It’s nail-biting time for hundreds of thousands of patients worldwide who have had a Riata defibrillator implanted next to their hearts (79,000 in the U.S., 5,300 in Canada, 4,000 in Australia – just for starters). The recent news about the Riata recall might feel like being told you now have a ticking time bomb inside your chest. Trouble is, you just don’t know if that time bomb will start firing when it shouldn’t, or fail to fire in time to resuscitate your heart when it should.
And worse, neither does your doctor.
In December 2011, following reports of premature erosion of the insulation around the electrical conductor lead wires in these devices, the FDA ordered an urgent Class 1 recall (the most serious type of recall) of all Riata and Riata ST Silicone Endocardial Defibrillation Leads manufactured by St. Jude Medical Inc. Here is the FDA recommendation to all patients with these Riata devices implanted in their bodies:*
“Patients should contact their cardiac physician to determine if they have the recalled leads, and to request additional information regarding care and monitoring. Physicians and patients should discuss the best approach to take based on individual need.”
Then the FDA got even tougher: a press release this week tells physicians that their patients who have one of these recalled Riata ICDs implanted should undergo “either a 2 view chest x-ray or fluoroscopy to check for abnormalities in the insulation surrounding the leads.”
Many cardiologists do not seem to like the FDA telling them what to do. Meanwhile, worried heart patients are curious about why more of their doctors are not screaming blue murder on their behalf, instead of demonstrating sputtering indignation about perceived FDA interference.
This isn’t the first case of an ICD recall, as all electrophysiologists will assure you. Over the past five years, device manufacturers like Medtronic, Boston Scientific and St. Jude Medical have had significant ICD issues resulting in device recalls. Let’s consider why heart patients are now moved to finally speak out about a recall.
But first, here are the basics of how this amazing little invention is designed to work: an implantable cardioverter defibrillator (ICD) is a small device that can be surgically inserted inside your chest if you’re at risk for certain types of heart arrhythmia, or if you have a heart condition that puts you at high risk forsudden cardiac arrest.
Your ICD has wires with electrodes on the ends that connect to one or more of your heart’s chambers to monitor heart rhythm. These wires connect to a small metal box implanted in your chest or abdomen. The box contains a battery, pulse generator, and small computer. When this computer detects irregular heartbeats, it triggers the ICD’s pulse generator to fire off electrical pulses; lead wires then carry these pulses to the heart. These leads typically have layers of insulation that protect electrical conductor wires inside the lead.
In the recalled Riata leads, it’s this insulation that’s been found to be defective - resulting in premature erosion of the insulation around the electrical conductor wires, known as insulation failure, as shown at left. (A study* reported in the medical journal Heart Rhythm, for example, showed that Riata’s structural lead failure with externalized cables like these was seen in 33.3% of patients, and 31% of the leads with exposed cables showed electrical failure).
When your ICD is working as it should, any irregular heart rhythm will trigger low-energy electrical pulses to prompt your heart to beat at a normal rate again. If these low-energy pulses can’t restore your heart’s normal rhythm, you might experience the defibrillator’s painful high-energy shock. One ICD patient described this shock to me as “feeling like somebody had thrown a baseball at my back as hard as they could!”
Even with leads that are working just fine, we know that ICDs can sometimes fire off unnecessary electrical pulses or shocks to the heart. These can be caused by damage to the wire, or by a very fast heart rate (likely due to physical exertion or forgetting to take your heart medications).
ICD pulses sent too often or at the wrong time can damage your heart or trigger an irregular, sometimes dangerous heartbeat. Patients – and their families – can find these shocks frightening and traumatic. The typical ICD recipient, even at the best of times, must overcome both the stress of experiencing a life-threatening cardiac arrhythmia as well as the challenge of adjusting to an ICD implanted inside their bodies. Some patients report the phenomenon of “phantom shocks”, in which an electrical shock is felt despite no recorded discharge from the device.
Indeed, clinical trials demonstrating the effectiveness of the ICD have focused primarily, as you might expect, on mortality outcomes – not so much on the quality of life issues affecting patients who wear them day in and day out. A number of studies have subsequently shown that in some ICD patients, however, the potentially reassuring and life-saving benefits of living with an ICD are outweighed by accompanying symptoms of anxiety and depression, particularly for patients with a “shock history” or for those who are under age 50. The reputation of the ICD as a “shock box” remains a significant source of anxiety to potential patients. Anxiety in fact is common – some estimates peg the percentage of clinically significant anxiety disorders among ICD patients at up to 38%.
And these are the ones who have not had their potentially defective ICD leads publicly targeted in an urgent Class 1 device recall.
But here’s the troubling reality now faced by patients who have had Riata ICDs implanted: the FDA, St. Jude, and the Heart Rhythm Society all recommend that these defective leads should NOT be routinely removed from patients (even if the cables have broken through the eroded insulating coating) because of risks associated with the surgery required to remove the leads.
In case doctors have not figured this part out yet, the scenario is your basic nightmare if you’re a patient now living with a Riata ICD.
Hugo Campos may well be one of the highest-profile ICD recipients around, famous among heart patients for his personal fight to be able to access his own cardiac data. Here’s an excerpt from what Hugo had to say in April in his pull-no-punches reaction to the Riata recall:
“In a world in which physicians’ views are sometimes marred by speaking fees and consulting arrangements with medical device companies, patients must rely on the media for information about recalls.
This is about the Class 1 recall of a lead that’s been implanted in 79,000 U.S. patients. These are people who, like me, were told the device would be there to save their lives in case they ever needed it, and who are now learning that this might not be the case.
“This is about how poorly the ‘the guys in the suits’ have handled this crisis so far: defensively and arrogantly. And how it reflects on their company’s image and reputation.
“Doctors and medical device companies should realize that a new world has emerged. It is a world in which patients are more empowered, equipped with information, and engaged in their care. We are connected through social media like never before and we are talking. We’re talking about doctors, therapies, brands of devices and even recalls.
“You can no longer control the message. Patients have the right to know. After all, we are the ones living with heart disease.
“That’s how WE put ourselves at the center of a device recall.”
Even the exact number of patients whose Riata ICD leads are defective is apparently uncertain, because the flaws are hard to detect with existing tests, and failure may not occur until an electric shock is needed.
Fran Lesicko, a psychologist who credits her ICD with saving her life nine times in the 11 years following her own sudden cardiac arrest, has this powerful reminder for us about the definition of “failure” in these recalled ICD leads:
“For many who have experienced sudden cardiac arrest and also have needed an ICD shock to save them, to have it fail means death.
“Hiding information from patients (‘what they don’t know won’t hurt them’) is deceptive and inappropriate. And it COULD hurt the patients.
“We used to have this attitude toward terminal patients, and now we know better.”
Even worse (and can it get much worse?), here’s what cardiologist Dr. Robert Hauser of Abbott Northwestern Hospital and the Minneapolis Heart Institute told his peers attending the American College of Cardiology 2012 Scientific Sessions in March:
“While investigators have focused on externalized ICD cables, our study suggests that the greater risk to patients is the loss of the insulating barrier between high-voltage components, particularly between an ‘outside-in’ abraded high-voltage defibrillator cable and the shocking coil or pulse generator can.”
Such short circuits are believed to be the cause of 22 deaths so far in patients with Riata leads described in the data Dr. Hauser presented at the ACC sessions, which were also published online in Heart Rhythm on March 26, 2012. He explained:
“Many of those deaths could not have been predicted; there were no signs. Generally, the ‘radiographically opaque’ shocking coils and generator cans will block fluoroscopy from showing how close they may be to insulation breaches.”
When interviewed by Heartwire in March, Dr. Hauser warned that, of the thousands of patients currently living with the Riata leads covered by the recall, some of them have insulation failures that are positioned in such a way that they are at risk of causing potentially fatal high-voltage short circuits “and there may not be a good way of identifying them.”
Meanwhile, as reported in Forbes recently, a recent St. Jude-sponsored physicians’ webinar about the Riata recall featured Dr. Neal Kay (who happens to have “consulting arrangements” with ICD manufacturers St. Jude, Medtronic and Biotronik) calmly reassuring his audience that “more than 85% of the externalized conductors continue to function normally.”
Dr. Bruce Wilkoff is the president of the Heart Rhythm Society, an organization that coincidentally receives over half of its annual funding from drug and device manufacturers – including St. Jude Medical Inc.
He was in Australia this week speaking at the 2012 Cardiac Society of Australia and New Zealand meetings in Brisbane. Australia’s Therapeutic Goods Administration (the country’s regulatory agency for all drugs and medical devices) had already issued a directive back in May to 4,000 patients there living with Riata ICDs: see your cardiologist, and undergo X-ray or fluoroscopy if you experience adverse events.
And speaking of adverse events, when such failures occur in the U.S., they are voluntarily reported by hospitals and doctors into a public FDA database called MAUDE, as Hugo Campos explains.
Manufacturers like St. Jude Medical Inc. are required to report deaths and injuries, but there are an unknown number of delays in adverse event reporting by all manufacturers. Thus the list of adverse events reported into MAUDE is incomplete. In fact, as reported by cardiologist Dr. Rita Redberg, testifying to the House Oversight Committee on June 2, 2011, only 5% of all adverse events are ever reported.
But I digress. Back to Dr. Wilkoff, who was speaking to a packed audience of doctors attending the Brisbane conference, where he dismissed Riata’s insulation failure problem with externalized leads as primarily just a “cosmetic” issue, adding:
“Externalized cables make you feel bad [but] we’re not treating how we feel.
“If you didn’t take a chest x-ray, you wouldn’t even know.”
I’m assuming from this kind of appallingly unfortunate word choice that neither Dr. Wilkoff nor any of his St. Jude pals are walking around with a Riata ICD time bomb ticking away inside their own chests.
Since I started following this story, I’ve observed growing online resentment from physicians over FDA’s recent attempts to interfere with their clinical practice by demanding x-rays or fluoroscopy of all U.S. patients implanted with the recalled Riata leads. As Dr. John Mandrola writes in his highly recommended Trials & Fibrillations column:
“It is an ominous precedent when a powerful agency inserts protocol and dogma into a situation best handled with nuance and shared decision-making.”
I was glad to see that Dr. John, unlike a number of his electrophysiology colleagues, at least acknowledges the most important party in this whole mess: the patient.
But here’s how he does it: he notes (in a surprisingly patronizing fashion) that “some patients would be devastated to know that their normally functioning lead had an externalization”.
The trouble is that, as Dr. Hauser has warned, a “normally functioning” Riata ICD lead today may very well be the cause of death tomorrow.
And as one Riata ICD patient (one of Dr. John’s column readers) responded to being thusly patronized:
“I’m the owner/operator of one of these leads, and I want a fluoroscopy, and I want to see the fluoro, at least if it’s abnormal.
“I’m sure that, as you write, everyone’s response thereafter might be different, but I for one want the information, then the doctor’s perspective, and then I want to decide.
“I’m one of those primary prevention people who didn’t sign up for the prospect of worrying about hairy looking leads floating around my chest. It’s already way more than I bargained for.”
Riata ICD patients are right to be worried, and yes, downright angry.
Why would patients be expected to meekly wait for “nuance” when what they deserve are accountability and safety?
Dr. Laurence Epstein of Brigham and Women’s Hospital in Boston admitted in an illuminating Heartwire interview that even the best ICD lead, when implanted poorly by a physician, is not going to survive. For example:
“Some ICD leads undergo quite a fair amount of stress. You can’t account for knuckleheads putting them in. Some lead failures are going to be expected, some of them just because of the harsh environment they’re in. Others fail because people put them in in horrible ways.”
I don’t know about you, but I find it distressing when cardiologists describe their professional colleagues as “knuckleheads” who are surgically implanting ICDs into their patients “in horrible ways”. And if this assessment is indeed true, someone please tell me what Dr. Epstein et al are doing to keep patients safe from the knuckleheads out there who want to operate on them.
Perhaps this is why some of us may actually be feeling genuinely grateful to the FDA for deciding that somebody, somewhere, has to finally do something to address this madness.
* Sunthosh V. Parvathaneni et al. “High prevalence of insulation failure with externalized cables in St. Jude Medical Riata family ICD leads: Fluoroscopic grading scale and correlation to extracted leads”. Heart Rhythm. Volume 9, Issue 8, August 2012, Pages 1218–1224
** Read the full text of the FDA Safety Communication: Premature Insulation Failure in Recalled Riata Implantable Cardioverter Defibrillator (ICD) Leads Manufactured by St. Jude Medical, Inc.
Portrait of Hugo Campos: Cristiano Siqueira
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Q: Have you had a Riata ICD implanted?