Medical Device Daily National Editor

BOSTON – A lead for a pacemaker or implantable cardioverter defibrillator (ICD) "isn't peanut butter."

Well, yes . . . and no.

This simple assertion was one of the most important to come out of an early Wednesday morning press conference presentation on pacemaker/ICD leads, kicking off the 30th annual scientific sessions of the Heart Rhythm Society (HRS; Washington), at the Boston Exhibition & Convention Center, the foremost annual gathering of electrophysiologists (EPs) and others implanting electronic medical devices.

But such a statement, as offered by William Maisel, MD, of the Minneapolis Heart Institute and co-chair of the task force that developed the guidelines, isn't as straightforward as it seems.

Malfunctioning leads can be as dangerous, and just as fatal, as salmonella-infected batches of peanut butter. But you can't "recall" them the same way as you would peanut butter.

This latter point was Maisel's main emphasis, and the society is using the guidance to recommend, among other things, that the FDA reconvene its risk management communications advisory panel to develop a set of terms as better alternatives to the "recall" of faulty pacemaker/ICD leads.

The term, of course, appears to mandate the explant and return to the manufacturer of these components – when this is frequently not feasible – and when a particular lead of the batch may still be functioning as intended. And, whether or not explant is necessary, the word recall sets off alarm bells, creating considerable anxiety among patients.

(The use of the word is a problem shared by a whole range of implantable devices, of course.)

The need for this revaluation of terminology was just one part of a general unveiling of a new guidance document – billed by HRS as the first-ever comprehensive guidance for these pacemaker/ICD components – developed in collaboration with the American College of Cardiology (Washington) and the American Heart Association (Dallas).

The need for stricter surveillance of these leads was highlighted most recently by the FDA's recall of the Sprint Fidelis leads made by Medtronic (Minneapolis), because being prone to fracture. This prompted the usual spate of patient lawsuits and – more importantly for the overall field of device regulation in the U.S. – lawsuits continuing to challenge the FDA's right to pre-empt state laws concerning faulty devices.

(Medtronic recently won a dismissal of a series of those lawsuits (MDD, March 12, 2009), thus supporting the decision by the Supreme Court in Riegel v. Medtronic last year [MDD Feb 21, 2008]).

Asked by Medical Device Daily during the Q&A portion of the presentation whether the Fidelis malfunctions had been the sentinel occasion prompting the new guidance, N.A. Mark Estes, MD, of Tufts University School of Medicine and president of HRS, essentially shifted the answer away from blame on a single manufacturer.

He said that the emphasis should be on the overall sector, not any single product, and the need to improve lead performance and patient outcomes.

Responding to further questions from MDD concerning how to characterize the extent of lead malfunctions, Robert Hauser, MD, of the Minneapolis Heart Institute and the other co-chair of the guidelines task force, said that after five years, 95% to 98% of the leads are functioning properly, and that the point of the new document is to push for the improved performance of these device components and enhance the transparency in their use for both patients and manufacturers.

Hauser, however, is one of the authors of a recent study reported in the HRS journal HeartRhythm, indicating that there could be a higher rate of failure for the Fidelis leads than previous studies indicate (<MDD, Feb. 26, 2009). That report showed that the incidence of failure in patients is significantly higher than what is found in the company's ongoing analysis of the leads, and that the Fidelis continues to function in only 88% of patients three years after being implanted

And one of the abstracts issued at the conference ("Assessment of Fidelis Lead Survival: A Large Single Center Experience) predicted "a disturbingly high failure rate of 10% at four years following lead implantation."

Whatever the rates of failures, they are not unexpected, given that a lead "may experience more than 500 million repetitive cardiac cycles during its lifetime," according to an HRS statement.

The exact method for notifying clinicians, regulators and patients concerning lead performance problems is hardly a simple matter, according to Maisel. He said that the use, or not, of the word recall, offers an array of legal implications and regulatory complications.

He said that its use has been shown oftentimes to lead to a "bad clinical decision," for instance when explant is not necessary and in some patients may result in post-surgical complications.

He added that there is a "feeling among physicians [it is] a bad word," and the society has found that "other words resonate equally – and as effectively."

"Safety alert" and "product danger alert" are among the alternative wordings suggested by the guidelines document.

But even to this he added a caveat: "Whether or not an alert is issued is a bit misleading; [a lead malfunction] is a continuum – there is no line where a product is bad or a product is good."

To begin the process of jumping through the required hoops and over the necessary hurdles, the FDA's advisory panel on risk communication should reconvene "to start the process to figure out exactly what steps will be necessary," he said.

Hauser said, that whatever the ultimate wording, "the language should be crafted to avoid unnecessary anxiety or inappropriate interventions." And he cited a recommendation in the guidelines that manufacturers should be required to provide standardized device performance reports semi annually in understandable ways."

Asked if changing the verbiage related to lead malfunctions would create more alerts, Maisel said that "more or fewer alerts" was not the main issue. The goal, he said, should be "improved product safety, improved patient safety, improved clinical outcomes."

The other recommendations of the guidance for the EP sector implanting these devices cover a range of issues. These include: pre-market evaluation, post-market monitoring; the threshold which should trigger action and communication once a performance malfunction is identified; the use of new remote monitoring technologies; the use of an already established ICD registry as a method of post-market surveillance; and appropriate protocols concerning clinical issues.

These latter recommendations relate to: informed consent; monitoring of device performance; clinical presentation of abnormal lead performance; clinical management when abnormal lead performance is suspected; considerations for pediatric patients; and clinical responsibilities for reporting suspected/definite lead problems.

The complete guidelines document will be published in the June issue of the HeartRhythm Journal.