Atrial Fibrillation Effect On Quality-of-Life Research Articles

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.

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.

Positive clinical benefit on patient care, quality of life and symptoms after radiofrequency ablation with contact force in persistent atrial fibrillation: analyses from PRECEPT

Abstract Background The management of persistent (PsAF) aims to prevent AF recurrence and associated disabilities while reducing side effects from treatment. Contact force (CF)-guided RF catheters have proven efficacious and safe for pulmonary vein isolation (PVI) to treat paroxysmal AF; however, there is limited evidence on clinical benefits with ablation of PsAF. Purpose To assess long-term clinical effects on patients care, symptoms and QOL after CF-guided RF ablation in PsAF. Methods PRECEPT was a multicenter study evaluating the safety and efficacy of CF RF catheters in the treatment of symptomatic PsAF (NCT02817776). PVI was performed with or without substrate modification. Patients were followed at 6, 9, 12 and 15 mos to collect the following data: Atrial Fibrillation Effect on Quality-of-Life (AFEQT) score, Canadian Cardiovascular Society Severity of Atrial Fibrillation (CCS-SAF) score, Class I/III AAD use, and incidence of cardioversion and cardiovascular hospitalization. Results A total of 333 enrolled patients (65.4±8.8 yrs, 71.2% male, CHA2DS2-VASC score 2.3±1.5) underwent PVI. Compared to baseline, 1) improvements in the AFEQT composite and subscores were seen from 6–15 mos, exceeding Clinical Important Difference (±5 points) in majority of subjects (Figure), 2) proportion of CCS-SAF Class 0 patients (asymptomatic with respect to AF) rose from 0.7% to 81.0%, 3) class I/III AAD use was reduced from 97.0% to 24.7%, and 4) incidence of cardioversion decreased from 62.0% to 10.7%. Moreover, the 1-yr Kaplan-Meier estimate of freedom from hospitalization was 84.2% [95% CI: 80.2%, 88.2%]. Conclusion CF-guided RF ablation in PsAF patients led to a clinically meaningful improvement in QOL, as well as a reduction in AAD use, cardioversion, and hospitalization. Figure 1. Mean AFEQT composite and subscore Funding Acknowledgement Type of funding source: Private company. Main funding source(s): This study was funded by Biosense Webster, Inc.

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.

Cohort profile: patient characteristics and quality-of-life measurements for newly-referred patients with atrial fibrillation—Keio interhospital Cardiovascular Studies-atrial fibrillation (KiCS-AF)

PurposeBesides the high rates of morbidity and mortality, atrial fibrillation (AF) is also associated with impairment of quality-of-life (QOL). However, reports covering non-selected AF population within Asian countries remain scarce....

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.

Patient-Reported Outcomes in AtrialFibrillation Research: Results of a Clinicaltrials.gov Analysis.

This study sought to determine how frequently patient-reported outcomes (PROs) are collected in registered clinical studies of atrial fibrillation (AF). Improving symptom burden and quality of life are important goals in the treatment of AF and are best measured with PROs. Data from Clincaltrials.gov were studied to identify PROs in AF studies. All studies reporting AF as the disease condition were included, and PROs were identified by search terms within the outcome measures field. Generic and AF-specific PROs were identified and assessed by study type and year. Clinicaltrials.gov reporting was compared with published reports of linked studies in PubMed. From 1999 to 2018, 1,709 studies including AF patients were posted; 238 studies (14%) included PROs. Collection of PROs was reported in 22% of trials (n= 83 of 386) studying procedural interventions and 11% of all Phase 3studies (n= 18 of 168). Among the 238 studies with PROs, most described "quality of life" (n= 194 [82%]), and most(n= 198 [83%]) included only generic (not AF-specific) PROs. Only 17% of studies (n= 40) reporting PROs specified a previously published AF-specific tool, most commonly the AFEQT (Atrial Fibrillation Effect on QualiTy-of-life) form (n= 20 [8.4%]). Among the available PubMed citations of 391 studies, 74 studies (19%) described collecting a specific PRO tool (n= 29 [7.4%]) for an AF-specific PRO. Despite increased emphasis on the importance of PROs in AF, a minority of registered clinical trialsreported collecting PROs, with very few using validated, AF-specific PROs. Improving outcomes that are mostimportant to patients will necessitate increased emphasis on these PROs in pivotal clinical studies.

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.

Atrial fibrillation reduction by renal sympathetic denervation: 12 months\u2019 results of the AFFORD study

AimThe purpose of this pilot study was to assess whether renal sympathetic denervation (RDN) decreases atrial fibrillation (AF) burden in hypertensive patients with symptomatic AF at 6- and 12-month follow-up, as measured using an implantable cardiac monitor (ICM).Methods and resultsA total of 20 patients with symptomatic paroxysmal or persistent AF (EHRA ≥ II) and primary hypertension with a mean office systolic blood pressure (BP) of > 140 mmHg were enrolled. After enrolment, an ICM was implanted 3 months pre-RDN to monitor AF burden. Quality of life (QOL) was assessed using the Atrial Fibrillation Effect on QualiTy-of-life (AFEQT) questionnaire. Mean age was 64 ± 7 years and 55% were females. AF burden in min/day decreased from a median (IQR) of 1.39 (0–11) pre-RDN to 0.67 (0–31.6) at 6 months (p = 0.64) and to 0.94 (0–6.0) at 12 months (pre-RDN vs. 12 months; p = 0.03). QOL improved significantly at both 6 months (+ 11 ± 15 points, p = 0.006) and 12 months (+ 10 ± 19, p = 0.04) as compared to pre-RDN. Office BP decreased significantly at 12-month follow-up (− 20 ± 19/− 7 ± 10 mmHg), p < 0.01) as compared to pre-RDN. Ambulatory BP decreased − 7 ± 16/− 3 ± 9 mmHg (p > 0.05) at 12-month follow-up as compared to pre-RDN.ConclusionThis pilot study suggests that RDN might be able to decrease AF burden in min/day as measured using an ICM, with a positive effect on QOL. Large-scale randomized trials are needed to prove the definite value of RDN in hypertensive patients with atrial fibrillation.