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

NCT ID: NCT07043777

Last Updated: 2025-07-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 274 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-01-01
• Study Completion Date: 2025-06-01

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.

Conditions

Acute Type A Aortic Dissection

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Modified bACP Group

Patients who underwent acute type A aortic dissection repair between 1 Jan 2021 and 30 Apr 2025 using the bilateral modified catheter antegrade cerebral perfusion (Modified bACP) technique.

Modified Catheter Antegrade Cerebral Perfusion (Modified bACP)

Intervention Type: PROCEDURE

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.

Conventional Perfusion Group

Patients who underwent acute type A aortic dissection repair in the same period using the conventional cerebral perfusion strategy (e.g., standard bilateral ACP or surgeon-preferred method). Serves as the comparison cohort.

Conventional Brain Perfusion

Intervention Type: PROCEDURE

Conventional cerebral perfusion strategy (e.g., standard bilateral antegrade cerebral perfusion) used during arch repair according to surgeon preference.

Interventions

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.

Intervention Type: PROCEDURE

Conventional Brain Perfusion

Conventional cerebral perfusion strategy (e.g., standard bilateral antegrade cerebral perfusion) used during arch repair according to surgeon preference.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

China Medical University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

En-Bo Wu, M.D.

Role: PRINCIPAL_INVESTIGATOR

Department of Anesthesiology, China Medical University Hospital

Locations

China Medical University Hospital

Taichung, , Taiwan

Countries

Taiwan

References

Pitts L, Kofler M, Montagner M, Heck R, Iske J, Buz S, Kurz SD, Starck C, Falk V, Kempfert J. Cerebral Protection Strategies and Stroke in Surgery for Acute Type A Aortic Dissection. J Clin Med. 2023 Mar 15;12(6):2271. doi: 10.3390/jcm12062271.

Reference Type: BACKGROUND

PMID: 36983272 (View on PubMed)

Other Identifiers

CMUH114-REC1-089

Identifier Type: -

Identifier Source: org_study_id