"Under"-reporting of complications following AF ablation: Comparison of the Manufacturer and User Facility Device Experience FDA database and a voluntary invitation-based registry - the POTTER-AF 3 Study.

BACKGROUND: The Manufacturer and User Facility Device Experience (MAUDE) database houses medical device reports of adverse events involving medical devices marketed in the United States submitted to the U.S. Food and Drug Administration (FDA) by mandatory and voluntary reporters. The MAUDE database is frequently used in clinical studies to report on device-related complications. Data about its efficacy are scarce. OBJECTIVE: To compare the mandatory MAUDE database (MAUDE group) with the invitation-based POTTER-AF Study (POTTER-AF 1 group) regarding data quality, procedural characteristics, diagnosis, treatment, and survival. METHODS: The reports of esophageal fistula esophageal fistula following atrial fibrillation (AF) ablation in the MAUDE database were compared to those in the POTTER-AF Study between 01/08/2009 and 31/08/2019. RESULTS: Esophageal fistula was reported in 47 patients in the MAUDE group and in 81 in the POTTER-AF 1 group. Procedures were performed with radiofrequency, cryoenergy or laser energy in 66.0%, 31.9% and 2.1% (MAUDE group) and in 96.3%, 2.5% and 1.2% (POTTER-AF 1 group). The median time to symptoms was 21 (14, 32.5) days (MAUDE group) and 18.0 (6.8, 22.3) days (POTTER-AF 1 group; p=0.031). The diagnostic method was reported in 38.3% of patients in the MAUDE group and in 98.8% in the POTTER-AF 1 group, the treatment in 57.4% and 100% and the outcome in all patients. In the MAUDE group, treatment was surgical (51.9%), endoscopic (37.0%), combined (3.7%) or conservative (7.4%), compared to 43.2%, 19.8%, 7.4% and 29.6% in the POTTER-AF 1 group. Overall mortality was 76.6% in the MAUDE group and 61.7% in the POTTER-AF 1 group (p=0.118). CONCLUSION: In the mandatory MAUDE database, less esophageal fistula cases were reported as compared to an invitation-based study. The data quality in the MAUDE database was significantly poorer.

Wide antral circumferential vs. ostial pulmonary vein isolation using pulsed field ablation-the butterfly effect.

Background: Wide antral circumferential ablation (WACA) in comparison to ostial pulmonary vein (PV) isolation (PVI) has been attributed with improved rhythm outcome. We investigated the feasibility, lesion formation, and rhythm outcome of WACA-PVI in comparison to ostial-PVI using pulsed field ablation (PFA). Methods: Symptomatic atrial fibrillation (AF) patients (69 years, 67% male; 67% paroxysmal AF) were prospectively enrolled into our single-center registry and underwent first-time ostial-PFA or WACA-PFA, N = 15 each. In all patients, eight pulse trains (2 kV/2.5 s, bipolar, biphasic, 4× basket/flower configuration each) were delivered to each PV. In WACA-PFA, two extra pulse trains in a flower configuration were added to the anterior and posterior antrum of the PVs. For comparison of PFA lesion size, pre- and post-ablation left atrial (LA) voltage maps were acquired using a multipolar spiral catheter together with a three-dimensional electroanatomic mapping system. Results: WACA-PFA resulted in a significant larger lesion formation than ostial-PFA (45.5 vs. 35.1 cm2, p = 0.001) with bilateral overlapping butterfly shape-like lesions and concomitant posterior LA wall isolation in 73% of patients. This was not associated with increased procedure time, sedation dosage, or exposure to radiation. One-year freedom from AF recurrence was numerically higher after WACA-PFA than ostial-PFA (94% vs. 87%) but not statistically significant (p = 0.68). No organized atrial tachycardias (ATs) were observed. Ostial-PFA patients more often underwent re-ablation due to recurrent AF episodes. Conclusion: WACA-PFA is feasible and resulted in significantly wider lesion sets than ostial-PFA. Concomitant posterior LA wall isolation occurred as an epiphenomenon in the majority of patients. The WACA approach was associated with neither increased procedure and fluoroscopy times nor statistically significant differences in 1-year rhythm outcome. ATs were absent.

Very-high-power short-duration ablation for treatment of premature ventricular contractions - The FAST-AND-FURIOUS PVC study.

Objectives: We sought to assess the efficacy, safety and short-term clinical outcome of very high-power short-duration (vHP-SD) radiofrequency (RF) catheter ablation for the treatment of idiopathic PVCs originating from the cardiac outflow tract (OT). Background: Power-controlled RF ablation is a widely used technique for the treatment of premature ventricular contractions (PVCs). A novel ablation catheter offers three microelectrodes and six thermocouples at its tip and provides temperature-controlled vHP-SD (90 Watts/4 s,) with the opportunity to switch to moderate-power mode. Methods: In this pilot study, twenty-four consecutive, prospectively enrolled patients underwent PVC ablation utilizing the vHP-SD ablation (study group) and were compared with 24 consecutive patients previously treated with power-controlled ablation (control group). Each group included 12 patients with PVCs originating from the right ventricular OT (RVOT) and 12 patients with PVCs originating from the left ventricular OT (LVOT). The acute endpoint was PVC elimination and was achieved in all patients. Results: In 16/24 (67%) patients (study group) it was achieved by using vHP-SD only. The median RF delivery time was 52 (interquartile range [IQR] 16, 156) seconds (study group) and 350 (IQR 240, 442) seconds (control group, p < 0.0001). No difference was observed regarding procedure duration (p = 0.489) as well as 6-months follow-up (p = 0.712). One (4%, study group) and 2 (8%, control group) severe adverse events occured (p = 0.551). Conclusion: In this study, vHP-SD PVC ablation was similarly effective and safe as compared to conventional power-controlled ablation. The RF time was significantly shorter.