St. Jude’s defective Riata defibrillator leads, which were recalled last year over possible risks of injury or death, are leaving patients with difficult options.
The U.S. Food and Drug Administration (FDA) recalled the St. Jude Medical’s Riata defibrillator in December, although some 76,000 Americans remain implanted with the faulty device, said the Star Tribune.
As we’ve mentioned, many problems caused by St. Jude’s Riata leads could have been prevented if more initiative had been taken to monitor its safety track record in patients. A recent study published in New England Journal of Medicine indicated that the Riata was recalled in 2010 due to the likelihood the metal leads used to send power to an implanted cardiac defibrillator would break free of their insulation coating. When defibrillator leads detach, it causes the life-saving heart device to stop working. If a defibrillator ceases to deliver a regulated shock to a patient’s heart, it could prevent a life-saving treatment to occur and if the wires deliver an unnecessary shock, patients’ lives are placed at significant risk.
Implantable defibrillators are meant to keep the heart beating regularly and to shock the heart back to its proper rhythm in the event the heart stops. A defibrillator lead is a thin wire attached to the heart wall that delivers an electrical impulse via the defibrillator. If the wire perforates the heart wall, the heart can bleed into its pericardial sac causing cardiac tamponade, a lethal condition in which pressure builds around the heart preventing it from beating effectively. Unfortunately, heart perforation is generally discovered after the wire has made its way through the heart wall.
Patients are unsure as to how to proceed with defective Riata leads hooked to their hearts, creating fierce debate and significant anxiety. St. Jude Medical has initiated an evaluation study of at least 500 patients in the United States, Canada, and Japan and has urged physicians to monitor patients implanted with the Riata device, said the Star Tribune.
“We need more data and more information to inform decision-making,” Dr. Mark Carlson, medical director and senior vice president at St. Jude, told the Star Tribune. “Now that it’s recalled, we don’t have the data we need to manage it,” said Dr. Robert Hauser, a cardiologist at Abbott Northwestern Hospital in Minneapolis, who conducted a “Riata Summit” on this January, said The Star Tribune. “We are ill-prepared to counsel our patients because we do not have the clinical evidence to support any recommendations,” he added.
St. Jude recalled the Riata leads last year but stopped marketing them in December 2010 after numerous reports indicated wires were breaking through the insulated coating. Further complicating the situation caused by the defective Riata leads is the lack of guidance data, informing patients and surgeons of the best course of action for Riata patients. In some cases, the lack of a standard course of action results in more experimental surgeries and puts more patient lives at risk.
Despite the call for more information, St. Jude defended its record-keeping and adherence to safety tracking, recently telling Bloomberg it has “the most active post-market surveillance program” among other companies competing with it for defibrillator lead sales.
Physicians and their patients have three options, said The Star Tribune: Leaving the lead connected and regularly monitor, although this can cause greater anxiety in patients; disconnect the lead, but leave it in place while inserting new wires next to it; or remove and replace the entire device. These last two options, of course, come with significant risks to patients who are already at cardiac risk, and surgery can be challenging and dangerous, noted The Star Tribune.