Novel Small-Diameter Defibrillation Lead safe, effective and reliable Confirms Global LEADR Pivotal Trial
USA: In a significant breakthrough for cardiac care, the Global LEADR pivotal trial has unveiled promising results regarding the safety, efficacy, and reliability of a groundbreaking small-diameter defibrillation lead. The study, conducted across multiple international sites, marks a significant advancement in cardiac device technology and offers new hope for patients with heart rhythm disorders.
The trial published in Heart Rhythm showed that a small-diameter, defibrillation lead that can be delivered through existing commercially available catheters for targeted placement is safe and durable, with no incidence of fractures in 1 year.
"The OmniaSecure lead exceeded prespecified primary endpoint performance goals for efficacy and safety, showing high defibrillation success and a low occurrence of lead-related major complications with zero lead fractures," the study stated. The OmniaSecure defibrillation lead is a small-diameter, novel, catheter-delivered lead designed for targeted placement as per the established SelectSecure SureScan MRI Model 3830 lumenless pacing lead platform.
Implantable cardioverter-defibrillators last longer, and there is a growing interest in reliable leads with targeted lead placement. Considering this, Pamela K. Mason, University of Virginia Medical Center, Charlottesville, Virginia, and colleagues assessed the safety and efficacy of the OmniaSecure defibrillation lead.
The worldwide LEADR pivotal clinical trial was conducted at 45 global sites and comprised 675 patients (mean age 62; 26% female) with an indication for de novo implantation of a defibrillator or a cardiac resynchronization therapy defibrillator (CRT-D). The mean LVEF was 35.3%, and 26% of patients had atrial fibrillation.
The primary efficacy endpoint was successful defibrillation at implantation per protocol. The primary safety endpoint was freedom from study lead–related major complications at six months. The primary safety and efficacy objectives were met if the lower bound of the 2-sided 95% credible interval was >88% and >90%, respectively.
The researchers reported the following findings:
· 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 12.7.
The findings showed that the unique design and small diameter of the OmniaSecure lead have the potential to offer significant clinical benefits for physicians and patients, such as comprehensive reliability, low complication rate, and ability to position the lead in the physician’s desired RV location, while exceeding or maintaining performance of historical larger diameter, stylet-delivered transvenous defibrillation leads.
Reference:
Crossley GH, Sanders P, Hansky B, De Filippo P, Shah MJ, Shoda M, Khelae SK, Richardson T, Philippon F, Zakaib JS, Tse HF, Sholevar DP, Stellbrink C, Pathak RK, Milašinović G, Chinitz JS, Tsang B, West MB, Ramza BM, Han X, Bozorgnia B, Carta R, Geelen T, Himes A, Platner M, Thompson AE, Mason P; Lead EvaluAtion for Defibrillation and Reliability Trial Investigators. Global LEADR pivotal trial results. Heart Rhythm. 2024 May 7:S1547-5271(24)02395-6. doi: 10.1016/j.hrthm.2024.04.067. Epub ahead of print. PMID: 38762820.
