Comprehensive Long-term Follow up of Adults With Arterial Switch Operation

Condition(s) studied

Investigational drug(s) / intervention(s)

No intervention is planed: No intervention is planed

Study summary

Background: Long-term outcomes in adults with prior arterial switch operation (ASO) have not yet been well defined. The aim of this study is to elucidate incidence and predictors of adverse cardiac outcomes in a prospectively followed cohort of adults after their ASO.

Methods: The comprehensive long-term follow up of adults with ASO is a project within the European collaboration for prospective outcome research in congenital heart disease (EPOCH). It is designed as a prospective, international multicenter cohort study. Consecutive patients (aged 16 years or more) with prior ASO will be included at 11 European tertiary care centers. Participants will be followed according to a standardized protocol following international recommendations, including standardized protocols for imaging and for exercise testing. Main outcome measures are all-cause and cardiac-related mortality, rate of cardiac re-intervention, neo-aortic dissection, myocardial infarction, stroke, infective endocarditis, sustained atrial and ventricular arrhythmias, new-onset or worsening pulmonary hypertension and new-onset heart failure. Secondary endpoints are frequency and progression of right ventricular outflow tract stenosis, neo-aortic root dilatation, neo-aortic valve regurgitation and ventricular dysfunction. The impact of demographic, anatomic (e.g. coronary artery anatomy) and functional variables on the above-mentioned outcomes, as well as quality of life and incidence of pregnancy related complications will also be assessed.

Aim: The prospective, international, multicenter EPOCH-ASO study will provide a better understanding of adverse outcomes and their predictors in adults after ASO. The results of the EPOCH-ASO study may help to optimize future care of this novel patient cohort in adult cardiology.

Eligibility

Primary outcome measure(s)

• Incidence of all-cause mortality — during a follow up of up to 20 years
  Determination of cause of death
• Incidence of cardiac-related mortality — during a follow up of up to 20 years
  Sudden cardiac death (death that ensues unexpected within one hour of onset of symptoms), death related to acute myocardial infarction, death that is primarily caused by heart failure or death within 30 days or during the hospital admission after a cardiac intervention.
• Incidence/rate of re-intervention — during a follow up of up to 20 years
  Includes all types of cardiac re-intervention with detailed analysis of the indication of re-intervention.
• Incidence/rate of neo-aortic dissection — during a follow up of up to 20 years
  Aortic dissection with entry within the neo-aortic root.
• Incidence of myocardial infarction — during a follow up of up to 20 years
  Defined according to the Fourth Universal Definition of Myocardial Infarction. Defined according to the Fourth Universal Definition of Myocardial Infarction.
• Incidence of arrhythmias — during a follow up of up to 20 years
  Atrial arrhythmias with a duration of \>30 seconds, or requiring anti-arrhythmic medication or ablation procedures and / or sustained ventricular tachycardia (heart rate \>100/min) for at least 30 seconds or requiring electrical cardioversion / defibrillation.
• Incidence of new onset / worsening heart failure — during a follow up of up to 20 years
  Hospital admission for heart failure or initiation of heart failure medication for symptoms of heart failure (excludes initiation of medication for asymptomatic deterioration of ventricular function), according to the current guidelines of the European Society of Cardiology.
• Incidence of stroke — during a follow up of up to 20 years
  Focal neurological symptoms and confirmation of cerebral ischemia or infarction by cerebral magnetic resonance imaging or computed tomography.
• Incidence of infective endocarditis — during a follow up of up to 20 years
  Defined according to the modified Duke's criteria, according to the current ESC guidelines.
• Incidence of pulmonary hypertension — during a follow up of up to 20 years
  Defined as an increase in mean pulmonary arterial pressure (PAPm) ≥20 mmHg at rest as assessed by right heart catheterization.

Trial sites (11)