NCT07043777

Effectiveness of Bilateral Modified Catheter Antegrade Cerebral Perfusion in Acute Type A Aortic Dissection Surgery

A Retrospective Chart-Review Evaluating Bilateral Modified Catheter Antegrade Cerebral Perfusion Versus Conventional Perfusion in Type A Aortic Dissection Surgery at CMUH (2021-2025)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 274 (actual)
• Sponsor: China Medical University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This single-center retrospective cohort study examines whether a Bilateral Modified Catheter Antegrade Cerebral Perfusion (Modified bACP) technique improves early clinical outcomes in adults undergoing emergency repair of acute Type A aortic dissection (ATAAD). Electronic medical records at China Medical University Hospital (CMUH) will be reviewed for all ATAAD operations performed between 1 January 2021 and 30 April 2025. Patients treated with Modified bACP will be compared with those managed by conventional perfusion strategies. The primary outcome is in-hospital stroke. Secondary outcomes include postoperative neurologic deficit, in-hospital mortality, 30-day mortality, hospital and ICU length of stay, mechanical-ventilation duration, need for tracheostomy, acute kidney injury, dialysis requirement, reoperation for bleeding, sepsis, atrial fibrillation, and myocardial infarction. Findings will clarify the efficacy and safety of Modified bACP and may inform future cerebral-protection protocols in aortic surgery.

Detailed description

Background and Rationale Acute Type A aortic dissection (ATAAD) is life-threatening and requires immediate surgical repair. During hypothermic circulatory arrest, neurologic injury remains a major concern. Conventional bilateral antegrade cerebral perfusion (bACP) provides brain protection but often requires an additional right-axillary arterial cannulation. Our center developed a Modified bACP technique that employs balloon-tipped catheters introduced directly into both carotid arteries, avoiding the extra axillary incision while aiming to maintain stable cerebral flow. Objectives Primary - To determine whether Modified bACP reduces the incidence of in-hospital stroke compared with conventional perfusion. Secondary - To evaluate the effect of Modified bACP on early mortality and major postoperative morbidities, and to quantify ICU / hospital resource utilization. Study Design Design: Retrospective chart review; observational cohort. Setting: China Medical University Hospital, Taichung, Taiwan. Population: All consecutive adult (≥ 18 y) patients who underwent ATAAD repair between 2021-01-01 and 2025-04-30. Groups: Modified bACP Group - bilateral modified catheter antegrade cerebral perfusion. Conventional Perfusion Group - standard bilateral ACP or surgeon-selected alternative. Data Collection Demographics, comorbidities, operative details (CPB time, circulatory-arrest temperature / duration), and postoperative outcomes will be extracted from the electronic medical record by a trained research team and de-identified before analysis. Outcome Measures Primary - In-hospital stroke (clinical deficit or imaging-confirmed cerebrovascular accident). Secondary - * Postoperative neurologic deficit * In-hospital mortality * 30-day all-cause mortality * Hospital length of stay (days) * ICU length of stay (days) * Mechanical-ventilation duration (hours) * Need for tracheostomy * Acute kidney injury (KDIGO criteria) * Dialysis requirement * Reoperation for bleeding * Sepsis (Sepsis-3) * Atrial fibrillation (new-onset) * Myocardial infarction (biomarker + ECG / clinical) Statistical Analysis Baseline differences will be balanced using inverse-probability weighting of the propensity score derived from age, sex, comorbidities, and operative variables. Logistic or linear regression models will estimate adjusted effect sizes (odds ratios or mean differences) with 95 % confidence intervals. Sensitivity analyses will test robustness to residual confounding. A two-sided P \< 0.05 will be considered statistically significant. Ethics and Oversight The protocol (MACP-2024-03; CMUH114-REC1-089) was approved by the CMUH Research Ethics Committee on 23 May 2025. All data are retrospectively collected and anonymized; informed consent was waived. No U.S. FDA-regulated product or IND/IDE is involved. Because this is a chart review, a formal data-monitoring committee is not required. Significance By analyzing an extended 2021-2025 cohort, the study increases statistical power to detect clinically relevant differences. Results may validate Modified bACP as a less invasive yet effective cerebral-protection strategy, guiding surgical practice and future prospective trials.

Conditions

• Acute Type A Aortic Dissection

Interventions

Type	Name	Description
PROCEDURE	Modified Catheter Antegrade Cerebral Perfusion (Modified bACP)	Bilateral modified catheter antegrade cerebral perfusion technique applied during acute type A aortic dissection repair; avoids additional right-axillary incision while providing continuous cerebral flow.
PROCEDURE	Conventional Brain Perfusion	Conventional cerebral perfusion strategy (e.g., standard bilateral antegrade cerebral perfusion) used during arch repair according to surgeon preference.

Timeline

• Start date: 2021-01-01
• Primary completion: 2025-04-30
• Completion: 2025-06-01
• First posted: 2025-06-29
• Last updated: 2025-07-03

Locations

1 site across 1 country: Taiwan