Risk assessment in patients with symptomatic and asymptomatic pre-excitation.

AIMS: Controversy remains as to whether the exercise stress test (EST) is sufficient for risk evaluation in patients with pre-excitation. This study aims to clarify the usefulness of EST in risk stratification in both asymptomatic and symptomatic patients presenting with pre-excitation. METHODS AND RESULTS: This prospective study includes consecutive asymptomatic and symptomatic patients with pre-excitation referred for risk assessment. All participants performed an incremental EST (bicycle) prior to an electrophysiology study (EPS). Primary data from the EST included loss of pre-excitation during exercise, and primary data from the EPS included the measurement of accessory pathway effective refractory period (APERP), shortest pre-excited RR interval (SPERRI), and inducible arrhythmia with the use of a beta-adrenergic receptor agonist if deemed necessary. One hundred and sixty-four patients (59 asymptomatic, 105 symptomatic) completed an EST and EPS. Forty-five patients (27%) demonstrated low-risk findings on EST, of which 19 were asymptomatic and 26 were symptomatic. Six patients with low-risk EST findings had SPERRI/APERP ≤ 250 ms at EPS, and two of them were asymptomatic. The sensitivity, specificity, positive predictive value, negative predictive value (NPV), and accuracy of low-risk EST for excluding patients with SPERRI/APERP ≤ 250 ms were 40, 91, 87, 51, and 60%, respectively. The number of patients with inducible arrhythmia at EPS was similar in the asymptomatic (36, 69%) and symptomatic (73, 61%) groups. CONCLUSION: Sudden loss of pre-excitation during EST has a low NPV in excluding high-risk APs. The EPS with the use of isoproterenol should be considered to accurately assess the risk of patients with pre-excitation regardless of symptoms (ClinicalTrials.gov Identifier: NCT03301935).

Cost-effectiveness of population screening for atrial fibrillation: the STROKESTOP study.

AIMS: Previous studies on the cost-effectiveness of screening for atrial fibrillation (AF) are based on assumptions of long-term clinical effects. The STROKESTOP study, which randomised 27 975 persons aged 75/76 years into a screening invitation group and a control group, has a median follow-up time of 6.9 years. The aim of this study was to estimate the cost-effectiveness of population-based screening for AF using clinical outcomes. METHODS AND RESULTS: The analysis is based on a Markov cohort model. The prevalence of AF, the use of oral anticoagulation, clinical event data, and all-cause mortality were taken from the STROKESTOP study. The cost for clinical events, age-specific utilities, utility decrement due to stroke, and stroke death was taken from the literature. Uncertainty in the model was considered in a probabilistic sensitivity analysis. Per 1000 individuals invited to the screening, there were 77 gained life years and 65 gained quality-adjusted life years. The incremental cost was €1.77 million lower in the screening invitation group. Gained quality-adjusted life years to a lower cost means that the screening strategy was dominant. The result from 10 000 Monte Carlo simulations showed that the AF screening strategy was cost-effective in 99.2% and cost-saving in 92.7% of the simulations. In the base-case scenario, screening of 1000 individuals resulted in 10.6 [95% confidence interval (CI): -22.5 to 1.4] fewer strokes (8.4 ischaemic and 2.2 haemorrhagic strokes), 1.0 (95% CI: -1.9 to 4.1) more cases of systemic embolism, and 2.9 (95% CI: -18.2 to 13.1) fewer bleedings associated with hospitalization. CONCLUSION: Based on the STROKESTOP study, this analysis shows that a broad AF screening strategy in an elderly population is cost-effective. Efforts should be made to increase screening participation.

Reimbursement practices for use of digital devices in atrial fibrillation and other arrhythmias: a European Heart Rhythm Association survey.

Since digital devices are increasingly used in cardiology for assessing cardiac rhythm and detecting arrhythmias, especially atrial fibrillation (AF), our aim was to evaluate the expectations and opinions of healthcare professionals in Europe on reimbursement policies for the use of digital devices (including wearables) in AF and other arrhythmias. An anonymous survey was proposed through announcements on the European Heart Rhythm Association website, social media channels, and mail newsletter. Two hundred and seventeen healthcare professionals participated in the survey: 32.7%, reported regular use of digital devices, 45.2% reported that they sometimes use these tools, 18.6% that they do not use but would like to. Only a minority (3.5%) reported a lack of trust in digital devices. The survey highlighted a general propensity to provide medical consultation for suspected AF or other arrhythmias detected by a consumer-initiated use of digital devices, even if time constraints and reimbursement availability emerged as important elements. More than 85% of respondents agreed that reimbursement should be applied for clinical use of digital devices, also in different settings such as post-stroke, post-cardioversion, post-ablation, and in patients with palpitations or syncope. Finally, 73.6% of respondents confirmed a lack of reimbursement fees in their country for physicians' consultations (tracings interpretation) related to digital devices. Digital devices, including wearables, are increasingly and widely used for assessing cardiac rhythm and detecting AF, but a definition of reimbursement policies for physicians' consultations is needed.

Performance-based risk-sharing arrangements for devices and procedures in cardiac electrophysiology: an innovative perspective.

There is an increasing pressure on demonstrating the value of medical interventions and medical technologies resulting in the proposal of new approaches for implementation in the daily practice of innovative treatments that might carry a substantial cost. While originally mainly adopted by pharmaceutical companies, in recent years medical technology companies have initiated novel value-based arrangements for using medical devices, in the form of 'outcomes-based contracts', 'performance-based contracts', or 'risk-sharing agreements'. These are all characterized by linking coverage, reimbursement, or payment for the innovative treatment to the attainment of pre-specified clinical outcomes. Risk-sharing agreements have been promoted also in the field of electrophysiology and offer the possibility to demonstrate the value of specific innovative technologies proposed in this rapidly advancing field, while relieving hospitals from taking on the whole financial risk themselves. Physicians deeply involved in the field of devices and technologies for arrhythmia management and invasive electrophysiology need to be prepared for involvement as stakeholders. This may imply engagement in the evaluation of risk-sharing agreements and specifically, in the process of assessment of technology performances or patient outcomes. Scientific Associations may have an important role in promoting the basis for value-based assessments, in promoting educational initiatives to help assess the determinants of the learning curve for innovative treatments, and in promoting large-scale registries for a precise assessment of patient outcomes and of specific technologies' performance.

Dynamic risk assessment to improve quality of care in patients with atrial fibrillation: the 7th AFNET/EHRA Consensus Conference.

AIMS: The risk of developing atrial fibrillation (AF) and its complications continues to increase, despite good progress in preventing AF-related strokes. METHODS AND RESULTS: This article summarizes the outcomes of the 7th Consensus Conference of the Atrial Fibrillation NETwork (AFNET) and the European Heart Rhythm Association (EHRA) held in Lisbon in March 2019. Sixty-five international AF specialists met to present new data and find consensus on pressing issues in AF prevention, management and future research to improve care for patients with AF and prevent AF-related complications. This article is the main outcome of an interactive, iterative discussion between breakout specialist groups and the meeting plenary. AF patients have dynamic risk profiles requiring repeated assessment and risk-based therapy stratification to optimize quality of care. Interrogation of deeply phenotyped datasets with outcomes will lead to a better understanding of the cardiac and systemic effects of AF, interacting with comorbidities and predisposing factors, enabling stratified therapy. New proposals include an algorithm for the acute management of patients with AF and heart failure, a call for a refined, data-driven assessment of stroke risk, suggestions for anticoagulation use in special populations, and a call for rhythm control therapy selection based on risk of AF recurrence. CONCLUSION: The remaining morbidity and mortality in patients with AF needs better characterization. Likely drivers of the remaining AF-related problems are AF burden, potentially treatable by rhythm control therapy, and concomitant conditions, potentially treatable by treating these conditions. Identifying the drivers of AF-related complications holds promise for stratified therapy.

Decentralising atrial fibrillation screening to overcome socio-demographic inequalities in uptake in STROKESTOP II.

OBJECTIVE: In the first STROKESTOP atrial fibrillation screening study, participation was influenced by socio-demographic and geographic factors. To improve uptake in the second study, two screening sites were added, closer to low-income neighbourhoods which had very low participation in the first study. This paper aims to analyse the geographic and socio-demographic disparities in uptake in the second trial and compare the results with the first trial. METHODS: Inhabitants of the Stockholm region born in 1940 and 1941 were randomised 1:1 to be invited to screening or serve as controls. Medical history, blood samples and single-lead-ECG were collected. Invitee's residential parish was used for geo-mapping analysis of the geographical disparities in participation, using hierarchical Bayes methods. Individual data for participants and non-participants were obtained for the socioeconomic variables: educational level, disposable income, immigrant and marital status. RESULTS: Higher participation was observed in those with higher education, high income, among non-immigrants and married individuals. Participation between the first and second studies improved significantly, where additional screening sites were introduced. These improvements were generally significant, in each population group according to socio-demographic characteristics. CONCLUSION: Decentralisation of screening sites in an atrial fibrillation screening program yielded a significantly positive impact on screening uptake. Adding local screening sites in areas with low uptake had beneficial impact on participation across a wide spectrum of socio-demographic groups. Decentralised screening substantially increased the screening uptake in deprived areas.

On-demand mobile health infrastructures to allow comprehensive remote atrial fibrillation and risk factor management through teleconsultation.

BACKGROUND: Although novel teleconsultation solutions can deliver remote situations that are relatively similar to face-to-face interaction, remote assessment of heart rate and rhythm as well as risk factors remains challenging in patients with atrial fibrillation (AF). HYPOTHESIS: Mobile health (mHealth) solutions can support remote AF management. METHODS: Herein, we discuss available mHealth tools and strategies on how to incorporate the remote assessment of heart rate, rhythm and risk factors to allow comprehensive AF management through teleconsultation. RESULTS: Particularly, in the light of the coronavirus disease 2019 (COVID-19) pandemic, there is decreased capacity to see patients in the outpatient clinic and mHealth has become an important component of many AF outpatient clinics. Several validated mHealth solutions are available for remote heart rate and rhythm monitoring as well as for risk factor assessment. mHealth technologies can be used for (semi-)continuous longitudinal monitoring or for short-term on-demand monitoring, dependent on the respective requirements and clinical scenarios. As a possible solution to improve remote AF care through teleconsultation, we introduce the on-demand TeleCheck-AF mHealth approach that allows remote app-based assessment of heart rate and rhythm around teleconsultations, which has been developed and implemented during the COVID-19 pandemic in Europe. CONCLUSION: Large scale international mHealth projects, such as TeleCheck-AF, will provide insight into the additional value and potential limitations of mHealth strategies to remotely manage AF patients. Such mHealth infrastructures may be well suited within an integrated AF-clinic, which may require redesign of practice and reform of health care systems.

Computed Tomography-Guided Risk Assessment in Percutaneous Lead Extraction.

OBJECTIVES: The aim of this study was to assess if pre-procedural computed tomography (CT) could identify high-risk operative features and predict increased procedural complexity. BACKGROUND: Unpredictable lead adhesions can make lead extraction complicated. Adhesions are known to affect leads with longer indwelling time but can unpredictably affect newer leads. METHODS: Consecutive patients who had CTs performed ≤90 days before their planned lead extraction (LE) were included. CTs were reviewed blinded to outcome according to a preset checklist. The outcome was a combined endpoint of procedural complexity and major complications. RESULTS: Between January 1, 2015 and July 1, 2018, 143 patients underwent CT and LE. Median age was 68 years (interquartile range [IQR]: 54.4 to 76.5), and 35% were female. Median age of extracted leads was 111 months, and 126 (43%) were >10 years. CT detected lead perforation ≥5 mm (n = 13), <5 mm (n = 55), severe lead adhesions (n = 65), leads touching vessel wall >1 cm (n = 102), lead fracture (n = 8), and severe ipsilateral venous stenosis/occlusion (n = 36). The procedure was complex in 63 cases. There were 2 deaths, and 6 major complications. Patients with severe lead adhesions had more complex procedures (n = 36 vs 29; p = 0.04), whereas none of the other findings on CT were significantly associated with worse outcome. In patients with leads that had an indwelling time <10 years (n = 72), severe lead adhesions on CT was associated with worse outcome in multivariable analysis (odds ratio: 6.4; 95% confidence interval: 1.4 to 30.2; p = 0.02). CONCLUSIONS: Pre-procedural CT can be used to locate severe lead adhesions in patients planned for lead extraction. In patients with indwelling leads <10 years, pre-procedural CT aids in identifying patients prone to complex extractions.

Designing an optimal screening program for unknown atrial fibrillation: a cost-effectiveness analysis.

AIMS: The primary objective of this study was to use computer simulations to suggest an optimal age for initiation of screening for unknown atrial fibrillation and to evaluate if repeated screening will add value. METHODS AND RESULTS: In the absence of relevant clinical studies, this analysis was based on a simulation model. More than two billion different designs of screening programs for unknown atrial fibrillation were simulated and analysed. Data from the published scientific literature and registries were used to construct the model and estimate lifelong effects and costs. Costs and effects generated by 2 147 483 648 different screening designs were calculated and compared. Program designs that implied worse clinical outcome and were less cost-effective compared to other programs were excluded from the analysis. Seven program designs were identified, and considered to be cost effective depending on what the health-care decision makers are ready to pay for gaining a quality-adjusted life-year (QALY). Screening at the age of 75 implied the lowest cost per gained QALY (€4 800/QALY). CONCLUSION: In conclusion, examining the results of more than two billion simulated screening program designs for unknown atrial fibrillation, seven designs were deemed cost-effective depending on how much we are prepared to pay for gaining QALYs. Our results showed that repeated screening for atrial fibrillation implied additional health benefits to a reasonable cost compared to one-off screening.

Geographic and socio-demographic differences in uptake of population-based screening for atrial fibrillation: The STROKESTOP I study.

BACKGROUND: The rationale behind screening for atrial fibrillation (AF) is to prevent ischemic stroke. Socio-demographic differences are expected to affect screening uptake. Geographic differences may provide further insights leading to targeted interventions for improved uptake. The objective of this study was to evaluate geographic and socio-demographic differences in uptake of AF screening in the population-based study STROKESTOP I. METHODS: STROKESTOP was carried out in two Swedish counties with a total population of 2.3 million inhabitants. Half of the residents aged 75-76years were randomized to the screening arm: invitation to clinical examination followed by ambulant ECG recording. Information on each invited person's residential parish (n=157) was used. On parish-level, aggregated data for the participants and non-participants, respectively, were obtained with respect to socioeconomic variables: educational level, disposable income, immigrant and marital status. Geo-maps displaying participation ratios were estimated by hierarchical Bayes methods. RESULTS: The overall participation rate was similar in men and women but lower in Stockholm, 47.6% (5665/11,903) than in Halland, 61.2% (1495/2443). Participation was clearly associated with the socioeconomic variables. Participation not taking into account socioeconomy varied more markedly across the parishes in the Stockholm county (range: 0.65-1.26) than in the Halland county (0.94-1.27). After adjustment for socioeconomic variables, a geographic variation remained in Stockholm, but not in Halland. CONCLUSION: Participation in AF screening varied according to socioeconomic conditions. Geographic variation in participation was marked in the Stockholm county, with only one screening clinic. Geo-mapping of participation yielded useful information needed to intervene for improved screening uptake.

Cost-effectiveness of mass screening for untreated atrial fibrillation using intermittent ECG recording.

AIMS: The aim of this study was to estimate the cost-effectiveness of 2 weeks of intermittent screening for asymptomatic atrial fibrillation (AF) in 75/76-year-old individuals. METHODS AND RESULTS: The cost-effectiveness analysis of screening in 75-year-old individuals was based on a lifelong decision analytic Markov model. In this model, 1000 hypothetical individuals, who matched the population of the STROKESTOP study, were simulated. The population was analysed for different parameters such as prevalence, AF status, treatment with oral anticoagulation, stroke risk, utility, and costs. In the base-case scenario, screening of 1000 individuals resulted in 263 fewer patient-years with undetected AF. This implies eight fewer strokes, 11 more life-years, and 12 more quality-adjusted life years (QALYs) per 1000 screened individuals. The screening implies an incremental cost of €50 012, resulting in a cost of €4313 per gained QALY and €6583 per avoided stroke. CONCLUSIONS: With the use of a decision analytic simulation model, it has been shown that screening for asymptomatic AF in 75/76-year-old individuals is cost-effective.