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Background Clinical outcome of pulmonary vein isolation (PVI) has been predominantly focused on the reoccurrence of atrial fibrillation (AF) and the maintenance of sinus rhythm. However, there has been a limited intermediate follow-up on health-related quality-of-life (HRQoL) of patients. Given the relatively high recurrence rate of persistent AF after PVI treatment, it is important to follow up with clinical outcomes on symptom improvement as well as health-related quality-of-life. This study was designed to investigate the recurrence rate of atrial tachyarrhythmia (ATa), AF-related symptoms and HRQoL after PVI in patients with persistent AF who were treated with the second generation cryoballoon. Methods Total 148 patients participated in the study who were treated by PVI between 2013 and 2017 for persistent AF. All patients visited the out-patient clinic 2–5 years after PVI. During this visit all patients filled-out an AF Effect on Quality-of-life (AFEQT) questionnaire and a seven-day Holter was applied. All rhythm recordings acquired post ablation were collected and analysed, and the modified European Heart Rhythm Association score (mEHRA) scores were calculated before and after the ablation. Results The average age of patients was 63±9 year old and 44 (27.9%) were female. Mean CHA2DS2 VASc score was 1.9±1.4, and moderate and severe left atrial (LA) dilation was present in 53 (36.1%) and 15 (10.2%) patients, respectively. After a follow-up of 3.7±1.0 years, 81 (54.7%) patients had an ATa recurrence and 35 (23.6%) patients underwent a repeat LA ablation. However, the mEHRA score significantly improved in 80.4% of the patients (p <0.001), with the median overall AFEQT score of 88.9 [70.4–97.2]. Conclusions There is a considerable ATa recurrence rate after PVI of persistent AF at intermediate-term follow-up. However, our data indicate that PVI significantly improved AF-related symptoms and resulted in a high HRQoL for 2–5 years in patients with persistent AF.

Aims To evaluate the extent and determinants of off-label non-vitamin K oral anticoagulant (NOAC) dosing in newly diagnosed Dutch AF patients. Methods and results In the DUTCH-AF registry, patients with newly diagnosed AF (&lt;6 months) are prospectively enrolled. Label adherence to NOAC dosing was assessed using the European Medicines Agency labelling. Factors associated with off-label dosing were explored by multivariable logistic regression analyses. From July 2018 to November 2020, 4500 patients were registered. The mean age was 69.6 ± 10.5 years, and 41.5% were female. Of the 3252 patients in which NOAC label adherence could be assessed, underdosing and overdosing were observed in 4.2% and 2.4%, respectively. In 2916 (89.7%) patients with a full-dose NOAC recommendation, 4.6% were underdosed, with a similar distribution between NOACs. Independent determinants (with 95% confidence interval) were higher age [odds ratio (OR): 1.01 per year, 1.01–1.02], lower renal function (OR: 0.96 per ml/min/1.73 m2, 0.92–0.98), lower weight (OR: 0.98 per kg, 0.97–1.00), active malignancy (OR: 2.46, 1.19–5.09), anaemia (OR: 1.73, 1.08–2.76), and concomitant use of antiplatelets (OR: 4.93, 2.57–9.46). In the 336 (10.3%) patients with a reduced dose NOAC recommendation, 22.9% were overdosed, most often with rivaroxaban. Independent determinants were lower age (OR: 0.92 per year, 0.88–0.96) and lower renal function (OR: 0.98 per ml/min/1.73 m2, 0.96–1.00). Conclusion In newly diagnosed Dutch AF patients, off-label dosing of NOACs was seen in only 6.6% of patients, most often underdosing. In this study, determinants of off-label dosing were age, renal function, weight, anaemia, active malignancy, and concomitant use of antiplatelets.

Purpose To evaluate the proportion of patients in whom parameters that define the diagnosis of HFpEF and HFmrEF persist versus normalize upon elimination of AF. Background Atrial fibrillation (AF) and heart failure with preserved or mid-range ejection fraction (HFpEF or HFmrEF) concur in many patients. Distinction between these two diagnoses remains challenging as one can cause or exacerbate the other. Adequate patient selection for invasive AF treatment is crucial to improve rhythm outcome. Methods Patients underwent thoracoscopic ablation, consisting of pulmonary vein isolation (PVI) alone or PVI with additional lines in the case of persistent AF. Patients were prospectively followed-up. HFmrEF or HFpEF was defined as left ventricular ejection fraction (LVEF) ≥40% or ≥50% respectively and N-terminal prohormone of brain natriuretic peptide (NT-proBNP) levels >125 pg/ml. Patients who remained free from AF, or any atrial tachycardia of more than 30 seconds, at 6 months postoperatively, were included in this study. Patients with AF recurrences during this period were excluded. The primary outcome was the change of NT-proBNP at 6 month follow-up. Results From 2008 to 2017, 92 patients undergoing thoracoscopic AF ablation fulfilled the aforementioned criteria and were included. Of these patients, mean age was 61±8 years and 66 (72%) were male. Median NT-proBNP was 366 pg/ml (128–2916) and mean LVEF was 53±7%. Thirty (35%) patients had a LVEF of 40–49%. Six months after elimination of AF, NT-proBNP was <125 pg/ml (Figure 1A: median 87 (50–122) vs 459 (137 – 2916) pg/ml at baseline; p<0.001) in 26 patients (28%), whereas in the remaining patients NT-proBNP was unchanged (Figure 1B: median 298 (126–1568) vs. 318 (128–2387) pg/ml at baseline; p=0.011). Figure 1. NT-proBNP alterations after thoracoscopic AF ablation from baseline to 6 month follow-up. A. Patients with normalization of NT-proBNP. B. Patients with unchanged high levels of NT-proBNP. Conclusion In 28% of patients the diagnostic criteria of HFpEF/HFmrEF are caused by AF and normalize upon elimination of AF with thoracoscopic ablation.

Introduction Pharmacological restoration of sinus rhythm (SR) in patients with symptomatic atrial fibrillation (AF) is expected to be accompanied by prompt alleviation of symptoms to avoid the need for electrical cardioversion (ECV) and/or hospitalization. The feasibility and safety of acute cardioversion of recent-onset (≤48 hours) symptomatic AF to SR with flecainide acetate oral inhalation (FlecIH) solution was shown in the Phase 2, open-label INSTANT trial. We examined symptoms, heart rate, time to discharge and need for ECV reported among patients in the INSTANT trial whose AF was successfully converted to SR (“conversion group”; N=25) versus those whose AF did not convert to SR (“no conversion group”; N=29). Methods Conversion success was determined using 12-lead Holter monitoring during a 90-minute observation period. Patients in the no conversion group were offered alternative treatment per the investigator discretion. Symptoms, vital signs, time to discharge, and the need for ECV were evaluated through Day 5. Results Data from 54 patients (33.3% female) with a mean age of 62.1 years and a mean BMI of 26.8 kg/m2 were analyzed. All patients reported at least one AF-related symptoms at baseline (palpitations=85%; dizziness=35%; shortness of breath=37%; chest discomfort=39%) and 83.3% presented with AF symptoms ≤24 hours in duration. At 90 minutes, 80.0% of the conversion group were asymptomatic compared to 37.9% of the no conversion group (p&lt;0.001). Mean (SD) ventricular rate at 90 minutes was 70.6 (12.5) bpm in the conversion group compared to 100.4 (29.4) bpm in the no conversion group (p&lt;0.001). Median time to discharge was 2.3 (IQR: 0.75) hours for the conversion group compared to 3.6 (IQR: 1.02) hours for the no conversion group (p=0.001). By Day 5, 23 (79.3%) patients in the no conversion group had undergone ECV; no patients in the conversion group experienced AF recurrence by Day 5 (0% required ECV; p&lt;0.001). Conclusions Conversion of recent onset AF to SR with inhaled flecainide was associated with a reduction in symptoms, normalization of heart rate, rapid hospital discharge and avoidance of ECV during a 5-day follow-up period. Funding Acknowledgement Type of funding sources: Private company. Main funding source(s): InCarda Therapeutics