The journal HeartRhythm said it stands by a study released last month showing St. Jude Medical Inc.’s recalled Riata wires, used to connect life-saving defibrillators to the heart, may fatally short-circuit.
St. Jude asked for a retraction of the paper on April 6, saying the report undercounted the number of deaths tied to a rival product from Medtronic Inc. Today, St. Paul, Minnesota-based St. Jude posted on its website its review of the U.S. Food and Drug Administration’s safety database showing 377 deaths among patients with Medtronic’s Quattro Secure leads.
St. Jude stopped selling the Riata wires, known as leads, in December 2010 and recalled them a year later amid reports they could break through the insulation coating and fail to work properly. The paper from Robert Hauser, a cardiologist at the Minneapolis Heart Institute, was reviewed by two independent researchers before it was accepted and the findings stand, said Douglas Zipes, editor-in-chief of HeartRhythm and a professor of cardiology at Indiana University School of Medicine.
“We will be as fair as possible, knowing that there are several people with a dog in the fight,” Zipes said in a telephone interview. “At least at the present time, the only thing that has been peer-reviewed has been Hauser’s manuscript and that will stay in place.”
Zipes said he spoke with Mark Carlson, St. Jude’s chief medical officer, last night and suggested the company write a letter to the editor presenting their data. Such a letter would also be sent to Hauser for a response, Zipes said.
St. Jude hasn’t yet sent anything to the journal, he said.
“I have no knowledge of their data and therefore cannot accept a statement from them to contravene the results from the peer review process,” Zipes said.
Hauser used the FDA’s Maude safety database, which includes information from the companies and doctors about complications that arise in patients with medical devices, to draw his conclusions about the St. Jude and Medtronic leads. Because the reports are in narrative form and don’t always directly tie a device to a death or other adverse event, the work was laborious, Hauser said in a telephone interview before the study was released last month.
“You have to find the reports, read them, and extract the data,” he said.
Hauser’s analysis turned up 133 deaths -- 71 in patients with St. Jude’s Riata and 62 with Medtronic’s Quattro Secure. Medtronic officials followed the methods detailed in Hauser’s study and reached a similar conclusion, said Chris Garland, a spokesman for the Minneapolis-based company.
St. Jude’s Review
St. Jude conducted an analysis, following the same search criteria detailed in the study, and said it found 74 deaths among Riata patients and 377 among Quattro Secure patients.
“Since the manuscript was published, the company has spent more than 300 hours attempting to reach the same conclusions as Dr. Hauser, but can find no way of analyzing the Maude database that reproduces the same numbers reported in the manuscript,” St. Jude said in its April 6 statement. “The company has identified duplicate reports, inconsistent categorizations and failures to include all available reports.”
Hauser said the safety reports, and therefore his study, aren’t comprehensive and probably don’t represent the full number of incidents stemming from both devices.