OBJECTIVE: The purpose of this study was to evaluate the acute safety and efficacy of a custom designed 8F variable loop multielectrode mapping and PFA catheter with contact sensing.
METHODS: This acute feasibility study recruited 30 patients undergoing de novo ablation of paroxysmal or persistent atrial fibrillation (AF). The ElectroPulse Study is a first-in-human, nonrandomized, prospective study of a novel PFA system that utilizes an 8F, 10-electrode variable loop steerable mapping and ablation catheter with 2800-V biphasic bipolar waveform. All patients had pulmonary vein isolation (PVI) and posterior wall isolation (PWI) using the PFA system. The main outcomes were the acute success of PV/PWI and periprocedural serious adverse events.
RESULTS: Complete PVI/PWI was successfully achieved in all 30 patients using 59.7 ± 7.2 applications. Total procedural time was 113.6 ± 26.3 minutes, fluoroscopy time 8.0 ± 5.5 minutes, and left atrial dwell time 78.7 ± 18.6 minutes. There was no esophageal injury, phrenic nerve palsy, clinical stroke, or death. Brain magnetic resonance imaging detected 2 new but transient silent cerebral lesions. Two patients (6.7%) had vascular access complications. Although there were changes in the biomarkers for hemolysis, none of the patients experienced clinical hemolysis or related acute kidney injury.
CONCLUSION: This first-in-human study demonstrated that PFA using a novel variable loop catheter with a contact sensing system safely achieved 100% acute PVI/PWI with safety profile comparable to existing PFA systems.
OBJECTIVE: The purpose of this study was to assess the safety of outpatient sotalol commencement.
METHODS: This is a multicenter, retrospective, observational study of patients initiated on sotalol in an outpatient setting. Serial electrocardiogram monitoring at day 3, day 7, 1 month, and subsequently as clinically indicated was performed. Corrected QT (QTc) interval and clinical events were evaluated.
RESULTS: Between 2008 and 2023, 880 consecutive patients who were commenced on sotalol were evaluated. Indications were atrial fibrillation/flutter in 87.3% (n = 768), ventricular arrhythmias in 9.9% (n = 87), and other arrhythmias in 2.8% (n = 25). The daily dosage at initiation was 131.0 ± 53.2 mg/d. The QTc interval increased from baseline (431 ± 32 ms) to 444 ± 37 ms (day 3) and 440 ± 33 ms (day 7) after sotalol initiation (P < .001). Within the first week, QTc prolongation led to the discontinuation of sotalol in 4 and dose reduction in 1. No ventricular arrhythmia, syncope, or death was observed during the first week. Dose reduction due to asymptomatic bradycardia occurred in 3 and discontinuation due to dyspnea in 3 within the first week. Overall, 1.1% developed QTc prolongation (>500 ms/>25% from baseline); 4 within 3 days, 1 within 1 week, 4 within 60 days, and 1 after >3 years. Discontinuation of sotalol due to other adverse effects occurred in 41 patients within the first month of therapy.
CONCLUSION: Sotalol initiation in an outpatient setting with protocolized follow-up is safe, with no recorded sotalol-related mortality, ventricular arrhythmias, or syncope. There was a low incidence of significant QTc prolongation necessitating discontinuation within the first month of treatment. Importantly, we observed a small incidence of late QT prolongation, highlighting the need for vigilant outpatient surveillance of individuals on sotalol.