Data from the global Leadless II IDE study evaluating the Aveir (Abbott) leadless pacemaker in patients with certain abnormal heart rhythms show that the device met its prespecified primary safety and efficacy endpoints .
The findings were presented today in a late-breaking session at the annual Scientific Sessions of the Asia Pacific Heart Rhythm Society (APHRS 2021; 11 – 14 November; Suzhou, China and virtual) and simultaneously published in the Journal of the American College of Cardiology: Clinical Electrophysiology. The data from the study has also been submitted to the US Food & Drug Administration (FDA) as the Aveir leadless pacemaker is evaluated for US approval.
Leadless pacemakers are implanted directly into the heart’s right ventricle via a minimally invasive procedure, requiring no cardiac leads to deliver therapy.
“The new Aveir pacing system holds the potential to help us advance treatment for patients who need a pacemaker but where physicians are concerned about more invasive surgery or in circumstances where we believe a patient’s therapy needs may change in the future and where retrievability will be a critical device feature,” said Vivek Y. Reddy, director of cardiac arrhythmia services, Mount Sinai Hospital, New York, USA.
Under the Leadless II trial design, primary safety and efficacy endpoints were analysed in the 200 patients enrolled in 43 centres in the USA, Canada and Europe. Patients were followed for six weeks.
Results of the study showed successful implant of the Aveir leadless pacemaker in 98% of patients, whilst also finding that, at six weeks post-implant, 96% of patients met the safety endpoint of no serious adverse device effects and 95.9% achieved the efficacy endpoint of acceptable therapy delivered to the patient (known as therapeutic pacing threshold and sensing amplitude).
Additionally, physicians were able to accurately position the device either the first time or with a single repositioning in 96% of clinical cases.
“As we developed the Aveir leadless pacemaker platform, our fundamental guiding principle was to design a device with extended battery life that could be retrievable, expandable to incorporate future innovation and provide improved patient outcomes with a minimally-invasive implant procedure,” said Randel Woodgrift, senior vice president, Cardiac Rhythm Management, Abbott. “The results of the Leadless II study are a strong indicator that once the device is approved, the Aveir system can help physicians manage the care of patients with certain abnormal heart rhythms.”
The Leadless II IDE study is a prospective, non-randomised, multicentre study designed to evaluate the clinical safety and efficacy of the Aveir leadless pacemaker in patients who were indicated for a VVI(R)—or ventricular demand pacing—pacemaker, which stimulates the heart only if the heart rate falls below a set level.
For the primary endpoint analyses, all patients were followed for six weeks post-implant to evaluate potentially serious adverse device effects. During this time, efficacy was measured as acceptable pacing capture threshold (≤2V at 0.4msec) and sensing amplitude (R wave ≥5mV, or a value equal to or greater than the value at implantation).