COVID-19-associated Brugada pattern electrocardiogram: Systematic review of case reports.

AIMS: To summarize published case reports of patients diagnosed with coronavirus disease 2019 (COVID-19) and Brugada pattern electrocardiogram (ECG). METHODS: The Preferred Reporting Items for Systematic Reviews and Meta-Analyses checklist were followed. A literature search was conducted using PubMed, EMBASE, and Scopus up until September 2021. The incidence, clinical characteristics, and management outcomes of COVID-19 patients with a Brugada pattern ECG were identified. RESULTS: A total of 18 cases were collected. The mean age was 47.1 years and 11.1% were women. No patients had prior confirmed diagnosis of Brugada syndrome. The most common presenting clinical symptoms were fever (83.3%), chest pain (38.8%), shortness of breath (38.8%), and syncope (16.6%). All 18 patients presented with type 1 Brugada pattern ECG. Four patients (22.2%) underwent left heart catheterization, and none demonstrated the presence of obstructive coronary disease. The most common reported therapies included antipyretics (55.5%), hydroxychloroquine (27.7%), and antibiotics (16.6%). One patient (5.5%) died during hospitalization. Three patients (16.6%) who presented with syncope received either an implantable cardioverter defibrillator or wearable cardioverter defibrillator at discharge. At follow-up, 13 patients (72.2%) had resolution of type 1 Brugada pattern ECG. CONCLUSION: COVID-19-associated Brugada pattern ECG seems relatively rare. Most patients had resolution of the ECG pattern once their symptoms have improved. Increased awareness and timely use of antipyretics is warranted in this population.

"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.