Hybrid vs. Conventional Surgery for Type A Aortic Dissection

The First Hospital of Hebei Medical University140 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

140

Conditions

Acute Stanford Type A Aortic Dissection

Interventions

One-Stop Hybrid SurgeryPROCEDURE

With the patient under moderate hypothermia (approx. 28°C) and cardiopulmonary bypass, surgeons perform a total arch replacement using a standard 4-branched graft. After the open repair is complete, a separate, distinct covered stent graft is deployed antegradely into the descending aorta through the open distal end of the arch graft. Completion angiography confirms correct placement.

Conventional Total Arch Replacement with Frozen Elephant TrunkPROCEDURE

With the patient under deep hypothermic circulatory arrest (23°C-25°C) and cardiopulmonary bypass, surgeons perform a total arch replacement using an integrated hybrid prosthesis (Frozen Elephant Trunk), which consists of a vascular graft sutured to a covered stent graft. This single device is deployed antegradely into the descending aorta, and the arch vessels are then reattached to the branches of the prosthetic graft.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Locations (1)

The Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Outcomes

Primary Outcomes

Incidence of the Composite Endpoint of 30-day Mortality, Stroke, and Acute Kidney Injury (Stage 2 or 3)

A composite outcome measure including all-cause mortality, any new focal neurological deficit lasting \>24 hours and confirmed by imaging (stroke), and acute kidney injury defined as Stage 2 or 3 by KDIGO criteria. The measure is the percentage of patients in each group who experience at least one of these events.

Time frame: Within 30 days post-procedure

Secondary Outcomes

All-Cause Mortality at 30 Days

The percentage of patients who died from any cause.

Time frame: Within 30 days post-procedure

Incidence of Postoperative Stroke

The percentage of patients with a new focal neurological deficit lasting \>24 hours, confirmed by imaging.

Time frame: Within 30 days post-procedure

Incidence of Stage ≥2 Acute Kidney Injury (AKI)

The percentage of patients developing AKI Stage 2 or 3, as defined by KDIGO criteria.

Time frame: Within 30 days post-procedure

Operative Metrics

Includes total operative time, cardiopulmonary bypass duration, and aortic cross-clamp duration. Measured in minutes or hours.

Time frame: Intraoperative

Duration of Mechanical Ventilation

The total time a patient requires mechanical ventilation support after surgery, measured in hours.

Time frame: During the postoperative hospital stay (up to 30 days post-procedure)

Incidence of Other Major Postoperative Complications

Data from ClinicalTrials.gov

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