German Heart Research Foundation

Background Mobile health (mHealth) apps can be used for cardiovascular disease (CVD) prevention. User-centered design, evidence-based content and user testing can be applied to ensure a high level of usability and adequate app access. Objective To develop and evaluate an mHealth app ( HerzFit ) for CVD prevention. Methods HerzFit ´s development included a user-centered design approach and guideline-based content creation based on the identified requirements of the target group. Beta testing and a preliminary usability evaluation of the HerzFit prototype were performed. For evaluation, German versions of the System Usability Scale (SUS) and the mHealth App Usability Questionnaire (GER-MAUQ) as well as free text feedback were applied. Results User-centered design thinking led to the definition of four personas. Based on their requirements, HerzFit enables users to individually assess, monitor, and optimize their cardiovascular risk profile. Users are also provided with a variety of evidence-based information on CVD and their risk factors. The user interface and system design followed the identified functional requirements. Beta-testers provided feedback on the structure and functionality and rated the usability of HerzFit ´s prototype as slightly above average both in SUS and GER-MAUQ rating. Participants positively noted the variety of functions and information presented in HerzFit , while negative feedback mostly concerned wearable synchronization. Conclusions The present study demonstrates the user-centered development of a guideline-based mHealth app for CVD prevention. Beta-testing and a preliminary usability study were used to further improve the HerzFit app until its official release.

Cardiopulmonary bypass (CPB) during left ventricular assist device (LVAD) implantation provides circulatory support and allows for safe inspection of the left ventricle (LV), whereas circulatory support by veno-arterial extracorporeal life support (va-ECLS) or off-pump implantation may reduce postoperative bleeding and inflammatory response. Retrospective analysis of 616consecutive adult patients who received an LVAD via median sternotomy between January 1, 2015 and December 31, 2019. All patients undergoing concomitant intracardiac procedures other than closure of persistent foramen ovale or atrial septal defect and redo surgeries were excluded from the analysis. The remaining patients (n=222) were divided into two groups and 1:1 propensity score-matched regarding preoperative parameters: patients who underwent LVAD implantation with LV inspection employing CPB (CPB group, n=62) and without LV inspection on va-ECLS or off-pump (non-CPB group, n=62). The groups were well balanced with regard to preoperative baseline characteristics (standard difference <0.1). Patients in the CPB group required more blood transfusions (median 2 vs. 0 units, p=0.031) during surgery and in the first 24h afterwards. The median intensive care unit stay was longer in the CPB group (18 vs. 11days, p=0.021). The CPB group showed an absence of perioperative stroke and a smaller number of events per patient-year for postoperative ischemic stroke (0.02 vs. 0.12, p=0.003). 30-day survival (87% vs. 87.1%) and 1-year survival (80.3% vs. 74%) were similar in both groups (p=0.78). Visual LV inspection on CPB may reduce the risk of postoperative ischemic stroke. Despite the negative effects of employing CPB in lieu of other intraoperative strategies, survival was similar in both groups.

Cardiac cachexia and frailty are major complications of advanced heart failure (AHF). Bioelectrical impedance analysis (BIA) may provide valuable information regarding fluid balance, muscle mass and prognosis. The main concerns regarding the use of BIA in AHF patients remain arrhythmias and electromagnetic interferences with cardiac implantable electronic devices (CIEDs). Reliable data regarding patients on continuous-flow ventricular assist device (cf-VAD) remain scarce. The aim of this study is to evaluate the safety of BIA in AHF patients on pro-arrhythmogenic therapy with an implanted CIED and/or with a cf-VAD. We prospectively performed 217BIA measurements in 143AHF patients at risk of severe arrhythmias due to inotropic support/a history of ventricular arrhythmias and/or treated with CIED, including 104patients with an ICD, CRT or pacemaker and 95patients with a cf-VAD. All patients were under continuous Electrocardiogram (ECG) monitoring and clinical surveillance for 24hours. No adverse events were observed during the 217BIA measurements: No rhythm disturbances were documented in the telemetric monitoring during or within 30minutes after the measurement. CIEDs showed no malfunction, regardless of the location measured or the device manufacturer. In particular, no inappropriate shocks were observed. No alarms, flow disturbances, or malfunctions of the cf-VAD occurred during or after the measurements. We consider BIA a safe measurement with major clinical relevance in our cohort of AHF patients, despite an increased arrhythmic potential on inotropic support or the presence of implanted electronic devices (ICD, CRT, pacemaker and cf-VAD).

Background: The optimization of primary preventive cardiovascular (CV) strategies is urgently needed. The objective of the present study was to evaluate the long-term effects of a standardized multimodal and lifestyle based therapeutic approach in high-risk-subjects according to the ESC-SCORE on predefined cardiovascular end-points. The ESC-SCORE allows a systematic estimation of the 10-year-risk for fatal CV events. Methods: The individual CV risk was assessed in a cohort of 4.196 employees of the Ford-Company, Germany, using the ESC-SCORE. Subjects were subsequently classified into three risk-groups. Subjects at high-risk, (ESC-SCORE ≥ 5%; n=447), were randomized either into a multimodal 15-week lifestyle based outpatient intervention program (INT n=224) or into a usual care group (UC n=223) and followed up for 36 months. The primary endpoint was a reduction of the ESC-SCORE in the INT as compared to the UC at the end of the trial. Secondary endpoints were a composite of fatal and non-fatal CV events (coronary artery disease, cerebrovascular or peripheral arterial disease, CV death and total mortality) and the time to the first CV event. An intention to treat analysis was performed. Results: After 36 months a difference of the ESC-SCORE development favoring the INT was achieved (INT: 8.70 to 10.03% vs. UC: 8.49 to 12.09%; p&lt;0.016). Moreover, a reduction in the composite secondary endpoint was observed (INT: n=11 vs. UC: n=27; p=0.032; HR 0.45 (CI 0.22 - 0.94). Conclusions: Our results demonstrate an intermediate-term improvement of the ESC-SCORE as well as a reduction of predefined CV endpoints by a primary CV prevention program within 36 months in a cohort of persons determined to be at high CV risk by assessment with the ESC-SCORE.