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

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningfagfællebedømt

  • Theo M M H de By
  • Paul Mohacsi
  • Brigitta Gahl
  • Armin Zittermann
  • Thomas Krabatsch
  • Gustafsson, Finn
  • Pascal Leprince
  • Bart Meyns
  • Ivan Netuka
  • Kadir Caliskan
  • Evaristo Castedo
  • Francesco Musumeci
  • André Vincentelli
  • Roland Hetzer
  • Jan Gummert
  • EUROMACS members

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.

OriginalsprogEngelsk
TidsskriftEuropean Journal of Cardio-Thoracic Surgery
Vol/bind53
Udgave nummer2
Sider (fra-til)309–316
ISSN1010-7940
DOI
StatusUdgivet - 1 feb. 2018

ID: 194976307