Hybrid vs. Conventional Surgery for Type A Aortic Dissection

Hebei Medical University

Status: Completed

Conditions: Acute Stanford Type A Aortic Dissection

Treatments: Procedure: Conventional Total Arch Replacement with Frozen Elephant Trunk; Procedure: One-Stop Hybrid Surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT07107711

2020139

Details and patient eligibility

About

This is a prospective, randomized controlled trial designed to compare the clinical efficacy and short-term outcomes of one-stop hybrid surgery versus conventional total arch replacement with frozen elephant trunk (FET) in patients with acute Stanford Type A Aortic Dissection. The study evaluates differences in perioperative metrics, postoperative complications, 30-day survival, aortic remodeling, and quality of life.

Full description

Stanford Type A Aortic Dissection (TAAD) is a life-threatening condition requiring urgent surgical repair. This study tests the hypothesis that a one-stop hybrid surgery protocol is superior to conventional repair. 140 patients with acute TAAD were randomized to one of two groups. The experimental group received a one-stop hybrid surgery, which combines open total arch replacement using a standard branched surgical graft with the antegrade deployment of a separate stent graft, performed under moderate hypothermia. The active comparator group underwent conventional total arch replacement using an integrated frozen elephant trunk (FET) hybrid prosthesis, performed under deep hypothermic circulatory arrest. The study's main objective is to compare key clinical outcomes between the two surgical strategies, including a primary composite endpoint of 30-day mortality, stroke, and acute kidney injury, to provide evidence on the optimal surgical approach for this high-risk population.

Enrollment: 140 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 18-70 years.
• Diagnosis of acute TAAD (symptom onset <72 hours) confirmed by imaging, with dissection involving the aortic arch requiring total arch replacement.
• Relative hemodynamic stability, defined as a systolic blood pressure >90 mmHg without high-dose vasopressor support (norepinephrine >0.1 µg/kg/min).
• Provision of informed consent.

Exclusion criteria

• Age >70 years.
• Stanford type B or non-dissection pathologies.
• Life-threatening comorbidities prohibitive of major cardiac surgery (e.g., advanced multiorgan failure from other causes, active malignancy).
• Absolute contraindications to surgery.
• History of previous ascending aorta or aortic arch surgery.
• Inability to provide informed consent.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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140 participants in 2 patient groups

Experimental: Hybrid Group (n=70)

Experimental group

Description:

Patients were randomized to undergo one-stop hybrid surgery, which included total aortic arch replacement with a standard 4-branched artificial vascular graft combined with antegrade stent grafting of the proximal descending aorta, performed in a single stage under moderate hypothermia (approx. 28°C).

Treatment:

Procedure: One-Stop Hybrid Surgery

Active Comparator: Conventional Group (n=70)

Active Comparator group

Description:

Patients were randomized to undergo conventional total arch replacement using an integrated frozen elephant trunk (FET) hybrid prosthesis. The procedure was performed under deep hypothermic circulatory arrest (target temperature 23°C-25°C).

Treatment:

Procedure: Conventional Total Arch Replacement with Frozen Elephant Trunk