New York, NY - For all of the brouhaha that has followed the Guidant recall announcements, some experts say the publicity may also have the effect of raising awareness about the true strengths and weaknesses of device-based therapies, the pros and cons of full disclosure, and the real scope of sudden death. Their immediate concern, however, is putting the device risks in perspective.

"The level of panic is absolutely not warranted, the number of devices that have failed is very small, and the risk of device failure is very low," Dr Kenneth Ellenbogen (Virginia Commonwealth University, Richmond) told heartwire. "Every company that has ever made these devices has had problems from time to time with one of them. These are incredibly complicated machines, there is much engineering and mechanical know-how as well as software involved here. There are probably millions of millions of ways that these machines could fail, and I think it's pretty amazing how rarely there is a problem. And this needs to be balanced against the risk of taking a device out and putting a new device in."

Around the globe, electrophysiologists like Ellenbogen are only now starting to meet with patients who received one of 50 000 implanted defibrillators identified by Guidant in collaboration with the FDA as having problems that could lead to malfunction and potential fatalities. According to the recall, the implantable cardioverter defibrillator (ICD) Ventak Prizm 2 DR Model 1861, manufactured on or before April 16, 2002, and the cardiac resynchronization therapy-defibrillators (CRT-Ds) Contak Renewal Model H135 and the Contak Renewal 2 Model H155, manufactured on or before August 26, 2004, might develop a short circuit, preventing them from delivering shocks as required. The Ventak Prizm AVT, Vitality AVT, and Renewal AVT devices have computer-memory problems that can be remedied by programming changes.

Dr Bruce Wilkoff (Source: Cleveland Clinic)

A critical point to remember, says Dr Bruce Wilkoff (Cleveland Clinic, OH), is that the failure rate anticipated for the recalled devices is comparable to the random failure rate for these devices, one that is typically explained to patients before implantation.

"These are manufactured devices, and manufactured devices have accepted failure rates that are very small: over the lifetime of the devices, less than half of one percent," Wilkoff says. "So these failures that we're talking about are in that order. When we put the defibrillator in, we accept that kind of a failure; the only difference here is that we know specifically how some of these failures can happen. This is not all that much news, frankly."

The level of panic is absolutely not warranted, the number of devices that have failed is very small, and the risk of device failure is very low.

The challenge in this instance, he points out, is that the Guidant recall represents an "in-between" situation not often encountered. "There have been other types of recalls—uncommon ones—where the problem isn't either quite this bad and couldn't result in death or where it is absolutely clear that you have to replace the device. In this case, if I replace the device with another device that also has a random component-failure rate, then I'm exchanging a small risk for another small risk and adding the surgical risk on top."

But the difference, says Dr Robert F Rea (Mayo Clinic, Rochester, MN), is that the problems occurring in the Guidant devices are not entirely unpredictable. "Random component failure is just that, it's random, and the thing here is that this is not random, it's systematic. And systematic enough that it has led to a manufacturing change, which I think is one of the things that certainly got the attention of the media. I can tell a patient that there is a low chance of random failure of a device, but that I have no idea how it would occur, how to prevent it, or how to treat it. And I could take one device out and put a new device in and they would have the same risk. But in this situation, I can tell them that I can replace their recalled device and that there is the chance of random-component failure in their new device, but I can tell them that it's not going to occur in the way that's been described for the devices now being recalled."

A separate, yet related, issue, centers on the timing of Guidant's disclosure to physicians earlier this year. Media organizations have trumpeted the fact that Guidant knew of problems with its Ventak Prizm 2 ICDs for three years before alerting physicians that certain devices were short-circuiting. As earlier reported by heartwire and other news agencies, the company received further bad publicity when it was revealed that it knowingly permitted the potentially flawed devices to be implanted in patients at a Minneapolis hospital for roughly four months after discovering the problem.

Guidant has insisted that the risk associated with device failure is infinitesimal compared with the risk of replacing devices and that this at least partly explained the company's decision not to alert physicians earlier to the risk.

Ellenbogen says he thinks Guidant "might have done a little bit better job of alerting doctors sooner," although what the impact of this might have been can never be known.

"Perhaps retrospectively, Guidant wishes it had alerted doctors more up front, but it is certainly being honest and careful about how it's dealing with the problem now," says Ellenbogen.

Wilkoff, by contrast, points out that full disclosure has a downside. "Society has decided that full disclosure fixes things, and that's not true. Guidant, by the way, did inform the FDA, and the FDA made some decisions that are reasonable. Individuals will disagree about the right level of disclosure, but ultimately it is the FDA's job to regulate this kind of information, and I think they probably made the right decision."

The ethics of disclosure, in this case, are complicated by the multiple layers of benefit derived from ICDs and CRT-Ds. The obvious benefit is the prevention of sudden death in the setting of a life-threatening arrhythmia. A second, and equally important, function of these devices is the reassurance they provide.

"These patients like their devices because they provide peace of mind, and if peace of mind is undermined, then as far as they're concerned, things aren't hunky-dory," Rea explained, noting that the situation is common to many conditions treated by electrophysiologists. "It's not just the arrhythmia that causes problems, it's the possibility of the arrhythmia that's constraining. If we do an ablation on someone who has two episodes of [supraventricular tachycardia] SVT a year, the benefit of ablation is much greater than just eliminating two episodes of SVT a year."

Wilkoff points out that the novel effects of ICD therapy extend beyond patients to their families and friends. "I just put a defibrillator in a patient whose family had bought a personal [automatic external defibrillator] AED, and they had been carrying it around and shadowing the patient everywhere he went. The wife told me, 'Until he went in to get his defibrillator, I worried every moment. Finally, when he went in for his procedure, I relaxed.' You can imagine—how do you go to sleep at night? Do you sleep with both eyes closed?"

Thus, he says, a downside of all the media fixation on the recalls could be the erosion of patient peace of mind. "Ultimately, the worst thing that could happen would be that patients could lose their trust in the safety and reliability of their devices," Wilkoff says. "Actually, they are very safe and very reliable, but if the perception is that they are not safe and reliable, that would be a catastrophe."

On the upside, several of the experts who spoke to heartwire pointed out that while media reports may have stirred unwarranted patient anxiety, they may also have the wider effect of improving awareness of sudden death and device-based therapies, and, more generally, streamlining the process of disclosure and informed consent.

As Ellenbogen points out, people tend to think differently about medical devices than they do about drugs, for which side effects are more or less accepted as a necessary evil. "I think people think that when they have a device, they're impenetrable: the device makes them like Superman," he says. "Well, devices don't do that, and in some ways they are far more complex than drugs. Not only is it a matter of manufacturing and engineering, it's a matter of software, too. ICDs and CRT-Ds are all software-based devices with chips and commands and different ways to program them, so there are tons of opportunities to have these little glitches. If you think about it, Bill Gates has to send out new software patches for Windows every week."

Rea, while concerned about the effect of media coverage on his patients, says he welcomes the discourse that has emerged as a result of the recalls and the media spotlight. "This discourse had to happen because we need to have some improved mechanisms for device surveillance," Rea says. "And whether this falls at the level of the government, the level of industry, the level of professional organizations like [the Heart Rhythm Society] or all of the above, I don't know. But it's pretty clear that the discussion in many circles has shifted away from the specifics of the Guidant recall to the larger issue of the process of disclosure and informed consent."

There is the concern that people will confuse the mountain and the
molehill. . . . If people don't get the treatment for the mountain because they are worried about the molehill, that's really a problem.

Indeed, earlier this week, the Heart Rhythm Society announced that it has formed a task force "to begin drafting recommendations for uniform notification standards to inform physicians and patients about safety alerts and recalls of ICDs." According to a press statement, the Task Force on Device Performance will include representatives from the FDA, media, industry, and clinicians, as well as members of cardiac and patient organizations. The committee will then deliver its findings in the fall, at a public-policy conference.

In the meantime, Wilkoff believes the media hype will inevitably raise public consciousness about the true problem of sudden death. "Any time something is in the news, it raises the level of awareness about it. Any publicity is good publicity. This should help people understand that we have a big public problem, which is sudden cardiac death, and we have a fabulous therapy for it. It's not perfect, but despite its imperfections, it does phenomenal job of keeping people alive."

His primary concern, for the time being, is that people at risk of sudden death reading the papers and surfing the internet will be put off ICD/CRT implantation. He says he has already met with patients who are rethinking their plans to get a device.

"There is the concern that people will confuse the mountain and the molehill," Wilkoff explains. "The mountain is this death rate from sudden cardiac death, where maybe 20% of people eligible for the therapy are getting the therapy. And then there's this molehill, which is the fact that the therapy is not perfect and occasionally it's going to fail. And if people don't get the treatment for the mountain because they are worried about the molehill, that's really a problem."