Percutaneous mitral valve repair in high-risk patients: initial experience with the Mitraclip system in Belgium.

AIMS: Treatment with percutaneous edge-to-edge mitral valve repair (Mitraclip) has recently been recommended as an alternative to conventional mitral valve repair for high surgical risk patients with symptomatic severe mitral regurgitation (MR). In this study, we report the first use of Mitraclip therapy in Belgium. METHODS AND RESULTS: This prospective registry includes 41 consecutive patients treated with the Mitraclip in two Belgian centres from October 2010 to June 2013. Acute procedural success, in-hospital safety end points and clinical status were analysed on an intention-to-treat basis up to one year after the procedure. In addition, determinants of major adverse cardiac events (MACE, death, surgical mitral valve intervention, and rehospitalization for heart failure) were analysed. Acute procedural success (successful clip placement and reduction of colour Doppler flow MR to < or = 2) was obtained in 32 patients (78%) and 18 of these patients received two clips. The primary safety end point was reached in 36 pts (88%): one patient died due to intracranial bleeding, there were three urgent surgical interventions and one severe access site bleeding. The MACE rate after one year was 41% (17 patients). There were 11 deaths (27%), six surgical interventions (15%) and 10 rehospitalizations for heart failure (24%). Additional subgroup analysis revealed that the one-year MACE rate was particularly high in patients with left ventricular ejection fraction (LVEF) < 25%: 62% vs. 36% in patients with LVEF > or = 5% (P = 0.05). At one year, MR < or = 2+ and NYHA class < or = 2 was present in 83% of the surviving patients CONCLUSION: In high-risk patients with functional MR, treatment with the Mitraclip-device is a feasible and safe option resulting in improvement of MR severity and clinical symptoms. However, as MACE is high in some subgroups (e.g. LVEF < 25%), careful patient selection is crucial to ensure the maximum benefit from this new technique.

Engagement of atrial fibrillation patients with the AF-EduApp, a new mobile application to support AF management.

Introduction: A multidisciplinary approach is needed for the management of atrial fibrillation (AF) in which the patient has a central role. Smart devices create opportunities to improve AF management. This paper aimed to evaluate the in-house developed AF-EduApp application on its usability, satisfaction, and communication effectiveness with the care team. Methods: During a multicenter, prospective randomized controlled trial, 153 AF patients were included in the AF-EduApp study, with a minimum follow-up of 12 months and a maximum follow-up of 15 months if taking oral anticoagulation (OAC). The AF-EduApp contains six main modules: Questionnaires, Education, Measurement data entry, Medication overview with reminders, Appointments, and Communication with the care team. The App focuses on four main goals: (1) to improve AF knowledge, (2) to increase self-care capabilities, (3) electronic monitoring to improve therapy adherence to OAC, and (4) communication with the care team. Patients unable to use the AF-EduApp were assigned to a no-App control group (n = 41) without intervention comparable to the standard care group (SC, n = 346) of the AF-EduCare study. Results: A total of 152 patients effectively used the App during a mean follow-up of 386.8 ± 108. 1 days (one included patient could not install the application due to an iPhone from the United States). They opened the application on average on 130.1 ± 144.7 days. Of the 109 patients still in follow-up after 12 months (i.e. patients who did not withdraw and on OAC), 90 patients (82.6%) actively used the application at least one day in the next 41 days. The Measurement module was the most used, with a median of used days over the total available days of 6.4%. A total of 75 App patients (49.3%) asked questions, mostly clinical-related questions (e.g. medication use, or actionability on clinical entered parameters). A mean score of 8.1 ± 1.7 about the "perceived quality of follow-up in the past year" was given by the App ITT patients, compared to a score of 7.7 ± 2.0 by the SC group (P = .072). Patients who used the App were more attracted to future follow-up with an application compared to patients who would be capable of using the application of the SC group (31.6% vs. 12.5%; P < .001). Conclusion: This study showed a positive attitude towards using a mobile application, with AF patients using the application one-third of the available days. Patients used the App most for entering measured parameters, and to contact the care team.

Baseline demographics of a contemporary Belgian atrial fibrillation cohort included in a large randomised clinical trial on targeted education and integrated care (AF-EduCare/AF-EduApp study).

Background: As the prevalence of atrial fibrillation (AF) increases worldwide and AF management becomes ever more diversified and personalised, insights into (regional) AF patient demographics and contemporary AF management are needed. This paper reports the current AF management and baseline demographics of a Belgian AF population recruited for a large multicenter integrated AF study (AF-EduCare/AF-EduApp study). Methods: We analyzed data from 1,979 AF patients, assessed between 2018 and 2021 for the AF-EduCare/AF-EduApp study. The trial randomised consecutive patients with AF (irrespective of AF history duration) into three educational intervention groups (in person-, online-, and application-based), compared with standard care. Baseline demographics of both the included and excluded/refused patients are reported. Results: The mean age of the trial population was 71.2 ± 9.1 years, with a mean CHA2DS2-VASc score of 3.4 ± 1.8. Of all screened patients, 42.4% were asymptomatic at presentation. Being overweight was the most common comorbidty, present in 68.9%, while 65.0% were diagnosed with hypertension. Anticoagulation therapy was prescribed in 90.9% of the total population and in 94.0% of the patients with an indication for thromboembolic prophylaxis. Of the 1,979 assessed AF patients, 1,232 (62.3%) were enrolled in the AF-EduCare/AF-EduApp study, with transportation problems (33.4%) as the main reason for refusal/non-inclusion. About half of the included patients were recruited at the cardiology ward (53.8%). AF was first diagnosed, paroxysmal, persistent and permanent in 13.9%, 47.4%, 22.8% and 11.3%, respectively. Patients who refused or were excluded were older (73.3 ± 9.2 vs. 69.8 ± 8.9 years, p < 0.001) and had more comorbidities (CHA2DS2-VASc 3.8 ± 1.8 vs. 3.1 ± 1.7, p < 0.001). The four AF-EduCare/AF-EduApp study groups were comparable across the vast majority of parameters. Conclusions: The population showed high use of anticoagulation therapy, in line with current guidelines. In contrast to other AF trials about integrated care, the AF-EduCare/AF-EduApp study managed to incorporate all types of AF patients, both out-patient and hospitalised, with very comparable patient demographics across all subgroups. The trial will analyze whether different approaches to patient education and integrated AF care have an impact on clinical outcomes. Clinical Trial Registration: https://clinicaltrials.gov/ct2/show/NCT03707873?term=af-educare&draw=2&rank=1, identifier: NCT03707873; https://clinicaltrials.gov/ct2/show/NCT03788044?term=af-eduapp&draw=2&rank=1, identifier: NCT03788044.

Adherence to oral anticoagulation measured by electronic monitoring in a Belgian atrial fibrillation population.

INTRODUCTION: Stroke prevention using oral anticoagulation (OAC) is the first management priority in atrial fibrillation (AF). Despite the importance of good therapy adherence, real-world adherence is still suboptimal. Patient education and adherence monitoring with new technologies are recommended. The main purpose of this sub-analysis of the AF-EduCare trial was to evaluate the effect of personalized follow-up strategies on adherence to OAC. METHODS: Regimen adherence was monitored by the electronic Medication Event Monitoring System cap at the start of the trial (M1) and after 12 months (M2), each for three months. Patients were part of one of three education groups (In-person, Online or App-based) or the standard care (SC) group. All are qualified for OAC therapy. RESULTS: A total of 768 patients were evaluated (11.8% SC vs. 86.8% any education group, mean age: 70.1 ± 7.9 years). Patients were taking non-vitamin K OAC (once daily 53.8%; twice daily 35.9%) or vitamin K antagonists (9.4%), equally distributed over the different study arms (p = 0.457). Mean therapy adherence was high (M1:93.8 ± 10.8%; M2:94.1 ± 10.1%). During both monitoring periods, the education group scored significantly higher than SC (M1:94.2 ± 10.0% vs. 91.3 ± 15.0%; p = 0.027; M2:94.4 ± 9.3% vs. 91.6 ± 14.0%; p = 0.006). More patients in the In-person and Online groups were able to keep or improve their adherence to > 90% compared to the SC. CONCLUSION: Overall adherence to OAC in all study groups, even in SC, was very high, without attrition over time. Nevertheless, targeted education led to a small but significantly improved adherence compared to SC.

Appropriateness of Non-vitamin K Antagonist Oral Anticoagulants Dosing According to Different Prescription Guides Used in Belgian Ambulatory Care.

BACKGROUND: Non-vitamin K antagonist oral anticoagulants (NOACs) are the preferred choice of anticoagulants to prevent stroke in most patients with atrial fibrillation (AF). NOAC's dosing algorithms are defined in the respective Summary of Product Characteristics (SmPC) but the European Heart Rhythm Association (EHRA) Practical Guide can also be used as it considers more complex clinical scenarios. Nevertheless, suboptimal dosing of NOACs compromises the efficacy and safety of this commonly prescribed therapy in the AF population. Clearer objectification of inappropriate dosing and its influencing factors is needed to optimise management of AF patients. OBJECTIVES: The primary aim of this study was  to investigate whether there is a difference in the perceived appropriateness of NOAC dosing with respect to the SmPC or the 2018 EHRA Practical Guide in AF patients criteria and influencing factors. The secondary aim was to explore if there were differences in appropriateness of NOAC dosing between primary care and specialist care, and when using different renal function formulas. METHODS: This retrospective study included AF patients treated with a NOAC in primary or in ambulatory specialist care in Antwerp (Belgium). Appropriateness of the NOAC dose was assessed according to the SmPC and 2018 EHRA recommendations. Univariate/multivariate analyses were performed to explore influencing factors for under- and overdosing of NOACs. RESULTS: Of the included 294 AF patients, 19.4% and 15.6% received an inappropriate dose according to the SmPC and the 2018 EHRA Practical Guide respectively (p = 0.003). Perceived frailty and higher weight were associated with underdosing relative to the SmPC, while a higher body mass index and the use of drugs/alcohol were associated with underdosing relative to the EHRA 2018 recommendations. Lower renal function and treatment with other NOACs than apixaban were associated with relative overdosing compared to both standards. CONCLUSIONS: Inappropriate NOAC dosing is present in almost twenty percent of AF patients according to the SmPC and requires further education of health care professionals and frequent reassessment of NOAC dosing. However, a significant lower prevalence of underdosing was present when judged by the 2018 EHRA criteria, likely reflecting decision making in complex AF patients. Perceived frailty, weight, renal function and type of NOAC are the main determinants of deviated dosing.

Cardiorespiratory Polygraphy for Detection of Obstructive Sleep Apnea in Patients With Atrial Fibrillation.

Background: Obstructive sleep apnea (OSA) is a modifiable risk factor of atrial fibrillation (AF) but is underdiagnosed in these patients due to absence of good OSA screening pathways. Polysomnography (PSG) is the gold standard for diagnosing OSA but too resource-intensive as a screening tool. We explored whether cardiorespiratory polygraphy (PG) devices using an automated algorithm for Apnea-Hypopnea Index (AHI) determination can meet the requirements of a good screening tool in AF patients. Methods: This prospective study validated the performance of three PGs [ApneaLink Air (ALA), SOMNOtouch RESP (STR) and SpiderSAS (SpS)] in consecutive AF patients who were referred for PSG evaluation. Patients wore one of the three PGs simultaneously with PSG, and a different PG during each of three consecutive nights at home. Severity of OSA was classified according to the AHI during PSG (<5 = no OSA, 5-14 = mild, 15-30 = moderate, >30 = severe). Results: Of the 100 included AF patients, PSG diagnosed at least moderate in 69% and severe OSA in 33%. Successful PG execution at home was obtained in 79.1, 80.2 and 86.8% of patients with the ALA, STR and SpS, respectively. For the detection of clinically relevant OSA (AHI ≥ 15), an area under the curve of 0.802, 0.772 and 0.803 was calculated for the ALA, STR and SpS, respectively. Conclusions: This study indicates that home-worn PGs with an automated AHI algorithm can be used as OSA screening tools in AF patients. Based on an appropriate AHI cut-off value for each PG, the device can guide referral for definite PSG diagnosis.

A new smartphone application for integrated transmural care of atrial fibrillation, AF-EduApp: Usability and validation study.

INTRODUCTION: Digital technology creates the opportunity to develop and evaluate new tools, such as smartphone applications, to support integrated atrial fibrillation management. This study aimed to develop, evaluate, and validate a new, integrated care application (AF-EduApp) mainly focusing on targeted atrial fibrillation education to improve patient self-care capabilities and therapy adherence. METHODS: The newly developed AF-EduApp, available for Android and iOS, consists of six different modules. The prototype was validated and optimized for its usability and functionality at Jessa Hospital Hasselt and Antwerp University Hospital in two phases: (1) validity evaluation with interviews of an expert panel with 15 healthcare professionals and 10 atrial fibrillation patients, and (2) a pilot study of 1 month with 20 atrial fibrillation patients. RESULTS: Both experts and patients found that the application aids atrial fibrillation management. Based on the input of patients and experts, the main optimizations concerned the medication module (patient choice on setting reminder; interactivity of reminders with a "taken" or "snooze" function) and development of a clinical dashboard for the caregivers allowing telemonitoring of measurements and feedback to the patients. After the pilot study (n = 20), 16 patients indicated they wanted to use the app for a longer period. The measurement (27%) and education (17%) modules were the two most used modules with a significant improvement in knowledge (71.9% to 87.5%; P = 0.013). DISCUSSION: The AF-EduApp received a positive evaluation from health professionals and atrial fibrillation patients. Further development should be focused on the medication module and improvement of the clinical dashboard.

The value of screening questionnaires/scoring scales for obstructive sleep apnoea in patients with atrial fibrillation.

BACKGROUND: Obstructive sleep apnoea (OSA) is an important modifiable risk factor for atrial fibrillation (AF) but is underdiagnosed in this population. Currently, polysomnography is the gold standard for diagnosing OSA, but is expensive and requires overnight examination. Alternatively, home sleep apnoea testing can be used as a diagnostic tool, but also requires a complete data review. Therefore, these OSA diagnostic modalities are not ideal screening methods. Several OSA screening tools exist, but their value in patients with AF remains unclear. AIM: To test the performance of existing screening questionnaires/scales for clinically relevant OSA in patients with AF referred for diagnostic polysomnography. METHODS: This prospective study compared the performance of seven screening tools (Epworth Sleepiness Scale, Berlin Questionnaire, Sleep Apnea Clinical Score, NoSAS, OSA50, STOP-Bang and MOODS) with polysomnography in the detection of clinically relevant OSA in consecutive patients with AF referred to two sleep clinics. RESULTS: A total of 100 patients referred for polysomnography and known previous AF were included. Polysomnography indicated at least clinically relevant OSA (i.e., apnoea-hypopnoea index≥15 events/hour) in 69% of cases, and 33% had severe OSA (apnoea-hypopnoea index>30 events/hour). In screening for clinically relevant OSA, only the SACS and NoSAS scores had fair areas under the curve (0.704 and 0.712, respectively). None of the seven screening tools was performant enough (i.e., had a fair area under the curve>0.7) in the detection of severe OSA. CONCLUSIONS: In this AF cohort referred for polysomnography, clinically relevant OSA was prevalent. None of the selected screening tools showed sufficient performance as a good discriminative screening tool for clinically relevant OSA in patients with AF. Given these findings, other screening modalities for OSA should be considered in the work-up of patients with AF.

Motivation of overweight patients with atrial fibrillation to lose weight or to follow a weight loss management program: a cross-sectional study.

AIMS: Overweight increases the risk of recurrence and progression of atrial fibrillation (AF). This study assesses the knowledge of overweight AF patients about the relation between their weight and AF, to gauge their motivation losing weight and/or following weight reduction programs. METHODS: A multicenter cross-sectional descriptive study was performed at three Belgian hospitals. A validated self-developed questionnaire was presented to AF patients with a body mass index (BMI) >27 kg/m2 and it addressed: motivation to reduce weight and its related factors; knowledge about the relation between weight and AF; and interest in weight reduction programs. RESULTS: One hundred and forty-three patients completed the questionnaire. 75.5% was currently motivated to reduce weight. Multivariate regression analysis showed that a higher BMI, a college/university degree, male gender, without hypertension, previous weight loss attempt(s) and living with a partner, were significantly associated with greater motivation for weight reduction. Only 69.9% of the patients was aware of the positive effect of weight reduction on the progression of AF. A completely home-based/telerehabilitation program was the preferred approach for 57.9% of the patients. CONCLUSIONS: AF patients with overweight need to be better informed about overweight as a risk factor for AF. Female AF patients with a lower degree of education, hypertension, living alone, who have never attempted to reduce weight and with a lower but still elevated BMI need more external motivation to lose weight. A tailored weight reduction program (home-based) is the preferred option for patients. This will require further development and validation of telecoaching programs for this patient group.

Effect of reinforced, targeted in-person education using the Jessa Atrial fibrillation Knowledge Questionnaire in patients with atrial fibrillation: A randomized controlled trial.

BACKGROUND: The knowledge level of atrial fibrillation patients about their arrhythmia, its consequences and treatment is poor. The best strategy to provide education is unknown. AIM: To investigate the effect of reinforced targeted in-person education using the Jessa Atrial fibrillation Knowledge Questionnaire (JAKQ). METHODS: Sixty-seven atrial fibrillation patients were randomized to standard care (including brochures) or targeted education. Follow-up visits were scheduled after one, three, six and 12 months. Targeted education during each visit focused on the knowledge gaps revealed by the JAKQ. Patients completed two questionnaires to assess their quality of life and symptom profile. Adherence to non-vitamin K antagonist oral anticoagulants was measured using electronic monitoring. RESULTS: Sixty-two patients (31 education; 31 standard care) completed follow-up. Median baseline score on the JAKQ was similar in education (62.5%) and standard care group (56.3%; p=0.815). The intervention group scored significantly better over time (one month: 75.0%, 12 months: 87.5%; p<0.001) whereas there was no significant improvement in the control group (one month: 62.5%, 12 months: 62.5%; p=0.085). Providing targeted education after completion of the JAKQ required on average 6.9±4.6 min. Some improvements in quality of life, symptom burden and adherence were shown, without significant differences between the two groups ( p-values between 0.282 and 0.677). CONCLUSION: The JAKQ is an effective tool for providing individualized education. A first targeted educational session significantly improved patients' knowledge level. Additional educational sessions maintained and strengthened this effect. A larger scale study is warranted to evaluate the impact on adherence and outcome measures.

Effectiveness and usability of an online tailored education platform for atrial fibrillation patients undergoing a direct current cardioversion or pulmonary vein isolation.

BACKGROUND: Atrial fibrillation (AF) care should strive for more informed, involved and empowered patients. However, few effective educational programs are available. The aim of this study was to evaluate the effectiveness of an online tailored education platform to inform AF patients undergoing a direct current cardioversion (DCC) or a pulmonary vein isolation (PVI). METHODS: 120 AF patients requiring DCC or PVI were allocated to an online education group (n = 35), a standard care group despite having online access (n = 36; randomized with group 1), and a group without a computer/tablet/smartphone receiving standard care (n = 49). The Jessa Atrial fibrillation Knowledge Questionnaire (JAKQ), supplemented with procedure-specific questions, had to be completed 1-3 weeks before hospitalization, at hospitalization, and 6 and/or 12 weeks post-procedurally. RESULTS: Major AF-related and procedure-related knowledge gaps were shown. The online tailored education group scored significantly better at hospitalization compared to baseline (P = 0.001). This knowledge increase was retained after 6 (P = 0.010) and 12 (P < 0.001) weeks. In the online standard care group there was no change in knowledge from planning till hospitalization (P = 1.000), although knowledge was improved 6 weeks post-procedurally (P = 0.010). Knowledge did not improve in the group without computer/tablet/smartphone at any time (P = 0.248). Most patients indicated that the platform was easy to use (87.9%), understandable (97.0%), and 72.7% indicated that an online platform was their preferred way to receive future AF-related information. CONCLUSIONS: Tailored online education is an effective strategy to improve AF- and procedure-related knowledge with lasting effects up to 12 weeks post-procedurally. The platform was positively evaluated by patients.