Atrial fibrillation (AF) is often treated with cryoablation, frequently performed as a day case. Early patient mobilisation is a key factor for discharge. The Statseal disc is a novel closure device which uses a hydrophilic polymer and potassium ferrate to form a seal, reducing access site bleeding. This study compares the effectiveness of the Statseal disc versus the modified figure-of-8 (mFO8) suture and three-way stopcock technique for venous closure following AF cryoablation. A total of 66 consecutive patients undergoing AF cryoablation at a high-volume tertiary electrophysiology unit were included. Each patient underwent pulmonary vein isolation using a standardized approach: conscious sedation, ultrasound-guided vascular access with a 12F Flexcath and an 8F sheath, uninterrupted anticoagulation, transeptal puncture, heparinization (ACT > 300 seconds), 28mm cryoballoon, and a same-day discharge protocol. Haemostasis was achieved either with the Statseal disc or the modified mFO8 suture based on operator preference. Patient baseline characteristics and post-operative vascular complications were recorded. The primary outcome was time-to-ambulation (TTA). Of the 66 patients, 36 received the Statseal disc and 30 received the mFO8 suture. There were no statistically significant differences between the two groups in terms of age (61.55 ± 10.17 vs 62.23 ± 8.15, years), BMI (28.31 ± 4.69 vs. 29.66 ± 3.70 kg/m²), eGFR (75.03 ± 14.06 vs. 72.93 ± 14.06 mL/min/1.73m²), intra-procedural heparin dose (12777 ± 2768 vs. 11766 ± 2967 units), or protamine dosing (64 ± 22.91 vs. 57.14 ± 18.90 units). (Table 1) The mean TTA was significantly shorter in the Statseal group (3.63 ± 1.20 hours vs. 5.09 ± 0.89 hours, p<0.01). (Figure 1) There were no major femoral bleeding complications requiring intervention in either group. There was one small haematoma in the F08 group. The use of the Statseal disc significantly reduces time to ambulation compared with the mFO8 suture technique following AF cryoablation, with a low incidence of access-site complications in both groups. The Statseal device may facilitate same-day discharge, supporting improved outcomes for patients and healthcare systems alike.Table 1 Figure 1

Background The SHAM-PVI (A Randomized Sham-Controlled Study of Pulmonary Vein Isolation in Symptomatic Atrial Fibrillation) trial demonstrated that pulmonary vein isolation (PVI) reduces atrial fibrillation (AF) burden and enhances quality of life (QoL). However, the relationship between QoL improvements and actual reductions in AF burden remains insufficiently studied, particularly with regard to the potential influence of the placebo effect. Objectives This study sought to investigate the relationship between AF burden and patient-reported QoL outcomes in the context of a sham-controlled, double-blind trial comparing PVI to a sham procedure. Methods This is a secondary analysis of the SHAM-PVI trial involving 126 patients with symptomatic paroxysmal or persistent AF. Participants were randomized to cryoballoon PVI or a sham procedure, with AF burden measured continuously via an implantable loop recorder. QoL was assessed using the Atrial Fibrillation Effect on Quality-of-Life (AFEQT), Mayo AF-Specific Symptom Inventory (MAFSI), and 36-Item Short Form Health Survey (SF-36) instruments. Associations between AF burden and QoL were analyzed using regression models, including interaction terms for treatment group. Results Reduction in geometric mean AF burden was statistically significantly associated with improvements in overall AFEQT score (estimate 0.971; 95% CI: 0.962 to 0.981; P < 0.0001), MAFSI symptom severity and frequency, and multiple SF-36 subdomains. The relationship between the geometric mean AF burden and QoL outcomes was constant between the 2 groups. Symptom-specific analysis highlighted stronger associations between AF burden and palpitations, dizziness, shortness of breath, tiredness, unable to exercise, and weakness. Conclusions In this secondary analysis of the SHAM-PVI trial, there was a statistically significant relationship observed between AF burden reduction and QoL improvements. The study provides robust evidence for the use of AF burden as a marker of success and further reinforces that PVI exhibits no placebo effect.

Importance There are concerns that pulmonary vein isolation for atrial fibrillation may have a profound placebo effect, but no double-blind randomized clinical trials have been conducted. Objective To determine whether pulmonary vein isolation is more effective than a sham procedure for improving outcomes in atrial fibrillation. Design, Setting, and Participants Double-blind randomized clinical trial conducted at 2 tertiary centers in the UK between January 2020 and March 2024 among patients with symptomatic paroxysmal or persistent atrial fibrillation. Major exclusion criteria included long-standing persistent atrial fibrillation, prior left atrium ablation, other arrhythmias requiring ablative therapy, a left atrium of 5.5 cm or larger, and ejection fraction of less than 35%. Intervention Participants were randomly assigned to receive pulmonary vein isolation with cryoablation (n = 64) or a sham procedure with phrenic nerve pacing (n = 62). Main Outcomes and Measures The primary end point was atrial fibrillation burden at 6 months, excluding a 3-month blanking period. Secondary outcomes included quality-of-life measures, time to events, and safety. Atrial fibrillation burden was measured by an implantable loop recorder. Results A total of 126 participants were randomized (mean age, 66.8 years; 89 men [70.63%]; 20.63% with paroxysmal atrial fibrillation). The absolute mean atrial fibrillation burden change from baseline to 6 months was 60.31% in the ablation group and 35.0% in the sham group (geometric mean difference, 0.25; 95% CI, 0.15-0.42; P < .001). The estimated difference in the overall Atrial Fibrillation Effect on Quality of Life score at 6 months, favoring catheter ablation, was 18.39 points (95% CI, 11.48-25.30 points). The Short Form 36 general health score also improved substantially more with ablation, with an estimated difference of 9.27 points at 6 months (95% CI, 3.78-14.76 points). Conclusions and Relevance Pulmonary vein isolation resulted in a statistically significant and clinically important decrease in atrial fibrillation burden at 6 months, with substantial improvements in symptoms and quality of life, compared with a sham procedure.

Importance:There are concerns that pulmonary vein isolation for atrial fibrillation may have a profound placebo effect, but no double-blind randomized clinical trials have been conducted. Objective:To determine whether pulmonary vein isolation is more effective than a sham procedure for improving outcomes in atrial fibrillation. Design, Setting, and Participants:Double-blind randomized clinical trial conducted at 2 tertiary centers in the UK between January 2020 and March 2024 among patients with symptomatic paroxysmal or persistent atrial fibrillation. Major exclusion criteria included long-standing persistent atrial fibrillation, prior left atrium ablation, other arrhythmias requiring ablative therapy, a left atrium of 5.5 cm or larger, and ejection fraction of less than 35%. Intervention:Participants were randomly assigned to receive pulmonary vein isolation with cryoablation (n = 64) or a sham procedure with phrenic nerve pacing (n = 62). Main Outcomes and Measures:The primary end point was atrial fibrillation burden at 6 months, excluding a 3-month blanking period. Secondary outcomes included quality-of-life measures, time to events, and safety. Atrial fibrillation burden was measured by an implantable loop recorder. Results:A total of 126 participants were randomized (mean age, 66.8 years; 89 men [70.63%]; 20.63% with paroxysmal atrial fibrillation). The absolute mean atrial fibrillation burden change from baseline to 6 months was 60.31% in the ablation group and 35.0% in the sham group (geometric mean difference, 0.25; 95% CI, 0.15-0.42; P < .001). The estimated difference in the overall Atrial Fibrillation Effect on Quality of Life score at 6 months, favoring catheter ablation, was 18.39 points (95% CI, 11.48-25.30 points). The Short Form 36 general health score also improved substantially more with ablation, with an estimated difference of 9.27 points at 6 months (95% CI, 3.78-14.76 points). Conclusions and Relevance:Pulmonary vein isolation resulted in a statistically significant and clinically important decrease in atrial fibrillation burden at 6 months, with substantial improvements in symptoms and quality of life, compared with a sham procedure. Trial Registration:ClinicalTrials.gov Identifier: NCT04272762.

INTRODUCTION:Pulmonary vein (PV) isolation has been shown to reduce atrial fibrillation (AF) burden and symptoms in patients. However, to date previous studies have been unblinded raising the possibility of a placebo effect to account for differences in outcomes. HYPOTHESIS & METHODS:The objective of this study is to compare PV isolation to a sham procedure in patients with symptomatic AF. The SHAM-PVI study is a double blind randomized controlled clinical trial. 140 patients with symptomatic paroxysmal or persistent AF will be randomized to either PV isolation (with cryoballoon ablation) or a sham procedure (with phrenic nerve pacing). All patients will receive an implantable loop recorder. The primary outcome is total AF burden at 6 months postrandomisation (excluding the 3 month blanking period). Key secondary outcomes include (1) time to symptomatic and asymptomatic atrial tachyarrhythmia (2) total atrial tachyarrhythmia episodes and (3) patient reported outcome measures. RESULTS:Enrollment was initiated in January 2020. Through April 2023 119 patients have been recruited. Results are expected to be disseminated in 2024. CONCLUSION:This study compares PV isolation using cryoablation to a sham procedure. The study will estimate the effect of PV isolation on AF burden.

Background: Ripple mapping (RM) displays electrograms asmoving bars over a three-dimensional surface displaying bipolar voltage, and has shown in a single-center series to be effective for atrial tachycardia (AT) mapping without annotation of local activation time or window-of-interest assignment. We tested the reproducibility of these findings in operators naive to RM, using it for the first time in postablation AT. Methods: Maps were collected with multielectrode catheters and CARTO ConfiDENSE. A diagnosis of the tachycardia mechanism was made using RM and an assessment of operator confidence was made according to a three-grade scale (1 highest-3 lowest). Results: The first 20 patients (64 +/- 9 years, median two previous ablations) undergoing RM-guided AT ablation across five sites were studied. High-density maps (2,935 +/- 1,328 points) in AT (CL = 296 +/- 95 milliseconds) were collected. Macroreentrant ATs bordered by scar or anatomical obstacles were identified in n = 12 (60%), small reentrant ATs around scar in n = 3 (15%), and focal ATs from scar in n = 5 (25%). Diagnostic confidence with RM was grade 1 in n = 13 (65%), where operators felt confident to proceed to ablation without entrainment. Ablation offered the correct diagnosis n = 18 (90%). Retrospective review of the accompanying LAT maps demonstrated potential sources for error related to the window of interest selection, interpolation, and differentiating regions of scar during tachycardia on the voltage map. Conclusion: RM was easy to adopt by operators using it for the first time, and identified the correct target for ablation with high diagnostic confidence in most cases of complex AT.

Right Ventricular Apical (RVA) pacing causes a non-physiological activation of the myocardium and can be associated with clinical complications. Clinical evidence supporting a benefit to pacing in alternative RV sites is conflicted. The present study was undertaken using conductance catheters to

This is a case of a persistent mobile mass in the left atrial appendage in which 3-dimensional transesophageal echocardiography provided excellent definition of the contour of the mass and helped in comparison during follow-up. The mass was incidentally found before atrial fibrillation ablation and initially thought to be a thrombus. As it persisted almost unchanged despite adequate anticoagulation, a tumour such as a fibroelastoma became the leading possibility, presenting us with a management dilemma. Ablation was cancelled, and, because the mass was stable with no embolic sequelae, a conservative approach was adopted. The patient was discharged on long-term anticoagulation.