Atrial Fibrillation Effect On Quality-of-Life Scores Research Articles

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 > 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<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.

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.

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.

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.

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.

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.

Differences in Atrial Fibrillation Symptoms and Quality of Life and Response to Therapy Across Race-Ethnicity

Objectives: To determine whether race-ethnicity modulates severity of atrial fibrillation (AF) symptoms, quality-of-life (QoL) and response to therapy. Background: Although the severity of AF symptoms is highly variable when selecting a rate or rhythm control approach, it remains unclear if race-ethnicity influences AF symptoms and QoL. Methods: We prospectively enrolled 453 patients with new-onset AF in a clinical-genetic registry. Baseline assessment of patients before treatment initiation included detailed patient history and administration of the Atrial Fibrillation Effect on QualiTy-of-life (AFEQT) questionnaire in African-Americans, European-Americans, and Hispanics/Latinos. We assessed AFEQT scores at baseline and average of 8 months after starting treatment on maximal doses. Results: Of 415 consecutive patients with AF, 181 (43.6%) were African-American, 139 (33.5%) European-American and 95 (22.9%) Hispanic/Latino with a mean age of 62.0{plus minus}13.1 years. Two-hundred fifteen (51.8%) were treated with rate control versus 200 (48.2%) with rhythm control. Both African-American (53.0%) and Hispanic/Latino (65.3%) patients were more likely to be initiated rate control as compared with European-Americans (41%; P=0.0002) despite lower baseline AFEQT scores (African-American: 73.6{plus minus}23.0; Hispanic/Latino: 74.8{plus minus}21.2; and European-American: 76.9{plus minus}20.6; P=0.05) and poorer QoL. In the rhythm control group, the AFEQT scores and QoL improved in African-Americans (ΔScore: 9.5{plus minus}26.0; P<0.001) and European-Americans (ΔScore: 9.7{plus minus}19.6; P<0.0001) and was associated with improvement in symptoms and activities of daily living. Multivariate predictors of improvement in QoL included rhythm therapy, obesity, coronary artery disease, and private health insurance. Conclusions: Our findings may have important clinical implications for the assessment of symptoms and management of AF in African-Americans and Hispanics/Latinos.

Abstract 15773: Differences in Atrial Fibrillation Symptoms, Quality of Life, and Response to Therapy Across Race-ethnicity

Introduction: Atrial fibrillation (AF) guidelines are heavily predicated on assessing the severity of symptoms experienced by individual patients when selecting either rate or rhythm control strategy. While the severity of symptoms can be highly variable, it remains unclear if race-ethnicity influences AF symptoms and quality-of-life (QoL). We sought to determine whether race-ethnicity modulates severity of AF symptoms, QoL and response to therapy. Methods: A prospective cohort study of 415 patients diagnosed with new-onset AF enrolled over a 30-month period in a clinical-genetic registry. Baseline assessment of patients prior to treatment initiation included a detailed patient history and the validated 20-item Atrial Fibrillation Effect on QualiTy-of-life (AFEQT) questionnaire. We divided the cohort into groups based on race-ethnicity (African American[AA], European American[EA], Hispanic/Latino[H/L]) and treatment strategy (rate or rhythm control). Results: Of 306 consecutive patients with AF, 113 (36.9%) were AA, 108 (35.3%) EA and 85 (27.8%) H/L. The mean age was 61.9±13.0 years, and 105 (34.3%) were female with 154 (50.3%) patients treated with rate control versus 152 (49.7%) with rhythm control therapy. Both AA (52.1%) and H/L (65.9%) patients were more likely to be initiated on rate control therapy as compared with EAs (36.1%; P=0.0002) despite lower baseline AFEQT scores (AA: 72.9.9±23.2; H/L: 75.1±20.7; and EA: 80.2±17.9; P=0.24) and greater impairment of QoL. The overall AFEQT scores and QoL improved significantly in AAs (Δscore: 10.4±28.2; P&lt;0.0001) and EAs (Δscore: 11.9±20.1; P&lt;0.0001) and was mostly associated with improvement in activities of daily living. Multivariate predictors of improvement in QoL in patients with AF included not only rhythm control therapy but also a history of both coronary artery disease and obesity. Conclusion: The severity and perception of AF symptoms is highly variable in individual patients. Our study showed that ethnic minorities with AF are more likely to receive rate control therapy when compared to patients of European descent despite poorer QoL. Our findings may have important clinical implications for the assessment of symptoms and management of AF in AAs and H/Ls.

Parameters used in the control of ventricular rate in patients with permanent atrial fibrillation

Purpose. To analyze the possibility of using high-sensitivity cardiac troponin I (hsTnI), N-terminal pro-B type natriuretic peptide (NT-proBNP), tissue hemodynamics parameters, echocardiographic data and the quality of life for selection of the individual regimen for ventricular rate (VR) control drug therapy in patients with permanent atrial fibrillation (AF). Methods. The study included 120 patients aged &gt;60 years old with the diagnosis of permanent AF, who gave the informed consent. Patients were randomized into 2 groups according to the target range of VR at rest: 60-79 bpm (first group, n=60) and 80-100 bpm (second group, n=60). Patients in both groups were prescribed a selective beta1 -adrenoceptors blocker bisoprolol for VR control. The following parameters were determined before randomization and after 6 months of VR control in the target ranges: atrial and ventricular remodeling with transthoracic echocardiography; biochemical markers hsTnI and NT-proBNP; the tissue hemodynamics by the mean flow velocity (Vm) and the value of the pulsatility index (PI) using high-frequency ultrasound Doppler flowmetry; the patients’ quality of life with the “Atrial Fibrillation Effect on QualiTy-of-life (AFEQT) Questionnaire” and the “EQ-5D-5L” system with a scale EQ-VAS.Results. VR at rest after 6 months was 70±3 and 88±4 bpm (p1, p2˂0.001) in the first and second groups, respectively (p1 - comparing the initial and achieved values, p2 - values of the first and second groups). The level of hsTnI significantly decreased in both groups, but it was more pronounced in the 60-79 bpm range group (p˂0.001). Spearman’s correlation coefficients between the degree of decrease in VR and decrease in the level of hsTnI were 0.45 (p˂0.001) and 0.44 (p˂0.001) in the first and second groups, respectively. AFEQT and EQ VAS scores of quality of life improved after 6 months in both groups: the increase in the total AFEQT score in the first group -56.2±17.0% (M±SD), in the second - 42.6±15.3% (p˂0.001); EQ VAS values also increased, but differences between groups were not significant (p=0.078). In both the first and second groups, a strong positive correlation was found between the degree of decrease in VR and increase in the total score of the AFEQT questionnaire. The tendency toward an increase in Vm and a decrease in PI observed in both groups was more pronounced in the group with VR of 80-100 bpm, where Vm increased by more than 10% (p1, p2˂0.001). Changes in NT-proBNP under the influence of therapy for the reported observation period did not reach statistical significance in both groups (p1 =0.092, p2 =0.063). There was no significant dynamics of echocardiographic parameters of myocardial remodeling.Conclusion. The degree of chronic myocardial damage caused by arrhythmia (estimated by hsTnI), as well as the tissue hemodynamic parameters Vm and PI, can be the basis for individualized selection of the target VR range. This approach will allow to find a balance between cardioprotection and improvement of tissue blood flow. In creating the algorithm of selecting the target VR for patients older than 60 years with permanent AF, it is advisable to use such parameter as the degree of the initial VR change and quality of life data from the “AFEQT Questionnaire”.

P956Improved quality of life and symptomatic atrial fibrillation reduction in patients treated with a standardized ablation index workflow

Abstract Background/Introduction The use of a standardized ‘CLOSE’ ablation workflow for pulmonary vein isolation (PVI), with defined inter-tag distance (ITD) with targeted ablation index (AI) values, has been shown in single centre reports to result in good outcomes. The effect of this approach on patients’ quality of life (QoL) has not been studied. Purpose To evaluate the effects of paroxysmal atrial fibrillation (PAF) ablation by the CLOSE workflow on QoL and symptomatic AF reduction in the multicenter VISTAX study. Methods 329 patients with PAF (61.5% male, 61.3 ± 10.1 year) were treated at 17 European centres by point-by-point radiofrequency ablation using the CLOSE protocol to achieve PVI. An ITD ≤6mm and AI values of ≥400 on the posterior wall and ≥550 on the anterior wall were targeted. The AI value on the posterior wall was lowered as per investigator discretion in case of safety concerns. Patients were monitored for atrial arrhythmia recurrences via weekly and symptom-activated transtelephonic monitoring (TTM), for 12 months post procedure. Patients completed an Atrial Fibrillation Effect on Quality-of-life (AFEQT) questionnaire at their baseline and 12-month follow up visits. Results Majority (83.3% [274/329]) of patients experienced freedom from symptomatic atrial recurrence through 12 months. Of the 70 documented recurrences, 34 (49%) were documented by trans-telephonic monitoring only. All domains captured on the AFEQT questionnaire showed improvement with the overall score improving by 25.7, which exceeded the threshold of clinically meaningful improvement (±5) (Table). Patient reported most improvements in PAF control and symptoms relieved. The overall AFEQT score improvement was seen both in patients with or without documented atrial arrhythmia recurrence, with improvement by 21.5 and 26.8, respectively. Conclusion PAF ablation using a standardized CLOSE workflow resulted in consistent improvements in QoL. The improved QoL was observed regardless of atrial arrhythmia recurrence likely reflecting the low residual arrhythmia burden in patients with documented recurrence identified only on TTM. AFEQT Scores Through 12 Months AFEQT Domain Baseline 12 Months Change from Baseline* Daily Activities 59.2 85.3 26.0 Treatment Concerns 62.2 88.1 26.0 Controlling PAF 50.2 87.8 37.5 Symptoms 63.7 89.0 25.1 Symptoms Relieved 52.0 88.4 36.3 Overall AFEQT Score 61.3 87.2 25.7 *only includes patients who completed both baseline and 12 month AFEQT questionnaire

Discrepancy in recognition of symptom burden among patients with atrial fibrillation

Our aim was to investigate the variability in physician recognition of atrial fibrillation (AF)-related symptoms, which greatly contributes to the management of AF patients. METHODS AND RESULTS: A total of 1493 newly-referredAF patients (67 ± 11 y/o, 1057 men) consecutively registered in an outpatient-based Japanese multicenter database (KiCS-AF) from September 2012 to December 2016 were analyzed. Self-reportedAF symptom burden was assessed via symptom and daily activities domains within the Atrial Fibrillation Effect on QualiTy-of-life (AFEQT) questionnaire. Physician symptom under-recognition (UR) was defined as no subjective complaints recorded in the medical records despite AFEQT score of <80; and physician's apparent over-recognition (OvR) was defined as documentation of subjective complaints despite total AFEQT score of ≥80. There was poor agreement between patient-reported and physicians-estimated symptom burden (kappa 0.28, 95% CI 0.23 to 0.33). In the logistic regression analysis, age> 75 (odds ratio [OR], 1.72; 95% confidence interval [CI], 1.13-2.62), male sex (OR, 1.82; 95% CI, 1.22-2.74), and persistent/permanent AF (OR 2.54/3.36; CI, 1.63-3.99/1.91-5.89, respectively) were predictors of UR. Conversely, heart failure (OR, 2.46; 95% CI, 1.44-4.25) and treatment in an ablation facility (OR, 1.43; 95% CI, 1.02-2.02) were associated with greater odds of OvR in addition to age, sex, and type of AF. CONCLUSIONS: Discordance in recognition of AF symptom burden by physicians was frequent in AF patients seen in outpatient management and involved both patient- and physician-related factors.

Paroxysmal and persistent atrial fibrillation ablation outcomes with the pulmonary vein ablation catheter GOLD duty-cycled phased radiofrequency ablation catheter: quality of life and 12-month efficacy results from the GOLD Atrial Fibrillation Registry.

AimsThe GOLD AF Registry has been designed to prospectively assess the population, indications, and outcomes using second-generation phased radiofrequency (RF) ablation (pulmonary vein ablation catheter GOLD) in a global examination of standard-of-care use for the treatment of paroxysmal and persistent atrial fibrillation (AF).Methods and resultsGOLD AF (NCT02433613) is a prospective, observational, multi-centre registry designed to characterize efficacy and safety of phased RF ablation in patients with AF. The primary endpoint was freedom from AF recurrence at 12-month follow-up after a 90-day blanking period. Ancillary objectives include safety, procedural efficiency, and quality of life (QoL). The QoL assessment using the Atrial Fibrillation Effect on QualiTy-of-Life (AFEQT) and the European Heart Rhythm Association (EHRA) Score of AF-related symptoms was collected at baseline and 12 months. In total, 1054 patients were included in this analysis (age 60.6, 67.6% male, 26.5% PersAF). Kaplan–Meier estimate of freedom from AF recurrence was 77.7% at 12 months. Peri-procedural device or procedure-related complications were observed in 26 (2.5%) patients, with a low stroke rate of 0.3%. One-year post-ablation, the EHRA AF Symptom score decreased in 68% of patients. The AFEQT score improvement was observed in 88.4% and 90.4% of patients who completed the questionnaire in-person or interviewed by phone at 12 month follow-up, respectively.ConclusionPhased RF ablation for the treatment of paroxysmal and persistent AF demonstrated a 77.7% freedom from AF recurrence at 12 months in addition to a significant reduction in arrhythmia symptoms and clinically meaningful improved QoL. Low peri-procedural complication rate of <3% was reported.

Treatment strategies and subsequent changes in the patient-reported quality-of-life among elderly patients with atrial fibrillation

BackgroundRhythm-control strategy, including catheter ablation (CA) application, constitutes an integral part of atrial fibrillation (AF) management. However, elderly patients are underrepresented in clinical trials, and reports on patient-reported outcome of various rhythm-control treatments remain limited. Therefore, we aimed to investigate the application of a rhythm-control strategy for elderly patients with AF. MethodsUsing a prospective, multicenter Japanese registry, we analyzed 733 patients with AF aged ≥70 years who completed the Atrial Fibrillation Effect on Quality-of-Life (AFEQT) questionnaire at baseline and 1-year visit. Improvement in patient-reported quality-of-life (QOL) was assessed according to their initial treatment strategy. ResultsA total of 321 patients (43.8%) were managed with rhythm-control strategy, of which 125 (17.1%) received treatment with antiarrhythmic drugs (AADs) alone and 196 (26.7%) underwent CA. Compared with the rate-control group, the rhythm-control group was younger and less likely to have comorbid conditions but had lower baseline AFEQT-overall summary (OS) scores (71.8 [standard deviation 20.3] vs. 80.0 [standard deviation 16.1]; P < .001). After the first year, AFEQT-OS scores improved regardless of treatment strategies (ie, rate- or rhythm-control). After adjusting for confounders, CA implementation and a lower baseline AFEQT score were associated with meaningful improvement in QOL (changes in AFEQT-OS score ≥5). QOL improvement among subgroups of rhythm-control patients with AADs alone was not clinically meaningful. ConclusionsIn contemporary Japanese clinical practice, rhythm-control strategy is widely implemented in elderly patients with AF, and CA use is associated with improvement in QOL in carefully selected patients.

Defining Clinically Important Difference in the Atrial Fibrillation Effect on Quality-of-Life Score

Background The Atrial Fibrillation Effect on Quality-of-Life (AFEQT) questionnaire has recently been validated to measure the impact of atrial fibrillation on quality of life, but a clinically important difference in AFEQT score has not been well defined. Methods and Results To determine the clinically important difference in overall AFEQT (score range= 0 [worst] to 100 [best]) and selected subscales, we analyzed data in the Outcomes Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT-AF) registry, a United States-based outpatient atrial fibrillation registry. AFEQT was assessed at baseline and 1 year in a subset of 1347 ORBIT-AF patients from 80 US sites participating in ORBIT-AF from June 2010 to August 2011. The mean change method was used to relate changes in 1-year AFEQT scores to clinically important changes in the physician assessment of European Heart Rhythm Association functional status (1 class improvement and separately 1 class deterioration). Clinically important differences and 95% CI corresponding to either a 1 European Heart Rhythm Association class improvement or deterioration were 5.4 (3.6-7.2) and -4.2 (-6.9 to -1.5) AFEQT points, respectively. Similarly, clinically important difference values were seen for a 1 European Heart Rhythm Association class improvement for the AFEQT subscales Activities of Daily Living and Symptoms: 5.1 (2.5-7.6) and 7.1 (5.3-9.0) AFEQT points, respectively. Conclusions Based on the anchor of 1 European Heart Rhythm Association class change, changes in AFEQT score of + or -5 points are clinically important changes in patients' health. Clinical Trial Registration URL: https://clinicaltrials.gov . Unique identifier: NCT01165710.

Improvement in the quality of life of patients with persistent or long-standing persistent atrial fibrillation after hybrid ablation.

Hybrid ablation (i.e., a combination of a thoracoscopic surgical ablation followed by a catheter ablation) is a treatment option for patients with non-paroxysmal atrial fibrillation (AF). Despite its promising efficacy, it is a surgical procedure with a relatively high risk of complications that could affect the quality of life (QoL) of patients, even when sinus rhythm is restored. To describe changes in the QoL of patients with non-paroxysmal AF before and after a hybrid ablation. Patients after hybrid ablation for persistent or long-standing persistent AF were prospectively studied. Follow-up visits were scheduled at 1, 3, 6, 9, and 12months. The maintenance of SR was assessed using 1-week Holter recordings at 6 and 12months and 24-h Holter recordings at 3 and 9months, or via an implantable loop recorder. QoL was assessed using the Atrial Fibrillation Effect on Quality-of-life (AFEQT) and the EuroQoL-5Dimensions (EQ-5D) questionnaires before and 12months after ablation. Seventy-five patients (49 men, age 62.9 ± 8.45years, 48 (64%) with long-standing persistent AF) were enrolled. Fifty-two (69.3%, SR group) were AF-free during the 12-month follow-up, 16 (21.3%, PAROX group) had only paroxysms of AF after ablation, and 7 (9.3%, PERM group) were on rate control due to permanent AF reoccurrence. The AFEQT score increased significantly in the SR group from 59.9 ± 19.4 to 91.4 ± 10.8 (p < 0.001), and in the PAROX group from 58.8 ± 19.0 to 81.5 ± 14.1 (p = 0.002) but remained unchanged in the PERM group (44.6 ± 7.5 vs. 47.4 ± 5.5, p = 0.24). The EQ-5D score significantly decreased in the descriptive part (from 7.90 ± 2.61 to 6.64 ± 1.90, p = 0.0001) and increased on the visual analog scale (from 63.56 ± 19.11 to 79.30 ± 16.9, p < 0.0001) in the SR group. In the PAROX group, no significant change was present on either the descriptive part (p = 0.3) or in the visual analog scale (p = 0.48). Similarly, no significant changes were present on either the descriptive part (p = 0.93) or the visual analog scale (p = 0.4) in the PERM group. The QoL of patients with non-paroxysmal AF and patients with AF paroxysms, after successful hybrid ablation, improved significantly in patients with SR. No significant improvement was present in patients on rate control after an unsuccessful ablation.

Abstract 130: Clinically Important Difference in the Atrial Fibrillation Effect on QualiTy-of-Life (AFEQT) Score: Results from the ORBIT-AF Registry

Background: The Atrial Fibrillation Effect on QualiTy-of-Life (AFEQT) survey has recently been validated to measure the impact of atrial fibrillation on patients’ quality of life, but a clinically important difference (CID) in AFEQT score has not been defined. Knowing the CID is needed to interpret the meaningfulness of differences between treatments in clinical trials; or patient populations for quality assessment. Objectives: To calculate CID values in AFEQT in the ORBIT registry. Methods: ORBIT-AF is a US-based outpatient AF registry that measured disease-specific QoL with the AFEQT tool (score range= 0 (worst) to 100) at baseline and at 1 year follow-up. Two anchor-based methods were used to relate changes in AFEQT to clinically important differences in the more established European Heart Rhythm Association (EHRA) measure of functional status. Ranging from 1 (no symptoms) to 4 (disabling), a change of 1 EHRA class was defined as an important change in the anchor. Both the mean change and receiver operating characteristics (ROC) methods were then used to identify CIDs in AFEQT at 1 year follow-up. This was done for both improvement and worsening on the anchor. The mean change method defines a CID as the mean change in AFEQT score among patients with a 1 EHRA class change. The ROC method identifies a CID as the point on the ROC curve that best discriminates patients who experienced an important change in the anchor (≥ 1 EHRA class change) from those who experienced no change. Results: AFEQT was assessed in 2008 AF patients at baseline and 1347 patients at 1 year from 99 US sites participating in ORBIT-AF. CIDs and 95% confidence intervals (CI) corresponding to an improvement in EHRA for the mean change method were 5.4 (3.6, 7.2) AFEQT points and 1.9 (0.4, 9.3) AFEQT points for the ROC method. CIDs corresponding to worsening in EHRA for the mean change method were -4.2 (-6.9,-1.5) AFEQT points and -7.4 (-13.9,-4.6) AFEQT points for the ROC method. Conclusions: Changes in AFEQT as small as 2 points may be clinically relevant, although CIDs vary depending on the method of calculation. The variability suggests identifying a single universal CID to assess improvement in quality of life in AF patients may not be ideal and improvement may relate to the nature of a patient’s symptoms and their baseline level of activity.