EUROMACS Registry to collect mechanical circulatory support data
Dendrite Clinical Systems is pleased to announced that EUROMACS has launched the EUROMACS Registry, a web-based registry that will collect procedural and outcomes data for patients receiving mechanical circulatory support (MCS).
The EUROMACS association was founded in December 2009, on the initiative of the two European hospitals with the largest clinical programmes in the field of mechanical circulatory support (Deutsches Herzzentrum Berlin and the Herz- und Diabeteszentrum NRW Bad Oeynhausen). Since then the Association has grown from the original 14 founding members to to 52 members (as of May 2011) from countries. The Association was established to create a European registry for data collection from patients with MCS systems.
Professor Jan Gummert (Herz- und Diabeteszentrum NRW Bad Oeynhausen), explained that although there is a MCS database in the US called INTERMACS (a national registry for patients who are receiving MSC device therapy to treat advanced heart failure), this registry only collects data on FDA-approved devices and therefore many devices used in Europe are not eligible for inclusion in the INTERMACS database. He added that there are also issues regarding patient consent and data ownership to establish a truly 'international" database.
As a result, Professor Roland Hetzer and I felt it was necessary to form a European Registry on the basis that most of the leading centres in Europe agree to share their data. Our goal is to get the data from each centre directly, as it is very difficult to collect the data on a national (by country) basis, said Gummert.
The aim is to get a picture of how MCS is performed in Europe. The data collected by the registry will inform physicians how many procedures are being performed and what the outcomes are. Currently, there is no information about MCS systems in Europe, although there is some single centre experience, there is no database recording multi-centre information on MCS systems.
We know for sure that there are approximately 800 MSC procedures in Germany per annum, but we do not know the figure for the whole of Europe. In addition, the registry will be collect data on devices so we can see the number of individual devices used, the outcomes and complication rates, he added. In Europe, there are probably ten or more devices with the CE Mark, compared to only a handful that are FDA-approved in the US. So hopefully, we will be able to collect a lot of data on many devices.
To record your data onto the registry, centres must become a member of EUROMACS and enter into a contract with the Association. This is to ensure that each party knows their responsibilities and obligations, and centres are obliged to enter complete patient data, which will allow EUROMACS to produce a comprehensive report in the next few years. The aim is to have an annual outcomes report, once the registry has collected a sufficient number of records and has complete datasets. The reports will be made freely available to all members who contribute data.
At the moment we have received very encouraging responses from European countries and we would like to expand the registry beyond Europe. Already, we have had enquiries from Turkey and Israel. So we would welcome registrants from beyond Europe.
All EUROMACS members will be provided a unique password to access and enter information into this very intuitive web-based database. The database is designed to allow each member immediate access to data that they have entered, and to obtain specific reports in real time (e.g. demographics and outcomes) for their own records and practices. Each member will be able to download their data and obtain reminders for pending follow-ups of their patients.
The Registry can be accessed using a standards web browser, allowing registrants to enter data without the need to install additional software or perform any complex system configurations. This web-based system allows the individual clinician to enter patient information onto a database whether at in hospital from an office-based practice or even at home.
As an organisation, EUROMACS is proud to have accomplished so much in very little time. We believe that the EUROMACS Registry will be a very important database for MCS, as we hope it will facilitate improved decision-making for physicians and healthcare providers by providing much needed clinical data. It is important that we establish the EUROMAC registry to determine current practice and to guide future practice.
The EuroMACS Registry is funded with the generous support of educational research grants from several companies from industry.
If you or a colleague/s are interested in registering registry your interest please visit: euromacs.org, email: firstname.lastname@example.org or phone +49(0)30-45 93 2000/2001