CDU Washington Writer

WASHINGTON – ICD malfunctions appear to be on the rise, according to a government report issued during the mid-September “Policy Conference on Pacemaker and ICD Performance,” and product surveillance needs to improve as a result.

The one-day gathering, convened by the Heart Rhythm Society (HRS; Washington) and the FDA, was provoked by the notable ICD recalls issued earlier this summer by Guidant (Indianapolis). While that recall continues to garner a good bit of attention, an FDA study that identified an increased rate of implanted device malfunctions between 1990 and 2002 was initiated two years ago, well ahead of any concerns raised by the recall, but indicated more than 17,000 device malfunctions over the 12-year study period.

Conference chair Mark Carlson, MD, opened the meeting by saying that its goal was to improve systems for collecting, analyzing and communicating device performance data. “This is the first step to solve a complex issue of national and international concern,” Carlson said as the gathering got under way. And after it ended, he concluded that he was “more confident today as a result of this conference than I have been before. I think that this is a message that we can send to patients that will be heartening to them.”

This confidence should be for improved future communication of problems concerning implantable cardiac devices, he said.

Guidant’s ICD recall, which surfaced in the midst of its planned acquisition by Johnson & Johnson (New Brunswick, New Jersey), clearly has shaken public confidence in the technology. While the recalls and subsequent lawsuits against Guidant have cast a shadow over the proposed $24.5 billion merger, it has resonated to the broader device industry and even more loudly among patients. A conference attendee who uses a cardiac device expressed numerous worries and charged that “the recent corporate behavior has made many of us feel like ticking time bombs.”

Such concerns were noted by Daniel Schultz, MD, director of the FDA’s Center for Devices and Radiological Health, who acknowledged that the agency sometimes falls short in “being able to connect the dots.”

Throughout the meeting, numerous speakers presented their opinions on fixing the system in light of risk/benefit considerations, including a well-received suggestion to establish quasi-data safety monitoring boards to observe marketed product performance. From government officials to industry representatives, and practicing physicians to patients, a range of stakeholders had something to say concerning better information gathering, analysis and dissemination to the public.

“We need your help in sending this raw information to us, often in the form of reports on what went right and what went wrong with some of the products your patients use,” said Scott Gottlieb, MD, the FDA’s deputy commissioner for medical and scientific affairs. “We need your help in weaving this information into useful facts.”

Among the recommendations were calls for more active surveillance, rather than the passive system currently set up at the agency. “The passive surveillance system is necessary, but not sufficient,” admitted Thomas Gross, CDRH’s director of post-market surveillance.

To overcome that, some suggested that professional medical societies set up reporting networks, and others encouraged the use of other databases already in existence to augment FDA systems. Additional suggestions called for mandating reports from clinicians and implementing device registries on an international basis.

Along those same lines came calls for using claims data, such as that culled from insurance companies, managed care organizations, the Medicare and Medicaid programs and the Department of Veterans Affairs.

“Here’s data that’s sitting there,” said David Malenka, MD, a professor at Dartmouth College (Hanover, New Hampshire), adding that such information is routinely collected and would cost nothing extra to share. “I think we need to look at it and plumb it,” he said.

Additional national registry suggestions called for electronic monitoring and enhanced coding, as well as for returns of all implanted devices that have been removed for any reasons, not just because of suspected defaults. That would include post-mortem evaluations of devices, though such efforts admittedly could lead to logistical hurdles related to retrieving products and gaining family consent.

For products found to be defective, registries should better classify the types of malfunctions to delineate relatively minor problems such as battery drain to more serious matters like outright failure. “Understanding the frequency and root cause of failure mechanisms, along with focus on improvement, is one basis for continuous quality improvement,” said Joseph Smith, MD, PhD, a senior vice president at Guidant.

A number of patient advocates called for better dialogue with product users, such as “Dear patient” letters. Others suggested that the industry and the FDA better align their advisory communications to the public.

“Our patients really want to be appropriately informed,” said Michael Barber, MD, PhD, the director of pacemaker and arrhythmia services for Centura Health-Penrose/St. Francis Healthcare Systems (Colorado Springs, Colorado). He noted also that patients want information from their doctors, not the media.

At the same time, industry representatives cautioned against over-reactions and misinterpretation of safety concerns, noting that all interested parties should not forget that implanted cardiac devices have proven vital. According to the Advanced Medical Technology Association (Washington), an estimated 30,000 lives were saved via use of ICDs during the same 1990-2002 period studied by the FDA.

And as noted by Anne Curtis, MD, president of the Heart Rhythm Society, all stakeholders must continue to work to “ensure continued patient confidence in these life-saving devices.” Going forward, the organization is continuing to collect public comments on its web site, where it will soon publish a full account of the proceedings of the policy conference.

FDA: ‘Trend’ must be addressed

In timing coordinated with the meeting, the FDA issued a statement promising faster, more efficient reporting of problems with implantable devices to the public. Outlining a variety of ways to achieve this better communication, the FDA also issued a report on malfunctions of these devices from 1990 through 2002, saying essentially that the public does not have to be alarmed by an increase in malfunctions during “the last half of the 1990s,” but that the agency must address what appears to be “a trend.”

As a broad conclusion, the report said that the FDA’s study indicates “that careful monitoring of device performance is needed, along with better ways for doctors to return explanted devices to companies for analysis and to report adverse events.”

The report was presented at the conference. Posted on the FDA’s web site early the morning of the meeting, the results of the study, the agency said, documented 17,323 of these devices explanted during the study period because of malfunction – about equally split between pacemakers and ICDs – with 61 deaths attributed “directly” to these malfunctions.

This troubling study data offered material for both public discussion and one-to-one buzz at the HRS gathering, with those representing the device manufacturers offering an early defense: the study's timing represented earlier models of the ICD and pacemaker technologies, often implanted before the study period, and that the more recently implanted devices reflected newer, more reliable technology and probably lower rates of malfunction. According to the study, the 17,323 devices explanted from 1990 to 2002, were from a total of nearly 2.7 million devices – 2.25 million pacemakers and 416,000 ICDs implanted in the U.S. It reported an annual ICD malfunction replacement rate of 20.7 per 1,000 implants, calling this “significantly higher” than the pacemaker malfunction replacement rate of 4.6 per 1,000 implants.

“The [pacemaker] malfunction replacement rate decreased significantly during the study,” the FDA statement said. “In contrast, the ICD malfunction replacement rate trended down during the first half of the 1990s but increased during the latter half of the study.” Additionally, it said that more than 50% of the ICD malfunctions occurred during the last three years of the study. It said that 61 deaths during this period were “confirmed as the direct result of the device malfunctions,” but that the “vast majority” of the documented problems “did not lead to death or serious injury.”

The FDA’s Gottlieb characterized pacemakers and ICDs as “[saving] many lives, and the benefits of the devices clearly outweigh the risks. All sophisticated medical devices like these have certain risks.” He added: “Our challenge remains to uncover these risks, measure them, and make information available to patients and doctors to help guide their personalized decisions about where the benefits of technologies like these outweigh known or potential risks from their use.”

In the agency’s statement, CDRH director Schultz said, “there is no action that [patients] need to take as a result of this report.” But he said it “does alert FDA that there is a trend that needs to be addressed and points out the need for our agency to improve the way it regulates these products, and we are doing just that. We have already begun to better coordinate our pre- and post-market regulation of these devices, to strengthen the link between how these products are approved and how they are monitored after clinical use. We are also considering whether we need additional data from manufacturers in their annual reports, and how we can communicate more effectively with physicians and patients when these devices malfunction.”

Earlier, Schultz had responded to a New York Times article discussing the industry’s reporting of device malfunctions by saying that the FDA did not have the necessary resources to review all of this information.

In its statement, the FDA said it was proposing several ways of improving the reporting of implantable device problems. These include:

• Increasing CDRH’s ability to obtain critical information about medical device failures and to communicate this information clearly and rapidly to physicians and the public so they can use it to make sound, informed medical decisions.

• Better coordination of company annual report information within CDRH to allow for an integrated approach, leading to more efficient and timely review.

• Formation of a working group, “for ICDs in particular ... tasked with improving communication within CDRH so information about problems with ICDs and pacemakers can be quickly reviewed and evaluated by staff, and shared more rapidly with the public.”

And it proposed “operational changes” in CDRH’s post-market programs for reviewing the performance of medical devices once they are approved and “in general use.” The changes “being considered,” the FDA said, are:

• Design of an electronic system “for adverse event reporting to make the information available to CDRH analysts more quickly.”

• “Targeting resources to inspections of firms that manufacture potentially higher risk devices.”

• Developing guidance for companies “that submit annual reports to make sure they provide information about failures and problems in a way that assures prompt, efficient review by FDA.”

• Developing guidance that “more clearly defines when changes to devices need prior review and approval by FDA before being implemented.’

In addition to these recommendations and those likely to be developed by the HRS as a result of the meeting, recommendations are expected from the industry by Guidant, which is establishing an independent panel to examine the issue.

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