Taming the Left Subclavian During Frozen Elephant Trunk Procedures: Early Results of a Novel Graft With an Integrated...

Left subclavian artery (LSA) revascularization during frozen elephant trunk (FET) procedures remains technically challenging, as no commercially available off-the-shelf graft provides direct in situ access. The COOK FET-FEN device (COOK Medical, Bloomington, IN) incorporates a dedicated LSA fenestration to facilitate standardized bridging stent placement. We report early clinical outcomes with this device.

A retrospective analysis was conducted on the first 48 consecutive patients who underwent total aortic arch replacement using the COOK FET-FEN device at 2 centres between June 2023 and June 2025. The graft consists of a proximal unstented polyester segment and a distal stented segment that incorporates an LSA fenestration for in situ stenting. Early cases used physician-modified grafts (5-mm cautery fenestration), followed by premanufactured fenestrated grafts (FEN; 8-10 mm). Outcomes included technical success, neurologic events, mortality, and reinterventions.

In situ LSA stenting was technically successful in all patients. Stroke occurred in 1 patient (2.1%), and hospital mortality was 4.2% (n = 2). At 18 months follow-up (median, 8.8 ± 2.1) overall survival was 93.5%, with one late death unrelated to the FET-FEN procedure. Reinterventions occurred in 19.2% of patients, including LSA-related reinterventions in 10.6%. Freedom from LSA reintervention and distal aortic reintervention at 1 year was 89.6% and 85.5%, respectively.

The COOK FET-FEN device enables reliable in situ LSA revascularization during FET procedures, with high technical success and acceptable early clinical outcomes. The fenestrated design provides a reproducible platform for LSA stenting, including complex arch reconstructions. Longer-term follow-up is required to assess durability and further refine patient selection.