Who are we missing? Language exclusivity of patient-reported outcomes in atrial fibrillation clinical trials.

INTRODUCTION: Patient-reported outcomes (PROs) are increasingly used to evaluate quality of life (QoL) in Atrial Fibrillation (AF) patients, providing crucial insights in clinical trials. This study examines the frequency of PRO use in AF trials and the linguistic accessibility of AF-specific PROs. BACKGROUND: As the United States becomes more multilingual, ensuring PROs are available in various languages is vital. The number of people speaking a language other than English at home has tripled from 23.1 million in 1980 to 67.8 million in 2019. This diversity necessitates the availability of PROs in multiple languages for inclusive clinical assessments. METHODS: We queried ClinicalTrials.gov for all US interventional AF trials up to November 28, 2023, reviewing each for PRO usage as primary or secondary outcomes. We identified the five most common AF-specific and generic PROs, extracting their available translations and original languages from published sources. RESULTS: Of 233 identified trials, 191 had associated publications, with 180 (94.2%) conducted solely in English. Only one trial (0.4%) used an AF-specific PRO as a primary outcome, compared to four (1.7%) with a generic PRO. Ten trials (4.3%) used AF-specific PROs as secondary endpoints, versus 22 (9.4%) using generic PROs. AF-specific PROs had significantly fewer translations than generic PROs (11.2 vs. 148.8; p < .001). The AF Effect on Quality-of-Life (AFEQT) was available in 24 languages, with limited translations in commonly spoken US languages like Arabic and Asian languages. CONCLUSION: The limited availability of AF-specific PRO translations highlights a barrier to inclusive AF clinical trials. Expanding translations for AF-specific PROs is crucial for equitable QoL assessments.

Structural phenotyping in atrial fibrillation with combined cardiac CT and atrial MRI: Identifying and differentiating individual structural remodelling types in AF.

INTRODUCTION: Atrial remodelling (AR) is the persistent change in atrial structure and/or function and contributes to the initiation, maintenance and progression of atrial fibrillation (AF) in a reciprocal self-perpetuating relationship. Left atrial (LA) size, geometry, fibrosis, wall thickness (LAWT) and ejection fraction (LAEF) have all been shown to vary with pathological atrial remodelling. The association of these global remodelling markers with each other for differentiating structural phenotypes in AF is not well investigated. METHOD: Patients referred for first-time AF ablation and controls without AF were prospectively recruited to undergo cardiac computed tomographic angiography (CCTA) and magnetic resonance imaging (MRI) with 3D atrial late-gadolinium enhanced (LGE) sequences. LAWT, atrial myocardial mass, LA volume and sphericity were calculated from CT. Biplane LA EF and LA fibrosis burden were derived from atrial MRI. Results were compared between patients with AF and controls. RESULTS: Forty two AF patients (64.3% male, age 64.6 ± 10.2 years, CHA2DS2-VASc 2.48 ± 1.5, 69.0% paroxysmal AF, 31% persistent AF, LVEF 57.9 ± 10.5%) and 37 controls (64.9% male, age 56.6 ± 7.2, CHA2DS2-VASc 1.54 ± 1.1, LVEF 60.4 ± 4.9%) were recruited. Patients with AF had a significantly higher LAWT (1.45 ± 0.52 mm vs 1.12 ± 0.42 mm, p = 0.003), tissue mass (15.81 ± 6.53 g vs. 12.18 ± 5.01 g, p = 0.011), fibrosis burden (9.33 ± 8.35% vs 2.41 ± 3.60%, p = 0.013), left atrial size/volume (95.68 ± 26.63 mL vs 81.22 ± 20.64 mL, p = 0.011) and lower LAEF (50.3 ± 15.3% vs 65.2 ± 8.6%, p < 0.001) compared to controls. There was no significant correlation between % fibrosis with LAWT (p = 0.29), mass (p = 0.89), volume (p = 0.49) or sphericity (p = 0.79). LAWT had a statistically significant weak positive correlation with LA volume (r = 0.25, p = .041), but not with sphericity (p = 0.86). LAEF had a statistically significant but weak negative correlation with fibrosis (r = -0.33, p = 0.008) and LAWT (r = -0.24, p = 0.07). CONCLUSION: AF is associated with significant quantifiable structural changes that are evident in LA size, tissue thickness, total LA tissue mass and fibrosis. These individual remodelling markers do not or only weakly correlate with each other suggesting different remodelling subtypes exist (e.g. fibrotic vs hypertrophic vs dilated). If confirmed, such a detailed understanding of the structural changes observed has the potential to inform clinical management strategies targeting individual mechanisms underlying the disease process.

Swallowing-induced atrial tachycardia: A rare demonstration on fluoroscopic esophagram.

BACKGROUND: Swallowing-associated arrhythmias are rare and most commonly present as atrial tachycardias. METHODS: We present a case of a 45-year-old female who experienced frequent episodes of palpitations and dyspnea occurring immediately after swallowing solid food. She was noted to have atrial tachycardia with deglutition that was recorded on the 12-lead electrocardiogram. She underwent fluoroscopic esophagram that demonstrated atrial tachycardia as the barium passed through the distal esophagus and gastroesophageal junction. CONCLUSION: Swallowing induced arrhythmias occur rarely and can be confirmed by EKG obtained during deglutition. Gastroesophageal evaluation is required to rule out primary esophageal disorders. Treatment of such arrhythmias is required if symptoms are intractable and can include pharmacotherapy and radiofrequency ablation.

Endocardial versus epicardial left atrial appendage exclusion for stroke prevention in patients with atrial fibrillation: Midterm follow-up.

BACKGROUND: Left atrial appendage closure (LAAC) became an alternative method for stroke prevention in patients with non-valvular atrial fibrillation (AF) intolerant to long term oral anticoagulation therapy. This study aimed to compare endocardial (Amulet and LAmbere occluders) and epicardial (Lariat) LAAC techniques. METHODS: A retrospective, observational case-control study included 223 consecutive CHA2 DS2 -VAS score-matched patients with AF who underwent LAAC in two centers. RESULTS: There were 55 matched cases with the mean CHA2DS2-VASs score 4.4 ± 1.22 (p = 1). Overall follow-up was 308.2 patient-years. The Endocardial group patients were older and more often females with congestive heart failure and peripheral vascular disease. The epicardial group more frequently had a stroke/transient ischemic attack history. There were no differences in hypertension, diabetes mellitus, and indications for procedure between both groups. The mean HAS-BLED score was significantly higher in the endocardial group than in the epicardial group (4.3 ± 0.9 vs. 3.7 ± 1.3, p = .011). There were no differences in annual rates of thromboembolic events (2.6% vs 0.5%) and annual stroke (0.87% vs. 0%) between the endocardial and epicardial groups. CONCLUSION: Endocardial and Epicardial LAAC techniques show comparable implantation outcomes and safety profile and stroke prevention in patients with AF. Future randomized studies are needed to corroborate these initial results and assess long term mortality.

Transforming a pre-existing MRI environment into an interventional cardiac MRI suite.

AIMS: To illustrate the practical and technical challenges along with the safety aspects when performing MRI-guided electrophysiological procedures in a pre-existing diagnostic magnetic resonance imaging (MRI) environment. METHODS AND RESULTS: A dedicated, well-trained multidisciplinary interventional cardiac MRI team (iCMR team), consisting of electrophysiologists, imaging cardiologists, radiologists, anaesthesiologists, MRI physicists, electrophysiological (EP) and MRI technicians, biomedical engineers, and medical instrumentation technologists is a prerequisite for a safe and feasible implementation of CMR-guided electrophysiological procedures (iCMR) in a pre-existing MRI environment. A formal dry run "mock-up" to address the entire spectrum of technical, logistic, and safety issues was performed before obtaining final approval of the Board of Directors. With this process we showed feasibility of our workflow, safety protocol, and bailout procedures during iCMR outside the conventional EP lab. The practical aspects of performing iCMR procedures in a pre-existing MRI environment were addressed and solidified. Finally, the influence on neighbouring MRI scanners was evaluated, showing no interference. CONCLUSION: Transforming a pre-existing diagnostic MRI environment into an iCMR suite is feasible and safe. However, performing iCMR procedures outside the conventional fluoroscopic lab, poses challenges with technical, practical, and safety aspects that need to be addressed by a dedicated multi-disciplinary iCMR team.

QT prolongation and T-wave alternans during catheter ablation of atrial fibrillation: a case report.

We report a case of a 63-year-old woman who developed profound QT prolongation, T-wave alternans, and spontaneous ventricular fibrillation during catheter ablation of atrial fibrillation. A thorough search into the possible mechanisms identified the use of sevoflurane, an inhalational gas anesthetic as the culprit. The patient was converted to propofol anesthesia and her QT interval normalized promptly.