Prevalence, outcomes and costs of a contemporary, multinational population with heart failure.

OBJECTIVE: Digital healthcare systems could provide insights into the global prevalence of heart failure (HF). We designed the CardioRenal and Metabolic disease (CaReMe) HF study to estimate the prevalence, key clinical adverse outcomes and costs of HF across 11 countries. METHODS: Individual level data from a contemporary cohort of 6 29 624 patients with diagnosed HF was obtained from digital healthcare systems in participating countries using a prespecified, common study plan, and summarised using a random effects meta-analysis. A broad definition of HF (any registered HF diagnosis) and a strict definition (history of hospitalisation for HF) were used. Event rates were reported per 100 patient years. Cumulative hospital care costs per patient were calculated for a period of up to 5 years. RESULTS: The prevalence of HF was 2.01% (95% CI 1.65 to 2.36) and 1.05% (0.85 to 1.25) according to the broad and strict definitions, respectively. In patients with HF (broad definition), mean age was 75.2 years (95% CI 74.0 to 76.4), 48.8% (40.9-56.8%) had ischaemic heart disease and 34.5% (29.4-39.6%) had diabetes. In 51 442 patients with a recorded ejection fraction (EF), 39.1% (30.3-47.8%) had a reduced, 18.8% (13.5-24.0%) had a mildly reduced and 42.1% (31.5-52.8%) had a preserved left ventricular EF. In 1 69 518 patients with recorded estimated glomerular filtration rate, 49% had chronic kidney disease (CKD) stages III-V. Event rates were highest for cardiorenal disease (HF or CKD) and all cause mortality (19.3 (95% CI 11.3 to 27.1) and 13.1 (11.1 to 15.1), respectively), and lower for myocardial infarction, stroke and peripheral artery disease. Hospital care costs were highest for cardiorenal diseases. CONCLUSIONS: We estimate that 1-2% of the contemporary adult population has HF. These individuals are at significant risk of adverse outcomes and associated costs, predominantly driven by hospitalisations for HF or CKD. There is considerable public health potential in understanding the contemporary burden of HF and the importance of optimising its management.

Cardiovascular magnetic resonance pulmonary perfusion for functional assessment of pulmonary vein stenosis.

BACKGROUND: Cardiovascular magnetic resonance (CMR) imaging allows to combine pulmonary perfusion measurements and pulmonary venous angiography during a single-session examination with both imaging modules representing the basis for accurate diagnosis and therapeutic stratification of pulmonary vein (PV) stenosis. The present study investigated the clinical utility of dynamic pulmonary perfusion imaging integrated into a comprehensive CMR protocol for the evaluation of patients with suspected PV stenosis. METHODS: 162 patients with clinically suspected PV stenosis after catheter ablation of atrial fibrillation underwent a combined single-session CMR examination (cardiac cine imaging, dynamic pulmonary perfusion, and three-dimensional PV angiography). CMR angiography was used for visual grading of PV stenoses; dynamic pulmonary perfusion imaging was evaluated per lung lobe visually and quantitatively. RESULTS: All PV stenosis ≥90% showed a visible perfusion deficit of the corresponding lung lobe (60/60, 100%) while all PVs with luminal narrowing <50% exhibited normal pulmonary perfusion (680/680, 100%). However, every third 70-89% stenosis showed a normal pulmonary perfusion (10/31, 32%) while every fourth 50-69% PV stenosis was associated with hypoperfusion of the corresponding lung lobe (9/39, 23%). For quantitative pulmonary perfusion measurements, ROC analysis demonstrated high discriminatory power regarding PV stenosis detection with the highest AUC values for time-to-peak enhancement (cut-off value, 8.5 s). CONCLUSIONS: The combination of CMR angiography and CMR pulmonary perfusion allowed for assessment of the anatomical degree of PV stenosis and its hemodynamic impact on the pulmonary parenchymal level. Thus, the proposed comprehensive CMR protocol provided an efficient diagnostic work-up of patients with suspected PV stenosis.

Cardiac tamponade complicating ventricular arrhythmia ablation: Real life data on incidence, management, and outcome.

BACKGROUND AND OBJECTIVE: Cardiac tamponade during ablation procedures is a life-threatening complication. While the incidence and management of tamponade in atrial fibrillation ablation have been extensively described, the data on tamponade during ventricular ablations are very limited. The purpose of this study is to shed light on the incidence, typical perforation sites, and optimal management as observed through real-life data in a tertiary referral center for ventricular ablation. METHODS AND RESULTS: Consecutive patients with structural heart disease undergoing ventricular tachycardia ablation from 2008-2020 were analyzed. Of the 1078 patients undergoing 1287 ventricular ablation procedures, 20 procedures (1.5%) were complicated by cardiac tamponade. In all but one patient, the tamponade was treated with emergent pericardial drainage, while nine patients eventually underwent surgical repair. The perforation occurred during transseptal or subxiphoid puncture in six patients, during ventricle mapping in two patients, and during ablation in five patients (predominantly basal left ventricle). Steam pop as definite perforation cause could only be established in two patients. Regardless of the management of the complication, all patients survived to discharge. CONCLUSION: Cardiac tamponade during ventricular ablation occurred in 1.5% of the procedures. In nine patients cardiac repair was necessary. Perforation was mostly associated with subxiphoid puncture or ablation of the basal left ventricle.

Prevalence, outcomes, and cost of chronic kidney disease in a contemporary population of 2·4 million patients from 11 countries: The CaReMe CKD study.

Background: Digital healthcare systems data could provide insights into the global prevalence of chronic kidney disease (CKD). We designed the CaReMe CKD study to estimate the prevalence, key clinical adverse outcomes and costs of CKD across 11 countries. Methods: Individual-level data of a cohort of 2·4 million contemporaneous CKD patients was obtained from digital healthcare systems in participating countries using a pre-specified common protocol; summarized using random effects meta-analysis. CKD and its stages were defined in accordance with current Kidney Disease: Improving Global Outcomes (KDIGO) criteria. CKD was defined by laboratory values or by a diagnosis code. Findings: The pooled prevalence of possible CKD was 10·0% (95% confidence interval 8.5‒11.4; mean pooled age 75, 53% women, 38% diabetes, 60% using renin-angiotensin-aldosterone system inhibitors). Two out of three CKD patients identified by laboratory criteria did not have a corresponding CKD-specific diagnostic code. Among CKD patients identified by laboratory values, the majority (42%) were in KDIGO stage 3A; and this fraction was fairly consistent across countries. The share with CKD based on urine albumin-creatinine ratio (UACR) alone (KDIGO stages one and two) was 29%, with a substantial heterogeneity between countries. Adverse events were common; 6·5% were hospitalized for CKD or heart failure, and 6·2% died, annually. Costs for renal events and heart failure were consistently higher than costs for atherosclerotic events in CKD patients across all countries. Interpretation: We estimate that CKD is present in one out of ten adults. These individuals experience significant adverse outcomes with associated costs. The prevalence of CKD is underestimated when using diagnostic codes alone. There is considerable public health potential in diagnosing CKD and providing treatments to those currently undiagnosed. Funding: The study was sponsored by AstraZeneca.

Impact analysis of heart failure across European countries: an ESC-HFA position paper.

Heart failure (HF) is a long-term clinical syndrome, with increasing prevalence and considerable healthcare costs that are further expected to increase dramatically. Despite significant advances in therapy and prevention, mortality and morbidity remain high and quality of life poor. Epidemiological data, that is, prevalence, incidence, mortality, and morbidity, show geographical variations across the European countries, depending on differences in aetiology, clinical characteristics, and treatment. However, data on the prevalence of the disease are scarce, as are those on quality of life. For these reasons, the ESC-HFA has developed a position paper to comprehensively assess our understanding of the burden of HF in Europe, in order to guide future policies for this syndrome. This manuscript will discuss the available epidemiological data on HF prevalence, outcomes, and human costs-in terms of quality of life-in European countries.

Hospitalisations for emergency-sensitive conditions in Germany during the COVID-19 pandemic: insights from the German-wide Helios hospital network.

BACKGROUND: While there are numerous reports that describe emergency care during the early COVID-19 pandemic, there is scarcity of data for later stages. This study analyses hospitalisation rates for 37 emergency-sensitive conditions in the largest German-wide hospital network during different pandemic phases. METHODS: Using claims data of 80 hospitals, consecutive cases between 1 January and 17 November 2020 were analysed and compared with a corresponding period in 2019. Incidence rate ratios (IRRs) comparing the two periods were calculated using Poisson regression to model the number of hospitalisations per day. RESULTS: There was a reduction in hospitalisations between 12 March and 13 June 2020 (coinciding with the first pandemic wave) with 32 807 hospitalisations (349.0/day) as opposed to 39 379 (419.0/day) in 2019 (IRR 0.83, 95% CI 0.82 to 0.85, p<0.01). During the following period (14 June-17 November 2020, including the start of second wave), hospitalisations were reduced from 63 799 (406.4/day) in 2019 to 59 910 (381.6/day) in 2020, but this reduction was not as pronounced (IRR 0.94, 95% CI 0.93 to 0.95, p<0.01). During the first wave hospitalisations for acute myocardial infarction, aortic aneurysm/dissection, pneumonitis, paralytic ileus/intestinal obstruction and pulmonary embolism declined but subsequently increased compared with the corresponding periods in 2019. In contrast, hospitalisations for sepsis, pneumonia, obstructive pulmonary disease and intracranial injuries were reduced during the entire observation period. CONCLUSIONS: There was an overall reduction of absolute hospitalisations for emergency-sensitive conditions in Germany during the first 10 months of the COVID-19 pandemic with heterogeneous effects on different disease categories. The increase in hospitalisations for acute myocardial infarction, aortic aneurysm/dissection and pulmonary embolism requires attention and further studies.

SARS-CoV-2 rapid antigen testing in the healthcare sector: A clinical prediction model for identifying false negative results.

OBJECTIVES: SARS-CoV-2 rapid antigen tests (RAT) provide fast identification of infectious patients when RT-PCR results are not immediately available. We aimed to develop a prediction model for identification of false negative (FN) RAT results. METHODS: In this multicenter trial, patients with documented paired results of RAT and RT-PCR between October 1st 2020 and January 31st 2021 were retrospectively analyzed regarding clinical findings. Variables included demographics, laboratory values and specific symptoms. Three different models were evaluated using Bayesian logistic regression. RESULTS: The initial dataset contained 4,076 patients. Overall sensitivity and specificity of RAT was 62.3% and 97.6%. 2,997 cases with negative RAT results (FN: 120; true negative: 2,877; reference: RT-PCR) underwent further evaluation after removal of cases with missing data. The best-performing model for predicting FN RAT results containing 10 variables yielded an area under the curve of 0.971. Sensitivity, specificity, PPV and NPV for 0.09 as cut-off value (probability for FN RAT) were 0.85, 0.99, 0.7 and 0.99. CONCLUSION: FN RAT results can be accurately identified through ten routinely available variables. Implementation of a prediction model in addition to RAT testing in clinical care can provide decision guidance for initiating appropriate hygiene measures and therefore helps avoiding nosocomial infections.

Inguinal vascular complications after ablation of atrial fibrillation: an economic impact assessment.

AIMS: Ablation of atrial fibrillation (AF) is recommended in the guidelines as a Class Ia/IIa indication. However, associated complications should not be dismissed; specifically, inguinal vascular complications (IVC). Although IVCs are generally considered trivial, they represent an economic burden for the procedure-performing hospital and the patient. Therefore, the ability to monitor and ultimately minimize potential complications is of considerable interest. METHODS AND RESULTS: An economic model was developed to calculate the economic impact for certain IVC-types from a large German single-centre perspective in 2015 and 2016. Twenty-nine of 1040 (2.79%) and 48 of 1152 (4.17%) AF-ablation patients had documented IVC in 2015 and 2016 (P = 0.08), respectively. Inguinal vascular complications that required invasive treatment (thrombin, intervention, surgery) occurred in 0.58% of the 2015 and in 0.87% of the 2016 AF-ablation cases. The expected excess costs (incorporating direct costs, benefit lost adjusted for reimbursement) per patient treated with AF-ablation were 139.54€ and 153.31€ in 2015 and 2016, respectively. This was mostly driven by opportunity costs, which could reach 15 544.71€ for certain IVC. Sensitivity analysis revealed the probability of occurrence, length of stay of certain IVC types, and the revenue per day influenced the expected costs per AF-ablation patient. CONCLUSION: Even relatively benign complications such as IVC can result in considerable cost increases. Therefore, measures to reduce them should be established and implemented.

Innovation in cardiovascular disease in Europe with focus on arrhythmias: current status, opportunities, roadblocks, and the role of multiple stakeholders.

The European Heart Rhythm Association (EHRA) held an Innovation Forum in February 2016, to consider issues around innovation. The objective of the forum was to extend the innovation debate outside of the narrow world of arrhythmia specialists and cardiology in general, and seek input from all stakeholders including regulators, strategists, technologists, industry, academia, health providers, medical societies, payers, and patients. Innovation is indispensable for a continuing improvement in health care, preferably at higher efficacy and lower costs. It requires people who have been trained in a good scientific environment, high-quality research for achieving ground breaking inventions and the certainty of return on innovation investments. In the context of cardiovascular disease, innovation can imply better risk assessment and stratification, device technology, drug development, and process design. Several areas of promising developments were identified as well as several roadblocks to innovation. To drive innovation forward all stakeholders need to play a significant role. In a globalized and extremely competitive world, the leading role of Europe in medical innovation can only be achieved through a combined and well-coordinated effort from all involved parties.

Exercise testing for non-invasive assessment of atrial electrophysiological properties in patients with persistent atrial fibrillation.

AIMS: Experimental studies suggest that the autonomic nervous system modulates atrial refractoriness and conduction velocity in atrial fibrillation (AF). These modulatory effects are, however, difficult to assess in the clinical setting. This study sought to non-invasively characterize in patients with persistent AF, the influence of autonomic modulation induced by exercise on atrial fibrillatory rate as marker of atrial refractoriness and to identify clinical and electrocardiographic predictors of atrial rate response. METHODS AND RESULTS: In 24 patients (16 males, mean age 60 +/- 13 years) with persistent AF (16 +/- 25 months), continuous ECGs were recorded during bicycle exercise testing. Fibrillatory rate (in fibrillations per minute, fpm) was assessed at baseline and immediately after termination of exercise with spatiotemporal QRST cancellation and time-frequency analysis. Ventricular response was characterized by time-domain HRV indices. Exercise had no influence on mean fibrillatory rate (409 +/- 42 vs. 414 +/- 43 fpm, P = NS). Seven patients responded to exercise with an increase in fibrillatory rate (26 +/- 10 fpm, P < 0.001 and three with a decrease (-21 +/- 8 fpm, P < 0.001), while the remaining 14 patients did not show a response. Responders' HRV indices changed in response to exercise similarly to that of non-responders. Their baseline fibrillatory rate was, however, lower than that of non-responders (387 +/- 18 vs. 425 +/- 48 fpm, P = 0.028). No other clinical or echocardiographic variable was associated with fibrillatory rate response. Twelve weeks after cardioverson, responders were more likely to remain in sinus rhythm than non-responders (88 vs. 46 %, P = 0.04). CONCLUSIONS: Exercise-induced autonomic activation produces changes in atrial electrophysiological properties that can be detected by time-frequency analysis. Higher baseline fibrillatory rates are associated with an impaired atrial response to exercise that suggests advanced electrical remodelling and reduced sensitivity to autonomic stimuli.