Developing Germany Chapter
The German Chapter of the MDEpiNet (Chairman: Dr Christian-Alexander Behrendt, Hamburg, Germany) has been launched at the University Medical Center Hamburg-Eppendorf in Hamburg, Germany during the first nationwide “German Summit on Real-World Evidence in Cardiovascular Medicine” (November 1, 2019). The further development of this national chapter will be accompanied by the research group GermanVasc (https://www.germanvasc.de). The GermanVasc group is well experienced in the scientific utilization of health insurance claims and registry data and is involved in national and international collaborations in cardiovascular medicine.
Various public and private stakeholders and representatives from different medical specialties are invited to join the multidisciplinary task force further developing the MDEpiNet German Chapter.
Recent and Ongoing Projects
Currently, two large real-world-evidence projects are ongoing under the lead of Dr Behrendt, and in close collaboration with the MDEpiNet national chapter. The multimethodological and multistage IDOMENEO and RABATT studies aim to develop data privacy compliant technical solutions to collect quality improvement data from registries and health insurance claims. The GermanVasc registry trial (NCT03098290; DRKS00014649) included 5,000 patients from 35 national vascular centers revascularized for symptomatic peripheral arterial occlusive disease. The developed registry platform provides randomization and benchmarking tools and will be used for the first pilot device registry studies in Germany through the end of 2020.
Health Insurance Claims
During the last years, this national chapter completed several studies concerning quality improvement in medical device research. To determine the long-term mortality after treatment with paclitaxel coated devices (PCX), BARMER health insurance claims including 37,914 patients were used. In this first large health insurance claims analysis, rapid adoption of PCX, higher long term survival, better amputation free survival, and lower rates of major cardiovascular events were seen after their use for the treatment of CLTI. (publication: https://www.ejves.com/article/S1078-5884(19)32708-X/fulltext)
Further projects concerned the treatment below the knee and the pharmacological treatment of those patients.
Quality Improvement Project
In 2020, a German-wide quality improvement initiative was established addressing the multidisciplinary treatment of peripheral arterial occlusive disease and its unwarranted variation.