Open Access

ARTICLE

Comprehensive Long-Term Follow up of Adults with Arterial Switch Operation– European Collaboration for Prospective Outcome Research in Congenital Heart Disease (EPOCH-ASO)–Study Design and Protocols

by Francisco Javier Ruperti-Repilado^1,#,*, Magalie Ladouceur^2,#, Pastora Gallego³, Laura Dos⁴, Joaquin Rueda Soriano⁵, Berto Bouma⁶, Harald Gabriel⁷, Markus Schwerzmann¹, Judith Bouchardy^8,9, Daniel Tobler^10,#, Matthias Greutmann^11,#

1 Center for Congenital Heart Disease, Cardiology, University Hospital Inselspital, University of Bern, Bern, Switzerland
2 Université de Paris, Hôpital Européen Georges Pompidou, AP-HP, Adult Congenital Heart Disease Unit, Centre de référence des Malformations Cardiaques Congénitales Complexes, M3C. Inserm U970, Paris Centre de Recherche Cardiovasculaire, Paris, France
3 Adult Congenital Heart Disease Unit, Department of Cardiology, Hospital Universitario Virgen del Rocio, Instituto de BioMedicina de Sevilla and CIBERCV, Sevilla, Spain
4 Unitat de Cardiopaties Congènites de l’Adolescent i l’Adult Vall d’Hebron-Sant Pau, Hospital Universitari Vall d’Hebron, Barcelona, Spain
5 Adult Congenital Heart Disease Unit, Department of Cardiology, Hospital Universitari i Politècnic La Fe and CIBERCV, València, Spain
6 Department of Cardiology, Academic Medical Center, Amsterdam, The Netherlands
7 Adult Congenital Heart Disease Program, Department of Cardiology, Medical University of Vienna, Vienna, Austria
8 Department of Cardiology and Cardiac Surgery, University Hospital Lausanne, Lausanne, Switzerland
9 Division of Cardiology, University Hospital Geneva, Geneva, Switzerland
10 Division of Cardiology, University Hospital of Basel, University of Basel, Basel, Switzerland
11 University Heart Center, Department of Cardiology, University of Zurich, Zurich, Switzerland
# These authors contributed equally to the study design, data interpretation, and manuscript preparation

* Corresponding Author: Francisco Javier Ruperti-Repilado. Email:

Congenital Heart Disease 2020, 15(5), 309-338. https://doi.org/10.32604/CHD.2020.012599

Received 06 July 2020; Accepted 24 August 2020; Issue published 23 September 2020

Abstract

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 longterm 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 (age ≥ 16 years) 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. Results: 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 or heart failure. Secondary endpoints are frequency and progression of right ventricular outflow 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. Conclusion: 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.

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