Atrial Fibrillation Effect On Quality-of-Life Research Articles

Quality of life improvement from thoracoscopic atrial fibrillation ablation in women versus men: a prospective cohort study.

Thoracoscopic ablation has proven to be an effective and safe rhythm control strategy, especially for persistent atrial fibrillation. However, its impact on quality of life and potential gender differences remains unclear. this prospective, single-centre observational study included consecutive patients with symptomatic atrial fibrillation undergoing thoracoscopic ablation. Quality of life was measured using the Short Form 36 (SF-36) and Atrial Fibrillation Effect on Quality-of-Life (AFEQT) questionnaires and longitudinal trend analysis including linear mixed models was used to assess gender-specific differences. 191 patients were included; mean age 63.9 ± 8.6 years, 61 (31.9%) women and 148 (77.5%) with non-paroxysmal atrial fibrillation. Women were older, more symptomatic and reported lower baseline quality of life. AFEQT summary scores substantially improved after three months (relative increase 51.5% from baseline; p < 0.001) and persisted up to 1-year (57.2%; p < 0.001). Women showed substantial quality of life improvement which was comparable to men at 1 year. Distinct gender-related trajectories for AFEQT were observed. Women showed more often clinically important decline over time, yet AF recurrence and age were predictive factors in both men and women. Patients with AF recurrence also experienced QoL improvements, albeit to a lesser extent than those in sinus rhythm (61.3% vs 26.9%, p < 0.001), with no differences between men and women. Thoracoscopic ablation for atrial fibrillation results in substantial quality of life improvement and was comparable for men and women. Understanding sex-specific and age-related trajectories is important to further enhance patient-centered atrial fibrillation care.

Predictors of quality of life improvement in patients undergoing catheter ablation for atrial fibrillation: a cluster-based analysis

Abstract Introduction Traditional classification of Atrial Fibrillation (AF) based on temporal patterns doesn't fully encompass the condition's complexity. Unsupervised cluster analyses have been used for classifying patients into groups with similar comorbid profiles. However, inconsistent comorbidity patterns have been found across different cohorts. Bayesian profile regression, a semi-supervised machine learning technique, may improve the precision of clustering by integrating outcome data, diminishing the variability observed with previous methods. Since quality of life (QoL) primarily drives the indication for AF ablation, we utilized the AF Effect on QualiTy-of-Life (AFEQT) questionnaire to cluster patients. Purpose Our aim is to use patient-reported outcome measures to identify clinically relevant phenotypes of AF that benefit the most from catheter ablation. Methods We implemented a single center follow-up (FUP) program for patients with AF referred for ablation since august 2020, including scheduled visits and remote monitoring through a digital health platform. AFEQT score reported by patients was analyzed using a non-linear mixed model and change in AFEQT by month 12 was used as outcome. Comorbidities, echocardiographic data, and biomarkers were collected. Profile regression mixture modelling guided by QoL improvement was performed to create clinically relevant patient groupings. Penalized multinomial logistic regression model was used for validation. Results From the 466 ablations performed, 354 patients were enrolled until July 2023. 211 patients had FUP &amp;gt; 12 months (age 59±10 years, 31% female, 80% paroxysmal). The overall AFEQT questionnaire completeness rate was 72%. Patients were classified into 3 clusters: 1) patients with long duration AF, left heart cavities enlargement and diastolic dysfunction (n=57); 2) patients with self-reported anxiety/depression (n=50); and 3) patients with low rates of comorbidities (n=104). For clinical application, 8 variables (dyslipidemia, AF type and duration since diagnosis, mitral E/A ratio, systolic pulmonary arterial pressure, left ventricle ejection fraction, and PROMIS T-score for anxiety and depression) were sufficient for classifying patients (85% accuracy in internal cross-validation). Patients with higher depressive and anxiety burden (cluster 2) had worse baseline AFEQT score (median: 46, IQR: 39-60) and derived less benefit (median improvement: 21, IQR: 12-32), while patients with low comorbid burden (cluster 3) displayed higher baseline (median: 58, IQR: 48-62) and final QoL (median improvement: 28, IQR: 21-36, p&amp;lt;0.01). Conclusion Our analysis identified 3 reproducible clinically relevant phenotypes of AF using widely available clinical data. These clusters have distinct associations with QoL, underscoring the heterogeneity of AF and importance of comorbidities and substrates. This approach may allow for the prediction of which patients are most likely to benefit from treatment.

Patient-reported outcomes in atrial fibrillation clinical trials: trends, utilisation, and implications

Abstract Background/Introduction Atrial fibrillation (AF) is the most prevalent clinical arrhythmia, and it is associated with diverse and consequential adverse outcomes that significantly impact the quality of life (QoL) experienced by patients. The evaluation and quantification of QoL have become an important aspect of assessing AF patients, with patient-reported outcomes (PROs) increasingly used in cardiovascular clinical trials. However, there is no consensus on which PROs are most suitable to report, and there is a limited understanding of their prevalence in AF clinical trials. Purpose This study aims to characterise the utilisation of PROs in AF clinical trials. We distinguish between AF-specific and AF-agnostic PROs, with the goal of understanding the evolving role of PROs and emphasising the significance of precise measurement of patient QoL in AF research. Methods We queried the ClinicalTrials.gov database for all available clinical trials that focused on AF as the primary condition from inception to August 1, 2023. This search yielded 3,208 clinical trials, encompassing a total of 65,545,864 participants. We filtered and manually reviewed each clinical trial for their use of PROs within the "outcomes measures" field and divided the results between AF-specific and AF-agnostic PROs. We displayed these findings over time (Figure) and conducted a linear regression analysis for each PRO. Results Of the 3,208 AF clinical trials, 569 (17.7%) reported using at least one PRO, with 178 (5.5%) using AF-specific PROs. There was a statistically significant increase in the use of PROs between 2000 and 2023 (8 vs. 518; P &amp;lt; 0.001; R2= 0.959). This finding held for both AF-specific PROs between 2000 and 2023 (0 vs. 79; P &amp;lt; 0.001; R2=0.930) and AF-agnostic PROs between 2000 and 2023 (8 vs. 360; P &amp;lt; 0.001; R2=0.969). The Atrial Fibrillation Effect on Quality-of-life (AFEQT) was the most used AF-specific PRO, utilized 130 times, with its usage increasing between 2000 and 2023 (0 vs. 61; P = 0.003; R2= 0.888). The EQ-5D was the most frequently used AF-agnostic PRO, employed 131 times. Conclusion The study reveals a significant increase in the use of PROs in AF clinical trials over time. While most trials use AF-agnostic PROs for measuring QoL, several AF-specific PROs, especially AFEQT, have gained wide adoption. These findings underscore the importance of patient-centred outcomes and suggest the increasing emphasis on PROs in AF research. However, significant heterogeneity remains in the choice of PROs, with limited utilisation of validated, AF-specific measures. Future research should focus on understanding the distinct strengths and limitations of AF-specific PROs compared to AF-agnostic ones and promoting their appropriate integration into AF clinical trials to improve patient-centred care for AF patients.Figure

Catheter ablation for persistent atrial fibrillation: patterns of recurrence and impact on quality of life and health care utilisation.

Patterns of atrial fibrillation (AF) recurrence post catheter ablation for persistent AF are not well described. This study aimed to describe the pattern of AF recurrence seen following catheter ablation for persistent AF (PsAF) and the implications for healthcare utilisation and quality of life. This was a post-hoc analysis of the CAPLA study, an international, multi-centre study that randomised patients with symptomatic PsAF to pulmonary vein isolation plus posterior wall isolation or pulmonary vein isolation alone. Patients underwent twice daily single lead ECG, implantable device monitoring or three monthly Holter monitoring. 154 of 333 (46.2%) patients (median age 67.3 years, 28% female) experienced AF recurrence at 12-month follow-up. Recurrence was paroxysmal in 97 (63%) patients and persistent in 57 (37%). Recurrence type did not differ between randomisation groups (p=0.508). Median AF burden was 27.4% in PsAF recurrence and 0.9% in paroxysmal AF (PAF) recurrence (p<0.001). Patients with PsAF recurrence had lower baseline left ventricular ejection fraction (PsAF 50% vs PAF 60%, p<0.001) and larger left atrial volume (PsAF 54.2±19.3 ml/m² vs PAF 44.8±11.6 ml/m², p=0.008). Healthcare utilisation was significantly higher in PsAF (45 patients [78.9%]) vs PAF recurrence (45 patients [46.4%], p<0.001) and lowest in those without recurrence (17 patients [9.5%], p<0.001). Patients without AF recurrence had greater improvements in quality of life as assessed by the Atrial Fibrillation Effect on Quality-of-Life (AFEQT) questionnaire (Δ33.3±25.2 points) compared to those with PAF (Δ24.0±25.0 points, p=0.012) or PsAF (Δ13.4±22.9 points, p<0.001) recurrence. AF recurrence is more often paroxysmal after catheter ablation for PsAF irrespective of ablation strategy. Recurrent PsAF was associated with higher AF burden, increased healthcare utilisation and antiarrhythmic drug use. The type of AF recurrence and AF burden may be considered important endpoints in clinical trials investigating ablation of PsAF.

Physician Estimates and Patient-Reported Health Status in Atrial Fibrillation

A primary objective in managing atrial fibrillation (AF) is to optimize patients' health status, which can be done only if physicians accurately quantify the outcomes associated with AF in patients' lives. To explore physicians' estimation of the health status of patients with AF and its association with subsequent care and outcomes. A multicenter, prospective cohort study was conducted in 2 outpatient practices in Tokyo, Japan. Participants included patients with newly diagnosed AF or those referred for initial treatment of AF at outpatient practices and treating physicians from November 8, 2018, to April 1, 2020. Data analysis was performed from December 22, 2022, to July 7, 2023. Participating patients completed the Atrial Fibrillation Effect on Quality-of-Life (AFEQT) questionnaire, a 20-item tool covering 4 domains with a 7-point Likert scale; 3 domains (symptoms, daily activities, and treatment concerns) were used in this study. Blinded to patients' responses, treating physicians answered a 3-item questionnaire quantifying each patient's AFEQT domain with a single item. Patients' mean Likert scale responses within each AFEQT domain were subtracted from the physicians' assessments so that higher scores (≥0.5 points) indicate physician underestimation, while lower scores (≤0.5 points) indicate physician overestimation of the health status of patients with AF. The independent association of physician-patient concordance with treatment escalation (alteration or initiation of antiarrhythmic drugs, cardioversion, or catheter ablation) and 1-year adjusted changes in AFEQT scores. Among 330 patients (238 [72.1%] men; mean [SD] age, 67.9 [11.9] years; 163 [49.4%] with paroxysmal AF), physicians correctly estimated health status in 112 patients (33.9%), underestimated it in 42 patients (12.7%), and overestimated it in 176 patients (53.3%). Treatment escalation occurred in 63.6% of patients whose health status was correctly estimated, 47.6% of those whose health status was underestimated, and 66.3% of patients whose health status was overestimated. After multivariable adjustment, underestimation of health status was independently associated with less treatment escalation (adjusted odds ratio, 0.43; 95% CI, 0.20-0.90) and less frequent AFEQT overall summary score improvement at 1 year (underestimated, 2.5 [95% CI, -1.6 to 6.7] vs correctly and overestimated health status, 8.4 [95% CI, 7.0-9.9] points; P = .01). In this cohort study, physician underestimation of the health status of patients with AF was common and associated with less aggressive treatment and less health status improvement at 1 year.

Clinical Utility of Baseline Brain Natriuretic Peptide Levels on Health Status Outcomes after Catheter Ablation for Atrial Fibrillation in Individuals without Heart Failure.

Catheter ablation (CA) benefits atrial fibrillation (AF) patients with heart failure (HF). Brain natriuretic peptide (BNP), a marker of left-ventricular pressure load, may serve as a potential surrogate for predicting quality of life (QOL) in a broader range of patients. Within the multicenter KiCS-AF registry, 491 AF patients underwent CA without clinical HF (e.g., documented history of HF, left ventricular ejection fraction ≤ 40%, or BNP levels ≥ 100 pg/mL). Participants, aged 61 ± 10 years, were categorized by baseline BNP quartiles. Atrial Fibrillation Effect on QualiTy-of-Life (AFEQT) questionnaire assessments were assessed at baseline and 1 year. A lower baseline BNP correlated with reduced AFEQT scores. Post CA, all groups showed significant AFEQT score improvements. The lower-BNP group displayed notable enhancements (18.2 ± 1.2, 15.0 ± 1.1, 12.6 ± 1.2, 13.6 ± 1.2, p < 0.005), especially in symptom and treatment concern areas. Even those with normal BNP levels (≤18.4 pg/mL) exhibited significant QOL improvements. Comparing paroxysmal AF (PAF) and non-PAF groups, the PAF group, especially with higher BNP levels, showed greater AFEQT score improvements. This study establishes BNP as a predictive marker for QOL enhancement in non-HF patients undergoing CA for AF. BNP levels represent AF stages, with individuals in earlier stages, especially within normal BNP levels, experiencing greater QOL improvements.

Catheter Ablation of Paroxysmal and Persistent Atrial Fibrillation in Patients with Secondary Atrial Septal Defect. Evaluation of the Results and Impact on the Quality of Life

Introduction. The presence of atrial fibrillation (AF) in patients with secondary atrial septal defect (ASD) has significant impact on their quality of life (QoL) and reduces life expectancy. Current guidelines recommend catheter ablation (CA) for patients with AF in case of medical treatment failure, however, its use in patients with AF and ASD is still poorly studied.&#x0D; The aim. To study the efficacy and safety of CA and its impact on the QoL in patients with AF and secondary ASD.&#x0D; Materials and methods. In 2003-2023, 1408 patients with secondary ASD were treated at the National Amosov Institute of Cardiovascular Surgery of the National Academy of Medical Sciences of Ukraine. Of these, 54 patients who had AF and underwent the CA procedure were included in group 1 of our study. There were 36 (66.7%) men and 18 (33.3%) women aged 24-76 years (mean age 61.4 ± 9.8 years). Four (9.3%) patients had persistent AF and 50 (90.7%) patients had paroxysmal AF. Fifty-six patients with paroxysmal or persistent AF and with the comparable age, duration of symptoms and associated pathology but without ASD were examined as group 2. The type and results of surgical interventions were analyzed according to surgical reports. The results of the treatment and QoL were assessed using the Atrial Fibrillation Effect on Quality-of-Life (AFEQT) questionnaire during the follow-up period 1, 2 and 3 months after the procedure.&#x0D; Results. Pulmonary vein isolation was performed in all 54 (100%) patients of the group 1, as well as cavotricuspid isthmus ablation in 26 (48.2%) cases, cavotricuspid isthmus ablation and left atrial linear ablation in 2 (3.6%) cases. Type, length and complication of the procedure were comparable to those in the group 2. Fourty-four (81.5%) patients with ASD were free from AF 3 months after procedure, and their results did not differ from those obtained in the group 2 (p &gt; 0.05). Average QoL indicators according to AFEQT significantly improved in both groups of patients who underwent CA. The differences in post-treatment QoL between patients of both groups were insignificant (p &gt; 0.05).&#x0D; Conclusions. CA was found to be safe and beneficial in patients with AF and secondary ASD. The rate of procedural complications and cure rate in patients with AF and secondary ASD (81.5%) were compatible to those in patients without ASD (80.5%). AF has negative effect on the main indicators of the patient’s life. In patients with secondary AF with ASD who underwent CA, a significant improvement in AF symptoms and QoL according to the AFEQT questionnaire (total score 56.1 ± 2.7 before the procedure vs. 78.7 ± 4.0 at follow-up) was noted.

Quality of life before and after pulmonary vein isolation for atrial fibrillation: results of a multicenter cohort study in the Netherlands

Abstract Background In the treatment of patients with symptomatic atrial fibrillation (AF) reducing AF-related symptoms and improving health-related quality of life (HRQol) are important drivers in the decision for pulmonary vein isolation (PVI). Eventhought the majority of PVI patients has improved HRQoL after PVI, up to a third of patients do not. We aim to assess the association between various patient characteristics, intervention and outcome variables and HRQol both prior to and one-year after PVI with specific attention for those groups that did not improve or were still impaired in HRQoL after PVI. Methods In this observational, retrospective multicenter cohort study, we used data from 8 hospitals participating within the Netherlands Heart Registration (NHR), a non-profit organisation facilitating high-quality registration of patients undergoing cardiac interventions within the Netherlands. Patients who underwent PVI between January 2016 and December 2019 and completed the Atrial Fibrillation Effect on Quality-of-Life (AFEQT) questionnaire both prior to and one-year after were included (N=2534). To interpret the relevance of findings, accepted cut-off values for the AFEQT Overall summary score were used; &amp;lt;80 points for impaired HRQoL and a delta of ≥5 points for clinically meaningful improvement. Results The majority of the population were men (65.7%) with normal left ventricular ejection fraction (87.1%), paroxysmal AF (77.1%) and a low median CHA₂DS₂-VASc score of 1 (interquartile range, 1–2). The mean AFEQT score was 55.6 ± 19.7 prior to intervention and 79.8 ± 20.2 one-year after PVI. Despite this major increase in mean AFEQT score, we found 39.5% of the population still impaired in HRQol (&amp;lt;80 points) one-year after PVI and 19.2% of the population failed to achieve a clinically meaningful improvement (delta of ≥5 points). Lower baseline AFEQT score (odds ratio [OR], 0.96 [per 1-point increase]; 95% CI, 0.96-0.97; P&amp;lt;0.001) and female sex (odds ratio [OR], 1.42; 95% CI, 1.16-1.75; P&amp;lt;0.001) found to be the most prominent related factors with impaired HRQol one-year after PVI. For failure to achieve clinically meaningful improvement higher baseline AFEQT score (odds ratio [OR], 1.04 [per 1-point increase]; 95% CI, 1.04-1.05; P&amp;lt;0.001) was strongly associated. Other independent risk factors were age (impaired HRQol); BMI (impaired HRQOL); CHA₂DS₂-VASc score (failure to achieve clinically meaningful improvement) and prior catheter ablation for AF (impaired HRQOL and failure to achieve clinically meaningful improvement). Conclusion Despite a major increase in HRQol across the population after PVI, over one third of patients were still impaired in HRQoL after PVI. Several factors were identified which could guide patient counseling for the best fitting treatment for atrial fibrillation.

Correlation between family function and quality of life in patients with atrial fibrillation.

Many studies have shown that the quality of life for patients with atrial fibrillation (AF) is significantly impaired, but the impact on family function is still unclear. This study aims to evaluate the family function and quality of life in patients with AF using scales, to analyze the correlation between family function and quality of life, and to predict the influencing factors of quality of life. A total of 223 patients with AF who were admitted to the Department of Cardiology and General Medicine of the Lanzhou University Second Hospital from January 1, 2021 to May 1, 2022, were selected as research subjects, the general information of patients with AF were collected via a questionnaire, the family function and quality of life were assessed by the Family Assessment Device (FAD) and Atrial Fibrillation Effect on Quality-of-Life (AFEQT) scale. The patients were divided into a non-family functional disorder group and a family functional disorder group on the basis of their FAD scores. The above data were analyzed using SPSS 26.0 statistical software. Among the 223 patients, 64 (28.70%) were in the non-family functional disorder group, and 159 (71.30%) were in the family functional disorder group. The total score of FAD and scores of all dimensions in the family functional disorder group were higher than those in the non-family functional disorder group (all P<0.01). AFEQT total score and symptoms, treatment concerns and daily activities in the non-family functional disorder group were significantly higher than those in the family functional disorder group (all P<0.01). The Pearson linear analysis showed that there was a linear negative correlation between the total score and each dimension of FAD with the total score and each dimension of AFEQT (all P<0.01). The variables with statistical significance in the univariate analysis were included in the multiple linear regression analysis, and the result showed that female, and the problem solving, role, affective involvement, and general functioning dimensions of family function had an impact on the quality of life (all P<0.01). Most patients with AF have different degrees of family dysfunction. The quality of life in patients with family functional disorder group is generally low. Female, and the problem solving, role, affective involvement, and general functioning of family function have a significant impact on the quality of life in patients with AF. In clinical treatment of AF, attention should be paid to the family function of patients, and family members can be involved in clinical intervention to improve family function and improve the quality of life.

His-Purkinje conduction system pacing combined with atrioventricular node ablation improves quality of life in older patients with persistent atrial fibrillation refractory to multiple ablation procedures.

Recurrence of atrial fibrillation (AF) is common in patients with persistent AF even after multiple ablation procedures. His-Purkinje conduction system pacing (HPCSP) combined with atrioventricular node ablation (AVNA) is effective in managing patients with AF and heart failure. This study aimed to determine whether HPCSP combined with AVNA can improve quality of life and alleviate symptoms in older patients with symptomatic persistent AF refractory to multiple ablation procedures, as well as evaluate the feasibility and safety of this therapy. Older patients (≥ 65 years) with symptomatic persistent AF refractory to at least two ablation procedures were treated with combined HPCSP and AVNA. The success rates and complications were recorded. Pacing parameters, European Heart Rhythm Association (EHRA) scores, and Atrial Fibrillation Effect on Quality-of-Life (AFEQT) scores obtained perioperatively were compared with those recorded at the 6-month follow-up examination. Thirty-one patients were enrolled; of those, only thirty patients were eventually treated with AVNA because one patient developed a complete atrioventricular block following the withdrawal of the His bundle pacing lead. The success rates were 100% for HPCSP (22 cases with His bundle pacing, and 9 cases with left bundle branch pacing) and 93.3% (28/30) for AVNA, respectively. By the 6-month follow-up examination, EHRA scores improved significantly (3.00 ± 0.73 vs. 2.44 ± 0.63, P = 0.014) and AFEQT scores increased markedly (49.6 ± 20.6 vs. 70.9 ± 14.0, P = 0.001). No severe complications developed. When used in older patients with symptomatic persistent AF refractory to multiple ablation procedures, HPCSP combined with AVNA significantly alleviated symptoms and improved quality of life during short-term follow-up. This therapy was proved to be safe and effective in this patient population.

Impact of frailty status on clinical and functional outcomes after concomitant valve replacement and bipolar radiofrequency ablation in patients aged 65 years and older

BackgroundTo evaluate the prognostic value of frailty in older recipients of concomitant valve replacement (VR) and bipolar radiofrequency ablation (BRFA), we examined whether clinical and functional outcomes differed between frail and non-frail groups of older patients referred for concomitant VR and BRFA.MethodsIn a single-center retrospective observational cohort study, we compared the clinical and functional outcomes in frail versus non-frail patients. Frailty was assessed using the 5-item Cardiovascular Health Study (CHS) frailty scale. Patients were divided into two groups, frail and non-frail. Functional outcome was assessed using the internationally validated Atrial Fibrillation Effect on QualiTy-of-Life (AFEQT) questionnaire.ResultsWe enrolled 185 patients aged ≥ 65 years who underwent concomitant VR and BRFA. About 36.2% (n = 67) of the patients were included in the frail group and the remaining patients (n = 118) in the non-frail group. Follow-up was complete with a median duration of 58 months (interquartile range 44–76 months). Significant differences were observed between the two groups with respect to postoperative pulmonary complications (frail vs. non-frail patients, 50.74% vs. 22.9%, respectively, P < .001) and hospital mortality (10.45% vs. 1.69%, respectively, P = .021). The frail group had a higher adjusted risk for all-cause mortality (adjusted HR 4.06; 95% CI 1.33 to 12.38; P = .014) and all-cause hospitalization (adjusted HR 2.24; 95% CI 1.12 to 4.50; P = .023). Frailty was associated with lower overall AFEQT scores at baseline (Estimate, − 0.400; 95% CI − 0.532 to − 0.267; P < .001). Compared to the non-frail group, the frail group continued to have lower overall AFEQT scores with no significant improvement in follow-up at 1 year and 2 years after concomitant VR and BRFA.ConclusionFrail patients had lower baseline AFEQT scores and were more likely to have adverse outcomes from postoperative pulmonary complications, and frailty was also an independent risk factor for long-term all-cause mortality and all-cause rehospitalization. Further studies are needed to assess the impact of frailty.

Characteristics and health-status outcomes in patients with atrial fibrillation detected via health screening.

Early detection of atrial fibrillation (AF) is important. Japan has a universal screening system, and regular health screening (HS) is available to support AF detection without a hospital visit. However, health-related outcomes and other characteristics of HS-detected and conventionally diagnosed AF remain unknown. That the characteristics and health-related outcomes of patients with HS-detected AF may differ from those of patients whose AF was detected by other procedures. In total, 3318 consecutive newly referred AF cases were enrolled; demographic characteristics and health-related and clinical outcomes were compared between two groups created based on the mode of AF detection (the HS and non-HS groups). Health-related outcomes were assessed using the AF Effect on QualiTy-of-life (AFEQT) questionnaire at baseline and after 1 year of follow-up. AF was detected by HS in 25.0% of patients; these patients had lower CHADS2 scores (1.01 vs. 1.50, p < .001), higher prevalence of persistent AF (odds ratio, 95% confidence interval; 2.21, 1.88-2.60) and asymptomatic presentation (3.19, 2.71-3.76), and better baseline QoL scores (83.6 vs. 75.0; p < .001). Catheter ablation was more frequently performed in the HS group at follow-up (44.4% vs. 34.1%; p < .001). At 1-year follow-up, the AFEQT scores of the HS group were significantly better in most subdomains. In the Japanese registry, AF was detected via HS in 25% of patients referred to specialty centers for management. Notably, the overall health status of patients with HS-detected AF improved after medical interventions, including catheter ablations.

Clinical Outcomes of Rhythm Control Strategies for Asymptomatic Atrial Fibrillation According to the Quality-of-Life Score: The CODE-AF (Comparison Study of Drugs for Symptom Control and Complication Prevention of Atrial Fibrillation) Registry.

Background Atrial fibrillation (AF) is associated with an increased risk of poor cardiovascular outcomes; appropriate rhythm control can reduce the incidence of these adverse events. Therefore, catheter ablation is recommended in symptomatic patients with AF. The aims of this study were to compare AF-related outcomes according to a baseline symptom scale score and to determine the best treatment strategy for asymptomatic patients with AF. Methods and Results This study enrolled all patients who completed a baseline Atrial Fibrillation Effect on Quality-of-Life (AFEQT) survey in a prospective observational registry. The patients were divided into 2 groups according to AFEQT score at baseline; scores ≤80 were defined as symptomatic, whereas scores >80 represented asymptomatic patients. The primary outcome was defined as a composite of hospitalization for heart failure, ischemic stroke, or cardiac death. This study included 1515 patients (mean age: 65.7±10.5 years; 998 [65.9%] men). The survival curve showed a poorer outcome in the symptomatic group compared with the asymptomatic group (log-rank P=0.04). Rhythm control led to a significantly lower risk of a composite outcome in asymptomatic patients (hazard ratio [HR], 0.47 [95% CI, 0.27-0.84], P=0.01). Rhythm control was associated with more favorable composite outcomes in the asymptomatic group with paroxysmal AF, left atrium diameter ≤50 mm, and CHA2DS2-VASc score ≥3. Conclusions Symptomatic patients with AF experienced more adverse outcomes compared with asymptomatic patients. In asymptomatic patients with AF, a strategy of rhythm control improved the outcomes, especially with paroxysmal AF, smaller left atrium size, or higher stroke risk. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT02786095.

Quality of life after the initial treatment of atrial fibrillation with cryoablation versus drug therapy.

The STOP AF First trial recently demonstrated that initial treatment with cryoballoon ablation (CBA) is safe and superior to antiarrhythmic drug (AAD) therapy for preventing atrial arrhythmia recurrence in patients with symptomatic atrial fibrillation (AF). The purpose of this study was to evaluate the change in quality of life (QoL) and symptoms after first-line CBA vs AAD therapy. Patients with symptomatic AF not previously receiving rhythm control therapy were randomized to AAD (class I or III) or CBA (Arctic Front Advance, Medtronic, Mounds View, MN). QoL was evaluated at baseline and at 6 and 12 months by using the Atrial Fibrillation Effect on QualiTy-of-Life (AFEQT) and the European Quality of Life-5 Dimensions questionnaires. A review of AF-associated symptoms was conducted at baseline and at 1, 3, 6, and 12 months. In total, 203 subjects received either CBA (n = 104 [51.2%]) or AAD therapy (n = 99 [48.8%]). Improvements in the AFEQT summary and subscale scores were significantly larger with CBA than with AAD therapy at 6 and 12 months (P < .02 for all). Clinically meaningful improvement (>5 points) in the AFEQT summary score from baseline to 12 months was observed in 96.0% (100) of patients in the CBA arm vs 72.2% (71) of patients in the AAD arm (P < .001). No significant between-group differences were observed in the change in the European Quality of Life-5 Dimensions index or visual analog scale scores. Overall, 54.4% (57) of the CBA group vs 29.7% (29) of the AAD group reported no AF-specific symptom recurrence after a 90-day blanking period (P = .0005). First-line CBA vs AAD therapy is associated with larger improvements in AF-specific QoL and a higher rate of symptom resolution.

Individualized Studies of Triggers of Paroxysmal Atrial Fibrillation

Atrial fibrillation (AF) is the most common arrhythmia. Although patients have reported that various exposures determine when and if an AF event will occur, a prospective evaluation of patient-selected triggers has not been conducted, and the utility of characterizing presumed AF-related triggers for individual patients remains unknown. To test the hypothesis that n-of-1 trials of self-selected AF triggers would enhance AF-related quality of life. A randomized clinical trial lasting a minimum of 10 weeks tested a smartphone mobile application used by symptomatic patients with paroxysmal AF who owned a smartphone and were interested in testing a presumed AF trigger. Participants were screened between December 22, 2018, and March 29, 2020. n-of-1 Participants received instructions to expose or avoid self-selected triggers in random 1-week blocks for 6 weeks, and the probability their trigger influenced AF risk was then communicated. Controls monitored their AF over the same time period. AF was assessed daily by self-report and using a smartphone-based electrocardiogram recording device. The primary outcome comparing n-of-1 and control groups was the Atrial Fibrillation Effect on Quality-of-Life (AFEQT) score at 10 weeks. All participants could subsequently opt for additional trigger testing. Of 446 participants who initiated (mean [SD] age, 58 [14] years; 289 men [58%]; 461 White [92%]), 320 (72%) completed all study activities. Self-selected triggers included caffeine (n = 53), alcohol (n = 43), reduced sleep (n = 31), exercise (n = 30), lying on left side (n = 17), dehydration (n = 10), large meals (n = 7), cold food or drink (n = 5), specific diets (n = 6), and other customized triggers (n = 4). No significant differences in AFEQT scores were observed between the n-of-1 vs AF monitoring-only groups. In the 4-week postintervention follow-up period, significantly fewer daily AF episodes were reported after trigger testing compared with controls over the same time period (adjusted relative risk, 0.60; 95% CI, 0.43- 0.83; P < .001). In a meta-analysis of the individualized trials, only exposure to alcohol was associated with significantly heightened risks of AF events. n-of-1 Testing of AF triggers did not improve AF-associated quality of life but was associated with a reduction in AF events. Acute exposure to alcohol increased AF risk, with no evidence that other exposures, including caffeine, more commonly triggered AF. ClinicalTrials.gov Identifier: NCT03323099.

Thoracoscopic ablation for symptomatic atrial fibrillation improves quality of life

Abstract Background Rhythm control has become an essential part of adequate management in atrial fibrillation (AF) to reduce symptoms and ultimately to improve health related quality of life (HRQoL). Totally thoracoscopic ablation has been established over the last years as an effective and safe rhythm control strategy, especially for persistent AF, but quality of life data are lacking. Purpose To assess the impact of totally thoracoscopic ablation on HRQoL in patients with symptomatic AF. Methods Consecutive patients with symptomatic AF undergoing totally thoracoscopic ablation at a referral centre in the Netherlands (July 2016 – October 2019) were included. The primary outcome was quality of life. Short Form 36 and Atrial Fibrillation Effect on Quality-of-Life (AFEQT) health surveys were collected at baseline, 1, 3, 6 and 12 months. Clinical improvement was measured as the relative increase of the QoL-score at 1 year compared to the baseline score (in %). Multilevel regression modelling was used, coupled with fractional polynomials for adjustment of age differences and nonlinear time trends, to investigate the one-year clinical trajectories of sex differences in QoL subscales. Secondary outcomes included rhythm success (freedom from any recurrence of atrial tachyarrhythmia&amp;gt;30 sec), mortality and stroke. Results 191 patients were included (63.9±8.6 years, 68% male, 22.5% paroxysmal AF, 69.6% persistent AF and 7.9% long-term persistent AF, 66.5% having at least one previous failed catheter ablation, with median Cha2ds2 Vasc score of 2 [IQR 1–3]). AFEQT sum scores (52.6 points at baseline) substantially improved after three months (49.8%; p&amp;lt;0.001) and remained stable up to 1-year (54.2%; p&amp;lt;0.001) despite adverse events. Patients with recurrent AF also showed significant improvement at 3 months which remained stable up to 1-year, but patients who remained in sinus rhythm had significantly more increase (61.3% vs 26.9%, p&amp;lt;.001). The SF36 physical and mental summary composite scores significantly improved after 3 months (12.3% and 11.9% respectively; p&amp;lt;.001) and remained stable up to 1-year (16.9% and 16.4% respectively; P&amp;lt;.001). Although female patients had significantly lower AFEQT and physical subscales at baseline, similar improvement in scores were observed over time compared to men, adjusted for age and sex interactions (P&amp;lt;.001). One-year stroke rate was 1.6 per 100 patient-years with an oral anticoagulation rate of 63%. One-year survival was 99.5%. Conclusions This study reveals significant improvement of HRQoL three months after thoracoscopic ablation that persisted up to 1-year, also when adjusted for sex and age differences. Despite AF recurrence or adverse events AF related QoL still improved. Trials are necessary to confirm these data. Funding Acknowledgement Type of funding sources: None.

Initial rhythm control with cryoballoon ablation vs drug therapy: Impact on quality of life and symptoms

Cryoballoon ablation (CBA) as a first-line rhythm control strategy is superior to antiarrhythmic drugs (AADs) for preventing atrial fibrillation (AF) recurrence; the impact of first-line CBA on quality of life (QoL) and symptoms has not been well characterized. Patients aged 18 to 75 with symptomatic paroxysmal AF naïve to rhythm control therapy were randomized (1:1) to CBA (Arctic Front Advance, Medtronic) or AAD (Class I or III). Symptoms and QoL were assessed at baseline, 1, 3, 6, 9, and 12 months using the EHRA classification and Atrial Fibrillation Effect on QualiTy-of-Life (AFEQT) and SF-36v2 questionnaires. Symptomatic palpitations were evaluated via patient diary. Overall, 107 patients were randomized to CBA and 111 to AAD; crossovers occurred in 9%. Larger improvements in the AFEQT summary, subscale and treatment satisfaction scores were observed at 12 months with CBA vs AAD (all P <0.05). At 12 months, the mean adjusted difference in the AFEQT summary score was 9.9 points higher in the CBA group (95% CI: 5.5 -14.2, P <0.001). Clinically important improvements in the SF-36 physical and mental component scores were observed at 12 months in both groups, with no significant between group differences at this timepoint. In the CBA vs AAD group, larger improvements in EHRA class were observed at 6, 9 and 12 months (P <0.05) and the incidence rate of symptomatic palpitations was lower (4.6 vs 15.2 days/year post-blanking; IRR: 0.30, P <0.001). In patients with symptomatic AF, first-line CBA was superior to AAD for improving AF-specific QoL and symptoms. ClinicalTrials.gov number: NCT01803438.

The role of the novel MyAlgos e-medicine Platform in promoting patient-centered self-care management in patients with atrial fibrillation: The emPOWERD trial

Abstract Funding Acknowledgements Type of funding sources: None. Background The emergence of digital health has revolutionized most aspects of healthcare. Meanwhile, atrial fibrillation (AF) remains the most common sustained arrhythmia associated with high morbidity and impaired quality of life. Patient-perceived treatment burden can be further optimized by digital health interventions utilizing smartphone technology. The MyAlgos platform is an integrated software system designed to enhance the remote management and communication between the patient and the healthcare practitioner. The mobile application encourages patient self-management through educational modules and tools to improve medication adherence. The web-based platform allows the health care practitioner to receive live updates on patient status and design personalized self-care management plans. Purpose To investigate whether the use of the MyAlgos platform by AF patients is safe and improves the quality of self-care, quality of life (QoL), and hospitalization rate. Methods We designed a single-center, randomized, controlled, prospective, open-label, pilot study to compare the effect of the use of the full-feature MyAlgos platform version versus a stripped-down control version of the platform on the QoL, medication adherence and hospitalization rate in patients with paroxysmal AF. The full version of the e-medicine platform includes active patient education, communication with the medical team, medication reminders as well as the full record of clinically significant data such as heart rate and blood pressure. Specialized algorithms monitor patient data and alert physicians for potential AF episodes. The control version only allows the recording of patient’s heart rate. Results A total of 80 patients with paroxysmal AF were randomized in a 1:1 ratio to receive either the full or the control version of the MyAlgos Platform. The mean age of all patients, 53 (66%) male, was 58.1 ± 9.1 years. Hypertension and diabetes were present in 47 (59%) and 7 (9%) respectively. At baseline, the majority of patients had AF-related symptoms classified as European Heart Rhythm Association (EHRA) I (45%) or EHRA II (24%), while the mean Atrial Fibrillation Effect on QualiTy-of-Life (AFEQT) score was 70.1 ± 17.0. Between the two groups, there were no statistically significant differences in the baseline characteristics of the participants. Conclusion The emPOWERD trial will provide data on the impact of a novel e-medicine platform on the QoL, medication adherence and hospitalizations of patients with paroxysmal AF. We anticipate better outcomes for the subjects receiving the full version of the MyAlgos platform, allowing it to positively affect the further management of paroxysmal AF. Abstract Figure. The MyAlgos e-medicine Platform

Symptom Under-Recognition of Atrial Fibrillation Patients in Consideration for Catheter Ablation

This study sought to investigate whether symptom under-recognition is associated with the application of catheter ablation.Atrial fibrillation (AF) symptom burden is frequently under-recognized and may affect the choice of treatment strategies.A total of 3,276 patients with AF consecutively registered in a Japanese multicenter database from 2012 to 2017 were analyzed. All patients underwent AF symptom burden assessment via the symptom and daily activities domain within the Atrial Fibrillation Effect on QualiTy-of-life (AFEQT) questionnaire. For the present analysis, 1,173 symptomatic patients (AFEQT score ≤80) with a clinical indication for catheter ablation were included. Under-recognition of symptom burden was defined as no subjective complaints checked by physicians despite self-reported AFEQT scores ≤80. Logistic regression analysis identified the predictors associated with receiving catheter ablation.Of the 1,173 patients (age: 68 ± 12 years, men: 61%) analyzed, 459 underwent catheter ablation (ablation group); they had lower overall AFEQT scores (p < 0.01 for all domains) compared with the nonablation group. At the 1-year follow-up, greater improvement in the AFEQT scores was noted in the ablation group, even after adjusting for clinically relevant factors (+20.0 ± 1.2, +14.2 ± 0.9, respectively; p < 0.001). Notably, 306 (28%) patients met the criteria for symptom under-recognition, which was associated with the nonuse of catheter ablation during follow-up (odds ratio: 0.41; 95% confidence interval: 0.28 to 0.60; p < 0.001).Under-recognition of AF symptom burden was frequently noted and was associated with less use of catheter ablation. Standardized recognition of symptoms using the application of validated questionnaires may facilitate outcome improvement.

Growth mixture models: a case example of the longitudinal analysis of patient\u2010reported outcomes data captured by a clinical registry

BackgroundAn assumption in many analyses of longitudinal patient-reported outcome (PRO) data is that there is a single population following a single health trajectory. One approach that may help researchers move beyond this traditional assumption, with its inherent limitations, is growth mixture modelling (GMM), which can identify and assess multiple unobserved trajectories of patients’ health outcomes. We describe the process that was undertaken for a GMM analysis of longitudinal PRO data captured by a clinical registry for outpatients with atrial fibrillation (AF).MethodsThis expository paper describes the modelling approach and some methodological issues that require particular attention, including (a) determining the metric of time, (b) specifying the GMMs, and (c) including predictors of membership in the identified latent classes (groups or subtypes of patients with distinct trajectories). An example is provided of a longitudinal analysis of PRO data (patients’ responses to the Atrial Fibrillation Effect on QualiTy-of-Life (AFEQT) Questionnaire) collected between 2008 and 2016 for a population-based cardiac registry and deterministically linked with administrative health data.ResultsIn determining the metric of time, multiple processes were required to ensure that “time” accounted for both the frequency and timing of the measurement occurrences in light of the variability in both the number of measures taken and the intervals between those measures. In specifying the GMM, convergence issues, a common problem that results in unreliable model estimates, required constrained parameter exploration techniques. For the identification of predictors of the latent classes, the 3-step (stepwise) approach was selected such that the addition of predictor variables did not change class membership itself.ConclusionsGMM can be a valuable tool for classifying multiple unique PRO trajectories that have previously been unobserved in real-world applications; however, their use requires substantial transparency regarding the processes underlying model building as they can directly affect the results and therefore their interpretation.