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.
Lessons from the Riata Recall– Part III
by Edward J Schloss MD
In two earlier posts on Cardiobrief (here and here), I have written in some detail about the St. Jude Riata/Riata ST lead recalls. In these pieces, I’ve summarized what we know about the design of these leads and their clinical performance. Ultimately I hope this updated information allows clinicians and other interested parties to make intelligent decisions regarding lead follow up and new lead model selection.
This week we’ve seen new important information that sheds additional light on the performance of Riata and Riata ST. As is often the case, new information leads to both new answers and new questions.
Accepted for publication in Heart Rhythm are two new manuscripts that reference these leads. From frequent contributor Robert Hauser and his group at Minneapolis Heart Institute Foundation comes this review of ICD lead related deaths from the FDA MAUDE database. Also accepted for publication is a prospective series of Riata and Riata ST leads that underwent fluoroscopic and electrical evaluation from Parvathaneni et al at Vanderbilt.
Hauser’s study has been previously reported on this site (20 Deaths Linked to New Problem with Riata Leads). It is notable for being one of the first Riata studies focusing on electrical, rather than structural failures. In the study, 22 (since corrected to 20 by St. Jude review) deaths discovered in the voluntary FDA MAUDE database were linked to failure of the Riata or Riata ST lead. Interestingly, nearly all deaths appear to be due to failure of the high voltage portion of the lead, and most were directly linked to insulation abrasion. This is a failure mechanism not commonly seen with other ICD leads, as noted in the article’s comparison to Medtronic Quattro Secure leads (in which failure of the low voltage conductors is the dominant mechanism). Hauser estimated that failure of the St. Jude leads had an incidence “about 9 times greater than Quattro.”
Close reading of the Hauser data raises some interesting and, at times, troubling points:
Click to continue reading…