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Background: Pulmonary vein isolation (PVI) can be performed using radiofrequency (RF) or cryoballoon (CB) ablation. Guidelines do not favor one technique and knowledge about complication rates is limited.

Objective: To report the procedural safety of RF and CB ablation using data from a German nation-wide real-world registry.

Methods: Using health records, all left atrial catheter ablation procedures using RF or CB ablation in Germany from 2013-2021 were analyzed. After adjustment for confounders, safety performance endpoints were compared.

Results: From 2013 to 2021, RF ablation was performed in 184,613 patients and CB ablation in 118,980 patients with increasing trends in patient numbers and performing centers for both procedures. Patients with RF ablation had slightly more comorbidities. In-hospital mortality (RF 0.08%; CB: 0.06%) and other investigated complications were rare. After adjustment for patient baseline characteristics, the risk of in-hospital mortality, serious bleeding, stroke, intracerebral bleeding and acute kidney injury did not differ. The risk of pericardiocentesis (RR 0.50; 95% CI: 0.46-0.55; p<0.001), vascular complication (0.36; 0-33-0.39; p<0.001) and ventilation > 48h (0.81; 0.66-0.99; p=0.042) was significantly lower for CB ablation. Pericardiocentesis risk negatively correlated with annual procedure numbers per center with a faster learning curve for CB ablation (both p<0.01).

Conclusion: RF and CB ablation had low overall procedural complication rates, with CB ablation showing a 50% reduced risk of pericardiocentesis. Centers with higher volume provided a better in-hospital safety with a faster learning curve for CB ablation.

Background: Pulsed-field ablation (PFA) has shown promising data in terms of safety and procedural efficiency for pulmonary vein isolation (PVI). Large-area focal PFA catheter designs might be suitable to deliver deep and durable lesions in ventricular myocardium.

Objective: To investigate the dose-response of a novel large-area focal 3D-enabled map-and-ablate PFA catheter for ventricular ablation in a chronic preclinical swine model.

Methods: A 8 F catheter with a 9 mm hexaspline tip was used for 3D mapping of both ventricles in a porcine model. Using a PFA generator (FARASTAR, Boston Scientific), with a proprietary waveform optimized for the catheter, left- and right-ventricular lesions were placed with either a monopolar or bipolar ablation vector, and with 1,2,or 4 applications per site (2.0 kV/application). Tissue contact was ensured using intracardiac echography and EGMs. The animals were survived for 1 week. Ablation lesions were assessed macroscopically after triphenyl tetrazolium chloride staining and using histopathology.

Results: A total of 69 chronic ventricular lesions from 7 pigs were available for analysis. By stacking 4 PFA applications rather than a single application, median chronic lesion depth increased from 4.8 mm (IQR 4.1-5.6) to 5.5 mm (IQR 5.0-6.2), p=0.06 with bipolar ablation, and from 4.9 mm (IQR 4.4-5.2) to 6.5 mm (IQR 5.9-6.9), p=0.002 with monopolar ablation. On histology, lesion borders were clearly demarcated, with vessels and nerves preserved.

Conclusion: A novel large-area focal ablation catheter with the ability for 3D-mapping and pulsed-field ablation was able to create dose-dependent deep ventricular lesions durable 1 week after ablation.

Background: The increasing prevalence of atrial fibrillation (AF) requires efforts to understand racial differences in disease distribution and risk factors.

Objective: To compare associations between risk factors and AF in white Europeans from the UK Biobank and Asians from the KNHIS-HEALS (Korean National Health Insurance Service-Health Screening) study.

Methods: This study included participants from the KNHIS-HEALS and UK Biobank, respectively. After matching for age and sex, 185,904 participants in KNHIS-HEALS and 185,904 participants in UK Biobank were enrolled in the study. The incidence of AF, its associations with biomarkers, prevalent cardiovascular disease, and population-attributable risk by race.

Results: During a median follow-up (KNHIS-HEALS 7.1 years, UK biobank 11.9 years), compared to population in KNHIS-HEALS, those in UK biobank showed higher incidence and risk of AF (3.99 vs. 3.41 per 1000 person-years; hazard ratio [HR] 1.20, 95% confidence interval [CI] 1.15-2.25). Body mass index (BMI), systolic blood pressure, alcohol, heart failure, myocardial infarction, or stroke were associated with an increased risk of new-onset AF in both cohorts. Among them, higher BMI and smoking were more strongly related to the increased risk of new-onset AF in UK Biobank compared to KNHIS-HEALS, with a relative risk ratio of 1.21 (95% CI, 1.17- 1.25) and 1.12 (95% CI, 1.02-1.21), respectively.

Conclusion: In this first large-scale comparison of Caucasian and Asian populations, the cumulative risk of developing AF was higher in the UK than in Korea. Higher BMI and smoking were associated with a higher risk of AF in the UK than in Korea.

Background: Pulsed field ablation (PFA) is a promising novel method of atrial ablation with preclinical data suggesting it to be a viable option for ventricular arrhythmias.

Objective: The objective was to report the feasibility, safety, and clinical efficacy of PFA for ventricular arrhythmias.

Methods: All-comer patients scheduled for ablation of premature ventricular complexes (PVC) or ventricular tachycardia (VT) (n=35, 24 PVC, 11 VT) underwent focal PFA using a PF generator and irrigated ablation catheters. Procedural and clinical outcomes were evaluated by 3-months Holter monitoring, implantable cardioverter defibrillator home monitoring, and chart review.

Results: A total of 11 (31%) of the patients had experienced previously failed radiofrequency ablation. Most PVC (58%) originated from the outflow tracts and most VTs were caused by ischemic cardiomyopathy (55%). Average procedure time was 187 ± 59 minutes. Acute procedural success was achieved in 91% of the patients. PFA was delivered combined endocardially and through the cardiac venous system in 25% of the PVC patients. During a mean follow-up of 288 ± 149 days the success was 75% for PVCs and 45% for VTs. A total of 5 patients were re-ablated during follow-up (4 VT, 1 PVC). We observed 7 (20%) complications including two transient conduction system blocks related to PF delivery and one stroke and one minor stroke.

Conclusion: Focal PFA exhibited satisfactory acute effectiveness for PVC and VT, but favourable clinical effectiveness was retained only in PVC patients. More data is needed to establish lesion durability, safety, and limitations of PFA in ventricular tissue.

Background: Atrial fibrillation (AF) is a relatively prevalent arrhythmia in patients with kidney failure requiring dialysis, who face a high risk of stroke and bleeding, and anticoagulation is a challenging decision. Although direct oral anticoagulants (DOACs) may offer advantages over warfarin K antagonists (VKAs), their use in this patient profile remains unclear.

Objective: We conducted a systematic review and meta-analysis to compare DOACs and VKAs in patients with AF undergoing dialysis.

Methods: PubMed, Embase, and Cochrane Central databases were analyzed. The outcomes analyzed were total stroke (a composite of ischemic and hemorrhagic stroke), ischemic stroke, all-cause death, cardiovascular death, myocardial infarction, major bleeding, clinically relevant non-major bleeding and gastrointestinal bleeding. Risk ratios (RRs) with 95% confidence intervals were calculated using a random effects model. R software (version 4.3.2) was used for statistical analyses. Heterogeneity was assessed with I² statistics.

Results: The final analysis included 486 patients from 4 RCT studies. The median follow-up ranged from 5.8 to 18 months. Although a reduction in total stroke was observed in the group receiving DOACs (RR 0.40; 95% CI 0.17 - 0.92; p=0.031; I2 =0%), no significant difference was found between the groups for ischemic stroke (RR 0.42; 95% CI 0.17 - 1.04; p=0.062; I2 =0%). Additionally, a statistically significant reduction in major bleeding was noted in the DOAC group (RR 0.64; 95% CI 0.41 - 0.98; p=0.044; I² = 0%). However, no significant differences were observed between the groups for all-cause death (RR 0.88; 95% CI 0.57 - 1.35; p=0.567; I2 =47%), cardiovascular death (RR 1.13; 95% CI 0.60 - 2.10; p=0.700; I2 =0%), or clinically relevant non-major bleeding (RR 1.11; 95% CI 0.67 - 1.84; p=0.669; I² = 0%).

Conclusion: In this meta-analysis, DOACs were associated with a lower risk of total stroke and major bleeding. However, DOACs and VKA groups exhibited similar rates of ischemic stroke, all-cause and cardiovascular death, clinically relevant non-major bleeding and gastrointestinal bleeding.

Background and objective: Limited evidence supports apixaban's use for atrial fibrillation (Af) in severe chronic kidney disease (CKD) or end-stage kidney disease (ESKD) patients, where warfarin is often contraindicated.

Methods: Using TriNetX data (2017-2023), we compared apixaban and warfarin in chronic Af patients after stage 5-CKD or ESKD. Propensity score matching (PSM) and Cox multivariate analysis were applied to reduce bias. Only exclusive users were included to prevent switching influence. Subdistribution hazard ratios (SHRs) and 95% CI for outcomes (cerebrovascular events, bleeding, and mortality) were adjusted for competing risks. Subgroup analyses considered sex, age, and dialysis status. We also compared apixaban doses to evaluate dose-related effects.

Results: After 1:1 PSM, our analysis included 1364 cases per group. The apixaban group showed significant advantages over the warfarin group in effectiveness (cerebral infarction: SHR=0.72, 95% CI=0.60-0.85; hemorrhagic stroke: SHR=0.42, 95% CI=0.28-0.63; cerebrovascular events: SHR=0.69, 95% CI=0.59-0.81), bleeding safety (gastrointestinal bleeding: SHR=0.77, 95% CI=0.61-0.97; blood transfusion: SHR=0.73, 95% CI=0.61-0.87; bleeding-related outcomes: SHR=0.75, 95% CI=0.64-0.87), and all composite outcomes (SHR=0.69, 95% CI=0.61-0.78). Subgroup analyses showed consistent improvements across gender, age, and dialysis status. Warfarin's time in therapeutic range was 44.4%. Sensitivity analysis still lacks sufficient evidence to determine whether the 5 mg or 2.5 mg dose of apixaban is superior.

Conclusions: This large cohort study highlights the lower risks of cerebrovascular events and bleeding associated with apixaban in patients with stage 5 CKD or those undergoing hemodialysis. However, the optimal dosage of apixaban requires further investigation in future studies.

Background: The SPHERE Per-AF trial demonstrated non-inferiority for a primary composite effectiveness endpoint in persistent atrial fibrillation (AF) patients treated with a 9-mm, lattice-tip, pulsed field (PF)/radiofrequency (RF) system (74%) vs. conventional contact force-sensing RF (65%). While operators were highly experienced with the control, the vast majority were new to the investigational system.

Objective: To assess the learning curve using this novel system.

Methods: Patients were grouped based on the sequential procedures performed per operator. Operators who performed ≤2 investigational procedures were excluded. The composite effectiveness endpoint was freedom from acute procedural failure, repeat ablation at any time, arrhythmia recurrence, drug initiation/escalation, or cardioversion each at one year excluding a 3-month blanking period. Efficiency endpoints included "skin-to-skin" procedure time.

Results: The total cohort included 443 patients (235 investigational [31 roll-in], 208 control). Primary effectiveness in the investigational cohort improved significantly with increased procedural order. Efficacy was 65% (74/114) for the first 5 patients per operator, 75% (33/44) for patients 6-10, and 80% (60/75) for patients >10. Kaplan-Meier effectiveness estimates at one year follow-up were significantly higher in the investigational cohort after 10 procedures performed, compared to control (80% vs. 65%, p<0.05). With the investigational system, total procedure time was reduced by 25 minutes (100 vs 125) within the first 5 procedures performed (p<0.001).

Conclusion: AF ablation with a novel dual-energy, lattice-tip ablation system resulted in greater clinical efficacy compared to conventional RF after a rapid operator learning curve, with superior procedural efficiency noted from the initial procedures onward.

Background: There is no consensus on the most efficient ablation strategy for patients with persistent atrial fibrillation (PerAF).

Objectives: This study aims to conduct a systematic review and network meta-analysis (NMA) to evaluate the effectiveness of different ablation strategies for PerAF.

Methods: PubMed, Embase, the Cochrane Library, and Web of Science were searched for eligible randomized controlled trials (RCTs). The primary efficacy outcome of this study was the recurrence of any atrial arrhythmia after a single ablation procedure during the follow-up period. The primary safety outcome of interest was any reported complications related to the procedure. The secondary outcome was the procedure time.

Results: Fifty-two studies with 9048 patients were included in this NMA. The studies were conducted between 2004 and 2024, and twenty-two different ablation strategies were identified. Pulmonary vein isolation + posterior wall box isolation + extra pulmonary vein isolation (PVI+PBOX+extra-PV) was the most effective ablation therapy for PerAF. In addition, most additional substrate modification ablation strategies do not show significant additional benefits. There were no significant differences in the incidence of procedure-related complications among the different ablation strategies. In addition, PVI combined with additional ablation sites increases the duration of the procedure.

Conclusions: The NMA found that PVI+PBOX+extra-PV was the most effective ablation combination therapy for PerAF. These findings can guide clinical decision-making in the management of PerAF. However, further research is needed to investigate the long-term effectiveness of different ablation strategies.