Theo M M H de By1, Christiaan F J Antonides2, Martin Schweiger3, Joanna Sliwka4, Ben Davies5, Felix Berger6, Michael Hübler3, Mustafa Özbaran7, Bohdan Maruszewski8, Carlos Pace Napoleone9, Daniel Zimpfer10, Eugen Sandica11, Herwig Antretter12, Bart Meyns13, Oliver Miera6. 1. EUROMACS, European Association for Cardio-Thoracic Surgery (EACTS), Windsor, UK. 2. Department of Cardiothoracic Surgery, Erasmus University Medical Center, Rotterdam, Netherlands. 3. Department of Congenital Pediatric Surgery, Children's Hospital Zürich, Zürich, Switzerland. 4. Department of Cardiac Surgery, Transplantology and Vascular Surgery, Silesian Center for Heart Diseases, Zabrze, Poland. 5. Great Ormond Street Hospital, London, UK. 6. Department of Congenital Heart Disease and Pediatric Cardiology, Deutsches Herzzentrum Berlin, Berlin, Germany. 7. Department of Cardiovascular Surgery, Ege Universitesi Tip Fakültesi, Izmir, Turkey. 8. Pediatric Cardiothoracic Surgery Department, Children's Memorial Hospital, Warsaw, Poland. 9. Pediatric Cardiac Surgery Department, Regina Margherita Children's Hospital, Torino, Italy. 10. Medical University Vienna, Vienna, Austria. 11. Clinic for Pediatric Cardiac Surgery and Congenital Heart Defects, Heart and Diabetes Centre North Rhine-Westphalia, Bad Oeynhausen, Germany. 12. Innsbruck University Clinics, Innsbruck, Austria. 13. Cardiale Heelkunde, Universitair Ziekenhuis Leuven, Leuven, Belgium.
Abstract
OBJECTIVES: A second paediatric report has been generated from the European Registry for Patients with Mechanical Circulatory Support (EUROMACS). The purpose of EUROMACS, which is operated by the European Association for Cardio-Thoracic Surgery, is to gather data related to durable mechanical circulatory support for scientific purposes and to publish reports with respect to the course of mechanical circulatory support therapy. Since the first report issued, efforts to increase compliance and participation have been extended. Additionally, the data provided the opportunity to analyse patients of younger age and lower weight. METHODS: Participating hospitals contributed pre-, peri- and long-term postoperative data on mechanical circulatory support implants to the registry. Data for all implants in paediatric patients (≤19 years of age) performed from 1 January 2000 to 1 July 2019 were analysed. This report includes updates of patient characteristics, implant frequency, outcome (including mortality rates, transplants and recovery rates) as well as adverse events including neurological dysfunction, device malfunction, major infection and bleeding. RESULTS: Twenty-nine hospitals contributed 398 registered implants in 353 patients (150 female, 203 male) to the registry. The most frequent aetiology of heart failure was any form of cardiomyopathy (61%), followed by congenital heart disease and myocarditis (16.4% and 16.1%, respectively). Competing outcomes analysis revealed that a total of 80% survived to transplant or recovery or are ongoing; at the 2-year follow-up examination, 20% died while on support. At 12 months, 46.7% received transplants, 8.7% were weaned from their device and 18.5% died. The 3-month adverse events rate was 1.69 per patient-year for device malfunction including pump exchange, 0.48 for major bleeding, 0.64 for major infection and 0.78 for neurological events. CONCLUSIONS: The overall survival rate was 81.5% at 12 months following ventricular assist device implant. The comparison of survival rates of the early and later eras shows no significant difference. A focus on specific subgroups showed that survival was less in patients of younger age (<1 year of age) (P = 0.01) and lower weight (<20 kg) (P = 0.015). Transplant rates at 6 months continue to be low (33.2%) The fact that the EUROMACS registry is embedded within the European Association for Cardio-Thoracic Surgery Quality Improvement Programme offers opportunities to focus on improving outcomes.
OBJECTIVES: A second paediatric report has been generated from the European Registry for Patients with Mechanical Circulatory Support (EUROMACS). The purpose of EUROMACS, which is operated by the European Association for Cardio-Thoracic Surgery, is to gather data related to durable mechanical circulatory support for scientific purposes and to publish reports with respect to the course of mechanical circulatory support therapy. Since the first report issued, efforts to increase compliance and participation have been extended. Additionally, the data provided the opportunity to analyse patients of younger age and lower weight. METHODS: Participating hospitals contributed pre-, peri- and long-term postoperative data on mechanical circulatory support implants to the registry. Data for all implants in paediatric patients (≤19 years of age) performed from 1 January 2000 to 1 July 2019 were analysed. This report includes updates of patient characteristics, implant frequency, outcome (including mortality rates, transplants and recovery rates) as well as adverse events including neurological dysfunction, device malfunction, major infection and bleeding. RESULTS: Twenty-nine hospitals contributed 398 registered implants in 353 patients (150 female, 203 male) to the registry. The most frequent aetiology of heart failure was any form of cardiomyopathy (61%), followed by congenital heart disease and myocarditis (16.4% and 16.1%, respectively). Competing outcomes analysis revealed that a total of 80% survived to transplant or recovery or are ongoing; at the 2-year follow-up examination, 20% died while on support. At 12 months, 46.7% received transplants, 8.7% were weaned from their device and 18.5% died. The 3-month adverse events rate was 1.69 per patient-year for device malfunction including pump exchange, 0.48 for major bleeding, 0.64 for major infection and 0.78 for neurological events. CONCLUSIONS: The overall survival rate was 81.5% at 12 months following ventricular assist device implant. The comparison of survival rates of the early and later eras shows no significant difference. A focus on specific subgroups showed that survival was less in patients of younger age (<1 year of age) (P = 0.01) and lower weight (<20 kg) (P = 0.015). Transplant rates at 6 months continue to be low (33.2%) The fact that the EUROMACS registry is embedded within the European Association for Cardio-Thoracic Surgery Quality Improvement Programme offers opportunities to focus on improving outcomes.
Authors: Matteo Ponzoni; Anna C Frigo; Biagio Castaldi; Alessia Cerutti; Giovanni Di Salvo; Vladimiro L Vida; Massimo A Padalino Journal: Artif Organs Date: 2021-09-12 Impact factor: 2.663