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LEADLESS published: Lead-free cardiac pacemaker shows good safety, performance at 1 year
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Confirming a previous report, a leadless cardiac pacemaker system demonstrated stable performance and good safety results at 1 year, according to data from the LEADLESS trial.
The leadless cardiac pacemaker (Nanostim, St. Jude Medical) was developed to overcome complications associated with transvenous leads in traditional pacemakers. The prospective, nonrandomized LEADLESS trial was designed to test the safety and feasibility of the device.
The 1-year results were presented at the Heart Rhythm Society Annual Scientific Sessions in May 2014 and have now been published in the Journal of the American College of Cardiology.
The researchers assessed 6-month and 1-year follow-up data for 31 of the 33 patients implanted with the leadless pacemaker between December 2012 and April 2013 (mean age, 76 years; 65% men). At implantation, one patient had cardiac tamponade and died due to massive cerebral artery ischemic infarct, and another required an implantable cardioverter defibrillator and underwent successful retrieval of the leadless pacemaker 7 days after implantation.
There were no pacemaker-related adverse events reported between 3 months and 1 year, the researchers wrote.
Mean pacing threshold at a 0.4-ms pulse width was 0.4 V at 6 months and 0.43 V at 1 year, R-wave amplitude was 10.6 mV at 6 months and 10.3 mV at 1 year, and impedance was 625 ohms at 6 months and 627 ohms at 1 year, according to the researchers.
At 1 year, the rate response sector was activated in 61% of patients, all of whom had an adequate rate response, the researchers found.
Michael R. Gold
In a related editorial, Michael R. Gold, MD, PhD, noted that the results were “outstanding” but that they have limitations, including a small sample size and that the implantations were performed at a small number of experienced European centers.
Gold, from the division of cardiology at Medical University of South Carolina, Charleston, wrote that “there are a number of questions that remain to be answered about this new technology. Will the device continue to perform at a high level in the long term and match the reliability of current pacemaker pulse generators? Is this device retrievable in the long term, and how are patients managed when systemic infection develops or the device reaches elective replacement? … Will there be any long-term thrombogenic complications associated with an indwelling right ventricular pacemaker?”
He concluded that “these devices should become the future of pacing in many types of devices rather than persist as a niche to compete in the single-chamber pacemaker market.” – by Erik Swain
Disclosures: The study was funded by Nanostim Inc., now owned by St. Jude Medical. The researchers report financial ties with Atricure, Biosense Webster, Biotronik, Boston Scientific, Daiichi Sankyo, Medtronic, Nanostim, Servier, Sorin and St. Jude Medical. Gold reports receiving consulting fees from and performing clinical trials with Boston Scientific, Medtronic and St. Jude Medical.
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