This is a prospective, randomized, non-inferiority clinical trial designed to compare the efficacy and safety of two surgical strategies for acute type A aortic intramural hematoma (TAIMH): (1) ascending aorta replacement or ascending aorta plus hemiarch replacement (AAR/AAR+HAR), and (2) ascending aorta replacement with total arch replacement and frozen elephant trunk implantation (AAR+TAR+FET). Patients will be enrolled based on CTA confirmation of a completely thrombosed false lumen in the ascending aorta and aortic arch. Eligible participants will be randomized in a 1:1 ratio to either group. The primary endpoint is the rate of reintervention on the aortic arch or descending aorta from 6 to 12 months after surgery. Secondary endpoints include circulatory arrest time, aortic cross-clamp time, major adverse cardiovascular events, other perioperative complications, and total hospitalization cost. A total of 400 participants will be enrolled.
Age ≥ 18 years and ≤ 80 years.
Diagnosis of type A aortic intramural hematoma (TAIMH).
Ability to understand the study procedure and provide written informed consent.
Preoperative CTA shows an open or partially thrombosed (mixed) false lumen in the ascending aorta or arch.
Primary tear located on the greater curvature of the aortic arch, necessitating total arch replacement.
Planned concomitant major cardiac surgery (e.g., CABG, valve replacement, atrial fibrillation ablation).
Previous history of aortic arch or distal aortic surgery.
Parallel
Ascending Aorta Replacement / Ascending Aorta Plus Hemiarch Replacement
Procedure/SurgeryThis procedure involves ascending aorta replacement alone or ascending aorta plus hemiarch replacement, according to the operative strategy. The ascending aorta is replaced with or without replacement of the proximal aortic arch, while the distal arch and supra-aortic vessels are preserved.
Ascending Aorta Replacement With Total Arch Replacement and Frozen Elephant Trunk
Procedure/SurgeryThis procedure involves ascending aorta replacement with total arch replacement and frozen elephant trunk implantation. The entire aortic arch is replaced, and a frozen elephant trunk is implanted into the proximal descending aorta.
Rate of reintervention on the aortic arch or descending aorta
The proportion of patients requiring any secondary surgical or endovascular procedure involving the aortic arch or descending aorta during follow-up after the index operation.
Aortic Cross-Clamp Time
Duration (minutes) of aortic cross-clamping during surgery.
Circulatory Arrest Time
Duration (minutes) of total circulatory arrest.
Major Adverse Cardiovascular Events (MACE)
Incidence of major adverse cardiovascular events during the perioperative period. The exact components should follow the study protocol and statistical analysis plan.
Other perioperative complications
Incidence of perioperative complications during the perioperative period, including but not limited to neurological events, renal dysfunction, infection, bleeding, and cardiac failure.
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