Medical Device Daily Executive Editor

SAN FRANCISCO — "Just because they haven't been written down doesn't mean that these things haven't been done."

So said Jack Epstein, MD, professor of medicine at the University of Alabama at Birmingham, in explaining some of the new guidelines that he said serve to bring together a variety of evidence-based guidances concerning the use of electronic implanted cardiovascular devices and formalize the need for optimal medical therapy (OMT), plus an underlining of emphasis on "what patients want," not just numbers.

His remarks were made at a Thursday press conference, during this year's Scientific Sessions of the Heart Rhythm Society (HRS; Chicago).

In a follow-up with Medical Device Daily, Epstein acknowledged that sometimes the right things for patients have not been done — in particular, implanting a device but not taking care of the whole patient, explaining this with a highly appropriate analogy: "putting in new spark plugs when the engine may be rusted out."

The guidelines document — titled "ACC/AHA/HRS 2008 Guidelines for Device-Based Therapy of Cardiac Rhythm Abnormalities" — is one of several "firsts" presented at the sessions, often with an increased emphasis on end-of-life considerations and the need for greater in-depth consultation with patients concerning what particular therapies might, or might not do for them.

Quizzed by reporters concerning the most important changes in the new guidelines, Epstein emphasized the document's consolidation of previous separate guidances for the different device therapies; that it provides greater clarification concerning the use of the standard ejection fraction percentage as a way of determining the uses of electronic implanted devices; and puts in writing the emphasis on OMT, or, as Epstein stated in a nutshell phrase, "taking care" of patients.

Asked why the need for specific wording concerning patient care, Epstein referred to the cardiovascular device industry's spate of negative headlines over the past two years or so.

"I think, especially with devices, the issue of recalls and advisories interfered with trust, if you will, with the public. It's a credibility issue. It's an attention to those factors that is one way, the right way, [for physicians] to say, "Yes, we do care about you. We want to do the right thing."

He said that in previous guidances [most recently issued in 2002], these things had been "implied ... but not always stated. It's always been there, but it's on paper now."

He called the guidance "unique [because], for the first time, we have really addressed human needs and not just numbers of patients," for instance in the "cutpoint" for entry into a clinical trial.

And "at the bedside, we need to find out what [patients] want. Globally, the document is unique in that we have emphasized not just taking care of rhythm problem or heart failure, but global cardiovascular disease."

Part of this emphasis, Epstein said, is in the use of OMT, saying that patients "must have OMT, in addition to the device."

Asked for more clarity about OMT, Epstein said it is most likely an emphasis on using the best drug therapies first. But, he added: "I'm not saying if you treat somebody with medicines, you don't have to put in a device."

"Optimal medical therapy is absolutely very important for these patients," and in the new guidance the "bedside approach to the patient is formally articulated, fresh," he said.

Throughout his presentation, Epstein frequently sounded the theme of the guidance's comprehensive quality in dealing with a variety of issues, from slow heartbeat to cardiac arrest to heart failure and "expanded indications in the areas of genetic cardiac disease," along with the availability of a "wide spectrum of devices in our armamentarium."

He said that the guidelines concerning pacemakers and ICDs are generally similar to what he referred to as the "old guidelines."

The main changes in the document related to technologies, he said, are for CRT therapy. "We have expanded that section greatly. Many trials have become available on this technology, and we have addressed who are the appropriate candidates" for CRT use.

In particular, he said that this section was expanded. "Many trials became available on this technology and we have addressed who are the appropriate candidates."

Another important change, according to Epstein, is a fuller discussion of the use of ejection fraction as a clinical decider, because "[s]ome of the literature in the last several years has made a cutoff ejection fraction very murky."

Clarified is the importance of the ejection fraction of 35% as a critical level to consider implantation of the device.

But Epstein also recommended the need to seek an improvement in the patient's ejection fraction, not just using it as the first, automatic cut-off point.

In introducing Epstein at the press conference, Richard Page, MD, first VP of HRS and head of the Division of Cardiology at the University of Washington School of Medicine (Seattle), said that the guidelines will be published in the "marquee journals" of the three cardiovascular associations that developed them, calling the document "tremendously important, not only to physicians caring for patients, but for a cardiologist who might refer to a specialist implanter, to heart failure experts, as well as to the community at large."