type II endoleak. There was no arch anastomosis complications. The Cook hybrid stent graft device provides encouraging midterm results in a high-risk cohort. This novel graft is simple to deploy, may be customized to patients' anatomy in elective cases, eases arch reconstruction, and allows versatility in the choice of arch grafts.