Acute Stanford Type A Aortic Dissection
Conditions
Brief summary
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.
Detailed 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.
Interventions
PROCEDUREOne-Stop Hybrid Surgery
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.
PROCEDUREConventional Total Arch Replacement with Frozen Elephant Trunk
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.
Sponsors
The First Hospital of Hebei Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of the Composite Endpoint of 30-day Mortality, Stroke, and Acute Kidney Injury (Stage 2 or 3) | Within 30 days post-procedure | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Aortic Morphology Score | 1 Month Post-procedure, 3 Months Post-procedure | Aortic remodeling assessed by a 7-parameter scoring system on Magnetic Resonance Imaging (MRI). The score ranges from 0 to 16, with lower scores indicating more favorable remodeling (a better outcome). |
| All-Cause Mortality at 30 Days | Within 30 days post-procedure | The percentage of patients who died from any cause. |
| Incidence of Postoperative Stroke | Within 30 days post-procedure | The percentage of patients with a new focal neurological deficit lasting \>24 hours, confirmed by imaging. |
| Incidence of Stage ≥2 Acute Kidney Injury (AKI) | Within 30 days post-procedure | The percentage of patients developing AKI Stage 2 or 3, as defined by KDIGO criteria. |
| Operative Metrics | Intraoperative | Includes total operative time, cardiopulmonary bypass duration, and aortic cross-clamp duration. Measured in minutes or hours. |
| Incidence of Other Major Postoperative Complications | During hospital stay (up to 30 days post-procedure) | Includes pulmonary infection, severe hypoxemia, postoperative delirium (assessed via CAM-ICU), and reoperation for bleeding. |
| Change in Quality of Life | 3 Months Post-procedure | Assessed using the Kansas City Cardiomyopathy Questionnaire (KCCQ) summary score. The score ranges from 0 to 100, where higher scores indicate better quality of life (a better outcome). |
| Incidence of Endoleak | 1 Month Post-procedure, 3 Months Post-procedure | Presence of any endoleak detected on follow-up MRI. |
| Incidence of Cardiovascular Events | Through study completion (3 months) | Number of patients experiencing major adverse cardiovascular events (e.g., myocardial infarction, repeat aortic intervention) during follow-up. |
| Length of Intensive Care Unit (ICU) Stay | During the postoperative hospital stay (up to 30 days post-procedure) | The total number of days a patient stays in the Intensive Care Unit (ICU) following surgery. |
| Total Postoperative Hospital Stay | During the postoperative hospital stay (up to 30 days post-procedure) | The total number of days from surgery until hospital discharge. |
| Duration of Mechanical Ventilation | During the postoperative hospital stay (up to 30 days post-procedure) | The total time a patient requires mechanical ventilation support after surgery, measured in hours. |
Countries
China
Outcome results
None listed