Predictors of low-voltage zones in patients with persistent atrial fibrillation eligible for catheter ablation: An observational study.

INTRODUCTION: The presence of low-voltage zones (LVZs) in the left atrium (LA) is associated with the recurrence of atrial fibrillation (AF) following pulmonary vein isolation (PVI). However, there is variability and conflict in the data regarding predictors of LVZs as reported in previous studies. The objective of this study was to identify predictors for the presence of LVZs in a cohort of patients with persistent AF. METHODS: The study prospectively enrolled 439 patients with persistent AF who were scheduled for ablation. Voltage map of the LA was collected using a multipolar catheter. An LVZ was defined as an area of ≥3 cm2 exhibiting a peak-to-peak bipolar voltage of <0.5 mV. RESULTS: The mean age of the cohort was 65.3 ± 8.6 years and 26.4% were female. Additionally, 25.7% had significant LVZs, most frequently located in the anterior wall of the LA. Multivariable analysis identified the following independent predictors for LVZ: advanced age (OR [odds ratio] = 1.08, 95% CI [confidence interval] = 1.03-1.13, p = .002); female sex (OR = 4.83, 95% CI = 2.66-8.76, p < .001); coronary artery disease (CAD) (OR = 3.20, 95% CI = 1.32-7.77, p = .01) and enlarged LA diameter (OR = 1.10, 95% CI = 1.04-1.17, p = .001). The area under the curve (AUC) of the receiver operating characteristic (ROC) curve for the final model was 0.829. CONCLUSION: Approximately 25% of the patients with persistent AF had LVZs. Advanced age, female sex, CAD, and a larger LA were independent predictors for LVZs with the model demonstrating a very good AUC for the ROC curve. These findings hold the potential to be used to tailor the ablation procedure for the individual patient.

Risk assessment in patients with symptomatic and asymptomatic pre-excitation.

AIMS: Controversy remains as to whether the exercise stress test (EST) is sufficient for risk evaluation in patients with pre-excitation. This study aims to clarify the usefulness of EST in risk stratification in both asymptomatic and symptomatic patients presenting with pre-excitation. METHODS AND RESULTS: This prospective study includes consecutive asymptomatic and symptomatic patients with pre-excitation referred for risk assessment. All participants performed an incremental EST (bicycle) prior to an electrophysiology study (EPS). Primary data from the EST included loss of pre-excitation during exercise, and primary data from the EPS included the measurement of accessory pathway effective refractory period (APERP), shortest pre-excited RR interval (SPERRI), and inducible arrhythmia with the use of a beta-adrenergic receptor agonist if deemed necessary. One hundred and sixty-four patients (59 asymptomatic, 105 symptomatic) completed an EST and EPS. Forty-five patients (27%) demonstrated low-risk findings on EST, of which 19 were asymptomatic and 26 were symptomatic. Six patients with low-risk EST findings had SPERRI/APERP ≤ 250 ms at EPS, and two of them were asymptomatic. The sensitivity, specificity, positive predictive value, negative predictive value (NPV), and accuracy of low-risk EST for excluding patients with SPERRI/APERP ≤ 250 ms were 40, 91, 87, 51, and 60%, respectively. The number of patients with inducible arrhythmia at EPS was similar in the asymptomatic (36, 69%) and symptomatic (73, 61%) groups. CONCLUSION: Sudden loss of pre-excitation during EST has a low NPV in excluding high-risk APs. The EPS with the use of isoproterenol should be considered to accurately assess the risk of patients with pre-excitation regardless of symptoms (ClinicalTrials.gov Identifier: NCT03301935).

Validation of diagnostic accuracy of a handheld, smartphone-based rhythm recording device.

AIM: Evaluation of the diagnostic accuracy of a rhythm recording device, for detection of atrial tachyarrhythmia (ATA) and atrial fibrillation (AF) compared to 12-lead-electrocardiogram (12-L-ECG). RESEARCH DESIGN AND METHODS: Two hundred 12-L-ECGs (reference standard) and Coala Heart Monitor (CHM) recordings (index test) were collected from 189 patients. Two electrophysiologists independently performed manual analysis of all 12-L-ECGs and CHM recordings in random order. The CHM recordings were also analyzed by an automatic algorithm and compared to the results of the reference standard. RESULTS: Manual analysis of CHM for ATA showed a sensitivity of 98.9% (95% confidence interval (CI): 94.0-100) and a specificity of 100% (CI: 96.6-100). Manual analysis for AF had a sensitivity of 100% (CI: 95.3-100) and a specificity of 97.5% (CI: 93.0-99.5). Automatic analysis for ATA showed a sensitivity of 93.5% (CI: 86.3-97.6) and a specificity of 92.6% (CI: 85.9-96.7). Automatic analysis for AF showed a sensitivity of 97.4% (CI: 91.0-99.7) and a specificity of 86.1% (CI: 78.6-91.7). CONCLUSION: CHM has a very high accuracy for ATA and AF in manual analysis and a high accuracy for ATA and AF in automatic analysis, making the device suitable for screening.

Women with atrial fibrillation undergoing pulmonary vein isolation are more symptomatic but improve more in health-related quality of life and symptom burden than men.

Gender differences in symptoms and perceived health-related quality of life (HRQOL) in patients with atrial fibrillation (AF) referred to pulmonary vein isolation (PVI) have been reported previously. Women experience a lower HRQOL, faster heart rate, and more symptoms such as palpitation and dyspnea than men. Furthermore, they experience worse physical functioning independently of other heart diseases or age. This study evaluates referral patterns and symptoms, morbidity, functional impairment, and HRQOL from a gender perspective in patients with AF before and 6 months after PVI. The study includes 242 patients (121 men), mean age 62 ± 9 years, referred for PVI. Symptoms were assessed with the Symptom Checklist: Frequency and Severity (SCL), HRQOL with Short Form 36 (SF-36), and the functional impairment with Sickness Impact Profile (SIP). The patients' own experiences of the referral process and history of their disease were evaluated with a supplementary questionnaire. The results showed that women improved more than men in HRQOL, SIP, and SCL 6 months post PVI. There were no sex differences in proportion of paroxysmal and persistent AF or ablation outcome. At baseline, women scored higher than men in both scales of the SCL (p < 0.001), scored lower in all components in SF-36, and scored higher in five categories of the SIP. Women were not more reluctant to accept referral for ablation when offered. The conclusion is that women with AF undergoing PVI are more symptomatic but also improve more in HRQOL and in symptom burden than men.

Instant electrocardiogram feedback with a new digital technique reduces symptoms caused by palpitations and increases health-related quality of life (the RedHeart study).

AIMS: Palpitations, particularly common in women, are generally considered benign symptoms rarely caused by clinically important arrhythmias. Nevertheless, palpitations may cause anxiety, depression, and decreased health-related quality of life (HRQOL). This study investigates to what degree palpitations cause symptoms such as anxiety and depression and affect HRQOL in women and whether direct feedback of underlying heart rhythm during palpitations decrease anxiety and depression and increase HRQOL in women. METHODS AND RESULTS: The study included 821 women, age 21-88 years (mean 57 ± 11 years), with symptomatic palpitations recruited using social media. For 60 days, the participants used a handheld electrocardiogram (ECG)-recording device (Coala Heart Monitor) connected to their smartphones. ECG was recorded twice a day and when symptoms were present and was automatically algorithm-interpreted with immediate response to the user. Non-benign arrhythmias were also analysed manually. Questionnaires addressing anxiety and depression-Hospital Anxiety and Depression Scale (HADS), Generalized Anxiety Disorder (GAD-7), HRQOL (RAND-36), and Symptoms Checklist: Frequency and Severity (SCL)-were analysed before and after the data were collected. A total of 101 804 ECG recordings were automatically analysed. In 94%, sinus rhythm or premature atrial/ventricular contraction were recorded; in 6%, atrial fibrillation or supraventricular tachycardia were recorded. Apart from premature ventricular contractions, no ventricular arrhythmias were documented. Anxiety and depression (HADS and GAD-7) decreased (P < 0.001) as did frequency and severity of symptoms, and HRQOL increased in all domains (P < 0.001) at the 2-month follow-up. CONCLUSION: Instant analysis of the ECG with direct response during palpitations decreases symptoms, anxiety, and depression and increases HRQOL in women.

Improving Efficiency of Clinical Studies Using a Total Digital Approach: Prospective Observational Study.

BACKGROUND: In general, most clinical studies have long recruitment periods. Signing the informed consent is particularly time-consuming when the participant must meet physically with the researchers. Therefore, introducing fully web-based techniques with the use of eAuthentication (BankID) and new digital electrocardiogram (ECG) monitoring could speed up inclusion time, increase adherence, and also reach out to more remote regions. OBJECTIVE: The objectives of this study were to explore whether inclusion of a large number of participants could be realized quickly by using a total digital approach both for information and signing of informed consent, along with ECG monitoring and instant feedback on a mobile device. We also explored whether this approach can increase adherence in registration of ECG recordings and answering questionnaires, and if it would result in a more geographically uniform distribution of participants covering a wide age span. METHODS: Women with palpitations were intensively studied over 2 months by means of a handheld ECG monitoring device (Coala Heart Monitor). The device connects to a smartphone or tablet, which allows the participants to obtain the results immediately. Recruitment, study information, and signing the informed consent form with the help of BankID were performed in a completely digital manner. RESULTS: Between March and May 2018, 2424 women indicated their interest in participating in the study. On June 19, 2018, presumptive participants were invited to log in and register. After 25 days, 1082 women were included in the study; among these, 1020 women fulfilled the inclusion criteria, 913 of whom completed all phases of the study: recording ECG using the handheld device, completion of the prestudy questionnaires, and completion of the poststudy questionnaires 2 months after the ECG recordings. The dropout rate was 9%. In total, 101,804 ECG recordings were made. The mean age was 56 (SD 11) years (range 21-88 years) and 35 participants were 75 years or older. The participants were evenly distributed between living in the countryside and in cities. CONCLUSIONS: Total digital inclusion recruitment of 1082 participants was achieved in only 25 days, and resulted in a good geographical distribution, excellent adherence, and ability to reach a vast age span, including elderly women. Studies using a total digital design would be particularly appealing during a pandemic since physical contact should be avoided as much as possible. TRIAL REGISTRATION: ISRCTN Registry ISRCTN22495299; http://www.isrctn.com/ISRCTN22495299.

Device profile of the Coala Heart Monitor for remote monitoring of the heart rhythm: overview of its efficacy.

Introduction: Several handheld thumb ECG devices for on-demand recording of heart rhythm have become available lately. These can be used both by health-care providers and purchased by laypersons for private use.Area covered: This profile describes the Coala Heart Monitor. This device differs from other handheld ECG monitors in three aspects: 1) it records both thumb and chest ECGs, 2) it uses both RR-dispersion and P-wave morphology for detecting atrial fibrillation, and 3) in synchronization with the chest ECG, it also records heart sounds presented as a phonocardiogram making measurement of systolic time intervals possible. The sensitivity and specificity for detecting atrial fibrillation are high. The use of systolic time interval in patients with heart failure has so far not been evaluated.Expert opinion: The increasing use of long-term prescribed and privately owned handheld ECG devices for on-demand recording of heart rhythm will most probably cause a paradigm shift in arrhythmia diagnostics. Coala Heart Monitor´s use of both chest and thumb recordings as well as analyzing both RR-dispersion and P-wave morphology may offer an advantage in diagnosing atrial fibrillation.

Atrio-ventricular junction ablation and pacemaker treatment: a comparison between men and women.

OBJECTIVES: To explore sex differences regarding indication for atrio-ventricular junction ablation (AVJ), choice of pacing system, complications to pacemaker treatment, long-term outcome, and cause of death after AVJ ablation. DESIGN: 700 patients who had undergone AVJ ablation between January 1990 and December 2010 were included. Data were retrieved from the patients´ medical records and the Swedish Pacemaker and Implantable Cardioverter-Defibrillator Registry. Information about admission to hospital and cause of death was retrieved from the National Board of Health and Welfare. RESULTS: Mean follow-up was 90 ± 64 months. Indication for AVJ ablation, choice of pacing system, and outcome after AVJ ablation differed between the sexes. The men had more often permanent atrial fibrillation, p = .0001, and a VVIR pacemaker or cardiac resynchronization therapy (CRT) implanted prior to ablation, p = .0001. Heart failure was present in 44% of the men vs. 28% of the women, p = .0001. LVEF decreased slightly in the whole cohort after the AVJ ablation. There were no sex differences in complication rates due to the pacemaker/ICD treatment, p = .3 or mortality due to AVJ ablation. CONCLUSION: In this long-term follow-up in patients with atrial fibrillation treated with AVJ ablation and pacing, indication, choice of pacing system, and morbidity differed but there were no sex differences regarding survival or primary cause of death found. The main factor influencing survival was age at the time of ablation. Women less often received treatment with ICD and/or CRT when indication was present compared with men.

Women with PSVT are often misdiagnosed, referred later than men, and have more symptoms after ablation.

OBJECTIVES: Using a patient and gender perspective, this study evaluates the experiences and perspectives of referral for paroxysmal supraventricular tachycardia (PSVT), and symptoms, Health-Related Quality of Life (HRQOL) and functional impairment before and six months after ablation. DESIGN: This prospective study includes 214 (109 women) patients with PSVT who completed questionnaires before and after ablation addressing referral patterns, duration of arrhythmia, socioeconomic status, symptoms, HRQOL, and functional impairment. RESULT: Women had a longer history of symptomatic arrhythmia before ablation compared to men (16.2 ± 14.6 vs. 9.9 ± 13.1 years, p = .001). From the patient's perspective, physicians more often incorrectly interpreted women's symptoms as anxiety, stress, panic attacks, or depression compared to men, delaying referral for ablation. More women than men stated they were not taken seriously when consulting for their tachycardia symptoms (17% vs.7%, p = .03). At baseline, there were minor differences between the sexes in HRQOL and functional impairment, but women had a higher symptom score on Symptoms Checklist Frequency (19 vs. 14, p < .001) and Severity Scale (12 vs. 16, p = .001). At six months, women were more symptomatic and their HRQOL improved less than in men. Both sexes reported improvement in recreation and pastime (p = .001). CONCLUSION: Women with PSVT are referred for ablation later, and are more symptomatic before and after ablation than men. Symptoms due to PSVT are often incorrectly diagnosed as panic attacks, stress, anxiety, or depression, misdiagnoses that delay referral for ablation, especially for women.

An active supply of analgesics during pulmonary vein isolation reduces pain.

AIM: Pulmonary vein isolation (PVI) is an established method for treatment of drug refractory atrial fibrillation. The aim of this study was to evaluate whether a more active regular supply of analgesic and sedative drugs reduces pain and discomfort. We also wanted to evaluate gender differences in pain perception and to compare standard radiofrequency (RF) with cryo balloon ablation (Cryo) from this perspective. METHODS: A total of 80 patients, 40 men, median age 58 (range 23-76) years, who underwent PVI under conscious sedation were studied. They were randomized to either standard treatment with morphine and diazepam (control group, C) or to a more active analgesic strategy (A) with pre-medication with oral midazolam mixture and intravenous alfentanil and midazolam regularly administrated during the procedure. Forty patients were treated with RF and 40 with Cryo. RESULTS: The majority of the patients experienced pain during the procedure. The maximal pain assessed with numerical rating scale (NRS), was lower in the active group compared with that in controls (p = 0.02). Women experienced more pain than men (p = 0.01). RF was more painful than Cryo (p < 0.001). CONCLUSION: An active regular supply of analgesic and sedative drugs reduce pain and discomfort during PVI. Women experience more pain than men during this procedure and PVI performed with Cryo is less painful than with RF.

Health-related quality of life in patients with atrial fibrillation undergoing pulmonary vein isolation, before and after treatment.

BACKGROUND: Atrial fibrillation (AF) is the most common arrhythmia and many AF patients experience a significantly impaired health-related quality of life (HRQOL). AF is also associated with a high risk of stroke and death. Many pharmacologic treatments for AF are ineffective and may have adverse effects. New methods, such as pulmonary vein isolation (PVI), have been developed to treat AF. AIMS: The aim of this study was to investigate the HRQOL issues in severe symptomatic AF patients before and after pulmonary vein isolation. METHODS: Forty patients treated with PVI were included of which 36 concluded the study with the self-reported HRQOL questionnaires before and once after PVI. A standardized control group was used. RESULTS: Compared to the control group the HRQOL before PVI was significantly lower in all domains except for bodily pain. The preoperative scores were compared with the scores obtained at the follow-up. All subscales of the SF-36 significantly improved after the PVI except for bodily pain, which remained unaltered. CONCLUSION: HRQOL is improved in AF patients with severe symptoms after PVI intervention.

Long-term health-related quality of life after maze surgery for atrial fibrillation.

BACKGROUND: Atrial fibrillation (AF) significantly impairs health-related quality of life (QoL). As pharmacologic treatment may have intolerable side effects and is not always effective, other techniques for curing AF have evolved. The maze III procedure has a high long-term success rate in restoring and maintaining sinus rhythm, but the long-term impact on QoL has not been sufficiently demonstrated. METHODS: Thirty-four patients underwent the maze III procedure for paroxysmal (n = 9), persistent (n = 15) or permanent (n = 10) AF. Quality of life was assessed with the Swedish Short Form-36 survey. Mean follow-up time was 35 +/- 6 months. RESULTS: Sinus rhythm was maintained in 32 patients (94%). For all domains except bodily pain, all patients reported substantial worse QoL at baseline as compared with healthy controls. Postoperatively all scores improved significantly to the level of the general population, and for the majority of the scoring items this was observed after 12 months. Improvement was maintained during the remaining observation period. CONCLUSIONS: The maze III procedure significantly improves QoL in patients with AF. The results are consistent during an observation time of 35 months. Based on QoL effects in a long-term perspective, maze surgery should be considered in symptomatic patients with AF refractory to pharmacologic treatment or catheter ablation.