A leadless pacemaker wirelessly paired with a subcutaneous implantable cardioverter-defibrillator successfully communicated in 98.8% of cases and met all performance goals, according to a recent study.
The MODULAR ATP study evaluated the safety and efficacy of a leadless pacemaker wirelessly communicating with a subcutaneous implantable cardioverter-defibrillator (ICD) in 293 patients at risk for sudden cardiac death due to ventricular arrhythmias. The primary endpoints were freedom from major leadless pacemaker–related complications and successful device communication.
At six months, 97.5% of patients were free from major pacemaker-related complications, meeting or surpassing the prespecified performance goal of 86%. Wireless communication between the pacemaker and ICD was successful in 98.8% of tests, exceeding the goal of 88%. 97.4% of patients had pacing thresholds of 2.0 V or lower at a 0.4-msec pulse width, surpassing the performance goal of 80%. The mean pacing threshold was 0.56 V at six months.
Antitachycardia pacing successfully terminated 61.3% of arrhythmia episodes. There were no instances of failed therapy delivery due to communication issues. Of the 162 patients in the 6-month cohort, eight (4.9%) died, with no deaths attributable to arrhythmias or the implantation procedure. The overall incidence of complications related to the system was 8.6%.
This study, published in The New England Journal of Medicine, demonstrated the modular pacing–defibrillator system met or exceeded its prespecified safety and performance goals. The system’s capability to provide antitachycardia pacing without the use of transvenous leads addresses some limitations of subcutaneous ICDs.
Full disclosures can be found in the published study.