Discussion and Conclusion
In summary, our examination of the FDA MAUDE database revealed significant decreases in reported rates of malfunctions associated with cardiac ablation percutaneous catheters, malfunctions associated with cardiac ablation percutaneous catheters for treatment of atrial fibrillation, and injuries associated with cardiac ablation percutaneous catheters for treatment of atrial flutter during the pandemic.  There are several potential explanations for the observed decreases. One explanation is that fewer cardiac ablations were performed during the pandemic due to underdiagnosis and undertreatment, leading to fewer adverse events. A German study of 74 hospitals demonstrated a decline in hospital admissions for atrial flutter and atrial fibrillation during the early phase of the pandemic, with daily admissions declining from 77.5 admissions/day to 44.4 admissions/day.5 The decline was even more evident for patients with no prior history of atrial flutter or atrial fibrillation; the daily admissions for this subset of patients declined from 41.1 admissions/day to 21.9 admissions/day.5 The decrease in admission rates may have been accompanied by underdiagnosis of cardiac diseases causing only moderate to mild symptoms; a Danish nationwide registry reported a 47% lower incidence of patients with new-onset atrial fibrillation or atrial flutter during the pandemic in comparison to the prior year.6 In a Polish study of a region inhabited by 4.6 million people, the number of patients hospitalized with atrial fibrillation or atrial flutter declined 60% during the nationwide pandemic lockdown in 2020, compared with the same period in the prior year.7 In the same Polish population, the number of percutaneous ablation procedures declined 69% during the nationwide pandemic lockdown in 2020, compared with the same period in the prior year.8 In an Italian survey of 104 physicians in 84 centers, 77.4% of centers reported a significant reduction in elective ablations during the pandemic.9 In Spain, the Spanish Catheter Ablation Registry reported an 18% decline in ablations procedures during the pandemic year 2020 versus the prior year 2019.10 In a study of the Health Episodes Statistics database of England, covering all 147 National Health Service (NHS) hospitals in England, the number of ablations for atrial fibrillation declined 83%, and all other ablations declined 64%, during three weeks of lockdown during the pandemic compared to the previous year.11 Given the cardiovascular complications of COVID-19, it might be expected that hospital admissions for atrial flutter or atrial fibrillation would increase, yet the opposite has been observed. Further investigation is needed to determine the extent of cardiovascular underdiagnosis and undertreatment during the COVID-19 pandemic