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

Completed

• Conditions: Acute Type A Aortic Dissection

• Registration Number: NCT07043777
• Lead Sponsor: China Medical University Hospital

Brief 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.

Study Timeline

• Study Start: 2021-01-01
• Primary Completion: 2025-04-30
• Status Verified: 2025-06
• Study Completion: 2025-06-01
• Study First Submitted: 2025-06-20
• Study First Submitted QC: 2025-06-20
• Study First Posted: 2025-06-29
• Last Update Submitted: 2025-06-30
• Last Update Posted: 2025-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 274

Inclusion Criteria

• Adults (≥ 18 years) who underwent acute Type A aortic dissection repair at China Medical University Hospital between 01 Jan 2021 and 30 Apr 2025.

Exclusion Criteria

• Documented preoperative stroke or severe neurological deficit prior to surgery.
• Pregnant patients.
• Patients < 18 years old.
• Insufficient or missing medical records that preclude data analysis or verification of outcomes.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Postoperative Stroke	Through hospital discharge (average about 14 days post-surgery)	New-onset cerebrovascular accident or imaging-confirmed stroke occurring after surgery and before hospital discharge. Diagnosis based on neurological examination and/or postoperative brain CT/MRI.

Secondary Outcome Measures

Name	Time	Method
Hospital Length of Stay	From end of surgery to discharge (max 30 days)	Total number of days from operation date to date of hospital discharge.
Postoperative Neurological Deficit	Through hospital discharge (average about 14 days post-surgery)	Any persistent neurological deficit (e.g., motor or sensory loss) documented after surgery and before hospital discharge.
30-Day Mortality	Assessed at 30 days post-surgery	All-cause mortality occurring within 30 days after the surgical procedure.
ICU Length of Stay	From end of surgery to ICU discharge (max 14 days)	Number of days from ICU admission after surgery until ICU discharge.
Mechanical Ventilation Duration	From end of surgery until extubation (max 120 hours)	Total hours of invasive mechanical ventilation post-operatively.
Number of Participants Requiring Re-operation for Bleeding	Through index hospitalization (average 72 hours)	Patients requiring return to OR for bleeding or hematoma evacuation.
Postoperative Acute Kidney Injury (AKI)	Through index hospitalization (average 10-14 days)	AKI defined by KDIGO criteria based on serum creatinine or urine output during hospitalization. KDIGO stages 0-3 (0 = no injury; 3 = worst). Higher stage = worse renal function.
Dialysis Requirement	Through index hospitalization (average 10-14 days)	Proportion of patients requiring renal replacement therapy post-operatively.
Number of Participants with Postoperative Atrial Fibrillation	Through index hospitalization (average within 7 days)	New-onset atrial fibrillation or arrhythmia episodes requiring treatment.
Myocardial Infarction	Through index hospitalization (average 10-14 days)	Post-operative MI confirmed by ECG changes and cardiac biomarkers.
Number of Participants with Sepsis (Sepsis-3)	Through index hospitalization (average within 7 days)	Sepsis per Sepsis-3 definition (infection + organ dysfunction) during hospital stay.

Trial Locations

Locations (1)

China Medical University Hospital; 🇨🇳 Taichung, Taiwan