German Registry for Cardiac Operations and Interventions in Patients with Congenital Heart Disease: Report 2020—Comprehensive Data from 6 Years of ExperienceFunding The responsible bodies for the registry are the German Society for Thoracic and Cardiovascular Surgery and the German Society for Pediatric Cardiology and Congenital Heart Defects. The registry receives financial support by all participating institutions and donations from the German Heart Foundation (DHS).
Background Based on a quality assurance initiative of the German Society for Thoracic and Cardiovascular Surgery (DGTHG) and the German Society for Pediatric Cardiology and Congenital Heart Defects (DGPK), a voluntary registry was founded for assessment of treatment and outcomes of patients with congenital heart disease in Germany. This evaluation by the German Registry for cardiac operations and interventions in patients with congenital heart disease reports the data and the outcome over a 6-year period in patients undergoing invasive treatment.
Methods This real-world database collects clinical characteristics, in-hospital complications, and medium-term outcome of patients who underwent cardiac surgical and interventional procedures within the prospective, all-comers registry. Patients were followed-up for up to 90 days.
Results In the period from 2013 to 2018, a total of 35,730 patients, 39,875 cases, respectively 46,700 procedures were included at up to 31 German institutions. The cases could be subcategorized according to the treatment intention into 21,027 (52.7%) isolated operations, 17,259 (43.3%) isolated interventions, and 1,589 (4.0%) with multiple procedures. Of these, 4,708 (11.8%) were performed in neonates, 10,047 (25.2%) in infants, 19,351 (48.5%) in children of 1 to 18 years, and 5,769 (14.5%) in adults. Also, 15,845 (33.9%) cases could be allocated to so-called index procedures which underwent a more detailed evaluation to enable meaningful comparability. The mean unadjusted in-hospital mortality of all cases in our registry ranged from 0.3% in patients with isolated interventions and 2.0% in patients with surgical procedures up to 9.1% in patients undergoing multiple procedures.
Conclusion This annually updated registry of both scientific societies represents voluntary public reporting by accumulating actual information for surgical and interventional procedures in patients with congenital heart disease (CHD) in Germany. It describes advancements in cardiac medicine and is a basis for internal and external quality assurance for all participating institutions. In addition, the registry demonstrates that in Germany, both interventional and surgical procedures for treatment of CHD are offered with high medical quality.
Keywordscongenital heart disease - outcomes - multicenter registry - pediatric cardiology - congenital heart surgery
Received: 10 December 2020
Accepted: 11 December 2020
26 February 2021 (online)
© 2021. The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/)
Georg Thieme Verlag KG
Rüdigerstraße 14, 70469 Stuttgart, Germany
- 1 Vener DF, Gaies M, Jacobs JP, Pasquali SK. Clinical databases and registries in congenital and pediatric cardiac surgery, cardiology, critical care, and anesthesiology worldwide. World J Pediatr Congenit Heart Surg 2017; 8 (01) 77-87
- 2 Faldum A, Pommerening K. An optimal code for patient identifiers. Comput Methods Programs Biomed 2005; 79 (01) 81-88
- 3 Franklin RCG, Béland MJ, Colan SD. et al. Nomenclature for congenital and paediatric cardiac disease: the International Paediatric and Congenital Cardiac Code (IPCCC) and the Eleventh Iteration of the International Classification of Diseases (ICD-11). Cardiol Young 2017; 27 (10) 1872-1938
- 4 O'Brien SM, Clarke DR, Jacobs JP. et al. An empirically based tool for analyzing mortality associated with congenital heart surgery. J Thorac Cardiovasc Surg 2009; 138 (05) 1139-1153
- 5 Jacobs JP, O'Brien SM, Pasquali SK. et al. Variation in outcomes for risk-stratified pediatric cardiac surgical operations: an analysis of the STS congenital heart surgery database. Ann Thorac Surg 2012; 94 (02) 564-571 , discussion 571–572
- 6 Bergersen L, Gauvreau K, Marshall A. et al. Procedure-type risk categories for pediatric and congenital cardiac catheterization. Circ Cardiovasc Interv 2011; 4 (02) 188-194
- 7 Jacobs ML, O'Brien SM, Jacobs JP. et al. An empirically based tool for analyzing morbidity associated with operations for congenital heart disease. J Thorac Cardiovasc Surg 2013; 145 (04) 1046-1057.e1
- 8 Hoffmann W, Latza U, Baumeister SE. et al. Guidelines and recommendations for ensuring good epidemiological practice (GEP): a guideline developed by the German Society for Epidemiology. Eur J Epidemiol 2019; 34 (03) 301-317
- 9 Guideline for good clinical practice. https://www.ema.europa.eu/en/ich-e6-r2-good-clinical-practice
- 10 World Medical Association. WMA Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects. Accessed January 11, 2021 at: https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/
- 11 Kaemmerer H, Bauer U, de Haan F. et al. Recommendations for improving the quality of the interdisciplinary medical care of grown-ups with congenital heart disease (GUCH). Int J Cardiol 2011; 150 (01) 59-64