LEADR LBBAP: Sternum Lead Implantation Safe for CRT-D or ICD Patients

Final results from the LEADR LBBAP study have indicated the safety and efficacy of implanting leads from below the sternum in patients receiving a cardiac resynchronization therapy defibrillator (CRT-D) or implantable cardioverter-defibrillator (ICD).1

These data were presented at the Heart Rhythm Society 2026 Showcase in Chicago, Illinois, as a late-breaking trial by Pugazhendhi Vijayaraman, MD, director of cardiology at Geisinger Wilkes-Barre. Following the conference, the editorial team at HCPLive spoke with Vijayaraman to learn more about the study and its implications for patients.1

“Where I see value with the lead is in one of the challenges that we’ve had – while we’ve found that left frontal branch area pacing works very well in many patients who need CRT and with outcomes comparable to traditional BI ventricular pacing, this involved placing 2 leads,” Vijayaraman told HCPLive. “That presence of 2 leads in the right ventricle is a new problem. This allows us to convert those 2 leads into 1 lead.”

The LEADR LBBAP study was a companion to the LEADR study, which aimed to assess the safety and efficacy of the Next Generation ICD lead. LEADR LBBAP involved implanting the lead in the left bundle branch area pacing location in patients with ICD and LOT-CRT. Collectively, both studies were conducted across 55 locations worldwide.2

Patients were eligible for inclusion in LEADR LBBAP if they met the current local clinical practice guidelines for ICD implantation or CRT-D system and will undergo either de novo Medtronic ICD system implant or de novo Medtronic CRT-D system implant, among other criteria. Patients were excluded if they had a contraindication for screw-in active fixation transvenous lead placement, an existing pacemaker, pre-existing or suspected pneumothorax, severe aortic stenosis, or unstable angina, among other criteria.2

The primary endpoints for LEADR LBBAP were the percentage of subjects successfully defibrillated at implant with the Next Generation ICD lead and lead-related major complication rates at 3 months.2

A total of 316 patients had a LBBAP implant attempt – of these patients, 29% were female, and the average age was 64.9 +/- 12.2 years. Freedom from major study lead-related major complications at 6 and 12 months were 97.7% and 96.8%, respectively (n = 8 complications). Additionally, throughout follow-up (9.9 +/- 4 months), the most common major complication was lead dislodgement (n = 4). For the 143 patients receiving LOT-CRT, Vijayaraman and colleagues noted a significant reduction in QRSd between baseline and LOT-CRT (170 +/- 29.8ms to 145.3 +/- 22.1ms; P <.001).1

Left ventricular ejection fraction improved from baseline to 6 months by a factor of 8.5% (P <.001), while quality of life improved from baseline to 6 months (KCCQ improvement, 14.2 +/- 20.1 points; P <.001; CCS: 85% improved or stabilized).1

“The benefits of this approach have to outweigh any risks in the long term, which is why we need a comparison study,” Vijayaraman said. “Historic biventricular pacing studies have provided a 70% clinical and echocardiographic response rate. Our goal is to improve that response rate closer to 90% or higher, and that’s feasible when we combine these approaches – we can get the best of both worlds.”

Editors’ Note: Vijayaraman reports disclosures with Abbott Laboratories, Boston Scientific, Biotronik, and Medtronic.

References

1. Vijayaraman P, Mason PK, Liu X, et al. EN-527958-005 longer-term safety and lot-CRT functional outcomes using a novel, small-diameter defibrillation lead: Final results of the LEADR LBBAP clinical trial. Heart Rhythm. 2026;23(4). doi:10.1016/j.hrthm.2026.03.1535

2. Medtronic Cardiac Rhythm and Heart Failure. Lead EvaluAtion for Defibrillation and Reliability (LEADR) / Lead Evaluation for Defibrillation and Reliability in Left Bundle Branch Area Pacing (LEADR LBBAP). ClinicalTrials.gov Identifier: NCT04863664. Updated December 9, 2025. Accessed May 13, 2026. https://clinicaltrials.gov/study/NCT04863664