Use of sacubitril/valsartan in patients with heart failure in primary care in Germany: the AURORA-HF noninterventional study.

BACKGROUND: Sacubitril/valsartan (Sac/Val) is the first angiotensin receptor-neprilysin inhibitor indicated for symptomatic chronic heart failure (HF) with reduced ejection fraction (HFrEF). Given most patients with HF in Germany are managed by general practitioners, AURORA-HF investigated the baseline characteristics and 1­year follow-up of patients starting Sac/Val in primary care in Germany. METHODS: This was a prospective, multicenter, observational study, with all treatment decisions independent of participation. The only inclusion criteria were adults (age ≥ 18 years) with symptomatic HFrEF. The study comprised four groups, depending on therapy on entry: initiation of (1) Sac/Val or (2) other HF therapy; and no change in HF regimen that (3) included or (4) did not include Sac/Val. Baseline data were captured for all groups; 1­year follow-up was recorded in groups 1 and 2. RESULTS: Of 1278 patients in the baseline analyses, 513 (40.1%) had newly started Sac/Val (449 [87.5%] completing the 1­year follow-up), 265 (20.7%) had newly started other HF regimens (245, 92.5%) with 1­year follow-up, while 249 with Sac/Val (19.5%) and 251 without Sac/Val (19.6%) patients had unchanged therapies. Patients treated with Sac/Val had a higher New York Heart Association (NYHA) class at baseline and more often a left ventricular ejection fraction (LVEF) < 35%. The only baseline parameter significantly correlating with Sac/Val discontinuation during the 1­year follow-up was diabetes mellitus (odds ratio: 2.44; 95% confidence interval: 1.14-5.24). In the Sac/Val group, 30.7% of patients were in NYHA class I/II on study entry, improving to 51.0% at 1­year follow-up. In the no Sac/Val group, the corresponding rates of NYHA I and II classes were 49.8% and 58.2%, respectively. The overall adverse event profile of Sac/Val was good, with only 6.0% patients experiencing serious adverse events leading to permanent discontinuation. CONCLUSION: In patients with symptomatic HFrEF treated in primary care, the group in whom Sac/Val was initiated was characterized by a higher NYHA class and lower LVEF compared to patients in whom Sac/Val was not initiated. Sac/Val was well tolerated, with a high proportion completing 1 year of therapy.

Management of heart failure with reduced ejection fraction in Europe: design of the ARIADNE registry.

AIMS: The introduction of sacubitril/valsartan (an angiotensin receptor-neprilysin inhibitor) is likely to change the approach to the management of patients with chronic heart failure with reduced ejection fraction (HFrEF). The Assessment of Real Life Care-Describing European Heart Failure Management (ARIADNE) registry will evaluate patient characteristics, practice patterns, outcomes, and healthcare resource utilization in the outpatient setting across Europe, with the main focus on factors that guide physicians' decisions to start and continue sacubitril/valsartan in patients with HFrEF. METHODS AND RESULTS: ARIADNE, a prospective, observational registry will enrol 9000 ambulatory patients with HFrEF in 23 European countries Supplement 1. The study will describe 4500 patients treated with conventional treatment (including an angiotensin-converting enzyme inhibitor/angiotensin receptor blocker), and 4500 patients started on sacubitril/valsartan. In each country, patients will be enrolled consecutively over an expected period of 12 months, and followed-up for 12 months. The primary objective is to describe the baseline clinical and demographic characteristics of patients with chronic HFrEF, which guide the decision of the treating physician to initiate sacubitril/valsartan or to continue conventional treatment. A co-primary objective is to identify the baseline characteristics that are associated with the likelihood of reaching the target dose of sacubitril/valsartan 97/103 mg twice daily during follow-up. CONCLUSIONS: The ARIADNE registry will provide a comprehensive profile of patients with chronic HFrEF in Europe, will elucidate how management varies between countries, and will help clarify the usage and outcomes associated with use of sacubitril/valsartan in real life.

Epidemiology of heart failure in Germany: a retrospective database study.

BACKGROUND: Chronic heart failure (HF) is associated with significant healthcare expenditure, morbidity, and mortality. This study investigated the epidemiology of HF in Germany. METHODS: This retrospective study used anonymous healthcare claims data from the German Health Risk Institute on individuals with statutory health insurance. Patients with uninterrupted data from 1 January 2009 to 31 December 2013 or death (whichever occurred first), and ≥2 recorded HF-related diagnoses in 2011, were included. Patients with newly diagnosed HF were identified. Patients were followed up for 2 years from first diagnosis. RESULTS: Of 3,132,337 eligible patients, 123,925 (55.0% women; mean age 76.2 years) had HF: a prevalence of 3.96%. Of these, 26,368 had newly diagnosed HF: an incidence of 655/100,000 persons at risk. Incidence increased with age and was similar regardless of sex. During follow-up, there were 48,159 hospital admissions among newly diagnosed patients (1.8 hospitalizations/patient/2 years); HF accounted for 6% of these. Additionally, 20,148 patients (16.3%) overall and 5983 newly diagnosed patients (22.7%) died. Most new cases of HF were diagnosed by office-based physicians (63.2%); new cases among hospital inpatients were predominantly diagnosed by internal medicine specialists (70.7%). Overall, 94.0% received their initial prescription for HF treatment from a family practitioner. CONCLUSIONS: The high prevalence and incidence observed in this representative sample emphasize the burden of HF in Germany. Substantial hospitalization rates and mortality highlight the need for early diagnosis and appropriate treatment, and for close cooperation between physician specialties and healthcare sectors.

Treatment of chronic heart failure in Germany: a retrospective database study.

BACKGROUND: Adherence to treatment guidelines affects outcomes in patients with chronic heart failure (HF). We investigated patient pathways and treatment patterns for HF in Germany. METHODS: This retrospective study used anonymous healthcare claims data from the German Health Risk Institute on individuals with statutory health insurance. Patients with uninterrupted data from 1 January 2009 to 31 December 2013 or death (whichever occurred first), and ≥2 recorded HF-related diagnoses in 2011, were included. Patients with newly diagnosed HF were identified. Use of treatment patterns recommended by the European Society of Cardiology (2008) and German Nationale VersorgungsLeitlinien (2011) guidelines was evaluated. RESULTS: Of 123,925 patients with HF, 21.3% were newly diagnosed. Overall, 63.2% of new HF diagnoses were made in the ambulatory setting; 61.6% of these were made by family practitioners and 14.8% by cardiologists. In the ambulatory setting, family practitioners were primarily responsible for treatment; specialists in internal medicine (70.3% cardiologists) were mainly responsible for performing HF-related technical diagnostics. One-fifth (20.9%) of patients received a New York Heart Association (NYHA) classification; 45.1% of these received a guideline-based treatment pattern. Application of the recommended treatment pattern decreased with advancing disease severity (NYHA class IV: 21.1% application) and older age (≥90 years: 28.3% application). CONCLUSIONS: Family practitioners play a key role in the diagnosis and initial treatment of HF in Germany. A substantial proportion of patients do not receive guideline-recommended pharmacotherapy. These findings should be reflected in the planning of national disease management programmes.

Assessing patient preferences in heart failure using conjoint methodology.

AIM: The course of heart failure (HF) is characterized by frequent hospitalizations, a high mortality rate, as well as a severely impaired health-related quality of life (HRQoL). To optimize disease management, understanding of patient preferences is crucial. We aimed to assess patient preferences using conjoint methodology and HRQoL in patients with HF. METHODS: Two modules were applied: an initial qualitative module, consisting of in-depth interviews with 12 HF patients, and the main quantitative module in 300 HF patients from across Germany. Patients were stratified according to the time of their last HF hospitalization. Each patient was presented with ten different scenarios during the conjoint exercise. Additionally, patients completed the generic HRQoL instrument, EuroQol health questionnaire (EQ-5D™). RESULTS: The attribute with the highest relative importance was dyspnea (44%), followed by physical capacity (18%). Of similar importance were exhaustion during mental activities (13%), fear due to HF (13%), and autonomy (12%). The most affected HRQoL dimensions according to the EQ-5D questionnaire were anxiety/depression (23% with severe problems), pain/discomfort (19%), and usual activities (15%). Overall average EQ-5D score was 0.39 with stable, chronic patients (never hospitalized) having a significantly better health state vs the rest of the cohort. CONCLUSION: This paper analyzed patient preference in HF using a conjoint methodology. The preference weights resulting from the conjoint analysis could be used in future to design HRQoL questionnaires which could better assess patient preferences in HF care.