Permanent Leadless Cardiac Pacing Device Safe, Effective
(HealthDay News) — A completely self-contained, single-chamber leadless cardiac pacemaker seems to be safe and feasible, according to a small study published online March 24 in Circulation.
Vivek Y. Reddy, MD, from the Mount Sinai School of Medicine in New York City, and colleagues tested the safety and clinical performance of a novel, completely self-contained leadless cardiac pacemaker in 33 patients (mean age, 77 years; 67% male). Freedom from complications at 90 days was the primary safety end point.
The researchers found that, among this cohort (with a primary indication for cardiac pacing due to permanent atrial fibrillation with atrioventricular block [67%]), the implant success rate was 97%. During the procedure, five patients required the use of more than one leadless cardiac pacemaker. Death (from stroke) occurred in one patient who developed right ventricular perforation and cardiac tamponade during the implant procedure. The complication-free rate was 94% overall. The measures of pacing performance (sensing, impedance, and pacing threshold) either improved or were stable within the accepted range after three months of follow-up.
"The absence of a transvenous lead and subcutaneous pulse generator could represent a paradigm shift in cardiac pacing," the authors write.
Several authors disclosed financial ties to Nanostim, which funded the study and manufactures the leadless cardiac pacemaker used in the study.