Leadless pacing-defibrillator system safe, effective at 6 months: MODULAR ATP
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Key takeaways:
- A leadless pacing-defibrillator system was safe and met its performance goals at 6 months.
- The system is the world’s first to provide antitachycardia pacing for patients with a subcutaneous ICD.
A system including a leadless pacemaker and a subcutaneous implantable cardioverter defibrillator that wirelessly communicate with each other was safe in patients at risk for fatal ventricular arrhythmias at 6 months, researchers reported.
The interim 6-month results of the MODULAR ATP trial of the leadless pacing-defibrillator system (mCRM system, Boston Scientific) were presented at Heart Rhythm 2024 and simultaneously published in The New England Journal of Medicine.
“The subcutaneous ICD [is] an alternative to transvenous ICDs for protection against sudden cardiac death,” Reinoud E. Knops, MD, PhD, cardiac electrophysiologist and professor of cardiology at Amsterdam University Medical Center, said during a presentation. “Both the PRAETORIAN and ATLAS trials have shown less lead-related and major complications with the subcutaneous ICD. However, due to its extra-thoracic position, the subcutaneous ICD has no bradycardia or antitachycardia pacing (ATP) capabilities, and the need for ATP is a contraindication for S-ICDs in the ICD guidelines.”
The mCRM system consists of a subcutaneous ICD (Emblem S-ICD, Boston Scientific) wirelessly communicating with a leadless pacemaker (Empower, Boston Scientific), Knops said during the presentation. “Any patient with an already existing S-ICD can be upgraded to have an mCRM system when the leadless pacemaker is commercially available. The stand-alone pacemaker delivers ATP after receiving a request from the S-ICD.” The leadless pacemaker is not yet available for commercial use in the United States, but the subcutaneous ICD is.
Knops presented interim results of the first 162 patients (mean age, 60 years; 17% women; mean left ventricular ejection fraction, 33.1%) who were implanted with the system.
The primary endpoint of freedom from leadless pacemaker-related major complications at 6 months occurred in 97.5% of patients, with a one-sided lower confidence limit of 92.5%, beating the performance goal of 86%, Knops said during the presentation, noting that two patients had myocardial perforation with tamponade, one had an adverse reaction of vasovagal syncope and one had the pacemaker inadvertently implanted in the LV.
There were four deaths at 6 months, none of which were related to the device, the procedure or arrhythmias, and no patients became pacemaker-dependent, he said.
The rate of wireless communication success was 98.8%, with a one-sided lower confidence limit of 97%, beating the performance goal of 88%, and 97.4% of patients had pacing thresholds of 2 V or less at 0.4 millisecond pulse width, with a one-sided lower confidence limit of 93.4%, beating the performance goal of 80%, according to the researchers.
The percentage of episodes of arrhythmia successfully terminated by antitachycardia pacing was 61.3%, and no patients had failure of therapy due to device miscommunication, reported pain or discomfort during device communication or therapy or requested that the leadless pacemaker therapy be inactivated, Knops said.
“This trial prospectively demonstrated safety and effectiveness of the first modular communicative leadless pacemaker-defibrillator system,” Knops said during the presentation. “These data will make S-ICD therapy available for a larger patient population by adding antitachycardia pacing and bradycardia pacing with a leadless pacemaker.”
Reference:
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Knops RE, et al. Late-breaking clinical trials and science – innovation. Presented at: Heart Rhythm 2024; May 16-19, 2024; Boston.
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