Doctors question FDA guidance on flawed heart device

Published date : 20 August 2012
Article date : 20 August 2012

In the U.S., the FDA's advice to routinely X-ray patients with a flawed St. Jude's Riata defibrillator lead has prompted top heart doctors to question the reasoning behind this decision. The agency doesn’t recommend that doctors treat patients any differently if they detect flaws and this coulod mean potentially subjecting thousands of patients to unnecessary medical tests.

The lead connects the heart to devices that shock irregular rhythms back to normal. Wires inside Riata leads, which St. Jude stopped selling in 2010 and were recalled last year, are prone to breaking through their insulation. In an unknown share of cases with insulation problems, the leads also have life-threatening electrical malfunctions.

X-rays can detect extruded leads to reveal loose wires floating in the heart. However, removing them can be dangerous and as St. Jude has pointed out, many extruded or externalized leads continue working normally. The FDA has therefore suggested that doctors watch patients carefully, mirroring the same guidance they offer for normal Riata devices.

The FDA is requiring St. Jude to conduct new studies to gather more information about the failures and management of patients with Riata leads.

A 2010 study of a commonly used techniques to remove the leads found that major complications occurred in about 1.5% of patients although doctors at some elite facilities who specialise in removing leads have lower complication rates. Cardiologists typically agree the procedure should only be performed by practiced experts.

Source: Christopher Weaver, Wall Street Journal, 17 August 2012 (U.S.)

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