European Registry of Type A Aortic Dissection

Helsinki University Central Hospital3,902 enrolled

Overview

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.

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

3,902

Conditions

Type A Aortic Dissection

Interventions

Surgery on the ascending aorta with or without repair of the aortic root and/or aortic archPROCEDURE

Surgical repair of the ascending aorta with or without surgical repair of the aortic root and/or aortic arch

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (20)

AZ St-Jan

Bruges, Belgium

Saint-Luc's Hospital

Brussels, Belgium

Outcomes

Primary Outcomes

Mortality rate

All-cause mortality

Time frame: 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

Time frame: During the index hospital stay until last follow-up control

Secondary Outcomes

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.

Time frame: 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

Time frame: 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.

Time frame: 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.

Time frame: From date of procedure until the date of hospital discharge, assessed up to 3 months

Data from ClinicalTrials.gov

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