Guest Post: FDA Clarifies Riata Imaging Recommendations

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 natural history of these insulation failures and risk factors that lead to failure.

FDA recommends physicians perform systematic imaging of their patients with Riata and Riata ST leads because”

“We believe that assessing the current condition of Riata and Riata ST leads is likely to help health care providers develop individualized plans for their patients, which may include recommendations on the frequency of remote monitoring and the necessity and frequency of repeat imaging.”

Specific recommendations of imaging are also spelled out.  Acceptable techniques include:

  • 2 view Chest X-Ray.  OK to use study obtained in last 3-6 months.  Recommend working with radiologist to obtain and interpret images.
  • Fluoroscopy

FDA also suggests that after this initial imaging, physicians “may consider performing fluoroscopy of the lead at the time of the generator replacement to check the lead condition.”  They also believe it is reasonable to repeat imaging to follow up manifest visual abnormalities.

Guidelines for management of specific clinical scenarios generally distill down to providing close follow up with attention to device performance.  They do not recommend extraction or replacement of leads with normal electrical function.

So where does this leave doctors and patients?  In an excellent perspective, cardiac electrophysiologist Dr. John Mandrola probably speaks for many of us when he writes of his frustration with these new mandates.  In medical school, we were taught never to get a test unless it influenced the subsequent management of the patient.  As John writes, “nobody knows the best way to manage these leads. Not the professors, not us masters of obvious in the clinical world, and surely not the amalgamizers in cubicles at the FDA.”  FDA indicates that physicians should develop “individualized plans for their patients.”  No room, however, is given to the thoughtful provider who may feel that his individualized treatment plan might best not include performing routine x-ray imaging.

Comments

  1. Jenny Smith says:

    As a patient who has a Durata Promote ICD, which was implanted in January of 2010, I am sad to say that I have a problem with one of my leads already. Actually, I had another lead that wasn’t inserted correctly and I had to return to have it extracted and a new one inserted. This was a mere 2 months after my initial surgery. I am thankful, however, for the device itself, because, after its implantation, my erstwhile ef of 15-20 percent rose to 45-50 percent almost immediately. Mine is an electrical issue,not a heart disease situation. So, with all of the flaws and frightening possibilities, I remain grateful that these kinds of devices, are available. My electrophysiologist has agreed to order a fluoroscope so that we can see if the compromised lead is frayed or crimped. Once he determines its disposition, we’ll know where to head.

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