Leadless, transvenous single-chamber pacemakers show little difference in acute complications

Reuters Health - 12/08/2021 - Although patient characteristics differ greatly, leadless and transvenous VVI pacemakers appear to have a similar rate of acute complications overall, according to a postmarket comparative-safety study of Medicare beneficiaries.

"Understanding the benefits and risks associated with leadless VVI pacemakers compared with transvenous VVI pacemakers can help clinicians and patients make informed treatment decisions," Dr. Mikhael El-Chami of Emory University School of Medicine, in Atlanta, and colleagues write in JAMA Cardiology.

In January of 2017, the U.S. Centers for Medicare and Medicaid Services issued a national coverage determination for leadless pacing, which "relies on generating evidence while collecting real-world data on all Medicare beneficiaries implanted with a leadless (and transvenous) single chamber pacemaker," Dr. El-Chami explained in an email to Reuters Health.

He and his colleagues used data from this continuously enrolling observational cohort study to identify more than 15,000 patients who had a pacemaker implanted between 2017 and 2018.

Of these, 5,746 patients received leadless VVI pacemakers and 9,662 patients were given transvenous VVI pacemakers. The patients' mean age was 81 years. Patients with leadless VVI pacemakers were significantly more likely to have end-stage kidney disease (12.0% vs. 2.3%) and kidney dysfunction, and had a higher Charlson Comorbidity Index score on averages.

The unadjusted rate of acute complications was higher in patients with leadless VVI pacemakers (8.4% vs. 7.3%, P=0.02), but the difference was no longer significant after adjustment (7.7% vs. 7.4%, P=0.49).

"There was higher rate of perforation with leadless pacemaker (0.8%) as compared to transvenous pacemakers (0.4%). On the other hand, device-related complications - infection, dislodgment, etc. - were higher with transvenous VVI pacemakers compared to leadless," Dr. El-Chami noted.

The rate of complications at six months was lower in the leadless pacemaker group (adjusted hazard ratio, 0.77; P = .02), the researchers report.

"This study highlights the advantages of the leadless pacemaker and allows physicians to discuss pros and cons of this technology with their patients," Dr. El-Chami said.

However, he and his colleagues write, "Additional studies are needed to ascertain the long-term impact of these differences in net clinical benefit in VVI pacemaker populations."

They also caution that the analysis was performed in a Medicare fee-for-service population, which primarily consists of patients 65 years and older with disabilities or end-stage kidney disease, and the results may not be applicable to other, particularly younger populations.

SOURCE: https://bit.ly/3fBKx6S JAMA Cardiology, online July 28, 2021.

By David Douglas

 



Posted on 12 August 202124 August 2021