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 is a vital topic to the EP community. Those who didn’t arrive early were relegated to a remote viewing station. Even there, the crowd was very large and engaged.
Kenneth Ellenbogen started the presentation with updated data on the VA Riata and Riata ST leads. Interestingly, these data actually showed an increased failure rate of Riata ST as compared to Riata. This stands in distinction to data from the Minneapolis Multicenter Data presented later in the late breaking trials session.
Things got interesting with the discussions of the clinical aspects of Riata lead management. Dr. Larry Epstein of Boston highlighted potential management strategies. He advised against placement of a sensing lead alone if the lead has failed. In explaining why “I’m scared about Riata,” he gave the account of a patient with completely normal lead parameters that fortuitously suffered a cardiac arrest in his hospital. The ICD was ineffective at terminating the arrhythmia and the patient had to be externally defibrillated. To screen for these sort of silent lead failures, he performs fluoroscopy and high-energy shock delivery on his Riata leads before scheduled generator changes.
Dr. Roger Carillo of Miami outlined his approach to Riata lead management as well. He expressed concern over the potential for thrombus formation on externalized leads. He advocated routine fluoroscopic exams on all Riata leads. He then performs transeosphageal echo on externalized leads and anticoagulates those with thrombus. He presented a step-by-step account of the unique challenges of Riata lead extraction. Warning of a variety of pitfalls and complications, he added, “if you fail to follow any of these steps, the lead will not forgive you.”
The session ended with more calming words from Charles Love of Columbus. In his talk on Durata leads, he repeatedly emphasized “it is a very, very different lead.” He spent some time going over the design of all St. Jude leads and pointed out the potential benefit of the Optim insulation coating added to Durata and Riata ST Optim leads. Active registries on these newer leads continue to show robust performance approaching 5 years. He did acknowledge the small numbers of leads in late follow up. But in the question and answer section, not all were convinced. Dr. Larry Epstein stated, “I still have issues with trust.”