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HRS: Riata lead problems still plague patients

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Best lead-monitoring strategy remains unclear

We need to know what happens to the Riata lead over time, so these are very important findings. The continuous increase in adverse lead events over time is concerning. It raises the question of what is the best strategy for monitoring patients who have a Riata lead. Is there something else we should be doing to better identify patients who are having a lead problem?

Mitchel L. Zoler/Frontline Medical News

Dr. Andrea M. Russo

For example, some electrophysiologists propose testing the ongoing function of Riata leads with a high-voltage test. We don’t yet know if this test would benefit patients, but these data give us better perspective on the risks these patients face.

The cable externalization seen with the Riata lead is an unusual type of lead failure that is different from what we see with most leads for implantable cardioverter defibrillators. In addition, no data exist to support routine extraction of these leads. The Food and Drug Administration has recommended “close monitoring” and regular imaging of the leads, but beyond that different centers handle follow-up in different ways.

We need a better way to screen for electrical failure because x-ray imaging alone does not seem effective enough. It will be interesting to see the results after the Canadian researchers do a more detailed analysis of their data to provide further insight into effective methods for screening patients with Riata leads.

Dr. Andrea M. Russo is professor and director of the electrophysiology and arrhythmia service at Cooper University Hospital in Camden, N.J. She made these comments in an interview. Dr. Russo has been a consultant to St. Jude, Biotronik, Boston Scientific and Medtronic.


 

AT HEART RHYTHM 2015

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One concern the new data did not stoke is the risk for lead shorting that produces sudden ICD failure. “I think [shorting] is not as much of a problem as we previously thought,” Dr. Parkash said.

“These data give credence to the strategy of keeping the Riata leads in place, and, if you are concerned about their function, capping them and putting in a new lead,” commented Dr. Fred M. Kusumoto, an electrophysiologist and professor of medicine at the Mayo Clinic, Florida in Jacksonville. In addition, the new data demonstrate that the problem is in both the 7F as well as the 8F leads. “The entire Riata design was not very good,” he said in an interview. But a reassuring result in the Canadian registry was the low rate of shorting, or high-voltage failure of the lead, Dr. Kusumoto said.

mzoler@frontlinemedcom.com

On Twitter @mitchelzoler

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