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Leadless pacemakers confer fewer short-term, midterm complications
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Compared with transvenous pacemakers, leadless cardiac pacemakers were associated with lower rates of short-term and midterm complications, according to findings published in HeartRhythm.
Daniel J. Cantillon, MD, medical director of the Central Monitoring Unit and research director of the section of cardiac electrophysiology and pacing at Cleveland Clinic, and colleagues compared 718 patients (mean age, 76 years; 62% men) who received a leadless cardiac pacemaker (Nanostim, Abbott) in the LEADLESS II trial with 1,436 patients (mean age, 76 years; 63% men) matched via a propensity score who were implanted with a single-chamber transvenous pacemaker between April 2010 and March 2014. The leadless pacemaker is not yet approved for commercial use in the United States.
Reduction in complications
“One of the objectives of leadless cardiac pacemakers is to reduce or eliminate complications associated with traditional transvenous pacemakers,” Cantillon, a Cardiology Today Next Gen Innovator, said in an interview. “This study was the first of its kind to compare leadless pacemakers to traditional pacemakers to give us a sense of where the two stack up in terms of complications. We hope to one day have a [randomized] trial, but in the meantime, these are the best data that we have to suggest that leadless pacemakers can reduce complications.”
Outcomes of interest were short-term complications, defined as occurring within 1 month after implant, and midterm complications, defined as occurring between 1 and 18 months.
During the study period, the leadless pacemaker group experienced fewer complications than the transvenous pacemaker group (HR = 0.44; 95% CI, 0.32-0.6), which was true for both the short-term period (5.8% vs. 9.4%; P = .01) and midterm period (0.56% vs. 4.9%; P < .001), according to the researchers.
In the short term, compared with the transvenous group, the leadless group had more pericardial effusions (1.53% vs. 0.35%; P = .005); similar rates of vascular events (leadless, 1.11%; transvenous, 0.42%; P = .085), dislodgements (leadless, 0.97%; transvenous, 1.39%; P = .54) and generator complications (leadless, 0.7%; transvenous, 0.28%; P = .17); and less thoracic trauma (0% vs. 3.27%), Cantillon and colleagues wrote.
In both time frames, lead-related, pocket-related and infectious complications were observed in the transvenous group but not the leadless group, according to the researchers, who noted that infectious complications occurred in 4.74%, lead-related complications occurred in 2.59% and pocket-related complications occurred in 1.15% of the transvenous group.
Alternate modality
“The most important finding is that leadless pacemakers can do what they are designed to do, which is to eliminate the burden of lead- and pocket-related complications,” Cantillon told Cardiology Today. “These account for the majority of complications we see with transvenous devices. Leadless pacing is here to stay in terms of an alternate modality to traditional transvenous pacemakers.”
However, he noted, current leadless pacemakers can only be used in “patients who require single-chamber, ventricular-only backup pacing. That only accounts for 10% of the U.S. population requiring a pacemaker,” but technological advancements in progress may expand the eligible population. – by Erik Swain
For more information:
Daniel J. Cantillon, MD, can be reached at Heart & Vascular Institute, Cleveland Clinic, 9500 Euclid Ave. J2-2, Cleveland, OH 44195; email: cantild@ccf.org.
Disclosures: The study was funded by Abbott. Cantillon reports he is a consultant for Abbott and Boston Scientific.
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