Rockville, MD - The US Food and Drug Administration's public statement [1] on Medtronic's decision to suspend sales of its Spring Fidelis defibrillator leads seemed intended to sooth nerves. But the reported reaction from Congress and public-interest groups [2] seemed as if the lead "recall" were an emerging public-health threat; or were they reacting to frustration borne of déjà vu?

"We know it can be frightening for a patient to learn that a product they rely on so much might have a serious defect," noted the FDA statement. "Patients can be assured that the likelihood of fracture is very low, and the FDA is committed to ensuring that the risk to patients is minimized."

That day, Medtronic had announced a small rise in the lead's fracture rate, not a statistically significant increase but one that seemed likely to become so over time [3,4]. As heartwire recently reported, five patients had died, possibly as a direct or indirect result of Spring Fidelis fractures. About 268 000 of the leads for implantable cardioverter-defibrillators (ICDs) and cardiac resynchronization therapy/defibrillator (CRT-D) devices had been implanted in patients worldwide, the company stated.

We know it can be frightening for a patient to learn that a product they rely on so much might have a serious defect.

"We recognize that some patients and healthcare professionals might inappropriately interpret the word 'recall' to mean that the devices must be surgically removed and returned to the manufacturer," the FDA stated. That's not what it is recommending, the agency emphasized, although no new ones should be put in patients. Any problems can be handled at the next scheduled clinic visit, it said.

Two days later, the Wall Street Journal reported, "Plaintiffs attorneys, a consumer group, and Iowa Sen Chuck Grassley [R-IA] are examining the history of the Sprint Fidelis leads" [2].

According to the article, from reporters Anna Wilde Mathews and Thomas M Burton, "Mr Grassley, a Republican, last night sent letters to the company and the [FDA] asking for more information about the leads. Separately, consumer group Public Citizen argued in a letter that the company and agency should have taken action sooner."

It went on, "In addition, a group of plaintiffs attorneys, which has been a leader in major heart-device lawsuits, filed suits against Medtronic related to the Sprint Fidelis leads in federal court in Minneapolis and Puerto Rico, according to Hunter Shkolnik, one of the lawyers."

Dr William Maisel

Such swift reactions to Medtronic's announcement may indicate a cautious new familiarity with ICDs, after a series of highly publicized recalls in 2005, most involving Guidant devices with design flaws that proved fatal in a few cases. As chronicled by heartwire, the medical literature, and just about every newspaper, those events and how Guidant handled them brought criticism to the company and the FDA and were followed by reforms in the oversight and reporting of ICD and pacemaker safety. Still, many are concerned, they likely undermined the confidence of patients and referring physicians in one of the most successful therapies cardiology has to offer.

"The bad press did two things. It educated patients and physicians, but it also left them with a bad taste in their mouth regarding the therapy," Dr William Maisel (Beth Israel Deaconess Medical Center, Boston, MA) told heartwire. "I'd say 90% of their questions are negative, questions about what can go wrong instead of about how the device can save their lives."

The current rate of ICD implantations throughout the US is widely perceived as stagnant or close to it despite a growing candidate population, a persisting belief that there are many more patients who qualify for ICDs than are actually getting them, and the opening up of the devices' Medicare reimbursement criteria.

When the Centers for Medicare and Medicaid Services (CMS) expanded Medicare eligibility criteria for primary-prevention devices—first by obviating electrophysiologic screening after the MADIT-2 trial and then, in 2005, extending it most patients with an LVEF <35% based on SCD-HeFT [6]—many predicted an explosion of ICD use [7,8].

All that growth in the therapy would put an untenable burden on third-party payers, and there may not even be enough qualified physicians to do the procedures, it was said [9].

Physicians have not spent enough time talking to patients about how it's possible to avoid shocks, infections, and lead problems to make the real risk of the intervention much smaller.

Maisel observed that ICD use climbed exponentially until sometime in 2005 or so, tapering off as the Guidant recall drew attention to the device's limitations. Also, projections based on identifying and referring increasing numbers of eligible patients proved wrong, at least for now.

The reasons all qualified patients aren't getting the devices have changed over the years, observed Maisel. "If you had asked two or three years ago, the answer would have been a lack of education [about ICD treatment guidelines] among referring physicians."

But in the past year or two, he said, it's an image problem. The recalls and unprecedented public scrutiny "took a bit of the shine off the therapy." Although many referring physicians seem to believe the ICD failure rate is high, "the actual risk of a device malfunction harming a patient is very small," he said. "The overall therapy is very effective at doing what it's supposed to do, reducing the risk of sudden death."

Dr Bruce Wilkoff

Dr Bruce Wilkoff (Cleveland Clinic, OH) confirmed that the rate of ICD implantations at his center has been flat for at least the past year. "It has a lot to do with perceptions of risk vs benefit," he agreed. In the wake of the Guidant recalls, patients and their doctors "had blown concern for the risks of the therapy out of proportion," he told heartwire. "And physicians have not spent enough time talking to patients about how it's possible to avoid shocks, infections, and lead problems to make the real risk of the intervention much smaller."

Guidant had reported an 15% increase in US sales of ICDs from 2003 to 2004 (18% worldwide) but, beset with device failures, 2005 sales in the US fell off by 12% (although by only 6% worldwide) [10,11]. Its US defibrillator sales declined further during the first three quarters of 2006 but then rose 13% in the fourth quarter [12].

The sense that you get a benefit from a defibrillator from the first day it's put in, reassurance that you are protected all the time—that part of the benefit has to be sold.

Over at Medtronic, worldwide ICD and CRT-D sales surged 23% from fiscal years 2005 to 2006—largess, in part, stemming from Guidant's troubles; they then leveled off, rising a scant 1% in fiscal year 2007 [13].

Both companies foresee a "stabilizing" ICD market in the US and elsewhere for the near future, at least officially. Medtronic spokesperson Kyra Schmitt told heartwire that the company projects a worldwide rate of 225 000 to 250 000 ICD and CRT-D implantations per year over all device manufacturers.

Use of the devices will grow again, "but it's going to grow more slowly," according to Wilkoff. "There's a fair amount of education that needs to be done, but it's going to take some time." One way to help regain the confidence of patients and physicians would be to portray ICDs as more than potentially life-saving. "The sense that you get a benefit from a defibrillator from the first day it's put in, reassurance that you are protected all the time—that part of the benefit has to be sold," he said.

"The therapy is obviously here to stay," observed Maisel. But, "I think it's unlikely we'll see the days of 15% to 20% growth again."

Dr Mandeep R Mehra

Dr Mandeep R Mehra (University of Maryland, Baltimore) agreed that fallout from the Guidant recalls "may have created some physician angst" that cut into ICD referrals, but told heartwire what he thinks is a more likely reason. "Taking care of the prevalent population created a new bolus of procedures." Referrals for ICDs did go up with broadening Medicare eligibility, he said, but that growth wasn't sustained and, in fact, soon subsided to a "steady-state level." Mehra acknowledged that this scenario hasn't necessarily been documented, but "it makes simple sense."

Agreed Dr Clyde Yancy (Baylor Heart and Vascular Institute, Dallas, TX), "At the beginning, you may have had lots of patients with a [primary-prevention] indication for the device, but in real time, the new candidates coming online for eligibility are not as many as people think."

Dr Clyde Yancy

Yancy told heartwire that the Guidant-recall saga probably didn't tarnish the ICD's image enough to entirely account for flagging implantation rates. "I think, at best, that's a minor reason." The major reasons are probably numerous and have less do with either recalls or reimbursement criteria than industry analysts think, he said.

Evidence-based therapy, whether drugs or devices, can take years to reach the level of routine patient care, Yancy observed. It's taken about 18 years for ACE inhibitors to reach the currently high level of guidelines-consistent use in heart failure, about 80%. Even beta blockers are at only about the 70% level, he noted.

As we persevere and uptitrate the beta blockers, we actually see ejection fractions improve to a point where they no longer meet the criteria for device implantation.

"That's been driven hard by guidelines and continuing medical education programs, and we're just barely moving the needle—getting better, admittedly, but not where we should be," Yancy said. "So one could make the argument that, based on the penetration of devices now, they could be ahead of the curve."

Mehra advanced the idea that the highly developed state of neurohormonal drug therapy for LV dysfunction and heart failure could help explain why ICDs haven't taken off as expected. "With a good high dose of beta blockers, many of these patients initially might look like we should put a device in them, but as we persevere and uptitrate the beta blockers, we actually see ejection fractions improve to a point where they no longer meet the criteria for device implantation," Mehra said. "So there is a gap, but it's not nearly as wide as originally projected."

He predicts that any significant growth in ICD use will come from expanding indications rather than by implanting more patients who qualify. Future ICD candidates might include, for example, patients with asymptomatic LV dysfunction, or, Mehra said, a population that's like to grow considerably as drug therapy improves: those who had been in heart failure but whose symptoms are entirely under control.