Medical journal documents heart perforations from St. Jude wires

(AP) - Wires from St. Jude Medical implantable defibrillators have perforated patients' hearts in four cases, a medical journal reported Monday, less than a month after rival Medtronic recalled its own similar wires.

One patient's wire had moved from inside the heart out to within a quarter inch of the patient's skin, according to the reports published by the medical journal PACE.

All four of the patients with St. Jude wires recovered, and the company issued no recall. Still, St. Jude Medical Inc. shares dropped almost 5 percent on the news.

Last month, Medtronic Inc. acknowledged five patient deaths linked breaks in its Sprint Fidelis wires, which it recalled.

Implantable defibrillators are meant to jolt the heart back to its proper rhythm. The wires, called leads, are attached to the heart wall and deliver the jolt. A failure of the lead can mean the defibrillator never senses the need for the jolt, or can't deliver it.

The journal PACE reported four women with perforations from St. Jude's Riata leads. The patients - one treated in Nebraska, one in New York, and two in the Czech Republic - all had their leads removed.

Dr. Stephen C. Vlay wrote in a PACE editorial that the wire problems are especially troubling because the perforation often isn't discovered until it is well through the heart wall.

One woman had no sign of problems. Doctors discovered her perforation in a routine follow-up visit about five weeks after her defibrillator had been implanted. The defibrillator had not been delivering a sufficient jolt, the journal said.

Doctor's found the perforation in another woman after her defibrillator shocked her five times within one 24-hour period.

Vlay wrote that doctors may have been under-reporting wire problems because they believed they were isolated events.

"It was only when multiple case reports emerged from different geographic areas and were submitted for publication that editors recognized a problem that seemed to be neither isolated nor rare," he wrote.

St. Jude on Monday issued a summary of a response it said PACE will publish in its December issue. The company said prior studies have shown perforations happen with 0.6 percent to 5.2 percent of defibrillator implants.

It said the perforation is often because of patient factors such as medical condition, heart disease, use of blood thinners, or design characteristics of the lead, or implant techniques.

St. Jude said it tracks the reports of lead perforations it receives. It said perforations have happened in just 0.08 percent of the 121,000 Riata leads implanted in the U.S.

"The performance of the Riata family of leads has been strong," the company said.

St. Jude shares fell $1.89, or 4.8 percent, to close at $37.13 on Monday.

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