Adverse events of subcutaneous loop recorders: Insights from the MAUDE database.

BACKGROUND: Complications using internal cardiac monitors (ICM) have been reported at a low rate. Targeted analyses of complications have not been well described in the literature. OBJECTIVE: To investigate and describe complications associated with ICM events reported to the FDA's Manufacturer and User Facility Device Experience (MAUDE) database. METHODS: Our team reviewed all reported events for the Reveal LINQ loop recorder submitted to the MAUDE database over 7 years (1/1/2013-12/31/2019). A 5% random selection of reports was audited by two researchers to ensure report validity. Two cardiologists manually reviewed death and incongruent events for final interpretation. RESULTS: 12,652 records were obtained during the observed time period. A total of 15,587 device complications were reported. Of this, undersensing (n = 4509, 28.93%), premature discharge of battery (n = 3262, 20.93%), oversensing (n = 2788, 17.89%), and other sensing issues (n = 1532, 9.83%) were most commonly reported. Patient adverse events were reported 1,030 times. Pain or discomfort (n = 275, 26.70%), site infection (n = 213, 20.68%), erosion (n = 138, 13.40%), and impaired healing (n = 49, 4.76%) were most commonly reported to affect patients. Death was reported four times; after expert review, no reports justified the device or procedure as a reasonable cause. CONCLUSION: Several non-life-threatening ICM complications were commonly noted from the analysis. This study supports the safe use of ICMs. A better understanding of the complication profile will help providers select patients, provide informed consent, and expected management.

A Visual Resolution of Cardiotoxicity: A Case Report of Digoxin-Induced Bidirectional Ventricular Tachycardia.

Digoxin is rarely used in modern cardiovascular disease management. Therefore, digoxin toxicity has been infrequently encountered and it is paramount to diagnose in a timely fashion. Bidirectional ventricular tachycardia is an unusual arrhythmia wherein every other beat has a different QRS axis as it travels alternately down different conduction pathways. The arrhythmia can be a manifestation of myocarditis, myocardial infarct, Andersen-Tawil syndrome, arrhythmogenic right ventricular cardiomyopathy, catecholaminergic polymorphic ventricular tachycardia, herbal aconite poisoning, and digoxin toxicity. This case illustrates the importance of clinician awareness of rare electrocardiogram (EKG) patterns of digoxin toxicity and visual resolution of fatal arrhythmia with timely treatment.

Uncertainty of Myocardial Perfusion Imaging in Chest Pain Risk Stratification.

BACKGROUND: Chest pain is a common presenting symptom in the emergency department (ED). Although the diagnostic workup for chest pain is well established, the best time to perform invasive cardiac catheterization in patients with low to moderate risk of coronary artery disease is still unclear, particularly if noninvasive tests such as the electrocardiogram (ECG) and nuclear myocardial perfusion scan show nonsignificant findings. CASE REPORT: We present the case of a 52-year-old female who presented to the ED with acute-onset chest pain that had started early in the morning while she was sleeping. She had presented to the ED 2 weeks prior with chest pain, but her ECG and transthoracic echocardiogram were normal, and her myocardial perfusion scan revealed no significant perfusion defect, so she was discharged. During her second ED visit, the patient developed an arrhythmia, diagnosed as supraventricular tachycardia, that was rapidly converted to sinus rhythm with one dose of intravenous adenosine. Because of her persistent chest pain and the arrhythmia, she underwent cardiac catheterization that revealed coronary artery disease with 80% middle left anterior descending artery stenosis. Percutaneous coronary intervention was performed, and the patient's symptoms resolved. CONCLUSION: Chest pain evaluation is challenging for ED physicians, hospitalists, and cardiologists. Although the nuclear myocardial perfusion scan has excellent sensitivity and specificity in ischemic detection, the clinical examination remains the primary determinant of further management.

A study of the partitioning of haloacetates into cetylpyridinium chloride micelles using semiequilibrium dialysis and ultrafiltration.

Haloacetic acids, formed in drinking water during disinfection by chlorination, pose significant risks to human health. Semiequilibrium dialysis and ultrafiltration experiments were used to examine the partitioning of the five regulated haloacetic acids (HAA(5)) viz. chloro-, dichloro-, trichloro-, bromo-, and dibromoacetic acids into cetylpyridinium chloride (CPC) micelles across a range of micellar mole fraction, surfactant concentration, and added NaCl conditions. The results of these experiments were successfully correlated using a nonlinear three-site equilibrium model, which combines thermodynamic relations with the Oosawa two-state binding theory, incorporates allowances for nonideality, and includes a parameter to account for haloacetate solubilization. Micellar-enhanced ultrafiltration using CPC provided excellent HAA(5) removal efficiencies of over 98%.