Cardiovascular Rounds

LEADLESS II trial findings support leadless cardiac pacemakers

by Julie Bass

The growth in demand for EP services is currently a hot topic in the CV world: there are more technologies entering the market to meet patient needs and hospital executives are turning toward EP as a way to grow CV service lines as traditional CV services decline. In fact, according to Advisory Board analysis outpatient EP services are expected to grow 15% in the next 5 years and 21% in the next 10 years.

Coupled with this increased focus on EP as a growth opportunity are technological advancements in EP devices. Recent findings from the LEADLESS II study published in the New England Journal of Medicine this summer suggest that a leadless cardiac pacemaker is a safe and effective alternative to conventional transvenous cardiac pacemakers. Leadless pacemakers present a promising alternative as leads are notorious for challenges with durability, extraction, and longevity.

About the study

The multicenter LEADLESS II study was a prospective, non-randomized trial of 526 patients across 56 sites in three countries. Feasibility of the leadless pacemaker was demonstrated in the LEADLESS trial, with LEADLESS II intended to further examine the clinical safety and efficacy of nonsurgical implantation of the Nanostim leadless cardiac pacemaker from St. Jude Medical.

Conventional transvenous pacemakers frequently lead to device-related complications—mainly infection and problems related to lead dislodgement. The Nanostim pacemaker is a miniature, fully self-contained leadless pacemaker, implanted in the patient’s right ventricle via a catheter. This type of implantation significantly reduces risk of infection when compared to traditional surgical implantation.

Among the study’s findings, authors noted that the leadless pacemaker was successfully implanted in 96% of patients. Additionally, safety and efficacy targets were met in 90% and 93.3% of patients, respectively. At six months post-implantation, serious adverse events were observed in 6.7% of patients. These device-related events included cardiac perforation, device dislodgement, and pacing-threshold elevation necessitating device replacement. As the LEADLESS II trial continues, stay tuned for updates.

What does this mean for your program?

In our recent research on perfecting CV short-stay patient management, many members shared their concerns about the safety and feasibility of same-day discharge for patients with new pacemaker implantations. In particular, members frequently cited lead dislodgment as a primary concern necessitating an overnight stay. The novel approach of leadless pacemakers inserted via nonsurgical means may present an opportunity to address this concern, leading to a shorter length of stay for patients in the hospital.

Your partner for high-value CV care

Readmissions penalties. Chronic, comorbid patients. Increased competition for CV volumes. These are just some of the challenges facing today's CV leaders. The Cardiovascular Roundtable can help you tackle them strategically by giving you tools and benchmarks, expert insight, and best practices from your peers.