CD&D National Editor

SAN FRANCISCO — "It's not buying a car it's the driving that makes the difference."

That statement, by Bruce Wilkoff, MD, chair of the Health Policy Committee of the Heart Rhythm Society (HRS; Chicago), served to sum up one of the major, and growing themes of the society at its annual meeting in the City by the Bay in May. Wilkoff's not overly subtle reference was to the management of implanted electronic medical devices post-implant. That concern clearly suggesting that this follow-on management is often missing was underlined by a first-day press conference to roll out recommendations, developed by HRS, the European Heart Rhythm Association (EHRA; Sophia Antipolis, France) and other U.S. and international cardiovascular groups concerning management and follow-up of what were termed cardiovascular implantable electronic devices (CIEDs). And Wilkoff acknowledged that the guidance addresses a gap in post-implant management.

"We have spent a lot of time understanding the reasons to implant these devices, and most of our energy in getting them in," Wilkoff said. "But," he added, "we have spent very little time on safety and monitoring of those devices over time." And he called the necessity of this follow-on management "moral contract made by the doctor, the nurse, government, [and] regulators."

In a statement accompanying the guidance, the society said this management should extend "from the time of implantation until explanation or the patient's death." Additionally, it issued "a call to action for the device industry, healthcare institutions and physician practices to provide the necessary infrastructure that will ensure patient care is safe and effective."

Wilkoff said that monitoring of these implantable cardiovascular devices is not anything new. It has been going on for some time, he said, but hasn't been "codified in a universal way." Hence, the new guidance from the society is an attempt to provide that sort of codification and emphasize its importance for the health of those implanted with the devices.

Wilkoff said there were "about" 1.78 million implantations of CIEDs in 2007, and up to 5.86 million "follow-up events" after implantation that the guidance addresses. While ac-knowledging these numbers were "estimates," he said they provided a general idea "of how important this [issue] is."

Funding missing

Wilkoff said that the follow-up events come with a breadth of information, as well as with new issues related to the handling of data, such as data security.

"Until now," Wilkoff said, "there has been little guidance for practicing physicians, hospitals, regulatory agencies and insurance agencies to provide the medically appropriate level of care for patients [implanted with CIEDs]."

Wilkoff and others presenting the guidance emphasized the emerging use of advanced, remote systems to improve monitoring for better care but noted the lack of reimbursement that pushes this type of device management forward. "Unfortunately," he said, "we've ignored the need to adequately fund ... the ongoing maintenance of the patient and their device.

Wilkoff has been leading the effort by the HRS over the past two years to win new codes for such follow-up, and he expressed optimism that the appropriate codes would be developed, but acknowledged, "I can give you only limited details because this is in process."

Besides emphasizing the need for device monitoring, Wilkoff called for expanded "patient monitoring" that includes "all levels of the healthy and unhealthy, young and old, sedentary and active. This is a very diverse population and a rapidly changing field because there's this sort of invasion of high-tech which the promise of improving health, but a little scary and a little complex."

Wilkoff also pointed to end-of-life considerations. "There's the emotional issue — what happens when the person [implanted with a CIED] will die for another reason. They may have the desire to withdraw therapy, or the perception that the device is going to do something adverse during the dying process. Is it possible to adjust [the device] to the appropriate situation? What are the considerations, how to handle the logistics under such circumstances?

"These are important but largely unsaid in the past. Now we have a complete discussion of what some of the most important considerations might be."

Panos Vardas, MD, PhD, of Heraklinion University Hospital (Heraklinion-Crete, Greece), said that the main goals of the guidance are to increase "the length and quality of the patient's life [via] appropriate monitoring of device therapy ... [for] fewer interruptions by hospital admissions and operative interventions."

Vardas said that the hurdles for developing the necessary registries to track CIEDs and gain the necessary reimbursement policies are even higher in Europe than in the U.S., given the 17 different health-care systems.

New definitions of OMT

Roll-out of this new guidance was followed later in the session by updating of guidelines that were issued by the society in 2002, emphasizing improved follow-up therapy, described as OMT, for optimum medical therapy.

Jack Epstein, MD, professor of medicine at the University of Alabama at Birmingham, said the updated document provides more details concerning the appropriate the use of electronic implanted cardiovascular devices but also the need for OMT, plus an underlining of emphasis on "what patients want," not just numbers.

The guidelines, titled "ACC/AHA/HRS 2008 Guidelines for Device-Based Therapy of Cardiac Rhythm Abnormalities," provide more detail concerning 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.

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 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," Another feature of the guidance, he said, is that the "bedside approach to the patient is formally articulated, fresh."

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."

Asked why the need for specific documentation and wording concerning appropriate 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, 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."

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 relating 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 a follow-up with CD&D, Epstein acknowledged that sometimes the right things for heart patients have not been done in particular, implanting a device but not taking care of the whole patient, explaining this with an automobile analogy similar to Wilkoff's earlier in the week: only just "putting in new spark plugs when the engine may be rusted out."

The guidelines will be published in the flagship journals of the three cardiovascular associations that developed them.

New pediatric, congenital issues a focus

Still another guidance rolled out at the meeting focused on increased use of ICDs and CRT devices in children with heart disease, and in people with congenital heart disease essentially a sort of "orphan" category in cardiovascular care. While HRS presenters acknowledged this area is probably too small to be addressed specifically by cardio device manufacturers, they emphasized the need to address these patients with improved training using available devices.

HRS, in collaboration with the Pediatric and Congenital Electrophysiology Society (PACES) formed a task force to deliver guidance in these areas the resultant document having the lengthy title, "Heart Rhythm Society/PACES Clinical Competency Statement: Training pathways for implantation of cardioverter-defibrillators and cardiac resynchronization therapy devices in pediatric and congenital heart patients."

Presenters said it was needed for two reasons: the relatively small number of these implants being done, but the varied specialties involved in doing them.

An additional issue is the lack of such devices designed specifically for these populations.

HRS said that the guidance is the first "to offer competency criteria and training pathways for a variety of specialties, such as pediatric and adult electrophysiology, pediatric and adult cardiology, as well as pediatric and adult cardiac surgery."

Richard Friedman, MD, of Texas Children's Hospital (Houston) and incoming president of PACES, termed the pediatric and congenital heart patients targeted by the document as "a very specialized population," including about one million adults in the U.S. needing continuing care as they age, and often developing difficult arrhythmias.

And pediatric heart patients, he said, need a more targeted approach because they "have complex anatomy, they are smaller, more active [and put] significant stress on these devices after they are implanted." He estimated from 600 to 1,000 device implantations in this group yearly in the U.S., with a somewhat lower number in Europe.

The guidelines provide what it terms "Universal Criteria" requiring physicians to have certification, as well as, for each institution, the following:

• Facility and staff appropriate for the patient population.

• An "organized" program for device tracking and follow-up.

• An "organized" program for tracking outcomes/complications.

•Pediatric and congenital interventional cath-eterization and cardiac surgical expertise at institutions that serve patients under 12, or patients with complex congenital heart disease.

No good database

J. Philip Saul, MD, of the Medical University of South Carolina (Charleston), noted that there had been no "adequate" database for these implants and where they are done, and so developing this was the task force's first goal.

He said the group found 49 programs worldwide implanting devices in this population but only 11 of them offering the relevant training, and with smaller centers doing an average of only about eight implants of this type each year.

With "such low volume," he said, "you have a hard time training an individual." Needed, he said, are "multiple years of training, extending beyond the initial formal training period."

Thus, HRS said the new guidelines are the first "that allow physicians to acquire the recommended number of procedures through either the use of additional years after formal training, or through participation in cases with an adult program."

Friedman and Saul agreed that the limited population being addressed probably works against manufacturers developing implanted electronic devices for these populations but that "indirectly, industry is trying to do that," in particular through the development of devices for smaller adult frames and the development of thinner and sometimes shorter leads.

"This is a help on both sides of the fence it's helpful on the adult side for those who are smaller, easier to implant." And, he added: "There are some special things that we would like and we have pushed the companies."

AF gets increasing emphasis

Interest in atrial fribrillation (AF) continues to grow among clinicians in the EP sector.

In addition to the several new guidance roll-outs, a primary feature of this year's HRS meeting was the continuing increased emphasis on the treatment of AF. It was just a year ago that HRS, for the first time, devoted a full day of its annual scientific session to AF.

In 2007, attendance of more than 1,200 persons at the "AF Summit" far exceeded what was expected by the society and, as a result, the event has now become a key fixture of the group's annual meeting.

"What we realized is that this is not just a one-time deal," said Hugh Calkins, MD, chairman of the organization's scientific and clinical guidelines committee.

Calkins, head of the EP lab at the Johns Hopkins Hospital (Baltimore), added that AF "remains incredibly important" to its members. As the most prevalent arrhythmia an estimated 5 million Americans are afflicted and the most difficult to treat AF has risen to a place of great importance to the electrophysiology (EP) community.

AF to be 'prominent'

In a keynote address kicking off this year's AF Summit sessions, John Camm, MD, of St. George's Hospital Medical School (London), told the audience that AF "will become a prominent part of your lives."

One of the promising new drugs he cited in his talk was dronedarone, discussed later that day in a Late-Breaking Clinical Trials session.

Camm described it as an analog to the widely used drug amiodarone, except that it is considerable safer. The drug, developed by Sanofi Aventis (Paris) and brand-named Multaq, had an excellent outcome and was part of the landmark ATHENA trial, the largest single anti-arrhythmic drug trial ever conducted.

According to Sanofi, it marks the first time in two decades that a clinical AF drug trial showed significant benefit.

The primary trial endpoint, which was the time to first cardiovascular hospitalization or death from any cause, was met with a statistically significant and impressive 24% benefit.

This drug does not yet have either CE-mark or FDA approval, but its potential to reduce AF-related hospitalizations is of major importance to the medical community as AF is estimated to account for about one-third of all hospital admissions arising from rhythm disturbances.

According to Christopher Cannon, MD, a cardiologist from Brigham and Women's Hospital (Boston), "this trial marks a potential paradigm change for the management of atrial fibrillation."

The other key AF treatment modalities, percutaneous catheter ablation, performed by EPs, and surgical ablation, performed by cardiac surgeons, also were prominently featured throughout the HRS sessions.

With a development pace that Camm described as "fast and furious," these two approaches are increasingly successful and an excellent alternative for the AF patients, the majority of whom are not successfully treated medically.

There has been and continues to be, however, widespread disagreement of the real success rate of catheter ablation, in part because of shoddy follow-up methods.

At a St. Jude Medical (St. Paul, Minnesota)-sponsored satellite symposium, Doug Packer, MD, of the Mayo Clinic (Rochester, Minnesota), said that he believes the success rate for paroxysmal AF (PAF; intermittent, typically early stage) patients is about 70%. This is notably higher than the success rates for persistent and long-standing persistent patients, which he pegged at about 50%.

One of Packer's main themes was that the isolation or ablation of the pulmonary veins (PVs), which is regarded as a gold standard for PAF, will produce mediocre clinical benefit for patients with longer, or persistent-standing AF. With longer-standing AF, additional lesions, such as ablating the ganglionic plexi and the ligament of Marshall, are required to terminate the AF and return the heart to normal sinus rhythm.

Supporting Packer's comments was Mark Wood, MD, an EP specialist from VCU Pauley Heart Center (Richmond, Virginia), who said that PAF catheter ablation success rates are far higher for catheter ablation and than for persistent AF. For the latter, Wood strongly supported minimally invasive surgery over catheter ablation.

He cited several advantages of minimally invasive AF surgery, including better excision of the left atrial appendage, faster weaning off of oral anti-coagulation medication, the ability to treat certain areas that require ablation for better results and the ability to treat certain patients (morbidly obese, very elderly) that may not be amenable to catheter ablation.

A surgeon's perspective

At a packed Atricure (West Chester, Ohio)-sponsored breakfast meeting, a surgeon's perspective was supplied by James Edgerton, MD, from the Texas Hospital of the Southwest (Plano, Texas). He noted that his clinical success has notably improved with both an extended lesion set and better tools. In regard to the latter, he cited the new Atricure Coolrail device, which was introduced to the U.S. market in mid-March.

The Coolrail, which appears to be receiving a strong reception, uses resistive heating to create full thickness lesions. Circulating internal cooling fluid in a closed-loop bi-polar radio-frequency system keeps surface temperature low and, as a result, energy is driven deeper into the tissue.

According to Ralph Damiano, MD, chief of cardiac surgery at Barnes-Jewish Hospital (St. Louis), Coolrail is a "significant addition ... for the minimally invasive treatment of persistent atrial fibrillation."

Although not exhibiting at the HRS meeting, ATS Medical (ATS; Minneapolis) is an important contender in the surgical AF ablation market.

At the annual meeting of the American Association of Thoracic Surgeons (Beverly, Massachusetts), held in San Diego earlier this year, it co-hosted an evening seminar with Intuitive Surgical (Sunnyvale, California).

ATS's surgical platform, which features the use of cryo-energy, has the strong support of its new medical director and legendary cardiac surgeon James Cox, MD, of the Washington University School of Medicine (St. Louis). Cox, who pioneered atrial fibrillation surgery, has said that "the only sure way" to achieve normal rhythm in AF patients is to cryo-ablate the coronary sinus.

Recent clinical results, presented in January with cases performed at East Carolina University (Greenville, North Carolina), are impressive. In a study of mostly persistent AF, 86% were in sinus rhythm without medication. These cases were all performed thoracoscopically using the Intuitive da Vinci robot.

Importantly, whereas Atricure's cases are being performed on a beating heart, all the ATS cases currently require full cardio-pulmonary bypass. Industry sources indicate that ATS is actively developing a beating-heart, cryo-ablation platform.