AIMS:Atrial fibrillation (AF) is highly prevalent among cardiac amyloidosis (CA) patients and contributes significantly to their morbidity and mortality. Evidence regarding AF ablation efficacy and safety in CA patients remains limited. The aim of our study is to evaluate baseline characteristics, clinical course and outcomes of AF ablation in a series of patients with transthyretin (ATTR) or light-chain (AL) CA from a multicentre international registry. METHODS AND RESULTS:Patients with CA who underwent AF ablation were included. Co-primary endpoints were: (i) atrial arrhythmia (AA) recurrence; (ii) a composite endpoint of all-cause mortality and heart failure hospitalization (HFH). 109 patients (mean age 72.4 ± 7.4 years, females 17.4%, persistent AF 64.2%, ATTR 78%, AL 22%) were included. Radiofrequency, cryo-balloon and pulsed-field ablation were performed in 67%, 15% and 18% of patients, respectively; 49.5% received pulmonary vein isolation plus additional ablations. Low voltage zones were documented in 34 out of 44 patients undergoing electro-anatomical mapping (77.3%). During a median follow-up of 22.7 months, 63 patients (58.3%) experienced AA recurrence (32.4% persistent AF recurrence), with no significant differences between CA subtypes (ATTR 59.5% vs. AL 54.2%, log-rank P = 0.55). The composite endpoint of HFH and all-cause death occurred in 27 patients (25%). Recurrence of persistent AF was associated with three-fold higher risk (OR 2.9, P = 0.02) of the composite endpoint. CONCLUSION:CA patients undergoing AF ablation present high prevalence of persistent AF. Freedom from AA after AF ablation is achieved in 42% of patients after a two-year follow-up. Patients with persistent AF recurrence have a three-fold higher risk of HFH and death.
This consensus recommendation of the Working Group for Congenital and Acquired Heart Disease and the Working Group for Rhythmology of the Austrian Society of Cardiology (ÖKG) describes the pathophysiological foundations, clinical presentation, diagnosis and treatment of arrhythmias in adult patients with congenital heart defects. It also illuminates malformation-specific aspects with respect to the anatomy, typical corrective interventions, risk of arrhythmia and treatment.
Background: Sodium glucose-linked transport 2 inhibitors (SGLT2-Is) are well known to exert beneficial effects in chronic heart failure (CHF) independent of left ventricular ejection fraction (LVEF). As inflammation plays a key role in cardiac diseases, data on the association of inflammatory biomarkers and ventricular arrhythmic (VA) burden in SGLT2-I-treated patients is lacking. Methods: This pre-defined subanalysis investigated changes in pre-specified inflammatory biomarkers from baseline to week 52 in response to 5 mg Ertugliflozin compared to placebo and their associations to the incidence of VA burden. Results: A total of 36 patients (18 versus 18) with available biobank samples were included in the analysis. At week 52, leukocyte and neutrophil counts, as well as high-sensitive C-reactive protein (hsCRP) and interleukin-6 (IL-6), were numerically higher in the Ertugliflozin group. In contrast, neutrophil-to-lymphocyte ratio (NLR) and platelet-to-lymphocyte ratio (PLR) were lower in the Ertugliflozin group, although these differences did not reach statistical significance. Notably, lymphocyte counts were significantly higher in Ertugliflozin showing a mean difference of 19.0 ± 10.78% (p = 0.028). Further, a significantly higher incidence of VA burden was observed among Ertugliflozin-treated patients with elevated hsCRP levels (incidence rate ratio [IRR] 3.58; 95% Confidence interval [CI], 1.12-11.40, p = 0.031). Conclusions: In patients with CHF, Ertugliflozin treatment was associated with a higher incidence of VA burden in those with elevated hsCRP levels. This may suggest a potential higher risk for VA in SGLT2-I-treated patients in the setting of heightened inflammatory activity. However, this finding is based on a single interaction analysis in a small sample size, and the results should therefore be considered exploratory and hypothesis-generating, and must be interpreted cautiously.
Same-day discharge (SDD) following electrophysiology (EP) and cardiac implantable electronic device (CIED) procedures has emerged as a contemporary care model driven by improvements in procedural safety, efficiency, and healthcare resource constraints. Despite growing evidence supporting its safety in selected patients, adoption of SDD across Europe remains heterogeneous. This clinical consensus statement, developed by the European Heart Rhythm Association (EHRA) of the ESC in collaboration with the Association of Cardiovascular Nursing & Allied Professions (ACNAP) of the ESC, provides an evidence-based and practice-oriented framework for the implementation of SDD pathways after EP and CIED interventions. Based on a structured review of contemporary trials, registries, and expert consensus, the document addresses patient selection, peri-procedural management, early complication surveillance, discharge criteria, and post-discharge follow-up. Procedure-specific considerations are provided for catheter ablation and device implantation. This consensus aims to harmonize clinical practice, reduce variability in care, and support the safe and sustainable expansion of SDD across diverse European healthcare systems.
BACKGROUND:The safety and effectiveness of the variable loop circular catheter (VLCC) pulsed field ablation (PFA) system was shown in atrial fibrillation (AF) registrational trials. OBJECTIVE:Assess acute safety and effectiveness of first-time pulmonary vein isolation (PVI) with the VLCC in standard clinical practice in the VARIPURE substudy of the ongoing, prospective, multicenter, observational SECURE postmarket follow-up study. METHODS:Data were extracted from Electronic Data Capture and the CARTONET data analytics software. Primary safety was the incidence of primary adverse events related to the VLCC and/or procedure. Primary effectiveness was acute procedural success, confirmed by electrical isolation of all targeted PVs. RESULTS:Among 1022 AF patients (mean age 64.9 years, 63.3% male, 63.5% paroxysmal AF; mean CHA2DS2-VASc 2.2; 22 European centers, 74 operators), 29.5% underwent ablations beyond the PVs (PVI+). The mean ± standard deviation procedure, left atrial dwell, and fluoroscopy times were 60.1 ± 21.9, 38.0 ± 15.6, and 5.2 ± 5.6 minutes, respectively. The primary adverse event rate was 0.8%, with no stroke, cerebrovascular accident, or transient ischemic attack. No ST elevation, coronary spasm, or acute kidney injury were reported. Acute reconnection was assessed per physician preference in a subset of patients (18.5% [78/421]). Acute PVI was achieved in 99.8% of patients. Using CARTONET (868 cases), the recommended workflow of 16-28 ablations for PVI was followed in 83.1% of patients with a 4-PV anatomy. CONCLUSION:In the largest real-world VLCC yet, PFA with the VLCC exhibits favorable safety, high acute efficacy, procedural efficiency, and recommended workflow adherence. Results may provide a strong foundation for future studies of this PFA technology upon 12-month follow-up completion. CLINICAL TRIAL REGISTRATION:ClinicalTrials.gov Identifier: NCT04750798 (https://clinicaltrials.gov/study/NCT04750798).
AIMS:Atrial fibrillation (AF) ablation by pulmonary vein isolation (PVI) and left atrial appendage closure (LAAC) are increasingly performed as standalone procedures. Given that PVI and LAAC share the same access route, a combined approach of pulsed field ablation (PFA)-based PVI and LAAC might be beneficial. The COCONUT study focused on safety, efficacy, and outcomes combining PVI by PFA with LAAC in one procedure. METHODS:This is a retrospective, multinational registry study. The primary endpoints were the following: (1) primary safety endpoint: serious adverse events; and (2) primary efficacy endpoint: success of PVI and LAA closure defined as the ability to isolate all pulmonary veins and the successful closure of the LAA. For secondary endpoints, peri-procedural data and follow-up data were collected. RESULTS:A total of 155 patients from 22 centres of nine European countries were treated by concomitant pentaspline catheter PFA-based PVI and LAAC. The mean CHA2DS2-VA score was 3.1 ± 1.4. The primary efficacy endpoint was achieved at 97.4% with successful PVI at 100% and successful LAAC in 151/155 patients (97.4%). The primary safety endpoint was observed in 3/155 patients (1.9%). Transoesophageal echocardiography and/or CCTA 67 ± 26 days after the procedure showed no device embolization and no device-related thrombus, 24/151 (15.9%) patients showed peri-device gaps of <5 mm while gaps of >5 mm have been observed in 3/151 (2.0%). Among 137/155 patients with available arrhythmia, a follow-up >6 months at 78.1% showed sinus rhythm. CONCLUSION:In this large multicentre study, concomitant PFA-based AF ablation and LAA closure proved to be feasible, effective, and safe and overall procedure duration was short.
BACKGROUND AND AIMS:This trial compared single-procedure efficacy and safety of pulsed field ablation (PFA) vs radiofrequency ablation (RFA) in patients with drug-resistant paroxysmal atrial fibrillation (AF). METHODS:BEAT PAROX-AF is a European, multicentre, open-label, randomized, controlled, superiority trial conducted across nine European sites. Eligible patients (aged 18-80 years) with symptomatic, drug-resistant paroxysmal AF were randomized (1:1) to either PFA (pentaspline) or RFA following the CLOSE protocol (contact force sensing catheter and electro-anatomical mapping system). The primary endpoint was the single-procedure success rate after 12 months defined as the absence of ≥30 s atrial arrhythmia recurrence, cardioversion, class I/III antiarrhythmic drug resumption after a 2-month blanking period, or any repeat ablation. RESULTS:From December 2021 to January 2024, 292 patients were randomized and 289 (median age 63.5 years, 58% male) were analysed (PFA n = 145, RFA n = 144). Single-procedure success at 12 months was 112/145 (77.2%) in the PFA group and 111/143 (77.6%) in the RFA group (adjusted difference 0.9%; 95% confidence interval -8.2% to 10.1%; P = .84). Procedure-related serious adverse events occurred in 5 (3.4%) PFA vs 11 (7.6%) RFA patients (difference -3.3% [-8.4%, 1.8%]). No deaths, persistent phrenic palsy nor stroke occurred. In the RFA group, two patients had pulmonary vein stenosis >70% and 12 > 50%, two tamponades, and one oesophageal bleed. CONCLUSIONS:This randomized trial performed in patients with paroxysmal AF did not demonstrate superior efficacy of single-shot PFA vs point-by-point RFA using the CLOSE protocol regarding single-procedure freedom from atrial arrhythmias, despite fewer safety events being observed in this study with PFA.
Atrial fibrillation (AF) is the most common cardiac arrhythmia in adults and often remains undetected until a clinical sequelae such as a stroke occurs. To enable early detection, a large-scale screening trial is being established in Austria using a smartphone app. This paper outlines the process and IT infrastructure supporting participant self-registration. Citizens receive a postal invitation with a QR code linking to the registration web app, which collects eligibility data, baseline information, and informed consent. Participants are randomised to the intervention or control group, with household members assigned to the same group via address-based pseudonymisation using hashed postal data. The randomisation concept was validated on an Austrian address database. The self-registration app was successfully piloted with 120 patients in Innsbruck and Graz. The approach proved feasible and will be implemented in the nationwide trial starting in Q2 2026.
Heart failure with preserved ejection fraction (HFpEF) accounts for nearly half of all heart failure cases. In addition to diastolic dysfunction, patients with HFpEF have a substantial risk of sudden cardiac death, suggesting a potential contribution of malignant ventricular arrhythmias. Recently, small conductance Ca2+-activated K+ (SK) channels have emerged as potential modulators of mitochondria-dependent production of harmful reactive oxygen species (ROS). This study aimed to evaluate SK channel enhancement as a novel strategy to reverse proarrhythmic changes in intracellular Ca2+ cycling and in mitochondrial redox and Ca2+ homeostasis in ventricular myocytes using obese ZSF1 rat model of HFpEF. Confocal imaging of Ca2+ and ROS was performed in ventricular myocytes isolated from lean and obese ZSF1 rats. Mitochondrial matrix Ca2+ and ROS levels were measured using matrix-targeted biosensors mtRCamp1h and MLS-HyPer7, respectively. SK channel activity was enhanced by adenoviral overexpression of rat SK channel type 2 and by pharmacological activators NS309 and Riluzole. Ventricular myocytes from obese ZSF1 rats, when periodically paced and exposed to the β-adrenergic agonist isoproterenol, showed increased pro-arrhythmic diastolic sarcoplasmic reticulum (SR) Ca2+ release, elevated mitochondrial ROS production, and marked mitochondrial Ca2+ overload. SK channel enhancement prevented mitochondrial Ca2+ overload, reduced ROS emission, and improved cytosolic Ca2+ cycling by suppressing diastolic SR Ca2+ release These findings identify SK channel activation as a potential antiarrhythmic therapeutic strategy in HFpEF by limiting mitochondrial Ca2+ uptake, reducing oxidative stress and stabilizing intracellular Ca2+ dynamics.
INTRODUCTION:Pulsed field ablation (PFA), based on irreversible electroporation, is a non-thermal modality designed to create myocardial lesions while minimizing collateral injury. The determinants of acute lesion effectiveness in humans remain incompletely understood. We evaluated the association of contact force (CF) and impedance drop (ID) with acute lesion effectiveness during focal PFA index-guided pulmonary vein isolation (PVI). METHODS AND RESULTS:Twenty-four patients undergoing PFA-guided PVI for atrial fibrillation (AF) ablation were included. Electroanatomical mapping was performed in sinus rhythm using high-density catheters. Ablation was delivered using a CF catheter in a point-by-point workflow guided by a PFA index. Lesion effectiveness was defined by acute electrophysiological criteria. CF, ID, and PFA index achievement were analyzed at each ablation point. A total of 1460 ablation points were analyzed (1407 successful, 53 unsuccessful). Median CF was significantly higher in successful compared with unsuccessful lesions (15 vs. 11.3 g, p < 0.001). A CF value of 8 g yielded high sensitivity (90.3%) but low specificity (38.9%) for lesion effectiveness. ID did not differ between groups (p = 0.58). Target PFA index achievement was more frequent in successful lesions (67% vs. 9.4%, p < 0.01). CONCLUSIONS:CF is a significant but imperfect predictor of acute lesion effectiveness in PFA, since averaged CF values may inadequately reflect the instantaneous catheter-tissue interaction at the moment of pulse delivery. These findings support a paradigm in which maintaining sufficient real-time CF, rather than achieving a fixed average threshold, is critical for effective lesion formation.
AIMS:Landiolol is an ultrashort-acting, highly cardio-selective beta1-adrenergic receptor blocker used for short-term control of tachyarrhythmias. While its real-world use has been described in Japan, data from European clinical practice are lacking. This study aimed to collect real-world data on landiolol use, effectiveness, and safety across diverse clinical settings in Europe. METHODS AND RESULTS:This multicentre, observational study included adult patients with supraventricular arrhythmias treated with landiolol. Patient characteristics, drug utilization patterns, efficacy, and safety were assessed. In total, 450 patients were enrolled and 449 were analysed (median age: 72 years, IQR 63-78) from 17 sites across 8 European countries. Most patients (73.1%) received landiolol for atrial fibrillation. The median (IQR) duration of infusion was 8.9 (2.3-34.0) h, with starting, minimum, and maximum doses of 5.3 (2.5-10.0), 4.0 (1.7-10), and 10.0 (6.0-30.0) µg/kg/min, respectively. Heart rate (HR) control, defined as HR ≤110 b.p.m. or a reduction of >20% from baseline, was achieved in 74.2% of patients within 4 h after treatment discontinuation, with 36.9% of arrhythmia patients restoring sinus rhythm. Blood pressure (BP) remained stable throughout treatment. A total of 123 adverse events and 113 major adverse cardiac events were reported, none of which were related to landiolol. CONCLUSION:In European clinical practice, landiolol dosing adhered to product information recommendations. Landiolol was effective in controlling HR, with minimal impact on BP. The treatment was well tolerated, and no new safety signals were identified. These findings support the efficacy and safety of landiolol across diverse clinical settings in Europe.