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.
As if on cue, just as the train pulled into the Nice-Ville station for this week’s Cardiostim 2012 meeting on the French Riviera, my Twitter stream and email lit up with news about a MAUDE case report about an externalized Durata:
Non invasive programmed stimulation of icd, revealed undersensing of ventricular fibrillation after induction. Fluoroscopy of lead revealed externalization of conductors. The externalization was confirmed at lead extraction. The externalization was adjacent to the distal coil of the lead.
Wall Street reacted promptly with a 6% drop in St. Jude’s stock price on Tuesday.
Though not widely reported, this was not the first report of an externalized Durata. As I reported previously, at the Riata Lead Summit in Minneapolis in January, St. Jude presented a case of a patient in Alaska with an externalized Durata lead. At that point, the company was able to dampen negative reaction with an analysis indicating that the externalization was caused by abrasion of the lead in an “outside-in” fashion from contact with a tricuspid valve annuloplasty ring.
Why did this new Durata story provoke such a strong reaction?
• The new MAUDE report arrived without any explanation or reaction from St. Jude Medical. The first references came from the financial analyst community and filtered out through online sources such as Twitter and Cafepharma.com. There have been no additional details beyond the brief summary in MAUDE . St. Jude Medical seemed to be as surprised as everyone else. A St. Jude spokesperson told Reuters: “We will make every effort to learn more about the report as quickly as possible.”
• This is the first important new development since last month’s Heart Rhythm Society Meeting in Boston. At that meeting, as reported in Med City News, Charles Love of Ohio State, offered a favorable perspective on Durata. This was counterbalanced by unfavorable data about the prior generation Riata lead and a scathing commentary by ICD watchdog Robert Hauser, as I then reported.
• The report comes on the eve of the Cardiostim Meeting here in Nice. This meeting serves as a European counterpart to last month’s HRS sessions and will provide a ready forum for reaction and consensus building.
• St. Jude has waged an aggressive defense of Durata, promoting “0% Externalized Conductors” in promotional materials (see photo at bottom). This “all-in” stance may have created lofty expectations for this lead’s performance. Even a single unsubstantiated case report therefore could create an unfavorable reaction.
It remains to be seen if this case report will be the “tip of the iceberg” or an isolated phenomenon. Its validity is even being questioned, as FDA cannot reveal its source and the details of the report have not yet been made available.
Those of us who have followed medical device failures closely over the years should know not to react too quickly to case reports. It seemed inevitable to me that there would be at least some Durata externalization reports given that lead’s similarity in design to the Riata ST lead. However, a single case report, or even a few cases reports, do not provide sufficient evidence to indict Durata at this time. More information may arrive soon in the form of an expected paper from Dr. Hauser on Durata electrical failures in the MAUDE database.
(Photo of Durata promotional truck at HRS courtesy of Dr. Wes)