DENVER – The first patient tests of a new leadless pacemaker show that the device can deliver the same life-saving therapy as a traditional single-chamber pacemaker without potential lead-related complications. The findings are part of the LEADLESS trial and were released today at Heart Rhythm 2013, the Heart Rhythm Society’s 34th Annual Scientific Sessions. View the full abstract .
While conventional pacemakers are overall safe and effective, the device leads, or wires that are implanted into the heart, can cause complications such as fracture or infection. The new percutaneously-delivered leadless pacemaker is implanted directly into the heart, eliminating the need for leads. The LEADLESS trial is a prospective, non-randomized, single arm study that evaluated the safety of the device as well as right ventricular (RV) pacing function, battery longevity, rate response, implant success rate and procedure times.
“Leadless pacemakers are a promising new technology that could eliminate one of the biggest complication risks with these life-saving devices – the lead,” said lead author Vivek Reddy, MD, Professor of Cardiology, Mount Sinai School of Medicine, and Director of the Cardiac Arrhythmia Service at Mount Sinai Hospital. “Our initial experience indicates that the procedure is faster and minimally invasive compared to traditional implantation surgery, which may dramatically improve recovery times for patients.”
Leadless pacemakers were implanted in 33 patients with bradycardia indications for a VVI pacemaker. The device was successfully implanted in 97 percent of the patients through femoral venous access using a deflectable delivery catheter under X-ray guidance. The mean procedure time was 28 minutes and device performance was evaluated at 2 days, 2 weeks, 6 weeks and 3 months after surgery. The pacing threshold, R-wave amplitude and impedance were all comparable to that of a conventional pacemaker and the battery life is approximately 8-17 years depending on pacing needs.
The leadless cardiac pacemaker (Nanostim Inc., Sunnyvale, Calif.) is an entirely self-contained intra-cardiac device with a screw-in active fixation mechanism. After placing an 18F sheath in the femoral vein, the device is delivered to the right ventricle using a deflectable delivery catheter with an extendable sleeve to protect the fixation helix. Once positioned, the sleeve is retracted and the device is undocked from the delivery catheter while maintaining a tethered connection to permit device measurements and assess stability. If the position is suboptimal, the leadless pacemaker can be re-engaged, unscrewed and repositioned.
“Percutaneous In Vivo Placement of a Novel Intracardiac Leadless Pacemaker: Results from the First-In-Man Leadless Study” [Friday, May 10, 2013, 1:30 p.m. – 3:00 p.m. MDT, Four Seasons Ballroom1]
“Percutaneous In Vivo Placement of a Novel Leadless Cardiac Pacer: A First-In-Man Report” [Wednesday, May 8, 2013, 6:00 p.m. – 7:30 p.m. MDT, Exhibit Hall]
Heart Rhythm 2013 is the most comprehensive educational program for heart rhythm professionals, featuring more than 8,000 attendees, 250 educational sessions and more than 130 exhibitors showcasing innovative products and services. The Heart Rhythm Society’s Annual Scientific Sessions have become the must-attend event of the year, allowing the exchange of new vital ideas and information among colleagues from every corner of the globe.