Heart failure high-wire act

“So this is a group of biomarkers that I think will potentially be important for telling us which patients a) should be admitted in the first place, and b) are at high risk, so should get earlier followup and maybe biomarker-guided therapy,” says Dr. Maisel.

Since troponins and BNP/NT-proBNP are already in wide use, Dr. Maisel says, “Now all we’re saying is just get a couple more, at least maybe one more, before they leave the hospital, so you can identify high-risk patients.” But how many, and when, are unknowns. Dr. Pang, who was part of a roundtable discussion on NPs in 2012 in Chicago, which focused on acute HF and readmissions (Pang PS, et al. Congest Heart Fail. 2012;18[5 Suppl. 1]:S5–S8), agrees that both BNP and NT-proBNP are valuable diagnostically and prognostically. “However, there are data going in both directions in terms of how much serial changes help you, at least in acute heart failure.”

And while it’s easy for clinicians to say, “Add a marker,” Dr. Maisel concedes that doing so places a burden on the lab. To make room for new assays like galectin-3 and ST2 at the San Diego VA, he says, he removed myoglobin and CK from the acute coronary syndrome rule-out menu.

Labs need to help keep an eye on test utilization, says Allan Jaffe, MD, a clinical cardiologist and professor of medicine and laboratory medicine and pathology, Mayo Clinic, and chair of the Division of Clinical Core Laboratory Services in Mayo’s Department of Laboratory Medicine and Pathology. “It would be easy to run up a big bill running a variety of poorly validated tests. You don’t want this effort to run amuck and be self-defeating, by generating so much lab testing that it is difficult for clinicians to interpret.”

While conceding that individual markers are making strong showings, Dr. Jaffe is pulled inexorably in other directions. If this were a horse race, while smart bettors were laying their money on ST2 and galectin-3, Dr. Jaffe would have wandered away from the track and be asking questions about the racing industry as a whole.

Dr. Jaffe’s fear is that the focus on 30-day readmissions will obscure other, possibly more important issues. In some ways, there’s no point in arguing the issue: CMS has spoken, and hospitals are jumping. But neither is his concern easily dispelled.

Of the heart failure patients who are readmitted 30 days after discharge, says Dr. Jaffe, one- third come back for recurring heart failure. The rest return due to other comorbidities that may not be related to heart failure. Many of these patients are older, he notes, and thus may have abnormalities in kidney function and be prone to falling or to getting infections. While renal function tracks with HF, other factors do not. Many of the HF readmissions might be due to lack of care integration or handling problems coincident with HF when patients are in the hospital, Dr. Jaffe suggests. Nonetheless, the penalties will still be levied. “If you have heart failure stamped on your forehead as your original diagnosis, it doesn’t matter what brings you back,” Dr. Jaffe says. It could be cancer; it could be a bump on the head after a fall. “That’s a readmission.”

“Part of that is unfair, but part of that is fair, too,” Dr. Jaffe says. “Clinicians should care for the patients, not just the disease. Why should we ignore other comorbidities?” Reimbursement for heart failure admission is modest, however, and there is pressure to move patients out of the hospital rapidly. The tension here is clear. In the past, heart failure has been treated as an acute, intermittent disease, he says, but the emphasis may be shifting to treating it as a more chronic disease.

Cardiovascular reasons don’t always drive the readmissions for heart failure patients, Dr. Pang agrees. “Managing the noncardiovascular comorbidities is equally important,” he says. Then, too, there are psychosocial and socioeconomic factors to consider, as well as self-care and health literacy. Dr. Pang calls it the patient’s “total journey,” and labs need to ride along, if for no other reason than financial necessity demands it.

The laboratory link is not tenuous, says Dr. Peacock. “The lab and clinicians are in the same boat on this,” he says, with all sharing the same financial risk. That, indeed, is the strategy behind reimbursement changes—to get everyone not only to recognize they’re in the same boat, but to get them all pulling the same way, he says.

But what can labs do? Ostensibly, says Dr. Jaffe, they’ll help identify patients at high risk for a readmission, and both galectin-3 and ST2 appear to work well for that, he says. But if two-thirds of heart failure patients are being readmitted due to non-HF reasons, focusing on HF biomarkers will be of limited value. And even if they prove to be useful in that narrow setting, says Dr. Jaffe, “I would argue that some of this could be shortsighted.” Financial pressures have made 30 days the magic number, he says, “But what you’d really like to know is whether the patient has a marker that will help the patient not only at 30 days but longer term as well. We’ve got it turned around—we’re asking for a marker that will help save the system money.”

With the move-’em-out approach still dominating HF treatment, there’s no telling how patients might fare if they’re kept longer and treated more effectively. “Maybe that solves the problem, and you wouldn’t need these markers. Because maybe the markers are simply telling you who’s substantially sick,” Dr. Jaffe says.

Not that there’s ample data to suggest that keeping patients longer will lead to better outcomes. “So we’re trying to play this both ways,” Dr. Jaffe says.

Even if galectin-3 and ST2 identify patients at risk, then what? What do you do with these at-risk patients?

Most patients seem to respond nicely to aldosterone antagonists. Dr. Jaffe says these agents have been advocated for use in high-risk patients for years, but have been substantially underused, for two reasons. One, they cause a rise in potassium. Two, the traditional agent, Aldactone (the aforementioned spironolactone), causes gynecomastia in some male patients. Dr. Jaffe offers no opinion about the legitimacy of these reasons, simply saying, “Maybe these tests [for galectin-3 and ST2] will get people to overcome that.”

He’s more focused on another question: Are the agents good for everyone? If so, he says, testing will be unimportant. And even if they work perfectly in the one-third of heart failure patients whose readmissions are HF-related, that still leaves two-thirds of returnees who will need care that’s more integrative. At his institution, such care includes bringing HF patients back for a followup visit one week after discharge.

Dr. Singer sees hospitals trying to develop standardized approaches to treating heart failure patients. This might include set criteria as to who gets discharged, who gets admitted, and who gets moved to the next level of care, as well as titrating medications based on weight, renal output, etc. While not focusing on new markers, such approaches could help ensure that current markers are used more efficiently.

Dr. Pang says his colleagues are looking at measures that are known to be effective but often overlooked. “In the past, people might check the box saying they’d given discharge instructions,” says Dr. Pang. But, he notes, handing out instructions and making sure patients understand them are two different things.

Labs are also joining in, says Fred Apple, PhD, medical director, clinical laboratories, Hennepin County Medical Center, Minneapolis, and professor, laboratory medicine and pathology, University of Minnesota School of Medicine. In attending clinical directors’ meetings at Hennepin, he says, it quickly became apparent to him that physician test ordering, including for heart failure, was often more quirky than uniform.

Such insights have led the lab to make changes in troponin ordering, for starters. Later this summer, he says, the lab plans to limit order sets (0, 3, 6, 9 hours) for troponin to one. Should an attending physician want to order a second set, they’ll have to justify it via computer validation. If house staff want a second set, they’ll need to confirm that their attending or a cardiology fellow approved it. “We do about 30,000 troponins annually,” Dr. Apple says. “I think we’ll be able to save 10,000 orders a year.”

Heart failure testing will be next. In early summer the lab did an EPIC survey to identify NT-proBNP ordering patterns and look for places to cut back on unnecessary testing. “We have to be more rigorous in understanding why they’re ordered and maybe challenge some of the orders indirectly. This is being driven by the office of the medical director with—in this case—my help,” Dr. Apple says. “Why do you have a three-day standing order set when you only need a two-day standing order set? You have to ruffle some feathers among clinicians.”

“It’s surprising,” Dr. Apple continues, “when you start doing it, how much waste you see.”

The waste might stem, in part, from clinicians who neglect biomarkers’ limitations. That’s the case even with BNP and NT-proBNP, which have a long history of clinical use. Both, over the years, have followed the familiar trajectory. “When they first came out,” says Dr. Singer, “this was the perfect test: If it’s positive, you have heart failure; if it’s negative, you don’t have heart failure. And just like with any other thing in medicine, as time goes by, people find out that, yes, it’s helpful—but.” The “but” with NPs is that while they’re good at the low and high ends of, respectively, ruling out and ruling in HF, they’re less useful in the middle zone, where many patients fall.

Unfortunately, says Dr. Singer, not all clinicians appreciate those limitations. “I think there are still people who are relying solely on biomarkers to make a diagnosis,” he says, “and of course that’s a mistake.” Or, as Dr. Peacock likes to say, “A fool with a tool is still a fool.”

Dr. Apple says that he and Dr. Wu did a survey on who ordered BNP when the test first became available: 40 percent of orders came from the ED, 40 percent from cardiology, with the remainder from other locations. Dr. Apple recently repeated the survey with a Hennepin resident. The ED still accounted for 40 to 45 percent of orders, “which makes sense,” Dr. Apple says. Cardiology had dropped to 10 to 20 percent, a decline Dr. Apple attributes to cardiologists “learning how to order the test.” Now, he found, family practitioners are ordering the remainder of tests—and likely inappropriately, he says. He explains: “We’re trying to cut back on how many orders we get. Instead of following the NP number (concentration)—which is what family practitioners may be doing—we want to follow the patient’s clinical course.”

In short, new biomarkers, though they might prove helpful, won’t solve even older problems.

And if a new biomarker does prove its worth, gaining traction takes time, given the usual marathon of educating clinicians about its use. Apart from the clinical evidence—no small matter—much depends, says Dr. Pang, on how compelling the problem is, and how striking the resultant benefit would be.

Thanks to the new CMS penalties, however, the problem of heart failure readmissions looks freshly compelling, as do the potential benefits of reducing them. As Dr. Apple puts it, “If there’s a financial incentive, there will be a focus.”

Karen Titus is CAP TODAY contributing editor and co-managing editor.