Cost, Efficiency and Outcomes of Pulsed Field Ablation versus Thermal Ablation for Atrial Fibrillation: A Real World Study.

BACKGROUND: With the exponential growth of catheter ablation (CA) for atrial fibrillation (AF), there is increasing interest in associated healthcare costs. Pulsed field ablation (PFA) using a single-shot pentaspline multi-electrode catheter has been shown to be safe and effective for AF CA, but its cost efficiency compared to conventional thermal ablation modalities (cryoballoon [CB] or radiofrequency [RF]) has not been evaluated. OBJECTIVE: To compare cost, efficiency, effectiveness and safety between PFA, CB and RF for AF ablation. METHODS: We studied 707 consecutive patients (208 PFA, 325 CB, 174 RF) undergoing first-time AF ablation. Individual procedural costs were calculated, including equipment, lab utilisation and hospital stay, and compared between ablation modalities, as effectiveness and safety. RESULTS: Skin-to-skin times and catheter lab times were significantly shorter with PFA (68min/102min) vs CB (91min/122min) and RF (89min/123 min); p<0.001. General anaesthesia utilisation differed across modalities (PFA 100%, CB 10.2%, RF 61.5%); p<0.001. Major complications occurred in 1% of cases, with no significant differences between modalities. Shorter procedural times resulted in lower staffing and lab costs with PFA, but these savings were offset by substantially higher equipment costs, resulting in higher overall median costs with PFA (£10,010) vs CB (£8,106) and RF (£8,949); p<0.001. CONCLUSION: In this contemporary real-world study of the three major AF CA modalities used concurrently, PFA had shorter skin-to-skin and catheter lab times than CB and RF, with similarly low rates of complications. However, PFA procedures were considerably more expensive, largely due to higher equipment cost.

Durability of thermal pulmonary vein isolation in persistent atrial fibrillation assessed by a mandated repeat invasive study.

BACKGROUND: No study has assessed the durability of pulmonary vein isolation (PVI) with radiofrequency (RF) and cryoballoon (CB) in patients with persistent atrial fibrillation. These data are especially lacking for those with a significantly diseased left atrium (LA). OBJECTIVES: The goals of this study were to assess PVI durability in patients with significant LA disease and to compare reconnection rates between RF and CB. METHODS: Forty-four patients (mean age 63 years; 77% male; median time since atrial fibrillation diagnosis 22.5 months; median indexed LA volume 36 mL/m2) were randomized 1:1 to RF (StablePoint catheter, Boston Scientific) or CB (Arctic Front Advance, Medtronic) PVI. A redo procedure using ultra-high-density electroanatomic mapping (Rhythmia, Boston Scientific) was mandated at 2 months, where PV reconnections were identified and reisolated. RESULTS: Thirty-eight patients underwent both procedures (CB n = 17; RF n = 21). Index RF procedures were longer (median 158 minutes vs 97 minutes; P < .001) but required less fluoroscopy (9.5 minutes vs 23 minutes; P < .001). At the index RF procedure, a median of 47% of the LA myocardium had voltage < 0.5 mV, suggesting that half of the mapped LA comprised scar. PV reconnection was observed in 73 of 152 PVs (48.0%) and was more frequent with CB (58.8%) than with RF (39.3%) (P = .022). Reconnection of at least 1 PV was detected in >75% of patients. Significantly more ablation was required at the redo procedure to reisolate PVs in the CB arm (median 10.8 minutes vs 1.2 minutes; P < .001). CONCLUSION: PVI durability may be poor in those with significant LA scarring and dilatation, even with modern thermal ablation technologies. RF resulted in significantly better PVI durability than did CB in this complex population. TRIAL REGISTRATION: clinicaltrials.gov identifier: NCT04111731.

Randomised controlled trial of population screening for atrial fibrillation in people aged 70 years and over to reduce stroke: protocol for the SAFER trial.

INTRODUCTION: There is a lack of evidence that the benefits of screening for atrial fibrillation (AF) outweigh the harms. Following the completion of the Screening for Atrial Fibrillation with ECG to Reduce stroke (SAFER) pilot trial, the aim of the main SAFER trial is to establish whether population screening for AF reduces incidence of stroke risk. METHODS AND ANALYSIS: Approximately 82 000 people aged 70 years and over and not on oral anticoagulation are being recruited from general practices in England. Patients on the palliative care register or residents in a nursing home are excluded. Eligible people are identified using electronic patient records from general practices and sent an invitation and consent form to participate by post. Consenting participants are randomised at a ratio of 2:1 (control:intervention) with clustering by household. Those randomised to the intervention arm are sent an information leaflet inviting them to participate in screening, which involves use of a handheld single-lead ECG four times a day for 3 weeks. ECG traces identified by an algorithm as possible AF are reviewed by cardiologists. Participants with AF are seen by a general practitioner for consideration of anticoagulation. The primary outcome is stroke. Major secondary outcomes are: death, major bleeding and cardiovascular events. Follow-up will be via electronic health records for an average of 4 years. The primary analysis will be by intention-to-treat using time-to-event modelling. Results from this trial will be combined with follow-up data from the cluster-randomised pilot trial by fixed-effects meta-analysis. ETHICS AND DISSEMINATION: The London-Central National Health Service Research Ethics Committee (19/LO/1597) provided ethical approval. Dissemination will include public-friendly summaries, reports and engagement with the UK National Screening Committee. TRIAL REGISTRATION NUMBER: ISRCTN72104369.

Cryoballoon pulmonary vein isolation as first-line treatment of typical atrial flutter: long-term outcomes of the CRAFT trial.

BACKGROUND: CRAFT was an international, multicentre, randomised controlled trial across 11 sites in the United UK and Switzerland. Given the evidence that pulmonary vein triggers may be responsible for atrial flutter (AFL) as well as atrial fibrillation (AF), we hypothesised that cryoballoon pulmonary vein isolation (PVI) would provide greater symptomatic arrhythmia reduction than cavotricuspid isthmus (CTI) ablation, whilst also reducing the subsequent burden of AF. Twelve-month outcomes were previously reported. In this study, we report the extended outcomes of the CRAFT study to 36 months. METHODS: Patients with typical AFL and no evidence of AF were randomised 1:1 to cryoballoon PVI or radiofrequency CTI. All patients received an implantable loop recorder (ILR) for continuous cardiac rhythm monitoring. The primary outcome was time-to-symptomatic arrhythmia recurrence > 30 s. Secondary outcomes included time-to-first-AF episode ≥ 2 min. The composite safety outcome included death, stroke and procedural complications. RESULTS: A total of 113 patients were randomised to cryoballoon PVI (n = 54) or radiofrequency CTI ablation (n = 59). Ninety-one patients reconsented for extended follow-up beyond 12 months. There was no difference in the primary outcome between arms, with the primary outcome occurring in 12 PVI vs 11 CTI patients (HR 0.97; 95% CI 0.43-2.20; p = 0.994). AF ≥ 2 min was significantly less frequent in the PVI arm, affecting 26 PVI vs 36 CTI patients (HR 0.48; 95% CI 0.29-0.79; p = 0.004). The composite safety outcome occurred in 5 PVI and 6 CTI patients (p = 0.755). CONCLUSION: Cryoballoon PVI shows similar efficacy to radiofrequency CTI ablation in reducing symptomatic arrhythmia recurrence in patients presenting with isolated typical AFL but significantly reduces the occurrence of subsequent AF.

Novel stroke prevention strategies following catheter ablation for atrial fibrillation.

Stroke prevention following successful catheter ablation of atrial fibrillation remains a controversial topic. Oral anticoagulation is associated with a significant reduction in stroke risk in the general atrial fibrillation population but may be associated with an increased risk of major bleeding, and the benefit: risk ratio must be considered. Improvement in successful catheter ablation and widespread use of cardiac monitoring devices may allow for novel anticoagulation strategies in a subset of patients with atrial fibrillation, which may optimize stroke prevention while minimizing bleeding risk. In this review, we discuss stroke risk in atrial fibrillation and the effects of successful catheter ablation on thromboembolic risk. We also explore novel strategies for stroke prevention following successful catheter ablation.

UltraSOUND-based characterization of ventricular tachycardia SCAR and arrhythmogenic substrate: The SOUNDSCAR study.

BACKGROUND: Intracardiac echocardiography (ICE) represents a valuable image integration technique, with the unique advantage of dynamic real-time scar characterization. OBJECTIVES: The goals of this study were to assess the correlation between ICE-defined and electroanatomic mapping (EAM)-defined scar in patients with ischemic cardiomyopathy and to define the outcomes of ICE-guided ventricular tachycardia (VT) ablation. METHODS: Thirty-eight patients with ischemic cardiomyopathy (SOUNDSCAR cohort) underwent full left ventricular (LV) ICE imaging and EAM. ICE-defined scar parameters (end-diastolic and end-systolic wall diameter [EDWD and ESWD], end-systolic wall thickening [percentage difference between EDWD and ESWD with respect to EDWD], slope [end-diastole to end-systole wall thickening], and American Heart Association wall motion scoring) were correlated with EAM-defined scar (voltage <1.5 mV). In a separate cohort (n = 21), outcomes of an ICE-guided VT ablation approach (EAM focused to ICE-defined scar regions) were compared with those of conventional ablation (full left ventricular mapping with EAM only; n = 21). RESULTS: In the 38 SOUNDSCAR patients (mean age 67 ± 11 years; 35 male [92%]; left ventricular ejection fraction 31% ± 10%; 2474 ICE segments; 524 ICE sectors), all ICE-defined parameters strongly predicted EAM-defined scar (area under the curve: American Heart Association score 0.873; ESWD 0.880; EDWD 0.827; slope 0.855; percentage difference between EDWD and ESWD with respect to EDWD, 0.851). All ICE-defined parameters had large effect sizes for predicting EAM-defined scar (logistic regression, P < .001). A detailed topographical comparison of ICE-defined (slope) and EAM-defined scar was possible in 25 patients and demonstrated 88% ± 10% overlap. Compared with conventional VT ablation, ICE-guided ablation was associated with shorter procedure times and comparable VT-free survival (ICE-guided vs conventional: procedure time 240 ± 20 minutes vs 298 ± 39 minutes; P < .001; VT recurrence 3 [14%] vs 7 [31%]; P = .19). CONCLUSION: ICE-defined scar demonstrates a strong correlation with EAM-defined scar. ICE-guided VT ablation is associated with enhanced procedural efficiency.

Silent pulmonary veins at redo ablation for atrial fibrillation: Implications and approaches.

BACKGROUND: Pulmonary vein isolation (PVI) is the cornerstone of atrial fibrillation (AF) ablation. Despite promising success rates, redo ablation is sometimes required. At redo, PVs may be found to be isolated (silent) or reconnected. We studied patients with silent vs reconnected PVs at redo and analysed associations with adverse outcomes. METHODS: Patients undergoing redo AF ablations between 2013 and 2019 at our institution were included and stratified into silent PVs or reconnected PVs. The primary outcome was a composite of further redo ablation, non-AF ablation, atrioventricular nodal ablation, and death. Secondary outcomes included arrhythmia recurrence. RESULTS: A total of 467 patients were included with mean 4.6 ± 1.7 years follow-up, of whom 48 (10.3%) had silent PVs. The silent PV group had had more often undergone >1 prior ablation (45.8% vs 9.8%; p<0.001), had more persistent AF (62.5% vs 41.1%; p=0.005) and had more non-PV ablation performed both at prior ablation procedures and at the analysed redo ablation. The primary outcome occurred more frequently in those with silent PVs (25% vs 13.8%; p=0.053). Arrhythmia recurrence was also more common in the silent PV group (66.7% vs 50.6%; p=0.047). After multivariable adjustment, female sex (aHR 2.35 [95% CI 2.35-3.96]; p=0.001) and ischaemic heart disease (aHR 3.21 [95% CI 1.56-6.62]; p=0.002) were independently associated with the primary outcome, and left atrial enlargement (aHR 1.58 [95% CI 1.20-2.08]; p=0.001) and >1 prior ablation (aHR 1.88 [95% CI 1.30-2.72]; p<0.001) were independently associated with arrhythmia recurrence. Whilst a finding of silent PVs was not itself significant after multivariable adjustment, this provides an easily assessable parameter at clinically indicated redo ablation which informs the clinician of the likelihood of a worse future prognosis. CONCLUSIONS: Patients with silent PVs at redo AF ablation have worse clinical outcomes.

Validating the predictive ability of the 2MACE score for major adverse cardiovascular events in patients with atrial fibrillation: results from phase II/III of the GLORIA-AF registry.

The 2MACE score was specifically developed as a risk-stratification tool in atrial fibrillation (AF) to predict cardiovascular outcomes. We evaluated the predictive ability of the 2MACE score in the GLORIA-AF registry. All eligible patients from phase II/III of the prospective global GLORIA-AF registry were included. Major adverse cardiac events (MACEs) were defined as the composite outcome of stroke, myocardial infarction and cardiovascular death. Cox proportional hazards were used to examine the relationship between the 2MACE score and study outcomes. Predictive capability of the 2MACE score was investigated using receiver-operating characteristic curves. A total of 25,696 patients were included (mean age 71 years, female 44.9%). Over 3 years, 1583 MACEs were recorded. Patients who had MACE were older, with more cardiovascular risk factors and were less likely to be managed using a rhythm-control strategy. The median 2MACE score in the MACE and non-MACE groups were 2 (IQR 1-3) and 1 (IQR 0-2), respectively (p < 0.001). The 2MACE score was positively associated with an increase in the risk of MACE, with a score of ≥ 2 providing the best combination of sensitivity (69.6%) and specificity (51.6%), HR 2.47 (95% CI, 2.21-2.77). The 2MACE score had modest predictive performance for MACE in patients with AF (AUC 0.655 (95% CI, 0.641-0.669)). Our analysis in this prospective global registry demonstrates that the 2MACE score can adequately predict the risk of MACE (defined as myocardial infarction, CV death and stroke) in patients with AF. Clinical trial registration: http://www.clinicaltrials.gov . Unique identifiers: NCT01468701, NCT01671007 and NCT01937377.

Interventions in Hypertrophic Obstructive Cardiomyopathy.

Obstructive hypertrophic cardiomyopathy is the most common genetically transmitted cardiomyopathy that is associated with significant morbidity and mortality. Despite contemporary treatments and interventions, the management of patients with obstructive hypertrophic cardiomyopathy remains poorly defined compared with other branches of cardiology. In this review, we discuss established and novel therapeutic interventions in patients with obstructive hypertrophic cardiomyopathy with a focus on percutaneous and surgical strategies including surgical myectomy, mitral valve repair or replacement, percutaneous alcohol septal ablation, pacemaker and cardioverter-defibrillator implantation, septal embolization, radiofrequency endocardial catheter ablation, and percutaneous intramyocardial septal radiofrequency ablation.

Persistent and Recurrent Device-Related Thrombus After Left Atrial Appendage Closure: Incidence, Predictors, and Outcomes.

BACKGROUND: Scarce data exist on the evolution of device-related thrombus (DRT) after left atrial appendage closure (LAAC). OBJECTIVES: This study sought to assess the incidence, predictors, and clinical impact of persistent and recurrent DRT in LAAC recipients. METHODS: Data were obtained from an international multicenter registry including 237 patients diagnosed with DRT after LAAC. Of these, 214 patients with a subsequent imaging examination after the initial diagnosis of DRT were included. Unfavorable evolution of DRT was defined as either persisting or recurrent DRT. RESULTS: DRT resolved in 153 (71.5%) cases and persisted in 61 (28.5%) cases. Larger DRT size (OR per 1-mm increase: 1.08; 95% CI: 1.02-1.15; P = 0.009) and female (OR: 2.44; 95% CI: 1.12-5.26; P = 0.02) were independently associated with persistent DRT. After DRT resolution, 82 (53.6%) of 153 patients had repeated device imaging, with 14 (17.1%) cases diagnosed with recurrent DRT. Overall, 75 (35.0%) patients had unfavorable evolution of DRT, and the sole predictor was average thrombus size at initial diagnosis (OR per 1-mm increase: 1.09; 95% CI: 1.03-1.16; P = 0.003), with an optimal cutoff size of 7 mm (OR: 2.51; 95% CI: 1.39-4.52; P = 0.002). Unfavorable evolution of DRT was associated with a higher rate of thromboembolic events compared with resolved DRT (26.7% vs 15.1%; HR: 2.13; 95% CI: 1.15-3.94; P = 0.02). CONCLUSIONS: About one-third of DRT events had an unfavorable evolution (either persisting or recurring), with a larger initial thrombus size (particularly >7 mm) portending an increased risk. Unfavorable evolution of DRT was associated with a 2-fold higher risk of thromboembolic events compared with resolved DRT.

Left Atrial Appendage Occlusion-A Choice or a Last Resort? How to Approach the Patient.

Left atrial appendage (LAA) occlusion is emerging as a viable alternative to oral anticoagulation in high-risk patients with atrial fibrillation. However, there remains limited evidence for this approach, especially in certain subgroups, and therefore patient selection is an important aspect of treatment. Here, the authors present arguments for LAA occlusion as either a last resort versus patient choice by evaluating contemporary studies on this topic and discuss practical steps in the approach of patients who may be suitable for LAA occlusion. Overall, an individualized and multidisciplinary team approach should be adopted in patients who are being considered for LAA occlusion.

Simplified Geleijnse score for identifying chest pain features associated with coronary ischemia.

BACKGROUND: The Geleijnse score, which was proposed to assess for coronary ischemia, has practical limitations. OBJECTIVES: Our aim was to design and evaluate a simplified version of the Geleijnse score. METHODS: We enrolled patients with suspected coronary heart disease but negative troponin T or absence of enzymatic curve, and a non-diagnostic 12-lead ECG. The initial study was performed in a retrospective derivation cohort and the results were subsequently validated in a prospective cohort. RESULTS: From 109 patients included in the derivation cohort, 33 (30.3%) received a diagnosis of coronary heart disease. Chest pain with both arms radiation (OR 3.54), severe intensity (OR 2.41), improvement by nitroglycerin (OR 1.61), associated dyspnea (OR 1.97) and prior exertional angina history (OR 2.91) were independently associated with an ischemic origin on multivariate logistic regression analysis. ROC curves comparison demonstrated both the original and simplified scores presented modest predictive ability with significant difference when analyzed using dichotomous cut-offs (0.647 [simplified] vs. 0.544 [original], p = 0.042) but not as a continuous variable (0.670 [simplified] vs. 0.621 [original], p = 0.396). In 305 patients from the validation cohort, the simplified score presented extensively increased predictive accuracy than the Geleijnse, in the continuous (c-indexes = 0.735 vs. 0.685, p = 0.040) and the dichotomic (c-indexes = 0.682 vs. 0.514, p<0.001) forms. CONCLUSIONS: A simplified version of the Geleijnse score, including some routine clinical manifestations associated with coronary heart disease, presented significantly better predictive ability compared to the original score.

Contemporary management of atrial fibrillation and the predicted vs. absolute risk of ischaemic stroke despite treatment: a report from ESC-EHRA EORP-AF Long-Term General Registry.

BACKGROUND: Risk stratification in patients with atrial fibrillation (AF) is important to facilitate guideline-directed therapies. The Calculator of Absolute Stroke Risk (CARS) scheme enables an individualized estimation of 1-year absolute risk of stroke in AF. We aimed to investigate the predicted and absolute risks of ischaemic stroke, and evaluate whether CARS (and CHA2DS2-VASc score) may be useful for identifying high risk patients with AF despite contemporary treatment. METHODS: We utilized the EORP-AF General Long-Term Registry which prospectively enrolled patients with AF from 250 centres across 27 participating European countries. Patients with sufficient data to determine CARS and CHA2DS2-VASc score, and reported outcomes of ischaemic stroke were included in this analysis. The primary outcome of ischaemic stroke was recorded over a 2-year follow-up period. RESULTS: A total of 9444 patients were included (mean age 69.1 [±11.4] years; 3776 [40.0%] females). There was a high uptake (87.9%) of anticoagulation therapy, predominantly with vitamin K antagonist (50.0%). Over a mean follow-up period of 24 months, there were a total of 101 (1.1%) ischaemic stroke events. In the entire cohort, the median CARS and absolute annual risks of ischaemic stroke were 2.60 (IQR 1.60-4.00) and 0.53% (95%CI 0.43-0.64%), respectively. There was no statistical difference between the predictive performance of CARS and CHA2DS2-VASc score (0.621 [95%CI 0.563-0.678] vs. 0.626 [95%CI 0.573-0.680], P = 0.725). CONCLUSION: Contemporary management of AF was associated with a low risk of ischaemic stroke. CARS and CHA2DS2-VASc score may be useful to identify high risk patients despite treatment who may benefit from more aggressive treatment and follow-up.

Incidence of vascular complications for electrophysiology procedures in the ultrasound era: a single-centre experience over 10,000 procedures in the long term.

BACKGROUND: Ultrasound (US) is being increasingly used to guide vascular access for electrophysiology (EP) procedures in many centres. Nonetheless, the incidence and predictors of vascular complications in the US era are limited. In this study, we describe our experience of vascular access-related complications associated with EP procedures which were performed with the routine use of US-guided vascular access. METHODS: A total of 10,158 consecutive EP procedures in 8361 patients performed from April 2014 (when our centre moved to a policy of routine US-guided vascular access for EP procedures) to March 2022 were included. The outcome of interest was any vascular access-related complication that occurred within 7 days of the procedure; these were classified as severe if surgical intervention and/or blood transfusion was required, major if non-surgical intervention or delayed hospital discharge was required, or minor if it did not fulfil the criteria for severe or major. RESULTS: During the study period, 2 (0.02%) severe vascular complications occurred, including 1 pseudo-aneurysm requiring surgery and 1 retroperitoneal haemorrhage requiring blood transfusion. Nine (0.09%) major complications occurred, including 6 hematomas managed by compression devices, 1 type B aortic dissection, 1 AV fistula managed conservatively and 1 haematoma managed conservatively but delayed hospital discharge. Eighteen (0.18%) minor haematomas were seen that did not require any intervention or delayed hospital discharge. On multivariable analysis, female sex [OR (95% CI): 2.5 (1.2, 5.4)] and use of an arterial access [OR (95% CI): 19.3 (7.1, 52.3)] were seen to be independent predictors of the 29 vascular complications. CONCLUSION: With the use of US-guided vascular access in EP procedures, major vascular complications are exceedingly rare, particularly those needing surgical intervention. Our results provide additional evidence for scientific guidelines to support US use.

Impact of ABC (Atrial Fibrillation Better Care) pathway adherence in high-risk subgroups with atrial fibrillation: A report from the ESC-EHRA EORP-AF long-term general registry.

BACKGROUND: Effects of Atrial Fibrillation Better Care (ABC) adherence among high-risk atrial fibrillation (AF) subgroups remains unknown. We aimed to evaluate the impact of ABC adherence on clinical outcomes in these high-risk patients. METHODS: EORP-AF General Long-Term Registry is a prospective, observational registry from 250 centres across 27 European countries. High-risk patients were defined as those with either CKD (eGFR <60 mL/min/1.73m2), elderly patients (≥75 years) or prior thromboembolism. Primary outcome was a composite event of all-cause death, thromboembolism and acute coronary syndrome. RESULTS: 6646 patients with AF were screened (median age was 70 [IQR 61 - 77] years; 40.2% females). There were 3304 (54.2%) patients with either CKD (n = 1750), older age (n = 2236) or prior thromboembolism (n = 728). Among these, 924 (28.0%) were managed as adherent to ABC. At 2-year follow-up, 966 (14.5%) patients reported the primary outcome. The incidence of the primary outcome was significantly lower in high-risk patients managed as adherent to ABC pathway (IRR 0.53 [95%CI, 0.43 - 0.64]). Consistent results were obtained in the individual subgroups. Using multivariable Cox proportional hazards analysis, ABC adherence in the high-risk cohort was independently associated with a lower risk of the primary outcome (aHR 0.64 [95%CI, 0.51 - 0.80]), as well as in the CKD (aHR 0.51 [95%CI, 0.37 - 0.70]) and elderly subgroups (aHR 0.69 [95%CI, 0.53 - 0.90]). Overall, there was greater reduction in the risk of primary outcome as more ABC criteria were fulfilled, both in the overall high-risk patients (aHR 0.39 [95%CI, 0.25 - 0.61]), as well as in the individual subgroups. CONCLUSION: In a large, contemporary cohort of patients with AF, we demonstrate that adherence to the ABC pathway was associated with a significant benefit among high-risk patients with either CKD, advanced age (≥75 years old) or prior thromboembolism.

Cryoballoon Pulmonary Vein Isolation as First-Line Treatment for Typical Atrial Flutter.

OBJECTIVE: We aimed to compare cryoballoon pulmonary vein isolation (PVI) with standard radiofrequency cavotricuspid isthmus (CTI) ablation as first-line treatment for typical atrial flutter (AFL). METHODS: Cryoballoon Pulmonary Vein Isolation as First-Line Treatment for Typical Atrial Flutter was an international, multicentre, open with blinded assessment trial. Patients with CTI-dependent AFL and no documented atrial fibrillation (AF) were randomised to either cryoballoon PVI alone or radiofrequency CTI ablation. Primary efficacy outcome was time to first recurrence of sustained (>30 s) symptomatic atrial arrhythmia (AF/AFL/atrial tachycardia) at 12 months as assessed by continuous monitoring with an implantable loop recorder. Primary safety outcome was a composite of death, stroke, tamponade requiring drainage, atrio-oesophageal fistula, pacemaker implantation, serious vascular complications or persistent phrenic nerve palsy. RESULTS: Trial recruitment was halted at 113 of the target 130 patients because of the SARS-CoV-2 pandemic (PVI, n=59; CTI ablation, n=54). Median age was 66 (IQR 61-71) years, with 98 (86.7%) men. At 12 months, the primary outcome occurred in 11 (18.6%) patients in the PVI group and 9 (16.7%) patients in the CTI group. There was no significant difference in the primary efficacy outcome between the groups (HR 1.11, 95% CI 0.46 to 2.67). AFL recurred in six (10.2%) patients in the PVI arm and one (1.9%) patient in the CTI arm (p=0.116). Time to occurrence of AF of ≥2 min was significantly reduced with cryoballoon PVI (HR 0.46, 95% CI 0.25 to 0.85). The composite safety outcome occurred in four patients in the PVI arm and three patients in the CTI arm (p=1.000). CONCLUSION: Cryoballoon PVI as first-line treatment for AFL is equally effective compared with standard CTI ablation for preventing recurrence of atrial arrhythmia and better at preventing new-onset AF. TRIAL REGISTRATION NUMBER: NCT03401099.

Adherence to the Atrial Fibrillation Better Care (ABC) pathway and the risk of major outcomes in patients with atrial fibrillation: A post-hoc analysis from the prospective GLORIA-AF Registry.

Background: The 'Atrial fibrillation Better Care' (ABC) pathway has been proposed to streamline a more holistic or integrated care approach to atrial fibrillation (AF) management. We aimed to analyse the impact of adherence to the ABC pathway on the risk of major adverse outcomes in a contemporary prospective global cohort of patients with AF. Methods: Patients enrolled Phase II and III of the GLORIA-AF Registry with complete data on ABC pathway adherence and follow-up were included in this post-hoc analysis between November 2011 and December 2014 for Phase II, and between January 2014 and December 2016 for Phase III. The primary outcome was the composite of all-cause death and major adverse cardiovascular events (MACEs). Multivariable Cox-regression and delay of event (DoE) analyses were used to evaluate the association between adherence to the ABC pathway and the risk of outcomes. Findings: We included 24,608 patients in this analysis (mean age: 70.2 (10.3) years, 10,938 (44.4%) females). Adherence to the ABC pathway was associated with a significant risk reduction for the primary outcome, with greatest magnitude observed for full ABC pathway adherence (adjusted Hazard Ratio [aHR] 0.54, 95% Confidence Interval [CI]: 0.44-0.67, p < 0.0001). ABC pathway adherence was also associated with reduced risk of mortality (aHR: 0.89, 95% CI: 0.79-1.00, p = 0.048), thromboembolism (aHR: 0.78, 95% CI: 0.65-0.94, p = 0.0078), and MACE (aHR: 0.82, 95% CI: 0.71-0.95, p = 0.0071). An increasing number of ABC criteria attained was associated with longer event-free survival in the DoE analysis. Interpretation: Adherence to the ABC pathway in patients with AF was associated with a reduced risk of major adverse events, including mortality, thromboembolism and MACE. This underlines the importance of using the ABC pathway in the clinical care of patients with AF. Funding: This study was funded by Boehringer Ingelheim.

Social determinants of health and catheter ablation after an incident diagnosis of atrial fibrillation: a Danish nationwide cohort study.

AIMS: To examine (i) the sex-specific associations between three social determinants of health (SDOH) and use of ablation after incident atrial fibrillation (AF), and (ii) the temporal trends in these associations. METHODS AND RESULTS: We conducted a nationwide cohort study of patients with an incident hospital diagnosis of AF between 2005 and 2018. SDOH at the time of AF diagnosis included three levels of educational attainment, tertile groups of family income, and whether the patient was living alone. Outcome was catheter ablation for AF. We used cause-specific proportional hazard models to estimate hazard ratios (HR) with 95% CI and adjusted for age. To examine temporal trends, we included an interaction term between the exposure and calendar years. Among 122 276 men, those with lower education [HR 0.49 (95%CI 0.45-0.53)] and 0.72 (0.68-0.77) for lower and medium vs. higher], lower income [HR 0.31 (0.27-0.34) and 0.56 (0.52-0.60) for lower and medium vs. higher], and who lived alone [HR 0.60 (0.55-0.64)] were less likely to receive AF ablation. Among 98 476 women, those with lower education [HR 0.45 (0.40-0.50) and 0.83 (0.75-0.91) for lower and medium vs. higher], lower income [HR 0.34 (0.28-0.40) and 0.51 (0.46-0.58) for lower and medium vs. higher], and who lived alone [HR 0.67 (0.61-0.74)] were less likely to receive AF ablation. We found no evidence of temporal trends in the associations. CONCLUSION: In the Danish universal healthcare system, patients with AF who had lower educational attainment, lower family income, or were living alone were less likely to undergo AF ablation.

Patient experience of very high power short duration radiofrequency ablation for atrial fibrillation under mild conscious sedation.

BACKGROUND: Very high power short duration (vHPSD) radiofrequency ablation (RFA) may reduce ablation times and improve patient tolerability, permitting pulmonary vein isolation (PVI) under mild conscious sedation (mCS) and promoting same day discharge (SDD). METHODS: First, a retrospective feasibility study was performed at 2 tertiary cardiac centres in the UK. Consecutive cases of first-time PVI using vHPSD ablation with 90 W lesions for up to 4 s were compared against cases performed using standard RF (sRF) and cryoballoon (Cryo) therapy. Subsequently, a prospective study of patients who had vHPSD or Cryo exclusively under mCS was undertaken. Questionnaires based on Likert and visual analogue scales (VAS) were used to measure anxiety, discomfort and pain. RESULTS: In total, 182 patients (59 vHPSD, 62 sRF and 61 Cryo) were included in the retrospective study, with 53 (90%) of vHPSD cases successfully performed under mCS. PVI ablation time in the vHPSD group (5.8 ± 1.7 min) was shorter than for sRF (16.5 ± 6.3 min, p < 0.001) and Cryo (17.5 ± 5.9 min, p < 0.001). Fifty-one vHPSD and 52 Cryo patients were included in the prospective study. PVI ablation time in the vHPSD group was shorter than for the Cryo group (6.4 ± 2.9 min vs 17.9 ± 5.7 min, p < 0.001), but overall procedure duration was longer (121 ± 39 min vs 95 ± 20 min, p < 0.001). There were no differences in the patient experience of anxiety, discomfort or pain. SDD rates were the same in both groups (61% vs 67%, p = 0.49). CONCLUSIONS: vHPSD RFA for PVI can be performed under mCS to achieve SDD rates comparable to cryoablation, without compromising patient experience.