May 17th, 2010
03:28 PM ET

New defibrillator

By Trish Henry
CNN Medical Producer

Researchers say they've developed a new defibrillator that's potentially less risky for patients.

One of the leading causes of death in the U.S. is cardiac arrest due to an irregular heartbeat, or ventrical fibrillation. Implantable cardioverter defibrillators detect heartbeat abnormalities and deliver a shock to as needed to it make the heartbeat regular again. It acts like a personal paramedic and can prevent sudden death.

Conventional defibrillators connect wires to the heart. But the new subcutaneous implantable dardioverter-defibrillator under development doesn't, making it less risky for patients.  Here's how it works: An electrode and shocking coil are positioned to the left of the sternum, with the lead wire connecting it to a pulse generator located over the ribs. The new device doesn't have to go into blood vessels at all. The device "prevents any vascular complications and it allows for leads that may be less subject to wear and tear damage," says Dr. Gordon Tomaselli, spokesman for the American Heart Association.

Leads have to be extremely flexible, especially with the heart beating 70-80 times a minute. They typically have to be replaced every five to seven years because over time the majority of them will break. The new device avoids the usual complications that doctors face of putting foreign materials into an organ. In addition, this new device allows for the leads to be placed in a spot much more easily accessed than with a traditional device.

Study author, Dr. Gust H. Bardy, says the new defibrillator offers the promise of saving lives without the high number of inappropriate shocks that the traditional device is known for. He says the procedure to implant the new defibrillator is easier on the patient and cheaper.

Not placing leads in the heart is especially beneficial, researchers say, for young patients who need defibrillators. "If you can avoid getting into the heart space early in their life and stay under the skin for one or two decades, that's a heck of an advantage…and they won't be subjected to long-term complications," Bardy said.
One disadvantage with the new device, researchers found, is that it won't help patients whose heartbeat abnormalities require both a defibrillator and a pacemaker to correct.

The study of 55 patients was sponsored by Cameron Health Inc., which is developing the new defibrillator. A larger study with 330 patients was recently launched in an effort to gain U.S. approval. The device already is available in Europe.

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