EUROMACS is part of the EACTS and maintains a register with the purpose of research of the outcomes of patients with a ventricular assist device (VAD) and patients with cardiac failure who have received a total artificial heart (TAH).
For those hospitals that have signed an agreement with EUROMACS, the EUROMACS Registry offers all possibilities to follow-up their patients with a mechanical circulatory support system (MCS).
Clinicians and researchers, can follow the patients on a day-to-day basis, both with a clinical purpose, as well as with the perspective of a longer-term scientific analysis. EUROMACS offers a data set for a unique human subjects research.
Patients with terminal heart failure will receive an LVAD, RVAD or TAH either as a bridge to heart transplantation or as a destination therapy. As the number of VAD patients per center is relatively low, the EUROMACS database is built to assemble comparable data on a large scale. By comparing local data of patients who underwent this type of surgery of the heart, with the similar data of all international participants, statistics based on larger numbers can be generated. Thus, the chance for significant outcomes is considerably enlarged.
With respect to the possibilities to register, the EUROMACS Committee has chosen unrestricted data entry. The participating centers and colleagues can enter both pediatric and adult patients. The number of mechanical circulatory support systems which can be entered is unlimited; the basic characteristics of all assist devices presently on the market are part of the EUROMACS standard dataset. In the future, new devices can be added.
The Registry of data and the information from hospital and clinician to the patient has been reviewed by several ethics committees, and no objections were received. Thus, a transparent and solid basis to obtain the necessary informed consent from VAD patients is available for all EUROMACS members.
The maintenance of the database has been outsourced to a professional and experienced company (Dendrite Clinical Systems in the UK). By contract such important aspects as 24 hour availability during 365 days per year have been secured. Moreover, compatibility with the data protection legislation has been safeguarded.
Finally, audits by EUROMACS will verify whether the contractual obligations with respect to strict security are fulfilled.