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The world's first leadless pacemaker has now proven that it's on par with conventional pacemakers. Dr. Vivek Reddy, director of arrhythmia services at Mount Sinai Hospital in New York, reported his findings last week at the Heart Rhythm Society's 35th Annual Scientific Sessions in San Francisco, Calif.
The leadless pacemaker is put directly into the heart during a catheter-guided procedure using the femoral vein in the groin. The device almost looks like a tiny, metal silver tube and is smaller than a triple-A battery, which is 10 percent the size of a conventional pacemaker.
The LEADLESS study spanned one year and evaluated 32 patients with a slowed heartbeat who successfully received St. Jude Medical's Nanostim leadless pacemaker at one hospital in Prague and another in Amsterdam. Reddy and his fellow researchers evaluated the device's performance and patient outcomes through 12 months of follow-up.
They found that the leadless pacemaker's pacing thresholds and sensing was the same as those in conventional pacemakers. Furthermore, it did not result in any infections or failure to sense, pace or communicate with the pacemaker.
"This is the first time we've seen one-year follow-up data for this innovative, wireless cardiac pacing technology and our results show the leadless pacemaker is comparable to traditional pacemakers," Reddy said in a statement. "Our latest findings further support the promising performance and safety of this minimally-invasive, non-surgical pacing device."
With this new technology, the patient does not require a surgical pocket and it's not visible under their chest skin. There is no incision scar because it does not require surgery and there are no connector wires or leads so it doesn't interfere with the patient's daily activities.
It may also lead to less discomfort, infections and device complications and dysfunction. But Reddy said that more follow-up research on those patients, as well as additional ongoing larger trials, are needed to get more insight into the potential advantages, benefits and complication risks.
In February, Reddy implanted the first leadless pacemaker in the U.S. at Mount Sinai Hospital, which started the LEADLESS II trial. The new trial is going to further test the pacemaker for safety and efficacy on 670 patients at 50 centers across the U.S. and Canada.
Over 4 million people worldwide have a pacemaker and 700,000 new patients receive one every year. It's used to closely monitor the heart's electrical rhythms and if the heart is beating too slowly, it generates electrical stimulation therapy in order to regulate it.
St. Jude's leadless pacemaker is pending U.S. Food and Drug Administration approval.
