Leadless pacemakers have been found to reduce the number of short-term and midterm complications compared to conventional device designs, a new study has shown.
Pacemakers
Research from the Cleveland Clinic shows that patients are less likely to experience complications if they have pacemakers that don’t use wires to connect the device to the heart.
Conventional pacemaker models are connected to the heart via a wire that stretches from the shoulder vein to the heart. According to previous research, these wires are the most common source of complications for patients.
Leadless pacemakers, which don’t need wires, are small, self-contained devices which are placed directly into the heart using a catheter that is carried from the leg to the heart via the thigh’s femoral vein.
Cleveland Clinic’s multicenter study compared short and mid-term complications between 718 patients receiving the Nanostim leadless pacemakers and 1,436 patients with conventional pacemakers.
The study found that at one month and up to 18 months, patients receiving the leadless pacemaker had fewer complications overall. The leadless pacemakers were found to eliminate lead and pocket complications, including infections.
In regard to rates of vascular complications, electrode dislodgement and generator complications, there were no significant differences between the two groups. The study did find however that those receiving leadless pacemakers had an increased risk of developing bleeding between the heart and the sac that surrounds it.
More than one million pacemakers are implanted annually worldwide, providing electrical stimulation to regulate a patient’s heartbeat. Conventional models are surgically placed under the skin of the chest, and connected to the heart via a wire that stretches from the shoulder vein to the heart.
The first leadless pacemaker was introduced in 2014 and approved by the U.S. Food & Drug Administration (FDA) two years later.
Lead author Dr. Daniel Cantillon, research director for Cardiac Electrophysiology and Pacing at Cleveland Clinic, said: “The data from this study is encouraging, and we expect complications from leadless pacemakers to continue to decline as the technology improves and physicians gain experience implanting these devices.
“While this research shows benefit for leadless pacing, we must keep in mind that the field is still too young to compare the long-term results of this technology, the implications of which will not be fully understood for at least another decade.”
The findings of the research appeared in the journal Heart Rhythm.