Leadless dual-chamber pacemaker met primary safety and performance end points at three months
By Elana Gotkine HealthDay Reporter
TUESDAY, May 30, 2023 (HealthDay News) — For patients with a conventional indication for dual-chamber pacing, a dual-chamber leadless pacemaker system consisting of two devices implanted percutaneously in the right atrium and the right ventricle safely provides atrial pacing and reliable atrioventricular synchrony, according to a study published online May 20 in the New England Journal of Medicine.
Reinoud E. Knops, M.D., Ph.D., from the Amsterdam University Medical Center, and colleagues conducted a prospective, multicenter, single-group study to examine the safety and performance of a dual-chamber leadless pacemaker system among patients with a conventional indication for dual-chamber pacing. Freedom from complications at 90 days was examined as the primary safety end point.
The researchers found that the implantation procedure was successful in 295 of 300 patients. Overall, 29 patients had 35 device- or procedure-related serious adverse events. The primary safety end point was met in 90.3 percent of patients, which exceeded the 78 percent performance goal. The first primary performance end point of a combination of adequate atrial capture threshold and sensing amplitude at three months was met in 90.2 percent of patients, exceeding the performance goal of 82.5 percent. None of the 21 patients with a P-wave amplitude of less than 1.0 mV required device revision for inadequate sensing. In 97.3 percent of the patients, at least 70 percent atrioventricular synchrony was achieved, exceeding the performance goal of 83 percent.
“The implantation procedure was successful in 295 patients (98.3 percent), and three-month safety and performance results exceeded the prespecified boundaries for success,” the authors write.
Several authors disclosed ties to biopharmaceutical and medical device companies, including Abbott Medical, which funded the study.
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