Contemporary guideline-directed medical therapy in de novo, chronic, and worsening heart failure patients: First data from the TITRATE-HF study.

AIMS: Despite clear guideline recommendations for initiating four drug classes in all patients with heart failure (HF) with reduced ejection fraction (HFrEF) and the availability of rapid titration schemes, information on real-world implementation lags behind. Closely following the 2021 ESC HF guidelines and 2023 focused update, the TITRATE-HF study started to prospectively investigate the use, sequencing, and titration of guideline-directed medical therapy (GDMT) in HF patients, including the identification of implementation barriers. METHODS AND RESULTS: TITRATE-HF is an ongoing long-term HF registry conducted in the Netherlands. Overall, 4288 patients from 48 hospitals were included. Among these patients, 1732 presented with de novo, 2240 with chronic, and 316 with worsening HF. The median age was 71 years (interquartile range [IQR] 63-78), 29% were female, and median ejection fraction was 35% (IQR 25-40). In total, 44% of chronic and worsening HFrEF patients were prescribed quadruple therapy. However, only 1% of HFrEF patients achieved target dose for all drug classes. In addition, quadruple therapy was more often prescribed to patients treated in a dedicated HF outpatient clinic as compared to a general cardiology outpatient clinic. In each GDMT drug class, 19% to 36% of non-use in HFrEF patients was related to side-effects, intolerances, or contraindications. In the de novo HF cohort, 49% of patients already used one or more GDMT drug classes for other indications than HF. CONCLUSION: This first analysis of the TITRATE-HF study reports relatively high use of GDMT in a contemporary HF cohort, while still showing room for improvement regarding quadruple therapy. Importantly, the use and dose of GDMT were suboptimal, with the reasons often remaining unclear. This underscores the urgency for further optimization of GDMT and implementation strategies within HF management.

Design of the Dutch multicentre study on opportunistic screening of geriatric patients for atrial fibrillation using a smartphone PPG app: the Dutch-GERAF study.

BACKGROUND: Screening of high-risk patients is advocated to achieve early detection and treatment of clinical atrial fibrillation (AF). The Dutch-GERAF study will address two major issues. Firstly, the effectiveness and feasibility of an opportunistic screening strategy for clinical AF will be assessed in frail older patients and, secondly, observational data will be gathered regarding the efficacy and safety of oral anticoagulation (OAC). METHODS: This is a multicentre study on opportunistic screening of geriatric patients for clinical AF using a smartphone photoplethysmography (PPG) application. Inclusion criteria are age ≥ 65 years and the ability to perform at least three PPG recordings within 6 months. Exclusion criteria are the presence of a cardiac implantable device, advanced dementia or a severe tremor. The PPG application records patients' pulse at their fingertip and determines the likelihood of clinical AF. If clinical AF is suspected after a positive PPG recording, a confirmatory electrocardiogram is performed. Patients undergo a comprehensive geriatric assessment and a frailty index is calculated. Risk scores for major bleeding (MB) are applied. Standard laboratory testing and additional laboratory analyses are performed to determine the ABC-bleeding risk score. Follow-up data will be collected at 6 months, 12 months and 3 years on the incidence of AF, MB, hospitalisation, stroke, progression of cognitive disorders and mortality. DISCUSSION: The Dutch-GERAF study will focus on frail older patients, who are underrepresented in randomised clinical trials. It will provide insight into the effectiveness of screening for clinical AF and the efficacy and safety of OAC in this high-risk population. TRIAL REGISTRATION: NCT05337202.

Outpatient Check-In Using an Online Portal.

Background: Despite ongoing digital and technological developments, incorporation of new developments in outpatient care tends to be slow. Regarding an increasing demand for outpatient care, digitalization of health care carries the potential of a much needed more efficient and patient-oriented system. Objective: To optimize classic face-to-face outpatient clinic follow-up consultations and evaluate the added value of an upfront digital consult preparation (DCP). Methods: A cross-sectional observational study was conducted at Rijnstate Hospital (Arnhem, the Netherlands) among all consecutive patients, 18 years or older, who visited the Cardiology (in June 2021) or Neurology (in September 2021) outpatient clinic. All received a DCP survey before their scheduled outpatient clinic appointment, containing three questions regarding their upcoming visit. In addition, the involved health care providers were approached by using a questionnaire to share their experience regarding the DCP. Data concerning the experience of patients and health care providers was anonymous and gathered using Qualtrics.com. Results: All 25 involved health care providers (12 cardiologists, 13 neurologists) provided feedback. According to the health care providers DCP decreased the workload and improved theirs and patients' preparation. In total, 785 of 1626 (48.3%) patients filled-in the DCP before their appointment within a predetermined period. Only 4% of the patients wanted to change or cancel the consultation. A total of 122 of the 300 (40.1%) patients approached, filled-in a questionnaire to reflect on the DCP. Patients experienced DCP as an improvement of consultation, more time-efficient, increasing patients' and health care providers' preparation, increasing a feeling of acknowledgement and improving co-decision on type of consultation. The DCP did not attribute to co-deciding on treatment. Conclusion: DCP was perceived as an improvement of the standard outpatient care by both health care providers and patients with automated integration into the electronic patient record being of key importance.

Comparison of Supraflex Cruz 60 µm Versus Ultimaster Tansei 80 µm Stent Struts in High Bleeding Risk PCI Patients: Study design and Rational of Compare 60/80 HBR trial.

Up to 45% of patients who underwent percutaneous coronary intervention (PCI) may have a high bleeding risk (HBR), depending on the bleeding risk definition.1 This condition is often associated with an enhanced risk of thrombotic events with a negative impact on short- and long-term outcomes,2-8 making the choice of an appropriate antithrombotic regimen after PCI particularly challenging. Advances in stent technologies, in which the introduction of newer generations of thinner strut drug-eluting stents (DES), have significantly reduced the rate of thrombotic complications and may justify a shorter dual antiplatelet therapy (DAPT) duration. Both in vitro and in vivo studies have shown that local hemodynamic factors may critically affect the natural history of atherosclerosis. Strut thickness correlates with flow disturbances and endothelial shear stress. Flow separation within struts determines areas of recirculation with low endothelial shear stress which promotes local concentration of activated platelets.9 By mitigating inflammation, vessel injury, and neointimal proliferation, thin and streamlined struts have been associated with faster vascular healing and re-endothelization and have resulted in lower rates of thrombotic events after PCI.10,11 The use of thin strut and ultra-thin strut stents may lead to a favorable trade-off in bleeding and ischemic events in patients with HBR. However, dedicated studies evaluating the performance of thin strut versus ultrathin strut stents in patients with HBR are lacking.

Impact of recurrent ischaemic and bleeding events on quality of life in patients with acute coronary syndrome: Insights from the FORCE-ACS registry.

OBJECTIVE: Patients with acute coronary syndrome (ACS) remain at high risk for recurrent ischaemic and bleeding events during follow-up. Our study aimed to quantify and compare the impact of these adverse events on quality of life (QoL). METHODS: Data from patients with ACS prospectively enrolled in the FORCE-ACS registry between January 2015 and December 2019 were used for this study. The primary ischaemic and bleeding events of interest were hospital readmission for ACS and Bleeding Academic Research Consortium type 2 or 3 bleeding during 12 months follow-up. QoL was measured using the EQ-5D Visual Analogue Scale (VAS) score and the 12-item Short Form Survey version 2 derived Physical Component Summary (PCS) and Mental Health Component Summary (MCS) scores at 12 months follow-up. RESULTS: In total, 3339 patients (mean age 66.8 years, 27.9% women) were included. During follow-up, ischaemic events occurred in 202 patients (6.0%) and bleeding events in 565 patients (16.9%). After adjustment for demographic and clinical characteristics, ischaemic events remained independently associated with lower QoL regardless of metric used. Bleeding was also independently associated with lower EQ-5D VAS and PCS scores, but not with a lower MCS score. The QoL decrement associated with ischaemic events was numerically larger than the decrement associated with bleeding. CONCLUSIONS: Ischaemic and bleeding events remain prevalent and are independently associated with lower QoL at 12 months follow-up in patients previously admitted for ACS. The incidence and impact of these adverse events should be considered when balancing individual ischaemic and bleeding risks.

Screening over 100 000 patients in 39 general practices in the Netherlands for anticoagulation underprescription in atrial fibrillation: a descriptive, cross-sectional study.

OBJECTIVES: To investigate the underprescription of oral anticoagulation (OAC) in individual atrial fibrillation (AF) patients in primary care. SETTING: Screening of patient records in 39 participating general practitioners (GPs) across the Netherlands. PARTICIPANTS: We screened 101 207 patient records identifying 2375 non-valvular AF patients. METHODS: Using electronic patient files, we were able to screen the entire GP population for AF, CHA2DS2-VASc stroke risk scores, and the use of guidelines recommended OAC prescription. In case of a deviation from guidelines recommended OAC prescription, we checked the electronic patient file for any documented reason. Additionally, 6 weeks following the screening, we asked all GPs to provide information on any actions taken for the underprescribed patients. RESULTS: We found a mean CHA2DS2-VASc score of 3.2. OAC prescription consisted of direct OAC in 1342/1984 (68%) and vitamin K-antagonists in the remainder of patients. OAC underprescription was present in 93/944 (9.9%) females and 101/1374 (9.7%) in males, respectively. In 111/146 (76.0%) of the underprescribed AF patients, no reason to withhold OAC was reported. Reported reasons to withhold OAC were patient refusal (n=10), cardiologist advice (n=7) and high risk of bleeding (n=7). Data regarding actions following the identification of OAC underprescription were available for 92/194 (47%) of the OAC underprescribed cases. After consultation OAC was initiated in 9/92 (10%) only. CONCLUSIONS: In this large Dutch study among GPs, we observed 9.8% underprescription of OAC in AF patients. In 76% of the AF patients lacking a prescription for OAC, no documentation for deviating from the guidelines was found. Only in a minority of cases detection of OAC underprescription lead to OAC initiation.

Less bleeding by omitting aspirin in non-ST-segment elevation acute coronary syndrome patients: Rationale and design of the LEGACY study.

BACKGROUND: Early aspirin withdrawal, also known as P2Y12-inhibitor monotherapy, following percutaneous coronary intervention (PCI) for non-ST-segment elevation acute coronary syndrome (NSTE-ACS) can reduce bleeding without a trade-off in efficacy. Still the average daily bleeding risk is highest during the first months and it remains unclear if aspirin can be omitted immediately following PCI. METHODS: The LEGACY study is an open-label, multicenter randomized controlled trial evaluating the safety and efficacy of immediate P2Y12-inhibitor monotherapy versus dual antiplatelet therapy (DAPT) for 12 months in 3,090 patients. Patients are randomized immediately following successful PCI for NSTE-ACS to 75-100 mg aspirin once daily versus no aspirin. The primary hypothesis is that immediately omitting aspirin is superior to DAPT with respect to major or minor bleeding defined as Bleeding Academic Research Consortium type 2, 3, or 5 bleeding, while maintaining noninferiority for the composite of all-cause mortality, myocardial infarction and stroke compared to DAPT. CONCLUSIONS: The LEGACY study is the first randomized study that is specifically designed to evaluate the impact of immediately omitting aspirin, and thus treating patients with P2Y12-inhibitor monotherapy, as compared to DAPT for 12 months on bleeding and ischemic events within 12 months following PCI for NSTE-ACS.

[Anticoagulation useful in short episodes of atrial fibrillation?] / Antistolling zinvol bij kortdurend atriumfibrilleren?

In patients with short episodes of clinical, non-triggered AF is the evidence for long-term anticoagulation based on the CHA2DS2-VASc score strong. In situations where a temporary trigger for AF is observed (e.g. after surgery or an infection), or when AF is only detected on a cardiac implantable electronic device (CIED) or smartwatch, the evidence for anticoagulation is less well established. Despite the short duration of the AF episode(s), both patients with subclinical or triggered AF are often at an inherently increased risk of stroke or thromboembolism. In some of these cases long-term anticoagulation can be considered, especially when other cardiovascular risk factors are present. Important considerations when deciding to start with long-term anticoagulation are the individually estimated risk of thrombosis and bleeding, the implementation of shared decision making, and the optimization of the overall cardiovascular risk management.

Patient motivation and adherence to an on-demand app-based heart rate and rhythm monitoring for atrial fibrillation management: data from the TeleCheck-AF project.

AIMS: The aim of this TeleCheck-AF sub-analysis was to evaluate motivation and adherence to on-demand heart rate/rhythm monitoring app in patients with atrial fibrillation (AF). METHODS AND RESULTS: Patients were instructed to perform 60 s app-based heart rate/rhythm recordings 3 times daily and in case of symptoms for 7 consecutive days prior to teleconsultation. Motivation was defined as number of days in which the expected number of measurements (≥3/day) were performed per number of days over the entire prescription period. Adherence was defined as number of performed measurements per number of expected measurements over the entire prescription period.Data from 990 consecutive patients with diagnosed AF [median age 64 (57-71) years, 39% female] from 10 centres were analyzed. Patients with both optimal motivation (100%) and adherence (≥100%) constituted 28% of the study population and had a lower percentage of recordings in sinus rhythm [90 (53-100%) vs. 100 (64-100%), P < 0.001] compared with others. Older age and absence of diabetes were predictors of both optimal motivation and adherence [odds ratio (OR) 1.02, 95% coincidence interval (95% CI): 1.01-1.04, P < 0.001 and OR: 0.49, 95% CI: 0.28-0.86, P = 0.013, respectively]. Patients with 100% motivation also had ≥100% adherence. Independent predictors for optimal adherence alone were older age (OR: 1.02, 95% CI: 1.00-1.04, P = 0.014), female sex (OR: 1.70, 95% CI: 1.29-2.23, P < 0.001), previous AF ablation (OR: 1.35, 95% CI: 1.03-1.07, P = 0.028). CONCLUSION: In the TeleCheck-AF project, more than one-fourth of patients had optimal motivation and adherence to app-based heart rate/rhythm monitoring. Older age and absence of diabetes were predictors of optimal motivation/adherence.

Reduction of Gastrointestinal Bleeding in Patients With Heyde Syndrome Undergoing Transcatheter Aortic Valve Implantation.

BACKGROUND: Heyde syndrome is the co-occurrence of aortic stenosis and gastrointestinal bleeding secondary to angiodysplasias. Surgical aortic valve replacement effectively reduces bleeding, but the effects of transcatheter aortic valve implantation (TAVI) are largely unknown. This study aimed to describe the reduction of gastrointestinal bleeding in patients with Heyde syndrome after TAVI and to identify the factors associated with rebleeding. METHODS: We enrolled patients with Heyde syndrome from a prospective TAVI registry. Gastrointestinal bleeding episodes were assessed by the Bleeding Academic Research Consortium classification, and cumulative incidence functions were used to calculate cessation rates. Factors potentially associated with rebleeding were analyzed using logistic regression. Differences between Heyde and non-Heyde patients were assessed through a case-cohort study. RESULTS: Between December 2008 and June 2020, 1111 patients underwent TAVI. There were 70 patients with Heyde syndrome (6.3%). In the first year following TAVI, gastrointestinal bleeding ceased in 46 of 70 patients (62% [95% CI, 50%-74%]). Bleeding episodes decreased from 3.2 (95% CI, 2.5-4.2) to 1.6 ([95% CI, 1.2-2.2] P=0.001) and hemoglobin levels increased from 10.3 (95% CI, 10.0-10.8) to 11.3 (95% CI, 10.8-11.6) g/dL (P=0.007). Between 1 and 5 years after TAVI (35 [interquartile range, 21-51] months), 53 of 62 patients (83% [95% CI, 72%-92%]) no longer experienced gastrointestinal bleeding. Paravalvular leakage (≥mild) was associated with rebleeding risk (odds ratio, 3.65 [95% CI, 1.36-9.80]; P=0.010). Periprocedural bleeding was more common in Heyde than in control patients (adjusted odds ratio, 2.55 [95% CI, 1.37-4.73]; P=0.003). CONCLUSIONS: Patients with Heyde syndrome are at increased risk for periprocedural bleeding. Post-TAVI, gastrointestinal bleeding disappears in the majority of patients. Paravalvular leakage may curtail these clinical benefits.

Fluid REStriction in Heart Failure vs Liberal Fluid UPtake: Rationale and Design of the Randomized FRESH-UP Study.

AIMS: It is common practice for clinicians to advise fluid restriction in patients with heart failure (HF), but data from clinical trials are lacking. Moreover, fluid restriction is associated with thirst distress and may adversely impact quality of life (QoL). To address this gap in evidence, the Fluid REStriction in Heart failure vs liberal fluid UPtake (FRESH-UP) study was initiated. METHODS: The FRESH-UP study is a randomized, controlled, open-label, multicenter trial to investigate the effects of a 3-month period of liberal fluid intake vs fluid restriction (1500 mL/day) on QoL in outpatients with chronic HF (New York Heart Association Classes II--III). The primary aim is to assess the effect on QoL after 3 months using the Overall Summary Score of the Kansas City Cardiomyopathy Questionnaire (KCCQ). Thirst distress, as assessed by the Thirst Distress Scale for patients with HF, KCCQ Clinical Summary Score, each of the KCCQ domains and clinically meaningful changes in these scores, the EQ-5D-5L, patient-reported fluid intake and safety (ie, death, HF hospitalizations) are secondary outcomes. The FRESH-UP study is registered at ClinicalTrials.gov (NCT04551729). CONCLUSION: The results of the FRESH-UP study will add substantially to the level of evidence concerning fluid management in chronic HF and may impact the QoL of these patients.

Major adverse cardiac events after elective infrarenal endovascular aortic aneurysm repair.

OBJECTIVE: There is a significant cardiac morbidity and mortality after endovascular aneurysm repair (EVAR). However, information about long-term risk of cardiac events after EVAR and potential predictors is lacking. Therefore, the aim of this study was to determine incidence and predictors of major adverse cardiac events (MACE) at 1 and 5 years after elective EVAR for infrarenal abdominal aortic aneurysms. METHODS: Baseline, perioperative, and postoperative information of 320 patients was evaluated. The primary outcome was the incidence of MACE after EVAR, which was defined as acute coronary syndrome, unstable angina pectoris, de novo atrial fibrillation, hospitalization for heart failure, mitral valve insufficiency, revascularization (including percutaneous coronary intervention and coronary artery bypass grafting), as well as cardiovascular and noncardiovascular death. Kaplan-Meier analyses were performed to determine incidences of MACE, MACE excluding noncardiovascular death and cardiac events by excluding noncardiovascular and vascular death from MACE. Predictors of MACE were identified using univariate and multivariate binary regression analysis. RESULTS: Through 1 and 5 years of follow-up after EVAR, freedom from MACE was 89.4% (standard error [SE], 0.018) and 59.8% (SE, 0.033), freedom from MACE excluding noncardiovascular death was 94.7% (SE, 0.013) and 77.5% (SE, 0.030) and freedom from cardiac events was 96.0% (SE, 0.011) and 79.1% (SE, 0.030), respectively. Predictors for MACE within 1 year were American Society of Anesthesiologists (ASA) score of III or IV (odds ratio [OR], 3.17; 95% confidence interval [CI], 1.52-6.59) and larger abdominal aortic diameter (OR, 1.04; 95% CI, 1.01-1.08). A history of atrial fibrillation (OR, 0.14; 95% CI, 0.03-0.60) was a negative predictor factor. Predictors for MACE through 5 years were a history of heart failure (OR, 4.10; 95% CI 1.36-12.32) and valvular heart disease (OR, 2.31; 95% CI, 0.97-5.51), American Society of Anesthesiologists score of 3 or 4 (OR, 1.66; 95% CI, 0.96-2.88), and older age (OR, 1.04; 95% CI, 1.01-1.08). CONCLUSIONS: MACE is a common complication during the first 5 years after elective EVAR. Cardiac diseases at baseline are strong predictors for long-term MACE and potentially helpful in optimizing future postoperative long-term follow-up.

Can a Single Measurement of Apixaban Levels Identify Patients at Risk of Overexposure? A Prospective Cohort Study.

Background Patients with atrial fibrillation (AF) are frequently treated with apixaban 2.5-mg twice daily (BID) off-label, presumably to reduce the bleeding risk. However, this approach has the potential to increase the risk of ischemic stroke. If a single measurement could reliably identify patients with high drug levels, the increased stroke risk may be mitigated by confining off-label dose reduction to such patients. Objectives This study aimed to determine whether a single high apixaban level is predictive of a similarly high level when the test is repeated in 2 months. Methods In this prospective cohort study of clinic patients receiving apixaban 5-mg BID for AF or venous thromboembolism, peak and trough apixaban levels were measured using the STA-Liquid anti-Xa assay at baseline and 2 months. We calculated the proportions of patients with levels that remained in the upper quintile. Results Of 100 enrolled patients, 82 came for a second visit, 55 of whom were treated with apixaban 5-mg BID. Seven (63.6%, 95% confidence interval [CI]: 35.4-84.8%) and nine (81.8%, 95% CI: 52.3-94.9%) of 11 patients with a baseline trough and peak level in the upper quintile, respectively, had a subsequent level that remained within this range. Only one (9.1%, 95% CI: 1.6-37.7%) patient had a subsequent level that fell just lower than the median. Conclusion The trough and peak levels of apixaban in patients who have a high level on a single occasion, usually remain high when the assay is repeated in 2 months. Accordingly, the finding of a high apixaban level in patients deemed to be at high risk of bleeding, allows physicians contemplating off-label use of the 2.5-mg BID dose to limit its use to selected patients who are less likely to be exposed to an increased risk of thrombosis.

The European TeleCheck-AF project on remote app-based management of atrial fibrillation during the COVID-19 pandemic: centre and patient experiences.

AIMS: TeleCheck-AF is a multicentre international project initiated to maintain care delivery for patients with atrial fibrillation (AF) during COVID-19 through teleconsultations supported by an on-demand photoplethysmography-based heart rate and rhythm monitoring app (FibriCheck®). We describe the characteristics, inclusion rates, and experiences from participating centres according the TeleCheck-AF infrastructure as well as characteristics and experiences from recruited patients. METHODS AND RESULTS: Three surveys exploring centre characteristics (n = 25), centre experiences (n = 23), and patient experiences (n = 826) were completed. Self-reported patient characteristics were obtained from the app. Most centres were academic (64%) and specialized public cardiology/district hospitals (36%). Majority of the centres had AF outpatient clinics (64%) and only 36% had AF ablation clinics. The time required to start patient inclusion and total number of included patients in the project was comparable for centres experienced (56%) or inexperienced in mHealth use. Within 28 weeks, 1930 AF patients were recruited, mainly for remote AF control (31% of patients) and AF ablation follow-up (42%). Average inclusion rate was highest during the lockdown restrictions and reached a steady state at a lower level after easing the restrictions (188 vs. 52 weekly recruited patients). Majority (>80%) of the centres reported no problems during the implementation of the TeleCheck-AF approach. Recruited patients [median age 64 (55-71), 62% male] agreed that the FibriCheck® app was easy to use (94%). CONCLUSION: Despite different health care settings and mobile health experiences, the TeleCheck-AF approach could be set up within an extremely short time and easily used in different European centres during COVID-19.

Self-Reported Mobile Health-Based Risk Factor and CHA2DS2-VASc-Score Assessment in Patients With Atrial Fibrillation: TeleCheck-AF Results.

INTRODUCTION: The TeleCheck-AF approach is an on-demand mobile health (mHealth) infrastructure incorporating mobile app-based heart rate and rhythm monitoring through teleconsultation. We evaluated feasibility and accuracy of self-reported mHealth-based AF risk factors and CHA2DS2-VASc-score in atrial fibrillation (AF) patients managed within this approach. MATERIALS AND METHODS: Consecutive patients from eight international TeleCheck-AF centers were asked to complete an app-based 10-item questionnaire related to risk factors, associated conditions and CHA2DS2-VASc-score components. Patient's medical history was retrieved from electronic health records (EHR). RESULTS: Among 994 patients, 954 (96%) patients (38% female, median age 65 years) completed the questionnaire and were included in this analysis. The accuracy of self-reported assessment was highest for pacemaker and anticoagulation treatment and lowest for heart failure and arrhythmias. Patients who knew that AF increases the stroke risk, more often had a 100% or ≥80% correlation between EHR- and app-based results compared to those who did not know (27 vs. 14% or 84 vs. 77%, P = 0.001). Thromboembolic events were more often reported in app (vs. EHR) in all countries, whereas higher self-reported hypertension and anticoagulant treatment were observed in Germany and heart failure in the Netherlands. If the app-based questionnaire alone was used for clinical decision-making on anticoagulation initiation, 26% of patients would have been undertreated and 6.1%-overtreated. CONCLUSION: Self-reported mHealth-based assessment of AF risk factors is feasible. It shows high accuracy of pacemaker and anticoagulation treatment, nevertheless, displays limited accuracy for some of the CHA2DS2-VASc-score components. Direct health care professional assessment of risk factors remains indispensable to ensure high quality clinical-decision making.

The photoplethysmography dictionary: practical guidance on signal interpretation and clinical scenarios from TeleCheck-AF.

Aims: Within the TeleCheck-AF project, numerous centres in Europe used on-demand photoplethysmography (PPG) technology to remotely assess heart rate and rhythm in conjunction with teleconsultations. Based on the TeleCheck-AF investigator experiences, we aimed to develop an educational structured stepwise practical guide on how to interpret PPG signals and to introduce typical clinical scenarios how on-demand PPG was used. Methods and results: During an online conference, the structured stepwise practical guide on how to interpret PPG signals was discussed and further refined during an internal review process. We provide the number of respective PPG recordings (FibriCheck®) and number of patients managed within a clinical scenario during the TeleCheck-AF project. To interpret PPG recordings, we introduce a structured stepwise practical guide and provide representative PPG recordings. In the TeleCheck-AF project, 2522 subjects collected 90 616 recordings in total. The majority of these recordings were classified by the PPG algorithm as sinus rhythm (57.6%), followed by AF (23.6%). In 9.7% of recordings, the quality was too low to interpret. The most frequent clinical scenarios where PPG technology was used in the TeleCheck-AF project was a follow-up after AF ablation (1110 patients) followed by heart rate and rhythm assessment around (tele)consultation (966 patients). Conclusion: We introduce a newly developed structured stepwise practical guide on PPG signal interpretation developed based on presented experiences from TeleCheck-AF. The present clinical scenarios for the use of on-demand PPG technology derived from the TeleCheck-AF project will help to implement PPG technology in the management of AF patients.

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.

Design and rationale of DUTCH-AF: a prospective nationwide registry programme and observational study on long-term oral antithrombotic treatment in patients with atrial fibrillation.

INTRODUCTION: Anticoagulation therapy is pivotal in the management of stroke prevention in atrial fibrillation (AF). Prospective registries, containing longitudinal data are lacking with detailed information on anticoagulant therapy, treatment adherence and AF-related adverse events in practice-based patient cohorts, in particular for non-vitamin K oral anticoagulants (NOAC). With the creation of DUTCH-AF, a nationwide longitudinal AF registry, we aim to provide clinical data and answer questions on the (anticoagulant) management over time and of the clinical course of patients with newly diagnosed AF in routine clinical care. Within DUTCH-AF, our current aim is to assess the effect of non-adherence and non-persistence of anticoagulation therapy on clinical adverse events (eg, bleeding and stroke), to determine predictors for such inadequate anticoagulant treatment, and to validate and refine bleeding prediction models. With DUTCH-AF, we provide the basis for a continuing nationwide AF registry, which will facilitate subsequent research, including future registry-based clinical trials. METHODS AND ANALYSIS: The DUTCH-AF registry is a nationwide, prospective registry of patients with newly diagnosed 'non-valvular' AF. Patients will be enrolled from primary, secondary and tertiary care practices across the Netherlands. A target of 6000 patients for this initial cohort will be followed for at least 2 years. Data on thromboembolic and bleeding events, changes in antithrombotic therapy and hospital admissions will be registered. Pharmacy-dispensing data will be obtained to calculate parameters of adherence and persistence to anticoagulant treatment, which will be linked to AF-related outcomes such as ischaemic stroke and major bleeding. In a subset of patients, anticoagulation adherence and beliefs about drugs will be assessed by questionnaire. ETHICS AND DISSEMINATION: This study protocol was approved as exempt for formal review according to Dutch law by the Medical Ethics Committee of the Leiden University Medical Centre, Leiden, the Netherlands. Results will be disseminated by publications in peer-reviewed journals and presentations at scientific congresses. TRIAL REGISTRATION NUMBER: Trial NL7467, NTR7706 (https://www.trialregister.nl/trial/7464).

When to withhold oral anticoagulation in atrial fibrillation - an overview of frequent clinical discussion topics.

Stroke prevention with oral anticoagulants in patients with atrial fibrillation predisposes for bleeding. As a result, in select patient groups anticoagulation is withheld because of a perceived unfavorable risk-benefit ratio. Reasons for withholding anticoagulation can vary greatly between clinicians, often leading to discussion in daily clinical practice on the best approach. To guide clinical decision-making, we have reviewed available evidence on the most frequently reported reasons for withholding anticoagulation: previous bleeding, frailty and age, and an overall high bleeding risk.