Effectiveness and Safety of Enteric-Coated vs Uncoated Aspirin in Patients With Cardiovascular Disease: A Secondary Analysis of the ADAPTABLE Randomized Clinical Trial.

Importance: Clinicians recommend enteric-coated aspirin to decrease gastrointestinal bleeding in secondary prevention of coronary artery disease even though studies suggest platelet inhibition is decreased with enteric-coated vs uncoated aspirin formulations. Objective: To assess whether receipt of enteric-coated vs uncoated aspirin is associated with effectiveness or safety outcomes. Design, Setting, and Participants: This is a post hoc secondary analysis of ADAPTABLE (Aspirin Dosing: A Patient-Centric Trial Assessing Benefits and Long-term Effectiveness), a pragmatic study of 15 076 patients with atherosclerotic cardiovascular disease having data in the National Patient-Centered Clinical Research Network. Patients were enrolled from April 19, 2016, through June 30, 2020, and randomly assigned to receive high (325 mg) vs low (81 mg) doses of daily aspirin. The present analysis assessed the effectiveness and safety of enteric-coated vs uncoated aspirin among those participants who reported aspirin formulation at baseline. Data were analyzed from November 11, 2019, to July 3, 2023. Intervention: ADAPTABLE participants were regrouped according to aspirin formulation self-reported at baseline, with a median (IQR) follow-up of 26.2 (19.8-35.4) months. Main Outcomes and Measures: The primary effectiveness end point was the cumulative incidence of the composite of myocardial infarction, stroke, or death from any cause, and the primary safety end point was major bleeding events (hospitalization for a bleeding event with use of a blood product or intracranial hemorrhage). Cumulative incidence at median follow-up for primary effectiveness and primary safety end points was compared between participants taking enteric-coated or uncoated aspirin using unadjusted and multivariable Cox proportional hazards models. All analyses were conducted for the intention-to-treat population. Results: Baseline aspirin formulation used in ADAPTABLE was self-reported for 10 678 participants (median [IQR] age, 68.0 [61.3-73.7] years; 7285 men [68.2%]), of whom 7366 (69.0%) took enteric-coated aspirin and 3312 (31.0%) took uncoated aspirin. No significant difference in effectiveness (adjusted hazard ratio [AHR], 0.94; 95% CI, 0.80-1.09; P = .40) or safety (AHR, 0.82; 95% CI, 0.49-1.37; P = .46) outcomes between the enteric-coated aspirin and uncoated aspirin cohorts was found. Within enteric-coated aspirin and uncoated aspirin, aspirin dose had no association with effectiveness (enteric-coated aspirin AHR, 1.13; 95% CI, 0.88-1.45 and uncoated aspirin AHR, 0.99; 95% CI, 0.83-1.18; interaction P = .41) or safety (enteric-coated aspirin AHR, 2.37; 95% CI, 1.02-5.50 and uncoated aspirin AHR, 0.89; 95% CI, 0.49-1.64; interaction P = .07). Conclusions and Relevance: In this post hoc secondary analysis of the ADAPTABLE randomized clinical trial, enteric-coated aspirin was not associated with significantly higher risk of myocardial infarction, stroke, or death or with lower bleeding risk compared with uncoated aspirin, regardless of dose, although a reduction in bleeding with enteric-coated aspirin cannot be excluded. More research is needed to confirm whether enteric-coated aspirin formulations or newer formulations will improve outcomes in this population. Trial Registration: ClinicalTrials.gov Identifier: NCT02697916.

Preimplant Hyponatremia Does Not Predict Adverse Outcomes in Patients With Left Ventricular Assist Devices.

Hyponatremia is a well-established marker of adverse outcomes in chronic heart failure (HF) but not well studied in patients with left ventricular assist device (LVAD). This is a retrospective study, single center study of HM3 [Abbott, USA] LVAD implants. We divided our population based on their sodium prior to LVAD implantation - hyponatremia if <135 mEq/L and normal sodium if 135-145 mEq/L. We compared postoperative and long-term outcomes. A total of 195 patients were included, preimplant hyponatremia was present in 40% with a sodium of 132.1 ± 2.1 vs 137.8 ± 1.9 mEq/L in the normal sodium group. No differences were observed in the postoperative or long-term outcomes. Preimplant hyponatremia was not associated with mortality or HF admissions, likely due to adequate left ventricular unloading and resolution of the mechanisms that lead to hyponatremia. These results suggest that optimization of mild hyponatremia may not be critical and should not delay LVAD placement.

COVID-19 Myocarditis: An Emerging Clinical Conundrum.

Coronavirus Disease 2019 (COVID-19) has been a significant cause of global mortality and morbidity since it was first reported in December 2019 in Wuhan, China. COVID19 like previous coronaviruses primarily affects the lungs causing pneumonia, interstitial pneumonitis, and severe acute respiratory distress syndrome (ARDS). However, there is increasing evidence linking COVID-19 to cardiovascular complications such as arrhythmias, heart failure, cardiogenic shock, fulminant myocarditis, and cardiac death. Given the novelty of this virus, there is paucity of data on some cardiovascular complications of COVID-19, specifically myocarditis. Myocarditis is an inflammatory disease of the heart muscle with a heterogenous clinical presentation and progression. It is mostly caused by viral infections and is the result of interaction of the virus and the host's immune system. There have been several case reports linking COVID-19 with myocarditis, however the true mechanism of cardiac injury remains under investigation. In this paper we review the clinical presentation, proposed pathophysiology, differential diagnoses and management of myocarditis in COVID-19 patients.

Suspected COVID-19-Induced Myopericarditis.

Background: The incidence of myocarditis in patients with coronavirus disease 2019 (COVID-19) remains unknown; however, increasing evidence links COVID-19 to cardiovascular complications such as arrhythmias, heart failure, cardiogenic shock, fulminant myocarditis, and cardiac death. We present a case of suspected COVID-19-induced myopericarditis and discuss the diagnostic implications, pathophysiology, and management. Case Report: A 72-year-old female was admitted to the hospital with acute on chronic respiratory failure in the setting of COVID-19. The next day, she developed pressure-like retrosternal chest pain. Laboratory findings revealed elevated cardiac enzymes and inflammatory markers consistent with myocardial injury. Electrocardiogram revealed diffuse ST segment elevations without reciprocal changes, concerning for myopericarditis. Transthoracic echocardiography showed new findings of severely reduced left ventricular (LV) systolic function, with an estimated ejection fraction (EF) of 20%. Her hospital course was further complicated by cardiogenic shock that required treatment in the intensive care unit with vasopressors and inotropes. During the next few days, she had almost full recovery of her LV function, with EF improving to 50%. However, her clinical status deteriorated, likely the result of a bowel obstruction. She was transitioned to comfort care at the request of her family, and she died shortly after. Conclusion: This case highlights diagnostic and therapeutic challenges that physicians may encounter when managing acute cardiac injury in the setting of COVID-19. The multiple mechanisms of COVID-19-related myocardial injury may influence the approach to diagnosis and treatment.

Leadless and Wireless Cardiac Devices: The Next Frontier in Remote Patient Monitoring.

In the last decade, advances in wireless and sensor technologies, and the implementation of telemedicine, have led to innovative digital health care for cardiac patients. Continuous monitoring of patients' biomedical signals, and acute changes in these signals, may result in timely, accurate diagnoses and implementation of early interventions. In this review, we discuss commonly used wireless and leadless cardiac devices including pulmonary artery pressure sensors, implantable loop recorders, leadless pacemakers and subcutaneous implantable cardioverter-defibrillators. We discuss the concept and function of each device, indications, methods of delivery, potential complications, consideration for implantation, and cost-effectiveness.