The European Registry for Patients with Mechanical Circulatory Support (EUROMACS) of the European Association for Cardio-Thoracic Surgery (EACTS): second report

TY - JOUR

T1 - The European Registry for Patients with Mechanical Circulatory Support (EUROMACS) of the European Association for Cardio-Thoracic Surgery (EACTS)

T2 - second report

AU - de By, Theo M M H

AU - Mohacsi, Paul

AU - Gahl, Brigitta

AU - Zittermann, Armin

AU - Krabatsch, Thomas

AU - Gustafsson, Finn

AU - Leprince, Pascal

AU - Meyns, Bart

AU - Netuka, Ivan

AU - Caliskan, Kadir

AU - Castedo, Evaristo

AU - Musumeci, Francesco

AU - Vincentelli, André

AU - Hetzer, Roland

AU - Gummert, Jan

AU - EUROMACS members

N1 - © The Author 2017. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.

PY - 2018/2/1

Y1 - 2018/2/1

N2 - 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.

AB - 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.

U2 - 10.1093/ejcts/ezx320

DO - 10.1093/ejcts/ezx320

M3 - Journal article

C2 - 29029117

SN - 1010-7940

VL - 53

SP - 309

EP - 316

JO - European Journal of Cardio-thoracic Surgery

JF - European Journal of Cardio-thoracic Surgery

IS - 2

ER -