Most cited article - PubMed ID 32865375
Early Rhythm-Control Therapy in Patients with Atrial Fibrillation
OBJECTIVES: The CEASE-AF trial demonstrated that epicardial-endocardial hybrid ablation (HA) had superior effectiveness compared to endocardial catheter ablation (CA) for non-paroxysmal atrial fibrillation (AF), without significantly increasing major complications during a 12-month period. Most contemporary AF ablation trials have not evaluated durability beyond 12 months. Therefore, 24-month effectiveness and safety of HA and CA are compared. METHODS: CEASE-AF is a prospective, multicentre, randomized trial. Patients 18-75 years of age with symptomatic, drug refractory persistent AF and left atrial diameter >4.0 cm or long-standing persistent AF were randomized 2:1 to HA (posterior wall and pulmonary vein isolation with left atrial appendage exclusion) or CA (pulmonary vein isolation). Secondary effectiveness was freedom from AF/atrial flutter/atrial tachycardia off class I/III anti-arrhythmic drugs except for those who previously failed at doses not exceeding those previously failed through a 24-month follow-up period. Major complications and reinterventions were evaluated. RESULTS: The intention-to-treat population was 102 patients with HA and 52 patients with CA. Seventy-five percent were male, 80.5% had persistent AF and 19.5% had long-standing persistent AF, with a mean age of 60.7 ± 7.9 years. Effectiveness for 24 months was 66.3% (63/95) with HA and 33.3% (17/51) with CA [absolute difference 33.0% (95% confidence interval 14.3%, 48.3%; P < 0.001)]. Major complication rates were 10.8% (11/102) with HA and 9.6% (5/52) with CA (P = 1.0), and fewer patients had reinterventions after HA than CA [18.9% (18/95) vs 52.9% (27/51), P < 0.001]. CONCLUSIONS: CEASE-AF demonstrated that the 32.4% absolute benefit of HA over CA for 12 months was durable for 24 months at 33% with continued similar safety rates and fewer reinterventions after HA (funded by AtriCure, Inc.; NCT02695277). CLINICALTRIALS.GOV REGISTRATION: NCT02695277.
- Keywords
- Atrial fibrillation, Catheter ablation, Hybrid ablation, Left atrial appendage, Surgical ablation,
- MeSH
- Adult MeSH
- Endocardium surgery MeSH
- Atrial Fibrillation * surgery MeSH
- Catheter Ablation * methods adverse effects MeSH
- Middle Aged MeSH
- Humans MeSH
- Adolescent MeSH
- Young Adult MeSH
- Prospective Studies MeSH
- Aged MeSH
- Pulmonary Veins surgery MeSH
- Treatment Outcome MeSH
- Check Tag
- Adult MeSH
- Middle Aged MeSH
- Humans MeSH
- Adolescent MeSH
- Young Adult MeSH
- Male MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Multicenter Study MeSH
- Randomized Controlled Trial MeSH
INTRODUCTION: Atrial fibrillation (AF) can cause or aggravate heart failure (HF). Catheter ablation (CA) is an effective treatment for AF. This study focused on the feasibility and outcomes of emergent AF ablation performed during hospitalization for acute HF. METHODS AND RESULTS: We retrospectively investigated patients who underwent emergent CA for AF during hospitalization for acute HF in 2018-2024. Arrhythmia recurrence was the primary endpoint. The combination of arrhythmia recurrence, HF hospitalization, and all-cause death was the secondary endpoint. Patients were censored 1 year after the index procedure. We included 46 patients, 35% females, with median age of 67 [interquartile rage: 61, 72] years and left ventricular ejection fraction (LVEF) of 25 [23, 28]%. Thermal CA was performed in 14 patients, and pulsed field ablation (PFA) in 32 patients. Procedure time was significantly shorter with PFA compared to thermal CA (77 [57, 91] vs. 166 [142, 200] minutes, p < 0.001). Fluoroscopy time was longer with PFA (9.5 [7.6, 12.0] vs. 3.9 [2.9, 6.0] minutes, p < 0.001), with a borderline trend towards higher radiation dose (75 [53, 170] vs. 50 [30, 94] μGy.m2, p = 0.056). Extrapulmonary ablation was frequent (86% and 84% for thermal CA and PFA, p > 0.9). The estimated freedom from the primary endpoint was 79% after PFA and 64% after thermal CA (p = 0.44). The estimated freedom from the secondary endpoint was 76% after PFA and 57% after thermal CA (p = 0.43). LVEF improved by 24% ± 2% (p < 0.001) in patients with the first manifestation of HF and by 14% ± 4% (p = .004) in patients with decompensated HF diagnosed earlier. CONCLUSIONS: Emergent CA of AF during acute HF hospitalization is safe and associated with improved LVEF and good clinical outcomes. In the PFA era, the rate of these procedures is progressively increasing as they are readily available and easy to perform compared to thermal ablation.
- Keywords
- acute heart failure, atrial fibrillation, catheter ablation, electroporation, posterior wall isolation, pulsed field ablation, thermal ablation,
- MeSH
- Action Potentials MeSH
- Acute Disease MeSH
- Time Factors MeSH
- Atrial Fibrillation * surgery physiopathology mortality diagnosis complications MeSH
- Ventricular Function, Left MeSH
- Hospitalization * MeSH
- Catheter Ablation * adverse effects mortality methods MeSH
- Middle Aged MeSH
- Humans MeSH
- Recovery of Function MeSH
- Patient Admission * MeSH
- Recurrence MeSH
- Retrospective Studies MeSH
- Risk Factors MeSH
- Aged MeSH
- Heart Rate MeSH
- Heart Failure * physiopathology mortality diagnosis therapy MeSH
- Feasibility Studies MeSH
- Stroke Volume MeSH
- Treatment Outcome MeSH
- Check Tag
- Middle Aged MeSH
- Humans MeSH
- Male MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
BACKGROUND: Short and rare episodes of atrial fibrillation (AF) are commonly detected using implanted devices (device-detected AF) in patients with prior stroke or transient ischemic attack (TIA). The effectiveness and safety of oral anticoagulation in patients with prior stroke or TIA and device-detected AF but with no ECG-documented AF is unclear. METHODS AND RESULTS: This prespecified analysis of the NOAH-AFNET 6 (Non-Vitamin K Antagonist Oral Anticoagulants in Patients With Atrial High Rate Episodes) trial with post hoc elements assessed the effect of oral anticoagulation in patients with device-detected AF with and without a prior stroke or TIA in the randomized, double-blind, double-dummy NOAH-AFNET 6 trial. Outcomes were stroke, systemic embolism, and cardiovascular death (primary outcome) and major bleeding and death (safety outcome). A prior stroke or TIA was found in 253 patients with device-detected AF randomized in the NOAH-AFNET 6 (mean age, 78 years; 36.4% women). There was no treatment interaction with prior stroke or TIA for any of the primary and secondary time-to-event outcomes. In patients with a prior stroke or TIA, 14 out of 122 patients experienced a primary outcome event with anticoagulation (5.7% per patient-year). Without anticoagulation, there were 16 out of 131 patients with an event (6.3% per patient-year). The rate of stroke was lower than expected (anticoagulation: 4 out of 122 [1.6% per patient-year]; no anticoagulation: 6 out of 131 [2.3% per patient-year]). Numerically, there were more major bleeding events with anticoagulation in patients with prior stroke or TIA (8 out of 122 patients) than without anticoagulation (2 out of 131 patients). CONCLUSIONS: Anticoagulation appears to have ambiguous effects in patients with device-detected AF and a prior stroke or TIA in this hypothesis-generating analysis of the NOAH-AFNET 6 in the absence of ECG-documented AF, partially due to a low rate of stroke without anticoagulation.
- Keywords
- CHA2DS2‐VASc score, NOAH‐AFNET 6, anticoagulation, atrial fibrillation, device‐detected atrial fibrillation, recurrent stroke,
- MeSH
- Anticoagulants * administration & dosage adverse effects therapeutic use MeSH
- Administration, Oral MeSH
- Time Factors MeSH
- Stroke * prevention & control etiology MeSH
- Double-Blind Method MeSH
- Atrial Fibrillation * drug therapy complications diagnosis MeSH
- Pacemaker, Artificial MeSH
- Hemorrhage chemically induced MeSH
- Humans MeSH
- Aged, 80 and over MeSH
- Aged MeSH
- Ischemic Attack, Transient * prevention & control etiology MeSH
- Treatment Outcome MeSH
- Check Tag
- Humans MeSH
- Male MeSH
- Aged, 80 and over MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Multicenter Study MeSH
- Randomized Controlled Trial MeSH
- Names of Substances
- Anticoagulants * MeSH
Pulsed field ablation (PFA) is an emerging technology for the treatment of atrial fibrillation (AF), for which pre-clinical and early-stage clinical data are suggestive of some degree of preferentiality to myocardial tissue ablation without damage to adjacent structures. Here in the MANIFEST-17K study we assessed the safety of PFA by studying the post-approval use of this treatment modality. Of the 116 centers performing post-approval PFA with a pentaspline catheter, data were received from 106 centers (91.4% participation) regarding 17,642 patients undergoing PFA (mean age 64, 34.7% female, 57.8% paroxysmal AF and 35.2% persistent AF). No esophageal complications, pulmonary vein stenosis or persistent phrenic palsy was reported (transient palsy was reported in 0.06% of patients; 11 of 17,642). Major complications, reported for ~1% of patients (173 of 17,642), were pericardial tamponade (0.36%; 63 of 17,642) and vascular events (0.30%; 53 of 17,642). Stroke was rare (0.12%; 22 of 17,642) and death was even rarer (0.03%; 5 of 17,642). Unexpected complications of PFA were coronary arterial spasm in 0.14% of patients (25 of 17,642) and hemolysis-related acute renal failure necessitating hemodialysis in 0.03% of patients (5 of 17,642). Taken together, these data indicate that PFA demonstrates a favorable safety profile by avoiding much of the collateral damage seen with conventional thermal ablation. PFA has the potential to be transformative for the management of patients with AF.
- MeSH
- Atrial Fibrillation * surgery therapy MeSH
- Catheter Ablation * adverse effects methods MeSH
- Middle Aged MeSH
- Humans MeSH
- Postoperative Complications epidemiology etiology MeSH
- Aged MeSH
- Treatment Outcome MeSH
- Check Tag
- Middle Aged MeSH
- Humans MeSH
- Male MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Multicenter Study MeSH
- Keywords
- Anticoagulation, Atrial fibrillation, Atrial high-rate episodes, Bleeding, CHA2DS2-VASc score, Device-detected atrial fibrillation, Kidney function, NOAH-AFNET 6, Stroke,
- MeSH
- Anticoagulants * administration & dosage therapeutic use MeSH
- Administration, Oral MeSH
- Stroke prevention & control epidemiology MeSH
- Atrial Fibrillation * drug therapy complications MeSH
- Cardiovascular Diseases prevention & control epidemiology MeSH
- Comorbidity MeSH
- Humans MeSH
- Aged MeSH
- Sex Factors MeSH
- Age Factors MeSH
- Treatment Outcome MeSH
- Check Tag
- Humans MeSH
- Male MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
BACKGROUND AND AIMS: Patients with long atrial high-rate episodes (AHREs) ≥24 h and stroke risk factors are often treated with anticoagulation for stroke prevention. Anticoagulation has never been compared with no anticoagulation in these patients. METHODS: This secondary pre-specified analysis of the Non-vitamin K antagonist Oral anticoagulants in patients with Atrial High-rate episodes (NOAH-AFNET 6) trial examined interactions between AHRE duration at baseline and anticoagulation with edoxaban compared with placebo in patients with AHRE and stroke risk factors. The primary efficacy outcome was a composite of stroke, systemic embolism, or cardiovascular death. The safety outcome was a composite of major bleeding and death. Key secondary outcomes were components of these outcomes and electrocardiogram (ECG)-diagnosed atrial fibrillation. RESULTS: Median follow-up of 2389 patients with core lab-verified AHRE was 1.8 years. AHRE ≥24 h were present at baseline in 259/2389 patients (11%, 78 ± 7 years old, 28% women, CHA2DS2-VASc 4). Clinical characteristics were not different from patients with shorter AHRE. The primary outcome occurred in 9/132 patients with AHRE ≥24 h (4.3%/patient-year, 2 strokes) treated with anticoagulation and in 14/127 patients treated with placebo (6.9%/patient-year, 2 strokes). Atrial high-rate episode duration did not interact with the efficacy (P-interaction = .65) or safety (P-interaction = .98) of anticoagulation. Analyses including AHRE as a continuous parameter confirmed this. Patients with AHRE ≥24 h developed more ECG-diagnosed atrial fibrillation (17.0%/patient-year) than patients with shorter AHRE (8.2%/patient-year; P < .001). CONCLUSIONS: This hypothesis-generating analysis does not find an interaction between AHRE duration and anticoagulation therapy in patients with device-detected AHRE and stroke risk factors. Further research is needed to identify patients with long AHRE at high stroke risk.
- Keywords
- Atrial fibrillation, Atrial high-rate episodes, NOAH-AFNET 6, Stroke,
- MeSH
- Anticoagulants therapeutic use MeSH
- Stroke * etiology prevention & control diagnosis MeSH
- Atrial Fibrillation * complications drug therapy diagnosis MeSH
- Humans MeSH
- Pyridines * MeSH
- Risk Factors MeSH
- Aged, 80 and over MeSH
- Aged MeSH
- Heart Atria MeSH
- Thiazoles * MeSH
- Check Tag
- Humans MeSH
- Male MeSH
- Aged, 80 and over MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Names of Substances
- Anticoagulants MeSH
- edoxaban MeSH Browser
- Pyridines * MeSH
- Thiazoles * MeSH
BACKGROUND: Investigate real-world outcomes of early rhythm versus rate control in patients with recent onset atrial fibrillation. METHODS: The Global Anticoagulant Registry in the FIELD-AF (GARFIELD-AF) is an international multi-centre, non-interventional prospective registry of newly diagnosed (≤6 weeks' duration) atrial fibrillation patients at risk for stroke. Patients were stratified according to treatment initiated at baseline (≤48 days post enrolment), and outcome risks evaluated by overlap propensity weighted Cox proportional-hazards models. RESULTS: Of 45,382 non-permanent atrial fibrillation patients, 23,858 (52.6 %) received rhythm control and 21,524 (47.4 %) rate control. Rhythm-controlled patients had lower median age (68.0 [Q1;Q3: 60.0;76.0] versus 73.0 [65.0;79.0]), fewer histories of stroke/transient ischemic attack/systemic embolism (9.4 % versus 13.0 %), and lower expected probabilities of death (median GARFIELD-AF death score 4.0 [2.3;7.5] versus 5.1 [2.8;9.2]). The two groups had the same median CHA2DS2-VASc scores (3.0 [2.0;4.0]) and similar proportions of anticoagulated patients (rhythm control: 66.0 %, rate control: 65.5 %). The propensity-score-weighted hazard ratios of rhythm vs rate control (reference) were 0.85 (95 % CI: 0.79-0.92, p-value < 0.0001) for all-cause mortality, 0.84 (0.72-0.97, p-value 0.020) for non-haemorrhagic stroke/systemic embolism and 0.90 (0.78-1.04, p-value 0.164) for major bleeding. CONCLUSION: Rhythm control strategy was initiated in about half of the patients with newly diagnosed non-valvular non-permanent atrial fibrillation. After balancing confounders, significantly lower risks of all-cause mortality and non-haemorrhagic stroke were observed in patients who received early rhythm control.
- Keywords
- Atrial fibrillation, Mortality, Rate control, Real-world evidence, Rhythm control, Stroke,
- Publication type
- Journal Article MeSH
Atrial high-rate episodes (AHRE) are atrial tachyarrhythmias detected by continuous rhythm monitoring by pacemakers, defibrillators, or implantable cardiac monitors. Atrial high-rate episodes occur in 10-30% of elderly patients without atrial fibrillation. However, it remains unclear whether the presence of these arrhythmias has therapeutic consequences. The presence of AHRE increases the risk of stroke compared with patients without AHRE. Oral anticoagulation would have the potential to reduce the risk of stroke in patients with AHRE but is also associated with a rate of major bleeding of ∼2%/year. The stroke rate in patients with AHRE appears to be lower than the stroke rate in patients with atrial fibrillation. Wearables like smart-watches will increase the absolute number of patients in whom atrial arrhythmias are detected. It remains unclear whether anticoagulation is effective and, equally important, safe in patients with AHRE. Two randomized clinical trials, NOAH-AFNET6 and ARTESiA, are expected to report soon. They will provide much-needed information on the efficacy and safety of oral anticoagulation in patients with AHRE.
- Keywords
- Anticoagulation, Atrial fibrillation, Atrial high-rate episodes, Continuous monitoring, Implantable cardiac monitor, Pacemaker, Stroke, Sub-clinical atrial fibrillation, Thrombo-embolic risk,
- MeSH
- Anticoagulants therapeutic use MeSH
- Stroke * diagnosis etiology prevention & control MeSH
- Atrial Fibrillation * complications diagnosis drug therapy MeSH
- Humans MeSH
- Risk Factors MeSH
- Aged MeSH
- Heart Atria MeSH
- Check Tag
- Humans MeSH
- Aged MeSH
- Publication type
- Journal Article MeSH
- Names of Substances
- Anticoagulants MeSH
AIMS: Atrial fibrillation (AF) recurrence during the first year after catheter ablation remains common. Patient-specific prediction of arrhythmic recurrence would improve patient selection, and, potentially, avoid futile interventions. Available prediction algorithms, however, achieve unsatisfactory performance. Aim of the present study was to derive from ESC-EHRA Atrial Fibrillation Ablation Long-Term Registry (AFA-LT) a machine-learning scoring system based on pre-procedural, easily accessible clinical variables to predict the probability of 1-year arrhythmic recurrence after catheter ablation. METHODS AND RESULTS: Patients were randomly split into a training (80%) and a testing cohort (20%). Four different supervised machine-learning models (decision tree, random forest, AdaBoost, and k-nearest neighbour) were developed on the training cohort and hyperparameters were tuned using 10-fold cross validation. The model with the best discriminative performance on the testing cohort (area under the curve-AUC) was selected and underwent further optimization, including re-calibration. A total of 3128 patients were included. The random forest model showed the best performance on the testing cohort; a 19-variable version achieved good discriminative performance [AUC 0.721, 95% confidence interval (CI) 0.680-0.764], outperforming existing scores (e.g. APPLE score: AUC 0.557, 95% CI 0.506-0.607). Platt scaling was used to calibrate the model. The final calibrated model was implemented in a web calculator, freely available at http://afarec.hpc4ai.unito.it/. CONCLUSION: AFA-Recur, a machine-learning-based probability score predicting 1-year risk of recurrent atrial arrhythmia after AF ablation, achieved good predictive performance, significantly better than currently available tools. The calculator, freely available online, allows patient-specific predictions, favouring tailored therapeutic approaches for the individual patient.
- Keywords
- Atrial fibrillation, Machine learning, Predictors, Recurrence, Transcatheter ablation,
- MeSH
- Atrial Fibrillation * diagnosis surgery MeSH
- Catheter Ablation * adverse effects methods MeSH
- Humans MeSH
- Recurrence MeSH
- Registries MeSH
- Risk Factors MeSH
- Machine Learning MeSH
- Treatment Outcome MeSH
- Check Tag
- Humans MeSH
- Publication type
- Journal Article MeSH
AIMS: Patients with atrial fibrillation (AF) treated with oral anticoagulation still suffer from cardiovascular complications including cardiovascular death, stroke, and major bleeding. To identify risk factors for predicting stroke and bleeding outcomes in anticoagulated patients, we assessed 2-year outcomes in patients with AF treated with edoxaban in routine care. We also report the age-adjusted risk predictors of clinical outcomes. METHODS AND RESULTS: The Edoxaban Treatment in Routine Clinical Practice for Patients With Non-Valvular Atrial Fibrillation (ETNA-AF) Europe (NCT02944019) is a prospective, multi-centre, post-authorisation, observational study with an overall 4-year follow-up conducted in 825 centres enrolling edoxaban-treated patients in 10 European countries. Of the 13 133 patients with AF (mean age: 73.6 ± 9.5 years), 5682 (43.3%) were female. At the 2-year follow-up, 9017/13 133 patients were still on edoxaban; 1830 discontinued treatment including 937 who died (annualised event rate of all-cause death was 3.87%). 518 (2.14%) patients died of cardiovascular causes; 234 (0.97%) experienced major bleeding and 168 (0.70%) experienced stroke or systemic embolic events (SEE). Intracranial haemorrhage was noted in 49 patients (0.20%). History of transient ischaemic attack (TIA) at baseline was the strongest predictor of ischaemic stroke or SEE (Wald χ2: 73.63; P < 0.0001). Low kidney function at baseline was the strongest predictor of major bleeding (Wald χ2: 30.68; P < 0.0001). History of heart failure (HF) was the strongest predictor of all-cause (Wald χ2: 146.99; P < 0.0001) and cardiovascular death (Wald χ2: 100.38; P < 0.0001). CONCLUSION: Patients treated with edoxaban in ETNA-AF-Europe reported low 2-year event rates in unselected AF patients. Prior stroke, reduced kidney function, and HF identify patients at high risk of stroke, bleeding and all-cause/cardiovascular death, respectively.
- Keywords
- Atrial fibrillation, Edoxaban, Non-vitamin K oral anticoagulant, Real-world, Registry,
- MeSH
- Anticoagulants adverse effects MeSH
- Stroke * diagnosis epidemiology prevention & control MeSH
- Embolism * MeSH
- Atrial Fibrillation * complications diagnosis drug therapy MeSH
- Factor Xa Inhibitors MeSH
- Brain Ischemia * prevention & control MeSH
- Hemorrhage chemically induced MeSH
- Middle Aged MeSH
- Humans MeSH
- Prospective Studies MeSH
- Aged, 80 and over MeSH
- Aged MeSH
- Heart Failure * drug therapy MeSH
- Treatment Outcome MeSH
- Check Tag
- Middle Aged MeSH
- Humans MeSH
- Male MeSH
- Aged, 80 and over MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Observational Study MeSH
- Research Support, Non-U.S. Gov't MeSH
- Names of Substances
- Anticoagulants MeSH
- edoxaban MeSH Browser
- Factor Xa Inhibitors MeSH