Everybody has called in sick at least once in their life—unless you coveted that perfect attendance award in school—but now physicians are hoping that their cardiac patients will call in "healthy" instead. New opportunities for remote monitoring of patients with conditions ranging from arrhythmias to heart failure (HF) are in high demand as the health care climate in the U.S. changes and technology progresses. 

"Ideally, remote monitoring would allow us to manage patients, or allow patients to manage themselves, within physician- or clinician-prescribed guidelines on a day-to-day basis to maintain a state of good health. That is really the ultimate goal here," said William T. Abraham, MD, chair of excellence in cardiovascular medicine and director of the division of cardiovascular medicine at The Ohio State University, in Columbus.

Unfortunately, Dr. Abraham and the other remote monitoring experts who spoke with CardioSource WorldNews know that we do not live in a perfect world. Our reality: remote monitoring and other telehealth strategies face many barriers, including patient participation, Food and Drug Administration (FDA) approval of emerging technologies, data management, and a lack of definitive proof of benefits. Despite that, physicians are not stuck on hold over telehealth solutions. In fact, many said that with the rapid technological advances occurring in all aspects of medicine, surgery and pharmaceuticals, it is just a matter of time until remote monitoring for patients with HF, in one form or another, takes off (or rather, stops calling out sick).

Speed Dialing

Since the Patient Protection and Affordable Care Act passed, there has definitely been a bit of a Black-Friday-at-the-mall-type stampede among health care organizations to research, perfect, and adopt systems for remote monitoring.

So why the sudden rush? The health care legislation has instituted new policies that begin to tie reimbursement to patient outcomes. Those organizations that establish themselves as accountable care organizations (ACOs) will be rewarded for decreasing health care costs while maintaining a high level of quality care. Initial guidelines for the establishment of ACOs under the Medicare Shared Savings Program encourage "investment in infrastructure and redesigned care processes for high quality and efficient service delivery." ACOs are, among other things, required to define processes to coordinate care, "such as through the use of telehealth, remote patient monitoring, and other such enabling technologies."

"Where there used to be just a few of us involved in remote monitoring, there is now an avalanche of various interested parties," said Gregg C. Fonarow, MD, associate chief of the University of California, Los Angeles Division of Cardiology. "With health care reform, there are now incentives being built in to try to manage HF patients remotely and financial penalties to hospitals with higher readmission rates."

This heightened sense of urgency surrounding telehealth for HF is not without cause: HF holds the highest rate of hospital readmission compared with any other medical or surgical cause of rehospitalization, according to Medicare data. And, as of October 2012, Medicare will penalize hospitals with high HF readmission rates.

All of this reform sounds good in theory, right? Better transitional care will lead to better at-home disease management, which will lead to fewer readmissions and less health care utilization. But when we remove the rose-colored glasses, we see that little established evidence supports the notion that remote monitoring for patients with HF without an implanted cardiac device reduces either cost or readmission rates.

HF Phone Home

Much of the excitement surrounding the use of telemonitoring for patients with HF has been fueled by observational studies and meta-analyses that report that remote monitoring of vital signs makes a difference in patient outcomes, according to Eiran Z. Gorodeski, MD, MPH, who is the medical director of post-acute care operations at Cleveland Clinic.

"Almost all of these are not randomized studies where systems have been put to the test," Dr. Gorodeski said. When it comes to results from randomized clinical trials testing telemonitoring in HF, the data are really "disappointing," he added.

How disappointing? In two large-scale trials looking exclusively at HF patients, telemedicine didn't really connect. The multicenter Telemonitoring to Improve Heart Failure Outcome (Tele-HF) randomly assigned more than 1,500 patients who had recently been hospitalized with HF to participate in usual care or telephone-based telemonitoring examining general health, weight, and symptom status daily, or usual care. When the results were published in 2010 in The New England Journal of Medicine, the researchers found no significant difference between the groups for readmission or all-cause death, which was the primary endpoint, and no differences for any of the secondary endpoints, which included HF hospitalization, length of stay, and number of hospitalizations.

The same type of message was left in the Telemedicine Interventional Monitoring in Heart Failure (TIM-HF) study: disheartening. Compared with usual care, remote telemedical management showed no reduction in mortality. The TIM-HF study looked at 710 patients with stable chronic NYHA class II-III HF who had been hospitalized within the prior two years or had a LVEF <25 percent. The remote care assigned in this study consisted of telemedical management using portable devices for ECG, BP, and body weight measurements, which were sent to medical centers via cell phones.

More recently, a study published in BMJ in June 2012 showed a lower mortality rate and lower emergency admission rates for patients in England assigned to a telehealth regimen. However, the study included patients with diabetes, chronic obstructive pulmonary disease, or HF; therefore, the affect of the regimen on just those patients with HF is still unclear.

"There is a realization that there are significant limitations of just trying to monitor symptoms and patients' weight at home and that more is going to be needed," Dr. Fonarow said. "That is a reality that more and more clinicians are coming to grips with."

Shotgun Wedding?

Although the health care community is waiting for more definitive results on home monitoring in HF patients, many organizations have rolled out transitional care and remote monitoring programs for their HF programs. This means that while health care organizations have only recently become married to the prospect of instituting these programs, many physicians can already speak to the real-world use of these programs for better or for worse. But despite the initial reception, the honeymoon may already be over for vital sign monitoring.

While implanted devices take the initiative to report data, those patients with HF with no device must depend on self-monitoring and reporting of daily symptoms and changes in weight.

"Unfortunately, those parameters are limited. We know, for example, that sensitivity of weight change for predicting HF hospitalization is only on the order of 10 to 20%," Dr. Abraham said. "It is very specific, so when it occurs, we know that patient is getting worse, but when it doesn’t occur, we can’t be reassured that they are doing okay." In fact, he noted, physicians will likely miss most instances of worsening HF based on monitoring changes in weight alone. Similarly, worsening HF symptoms may only occur a day or 2 before hospitalization, practically slamming the window of opportunity for intervention shut.

Dr. Gorodeski, who has been monitoring vital signs out of the Cleveland Clinic for about two years, shares a high level of skepticism about the utility of monitoring vital signs remotely. The reality is that in some patients it may work, but in others it may do harm.

"We may be able to identify the patient with a classic rise in weight who is going into HF," he said. On the other hand, patients who develop a pattern of vital sign changes may experience an overreaction by physicians that leads to readmittance rather than just a situational review. Most people will fall somewhere in the middle of these two situations. Dr. Gorodeski’s team of telehealth nurses who deal with the data day-in and day-out admit that, given the amount of data, it is hard to interpret what it all means.

How Do I Challenge Thee? Let Me Count the Ways

Tracking, storing, interpreting and acting on the plethora of data coming into the office is just one hurdle associated with remote monitoring of HF patients. Another challenge high on the list: the same people these programs are designed to help sometimes forget to help themselves. Even when participation only requires lying down by a sensor or stepping on a scale once a day, patients' commitment and adherence to remote monitoring systems still fall short.

In the Tele-HF study, the researchers underscored that noncompliance and nonadherence were both issues. Fourteen percent of patients assigned telemonitoring never used it, and among those who did, about 90 percent used the system in the first week, which dropped to 55 percent by study end.

Even studies employing automated scales to obtain daily weights on HF patients have generally failed because of compliance. "Just getting the patient to step on the scale each day has been relatively poor," added Dr. Abraham.

Another snag: despite government encouragement to adopt remote monitoring technologies, everybody knows that money talks. Although the deadline has passed to implement strategies to become an ACO, little compensation has been put into place for monitoring HF patients who do not have cardiac devices. "There is little to no direct reimbursement for any of these things, other than hoping that you improve outcomes and reduce readmissions and save money that way," Dr. Gorodeski said.

One Ringy-Dingy

HF experts are hoping to take a page from the book of a first cousin, implantable devices. The ideal for patient monitoring would be to download data directly from the patient, just as implantable devices allow. Although many patients with HF have implantable devices, when it comes to outcomes and reimbursement, the field of electrophysiology is on another planet from vital sign monitoring.

Multiple randomized clinical trials have supported the theory that the use of remote monitoring—although it may not reduce mortality or hospitalizations—does reduce the number of in-clinic evaluations and the time from a clinically actionable event to a clinical decision.

Bruce L. Wilkoff, MD, director of cardiac pacing and tachyarrhythmia devices at the Cleveland Clinic Lerner College of Medicine of Case Western Reserve University, has tapped into this resource for some time, and now monitors patients across four continents, 19 countries, and virtually every state. "A lot of HF monitoring can be done with these devices, but if patients do not have a device and have to have home-type monitoring, physicians have more difficulty getting the specific information required for clinical decision making."

Within the implantable device field, multiple manufacturers have established systems for remote monitoring of these devices, including industry bigwigs like Boston Scientific's Latitude, Medtronic's Carelink, and St. Jude Medical’s Housecall Plus. These systems work as a network to receive, store, and process data transmitted from the devices.

"We have converted 90% or more of our patients to follow-up using the Carelink system, and have reduced follow-up burden in our office substantially," said Mark Mitchell, MD, electrophysiology director of cardiac care at Forsyth Medical Center, Winston-Salem, North Carolina. Using physician-set parameters, alarms are triggered when any transmitted data falls outside a normal range. Forsyth nurses review all of the alarms and if needed, bring them to the attention of a physician.

Staying in Touch Without Being Hands On

Ultimately, experts agree that the true success of home or remote monitoring of HF patients will depend on devices similar to ICDs that allow action on the part of physicians or patients themselves. The secret may be to embrace a bit of the future and perhaps a bit of the past. 

The HF community continues to investigate what it feels will be a turning point in remote monitoring of HF patients: hemodynamic monitors, permanently implantable devices with wireless technology to transmit information about cardiac output, blood pressure, and heart rate. The recently published CHAMPION study showed that HF patients who had been previously admitted to the hospital who were given an implantable hemodynamic monitor from CardioMEMS had significantly fewer HF-related hospitalizations than the control group. Despite these positive results, the FDA did not approve the device, citing a possible bias due to human intervention.

"Hemodynamic monitors provide us with information that is directly and immediately actionable," said Dr. Abraham, who was a lead investigator on the CHAMPION study. "The current device-based or vital sign–based diagnostics may tell us whom to worry about, but they do not allow us to make those day-to-day medication changes that will ultimately reduce risk."

He added that the use of these monitors may someday allow HF to be managed similarly to diabetes, with patients using data transmitted from these hemodynamic monitors to adjust their medications within physician-prescribed guidelines.

In the meantime, Dr. Gorodeski feels that the real magic of remote monitoring will be to embrace new and emerging technologies, like hemodynamic monitors, iPads, and wireless technologies, and use them to get back in touch with patients in their homes: a virtual house call.

"At the Cleveland Clinic, we are rapidly and aggressively trying to figure out how to utilize virtual video visits in order to simulate face-to-face home visits where we can talk to patients and discuss symptoms as well as educate the patient," Dr. Gorodeski said.

Although many of these things may still be a long way from day-to-day reality, the chances of the health care community giving up on telehealth and remote monitoring are just that: remote.—by Leah Lawrence

Drs. Fonarow and Gorodeski reported no relevant disclosures.
Dr. Mitchell has worked as a speaker or consultant for Medtronic, Sorin, and Biotronic.
Dr. Wilkoff is physician advisor for Medtronic and St. Jude Medical, which produce ICDs, CRT devices, and pacemakers that are monitored using this technology.

References

1. Abraham WT, Adamson PB, Bourge RC, et al. Lancet. 2011;377:658-66.
2. Afolabi BA, Kusumoto FM. European Cardiology. 2012;8:88-93.
3. Chaudhry SI, Mattera JA, Curtis Jeptha, et al. N Engl J Med. 2010;363:2301-09.
4. Koehler F, Winkler S, Schieber S, et al. Circulation. 2011;123:1873-80.
5. Healthcare.gov. Accountable care organizations: improving care coordination for people with Medicare. http://www.healthcare.gov/news/factsheets/2011/03/accountablecare03312011a.html. Accessed on September 16, 2012.
6. Steventon A, Bardsley M, Billings J, et al. BMJ. 2012;344:e3874.

Keywords: Health Care Reform, House Calls, Body Weight, Disease Management, Blood Pressure, Health Care Costs, Electrocardiography, Length of Stay, Electrophysiology, Pulmonary Disease, Chronic Obstructive, United States Food and Drug Administration, Heart Failure, Monitoring, Physiologic, Hospitalization, United States, Diabetes Mellitus, England

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