Data collected from the EFFORTLESS study-the largest post-market registry for the Subcutaneous Implantable Defibrillator (S-ICD) system (Boston Scientific)-were presented as a late-breaking clinical trial at the 37th Annual Scientific Sessions of the Heart Rhythm Society (HRS) in San Francisco, USA.
The results confirmed long-term safety and efficacy for the device, which is designed to treat sudden cardiac arrest without leads touching the heart and vasculature.
The multi-national registry included 985 patients who were observed for up to five years post-implant. Primary results demonstrate low complication rates associated with the S-ICD device, with a complication-free rate of 99.7% at 30 days, and 98% at 360 days post-procedure.
The efficacy of the S-ICD system was validated in this analysis, according to Boston Scientific, with a 97.4% conversion rate of discrete arrhythmias that can lead to sudden death.
Follow-up at an average 3.1 years revealed that few S-ICDs were removed due to a change of patient indication. Only five (0.5%) S-ICDs were removed in order to implant a patient with a defibrillator with anti-tachycardia pacing (ATP) capabilities, and only one (0.1%) was removed to allow for a device with bradycardia pacing capabilities.
Kenneth Stein, chief medical officer, Rhythm Management, Boston Scientific, says, “We are developing the Empower modular pacing system, which includes our leadless pacemaker and the Emblem S-ICD system. Whether patients with life-threatening arrhythmias subsequently develop a need for pacing or vice versa, we are designing this modular solution to enable electrophysiologists to treat patients with the therapies they need, when they need them.”