European Registry of Type A Aortic Dissection (ERTAAD)

Acute Stanford type A aortic dissection (TAAD) is a life-threatening condition. Surgery is usually performed as a salvage procedure and is associated with significant postoperative early mortality and morbidity. Understanding the patient's conditions and treatment strategies which are associated with these adverse events is essential for an appropriate management of acute TAAD.

Study Overview

• Status: Completed
• Conditions: Type A Aortic Dissection
• Intervention / Treatment: Procedure: Surgery on the ascending aorta with or without repair of the aortic root and/or aortic arch

Detailed Description

Twenty centers from eight European centers of cardiac surgery have collaborated to create a multicentre observational registry (ERTAAD), which will enroll consecutive patients who underwent surgery for acute TAAD from January 2005 to March 2021. The investigators will compare patient's comorbidities, condition at referral, surgical strategies and perioperative treatments in patients with and without early and late adverse events. The primary clinical outcome will be in-hospital mortality, late mortality and reoperations on the aorta. Secondary outcomes will be stroke, acute kidney injury, surgical site infection, reoperation for bleeding, transfusion of blood products and length of stay in the intensive care unit.

• Study Type: Observational
• Enrollment (Actual): 3902

Contacts and Locations

Study Locations

• Belgium
  • Brugge, Belgium
    • AZ St-Jan
  • Brussels, Belgium
    • Saint-Luc's Hospital
  • Edegem, Belgium
    • University Hospital Antwerp
  • Genk, Belgium
    • Ziekenhuis Oost-Limburg
  • Leuven, Belgium
    • University Hospitals Leuven
• Czechia
  • Prague, Czechia
    • Institute of clinical and experimental medicine
• Finland
  • Helsinki, Finland
    • Helsinki University Hospital
• France
  • Besançon, France
    • University Hospital Jean Minjoz
  • Paris
    • Créteil, Paris, France
      • Henri Mondor University Hospital
• Germany
  • Hamburg, Germany
    • University Heart & Vascular Centre Hamburg
  • Leipzig, Germany
    • Leipzig Heart Center
  • Münster, Germany
    • Münster University Hospital
• Italy
  • Torino, Italy
    • University of Torino
  • Udine, Italy
    • University of Udine
  • Verona, Italy
    • University Of Verona Medical School
• Spain
  • Barcelona, Spain
    • Hospital Clínic de Barcelona
• United Kingdom
  • Leicester, United Kingdom
    • University Hospitals of Leicester
  • Liverpool, United Kingdom
    • Liverpool Heart and Chest Hospital
  • Sheffield, United Kingdom
    • Northern General Hospital
  • Southampton, United Kingdom
    • Southampton University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients who underwent surgical repair for acute type A aortic dissection or intramural hematoma involving the aortic root/ascending aorta.

Description

Inclusion Criteria:

• Type A aortic dissection or intramural hematoma involving the aortic root/ascending aorta;
• Patients aged > 18 years:
• Symptoms started within 7 days from surgery;
• Primary surgical repair of acute type A aortic dissection;
• Any other major cardiac surgical procedure concomitant with surgery for type A aortic dissection.

Exclusion Criteria:

• Patients aged < 18 years;
• Onset of symptoms > 7 days from surgery;
• Prior procedure for type A aortic dissection;
• Retrograde type A aortic dissection (with primary tear located in the descending aorta);
• Concomitant endocarditis;
• Type A aortic dissection secondary to blunt or penetrating chest trauma.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Acute type A aortic dissection; Patients who underwent surgery for acute type A aortic dissection	Procedure: Surgery on the ascending aorta with or without repair of the aortic root and/or aortic arch; Surgical repair of the ascending aorta with or without surgical repair of the aortic root and/or aortic arch

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality rate	All-cause mortality	During the index hospital stay until last follow-up control
Cumulative incidence of reoperation on the aorta	Any surgical and endovascular procedure on any segment of the aorta for aortic dissection or its related complication	During the index hospital stay until last follow-up control

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of stroke	change in the level of consciousness, hemiplegia, hemiparesis, numbness, or sensory loss affecting one side of the body, dysphasia or aphasia, hemianopia, amaurosis fugax, or other neurological signs or symptoms consistent with stroke duration of a focal or global neurological deficit ≥ 24 h; OR <24 h if available neuroimaging documents a new brain hemorrhage or infarct; OR the neurological deficit results in death.	From date of procedure until the date of hospital discharge, assessed up to 3 months
Incidence of acute kidney injury	It will be defined according to postoperative change in serum creatinine levels and its severity will be stratified according to the Kidney Disease: Improving Global Outcomes (KDIGO) criteria	From date of procedure until the date of hospital discharge, assessed up to 3 months
Incidence of surgical site infection	Proven infection involving deep sternal wound tissues and/or mediastinum.	From date of procedure until the date of hospital discharge, assessed up to 3 months
Incidence of reoperation for bleeding	Chest reopening for excessive bleeding.	From date of procedure until the date of hospital discharge, assessed up to 3 months
Incidence and amount of blood transfusion	Transfusions of red blood cells	From date of procedure until the date of hospital discharge, assessed up to 3 months
Length of stay in the intensive care unit	Duration of stay in the intensive care unit	From date of procedure until the date of hospital discharge, assessed up to 3 months
Incidence of global brain ischemia	Diffuse hypoxic damage as diagnosed at brain imaging and electroencephalography.	From date of procedure until the date of hospital discharge, assessed up to 3 months
Incidence of paraplegia/paraparesis	Bilateral weakness and/or multimodality sensory disturbance below the level of the ischemic spinal lesion.	From date of procedure until the date of hospital discharge, assessed up to 3 months

Collaborators and Investigators

• Sponsor: Helsinki University Central Hospital
• Collaborators: Assistance Publique - Hôpitaux de Paris; Universitaire Ziekenhuizen KU Leuven; Azienda Ospedaliera Universitaria Integrata Verona; University Hospital Muenster; Institute for Clinical and Experimental Medicine; Centre Hospitalier Universitaire de Besancon; University Hospitals, Leicester; University Hospital, Antwerp; AZ Sint-Jan AV; Cliniques universitaires Saint-Luc- Université Catholique de Louvain; University of Turin, Italy; University Hospital Southampton NHS Foundation Trust; Ziekenhuis Oost-Limburg; Liverpool Heart and Chest Hospital NHS Foundation Trust; University of Hamburg-Eppendorf; Heart Center Leipzig - University Hospital; University of Barcelona; University Hospital, Udine, Italy; Northern General Hospital, Herries Road, Sheffield
• Investigators: Principal Investigator: Fausto Biancari, Helsinki University Hospital, Helsinki, Finland

Publications and helpful links

General Publications

• Biancari F, Mariscalco G, Yusuff H, Tsang G, Luthra S, Onorati F, Francica A, Rossetti C, Perrotti A, Chocron S, Fiore A, Folliguet T, Pettinari M, Dell'Aquila AM, Demal T, Conradi L, Detter C, Pol M, Ivak P, Schlosser F, Forlani S, Chetty G, Harky A, Kuduvalli M, Field M, Vendramin I, Livi U, Rinaldi M, Ferrante L, Etz C, Noack T, Mastrobuoni S, De Kerchove L, Jormalainen M, Laga S, Meuris B, Schepens M, El Dean Z, Vento A, Raivio P, Borger M, Juvonen T. European registry of type A aortic dissection (ERTAAD) - rationale, design and definition criteria. J Cardiothorac Surg. 2021 Jun 10;16(1):171. doi: 10.1186/s13019-021-01536-5. Erratum In: J Cardiothorac Surg. 2021 Aug 9;16(1):225. doi: 10.1186/s13019-021-01606-8.

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2023
• Primary Completion (Actual): December 6, 2024
• Study Completion (Actual): December 6, 2024

Study Registration Dates

• First Submitted: March 29, 2021
• First Submitted That Met QC Criteria: April 2, 2021
• First Posted (Actual): April 5, 2021

Study Record Updates

• Last Update Posted (Estimated): December 11, 2024
• Last Update Submitted That Met QC Criteria: December 6, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Aortic dissection
• Additional Relevant MeSH Terms: Dissection, Blood Vessel; Acute Aortic Syndrome; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases; Aneurysm; Aortic Dissection
• Other Study ID Numbers: 100968

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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