A Real­World Pharmacovigilance Study of FDA Adverse Event Reporting System (FAERS) for Mavacamten.

BACKGROUND: Mavacamten is a first-in-class cardiac myosin inhibitor approved by the US Food and Drug Administration (FDA) for symptomatic obstructive hypertrophic cardiomyopathy (HCM). This pharmacovigilance study aimed to assess mavacamten-related adverse drug reactions (ADRs) in the real world as reported in the FDA Adverse Event Reporting System (FAERS). METHODS: We conducted disproportionality analyses with four signal detection algorithms-reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian confidence propagation neural network, and the multi-item gamma Poisson shrinker to identify mavacamten-related ADRs. RESULTS: Out of 4,500,131 reports from the FAERS database, 1004 mavacamten-related ADRs were identified from 1 January 2022 to 30 September 2023. A total of 26 significant disproportionality preferred terms (PTs) conforming to the four signal detection algorithms were noted. Some of the statistically significant cardiac ADRs at PT level include decreased ejection fraction (EF) [ROR 33.60 (95% confidence interval, CI 21.79-51.82), PRR 32.86 (χ2 615.96), information component (IC) 5.03, IC025 4.61, empirical Bayesian geometric mean (EBGM) 32.77, EBGM05 21.25], cardiac failure [ROR 9.39 (95% CI 6.49-13.60), PRR 9.13 (χ2 202.42), IC 3.19, IC025 2.83, EBGM 9.12, EBGM05 6.30], and atrial fibrillation [ROR 16.63 (95% CI 12.72-21.75), PRR 15.66 (χ2 769.93), IC 3.97, IC025 3.71, EBGM 15.64, EBGM05 11.96]. CONCLUSIONS: The results of our study were consistent with the safety data of clinical trials, including reduced ejection fraction, atrial fibrillation, dyspnea, and syncope. We also found potential new and unexpected ADR signals, such as urinary tract infection, gout, and peripheral edema.

Percutaneous Edge-to-Edge Valve Interventions: The Role of Surgical Salvage in Complex Percutaneous Techniques.

Hemodynamically significant mitral regurgitation (MR) is associated with major morbidity and mortality. Transcatheter edge-to-edge repair (TEER) is an interventional procedure for MR, which has gained popularity in recent years as an alternative solution to surgical valve repair in high-risk surgical candidates. However, there are no definite guidelines following TEER failures to determine if patients would benefit from a redo TEER or surgical mitral valve (MV) repair. Here, we present one such clinical dilemma. In patients who have failed the TEER of the MV, surgical risk must be determined in conjunction with a multidisciplinary team, as surgical MV replacement may be performed at advanced centers in high-risk patients with good results.

Atrioventricular Synchrony Restoration Aided by a Temporary Permanent Pacemaker in Right Ventricular Infarction and Complete Heart Block.

Pacemakers are effective treatments for a variety of bradyarrhythmias. Cardiac pacemakers generally consist of a pulse generator and one or more leads. The conventional temporary transvenous ventricular cardiac pacemaker utilizing a passive fixation lead is commonly associated with multiple complications such as increased infection rate, lead dislodgement, venous thrombosis, longer duration of hospital stay, and atrioventricular (AV) dyssynchrony. On the other hand, temporary permanent pacemakers (TPPM) utilize active fixation leads; hence, they provide lower capture thresholds, reliable pacing, lower rates of displacement, and fewer pacemaker-related infections. Here, we present a case of TPPM aiding AV synchrony restoration in complete heart block accompanying right ventricular (RV) infarction with refractory cardiogenic shock. Pacemakers are effective treatments for a variety of bradyarrhythmias. Cardiac pacemakers generally consist of a pulse generator and one or more leads. We present a case of TPPM aiding AV synchrony restoration in complete heart block accompanying RV infarction with refractory cardiogenic shock. TPPM pacing is a safe and effective technique for temporary bridge pacing to prevent AV dyssynchrony in hemodynamically unstable patients with cardiogenic shock from RV infarction and complete heart block. It also hastens recovery compared to a traditional single-chamber temporary pacemaker.

Catheter ablation versus medical therapy in atrial fibrillation: an umbrella review of meta-analyses of randomized clinical trials.

This umbrella review synthesizes data from 17 meta-analyses investigating the comparative outcomes of catheter ablation (CA) and medical treatment (MT) for atrial fibrillation (AF). Outcomes assessed were mortality, risk of hospitalization, AF recurrence, cardiovascular events, pulmonary vein stenosis, major bleeding, and changes in left ventricular ejection fraction (LVEF) and MLHFQ score. The findings indicate that CA significantly reduces overall mortality and cardiovascular hospitalization with high strength of evidence. The risk of AF recurrence was notably lower with CA, with moderate strength of evidence. Two associations reported an increased risk of pulmonary vein stenosis and major bleeding with CA, supported by high strength of evidence. Improved LVEF and a positive change in MLHFQ were also associated with CA. Among patients with AF and heart failure, CA appears superior to MT for reducing mortality, improving LVEF, and reducing cardiovascular rehospitalizations. In nonspecific populations, CA reduced mortality and improved LVEF but had higher complication rates. Our findings suggest that CA might offer significant benefits in managing AF, particularly in patients with heart failure. However, the risk of complications, including pulmonary vein stenosis and major bleeding, is notable. Further research in understudied populations may help refine these conclusions.

Chest Pain Risk Stratification in the Emergency Department: Current Perspectives.

Chest pain is the second leading cause of all emergency department (ED) visits in adults in the United States, with nearly 11 million encounters yearly. While identifying low-risk patients is crucial for early discharge, identifying high-risk patients in ED is vital in timely and appropriate acute coronary syndrome (ACS) management. Traditional methods such as physical examination, cardiac markers, or imaging tests cannot reliably confirm or rule out ACS; they cannot be singularly incorporated to risk stratify patients. Various clinical risk scores have been proposed to address this challenge for risk stratification in patients being evaluated for suspected ACS. The ideal risk score should demonstrate high sensitivity and specificity to accurately differentiate between patients with varying levels of risk, particularly in identifying those at high risk for major adverse cardiovascular events. Simultaneously, an ideal scoring system should also be able to compute information for other non-coronary etiologies of chest pain that require time-sensitive interventions and workups (eg, aortic dissection and pulmonary embolism). In this review, we have assembled major risk scores used for risk stratification in patients with acute chest pain in ED. We have abbreviated their salient features to assist readers in their clinical decision-making.