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

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

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.

Study Overview

• Status: Completed
• Conditions: Acute Type A Aortic Dissection
• Intervention / Treatment: Procedure: Modified Catheter Antegrade Cerebral Perfusion (Modified bACP); Procedure: Conventional Brain Perfusion

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 Type: Observational
• Enrollment (Actual): 274

Contacts and Locations

Study Locations

• Taiwan
  • Taichung, Taiwan, 40447
    • China Medical University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Consecutive adult patients treated for acute Stanford Type A aortic dissection with open surgical repair at a single tertiary medical center (China Medical University Hospital, Taichung, Taiwan) between 2021-01-01 and 2025-04-30. The population comprises two retrospectively identified cohorts based on intra-operative cerebral-perfusion strategy (modified bilateral catheter ACP vs conventional perfusion).

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	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.
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.	Procedure: Conventional Brain Perfusion; Conventional cerebral perfusion strategy (e.g., standard bilateral antegrade cerebral perfusion) used during arch repair according to surgeon preference.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative Stroke	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.	Through hospital discharge (average about 14 days post-surgery)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative Neurological Deficit	Any persistent neurological deficit (e.g., motor or sensory loss) documented after surgery and before hospital discharge.	Through hospital discharge (average about 14 days post-surgery)
30-Day Mortality	All-cause mortality occurring within 30 days after the surgical procedure.	Assessed at 30 days post-surgery
Hospital Length of Stay	Total number of days from operation date to date of hospital discharge.	From end of surgery to discharge (max 30 days)
ICU Length of Stay	Number of days from ICU admission after surgery until ICU discharge.	From end of surgery to ICU discharge (max 14 days)
Mechanical Ventilation Duration	Total hours of invasive mechanical ventilation post-operatively.	From end of surgery until extubation (max 120 hours)
Dialysis Requirement	Proportion of patients requiring renal replacement therapy post-operatively.	Through index hospitalization (average 10-14 days)
Myocardial Infarction	Post-operative MI confirmed by ECG changes and cardiac biomarkers.	Through index hospitalization (average 10-14 days)
Postoperative Acute Kidney Injury (AKI)	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.	Through index hospitalization (average 10-14 days)
Number of Participants Requiring Re-operation for Bleeding	Patients requiring return to OR for bleeding or hematoma evacuation.	Through index hospitalization (average 72 hours)
Number of Participants with Sepsis (Sepsis-3)	Sepsis per Sepsis-3 definition (infection + organ dysfunction) during hospital stay.	Through index hospitalization (average within 7 days)
Number of Participants with Postoperative Atrial Fibrillation	New-onset atrial fibrillation or arrhythmia episodes requiring treatment.	Through index hospitalization (average within 7 days)

Collaborators and Investigators

• Sponsor: China Medical University Hospital
• Investigators: Principal Investigator: En-Bo Wu, M.D., Department of Anesthesiology, China Medical University Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Actual): April 30, 2025
• Study Completion (Actual): June 1, 2025

Study Registration Dates

• First Submitted: June 20, 2025
• First Submitted That Met QC Criteria: June 20, 2025
• First Posted (Actual): June 29, 2025

Study Record Updates

• Last Update Posted (Actual): July 3, 2025
• Last Update Submitted That Met QC Criteria: June 30, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Cardiovascular Surgery; Retrospective Cohort; Modified bACP; Bilateral Modified Catheter Antegrade Cerebral Perfusion; Cerebral Protection; Neurologic Complications; China Medical University Hospital; Ascending Aortic Graft Replacement
• Additional Relevant MeSH Terms: Dissection, Blood Vessel; Acute Aortic Syndrome; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases; Aneurysm; Aortic Dissection
• Other Study ID Numbers: CMUH114-REC1-089

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared because institutional privacy policies and the CMUH IRB approval restrict release of de-identified datasets to internal use; any external sharing would require a separate ethics application.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No