The European Registry for Patients with Mechanical Circulatory Support (EUROMACS) of the European Association for Cardio-Thoracic Surgery (EACTS): second report
Theo M M H de By, Paul Mohacsi, Brigitta Gahl, Armin Zittermann, Thomas Krabatsch, Finn Gustafsson, Pascal Leprince, Bart Meyns, Ivan Netuka, Kadir Caliskan, Evaristo Castedo, Francesco Musumeci, André Vincentelli, Roland Hetzer, Jan Gummert, EUROMACS members, Theo M M H de By, Paul Mohacsi, Brigitta Gahl, Armin Zittermann, Thomas Krabatsch, Finn Gustafsson, Pascal Leprince, Bart Meyns, Ivan Netuka, Kadir Caliskan, Evaristo Castedo, Francesco Musumeci, André Vincentelli, Roland Hetzer, Jan Gummert, EUROMACS members
Abstract
Objectives: The European Registry for Patients with Mechanical Circulatory Support (EUROMACS) was founded in Berlin, Germany. EUROMACS is supported fully by the European Association for Cardio-Thoracic Surgery (EACTS) and, since 2014, has functioned as a committee of the EACTS. The purpose of having the EUROMACS as a part of the EACTS is to accumulate clinical data related to long-term mechanical circulatory support for scientific purposes and to publish annual reports.
Methods: Participating hospitals contributed surgical and cardiological pre-, peri- and long-term postoperative data of mechanical circulatory support implants to the registry. Data for all implants performed from 1 January 2011 to 31 December 2016 were analysed. Several auditing methods were used to monitor the quality of the data. Data could be provided for in-depth studies, and custom data could be provided at the request of clinicians and scientists. This report includes updates of patient characteristics, implant frequency, mortality rates and adverse events.
Results: Fifty-two hospitals participated in the registry. This report is based on 2947 registered implants in 2681 patients. Survival of adult patients (>17 years of age) with continuous-flow left ventricular assist devices with a mean follow-up of 391 days was 69% (95% confidence interval 66-71%) 1 year after implantation. On average, patients were observed for 12 months (median 7 months, range 0-70 months). When we investigated for adverse events, we found an overall event rate per 100 patient-months of 3.56 for device malfunction, 6.45 for major bleeding, 6.18 for major infection and 3.03 for neurological events within the first 3 months after implantation.
Conclusions: Compared to the first EUROMACS report, the number of participating hospitals increased from 21 to 52 (+148%), whereas the number of registered implants more than tripled from 825 to 2947 (+257%). The increase in the number of participating hospitals led us to increase the quality control measures through data input control, on-site audits and statistical analyses.
Keywords: End-stage heart failure; Mechanical circulatory support; Registry; Ventricular assist device.
© The Author 2017. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.
Source: PubMed