Editor’s Note: The following guest post is published with the permission of its author, Edward J. Schloss, MD, (Twitter ID @EJSMD) the medical director of cardiac electrophysiology at Christ Hospital in Cincinnati, OH.
After an Unprecedented Request for a Retraction, A Close Look at the Data
by Edward J Schloss MD
Last week, St. Jude Medical took the unusual step of requesting a retraction of an article accepted for publication in Heart Rhythm Journal. In this article Deaths Caused by the Failure of Riata and Riata ST Implantable Cardioverter-Defibrillator Leads, Dr. Robert Hauser et al analyzed patient deaths in the FDA MAUDE database associated with St. Jude Medical and Medtronic ICD leads. This week, Dr. Douglas Zipes, Heart Rhythm editor, declined that request. (Please see my previous Cardiobrief coverage of Hauser’s article.)
In a company news release, St. Jude accused Hauser’s group of “inaccurate facts and biased analysis.” The sub-headline reads: “Research undercounted and excluded MAUDE data reports for Medtronic resulting in substantial factual errors.”
St. Jude’s most prominent concern revolves around the number of reported deaths in the analysis of Riata/Riata ST leads and the comparison lead, Medtronic Quattro Secure. St. Jude wrote: “using the same search criteria outlined in the manuscript, the company has identified that Dr. Hauser’s research substantially undercounted total deaths in the MAUDE database for Quattro Secure.” St. Jude counts 377 deaths compared to Hauser’s 62.
In an effort to clarify the reasons for this discrepancy, I undertook an independent analysis of the facts available. My sources are the original Hauser article and the PDF file from St. Jude listing the details of their database search. I then examined the methodology of both database searches to compare consistency of data entry. Finally, I performed an independent review of all MAUDE database entries supplied by St. Jude and attempted to classify the 377 deaths Quattro Secure deaths identified by St. Jude into Hauser’s defined categories: lead-related, indeterminate, and not lead-related, using the methods he described in his paper.
I hypothesized that differences in search methodology may explain the large discrepancy in numbers of deaths found by Hauser and St. Jude.
The Hauser study queried the MAUDE data using the “simple search feature” entering term “Quattro Secure death.” Results were “refined” to include only model 6947 leads. Finally, “Reports were excluded from the study if there was no known lead problem or allegation of lead malfunction, and if a returned product analysis found no anomalies that were not caused by the explant procedure.” With this methodology, the query returned 62 Medtronic Quattro Secure deaths.
The St. Jude data collection methodology is discussed on page one of the PDF document. The “simple search” function specified by Hauser is not used. Rather in the standard search fields, individual entries are made for Brand: Quattro, Manufacturer: Medtronic, and Event: Death. Results were then refined to model 6947 excluding duplicates. Also in contrast to the Hauser data, no pre-specified exclusions were indicated. This query listed 377 Medtronic Quattro Secure deaths.
Hauser categorized his 62 deaths as 5 (8%) lead-related, 25 (40%) indeterminate, and 32 (52%) not lead-related.
St. Jude did not categorize the 377 deaths. My individual analysis found 7 (2%) lead-related, 129 (34%) indeterminate, and 241 (64%) not lead-related. (Lead-related death MDR Identifiers were 71402, 1438305, 1523151, 1760409, 1944512, 2016463, and 2025526.) I have asked St. Jude for their own analysis of the data into these categories, but have not received a reply.
My review confirmed significant methodological differences in the database query specified by Hauser and St. Jude that may explain the differences in the numbers of deaths reported. This stands in contrast to St. Jude’s assertion that they used “the same search criteria outlined in the manuscript.”
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