Two decades ago in heart failure treatment, beta blockers were contraindicated, aldosterone antagonists were not known to improve outcomes, and cardiac resynchronization therapy did not exist. Yet patients with heart failure were actually readmitted to the hospital less often, Gregg C. Fonarow, MD, told attendees at the American College of Cardiology's annual meeting, held in Chicago in March.
“If we look at the 30-day rates of rehospitalization for heart failure, at least among fee-for-service Medicare patients, they've actually risen in the past few decades, a time period where we've seen a number of therapeutic advances,” said Dr. Fonarow, who is a cardiologist and professor of medicine at the University of California Los Angeles. “Effective strategies to prevent rehospitalization traditionally have been underutilized.”
These readmissions are important not only because they are a growing area of interest to payers, but because they have significant negative effects on patients' health, he added. “Some people have raised the question whether early rehospitalization may actually be a good thing, but with each successive rehospitalization, the early mortality risk is actually going up, not down. So that dispels the rumor,” Dr. Fonarow said.
Experts also suspect that many of these admissions (estimates range from 15% to 67% of all heart failure rehospitalizations) may be preventable. “With over a million hospitalizations annually, even at 15 to 20% that's a staggeringly high number of hospitalizations that can potentially be prevented with better attention,” said Dr. Fonarow.
To make a start toward resolving this costly, damaging problem, he and other researchers at the conference discussed the potential of different strategies, particularly telemedicine, to focus this attention effectively.
Paying close attention to heart failure patients is nothing new for Harlan Krumholz, MD, professor of cardiology at Yale University. And he has viewed telemonitoring, or technologies that use telecommunications to monitor health status from a distance, as a potentially valuable tool for bringing changes in a patient's condition to a physician's attention.
But the value of the new technology must be confirmed by evidence, Dr. Krumholz told ACC attendees. “We have weak evidence for what's been evaluated, and either poor-quality or negative results, and many, many cases of the developers doing the evaluation, so you have the potential for confirmation bias from the people who have a great stake in the outcome,” he said.
In search of more definitive data, he undertook his own investigation of telemonitoring. Heart failure patients participating in Dr. Krumholz's trial either received phone calls or were asked to call in to answer a series of questions about their current status—”the typical kind of questions that heart failure patients might get if they were coming into the office”—asking about shortness of breath, weight gain, and dizziness. A nurse then reviewed their answers and brought any problematic ones to a physician's attention.
The goal was to reduce readmissions and mortality, but the researchers found that their project had little effect on process, let alone outcomes. “By week 26, we had only about 55% of patients who were calling at least three times a week,” said Dr. Krumholz. “Everyone consented and agreed to be part of this study. They said they were dedicated to being part of this intervention ….This is better than real world.”
The disappointing adherence to the study protocol was matched by disappointing results. No benefit was found to the program, for the trial population as a whole or any studied subgroup. “We went into a lot of reflection,” said Dr. Krumholz. “We said maybe we didn't have good enough compliance. Maybe we made a mistake by not having higher technology. Maybe we should have involved more intervention.”
But shortly after the publication of his study came a German trial of telemonitoring, with more advanced technology (wired scales, streaming electrocardiography) and better patient adherence. “I said, ‘They're going to show that we should have done all this stuff,’” said Dr. Krumholz. Yet the German study found no change in outcomes. “They didn't find a darn thing. Nothing.”
The failure of the two largest, most comprehensive trials of heart failure telemonitoring was very disappointing. “But I don't think it's a verdict on telemonitoring,” said Dr. Krumholz. “We need to maybe think about this in different ways, because it still makes a lot of sense. We just haven't hit it right.”
Perhaps the spot to hit with telemonitoring could actually be inside patients' chests. That's the concept that Niraj Varma, MD, PhD, a cardiologist and electrophysiologist from the Cleveland Clinic, presented to ACC attendees.
Research has shown that cardiac resynchronization therapy (CRT) can reduce heart failure hospitalizations directly, at least in some heart failure patients, he reported. “An important part of reducing heart failure readmissions in the community would be to adopt this therapy more comprehensively. At the same time, it has to be directed more carefully,” Dr. Varma said. The technology appears to work best in patients with New York Heart Association Class I or II heart failure and a wide QRS of the left bundle branch block type, he added.
But the benefits of implanted devices are not limited to their direct cardiac effects. Data can also be collected from them (typically through downloads in the office, but potentially also by telemonitoring) and could possibly be used to predict, and ideally prevent, exacerbations that would otherwise require hospitalization. For example, atrial fibrillation, a common occurrence in heart failure patients, can be detected weeks in advance of clinical deterioration based on data from implanted devices, said Dr. Varma.
The details (for example, which patients would benefit most from such a strategy or how physician practices would handle the large quantity of data provided by the devices) have yet to be worked out, but there's clear potential. “Implanted device diagnostics are a rich resource for data which may help in disease monitoring, or in anticipating future heart failure decompensations,” Dr. Varma concluded.
Remote monitoring is not a futuristic concept to Robert C. Bourge, MD, professor of cardiology at the University of Alabama at Birmingham. “I've been working on the development of remote monitoring in heart failure (implanted hemodynamic monitoring [IHM] systems) since the early ‘90s,” he said.
Hemodynamics, most particularly pulmonary artery pressure, have proven to be a good predictor of heart failure exacerbations and can be measured remotely by implanted devices, Dr. Bourge and other researchers have found.
“Pressure changes occurred as far out as six to eight weeks before an event. They began going up—sometimes precipitated by arrhythmias, sometimes not. Sometimes precipitated by clear dietary indiscretions or medication indiscretion, sometimes not,” he said. In addition, studies have shown a direct correlation with elevations in chronically monitored cardiac filling pressures and subsequent hospitalizations for acute exacerbations of heart failure.
In various studies, he found that monitoring these pressures, and rapidly responding to the data with treatment, can result in a reduction in cardiovascular events for heart failure patients. The latter part of the process is a key issue, Dr. Bourge emphasized. “We're not testing the accuracy of the device. It works. We're testing whether anybody acts on that advice,” he said. “One has to review the information and act on it to help to improve outcomes.”
Once a system is in place, acting on the findings doesn't have to be time-consuming for physicians. New IHM systems under investigation can be adjusted to inform health professionals on hemodynamics when and if they fall outside of prescribed ranges. “I have most of our patients transmit their information from one IHM system directly to me on my smartphone and I individualize their pressure medications,” said Dr. Bourge.
Research is currently underway aimed at making implanted hemodynamic monitors ever smaller and easier to use, according to Dr. Bourge. “We hope that this type of information will be widely applicable as part of maybe a telemedicine system, but certainly a part of an overall comprehensive approach to guided care in patients with moderate to severe heart failure,” he said.
A comprehensive approach is most definitely needed, agreed all the heart failure experts. The good news is that the current environment—both technologically and financially—may be ripe for the development of one, according to Dr. Fonarow. “There have not traditionally been incentives to prevent these rehospitalizations,” he said. “Now with public reporting and value-based health care, there are these incentives to focus on all the things that may allow us to prevent rehospitalizations in heart failure ….We really have the opportunity, but also now the motivation to improve.”