"Under"-reporting of complications following AF ablation: Comparison of the Manufacturer and User Facility Device Experience FDA database and a voluntary invitation-based registry - the POTTER-AF 3 Study.

BACKGROUND: The Manufacturer and User Facility Device Experience (MAUDE) database houses medical device reports of adverse events involving medical devices marketed in the United States submitted to the U.S. Food and Drug Administration (FDA) by mandatory and voluntary reporters. The MAUDE database is frequently used in clinical studies to report on device-related complications. Data about its efficacy are scarce. OBJECTIVE: To compare the mandatory MAUDE database (MAUDE group) with the invitation-based POTTER-AF Study (POTTER-AF 1 group) regarding data quality, procedural characteristics, diagnosis, treatment, and survival. METHODS: The reports of esophageal fistula esophageal fistula following atrial fibrillation (AF) ablation in the MAUDE database were compared to those in the POTTER-AF Study between 01/08/2009 and 31/08/2019. RESULTS: Esophageal fistula was reported in 47 patients in the MAUDE group and in 81 in the POTTER-AF 1 group. Procedures were performed with radiofrequency, cryoenergy or laser energy in 66.0%, 31.9% and 2.1% (MAUDE group) and in 96.3%, 2.5% and 1.2% (POTTER-AF 1 group). The median time to symptoms was 21 (14, 32.5) days (MAUDE group) and 18.0 (6.8, 22.3) days (POTTER-AF 1 group; p=0.031). The diagnostic method was reported in 38.3% of patients in the MAUDE group and in 98.8% in the POTTER-AF 1 group, the treatment in 57.4% and 100% and the outcome in all patients. In the MAUDE group, treatment was surgical (51.9%), endoscopic (37.0%), combined (3.7%) or conservative (7.4%), compared to 43.2%, 19.8%, 7.4% and 29.6% in the POTTER-AF 1 group. Overall mortality was 76.6% in the MAUDE group and 61.7% in the POTTER-AF 1 group (p=0.118). CONCLUSION: In the mandatory MAUDE database, less esophageal fistula cases were reported as compared to an invitation-based study. The data quality in the MAUDE database was significantly poorer.

All-cause mortality due to conduction abnormalities in the United States: Sex, racial, and geographic variations from 1999 to 2022.

BACKGROUND: Mortality related to conduction abnormalities in the United States (US) population is not well documented. Population-based stratification approaches can improve public health policies and targeted strategies. OBJECTIVE: The purpose of this study was to evaluate all-cause mortality related to conduction abnormalities in the US population METHODS: The Centers for Disease Control and Prevention Wide-Ranging Online Data for Epidemiologic Research database was used to calculate the age-adjusted mortality rate (AAMR) per 100,000 individuals older than 35 years related to conduction abnormalities between 1999 and 2022. RESULTS: A total of 207,861 deaths were attributed to conduction abnormalities throughout the study period ,with 56,186 of these deaths occurring between 2020 and 2022. All-cause mortality related to conduction abnormalities has increased during the past decade with an exponential growth in 2020-2021 (coronavirus disease 2019 era; annual percent change of 16.6% per year). Although the mortality rates decreased in 2022, they remained elevated compared to 2019-2020. Throughout the past 2 decades, males consistently exhibited higher mortality rates than females, with the rate in 2022 being 1.5 times higher (AAMR 11.4 vs 7.0 per 100,000). Non-Hispanic Black patients experienced a significantly higher mortality rate compared to non-Hispanic White individuals in the study period (AAMR 13.7 vs 8.6 per 100,000 in 2022). In the past 2 decades, mortality has been persistently higher in rural and small- to medium-sized metropolitan areas than in large metropolitan urban areas. CONCLUSION: Mortality rates related to conduction abnormalities have increased over the past decade, and persistent disparities have been observed. These data suggest that continued innovative outreach approaches and engagement with underrepresented populations remain essential.

PTSD and mood disorders in implantable cardioverter defibrillator patients: is more psychological assessment needed?

INTRODUCTION: The aim of this review is to identify common mood concerns in ICD patients and suggest brief psychological screeners essential for early detection and monitoring in patient care. AREAS COVERED: Reliable and valid psychological assessment tools are reviewed, including those specifically designed for ICD patient populations. EXPERT OPINION: Psychological assessment, in combination with cardiologic standard of care, can help overcome many barriers associated with poor implantable cardioverter-defibrillator (ICD) management and related cardiovascular outcomes. Earlier identification and treatment of mood concerns in ICD patients has been shown to improve quality of life (QOL) and patient outcomes. At this time, however, logistical challenges and time restraints, in addition to knowledge of appropriate treatment plans or referral options, remain central barriers to providing integrated, patient-centered care. Ultimately, all cardiology clinics would benefit from a collaborative care team that includes a mental health consultant or in-house psychologists who can provide consultations or referral services. Additionally, all patients that come to the clinics should complete proactive screening measures as routine component of care to assess the presence of mood concerns to improve patient outcomes and aid in treatment planning.

Recovery of Transient High-Grade Atrioventricular Block Managed With Corticosteroid Therapy Without Device Implantation in Newly Diagnosed Cardiac Sarcoidosis: A Case Report.

Atrioventricular blocks (AVBs) presenting in cardiac sarcoidosis (CS) remain an ongoing challenge for clinicians. While most initiate immunosuppressive therapy with the goal of pursuing device implantation, there is some ambiguity as to which patient cohorts actually benefit from device therapy. We present a case of a 39-year-old African American male with a past medical history of hypertension and no prior cardiac history who presented with substernal chest pain in the setting of a hypertensive emergency. He was later diagnosed with cardiac sarcoidosis by cardiac magnetic resonance imaging. His hospital course was complicated by transient Mobitz II atrioventricular block. He was started on prednisone, and while initially scheduled for an implantable cardioverter-defibrillator (ICD), his conduction block recovered. Through a multidisciplinary approach, the patient was discharged on medical management with outpatient follow-up. Since his initial hospitalization, the patient has not had any concerning cardiovascular events over the past year and has not been treated with device therapy. Our case illustrates the feasibility of effectively managing patients with cardiac sarcoidosis presenting with transient atrioventricular blocks only with corticosteroid therapy without needing device implantation.

High-Risk Apical Hypertrophic Cardiomyopathy Requiring an Implantable Cardioverter-Defibrillator: A Case Report of an Overlooked Etiology.

Apical hypertrophic cardiomyopathy is a rare variant of hypertrophic cardiomyopathy characterized by abnormal heart muscle thickening, specifically affecting the left ventricle's apex. Classically revealing both giant T-wave inversions in the precordial leads of an electrocardiogram and a spade-like configuration of the left ventricular cavity on ventriculograms, the diagnosis of the apical variant has evolved with cardiac magnetic resonance imaging. Despite being well known among East Asian populations, the diagnosis of apical hypertrophic cardiomyopathy is often underestimated and overlooked among American patients due to the non-specific nature of echocardiography. In this case report, we present the diagnosis of apical hypertrophic cardiomyopathy in a middle-aged African American male with chronic palpitations. The diagnosis was confirmed using cardiac magnetic resonance imaging, which revealed extensive myocardial fibrosis. Ultimately, the patient was treated with an implantable cardioverter-defibrillator. Our case aims to enhance the understanding and facilitate the recognition and management of apical hypertrophic cardiomyopathy, particularly among non-Asian individuals. Current challenges revolve around robust risk stratification strategies for patients at high risk for sudden cardiac death that require device therapy.

A Case of Sick Sinus Syndrome With Prolonged Asystole Masquerading as a Transient Ischemic Attack.

Sick sinus syndrome (SSS) is a term used to describe dysfunction of the sinoatrial (SA) node that can lead to various cardiac arrhythmias that predominately manifest in the elderly. Commonly implicated arrhythmias vary from inappropriate bradycardia, tachycardia, sinus pauses, and rarely sinus arrest. Despite being a common reason for permanent pacemaker implantation, little is known regarding the incidence of SSS and there is even less reporting on SSS complicated by prolonged asystole. We present a case highlighting an infrequently observed manifestation of SSS with recurrent, prolonged ventricular asystolic episodes that were causing previously unexplained episodes of confusion and agonal breathing. Our patient was a 75-year-old male with a past medical history of hypertension, dyslipidemia, and prior transient ischemic attacks (TIAs) that presented after an acute mental status change. The initial leading differential diagnosis was believed to be a TIA and he was admitted to neurology service for further evaluation. The patient had recurring episodes of confusion associated with agonal breathing that upon closer review of the cardiac telemetry revealed sinus bradycardia to the 40s interrupted by several prolonged episodes of asystole, the longest lasting 20 seconds. Due to his symptoms and to avoid potential deterioration resulting in hemodynamic instability, the electrophysiology service urgently placed a temporary transvenous pacemaker and then later implanted a leadless pacemaker. On outpatient follow-up, he no longer had episodes of confusion, and no further asystolic episodes were noted on his device check.

COVID-19-associated Brugada pattern electrocardiogram: Systematic review of case reports.

AIMS: To summarize published case reports of patients diagnosed with coronavirus disease 2019 (COVID-19) and Brugada pattern electrocardiogram (ECG). METHODS: The Preferred Reporting Items for Systematic Reviews and Meta-Analyses checklist were followed. A literature search was conducted using PubMed, EMBASE, and Scopus up until September 2021. The incidence, clinical characteristics, and management outcomes of COVID-19 patients with a Brugada pattern ECG were identified. RESULTS: A total of 18 cases were collected. The mean age was 47.1 years and 11.1% were women. No patients had prior confirmed diagnosis of Brugada syndrome. The most common presenting clinical symptoms were fever (83.3%), chest pain (38.8%), shortness of breath (38.8%), and syncope (16.6%). All 18 patients presented with type 1 Brugada pattern ECG. Four patients (22.2%) underwent left heart catheterization, and none demonstrated the presence of obstructive coronary disease. The most common reported therapies included antipyretics (55.5%), hydroxychloroquine (27.7%), and antibiotics (16.6%). One patient (5.5%) died during hospitalization. Three patients (16.6%) who presented with syncope received either an implantable cardioverter defibrillator or wearable cardioverter defibrillator at discharge. At follow-up, 13 patients (72.2%) had resolution of type 1 Brugada pattern ECG. CONCLUSION: COVID-19-associated Brugada pattern ECG seems relatively rare. Most patients had resolution of the ECG pattern once their symptoms have improved. Increased awareness and timely use of antipyretics is warranted in this population.

Physician antibiotic hydration preferences for biologic antibacterial envelopes during cardiac implantable device procedures.

Background: Cardiac implantable electronic device (CIED) infection is a potentially serious complication of CIED procedures. Infection risk mitigation includes using guideline-recommended pre-operative intravenous antibacterial prophylaxis (IV ABX). The use of antibiotic-eluting CIED envelopes has also been shown to reduce infection risk. The relationship between and potential benefits associated with guideline-recommended IV ABX in combination with antibacterial envelopes have not been characterized. Methods: Biologic envelopes made from non-crosslinked extracellular matrix (ECM) were implanted into 1,102 patients receiving CIEDs. The implanting physician decided patient selection for using a biologic envelope and envelope hydration solution. Observational data was analyzed on IV ABX utilization rates, antibacterial envelope usage, and infection outcomes. Results: Overall compliance with IV ABX was 96.6%, and most patients received a biologic envelope hydrated in antibiotics (77.1%). After a mean follow-up of 223 days, infection rates were higher for sites using IV ABX <80% of the time vs. sites using ≥80% (5.6% vs. 0.8%, p = 0.008). Physicians demonstrated preference for hydration solutions containing gentamicin in higher-risk patients, which was found by multivariate analysis to be associated with a threefold reduction in infection risk (OR 3.0, 95% CI, 1.0-10.0). Conclusion: These findings suggest that use of antibiotics, particularly gentamicin, in biologic envelope hydration solution may reduce infection risk, and use of antibacterial envelopes without adjunct IV ABX may not be sufficient to reduce CIED infections. Clinical trial registration: [https://clinicaltrials.gov/], identifier [NCT02530970].

Effects of opioid receptor agonist and antagonist medications on electrocardiogram changes and presentation of cardiac arrhythmia: review article.

BACKGROUND/PURPOSE: Mortality associated with prescription opioids has significantly increased over the past few decades and is considered a global pandemic. Prescribed opioids can cause cardiac arrhythmias, leading to fatal outcomes and unexpected death, even in the absence of structural cardiac disease. Despite the extent of cardiac toxicity and death associated with these medications, there is limited data to suggest their influences on cardiac electrophysiology and arrhythmias, with the exception of methadone. The goal of our review is to describe the possible mechanisms and to review the different ECG changes and arrhythmias that have been reported. METHODS: A literature search was performed using Google Scholar, PubMed, Springer, Ovid, and Science Direct to identify studies that demonstrated the use of prescription opioids leading to electrocardiogram (ECG) changes and cardiac arrhythmias. RESULTS: Many of the commonly prescribed opioid medications can uniquely effect the ECG, and can lead to the development of various cardiac arrhythmias. One of the most significant side effects of these drugs is QTc interval prolongation, especially when administered to patients with a baseline risk for QTc prolongation. A prolonged QTc interval can cause lethal torsades de pointes and ventricular fibrillation. Obtaining an ECG at baseline, following a dosage increase, or after switching an opioid medication, is appropriate in patients taking certain prescribed opioids. Opioids are often used first line for the treatment of acute and chronic pain, procedural sedation, medication opioid use disorders, and maintenance therapy. CONCLUSIONS: To reduce the risk of cardiac arrhythmias and to improve patient outcomes, consideration of accurate patient selection, concomitant medications, electrolyte monitoring, and vigilant ECG monitoring should be considered.

Intermittent Epicardial Lead Failure Detected Using a Continuous Ambulatory Electrocardiogram Monitor.

A 69-year-old man received epicardial pacing leads for complete atrioventricular block that occurred during a mechanical tricuspid valve replacement procedure. During follow-up, the patient reported intermittent episodes of dizziness and bradycardia. Remote transmissions and device interrogations failed to elucidate the cause of his symptoms. A continuous ambulatory electrocardiogram (ECG) monitor was used as an alternative diagnostic tool. Multiple pauses were detected by the monitor and, upon review, these events were deemed to be due to the intermittent loss of capture by the epicardial lead. Once this diagnosis was made and the malfunctioning lead was replaced, the patient's symptoms resolved. This case highlights the novel use of a continuous ambulatory ECG monitor in diagnosing intermittent loss of capture, which was not detected by remote monitoring or device interrogations.

Late massive radial artery pseudoaneurysm following cardiac catheterization: A case report.

INTRODUCTION: Transradial artery approach for cardiac catheterization was first introduced in the late 1980s and has now become the approach of choice due to its anatomical advantage, reduction in complications, and overall improved patient experience. CASE PRESENTATION: We present a case of a 77 year-old female who presented with an extremely rare and late complication of radial artery pseudoaneurysm after transradial coronary intervention. The patient presented at a post-procedural follow-up with severe pain at the radial access site and was found to have a partially thrombosed pseudoaneurysm. Given the anatomical variance of the pseudoaneurysm, the patient underwent successful open surgical repair. CLINICAL DISCUSSION: Although radial artery access is a relatively safe approach in comparison to the transfemoral approach, the risk of adverse events still exists. Among the complications of the transradial approach, pseudoaneurysms are relatively rare, occurring in less than 0.1% of cases. Regardless, early identification of this complication is essential to timely intervention. CONCLUSION: Our case highlights the importance of post procedural monitoring and early identification and diagnosis of the complication to facilitate appropriate therapy.

Antibiotic-Eluting Envelopes to Prevent Cardiac-Implantable Electronic Device Infection: Past, Present, and Future.

OBJECTIVE: Cardiac-implantable electronic device (CIED) infections are associated with significant morbidity and mortality. In this review, we describe the risk factors and pathogenesis of CIED infections and review the rationale and the evidence for the use of antibiotic-eluting envelopes (ABEs) in patients at increased risk for CIED infections. FINDINGS: The majority of CIED infections are caused by staphylococci that involve generator pocket and occur due to contamination of the device or the pocket tissues at the time of implantation. Clinical trials have shown that extending the duration of post-operative systemic antibacterial therapy is not beneficial in reducing CIED infection rate. However, ABEs that reduce device migration after implantation and provide sustained local delivery of prophylactic antibiotics at the pocket site, may provide benefit in reducing infection. Currently, there are two types of commercially available CIED envelope devices in the United States. The first ABE device (TYRX™, Medtronic Inc., Monmouth Junction, NJ) is composed of a synthetic absorbable mesh envelope that elutes minocycline and rifampin and has been shown to reduce CIED pocket infections in a large multi-center randomized clinical trial. The second ABE device (CanGaroo-G™, Aziyo Biologics, Silver Spring, MD) is composed of decellularized extracellular matrix (ECM) and was originally designed to stabilize the device within the pocket, limiting risk for migration or erosion, and providing a substrate for tissue ingrowth in a preclinical study. This device has shown promising results in a preclinical study with local delivery of gentamicin. Compared with artificial materials, such as synthetic surgical mesh, biologic ECM has been shown to foster greater tissue integration and vascular ingrowth, a reduced inflammatory response, and more rapid clearance of bacteria. CONCLUSIONS AND RELEVANCE: ABE devices provide sustained local delivery of antibiotics at the generator pocket site and appear beneficial in reducing CIED pocket infections. Given the continued increase in the use of CIED therapy and resultant infectious complications, innovative approaches to infection prevention are critical.

Proarrhythmic Manifestations of Neuromuscular Dystrophinopathies.

Muscular dystrophy has been an elusive term ever since it was first described in the 19th century. Introduced in 1891 by Wilhelm Heinrich Erb, muscular dystrophy has been classified as part of a larger group of genetically determined, progressive degenerative neuromuscular disorders termed "dystrophinopathies." Cardiac arrhythmias may occur during the neurologic course of the disease. Although descriptions of the dystrophinopathies have been reported in the literature, few articles address the use of antiarrhythmic pharmacotherapy in patients with muscular dystrophy. We discuss the pathophysiology of the most common dystrophinopathies, their proarrhythmic sequelae, and the therapeutic use of antiarrhythmic agents in the clinical setting.