IMPORTANT - EIN Presswire is proud to announce the launch of its AI-powered press release generator. Try it now!

There were 795 press releases posted in the last 24 hours and 394,046 in the last 365 days.

Small wireless pacemaker is safe, effective in early testing

Study Highlights:

  • A battery-sized, wireless pacemaker was safe and effective in early testing.
  • The smaller leadless device may reduce the risk of complications that occur with traditional pacemakers.

Embargoed until 3 p.m. CT/4 p.m. ET Monday, March 24, 2014

(NewMediaWire) - March 24, 2014 - DALLAS - A new small, wireless self-contained pacemaker appears safe and feasible for use in patients, according to a small study in the American Heart Association journal Circulation.

Although traditional pacemakers pose minimal risk, patients are still vulnerable to some short- or long-term complications, said Vivek Y. Reddy, M.D., lead author of the study and director of the Cardiac Arrhythmia Service at Mount Sinai Hospital in New York City.

Those complications can stem from the pulse generator implanted under the skin of the chest, where infections or skin breakdown can occur, and particularly from the leads, or wires, that run from the generator through a vein to the heart. Leads can break, dislodge or contribute to a vein blockage.

However, the new pacemaker has no leads — its pulse generator lies within the unit in the heart – and is placed without the need for surgery.

At 6 millimeters in diameter and about 42 millimeters long, the wireless device is smaller than a triple-A battery. It’s faster and easier to implant than traditional pacemakers, Reddy said, and it’s programmed and monitored similarly.

“While a much larger study is required to prove this, one may expect the leadless pacemaker to be associated with less chance of infection and lead-related problems such as lead fracture,” Reddy said. “Overall, the self-contained pacemaker is a paradigm shift in cardiac pacing.”

The study, called LEADLESS, was conducted in 33 Caucasian patients, average age 77, two-thirds men, at two hospitals in Prague and one in Amsterdam. The self-contained pacemaker was successfully implanted in 32 patients, or 97 percent. Ninety-four percent were free of complications through the three-month study period, the researchers reported.

The new device is a self-modulating pacer guided into place using a catheter inserted in the femoral vein and is affixed to the heart in the right ventricle, the same place a standard lead would be located. The device is for patients who require single-chamber pacing, or roughly 20 percent to 30 percent of U.S. and European patients who need pacemakers. Patients who need dual-chamber pacing would still require traditional pacemakers, according to Reddy.

Among the study’s 33 patients, one suffered complications during the procedure and underwent emergency surgery but later died after suffering a stroke.

After three months, the new pacemakers were functioning well, the researchers found. They are continuing to track the patients and expect to report longer-term outcomes later this year. Meanwhile, a much larger study at multiple U.S. locations that will include longer-term follow-up is under way, Reddy said.

Co-authors are Reinoud E. Knops, M.D.; Johannes Sperzel, M.D.; Marc A. Miller, M.D.; Jan Petru, M.D.; Jaroslav Simon, M.D.; Lucie Sediva, M.D.; Joris R. de Groot, M.D., Ph.D.; Fleur V.Y. Tjong, M.D.; Peter Jacobson, B.S.; Alan Ostrosff, M.S.; Srinivas R. Dukkipati, M.D.; Jacob S. Koruth, M.D.; Arthur A.M. Wilde, M.D., Ph.D.; Josef Kautzner, M.D., Ph.D.; and Petr Neuzil, M.D., Ph.D. Author disclosures are on the manuscript.

(Updated 3/21/14) St. Jude Medical, the manufacturer of the Nanostim pacemaker, funded the study.

Beating Heart Animation available on the right column of the release link

For the latest heart and stroke news, follow us on Twitter: @HeartNews.

For updates and new science from the Circulation journal, follow @CircAHA.


Statements and conclusions of study authors published in American Heart Association scientific journals are solely those of the study authors and do not necessarily reflect the association’s policy or position.  The association makes no representation or guarantee as to their accuracy or reliability.  The association receives funding primarily from individuals; foundations and corporations (including pharmaceutical, device manufacturers and other companies) also make donations and fund specific association programs and events.  The association has strict policies to prevent these relationships from influencing the science content.  Revenues from pharmaceutical and device corporations are available at

For Public Inquiries: (800) AHA-USA1 (242-8721)