"Leadless" leading the way ahead - JAMA study provides reassuring results for leadless pacemakers.

The safety and efficacy of leadless VVI pacemakers have been demonstrated in multiple clinical trials, but the comparative performance of the device in a large, real-world population has not been examined. Piccini et al in a pivotal cohort study published in JAMA cardiology have now shown that patients implanted with leadless pacemakers have lower rates of other device-related complications and requirements for device revision at 6 months compared to transvenous implants.

Understanding the benefits and risks associated with leadless VVI pacemakers compared with transvenous VVI pacemakers can help clinicians and patients make informed treatment decisions.

Leadless technology was designed to reduce complications related to transvenous pacing leads and subcutaneous pockets—the most common sources of transvenous pacemaker-related complications.

The objective of this analysis is to compare the safety and complication rates of patients treated with leadless VVI pacemakers with a contemporary cohort of patients treated with transvenous VVI pacemakers.

The Micra CED is a continuously enrolling observational cohort study evaluating complications, utilization, and outcomes of leadless VVI pacemakers. The main outcomes were acute (30-day) complications and 6-month complications. This comparison has generated following findings:

1. Despite significant differences in patient characteristics, the rate of the complications measured through 6 months was significantly lower in patients who were implanted with leadless VVI pacemakers after adjustment.

2. Patients with a leadless VVI pacemaker had a substantially lower rate of device revision in the 6 months after implantation.

3. Finally, although the adjusted risk of cardiac effusion and/or perforation at 30 days was higher with leadless VVI pacing, device-related complications were significantly lower.

4. It is important to note that the adjusted rate of pericardial effusion and/or perforation was higher with leadless VVI pacemaker implantation compared with transvenous VVI pacemaker implantation (0.8% vs 0.4%); however the absolute rate was less than 1%.

This report provides an initial assessment of outcomes in this ongoing study and a direct comparison between patients with leadless VVI pacemakers and patients with transvenous VVI pacemakers in the Medicare setting.

Despite the older patient age and higher comorbidity burden, outcomes of leadless pacing observed in the investigational device exemption and postapproval registry trials appear to be maintained in this study of general clinical practice.

The results from this study further develop the evidence on leadless pacemakers in practice and can inform shared decision-making about device choice for patients and physicians. Additional studies are needed to ascertain the long-term impact of these differences in net clinical benefit in VVI pacemaker populations.

Source: JAMA Cardiology: doi:10.1001/jamacardio.2021.2621