Late-breaking data show reliable performance of small-diameter defibrillation lead, the OmniaSecure.- Medtronic.

Late breaking results were presented at Heart Rhythm 2024 and simultaneously published in the journal Heart Rhythm).

Worldwide, the OmniaSecure defibrillation lead is investigational and not yet approved for sale or distribution.

Implantable cardioverter defibrillators (ICDs) are the gold standard for preventing sudden cardiac death. Yet transvenous defibrillator leads, which are thin wires connected to the ICD and threaded through the veins into the heart muscle, remain the weakest point of the system, given the harsh environment inside the human body where the lead must remain attached and yet flex with millions of heart contractions over a patient's lifetime. Existing defibrillation leads have a large diameter (7-8 French), which can contribute to venous occlusion or tricuspid valve complications. For patients where an extravascular defibrillator may not be appropriate, Medtronic engineers designed the OmniaSecure defibrillation lead based on the Medtronic SelectSecure Model 3830 pacing lead, which has offered safe and effective treatment to patients for more than 20 years. By beginning with this highly reliable pacing lead and building a larger lead suitable for defibrillation therapy, the Medtronic OmniaSecure lead is the world's smallest transvenous defibrillation lead (4.7 French, equivalent to the diameter of graphite in a wooden pencil.

LEADR Primary Results: Effectiveness : Defibrillation testing conducted at device implantation in 119 patients was successful in 97.5% of cases. The study exceeded the prespecified efficacy goal of 88%. LEADR Primary Results: Safety : At six months, 97.1% (Kaplan-Meier estimate) of 657 patients with an implant attempt were free from lead-related major complications such as hospitalization, lead fracture, system revision, or death. The study exceeded the prespecified safety performance goal of 90%. There were no lead-related major complications observed between six and 12 months (average follow up of 12.7±4.8 months).

The LEADR Pivotal trial is a prospective, multicenter, single-arm, non-randomized, global clinical study that assess the safety and effectiveness of the Medtronic OmniaSecure defibrillation lead when placed at traditional locations in the right ventricle to achieve defibrillation, sensing, pacing and cardioversion in patients at risk of sudden cardiac death. The study enrolled 675 patients at 45 sites in 17 countries in North America, Europe, Asia, and Australia.

Secondary and Ancillary Results: Reliability :The lead demonstrated reliable performance with zero (0) study lead fractures through an average follow up of 12.7±4.8 months. Medtronic developed and validated an in-vitro model that accurately predicts lead reliability out to 10 years, and then applied that model within the study to predict a fracture-free survival of 99.9% at two years for the investigational OmniaSecure lead. The lead also demonstrated a 97.9% implant success rate, and stable electricals (R-wave, pacing capture threshold, and pacing impedance) through 12 months. Nearly 12% of patients in the study received appropriate therapy (shock, or anti-tachycardia pacing [ATP]) for dangerously fast ventricular arrhythmias by 14.0±5.0 months. ATP terminated 74.9% of episodes, preventing a shock in 49 patients.

Medtronic plans to present additional reliability model results from the LEADR study in the coming months.

In addition to the LEADR results presented at Heart Rhythm 2024, Medtronic recently initiated the LEADR LBBAP study (Lead Evaluation for Defibrillation and Reliability in Left Bundle Branch Area Pacing), which is assessing the safety and efficacy of the investigational OmniaSecure defibrillation lead when placed at the Left Bundle Branch Area in patients eligible for an ICD or Left Bundle Branch-Optimized Cardiac Resynchronization Therapy (LOT-CRT)

Placing the defibrillation lead in the left bundle branch area is being evaluated as an alternative to right ventricular stimulation for sensing, pacing, cardioversion and defibrillation. First implants were recently conducted by Muhammad Afzal, M.D., MBBS, principal investigator at The Ohio State Medical Center Wexner Medical Center, and John Zakaib, M.D., principal investigator at Minneapolis Heart Institute Foundation.

"The positive results from the LEADR Pivotal trial are a significant advancement for patients at risk of sudden cardiac death who rely on ICDs to deliver life-saving therapy in the event of a dangerous heart rhythm," said George H. Crossley, M.D., Director of the Electrophysiology Lab and Cardiac Research Enterprise, Vanderbilt University Medical Center, Nashville, Tenn., and LEADR Pivotal trial steering committee chair. "Patients with defibrillators are living longer today, and we need to strive for reliable therapy for the lifetime of the patient. This innovative, low-profile defibrillation lead leverages a highly reliable pacing lead design to help achieve this goal, and the unique catheter-based method of implantation helps the physician place the lead in the optimal position for the patient."

See- "Global LEADR pivotal trial results; George H. Crossley, MD, Prashanthan Sanders, MBBS, PhD, Bert Hansky, MD, Amy E. Thompson, MS, Pamela Mason, MD. for theLead EvaluAtion for Defibrillation and Reliability Trial Investigators Open Access.Published: May 17, 2024DOI:https://doi.org/10.1016/j.hrthm.2024.04.067.