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

A Retrospective Cohort Study Evaluating the Efficacy of Bilateral Modified Catheter Antegrade Cerebral Perfusion (Modified bACP) in Acute Type A Aortic Dissection Surgery

This retrospective cohort study aims to evaluate the efficacy of a Bilateral Modified Catheter Antegrade Cerebral Perfusion (Modified bACP) technique in acute Type A aortic dissection surgery. Medical records from January 1, 2021, through October 31, 2024, at China Medical University Hospital will be reviewed. The primary outcomes include in-hospital mortality and stroke rate, while secondary outcomes include ICU/hospital stay, mechanical ventilation duration, and other postoperative complications (e.g., acute kidney injury, sepsis, myocardial infarction).

Study Overview

• Status: Terminated
• 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 a life-threatening condition requiring urgent surgical repair. Prolonged circulatory arrest increases the risk of neurological complications. Bilateral antegrade cerebral perfusion (bACP) has shown potential to reduce ischemic injury. However, conventional bACP requires additional surgical access. This study examines a Modified bACP approach that may reduce surgical trauma while maintaining adequate cerebral perfusion.

Objectives This retrospective cohort study evaluates whether Modified bACP improves postoperative outcomes compared to conventional perfusion strategies in ATAAD surgery at China Medical University Hospital (2021/1/1-2024/10/31).

Methods We will collect and analyze medical records of adult patients who underwent ATAAD repair, comparing those who received Modified bACP to those managed with conventional perfusion.

Outcome Measures

Primary Outcomes:

In-hospital mortality 30-day mortality

Secondary Outcomes:

Hospital length of stay (day) ICU length of stay (day) Mechanical ventilation duration (hours) Need for tracheostomy Stroke Postoperative neurological deficit Paraplegia Coma Atrial fibrillation (Af) Myocardial infarction Acute kidney injury (AKI) Dialysis requirement Reoperation for bleeding Sepsis Significance This study aims to provide comprehensive data on the safety and efficacy of Modified bACP in ATAAD surgery, potentially improving neurological protection and reducing other major complications and resource utilization. The findings may guide clinical practice and inform future protocol developments.

• Study Type: Observational
• Enrollment (Actual): 273

Contacts and Locations

Study Locations

• Taiwan
  • Taichung City, 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

Adult patients diagnosed with acute Type A aortic dissection who underwent surgical repair at China Medical University Hospital. The population includes individuals receiving either Modified bACP or conventional perfusion during the specified period.

Description

Inclusion Criteria:

• Adults (≥ 18 years old) who underwent acute Type A aortic dissection repair at China Medical University Hospital between January 1, 2021, and October 31, 2024.

Exclusion Criteria:

• Preexisting severe neurological impairment (e.g., stroke or other major neurological deficits before surgery).
• Age < 18 years.
• Pregnant patients.
• Insufficient or missing medical records preventing data analysis.

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 using the Bilateral Modified Catheter Antegrade Cerebral Perfusion (Modified bACP) technique. This observational group received the modified perfusion strategy aimed at reducing surgical trauma and enhancing cerebral protection.	Procedure: Modified Catheter Antegrade Cerebral Perfusion (Modified bACP); A modified bilateral catheter antegrade cerebral perfusion technique used for acute Type A aortic dissection repair. This approach aims to reduce surgical trauma by avoiding additional right axillary access while maintaining stable cerebral perfusion.
Conventional Perfusion Group; Patients who underwent acute Type A aortic dissection repair using the conventional brain perfusion technique (e.g., standard bilateral antegrade cerebral perfusion). This group serves as the comparison cohort for evaluating the effects of the modified technique.	Procedure: Conventional Brain Perfusion; Patients receiving the conventional perfusion strategy for aortic arch surgery, which may include standard bilateral ACP based on the surgeon's preference and the patient's condition.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stroke	New-onset cerebrovascular accident or imaging-confirmed stroke during hospitalization.	Through hospital discharge (on 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/sensory deficits) identified after surgery.	Through hospital discharge (on 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 Stay (day)	Total number of days from the operation date to the date of hospital discharge.	From end of surgery to hospital discharge (up to 21 days).
ICU Stay (day)	Length of stay in the intensive care unit after surgery.	From end of surgery to ICU discharge (up to 10 days).
Mechanical Ventilation (hour)	Duration of mechanical ventilation in hours.	From end of surgery until extubation (up to 72 hours).
Acute Kidney Injury (AKI)	Acute kidney injury defined by changes in serum creatinine or urine output (e.g., KDIGO criteria).	During the index hospitalization (on average about 10-14 days post-surgery)
Dialysis Requirement	Proportion of patients requiring renal replacement therapy (dialysis) postoperatively.	During the index hospitalization (on average about 10-14 days post-surgery)
Reoperation for Bleeding	Number of patients requiring a return to the operating room for bleeding control or hematoma.	During the index hospitalization (on average about 72 hours post-surgery)
Sepsis	Incidence of sepsis as defined by current guidelines (e.g., Sepsis-3), typically requiring positive cultures and organ dysfunction.	During the index hospitalization (on average within 7 days post-surgery)
Atrial Fibrillation (Af)	New-onset atrial fibrillation or documented arrhythmia episodes requiring clinical management.	During the index hospitalization (on average within 7 days post-surgery)
Myocardial Infarction	Clinically confirmed myocardial infarction based on ECG changes, cardiac enzymes, and clinical symptoms.	During the index hospitalization (on average about 10-14 days post-surgery)

Collaborators and Investigators

• Sponsor: China Medical University Hospital
• Investigators: Principal Investigator: En-Bo Wu, M.D., Department of Anesthesiology, China Medical University Hospital, China Medical University, Taichung City 404, Taiwan

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): October 31, 2024
• Study Completion (Actual): April 11, 2025

Study Registration Dates

• First Submitted: April 16, 2025
• First Submitted That Met QC Criteria: April 22, 2025
• First Posted (Actual): April 24, 2025

Study Record Updates

• Last Update Posted (Actual): May 7, 2025
• Last Update Submitted That Met QC Criteria: May 5, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Retrospective Cohort; Acute Type A Aortic Dissection; Bilateral Catheter Antegrade Cerebral Perfusion; Neurological Complications; Modified bACP
• Additional Relevant MeSH Terms: Dissection, Blood Vessel; Acute Aortic Syndrome; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases; Aneurysm; Aortic Dissection
• Other Study ID Numbers: CMUH113-REC1-183 (Other Identifier: Institutional Review Board, China Medical University Hospital)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD will not be shared due to institutional privacy policies and IRB regulations that restrict the release of patient-level data. The de-identified data are only approved for internal use by the research team and cannot be disclosed to external parties without additional 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