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

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)

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07043777
Acronym
MACP
Enrollment
201
Registered
2025-06-29
Start date
2021-01-01
Completion date
2025-06-01
Last updated
2026-07-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Type A Aortic Dissection

Keywords

Cerebral Protection, Neurologic Complications, Retrospective Cohort, Cardiovascular Surgery, China Medical University Hospital, Direct Three-Vessel Antegrade Cerebral Perfusion, Modified Antegrade Cerebral Perfusion, Unilateral Antegrade Cerebral Perfusion, Total Arch Replacement, Acute Type A Aortic Dissection, Postoperative Stroke

Brief summary

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.

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.

Interventions

PROCEDUREDirect 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.

PROCEDUREUnilateral Right Axillary Antegrade Cerebral Perfusion (uACP)

Unilateral antegrade cerebral perfusion delivered through right axillary artery cannulation during emergency total arch replacement.

Sponsors

China Medical University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Postoperative StrokeDuring 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.

Secondary

MeasureTime frameDescription
In-Hospital MortalityDuring the index admission, up to hospital discharge.Death before discharge during the index admission.
Hospital Length of StayFrom surgery to hospital discharge.Length of hospital stay, measured in days from surgery to hospital discharge.
ICU Length of StayFrom 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.
Mechanical Ventilation DurationDuring 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.
Postoperative Acute Kidney Injury (AKI)Within 7 postoperative days.Acute kidney injury was defined as KDIGO stage 1 or higher within 7 postoperative days, based on serum creatinine criteria.
Dialysis RequirementDuring the index admission, up to hospital discharge.Requirement for new postoperative renal replacement therapy during the index admission.
Number of Participants Requiring Re-operation for BleedingDuring the index admission, up to hospital discharge.Return to the operating room for postoperative bleeding or haematoma evacuation during the index admission.
Number of Participants with Sepsis (Sepsis-3)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.
Number of Participants with Postoperative Atrial FibrillationDuring the index admission, up to hospital discharge.Postoperative atrial fibrillation was defined as new-onset atrial fibrillation documented after surgery during the index admission.
TracheostomyDuring the index admission, up to hospital discharge.Placement of a tracheostomy after surgery during the index admission.

Countries

Taiwan

Contacts

PRINCIPAL_INVESTIGATOREn-Bo Wu, M.D.

Department of Anesthesiology, China Medical University Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 2, 2026