Leadless Pacemaker Continues to Impress, But Is It Ready for Prime Time?

Summary and Comment |
October 2, 2015

Leadless Pacemaker Continues to Impress, But Is It Ready for Prime Time?

  1. Mark S. Link, MD

In a second, larger series of a leadless pacemaker, successful implantation without complications occurred in a majority of patients.

  1. Mark S. Link, MD

Leads are the Achilles heel of pacemakers and implantable defibrillators. Leads not only wear out over time, but provide a portal of entry for infection into the vasculature. Development of a permanent pacemaker without leads has been a goal for decades. Researchers now report interim results from an industry-sponsored clinical trial of the St. Jude Nanostim VVI leadless permanent pacemaker.

There were a total of 526 patients: 300 patients in the primary cohort who were followed for 6 months, and an additional 226 more-recent participants. Of the total cohort, 504 were successfully implanted with the PPM.

In the primary cohort, 270 patients (90%) met the primary outcome of acceptable pacing parameters for 6 months. Serious adverse events occurred in 20 patients (6.7%), including dislodgement with percutaneous retrieval in 1.7%, cardiac perforation in 1.3%, and threshold elevation in 1.3%.

Comment

In this observational trial, the Nanostim leadless PPM performed reasonably well. I continue to have concerns about complications and the retrievability of PPMs over the long term. In the current report, complications occurred in 1 in 15 patients. I await further data on this exciting new technology.

Editor Disclosures at Time of Publication

  • Disclosures for Mark S. Link, MD at time of publication Grant / Research support Unequal Technologies Editorial boards UpToDate; Heart Rhythm Leadership positions in professional societies Heart Rhythm Society (Chair, CME Compliance Committee); American Heart Association (Chair, ACLS Writing Group; Member, Emergency Cardiovascular Care)

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