Cardiovascular leaders to review data for Riata and Riata ST ICD leads

Minneapolis Heart Institute FoundationJan 4 2012

2 major health-care providers align to develop a consensus on recent Class I implantable cardioverter-defibrillator (ICD) recall

Cardiovascular leaders will gather in Minneapolis for a one-day summit on Jan. 20, to review data for Riata and Riata ST implantable cardioverter-defibrillator (ICD) leads, which recently underwent a Class I FDA recall. Physicians from the Minneapolis Heart Institute Foundation and Mayo Clinic have organized the summit to develop a consensus regarding the management of patients who have these leads.

Approximately 80,000 active patients have Riata or Riata ST ICD leads in the U.S. These leads, manufactured by St. Jude, have exhibited externalized cables whereby the cables appear outside the lead body on fluoroscopy. Leads with externalized cables may be functioning normally and electrically intact, or there may be signs of malfunction. Therefore, it is not clear how patients with these leads should be managed, which is why the physicians organized the one-day summit.

The summit directors are Robert G. Hauser, MD, senior cardiologist at the Minneapolis Heart Institute- at Abbott Northwestern Hospital, and David L. Hayes, MD, professor of medicine at Mayo Clinic in Rochester, Minn. Both Dr. Hauser and Dr. Hayes are past presidents of the Heart Rhythm Society.

"This Class FDA recall will impact many patients throughout the United States, as well as the caregivers tasked with ensuring the best possible treatment for those patients," said Dr. Hauser. "Cardiac electrophysiologists, along with their fellow physicians and allied health personnel who take care of patients that have had Riata ICD leads should attend this summit."

The consensus on patient management strategies will seek to include follow-up and approaches to leads that have failed and require replacement. Similar ICD lead issues have occurred with other manufacturers and remain an ongoing challenge of the ICD industry.

"We are looking to gather together numerous U.S. and international caregivers to thoroughly review the data and form a unified opinion how to proceed with these patients," Dr. Hauser said. "If you're responsible for the care of these patients, then you should attend this summit."