BOSTON — An investigative small-diameter defibrillation lead for implantable cardioverter-defibrillators has exceeded its security and efficacy expectations in a pivotal medical trial.
The LEADR trial implanted OmniaSecure leads in 643 sufferers. It discovered that just about 98% of the experimental leads had been efficiently implanted, and 99.5% had been positioned exactly within the desired location in the proper ventricle.
Round 97% of sufferers had no lead-related main problems within the 12 months of the examine, and not one of the leads fractured throughout the examine interval, George H. Crossley III, MD, of Vanderbilt College Medical Heart in Nashville, Tennessee, reported on the Coronary heart Rhythm Society (HRS) 2024 assembly. The outcomes had been revealed concurrently within the journal Coronary heart Rhythm.
“The massive level right here is that it is a new strategy to creating a brand new defibrillator lead by taking a very strong pacemaker lead and altering the insulation,” Crossley mentioned in an interview. These modifications make the catheter extra versatile so the operator can ship the lead quicker and with extra exact placement, he mentioned.
The OmniaSecure lead, made by medical system maker Medtronic, is appropriate with many commercially out there catheters. It is based mostly on Medtronic’s SelectSecure Mannequin 3830 pacing lead, which has been in use since 2003. Each leads have a cable-based tip conductor that reduces the lead diameter whereas sustaining flexibility and tensile power, mentioned Crossley.
OmniaSecure has a thickened layer of polyurethane insulation on the high-voltage conductor and a bigger 4.7-French lead than the SelectSecure’s 4.1-French lead. “So that is actually an upsized 3830,” Crossley mentioned.
Trial Outcomes
Along with profitable and correct placements, “the noticed defibrillation efficacy at implant was 97.5%, so the first efficacy threshold was exceeded,” mentioned Crossley.
Antitachycardia pacing efficacy was excessive, Crossley famous, at 74.9% (359 of 479 episodes), whereas the ambulatory shock efficacy was 95% (95 of 100 episodes).
“The inappropriate shock fee at 12 months was low,” he added. The one-chamber fee was 2.7%, and the dual-chamber/cardiac resynchronization remedy fee was 2.8%.
“The opposite and probably probably the most distinctive a part of this examine was the engineering evaluation of lead failure, which was based mostly upon the strategies that had been developed in response to the Fidelis lead failure,” Crossley mentioned, referring to the Dash Fidelis leads that had been pulled from the market in 2007 after stories surfaced of excessive failure charges.
OmniaSecure was developed and validated utilizing leads with recognized medical efficiency, with Fidelis as a poorly performing management and Quattro as a well-performing management, he mentioned. “These knowledge had been then used to drive the bench-top testing,” he mentioned, which indicated a excessive chance of success with the OmniaSecure, which has now been borne out within the medical trial.
The Case for Vigilance
Robert Hauser, MD, of the Minneapolis Coronary heart Institute Basis, Minneapolis, mentioned the OmniaSecure is a “substantial enchancment” over the SelectSecure lead. “The lead has large potential for versatility; not simply the defibrillator lead that you simply put in the proper ventricle, however it’s a defibrillator lead that you are able to do different issues with,” he mentioned.
However he additionally raised one potential subject: The polyurethane insulation will exhibit some environmental stress cracking over time. The larger thickness on its sleeve vs the SelectSecure, nevertheless, ought to assist keep away from any potential points. “However you [should] preserve your eyes open,” to the chance, Hauser mentioned, by doing routine fibrillation threshold testing.
“Whereas some implanting physicians consider that fibrillation threshold testing is just not crucial at implant, many people consider it ought to be achieved routinely no matter lead mannequin,” he mentioned. “It definitely ought to be achieved throughout OmniaSecure implantation.”
