Guest Post: FDA Clarifies Riata Imaging Recommendations 1

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. Additional clarity regarding yesterday’s St. Jude Riata/Riata ST imaging recommendations has arrived in the form of another FDA Safety Communication available at the FDA web site. According to the FDA, Riata and Riata ST leads “have an increased risk of premature insulation failure that can impact the lead’s ability to function properly.”  They add that there is currently insufficient information to determine the More…

Guest Post: FDA Calls For X-Ray Screening Of Riata Leads And Additional Followup Studies 1

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. St. Jude’s troubled implantable defibrillator leads came under a fresh layer of scrutiny today with new FDA imaging recommendations and post-market study requirements.  For the first time, the newer generation Durata and Riata ST Optim leads have been placed under enhanced review. The problems with St. Jude’s ICD leads date back to the first reports of Riata model lead externalization in 2010.  By More…

Robert Hauser, ICD Watchdog, Offers Viewpoint On Riata Controversy At HRS Reply

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. Robert Hauser, ICD Watchdog, Offers Viewpoint On Riata Controversy At HRS by Edward J Schloss MD The St. Jude Riata ICD lead controversy took center stage at last week’s Heart Rhythm Scientific Sessions in Boston, as previously reported here.  Near the end of the meeting a leading figure in the field, Dr. Robert Hauser, of the Minneapolis Heart Institute, summarized the current state of More…

Guest Post: Shedding Light On Riata At The Heart Rhythm Society Meeting 2

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. Shedding Light On Riata At The Heart Rhythm Society Meeting by Edward J Schloss MD This morning in Boston, HRS 2012 sessions began with a state of the art session on St. Jude ICD leads.  Riata, Riata ST and Durata are being discussed at the first large electrophysiology meeting since this lead came under FDA recall. It was obvious at the outset, that this More…

Round Two: Heart Rhythm Editor Rejects St Jude Request to Retract Riata Paper Reply

Douglas Zipes, the editor of Heart Rhythm, said the journal will not retract a controversial paper that has raised new safety concerns about St. Jude’s embattled Riata leads. On Friday (as reported here) St. Jude issued a press release alleging numerous mistakes and oversights in an article by Robert Hauser published online in Heart Rhythm linking the company’s Riata and Riata ST leads to 20 or more deaths. The company publicly asked the journal, which is published by the Heart Rhythm Society, to retract the article. On Tuesday, the New York Times reported that Zipes stood by the journal’s peer More…

St. Jude Seeks Retraction of Hauser Article On Riata Leads 3

St. Jude Medical is seeking the retraction of an article by Robert Hauser in Heart Rhythm linking the company’s Riata and Riata ST leads to 20 or more deaths. In a press release (see below) issued on Friday afternoon, St. Jude alleges numerous mistakes and oversights in the Hauser paper. In a brief statement to CardioBrief, Hauser wrote: We stand by the conclusion of our study, namely: “Riata and Riata ST ICD leads appear prone to high-voltage failures that have resulted in multiple deaths.” In response to a message thread on CafePharma,  St. Jude seeks retraction of Hauser’s More…

Guest Post: Lessons from the Riata Recall– Part III 1

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 More…

20 Deaths Linked to New Problem with Riata Leads 1

Electrical malfunctions, not externalized conductors, may be the cause of 20 or more deaths associated with the troubled Riata ICD leads from St. Jude Medical, according to a new report published online in Heart Rhythm. Robert Hauser and colleagues at the Minneapolis Heart Institute searched the FDA’s MAUDE database and found 22 deaths caused by Riata or Riata ST lead failure. By contrast, only five deaths were caused by failure of the more widely implanted Quattro Secure lead. The authors reported that the Riata deaths “were typically caused by short-circuits between high voltage components. No More…

Guest Post: More Lessons From the Riata ICD Lead Recall 7

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. This post is longer and far more technical than most of the content published on CardioBrief. Due to the extraordinary nature of the material, however, I believe this post will likely be of considerable interest to many cardiovascular healthcare professionals. More Lessons From the Riata ICD Lead Recall by Edward J. Schloss, MD In an earlier guest post (What are the Lessons of the More…

Guest Post: What Are the Lessons of the Riata ICD Lead Recall? 2

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. What Are the Implications of the Riata ICD Recall? by Edward J. Schloss, MD This week the New England Journal of Medicine published an important perspective piece from Robert G. Hauser of the Minneapolis Heart Institute regarding the St. Jude Riata ICD lead recall. For those involved in cardiac arrhythmia care, Dr. Hauser needs no introduction. He has effectively served a watchdog role for More…

St Jude Medical Statement on the Riata ICD Lead Summit 2

In response to the guest post summarizing the Riata ICD Lead Summit, St. Jude Medical sent the following statement to CardioBrief: We recognize that the phenomenon of externalized conductors presents a complex patient management scenario for physicians who may be able to visualize an anomaly, but it is important to remember that most leads with externalized conductors continue to function properly.

Guest Post: Report from the Riata ICD Lead Summit 8

Second update: Click here to review the slides from the meeting (posted by the Minneapolis Heart Institute), Update: Click here to read a statement from St Jude Medical in response to this post. Editor’s Note: Edward J. Schloss (Twitter ID @EJSMD), the medical director of cardiac electrophysiology at the Christ Hospital in Cincinnati, OH, returned yesterday from the Riata ICD Lead Summit. Dr. Schloss has kindly forwarded his summary of the meeting to CardioBrief. “As the audience was restricted to clinicians and St. Jude personnel, this may be the first and only public account of this More…

Guest Post: How Sure Can We Be About Optisure? 2

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. How Sure Can We Be About Optisure? by Edward J. Schloss, MD On March 24, St. Jude Medical announced the global launch of the Optisure family of ICD leads. It’s been a while since a new ICD lead was launched, and I’m probably not the only one who was caught by surprise. I’d like to explore why this approval is important for More…

Guest Post: Case Report Of Durata Lead Failure Raises Fresh Concerns Reply

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. Case Report Of Durata Lead Failure Raises Fresh Concerns by Edward J. Schloss, MD  A case report of a failed St. Jude Medical Durata ICD lead was published yesterday, raising suspicions that this lead may share some of the same potential failure mechanisms of its troubled predecessor, the Riata lead. St. Jude’s ICD lead troubles date back to early case reports involving the Riata More…

FDA Releases St. Jude Warning Letter Reply

The FDA on Tuesday released the full text of a warning letter sent last week to St. Jude Medical. The company had previously disclosed the existence of the letter in an SEC filing but did not make clear the full extent of the FDA warning. The letter from the FDA is the latest in a series of setbacks, short term loans UK and challenges to the company’s Durata and Riata ICD leads. Click here to read the full post on Forbes.

2012 In Review: A Bad Year For Conventional Wisdom 3

This was a really grim year for anyone who thought we had things pretty well figured out. Time and again conventional wisdom was thrown out the window. 2012 forced the cardiology community to reconsider what it thought it knew about HDL cholesterol, platelet function tests, aspirin resistance, triple therapy, IABP, and more. One device company, with a lot of help, did just about everything right when it introduced a radical, highly disruptive new technology. Another device company did just about everything wrong in handling a series of crises. The new generation oral anticoagulants continued to More…

2012 In Review: Social Media In Cardiology 5

For a whole variety of reasons most cardiologists are not really comfortable diving into social media. For some reason they’re more comfortable remaining poolside, reading Braunwald or the latest mini JACC or Circulation than writing a blog or interacting with each other or their patients on Facebook or Twitter. Most cardiologists who do get their feet wet send out a few isolated tweets or posts and then disappear into the great digital void. So here’s a special shout out to a few brave cardiologists who are at least making an effort (feel free to add to this list in the comments More…

Guest Post: New Questions Raised About Latest Generation St. Jude ICD Leads Reply

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.  New Questions About Latest Generation ICD Leads From St. Jude by Edward J. Schloss A highly anticipated study analyzing failures of St. Jude Durata and Riata ST Optim ICD leads was published online today in Europace by prominent electrophysiologist and ICD critic Dr. Robert Hauser along with associates from the Minneapolis Heart Institute. Over the last year St. Jude Medical has been beset with bad More…

Single Case Report Casts New Doubts About St. Jude Durata ICD Leads 1

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 More…

Heart Rhythm Editor Douglas Zipes Defends Peer Review 4

Rejecting an extraordinary request from industry to retract a controversial paper, Douglas Zipes, the editor-in-chief of HeartRhythm, has written a rare, highly pointed editorial defending the publication process. “If one disagrees with facts/statements in a publication,”  writes the editor, Douglas Zipes, “there is a well-defined approach that can begin with a letter to the editor or submission of one’s own data for peer review to counter the conclusions in the article.” Zipes was responding to a request from St. Jude alleging numerous mistakes and oversights in an article by Robert Hauser published online in HeartRhythm linking the company’s Riata and Riata ST More…

Guest Post: After an Unprecedented Request for a Retraction, A Close Look at the Data 3

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 More…

St Jude Withdraws Older LV CRT Leads From Market Reply

St. Jude Medical today issued an advisory about its QuickSite and QuickFlex Left-Ventricular (LV) Leads, which connect to Cardiac Resynchronization (CRT) devices. The company said it would no longer sell these leads, but that it had received no reports of death or serious injury associated with the problem. The problem with the LV leads closely parallels the previously-reported problem with the company’s Riata leads. In both cases, there have been reports of externalization of lead conductors with silicone insulation, though the ultimate clinical implications of the reports are unclear. St. Jude reported that there have been More…

Global Monitor: Early Signs of Possible Problems with ICD Leads, Dabigatran Reply

Reports from Ireland and New Zealand may herald new concerns about the Riata defibrillator leads (St. Jude Medical) and dabigatran (Pradaxa). A poster presented at the European Society of Cardiology meeting last month by researchers at the Royal Victoria Hospital in Belfast found that  15% of 212 patients who received Riata leads had an insulation breach on screening. The researchers reported that 20% of the patients had “clinically significant events.” Quoted in an article in the Minneapolis Star Tribune. the chief of the Arrhythmia Service at Brigham and Women’s Hospital, Laurence Epstein, acknowledges the small size of More…