In Germany, contemporary data on the prevalence of patients with an implantable cardioverter-defibrillator (ICD) is lacking. Recently, ICD patients with heart failure (HFP) fulfilling pre-defined criteria by the G-BA (Federal Joined Committee) are eligible for RM reimbursement. Therefore, information on the exact number of ICD HFPs as well as the recent trend in ICD patient prevalence is of significant importance for implementation of this RM care strategy. The model described here, aims to evaluate the current prevalence of ICD HFPs meeting the main G-BA criteria RM in Germany.
Methods:
Annual national quality assurance system data from all German hospitals on newly implanted ICD devices, NYHA class, and LVEF covering years 2010-2021 was obtained to build a prevalence model. For 2022, we projected first-time ICD implantation numbers based on the previous period. For each implantation year, annual mortality rate was applied to estimate the cumulative number of ICD patients alive over 2010-2022. Subsequently, the number of ICD patients eligible for RM was calculated by applying the main G-BA inclusion criteria. To account for the ICD patient population implanted prior to 2010 (historical start cohort), data from a previous implantable electrical devices (CIED) prevalence model was integrated.
Results:
The course of the ICD prevalence over 2010-2022 is displayed in the Figure. The prevalence showed an increase with a peak prevalence of 202.637 patients in 2017. In the year 2022, the model estimated a total prevalence of 190.698 patients with an ICD. The estimated number of ICD HFPs eligible for RM resulted in 120940. According to our model, this number reflects 63 % of the total estimated ICD patient population in Germany.
Discussion:
The current investigation focussed on evaluating the prevalence of HFPs with an ICD, meeting the main inclusion criteria for RM set by the G-BA. The current model estimated a large patient population (120.941 patients) eligible for RM in 2022. To our knowledge, this is the first study that provides information on the size of this patient group in Germany, utilising comprehensive national quality assurance data. With only a fraction of eligible patients currently receiving RM, these results may facilitate the future planning, resource calculations, and scale-up of RM. The building of a specific infrastructure that is focused on efficient use of resources reflects a necessary prerequisite for successful RM implementation within this large patient population.
Figure: ICD patient prevalence over 2010-2022 in Germany and ICD heart failure patient population eligible for remote monitoring according to main G-BA criteria
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