title: Mid-term mechanical circulatory support: comparison of single-centre data with the EUROMACS registry.
abstract: OBJECTIVE
  Mechanical circulatory support (MCS) is an established therapy for end-stage heart failure. The EUROMACS registry was created to promote research in patients with MCS and became a committee of the European Association for Cardio-Thoracic Surgery (EACTS) in 2014. Since 1 January 2011, increasing numbers of European centres implanting durable MCS have reported their patient data to EUROMACS. The aim of this study is to compare, as an example of internal quality control, data from a single centre (Bern) with those from the EUROMACS database with respect to mortality rates and preoperative patient characteristics and to describe complications in Bern.
  
  
  METHODS
  Patients implanted with MCS between 1 January 2011 and 30 June 2014 in participating centres were included, with extended follow-up as of 31 December 2014. Patient characteristics, operative and postoperative data, clinically significant adverse events and routine follow-up data were reported to the registry. The entire EUROMACS cohort (including the Bern data) was compared with patients from Bern only. Baseline characteristics, operative data and outcomes were compared using standard 95% confidence intervals (CIs) for means, Wilson's continuity corrected CIs for categories and Kaplan-Meier estimates with CIs.
  
  
  RESULTS
  Kaplan-Meier estimates show a higher survival rate in the Bern cohort than in the entire EUROMACS cohort at 6 (92%, CI 73-98, vs 66%, CI 62-69), 12 (85%, CI 57-95, vs 56%, CI 52-60) and 18 months (85%, CI 57-95, vs 51%, CI 47-55) after the index operation, respectively. This difference might be caused by the earlier implantation time in Bern (implantation at INTERMACS levels 3-4) versus that of the entire EUROMACS cohort (implantation at INTERMACS levels 2-3). The median number of follow-up records per patient was 2 in the entire EUROMACS cohort and 4 in the Bern (P = 0.001) cohort. During follow-up, neurological dysfunction occurred in 42% of patients, a bleeding event occurred in 42% of patients, significant infection occurred in 36% of patients and a device malfunction occurred in 31% of patients within 12 months of implantation in the Bern patients.
  
  
  CONCLUSIONS
  MCS is a valuable therapeutic option with excellent survival rates; nevertheless, it is associated with clinically significant complication rates. International registries are important tools that allow, as an example, internal quality control of mortality, complication and morbidity rates from a single centre compared with the EUROMACS database.
authors: Department of Cardiology, University Hospital Bern, Bern, Switzerland.
authors: Katarzyna
authors: K
authors: Zuk
authors: Department of Cardiology and Cardiovascular Surgery, University Hospital Bern, Bern, Switzerland.
authors: Brigitta
authors: B
authors: Gahl
authors: Department of Cardiology, University Hospital Bern, Bern, Switzerland.
authors: Martina
authors: M
authors: Susac
authors: Department of Cardiology, University Hospital Bern, Bern, Switzerland.
authors: Juliane
authors: J
authors: Vierecke
authors: EUROMACS e.V. c/o, Deutsches Herzzentrum Berlin, Berlin, Germany.
authors: Theo M M H
authors: TM
authors: de By
authors: Department of Cardiology, University Hospital Bern, Bern, Switzerland.
authors: Stephan
authors: S
authors: Windecker
authors: Department of Cardiology and Cardiovascular Surgery, University Hospital Bern, Bern, Switzerland.
authors: Lars
authors: L
authors: Englberger
authors: Department of Cardiology and Cardiovascular Surgery, University Hospital Bern, Bern, Switzerland.
authors: Thierry
authors: T
authors: Carrel
authors: EUROMACS e.V. c/o, Deutsches Herzzentrum Berlin, Berlin, Germany.
authors: Roland
authors: R
authors: Hetzer
authors: Department of Thorax and Cardiovascular Surgery, Heart and Diabetes Centre NRW, Bad Oeynhausen, Germany.
authors: Jan
authors: J
authors: Gummert
authors: Department of Cardiology, University Hospital Bern, Bern, Switzerland paul.mohacsi@insel.ch.
authors: Paul
authors: P
authors: Mohacsi
mesh_terms: D005260:Female; D005500:Follow-Up Studies; D006333:Heart Failure / Q000453:epidemiology / Q000601:surgery*; D006353:Heart-Assist Devices; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D009017:Morbidity / Q000639:trends; D012042:Registries; D012189:Retrospective Studies; D015996:Survival Rate / Q000639:trends; D013557:Switzerland / Q000453:epidemiology; D013997:Time Factors
keywords: EUROMACS; Mechanical circulatory support; Ventricular assist device