Leadless permanent pacemaker implant shows favorable safety at 5 years
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Key takeaways:
- Long-term real-world data showed favorable performance of a leadless permanent pacemaker implant.
- The 5-year rates of major complications and need for system revision were low, with no removals for infection.
The 5-year rates of major complications and need for system revision were very low for patients receiving a transcatheter leadless pacemaker implant, according to real-world data published in the European Heart Journal.
“This was the first multicenter registry report of long-term follow up of a leadless pacemaker. It showed low complication rate and low revision rate — less than 5% — through 5 years of follow-up,” Mikhael F. El-Chami, MD, associate professor and medical director of cardiac electrophysiology at Emory University Hospital Midtown, told Healio. “Only 2% of patients required upgrade to [cardiac resynchronization therapy] during follow-up despite high burden of right ventricular pacing. It also shed light on the lifecycle management of leadless pacemakers and how physicians managed the leadless pacemaker at time of device upgrade or revision. The most important finding is that among 1,792 patients that were implanted and followed for a median duration of 5 years, no infection requiring device removal was seen.”
In 2016, the FDA approved the world’s first leadless pacing system (Micra transcatheter pacing system, Medtronic) based on the results of the Micra investigational device exemption (IDE) study, in which the leadless pacing system met its 6-month safety performance and efficacy endpoints.
In 2017, El-Chami presented real-word data from 795 Micra IDE registry patients (mean age, 75 years; 62% men) at the Heart Rhythm Society Annual Scientific Sessions.
As Healio previously reported, transcatheter implantation of a leadless pacemaker resulted in a high rate of success and low rate of major 30-day complications.
For the present study, El-Chami used data from the Micra post-approval registry (PAR) to assess 60-month system- or procedure-related major complications and rate system revision. The researchers also compared 36-month rates between the Micra PAR cohort and a reference cohort of patients who had a transvenous pacemaker implanted.
From July 2015 to March 2018, 1,809 patients (mean age, 76 years) underwent attempted transcatheter implant at 179 centers in 23 countries. The median follow-up was 51.1 months.
The 60-month rate of major complications was 4.5% (95% CI, 3.6-5.5) and the rate of all-cause system revision was 4.9% (95% CI, 3.9-6.1).
Compared with a cohort of 2,667 patients who underwent transvenous pacemaker implant, the 36-month rate of major complications (4.1% vs. 8.5%; HR = 0.47; 95% CI, 0.36-0.61; P < .001) and all-cause system revision (3.2% vs. 6.6%; HR = 0.47; 95% CI; 0.34-0.65; P < .001) was lower for patients who received the transcatheter leadless pacing system.
Moreover, system revisions for those who received the transcatheter leadless pacemaker implant were mostly for device upgrades (41.2%) or elevated thresholds (30.6%), and the researchers reported no removals due to infection.
“I was not surprised but rather reassured as this multicenter data confirmed what I encounter in my clinical practice. The benefit of leadless pacemakers is accentuated during long-term follow up. Almost all of these complications are seen within 30 days of implant and after that, complication rate is low,” El-Chami told Healio. “It will be important to see how these pacemakers perform during longer follow-up, and the Micra post-approval registry will provide data on 9-year follow up in the future.
“It will be important to make sure that these results apply to other leadless pacemakers on the market and also to multi-chamber leadless pacemakers as they become more widely used,” he said.
For more information:
Mikhael F. El-Chami, MD, can be reached at melcham@emory.edu.
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