Three-Vessel Versus Unilateral Antegrade Cerebral Perfusion in Emergency Total Arch Replacement for Acute Type A Aortic Dissection (MACP)

June 28, 2026 updated by: China Medical University Hospital

A Retrospective Chart-Review Evaluating Direct Three-Vessel Antegrade Cerebral Perfusion Versus Unilateral Right Axillary Antegrade Cerebral Perfusion in Emergency Total Arch Replacement for Acute Type A Aortic Dissection at CMUH (2021-2025)

This single-centre retrospective observational cohort study describes the technical feasibility of direct three-vessel antegrade cerebral perfusion, designated modified antegrade cerebral perfusion (MACP), during emergency total arch replacement for acute type A aortic dissection. MACP delivers antegrade cerebral perfusion directly to the brachiocephalic, left common carotid, and left subclavian arteries. Outcomes are summarised descriptively and compared exploratorily with unilateral right axillary antegrade cerebral perfusion (uACP). Because perfusion strategy and treating surgeon were completely confounded, the comparative analyses are intended only to contextualise the technical experience and generate hypotheses.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Background and Rationale

Acute type A aortic dissection requires emergency surgical repair. When total arch replacement is performed, cerebral protection during circulatory arrest is usually provided with hypothermia and antegrade cerebral perfusion. The optimal branch-level configuration of antegrade cerebral perfusion in emergency arch repair remains uncertain.

This study evaluates a direct three-vessel antegrade cerebral perfusion strategy, designated modified antegrade cerebral perfusion (MACP). MACP was delivered using balloon-tipped catheters inserted into the brachiocephalic, left common carotid, and left subclavian arteries and connected to a three-line manifold from the cardiopulmonary bypass pump. The comparator was unilateral antegrade cerebral perfusion delivered through right axillary artery cannulation (uACP).

Study Design and Population

This is a single-centre retrospective observational cohort study conducted at China Medical University Hospital, Taichung, Taiwan. Consecutive adults aged 18 years or older who underwent emergency surgical repair for acute type A aortic dissection between 1 January 2021 and 30 April 2025 were identified from electronic health records and intraoperative perfusion records. The manuscript analytic cohort was restricted to patients undergoing emergency total arch replacement with either MACP or uACP.

Objectives

The primary objective is to describe the technical feasibility of MACP during emergency total arch replacement for acute type A aortic dissection. A secondary objective is to provide exploratory contextual outcome comparisons between MACP and uACP. The study is retrospective and observational; the comparative analyses are intended to generate hypotheses rather than to establish treatment effects.

Outcome Measures

The index outcome for the exploratory comparison is postoperative stroke during the index admission, defined as an abrupt focal neurological deficit due to cerebral infarction or intracranial haemorrhage confirmed on postoperative computed tomography or magnetic resonance imaging and adjudicated by a consultant neurologist. Secondary outcomes include in-hospital mortality, acute kidney injury, new dialysis, reoperation for bleeding, sepsis, postoperative atrial fibrillation, tracheostomy, mechanical ventilation duration, intensive care unit stay, and hospital stay.

Statistical Analysis

Continuous data are summarised as median and interquartile range, and binary data as n/N and percentage. Propensity scores for MACP were estimated using baseline covariates selected a priori and constrained by the small number of MACP patients. The primary exploratory comparison used 1:2 nearest-neighbour propensity score matching without replacement. Binary outcomes were analysed using Firth-penalised logistic regression, and continuous outcomes were compared using non-parametric methods with bootstrap confidence intervals. Sensitivity analyses examined alternative matching specifications, an unmatched propensity-score-adjusted model, and overlap-weighted covariate-balance diagnostics. All analyses are exploratory; p values are descriptive and no adjustment for multiplicity was performed.

Ethics and Oversight

The protocol was approved by the China Medical University Hospital Research Ethics Committee. All data were retrospectively collected and anonymised; informed consent was waived. No U.S. FDA-regulated drug, device, IND, or IDE is involved. Because this is a retrospective chart-review study, a formal data-monitoring committee was not required.

Study Type

Observational

Enrollment (Actual)

201

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Consecutive adult patients who underwent emergency total arch replacement for acute type A aortic dissection at China Medical University Hospital, Taichung, Taiwan, between 1 January 2021 and 30 April 2025. The analytic population was restricted to patients who received either direct three-vessel antegrade cerebral perfusion (MACP) or unilateral right axillary antegrade cerebral perfusion (uACP).

Description

Inclusion Criteria:

  • Adults aged 18 years or older.
  • Patients who underwent emergency total arch replacement for acute type A aortic dissection at China Medical University Hospital between 1 January 2021 and 30 April 2025.
  • Patients who received either direct three-vessel antegrade cerebral perfusion (MACP) or unilateral right axillary antegrade cerebral perfusion (uACP).

Exclusion Criteria:

  • Incomplete key clinical, operative, or outcome data precluding analysis.
  • Preoperative modified Rankin Scale score of 4 or higher.
  • Ischemic stroke within 30 days before surgery.
  • Remote prior stroke history or unavailable prior-stroke status.
  • Patients managed with cerebral perfusion strategies other than MACP or uACP.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Direct Three-Vessel ACP (MACP) Group
Patients undergoing emergency total arch replacement for acute type A aortic dissection in whom direct three-vessel antegrade cerebral perfusion was delivered to the brachiocephalic, left common carotid, and left subclavian arteries.
Procedure: Direct Three-Vessel Antegrade Cerebral Perfusion (MACP)
Direct antegrade cerebral perfusion through balloon-tipped catheters inserted into the brachiocephalic, left common carotid, and left subclavian arteries during emergency total arch replacement.
Unilateral Right Axillary ACP (uACP) Group
Patients undergoing emergency total arch replacement for acute type A aortic dissection in whom antegrade cerebral perfusion was delivered unilaterally through right axillary artery cannulation.
Procedure: Unilateral Right Axillary Antegrade Cerebral Perfusion (uACP)
Unilateral antegrade cerebral perfusion delivered through right axillary artery cannulation during emergency total arch replacement.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative Stroke
Time Frame: During the index admission, up to hospital discharge.
Postoperative stroke during the index admission, defined as an abrupt focal neurological deficit due to cerebral infarction or intracranial haemorrhage confirmed on postoperative computed tomography or magnetic resonance imaging and adjudicated by a consultant neurologist.
During the index admission, up to hospital discharge.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
In-Hospital Mortality
Time Frame: During the index admission, up to hospital discharge.
Death before discharge during the index admission.
During the index admission, up to hospital discharge.
Hospital Length of Stay
Time Frame: From surgery to hospital discharge.
Length of hospital stay, measured in days from surgery to hospital discharge.
From surgery to hospital discharge.
ICU Length of Stay
Time Frame: From postoperative ICU admission to ICU discharge during the index admission.
Length of postoperative intensive care unit stay, measured in days from postoperative ICU admission to ICU discharge.
From postoperative ICU admission to ICU discharge during the index admission.
Mechanical Ventilation Duration
Time Frame: During the index admission, up to liberation from invasive ventilation.
Mechanical-ventilation duration was measured from postoperative intensive-care unit admission to liberation from invasive ventilation.
During the index admission, up to liberation from invasive ventilation.
Postoperative Acute Kidney Injury (AKI)
Time Frame: Within 7 postoperative days.
Acute kidney injury was defined as KDIGO stage 1 or higher within 7 postoperative days, based on serum creatinine criteria.
Within 7 postoperative days.
Dialysis Requirement
Time Frame: During the index admission, up to hospital discharge.
Requirement for new postoperative renal replacement therapy during the index admission.
During the index admission, up to hospital discharge.
Number of Participants Requiring Re-operation for Bleeding
Time Frame: During the index admission, up to hospital discharge.
Return to the operating room for postoperative bleeding or haematoma evacuation during the index admission.
During the index admission, up to hospital discharge.
Number of Participants with Sepsis (Sepsis-3)
Time Frame: During the index admission, up to hospital discharge.
Sepsis during the index admission, defined according to Sepsis-3 criteria as suspected or documented infection with organ dysfunction.
During the index admission, up to hospital discharge.
Number of Participants with Postoperative Atrial Fibrillation
Time Frame: During the index admission, up to hospital discharge.
Postoperative atrial fibrillation was defined as new-onset atrial fibrillation documented after surgery during the index admission.
During the index admission, up to hospital discharge.
Tracheostomy
Time Frame: During the index admission, up to hospital discharge.
Placement of a tracheostomy after surgery during the index admission.
During the index admission, up to hospital discharge.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

China Medical University Hospital

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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 1, 2026

Last Update Submitted That Met QC Criteria

June 28, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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 publicly because the dataset was derived from retrospective electronic health records and contains potentially sensitive clinical information. Any external access, if considered, would require separate institutional review and ethics approval.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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