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 meeting,” wrote Dr. Schloss. (As the editor of CardioBrief, I would like to express my keen disappointment that a meeting of this general importance was closed to outside observers, including journalists, analysts, and representatives from other companies.)

 Report from the Riata ICD Lead Summit

by Dr. Edward J. Schloss

Sixty-three registered health care professionals and St. Jude Medical industry representatives gathered today at the Minneapolis Airport Marriott Hotel for the Riata ICD Lead Summit. This conference, organized by The Minneapolis Heart Institute Foundation and Mayo Clinic, was organized to review available data and develop a consensus regarding St. Jude ICD leads currently on recall or subject to increased scrutiny.

Course directors Robert G. Hauser, MD and David L. Hayes, MD presided over a series of lectures and panels of experts in the field.

Dr. Hayes first polled the conference attendees about the current landscape. A full 35% of attendees thought Riata leads posed a greater concern to them than the Medtronic Fidelis recall. In addition, 41% felt enough concern about the currently marketed Durata lead that they have elected not to implant this lead. The Durata lead, although not on recall, shares many design elements with the Riata ST.

Dr. Hauser reviewed available clinical and engineering data. The failures of Riata leads appears to be due to a unique “inside-out” form of lead insulation abrasion. In some, but not all cases, lead cables have been shown to externalize. Commonly, however, externalization is not associated with failure and vice versa. There is no single common sign of lead failure on electrical measurements.

One common theme throughout the conference was the unknown significance of lead cable externalization. Dr. Ernest W. Lau presented the early data from Northern Ireland that first brought to light the problem. With systemic fluoroscopic screening, his group showed a 15% incidence of externalization in a population that included a high incidence of single coil leads. Later in the day, Dr. Christopher Ellis of Vanderbilt University presented his US data showing an even higher incidence of 26% fluoroscopic lead cable abnormalities in a population with predominantly dual coil leads. Both groups found that leads with externalized conductors commonly have normal electrical performance.

St. Jude engineering bench data was discussed showing normal electrical and mechanical performance of externalized cables, prompting medical director Dr. Mark Carlson’s admonition “the appearance of an externalized conductor alone should not provoke an overreaction.” There was concern among the clinicians, but no consensus reached about what would be the expected natural history of these electrically silent insulation breaches. Carlson emphasized that no electrical failures St. Jude has observed have been independently due to cable insulation breach. These and other observations prompted some attendees to suggest that externalization may simply be a “symptom” or epiphenomenon related to lead electrical failure. Only 146 Riata leads have been returned to St. Jude for analysis and a call was made to the medical community that better product reporting is essential.

Electrical performance of Riata leads was looked at systematically in an industry independent multicenter retrospective trial reported by Dr. Raed H. Abdelhadi from Minneapolis Heart Institute. In a seven center collection of 1060 leads (773 8f Riata, 287 7F Riata ST), the overall incidence of measured electrical abnormality was 5.8%. The performance when plotted was intermediate between non-recalled high performing leads and Medtronic Fidelis. There was no systematic search for externalized conductors in the study. Dr. Edmund C. Keung presented similar data from the VA registry also in the US.

St. Jude Medical Industry personnel were a strong presence at the meeting and were the only non-clinicians present. Attendees repeatedly sought comments regarding engineering data and failure analysis. Dr. Carlson described an ongoing prosective multicenter trial of upwards of 500 Riata leads looking systemically at fluoroscopic appearance and electrical performance.

In afternoon sessions, Dr. Laurence Epstein from Brigham and Women’s Hospital presented strategies regarding lead extraction of Riata. Unique challenges with this lead were shown relating to the behavior of the externalized cables. He repeatedly emphasized that experience and preparation is critical for anyone planning to extract this lead. There was a strong consensus that this lead may be difficult to extract and should not be removed prophylactically.

Closing out the presentations, Drs. Kenneth Ellenbogen and Charles Swerdlow presented diagnostic strategies for follow up of Riata leads. Both agreed that detection of failures has been challenging given the varied and sometimes subtle changes seen. Dr. Raveen Bazaz of University of Pittsburgh Medical Center presented his data showing a correlation between cable externalizations and the angles of deflection of the ICD lead within the right heart. He postulated that a radiographic index could be created using these angles to predict future externalizations.

The attendees were polled again at the completion of the session and already high concerns were amplified. A higher proportion than earlier (58%) of those polled felt the Riata situation was a more serious problem than the Fidelis recall and 44% indicated that they had enough concern about the market released Durata lead that they would not be using this in the future. Despite HRS consensus recommendations to the contrary, 55% of attendees favored routine repeated fluoroscopic monitoring.

Conference organizer Hauser closed out the session expressing frustration that industry and FDA has known about Riata problems for over a year and is only now collecting prospective data. He emphasized that the Durata lead needs to be watched more closely: “put it under a microscope.”


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8 comments

  1. Thanks for this report.This is a very important issue. Having had a patient who suffered this problem I have worked diligently fo aquire more data points-and the process has been frustratingly difficult. The recent HRS summit was of no benefit. Kudos to Dr. Hauser for arranging this summit and to Dr. Schloss for sharing this excellant summary. I am not confidant that the recommendations we receive from official sources will be so objective.

  2. After you read this do a search for dan Starks q3 financial quarterly review. He praised his lead and blamed medtronic for bashing riata durata… He should pay for bs words to investors -ep’s and patients.

  3. I’m not sure I understand the point of this reporting. Is it to scare patients?

    Having had a number of patients that ended up having to have their Fidelis leads explanted, to suggest that this of comparable significance is absurd. We’re talking about tens of thousands of Fidelis explants, the worst event in the industry’s history.

    • The point of my report was to get the facts of this meeting out to the public (important, as reporters were not allowed to attend). I made an effort to stay as objective as I could and simply pass on what was said.

      I too was struck by the comments comparing the Riata recall to Fidelis. I voted on both occasions that Fidelis was a bigger problem, and found the poll results to be quite surprising.

      I’m not entirely I totally understand the for that poll result. I suspect it had a lot to do with the level of uncertainty and fear that another “shoe would drop” over time. People are also a lot more scared about the extraction difficulty with this lead over Fidelis.

  4. Pingback: Guest Post: What Are the Lessons of the Riata ICD Lead Recall? « CardioBrief

  5. Pingback: Left to My Own Devices | Left to my own Devices

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