Global LEADR pivotal trial results.

BACKGROUND: Implantable cardioverter-defibrillators last longer, and interest in reliable leads with targeted lead placement is growing. The OmniaSecure™ defibrillation lead is a novel small-diameter, catheter-delivered lead designed for targeted placement, based on the established SelectSecure SureScan MRI Model 3830 lumenless pacing lead platform. OBJECTIVE: This trial assessed safety and efficacy of the OmniaSecure defibrillation lead. METHODS: The worldwide LEADR pivotal clinical trial enrolled patients indicated for de novo implantation of a primary or secondary prevention implantable cardioverter-defibrillator/cardiac resynchronization therapy defibrillator, all of whom received the study lead. The primary efficacy end point was successful defibrillation at implantation per protocol. The primary safety end point was freedom from study lead-related major complications at 6 months. The primary efficacy and safety objectives were met if the lower bound of the 2-sided 95% credible interval was >88% and >90%, respectively. RESULTS: In total, 643 patients successfully received the study lead, and 505 patients have completed 12-month follow-up. The lead was placed in the desired right ventricular location in 99.5% of patients. Defibrillation testing at implantation was completed in 119 patients, with success in 97.5%. The Kaplan-Meier estimated freedom from study lead-related major complications was 97.1% at 6 and 12 months. The trial exceeded the primary efficacy and safety objective thresholds. There were zero study lead fractures and electrical performance was stable throughout the mean follow-up of 12.7 ± 4.8 months (mean ± SD). CONCLUSION: The OmniaSecure lead exceeded prespecified primary end point performance goals for safety and efficacy, demonstrating high defibrillation success and a low occurrence of lead-related major complications with zero lead fractures.

Quinine and the ABCs of Long QT: A Patient's Misfortune with Arthritis, (Alcoholic) Beverages, and Cramps.

A 91-year-old woman presented to the emergency department by ambulance after her family found her minimally responsive. Telemetry monitoring demonstrated episodes of non-sustained polymorphic ventricular tachycardia (PMVT) associated with significantly prolonged repolarization. Her medical history revealed that she was taking quinine or a derivative in three different forms: hydroxychloroquine, quinine sulfate (for leg cramps), and her gin mixed with tonic water (containing quinine). The present case is illustrative of classic etiologies and findings of acquired long QT syndrome, and serves as an important reminder for providers to take a complete medication history, including use of duplicative and alternative medicines and type of alcohol consumption.

Malignant conversion of benign right ventricular outflow track ventricular tachycardia 18 years post-ablation.

This case report describes the rare phenomenon of malignant conversion of benign right ventricular outflow tract ventricular tachycardia into idiopathic ventricular fibrillation 18 years after successful ablation, in the absence of any type of heart disease. We review the current literature looking at predictors for this event, with the conclusion that there are no reliable risk predictors available. Until clear guidelines exist, we suggest patients be informed and monitored for the possibility of "malignant conversion" following ablation for benign idiopathic outflow tract ventricular tachycardia.

Late-onset advanced heart block due to vagal nerve stimulation.

Vagal nerve stimulation (VNS) is widely accepted as an effective and safe therapy for refractory seizure disorders. Significant cardiac complications, such as complete heart block or symptomatic bradycardia, are extremely rare. We present a case report of a 40-year-old man with drug-resistant epilepsy, treated with VNS, who developed the late-onset (12 months after implant), stimulation-related, symptomatic advanced heart block that was initially misinterpreted for a new type of seizure. The patient was otherwise free from other stimulation-related side effects. To our knowledge, this is the first case report of late-onset advanced heart block due to VNS.

Prominent crista terminalis appearing as a right atrial mass on transthoracic echocardiogram.

The crista terminalis is a fibromuscular ridge formed by the junction of the sinus venosus and primitive right atrium. In these case reports, transthoracic echocardiography suggested the presence of a right atrial mass. However, subsequent transesophageal echocardiography revealed that the "right atrial mass" was actually a prominent crista terminalis. An understanding of the anatomy and the echocardiographic appearance of a prominent crista terminalis will minimize the misdiagnosis of this structure.