A 44-year-old woman with a history of factor V Leiden deficiency and recurrent pulmonary emboli was diagnosed with coronavirus disease 2019 (COVID-19) three weeks prior presented to her local ED with severe chest pain. She was found to have a large hemorrhagic pericardial effusion by cardiac MRI with echocardiographic signs of tamponade. She underwent the creation of a pericardial window and was treated with colchicine with improvement in symptoms.

Background A significant proportion of implantable cardioverter-defibrillators (ICDs) have been subject to FDA advisories. The impact of device advisories on mortality or patient care is poorly understood. Although estimated risks of ICD generators under advisory are low, dependency on ICD therapies to prevent sudden death justifies assessment of long-term mortality. Objective To test association of FDA advisory status with long-term mortality. Methods The study was a retrospective, single-center review of clinical outcomes, including device malfunctions, in patients from implantation to either explant or death. Patients with ICDs first implanted at Cleveland Clinic between 8/96-5/04 who became subject to FDA advisories on ICD generators were identified. Mortality was determined using the Social Security Death Index. Results In 1644 consecutive patients receiving first ICD implants, 704 (43%) became subject to an FDA advisory, of which 172 (10.5%) were Class I and 532 (32.3%) were Class II. ICDs were explanted before advisory notifications in 14.0% of Class I and 10.1% of Class II advisories. Among ICDs under advisory, 28 (4.0%) advisory related and 15 non-advisory related malfunctions were documented. Over a median follow-up of 70 months, 814 patients died. Kaplan-Meier 5-year survival was 65.6% overall, and 64.2%, 61.1%, and 69.3% in patients with no, Class I, and Class II advisories, respectively, p=0.17. Conclusions ICD advisories impacted 43% of patients. Advisory-related malfunctions affected 4% within the combined Advisory group. Based on a conservative management strategy ICDs under advisory were not associated with increased mortality over a background of significant disease-related mortality.

In patients with heart disease, diabetes and age predict adverse outcomes. It remains unclear whether persons with diabetes who have implantable cardioverter defibrillators (ICDs) have fewer appropriate and inappropriate ICD shocks. The objective of this study is to determine if persons with diabetes who have ICDs receive a similar amount of appropriate and inappropriate shocks compared to persons without diabetes. In a post hoc analysis of 1,528 patients enrolled in the INTRINSIC RV trial, all-cause mortality and ICD shocks between persons with and without diabetes, stratified by age, was compared. The relationship between shock and mortality was also assessed. Mortality 1 year after ICD implant was lower for persons without diabetes vs. persons with diabetes (3.5% vs. 7.9%, p < 0.001). Young and old persons with diabetes received a similar number of total and appropriate ICD shocks. However, older persons with diabetes were less likely to receive inappropriate ICD shocks vs. older persons without diabetes (1.9% vs. 6.9%, p < 0.01). ICD shocks were not temporally related to mortality regardless of diabetes status. In the INTRINSIC RV trial, persons with diabetes and older persons without diabetes undergoing ICD implant were at a higher risk of death. Older persons with diabetes received less inappropriate shocks and still had a similar amount of appropriate shocks compared to persons without diabetes of similar age.

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