Comprehensive Long-term Follow up of Adults With Arterial Switch Operation (EPOCH-ASO)

Comprehensive Long-term Follow up of Adults With Arterial Switch Operation - European Collaboration for Prospective Outcome Research in Congenital Heart Disease

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Transposition of Great Vessels
• Intervention / Treatment: Other: No intervention is planed

• Study Type: Observational
• Enrollment (Actual): 540

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria
    • University Hospital Vienna
• France
  • Paris, France
    • CHU Paris IdF Ouest - HEGP Hôpital Européen Georges Pompidou
• Netherlands
  • Amsterdam, Netherlands
    • Amsterdam University Medical Center
• Spain
  • Barcelona, Spain
    • Hospital Universitari Vall d'Hebron
  • Sevilla, Spain
    • Hospital Universitario Virgen Del Rocio
  • Valencia, Spain
    • Hospital Universitario y Politécnico La Fe Valencia
• Switzerland
  • Basel, Switzerland
    • University Hospital Basel
  • Bern, Switzerland
    • University Hospital Inselspital Bern
  • Geneva, Switzerland
    • University Hospital Geneva
  • Lausanne, Switzerland
    • University Hospital Lausanne
  • Zurich, Switzerland
    • University Hospital Zurich

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adults (≥16 years) with transposition of great arteries or a Taussig-Bing anomaly who underwent repair by an ASO, and who are actively followed at one of the participating centers will be enrolled. Exclusion criteria are incapability of giving informed consent and previous heart transplant.

Description

Inclusion Criteria:

• Adults (≥16 years)
• with transposition of great arteries or a Taussig-Bing anomaly
• who underwent repair by an ASO, and who are actively followed at one of the participating centers will be enrolled.

Exclusion Criteria:

• Incapability of giving informed consent and previous heart transplant.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Arterial Switch Operation - Transposition of Great Arteries; Patients with previous arterial switch operation for the treatment of a transposition of great arteries will constitute the sole group of the cohort.	Other: No intervention is planed; No intervention is planed

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of all-cause mortality	Determination of cause of death	during a follow up of up to 20 years
Incidence of cardiac-related mortality	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.	during a follow up of up to 20 years
Incidence/rate of re-intervention	Includes all types of cardiac re-intervention with detailed analysis of the indication of re-intervention.	during a follow up of up to 20 years
Incidence/rate of neo-aortic dissection	Aortic dissection with entry within the neo-aortic root.	during a follow up of up to 20 years
Incidence of myocardial infarction	Defined according to the Fourth Universal Definition of Myocardial Infarction. Defined according to the Fourth Universal Definition of Myocardial Infarction.	during a follow up of up to 20 years
Incidence of arrhythmias	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.	during a follow up of up to 20 years
Incidence of new onset / worsening heart failure	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.	during a follow up of up to 20 years
Incidence of stroke	Focal neurological symptoms and confirmation of cerebral ischemia or infarction by cerebral magnetic resonance imaging or computed tomography.	during a follow up of up to 20 years
Incidence of infective endocarditis	Defined according to the modified Duke's criteria, according to the current ESC guidelines.	during a follow up of up to 20 years
Incidence of pulmonary hypertension	Defined as an increase in mean pulmonary arterial pressure (PAPm) ≥20 mmHg at rest as assessed by right heart catheterization.	during a follow up of up to 20 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of right ventricular outflow tract stenosis	At least 1 of the following criteria: Branch pulmonary artery minimal diameter: maximal diameter at least 1:2 on CT or MRI; Echocardiographic systolic peak gradient across branch pulmonary arteries > 16mmHg (peak velocity > 2.0m/s); Estimated right ventricular systolic pressure > 40mmHg (determined by RV/RA-pressure gradient and estimated central venous pressure, see echocardiography protocol for details)	during a follow up of up to 20 years
Rate of the different patterns of the coronary anatomy	To study the impact of coronary artery anatomy and type of coronary reimplantation on cardiovascular morbidity, ventricular function and functional capacity with a specific focus on presence of coronary artery obstruction, acute proximal angulation and inter-arterial or intramural course.	during a follow up of up to 20 years
Incidence/rate of neo-aortic root dilatation	Increase of neo-aortic root dilatation of at least 3mm, determined with the same imaging modality and appropriate side-by-side comparison of actual images.	during a follow up of up to 20 years
Incidence of progression of neo-aortic root dilatation	Increase of neo-aortic root dilatation of at least 3mm, determined with the same imaging modality and appropriate side-by-side comparison of actual images.	during a follow up of up to 20 years
Incidence/rate of neo-aortic regurgitation	Assessment by echocardiography: - Mild, moderate, severe (50) Assessment by CMR - Regurgitation fraction and volume by flow measurements in proximal aortic root.	during a follow up of up to 20 years
Incidence of progression of neo-aortic regurgitation	Increase > 1 grade (echocardiography) Increase of regurgitant fraction >10% on CMR.	during a follow up of up to 20 years
Incidence/rate of left ventricular systolic dysfunction	Echocardiography: - Left ventricular ejection fraction (LVEF) biplane Simpson <52% for men and <54% for women (33) CMR: - LVEF < 52%	during a follow up of up to 20 years
Incidence/rate of left ventricular diastolic dysfunction	Echocardiography: - Defined according to the current recommendations for the evaluation of left ventricular diastolic function by the America society of echocardiography and the European association of cardiovascular Imaging.	during a follow up of up to 20 years
Incidence of worsening left ventricular function	Decrease of LVEF >5%	during a follow up of up to 20 years
Incidence/rate of Right ventricular dysfunction	Echocardiography: - At least 2 of the following; FAC <30%; TAPSE <18mm; TAPSE S' <10cm/s CMR: - RVEF < 50%	during a follow up of up to 20 years
Incidence of worsening right ventricular function	Echocardiography (not valid in case of worsening tricuspid regurgitation) - At least 2 of the following: Decrease in Fac > 10%; Decrease in TAPSE >5mm; Decrease in TAPSE S' >3cm/s CMR: - Decrease in RVEF >5%	during a follow up of up to 20 years
Rate of poor functional capacity	As determined by cardiopulmonary exercise testing by measuring Lung Function (flow volume loops), oxygen consumption during exercise (VO2 max), anaerobic threshold, heart performance during exercise (O2-Heart rate)	during a follow up of up to 20 years
Incidence of pregnancy	To study the impact of pregnancy on mortality and cardiovascular morbidity.	during a follow up of up to 20 years

Collaborators and Investigators

• Sponsor: University of Zurich
• Investigators: Principal Investigator: Matthias Greutmann, MD, University of Zurich

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 1, 2019
• Primary Completion (ANTICIPATED): September 30, 2039
• Study Completion (ANTICIPATED): September 30, 2039

Study Registration Dates

• First Submitted: March 23, 2020
• First Submitted That Met QC Criteria: April 2, 2020
• First Posted (ACTUAL): April 6, 2020

Study Record Updates

• Last Update Posted (ACTUAL): November 8, 2022
• Last Update Submitted That Met QC Criteria: November 7, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: outcome; transposition of the great arteries; arterial switch operation; coronary artery anomaly
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Congenital Abnormalities; Heart Defects, Congenital; Cardiovascular Abnormalities; Transposition of Great Vessels
• Other Study ID Numbers: EPOCH

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