Distal Reinterventions after Branched Stented Anastomosis Frozen Elephant Trunk Repair (B-SAFER): A Report from a Prospective Trial.

OBJECTIVE

Optimal timing for distal reintervention after frozen elephant trunk repair remains debated. We evaluated patient characteristics, clinical outcomes, and predictors of distal aortic reintervention following Branched Stented Anastomosis Frozen Elephant Trunk Repair (B-SAFER).

METHODS

From May 2021 to January 2025, 405 patients underwent B-SAFER in a prospective, single-arm, nonrandomized PS-IDE cohort. Among them, 117 patients required 148 distal reinterventions. Indications for initial repair were acute type A dissection (36/189, 31%), chronic dissection (62/138, 53%), and degenerative aneurysm (19/78, 16%). Most reinterventions (n=132, 92%) were planned. Primary endpoints were operative mortality, stroke, and paralysis. Kaplan-Meier analysis assessed survival and freedom from reintervention. Median follow-up was 1.3 years, and median time to reintervention was 8.7 months.

RESULTS

Mortality after first reintervention was 6.5% (n=8). Permanent stroke occurred in one patient (0.8%), with no cases of paralysis. Causes of death included sepsis (n=4), hemorrhagic shock (n=2), pulmonary embolism (n=1), and intracranial hemorrhage (n=1). Freedom from reintervention at 2 years was 64%, lowest in chronic dissections (48%), intermediate in degenerative aneurysms (71%), and highest in acute dissections (74%). Larger descending and abdominal aortic diameters were the strongest predictors of reintervention. Survival at 2.5 years was similar across groups (81% acute, 81% chronic, 77% degenerative).

CONCLUSIONS

Distal reinterventions after B-SAFER are common, safe, and are associated with acceptable early outcomes. Disease chronicity and aortic diameter predict reintervention risk. Frozen elephant trunk is an effective platform for staged aortic repair, and earlier reintervention in high-risk patients warrants further study. (245).