Survival of patients undergoing cardiac resynchronization therapy with or without defibrillator: the RESET-CRT project.

AIMS: Cardiac resynchronization therapy (CRT) is an established treatment for heart failure. There is contradictory evidence whether defibrillator capability improves prognosis in patients receiving CRT. We compared the survival of patients undergoing de novo implantation of a CRT with defibrillator (CRT-D) option and CRT with pacemaker (CRT-P) in a large health claims database. METHODS AND RESULTS: Using health claims data of a major German statutory health insurance, we analysed patients with de novo CRT implantation from 2014 to 2019 without indication for defibrillator implantation for secondary prevention of sudden cardiac death. We performed age-adjusted Cox proportional hazard regression and entropy balancing to calculate weights to control for baseline imbalances. The analysis comprised 847 CRT-P and 2722 CRT-D patients. Overall, 714 deaths were recorded during a median follow-up of 2.35 years. A higher cumulative incidence of all-cause death was observed in the initial unadjusted Kaplan-Meier time-to-event analysis [hazard ratio (HR): 1.63, 95% confidence interval (CI): 1.38-1.92]. After adjustment for age, HR was 1.13 (95% CI: 0.95-1.35) and after entropy balancing 0.99 (95% CI: 0.81-1.20). No survival differences were found in different age groups. The results were robust in sensitivity analyses. CONCLUSION: In a large health claims database of CRT implantations performed in a contemporary setting, CRT-P treatment was not associated with inferior survival compared with CRT-D. Age differences accounted for the greatest part of the survival difference that was observed in the initial unadjusted analysis.

A long-term cost-effectiveness analysis of cardiac resynchronisation therapy with or without defibrillator based on health claims data.

BACKGROUND: In Germany, CRT devices with defibrillator capability (CRT-D) have become the predominant treatment strategy for patients with heart failure and cardiac dyssynchrony. However, according to current guidelines, most patients would also be eligible for the less expensive CRT pacemaker (CRT-P). We conducted a cost-effectiveness analysis for CRT-P devices compared to CRT-D devices from a German payer's perspective. METHODS: Longitudinal health claims data from 3569 patients with de novo CRT implantation from 2014 to 2019 were used to parametrise a cohort Markov model. Model outcomes were costs and effectiveness measured in terms of life years. Transition probabilities were derived from multivariable parametric survival regression that controlled for baseline differences of CRT-D and CRT-P patients. Deterministic and probabilistic sensitivity analyses were conducted. RESULTS: The Markov model predicted a median survival of 84 months for CRT-P patients and 92 months for CRT-D patients. In the base case, CRT-P devices incurred incremental costs of € - 13,093 per patient and 0.30 incremental life years were lost. The ICER was € 43,965 saved per life year lost. In the probabilistic sensitivity analysis, uncertainty regarding the effectiveness was observed but not regarding costs. CONCLUSION: This modelling study illustrates the uncertainty of the higher effectiveness of CRT-D devices compared to CRT-P devices. Given the difference in incremental costs between CRT-P and CRT-D treatment, there would be significant potential cost savings to the healthcare system if CRT-D devices were restricted to patients likely to benefit from the additional defibrillator.

Lead-Time Corrected Effect on Breast Cancer Survival in Germany by Mode of Detection.

(1) Background: Screen-detected breast cancer patients tend to have better survival than patients diagnosed with symptomatic cancer. The main driver of improved survival in screen-detected cancer is detection at earlier stage. An important bias is introduced by lead time, i.e., the time span by which the diagnosis has been advanced by screening. We examine whether there is a remaining survival difference that could be attributable to mode of detection, for example, because of higher quality of care. (2) Methods: Women with a breast cancer (BC) diagnosis in 2000-2022 were included from a population-based cancer registry from Schleswig-Holstein, Germany, which also registers the mode of cancer detection. Mammography screening was available from 2005 onwards. We compared the survival for BC detected by screening with symptomatic BC detection using Kaplan-Meier, unadjusted Cox regressions, and Cox regressions adjusted for age, grading, and UICC stage. Correction for lead time bias was carried out by assuming an exponential distribution of the period during which the tumor is asymptomatic but screen-detectable (sojourn time). We used a common estimate and two recently published estimates of sojourn times. (3) Results: The analysis included 32,169 women. Survival for symptomatic BC was lower than for screen-detected BC (hazard ratio (HR): 0.23, 95% confidence interval (CI): 0.21-0.25). Adjustment for prognostic factors and lead time bias with the commonly used sojourn time resulted in an HR of 0.84 (CI: 0.75-0.94). Using different sojourn times resulted in an HR of 0.73 to 0.90. (4) Conclusions: Survival for symptomatic BC was only one quarter of screen-detected tumors, which is obviously biased. After adjustment for lead-time bias and prognostic variables, including UICC stage, survival was 27% to 10% better for screen-detected BC, which might be attributed to BC screening. Although this result fits quite well with published results for other countries with BC screening, further sources for residual confounding (e.g., self-selection) cannot be ruled out.

Device runtime and costs of cardiac resynchronization therapy pacemakers - a health claims data analysis.

Introduction: This study investigates the runtime and costs of biventricular defibrillators (CRT-D) and biventricular pacemakers (CRT-P). Accurate estimates of cardiac resynchronization therapy (CRT) device runtime across all manufactures are rare, especially for CRT-P. Methods: Health claims data of a large nationwide German health insurance was used to analyze CRT device runtime. We defined device runtime as the time between the date of implantation and the date of generator change or removal. The median costs for implantation, change, and removal of a CRT device were calculated accordingly. Results: In total, the data set comprises 17,826 patients. A total of 4,296 complete runtimes for CRT-D devices and 429 complete runtimes for CRT-P devices were observed. Median device runtime was 6.04 years for CRT-D devices and 8.16 years for CRT-P devices (log-rank test p<0.0001). The median cost of implantation for a CRT-D device was 14,270 EUR, and for a CRT-P device 9,349 EUR. Conclusions: Compared to CRT-P devices, CRT-D devices had a significantly shorter device runtime of about two years. Moreover, CRT-D devices were associated with higher cost. The study provides important findings that can be utilized by cost-effectiveness analyses.

Cardiac Resynchronisation Therapy in Patients with Moderate to Severe Heart Failure in Germany: A Cost-Utility Analysis of the Additional Defibrillator.

BACKGROUND: Cardiac resynchronisation therapy (CRT) is a well-established form of treatment for patients with heart failure and cardiac dyssynchrony. There are two different types of CRT devices: the biventricular pacemaker (CRT-P) and the biventricular defibrillator (CRT-D). The latter is more complex but also more expensive. For the majority of patients who are eligible for CRT, both devices are appropriate according to current guidelines. The purpose of this study was to conduct a cost-utility analysis for CRT-D compared to CRT-P from a German payer's perspective. METHODS: A cohort Markov-model was developed to assess average costs and quality-adjusted life-years (QALY) for CRT-D and CRT-P. The model consisted of six stages: one for the device implementation, one for the absorbing state death, and two stages ("Stable" and "Hospital") for either a CRT device or medical therapy. The time horizon was 20 years. Deterministic and probabilistic sensitivity analyses and scenario analyses were conducted. RESULTS: The incremental cost-effectiveness ratio (ICER) of CRT-D compared with CRT-P was €24,659 per additional QALY gained. In deterministic sensitivity analysis, the survival advantage of CRT-D to CRT-P was the most influential input parameter. In the probabilistic sensitivity analysis 96% of the simulated cases were more effective but also more costly. CONCLUSIONS: Therapy with CRT-D compared to CRT-P resulted in an additional gain of QALYs, but was more expensive. In addition, the ICER was subject to uncertainty, especially due to the uncertainty in the survival benefit. A randomised controlled trial and subgroup analyses would be desirable to further inform decision making.

Long-Term Effects of an Intensive Prevention Program After Acute Myocardial Infarction.

Effective long-term prevention after myocardial infarction (MI) is crucial to reduce recurrent events. In this study the effects of a 12-months intensive prevention program (IPP), based on repetitive contacts between non-physician "prevention assistants" and patients, were evaluated. Patients after MI were randomly assigned to the IPP versus usual care (UC). Effects of IPP on risk factor control, clinical events and costs were investigated after 24 months. In a substudy efficacy of short reinterventions after more than 24 months ("Prevention Boosts") was analyzed. IPP was associated with a significantly better risk factor control compared to UC after 24 months and a trend towards less serious clinical events (12.5% vs 20.9%, log-rank p = 0.06). Economic analyses revealed that already after 24 months cost savings due to event reduction outweighted the costs of the prevention program (costs per patient 1,070 € in IPP vs 1,170 € in UC). Short reinterventions ("Prevention Boosts") more than 24 months after MI further improved risk factor control, such as LDL cholesterol and blood pressure lowering. In conclusion, IPP was associated with numerous beneficial effects on risk factor control, clinical events and costs. The study thereby demonstrates the efficacy of preventive long-term concepts after MI, based on repetitive contacts between non-physician coworkers and patients.

Determinants of Frequent Attendance of Outpatient Physicians: A Longitudinal Analysis Using the German Socio-Economic Panel (GSOEP).

There is a lack of population-based longitudinal studies which investigates the factors leading to frequent attendance of outpatient physicians. Thus, the purpose of this study was to analyze the determinants of frequent attendance using a longitudinal approach. The used dataset comprises seven waves (2002 to 2014; n = 28,574 observations; ranging from 17 to 102 years) from the nationally representative German Socio-Economic Panel (GSOEP). The number of outpatient physician visits in the last three months was used to construct the dependent variable "frequent attendance". Different cut-offs were used (top 25%; top 10%; top 5%). Variable selection was based on the "behavioral model of health care use" by Andersen. Accordingly, variables were grouped into predisposing, enabling, and need characteristics as well as health behavior, which are possible determinants of frequent attendance. Conditional fixed effects logistic regressions were used. As for predisposing characteristics, regressions showed that getting married and losing one's job increased the likelihood of frequent attendance. Furthermore, age was negatively associated with the outcome measure. Enabling characteristics were not significantly associated with the outcome measure, except for the onset of the "practice fee". Decreases in mental and physical health were associated with an increased likelihood of frequent attendance. Findings were robust across different subpopulations. The findings of this study showed that need characteristics are particularly important for the onset of frequent attendance. This might indicate that people begin to use health services frequently when medically indicated.

[Social problems in primary health care - prevalence, responses, course of action, and the need for support from a general practitioners' point of view]. / Soziale Probleme in der hausärztlichen Versorgung ­ Häufigkeit, Reaktionen, Handlungsoptionen und erwünschter Unterstützungsbedarf aus der Sicht von Hausärztinnen und Hausärzten.

BACKGROUND: Very often patients utilize primary care services for health conditions related to social problems. These problems, which are not primarily medical, can severely influence the course of an illness and its treatment. Little is known about the extent to which problems like unemployment or loneliness occur in a general practice setting. OBJECTIVES: What are the most frequent health-related social problems perceived by general practitioners (GPs)? How are these problems associated with GP- or practice characteristics? How do general practitioners deal with the social problems they perceive and what kind of support do they need? MATERIALS AND METHODS: Cross-sectional, postal questionnaire survey with questions derived from "Chapter Z social problems" of the International Classification of Primary Care - 2nd edition. The questionnaire was mailed to available GP addresses in the federal states of Hamburg (n=1,602) and Schleswig-Holstein (n=1,242). RESULTS: N=489 questionnaires (17.2 %) were analyzed. At least three times a week, GPs were consulted by patients with poverty/financial problems (53.4 %), work/unemployment problems (43.7 %), patients with loneliness (38.7 %) as well as partnership issues (25.5 %). Only rarely did GPs report having perceived assault/harmful event problems (0.8 %). The highest frequency of problems was encountered by practices with a high proportion of a migrant population. CONCLUSIONS: Social problems are a common issue in routine primary care. GPs in Northwestern Germany usually try to find internal solutions for social problems but also indicated further interest in institutionalized support. A possible approach to solving these issues are community-based, locally organized networks.