Implementation of an intravenous sotalol initiation protocol: Implications for feasibility, safety, and length of stay.

INTRODUCTION: Oral sotalol initiation requires a multiple-day, inpatient admission to monitor for QT prolongation during loading. A 1-day intravenous (IV) sotalol loading protocol was approved by the United States Food and Drug Administration in March 2020, but limited data on clinical use and administration currently exists. This study describes implementation of an IV sotalol protocol within an integrated health system, provides initial efficacy and safety outcomes, and examines length of stay (LOS) compared with oral sotalol initiation. METHODS: IV sotalol was administered according to a prespecified initiation protocol to adult patients with refractory atrial or ventricular arrhythmias. Baseline characteristics, safety and feasibility outcomes, and LOS were compared with patients receiving oral sotalol over a similar time period. RESULTS: From January 2021 to June 2022, a total of 29 patients (average age 66.0 ± 8.6 years, 27.6% women) underwent IV sotalol load and 20 patients (average age 60.4 ± 13.9 years, 65.0% women) underwent oral sotalol load. The load was successfully completed in 22/29 (75.9%) patients receiving IV sotalol and 20/20 (100%) of patients receiving oral sotalol, although 7/20 of the oral sotalol patients (35.0%) required dose reduction. Adverse events interrupting IV sotalol infusion included bradycardia (seven patients, 24.1%) and QT prolongation (three patients, 10.3%). No patients receiving IV or oral sotalol developed sustained ventricular arrhythmias before discharge. LOS for patients completing IV load was 2.6 days shorter (mean 1.0 vs. 3.6, p < .001) compared with LOS with oral load. CONCLUSION: IV sotalol loading has a safety profile that is similar to oral sotalol. It significantly shortens hospital LOS, potentially leading to large cost savings.

Comparison of Sodium-Glucose Cotransporter-2 Inhibitor and Glucagon-Like Peptide-1 Receptor Agonist Prescribing in Patients With Diabetes Mellitus With and Without Cardiovascular Disease.

Sodium-glucose cotransporter-2 inhibitors (SGLT2is) and glucagon-like peptide-1 receptor agonists (GLP1-RAs) reduce cardiovascular events and mortality in patients with type 2 diabetes mellitus (T2DM). We sought to describe trends in prescribing for SGLT2is and GLP1-RAs in diverse care settings, including (1) the outpatient clinics of a midwestern integrated health system and (2) small- and medium-sized community-based primary care practices and health centers in 3 midwestern states. We included adults with T2DM and ≥1 outpatient clinic visit. The outcomes of interest were annual active prescription rates for SGLT2is and GLP1-RAs (separately). In the integrated health system, 22,672 patients met the case definition of T2DM. From 2013 to 2019, the overall prescription rate for SGLT2is increased from 1% to 15% (absolute difference [AD] 14%, 95% confidence interval [CI] 13% to 15%, p <0.01). The GLP1-RA prescription rate was stable at 10% (AD 0%, 95% CI -1% to 1%, p = 0.9). In community-based primary care practices, 43,340 patients met the case definition of T2DM. From 2013 to 2017, the SGLT2i prescription rate increased from 3% to 7% (AD 4%, 95% CI 3% to 6%, p <0.01), whereas the GLP1-RA prescription rate was stable at 2% to 3% (AD 1%, 95% CI -1 to 1%, p = 0.40). In a fully adjusted regression model, non-Hispanic Black patients had lower odds of SGLT2i or GLP1-RA prescription (odds ratio 0.56, 95% CI 0.34 to 0.89, p = 0.016). In conclusion, the increase in prescription rates was greater for SGLT2is than for GLP1-RAs in patients with T2DM in a large integrated medical center and community primary care practices. Overall, prescription rates for eligible patients were low, and racial disparities were observed.

Esophageal temperature management during cryoballoon ablation for atrial fibrillation.

INTRODUCTION: Esophageal thermal injury (ETI) is a well-recognized complication of atrial fibrillation (AF) ablation. Previous studies have demonstrated that direct esophageal cooling reduces ETI during radiofrequency AF ablation. The purpose of this study was to evaluate the use of an esophageal warming device to prevent ETI during cryoballoon ablation (CBA) for AF. METHODS: This prospective, double-blinded study enrolled 42 patients with symptomatic AF undergoing CBA. Patients were randomized to the treatment group with esophageal warming (42°C) using recirculated water through a multilumen, silicone tube inserted into the esophagus (EnsoETM®; Attune Medical) (WRM) or the control group with a luminal single-electrode esophageal temperature monitoring probe (LET). Patients underwent upper endoscopy esophagogastroduodenoscopy (EGD) the following day. ETI was classified into four grades. RESULTS: Baseline patient characteristics were similar between groups. Procedural characteristics including number of freezes, total freeze time, early freeze terminations, coldest balloon temperature, procedure duration, posterior wall ablation, and proton pump inhibitor and transesophageal echocardiogram use before procedure were not different between groups. The EGD was completed in 40/42 patients. There was significantly more ETI in the WRM group compared to the LET group (n = 8 [38%] vs. n = 1 [5%], p = 0.02). All ETI lesions were grade 1 (erythema) or 2 (superficial ulceration). Total freeze time in the left inferior pulmonary vein was predictive of ETI (360 vs. 300 s, p = 0.03). CONCLUSION: Use of a luminal heat exchange tube for esophageal warming during CBA for AF was paradoxically associated with a higher risk of ETI.

Inter-Patient Atrial Flutter Classification Using FFT-Based Features and a Low-Variance Stacking Classifier.

OBJECTIVE: Atrial Flutter (AFL) is a supraventricular tachyarrhythmia typically arising from a macroreentry circuit that can have variable atrial anatomy. It is often treated by catheter ablation, the success of which depends upon the correct determination of the electroanatomic circuit, generally through invasive electrophysiological (EP) study. We hypothesized that machine learning (ML) methods applied to the diagnostic 12-lead surface electrocardiogram (ECG) could determine the specific circuit prior to any invasive EP study. METHODS: The 12-lead ECGs were reduced to eight independent leads: I, II, V1 - V6. Through an algorithm using ventricular complex cancellation methods, windows of atrial activity in the ECG were uncovered and spectra were generated. Three ML classifier approaches were applied: Support Vector Machine (SVM), Random Forest (RF) and k-Nearest Neighbors (KNN), and their outputs combined using soft voting. RESULTS: Ten-second surface ECGs taken from 419 AFL patients prior to invasive EP study and ablation were analyzed retrospectively. Of the 419 patients, 285 had typical cavotricuspid isthmus (CTI)-dependent AFL, 41 had atypical right-atrial AFL and 93 had left-atrial AFL, as determined during the subsequent EP study. Lead V5 was found to be most useful giving a test accuracy of 98% and f1 score of 0.97. CONCLUSION: We conclude that ML methods have the potential to automatically determine the AFL macroreentry circuit from the surface ECG. SIGNIFICANCE: The AFL classification method presented in this investigation achieves 95+% accuracy on an unbalanced inter-patient dataset which has important clinical applications.

Use of a novel 4D intracardiac echocardiography catheter to guide interventional electrophysiology procedures.

INTRODUCTION: Standard two-dimensional (2D), phased-array intracardiac echocardiography (ICE) is routinely used to guide interventional electrophysiology (EP) procedures. A novel four-dimensional (4D) ICE catheter (VeriSight Pro, Philips) can obtain 2D and three-dimensional (3D) volumetric images and cine-videos in real-time (4D). The purpose of this study was to determine the early feasibility and safety of this 4D ICE catheter during EP procedures. METHODS: The 4D ICE catheter was placed from the femoral vein in ten patients into various cardiac chambers to guide EP procedures requiring transseptal catheterization, including ablation for atrial fibrillation and left atrial appendage closure. 2D- and 3D-ICE images were acquired in real-time by the electrophysiologist. A dedicated imaging expert performed digital steering to optimize and postprocess 4D images. RESULTS: Eight patients underwent pulmonary vein isolation (cryoballoon in seven patients, pulsed field ablation in one, additional radiofrequency left atrial ablation in one). Two patients underwent left atrial appendage closure. High quality images of cardiac structures, transseptal catheterization equipment, guide sheaths, ablation tools, and closure devices were acquired with the ICE catheter tip positioned in the right atrium, left atrium, pulmonary vein, coronary sinus, right ventricle, and pulmonary artery. There were no complications. CONCLUSION: This is the first experience of a novel deflectable 4D ICE catheter used to guide EP procedures. 4D ICE imaging is safe and allows for acquisition of high-quality 2D and 3D images in real-time. Further use of 4D ICE will be needed to determine its added value for each EP procedure type.

Fulminant myocarditis in a patient with coronavirus disease 2019 and rapid myocardial recovery following treatment.

Coronavirus disease 2019 (COVID-19) is a global pandemic increasingly encountered in the clinical setting. It typically manifests as a respiratory illness, although cardiac involvement is common and portends a worse prognosis. We present the case of a 56-year-old male admitted with COVID-19 fulminant myocarditis and cardiogenic shock. We discuss important aspects of the multidisciplinary and interventional care involved in treating cardiogenic shock as well as the likely mechanisms of, and potential treatment for, COVID-19 myocarditis. The various pathways of myocardial injury, including direct viral damage, macrophage activation, and lymphocytic infiltration, are outlined in detail in addition to associated pathology such as cytokine release syndrome. COVID-19 is a complex and multisystem disease process; in addition to supportive care, specific consideration should be given to the underlying mechanism of injury for each patient.

Development of a Portable Tool to Identify Patients With Atrial Fibrillation Using Clinical Notes From the Electronic Medical Record.

BACKGROUND: The electronic medical record contains a wealth of information buried in free text. We created a natural language processing algorithm to identify patients with atrial fibrillation (AF) using text alone. METHODS AND RESULTS: We created 3 data sets from patients with at least one AF billing code from 2010 to 2017: a training set (n=886), an internal validation set from site no. 1 (n=285), and an external validation set from site no. 2 (n=276). A team of clinicians reviewed and adjudicated patients as AF present or absent, which served as the reference standard. We trained 54 algorithms to classify each patient, varying the model, number of features, number of stop words, and the method used to create the feature set. The algorithm with the highest F-score (the harmonic mean of sensitivity and positive predictive value) in the training set was applied to the validation sets. F-scores and area under the receiver operating characteristic curves were compared between site no. 1 and site no. 2 using bootstrapping. Adjudicated AF prevalence was 75.1% at site no. 1 and 86.2% at site no. 2. Among 54 algorithms, the best performing model was logistic regression, using 1000 features, 100 stop words, and term frequency-inverse document frequency method to create the feature set, with sensitivity 92.8%, specificity 93.9%, and an area under the receiver operating characteristic curve of 0.93 in the training set. The performance at site no. 1 was sensitivity 92.5%, specificity 88.7%, with an area under the receiver operating characteristic curve of 0.91. The performance at site no. 2 was sensitivity 89.5%, specificity 71.1%, with an area under the receiver operating characteristic curve of 0.80. The F-score was lower at site no. 2 compared with site no. 1 (92.5% [SD, 1.1%] versus 94.2% [SD, 1.1%]; P<0.001). CONCLUSIONS: We developed a natural language processing algorithm to identify patients with AF using text alone, with >90% F-score at 2 separate sites. This approach allows better use of the clinical narrative and creates an opportunity for precise, high-throughput cohort identification.

Factors Associated With Excess Myocardial Infarction Risk in HIV-Infected Adults: A Systematic Review and Meta-analysis.

OBJECTIVES: To estimate the pooled relative risk (RR) of incident acute myocardial infarction (AMI) among HIV-infected adults compared with HIV-uninfected controls and explore the contribution of traditional and HIV-related risk factors. BACKGROUND: Understanding AMI risk and associated risk factors in HIV-infected populations has the potential to inform clinical management and prevention strategies. METHODS: We systematically identified cohort studies of HIV-infected or HIV-infected and matched uninfected adults reporting AMI incidence rates published up to January 1, 2017. Random-effects meta-analysis models were used to estimate the aggregate RR of AMI by HIV status. Subgroup analysis and meta-regression were used to explore factors affecting risk. RESULTS: Sixteen studies (N = 1,619,690, median age 38.5 years, 78.9% male, mean follow-up of 6.5 years) were included. In pooled analyses of HIV-infected and matched uninfected cohorts (n = 5), HIV-infected individuals had higher AMI incidence rates (absolute risk difference = 2.2 cases per 1000 persons per year) and twice the risk of AMI [RR = 1.96 (1.5-2.6)] compared with matched HIV-uninfected controls. In a multivariate meta-regression, each additional percentage point in the proportion of male participants [odds ratio (OR) = 1.20 (1.14-1.27)] and each additional percentage point in the prevalence of hypertension [OR = 1.19 (1.12-1.27)], dyslipidemia [OR = 1.09 (1.07-1.11)], and smoking [OR = 1.09 (1.05-1.13)] were independently associated with increased AMI risk in HIV-infected adults. CONCLUSIONS AND RELEVANCE: Chronic HIV infection is associated with a 2-fold higher AMI risk. Traditional risk factors such as hypertension, dyslipidemia, and smoking are significant contributors to AMI risk among HIV-infected adults and should be aggressively targeted in routine HIV care.

Acquired Methemoglobinemia Associated with Topical Lidocaine Administration: A Case Report.

A 55-year-old male was admitted to the hospital with pneumonia. During an intubation procedure, the patient received an application of endobronchial lidocaine (4% gel). Within 2 h of intubation, the patient developed worsening hypoxia, and investigation of arterial blood gasses revealed a pH of 7.21, carbon dioxide partial pressure (PaCO2) of 3.3 kPa, oxygen partial pressure (PaO2) of 55.1 kPa, and measured oxygen saturation of 49%. Co-oximetry of this sample returned a methemoglobin level of 53%. Intravenous methylthioninium chloride (1% solution at 1 mg/kg) was delivered, and subsequent arterial blood gasses, at 30 min and 1 h post administration, showed methemoglobin levels of 12 and 9%, respectively, with return of oxygen saturation to > 90%.

Mental Stress-Induced-Myocardial Ischemia in Young Patients With Recent Myocardial Infarction: Sex Differences and Mechanisms.

BACKGROUND: Mental stress-induced myocardial ischemia (MSIMI) is frequent in patients with coronary artery disease and is associated with worse prognosis. Young women with a previous myocardial infarction (MI), a group with unexplained higher mortality than men of comparable age, have shown elevated rates of MSIMI, but the mechanisms are unknown. METHODS: We studied 306 patients (150 women and 156 men) ≤61 years of age who were hospitalized for MI in the previous 8 months and 112 community controls (58 women and 54 men) frequency matched for sex and age to the patients with MI. Endothelium-dependent flow-mediated dilation and microvascular reactivity (reactive hyperemia index) were measured at rest and 30 minutes after mental stress. The digital vasomotor response to mental stress was assessed using peripheral arterial tonometry. Patients received 99mTc-sestamibi myocardial perfusion imaging at rest, with mental (speech task) and conventional (exercise/pharmacological) stress. RESULTS: The mean age of the sample was 50 years (range, 22-61). In the MI group but not among controls, women had a more adverse socioeconomic and psychosocial profile than men. There were no sex differences in cardiovascular risk factors, and among patients with MI, clinical severity tended to be lower in women. Women in both groups showed a higher peripheral arterial tonometry ratio during mental stress but a lower reactive hyperemia index after mental stress, indicating enhanced microvascular dysfunction after stress. There were no sex differences in flow-mediated dilation changes with mental stress. The rate of MSIMI was twice as high in women as in men (22% versus 11%, P=0.009), and ischemia with conventional stress was similarly elevated (31% versus 16%, P=0.002). Psychosocial and clinical risk factors did not explain sex differences in inducible ischemia. Although vascular responses to mental stress (peripheral arterial tonometry ratio and reactive hyperemia index) also did not explain sex differences in MSIMI, they were predictive of MSIMI in women only. CONCLUSIONS: Young women after MI have a 2-fold likelihood of developing MSIMI compared with men and a similar increase in conventional stress ischemia. Microvascular dysfunction and peripheral vasoconstriction with mental stress are implicated in MSIMI among women but not among men, perhaps reflecting women's proclivity toward ischemia because of microcirculatory abnormalities.

Feasibility, Process, and Outcomes of Cardiovascular Clinical Trial Data Sharing: A Reproduction Analysis of the SMART-AF Trial.

Importance: Data sharing is as an expanding initiative for enhancing trust in the clinical research enterprise. Objective: To evaluate the feasibility, process, and outcomes of a reproduction analysis of the THERMOCOOL SMARTTOUCH Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation (SMART-AF) trial using shared clinical trial data. Design, Setting, and Participants: A reproduction analysis of the SMART-AF trial was performed using the data sets, data dictionary, case report file, and statistical analysis plan from the original trial accessed through the Yale Open Data Access Project using the SAS Clinical Trials Data Transparency platform. SMART-AF was a multicenter, single-arm trial evaluating the effectiveness and safety of an irrigated, contact force-sensing catheter for ablation of drug refractory, symptomatic paroxysmal atrial fibrillation in 172 participants recruited from 21 sites between June 2011 and December 2011. Analysis of the data was conducted between December 2016 and April 2017. Main Outcomes and Measures: Effectiveness outcomes included freedom from atrial arrhythmias after ablation and proportion of participants without any arrhythmia recurrence over the 12 months of follow-up after a 3-month blanking period. Safety outcomes included major adverse device- or procedure-related events. Results: The SMART AF trial participants' mean age was 58.7 (10.8) years, and 72% were men. The time from initial proposal submission to final analysis was 11 months. Freedom from atrial arrhythmias at 12 months postprocedure was similar compared with the primary study report (74.0%; 95% CI, 66.0-82.0 vs 76.4%; 95% CI, 68.7-84.1). The reproduction analysis success rate was higher than the primary study report (65.8%; 95% CI 56.5-74.2 vs 75.6%; 95% CI, 67.2-82.5). Adverse events were minimal and similar between the 2 analyses, but contact force range or regression models could not be reproduced. Conclusions and Relevance: The feasibility of a reproduction analysis of the SMART-AF trial was demonstrated through an academic data-sharing platform. Data sharing can be facilitated through incentivizing collaboration, sharing statistical code, and creating more decentralized data sharing platforms with fewer restrictions to data access.

Effects of Different Dietary Interventions on Blood Pressure: Systematic Review and Meta-Analysis of Randomized Controlled Trials.

Previous studies have shown beneficial effects of individual dietary approaches for blood pressure (BP) control, but their relative effectiveness is not well established. We performed a systematic review of published dietary pattern interventions and estimated the aggregate BP effects through meta-analysis. PubMed, EMBASE, and Web of Science databases were searched to identify studies published between January 1, 1990 and March 1, 2015. Studies meeting specific inclusion and exclusion criteria were selected. Data were pooled using random effects meta-analysis models. Twenty-four trials with 23 858 total participants were included. The overall pooled net effect of dietary intervention on systolic BP and diastolic BP was -3.07 mm Hg (95% confidence interval, -3.85 to -2.30) and -1.81 mm Hg (95% confidence interval, -2.24 to -1.38), respectively. The Dietary Approaches to Stop Hypertension diet had the largest net effect (systolic BP, -7.62 mm Hg [95% confidence interval, -9.95 to -5.29] and diastolic BP, -4.22 mm Hg [95% confidence interval, -5.87 to -2.57]). Low-sodium; low-sodium, high-potassium; low-sodium, low-calorie; and low-calorie diets also led to significant systolic and diastolic BP reductions, whereas Mediterranean diet participants experienced a significant incremental reduction in diastolic but not systolic BP. Subgroup analysis also showed important variations in effectiveness based on duration, size, and participant demographics. In conclusion, dietary modifications are associated with clinically meaningful, though variable, reductions in BP. Some diets are more effective than others and under different circumstances, which has important implications from both clinical and public health perspectives.