St. Jude Medical Inc. wrote a warning letter to doctors in December 2010 that acknowledged the dangers associated with Riata defibrillator leads. According to the letter, cables connecting the heart to implantable defibrillators exhibited a propensity for failure. Subsequently, inside-out abrasion was responsible for sending unnecessary jolts to the heart or failing to deliver life-saving shocks. After dozens of cases revealed these flaws, Riata defibrillators were removed from the market in 2010. However, several healthcare professionals claim to have encountered this so-called “inside-out abrasion” in their own practices between 2006 and 2009.
Manufactured by St. Jude Medical, Inc., Riata and Riata ST Silicone Defibrillation Leads are specific models of cardiac electrodes (thin wires) that connect an implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D) directly to localized cardiac tissue. ICDs and CRT-Ds are devices that monitor and regulate a patient’s heart rate by providing pacing and delivery of high voltage therapy for ventricular arrhythmias.
Unfortunately, however, an influx of adverse reports in 2010 have exposed potentially dangerous and life-threatening complications with these leads. Those with externalized conductors may develop electrical dysfunction and not work as intended. The leads themselves exhibited a propensity to break through their insulation from the inside, exposing electrical wires to the patient. The problem, which ultimately led to a recall last year, could cause defibrillators to send unnecessary jolts to the heart or fail to deliver lifesaving shocks to return chaotic heart rhythms back to normal.
However, before the 2010 warning, healthcare professionals including Alan Cheng, director of Johns Hopkins Medicine’s arrhythmia service; Samir Saba, chief of electrophysiology at the University of Pittsburgh Medical Center; and Ernest Lau at the Royal Victoria Hospital in Belfast, Ireland, say they had encountered this so-called “inside-out abrasion” in their own practices between 2006 and 2009.
When attempting to alert St. Jude Medical, Inc. of the complications they had encountered, these medical professionals were turned away. According to company officials and field representatives, the incidents they described were isolated and not life-threatening.
Company documents collected by the U.S. Food and Drug Administration (FDA) acknowledged that St. Jude had known of these problems since October 2005. Subsequently, several internal audits by St. Jude had already existed by April 2008; each of which acknowledged the problem of inside-out abrasion and suggested wrongdoing.
While it is still uncertain how many cases of inside-out abrasion were revealed, the 2008 audit confirmed 246 cases of insulation breach. The audit, which had began looking broadly at insulation problems in 2006, included a special section on inside-out abrasion, which cited examples of inside-out abrasion in at least two devices extracted from patients and also in lab testing. Included in the report were 32 incidents in which leads were damaged enough to prevent them from providing a life-saving shock.
However, it wasn’t until several publications acknowledged their findings of inside-out abrasion and St. jude issued their warning letter that the healthcare community began to realize the dangers associated with these leads.
“It’s incumbent on the companies to start sharing information early between themselves and the medical community,” said Harlan Krumholz, a Yale cardiologist who studies drug and device safety. “We can’t leave it to chance whether or not we discover problems.”
In response to the growing concerns, Edmund Keung, MD, of the University of California San Francisco, conducted a retrospective analysis of the defective leads. Keung and colleagues performed an electrical survival analysis of the Riata/ST, Quattro, Fidelis, and Endotak leads using data collected by the VA National Cardiac Device Surveillance Center. The study included 24,300 patients who had remote transmissions from 2002 to 2012. Leads included 1,403 Riata/ST, 6,091 Quattro, 5,072 Fidelis, and 2,401 Endotak. Overall, there were 466 lead failures documented during the study.
According to his research, the 5-year survival rate for the Riata/ST leads was 97.5%, which was significantly lower than the rates with the Sprint Quattro Secure and Endotak Reliance G/SG leads (99.2% and 99.5%, respectively, P<0.0001). Among the 47 Riata/ST failures, one patient did not have a revision, 17 underwent extraction, and 29 had new leads implanted without removing the old ones.
“Careful long-term follow-up should be maintained in patients with Riata/ST in order to prevent inappropriate shocks or failed device interventions,” said researchers associated with Keung’s study. “Our results … suggest that large-scale remote monitoring may be an effective tool for continued ICD system surveillance.”
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