This is the first large-scale, retrospective healthcare claims database study to report real-world patterns of HF treatment in Germany in 2009–2013, with a focus on the patient pathway and the use of treatment regimens linked to European and German guidelines in the 2 years after diagnosis of HF in 2011.
Pathway of patients with newly diagnosed HF
The findings of our study demonstrate the pivotal role played by family practitioners as the primary point of contact in the initial diagnosis of HF and its treatment. Almost two-third of initial HF diagnoses were made in the ambulatory setting, and of these, almost two-third were made by a family practitioner. In addition, unlike hospital visits, almost all patients visited an office-based physician at least once every quarter in the two years after the first diagnosis of HF. The responsibility for treatment-related activities and procedures also appears to lie primarily with family practitioners in the ambulatory setting, with cardiologists and other internal medicine specialists involved to a lesser degree. The element of care in which family practitioners appeared to be less involved was HF-related technical diagnostics, for which internal medicine specialists (including cardiologists) in both the ambulatory and the hospital settings took responsibility. Hence, our findings confirm two important notions: (1) physicians from various specialities and healthcare sectors are involved in the treatment of patients with HF, underlining the need for structured rules of communication and interaction between these parties; (2) the primary contact for most patients with HF is their family practitioner who acts as gatekeeper for the diagnosis and treatment of HF; such a role, however, mandates close cooperation with specialists in internal medicine required for technical diagnostics, in particular echocardiography.
Use of common guideline-recommended treatment regimens in all patients with HF
Overall, in 2011, the treatment of patients with HF and an assigned NYHA class complied with the strict treatment pattern in 45.1% of individuals. Adherence to this regimen decreased with older age and severity of disease: approximately one-fifth of all patients with HF assigned NYHA classes III–IV, and one-quarter of patients aged ≥90 years, were treated according to this common guideline-recommended pattern. As expected, the application of the less strict version of the treatment regimen was greater than that of the strict regimen across HF of NYHA classes III–IV. These findings were expected because the less strict pattern does not mandate the use of an MRA in patients with HF of NYHA class III–IV who have contraindications to the drug class. Therefore, the results for the less strict pattern are likely to overestimate the proportion of patients receiving common guideline-recommended treatment regimens, whereas those for the strict pattern are likely to underestimate the proportion.
Of all the patients who died, just one-quarter were found to have received treatment according to the strict pattern; mortality was lower among individuals treated according to this pattern than among those who were not. Similar findings regarding physician’s adherence to guideline-recommended treatment were reported in an international study of 6669 outpatients with HFreF, where poor adherence was associated with significantly higher overall mortality and heart failure mortality [
22]. However, in our study, the proportion of elderly patients (aged >80 years) was greater in the subgroup of patients who were not receiving treatment according to the strict pattern, which may confound the interpretation of higher mortality in this group.
The observation that the number of patients receiving treatment regimens consistent with guidelines declines with age has been documented previously [
17], and can perhaps be explained by the fact that older patients often have several comorbidities, and therefore, are likely to be receiving additional medication. Elderly patients frequently have impaired renal function and may, therefore, be less tolerant of aggressive treatment regimens and more susceptible to drug–drug interactions or drug-related adverse events. Therefore, physicians may prioritize the overall health of their patient over rigorous compliance with guidelines; in particular, physicians may be less willing to prescribe MRAs in patients with reduced renal function than in those with normal renal function [
2,
17,
23]. Moreover, the risk of falls in elderly patients is a particular concern, and this is increased in individuals with low blood pressure; therefore, physicians may also be less willing to prescribe blood pressure-reducing medications extensively, such as those used for the treatment of HF. The decline in guideline-consistent therapy with increased severity of HF may be explained by the increased complexity of the recommended pharmacological regimen. Furthermore, patients with more severe disease are more likely to be elderly, and therefore, are more likely to have the aforementioned comorbidities and complexities.
It should be emphasized that the treatment regimens analysed here are recommended only for HFrEF. It was assumed that approximately half of the patients in this analysis would have this type of HF [
15]; the other half would have HFpEF. The guidelines focus on the treatment of underlying diseases in patients with HFpEF; hence, 100% usage of these treatment regimens was not expected. As treatment for individuals with HFpEF is typically less aggressive than treatment for patients with HFrEF [
24], the proportions treated according to common guideline-based treatment patterns would be expected to be higher in a patient group including only individuals with HFrEF; values are, therefore, likely to underestimate the use of these patterns among patients with HFrEF. Indeed, the results of other recent studies of adherence to ESC guidelines for management of HF in Germany suggest that adherence is high [
2,
17,
18], with rates of more than 80% in some cases [
2]. However, these studies analysed treatment patterns in patients with HFrEF only, rather than a mixed group of patients, so adherence rates would be expected to be higher than those in the current study. These studies were also relatively small, and examined a small range of settings, so the proportion of patients treated by specialists would have differed from that found in the current study. It should also be noted that rigorous adherence to treatment guidelines is not always appropriate. Treatment steps are dependent on whether the patient’s condition is stable under current therapy. In the present study, this was not easily discernible from the data available, with change in NYHA class used as an approximate measure. Detailed information on comorbidities and other factors that may be contraindications for medication was also unavailable. When such factors are considered, the use of guideline-consistent treatment increases further [
21].
Clinical implications
How can HF be optimally managed in the German healthcare system? What is the best way to address the intersectoral information and care gaps? Multidisciplinary care programmes and nurse-facilitated care are among the strongest recommendations in all HF guidelines since 2008 (class IA indication). There is evidence from randomized controlled trials that involvement of dedicated staff improves mortality risk, long-term morbidity, quality of life, and left ventricular remodelling [
25]. There is further evidence that a sizeable part of this effect is due to up-titration in the multi-faceted treatment plans of this complex patient population [
26]. However, in the German healthcare system, such an approach is not reimbursed, and therefore, does not form part of general practice. The currently planned HF Disease Management Programme should incorporate these well-founded recommendations to become effective on a larger scale.
Strengths and limitations
Strengths of this study include the large sample size used—at least an order of magnitude larger than that in recent similar studies in Germany [
2,
17,
18]—and the fact that data were taken from a well-validated database [
19]. In addition, in contrast to many other observational studies, the patients in our study are likely to be highly representative of the German population. This is because other non-interventional or registry studies often analyse data obtained from a limited number of sites, which are often in the tertiary care setting. Our study analysed data from a range of healthcare settings, including hospitals and outpatient care centres, as well as from the ambulatory setting.
This study is subject to limitations typical of observational studies, relating to the quality and representativeness of the underlying data. The HRI database captures only individuals with SHI and not those with private health insurance. There is also a reliance on the accuracy of diagnoses and coding. Documentation of NYHA functional class was available in only a subset of the population, and the nature of the data set does not allow statements to be made about the generalizability of our findings to patients in whom NYHA class was not documented.