This article is more than 5 years old. Information may no longer be current.
Leadless pacemaker confers low complication rate at 12 months
At 12 months, complication rates for a real-world population implanted with a transcatheter leadless pacemaker were lower than for those implanted with a transvenous pacemaker, researchers reported.
The leadless pacemaker (Micra, Medtronic) also had similar performance in the real-world registry as in a randomized controlled trial, according to the researchers.
As Cardiology Today previously reported, the device was associated with few complications at 30 days in the Micra Post-Approval Registry. Mikhael F. El-Chami, MD, FHRS, director of electrophysiology at Emory Midtown and associate professor of medicine at Emory University School of Medicine, and colleagues reported the 12-month results in HeartRhythm.
The researchers analyzed 12-month results from 1,817 patients from the Micra post-approval registry study (mean age, 76 years; 61% men) and compared them with 726 patients from the Micra investigational device exemption study (59% men) and 2,667 patients implanted with transvenous pacemakers (61% men).
The primary outcome was system- or procedure-related major complications at 12 months.
The leadless pacemaker was successfully implanted in 99.1% of patients in the registry, according to the researchers.
At 12 months, the major complication rate in the registry was 2.7% (95% CI, 2-3.7), which was 63% lower than that seen in the transvenous pacemaker cohort at 12 months (HR = 0.37; 95% CI, 0.27-0.52), El-Chami and colleagues wrote.
There was a trend toward fewer major complications in the registry cohort vs. the IDE cohort (HR = 0.71; 95% CI, 0.44-1.1), driven by lower incidence of pericardial effusion, according to the researchers.
The registry cohort also had lower rates of hospitalization and system revision than the transvenous pacemaker cohort at 12 months (P < .0001 for both).
Three patients in the registry had infections, but none required removal of the device, and there were no cases of battery or telemetry issues, El-Chami and colleagues wrote.
“This low rate of infection may be related to the absence of a subcutaneous pocket and hence a lower likelihood of bacterial translocation into the pacemaker site, in addition to the small surface area of leadless pacemakers relative to transvenous leads, and their tendency for encapsulation, which could make bacterial adherence to the device less likely,” El-Chami and colleagues wrote. “Given the absence of infections requiring device removal across all leadless pacing data sets, more work to understand the clinical mechanisms for this observation is warranted.”
Pacing thresholds were consistent over time in the registry population, according to the researchers. – by Erik Swain
Disclosures: The study was funded by Medtronic. El-Chami reports he received compensation for services from Boston Scientific and Medtronic. Please see the study for all other authors’ relevant financial disclosures.