updated 5/13/2009 3:21:43 PM ET 2009-05-13T19:21:43

Medical specialists say more physicians are needed who can expertly remove heart device wires, following a recent product recall affecting thousands of U.S. patients.

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New recommendations published Wednesday by the Heart Rhythm Society also say that more data is needed about how to successfully remove leads, electrical wires that connect pacemakers and defibrillators to the heart. The society is made up of physicians who implant and prescribe the devices.

The group suggests additional testing in patients may be necessary for some new types of leads.

A requirement for increased testing could cost manufacturers millions of dollars to conduct trials in thousands of patients. Along with Medtronic Inc., the leading companies in the sector are Boston Scientific Corp. and St. Jude Medical.

Sales of implantable heart-shocking defibrillators saw double-digit growth earlier in the decade, and they remain the one of the industry's best-selling products.

The medical group set to work on the recommendations after Medtronic pulled its Sprint Fidelis defibrillator leads off the market in 2007 because of a defect that can cause them to crack. The company now estimates that 13 deaths may have been caused by the problem.

More than a quarter-million Sprint Fidelis leads were implanted in patients around the world, and many are expected to undergo surgery to remove the devices in coming years.

Removing the wires is challenging because they are close to the heart and can often become intertwined with tissue.

Heart Rhythm Society President Dr. Mark Estes said the increased focus on lead performance underscores the need for more reliable products and physicians who are comfortable removing them.

"The number of implantable heart devices continues to grow and as that happens the absolute number of leads that will need to be removed will grow," Estes said in an interview with the Associated Press. "Lead removal is technically and clinically challenging and there are definite risks associated with it."

The society warns there are not enough physicians trained in removing leads to keep up with demand. The group states that only medical centers that perform a large number of extraction each year should train physicians to perform the surgery.

The group recommends physicians perform at least 40 extractions under expert supervision before operating on their own. Supervising physicians should have performed at least 75 extractions with a high rate of success, the group states.

The 12-member panel that drafted the paper also wants a national database where hospitals can record success and failure rates, giving physicians a clearer picture of best practices for the difficult procedures.

Companies like Medtronic have advised patients to leave potentially defective leads in place because the risk of surgery may outweigh the risk of a device malfunction. The panel concurs with that advise, but outlines detailed guidance for when to remove leads. For instance, removal is recommended for patients with a dysfunctional lead who are also at risk of irregular heart rhythms. But the society does not recommend removing a dysfunctional lead if a patient's life expectancy is less than one year.

Estes and colleagues also ask the Food and Drug Administration to clarify when leads should be tested in patients before they are approved for the market. Many of the devices are approved without human testing because they are considered "minor" modifications of older products. However, the group's recommendations suggest closer examination could be needed by regulators.

But recalls beginning in 2005 have slowed that growth. First Medtronic recalled some of its implantable defibrillators that year because their batteries were draining without warning. Then Guidant, now part of Boston Scientific, began the first of a series of major recalls.

That prompted some heart patients to avoid getting a defibrillator, and some doctors to treat their symptoms with drugs instead of a device implant.

Since 2005 the U.S. market for implantable defibrillators has declined nearly 4 percent to about $4.1 billion, according to Wachovia Capital Markets. Sales this year have been flat.

Defibrillators are implanted in the upper chest where they monitor heart rhythms and send powerful electrical jolts to correct potentially dangerous irregular heart beats. They work differently than pacemakers, which use low-level electrical pulses to maintain steady heart beats.

Copyright 2009 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.


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