Medical Device Daily Washington Editor

WASHINGTON – A Monday morning session addressing the future of cardiovascular devices during the first day of AdvaMed 2008 painted a complex picture. While sheer demographic trends promise a robust market, concerns over the appropriateness of the use of many cardiovascular devices hint that getting a device accepted by the market will require more work.

Another problem is that patients have a tough time deciphering the data behind the devices, but one panelist said that the doctors have almost as much difficulty making sense of those numbers.

The session's moderator, Peter Groeneveld, MD, assistant professor of medicine at the University of Pennsylvania (Philadelphia), said the standard of care for infarction in 1965 did not include many things taken for granted today, such as defibrillators and stents. Even beta blockers, which were available, were not typically used.

"The 30-day mortality rate for [infarction] patients over 75 has been halved" in the interim, Groeneveld said, which nonetheless came at a cost. The advent of Medicare, which he characterized as "the most important event in healthcare history," occurred at a time when healthcare spending "represented less than 1% of GDP." However, that number has risen to 3%, despite substantial economic growth.

"It really is new healthcare technologies ... which are driving the coming fiscal challenge," Groeneveld said, adding that the situation "presents a value imperative" that will incur either "policy changes ... or differential access to care."

David Magid, MD, director of research at Colorado Permanente Group (Denver), said the approach to translating the latest data into clinical practice "takes too much time and is too expensive." He said that the Cardiovascular Research Network (CRN), a Kaiser effort, is looking into costs and outcomes to establish value.

Fourteen of the 15 participating healthcare centers "have electronic medical records," Magid said, but added that "one of the challenges of working together is to take these 15 healthcare systems' data" and reformat all that data "into a common data dictionary" that permits useful analysis.

"Each of the organizations was not thrilled with the idea of just sending their data to a repository," Magid said, so the data are stored behind a firewall so as to ensure patient privacy.

CRN is only a year old, but its coronary stent analytical effort "indicated that outcomes were better with DES than with bare-metal stents" with regard to infarction and death, Magid said.

The network has a grant to look at anti-platelet therapy in conjunction with DES use, and a project on ICD use "based on eligibility criteria" also is in the works. CRN also is hoping to extend the ICD effort to look at quality of life.

"Standardized data formats have really been the key to our success so far," he said, but he also acknowledged that definitions of a disease state – which vary between organizations, often depending on severity – is an issue "that goes beyond the standardization."

Magid said CRN found it had to adopt a uniform definition for disease states because otherwise "you can make errors in your interpretation" and potentially invalidate the conclusion. However, he said the data format question looms larger, stating that CRN has spent "a huge amount of time standardizing the format."

Sarah Goodlin, MD, president of Patient-Centered Education and Research (Salt Lake City), said about 6 million persons in the U.S. are diagnosed with congestive heart failure. She acknowledged "clear geographic variations in approaches to [medical] management" and rates of implantation of implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy (CRT) units, the latter of which combines pacing and defibrillation.

Goodlin referred to well-known data that indicate "a substantial disparity in ICDs for black men versus white men [and] for women versus men," adding that "the lowest proportion receiving ICDs were black women."

However, she said there is little or no data on comparing outcomes, which might clarify the question of which patients are not good candidates. She said the data indicating the low rates of fire for most such equipment suggest that most patients are "clearly not even meeting the criteria.

"Many issues influence the way decisions are made," Goodlin said, adding "we know very clearly that people's choices are clearly influenced by the way the choice is anchored." There is a difference, she said, when a doctor says 30% of patients survive compared to telling the patient that 70% of patients die.

"In the face of uncertainty, people tend not to follow logical decision making," she stated, noting that most patients experience "substantial difficulty understanding numerical data."

On the other hand, "we also know that clinicians [also] have difficulty understanding numerical data," which makes it tough for docs to advise their patients, Goodlin said. And since "we don't have a good way to predict the course of heart failure," and "many heart failure patients are unaware of its life-limiting potential," the decision-making process is further muddied.

The situation calls for "clear information, and tools to facilitate patient selection and comprehension" as well as "education for clinicians in participatory decision making." There are other issues from within the clinical setting, but she made the case that unlike a drug, which can be stopped at any time, "a device is likely to take someone down a path from which they cannot simply turn back" on short notice. Consequently, burdens and benefits have to be explained in terms that make sense to the patient.

Part of the problem is that "there clearly are benefit for cardiologists who implant ICDs to implant more ICDs," and while "there are some very clear guidelines on how long someone should be on optimal [medical] management" before referral, "those guidelines are often not followed," Goodlin said.

She said that she sees patients aged 80 and older who get ICDs despite profoundly complicating co-morbidities and "who don't understand what [the device] is." Some such patients are completely taken by surprise when the ICD shocks their heart, she said.