Novel defibrillation lead beats safety, efficacy goals
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Key takeaways:
- A novel defibrillation lead beat safety and efficacy goals in a pivotal trial.
- The goal of physicians is for the lead to last a patient’s entire lifetime.
A novel lead for use in implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators exceeded the safety and efficacy thresholds in the LEADR trial, researchers reported at Heart Rhythm 2024.
The defibrillation lead (OmniaSecure, Medtronic) was evaluated in the pivotal LEADR trial of 675 patients with a de novo indication for an ICD or CRT-D for primary or secondary prevention (mean age, 62 years; 26% women). Patients with NYHA class IV HF were excluded. The results were simultaneously published in HeartRhythm.
“This lead was designed to meet the needs of letting us put the lead wherever we want in the heart and have increased reliability compared to what we’ve got now,” George H. Crossley, MD, director of the electrophysiology lab and cardiac research enterprise at Vanderbilt University Medical Center, who presented the findings, told Healio. “The leads we have now are put in with stylets ... so we have fewer choices with the current lead placement than we do with catheter-based lead placement, which enables us to put the lead wherever we think is the right place in the heart. The current defibrillator lead Medtronic uses has been around for over 20 years and has incredible longevity. But it’s a big-diameter lead and it has features that we know are unlikely to make it last a really long time. This lead is built on the platform of a pacemaker lead ... which has a phenomenal resistance to fracture and failure. It is built in exactly the same way, just with the wire brought to the outside instead of to the inside, with a bit more insulation because it is the shocking wire.”
Among the cohort, 657 patients had an attempted implant, and 97.9% of those were successful, with 99.5% of leads placed in the desired location, Crossley said during a presentation.
Performance goals met
The primary efficacy threshold, evaluated through a defibrillation testing protocol at implant, was achieved in 97.5% of patients, with a lower bound of the 95% credible interval of 91%, beating the performance goal of 88%, Crossley said.
The primary safety endpoint of freedom from lead-related major complications at 6 months and 12 months was achieved in 97.1% of patients, with a lower bound of the 95% credible interval of 95.2%, beating the performance goal of 90%, he said.
There were no deaths determined to be causally related to the lead, Crossley said, noting that three deaths were investigated, one of whom was in a patient with sepsis and an indwelling catheter, one of whom was unwitnessed and had no additional data and one of whom had Brugada syndrome but was found on autopsy to have multiple myeloma and systemic amyloidosis with endocardial scarring.
At a mean follow-up of 12.7 months, there were no cases of lead fracture and electrical performance was stable, he said.
He also said 11.8% of patients received appropriate therapy, the efficacy of antitachycardia pacing was 74.9% and the efficacy of ambulatory shock was 95%. At 12 months, the rates of inappropriate shock were 2.7% for patients with a single-chamber device and 2.8% for patients with a dual-chamber or CRT device, he said.
‘A lead for life’
“This lead functioned really well, and it is really an upsized pacemaker lead and not a downsized defibrillator lead,” Crossley told Healio. “When we have tried to ... shrink the elements of a defibrillator lead, we have run into problems. Instead, we upsized a pacemaker lead that has incredible performance, and can use that going forward. While this is not a promise that this is a lead for life, that is the goal for us [physicians]. We would love to have a reasonable expectation that when we put a lead into a patient, it is going to outlive them.”
The researchers also performed a modeling analysis to get a sense of long-term performance of the novel lead. It showed an encouraging 2-year survival rate, and work is ongoing to determine a 10-year survival rate, Crossley told Healio.
A trial evaluating the lead when it is placed in the conduction system has begun, he said.
The lead is not yet approved for commercial use in the United States.
Reference:
For more information:
George H. Crossley, MD, can be reached at george.crossley@vanderbilt.edu.
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Crossley GH, et al. Late-breaking clinical trials and science – CIEDs. Presented at: Heart Rhythm 2024; May 16-19, 2024; Boston.
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