September 26, 2007 (Washington, DC) - Automated telemonitoring systems, used by heart-failure care providers with some success to stay on top of their patients' changing management needs, may hit a wall in their ability to improve outcomes under some circumstances--for example, in some special patient populations or when medical therapy is already tightly managed, according to investigators from a randomized trial [ 1].
One such device, the DayLink monitor (Alere, Reno NV), made no apparent impact on mortality, heart-failure hospitalizations, or other important end points in a population that had been deliberately enriched with women and ethnic minorities and managed by primary-care physicians in a community setting, reported Dr Z Ozlem Soran (University of Pittsburgh, PA) here at the Heart Failure Society of America 2007 Scientific Meeting. Prior to randomization in the study, she said, care providers had received special instruction in managing outpatients with heart failure, including education in current evidence-based treatment guidelines and how to adjust drug dosages.
"The trial assessed the utility of this heart-failure monitoring system in a real-world setting, rather than in the confines of an academic medical center," Soran told heartwire . Patients in other heart-failure telemonitoring studies, she observed, have been predominantly male, white, drawn from large university-affiliated institutions, and receiving care from specialists or in disease-management programs.
Observing that the study's patients ultimately were on optimal, guidelines-based therapy more reliably than usually occurs in primary care, Soran said automated telemonitoring devices aren't necessarily helpful in all heart-failure populations. On the other hand, she said, the study also supports a strategy of education-enhanced primary care as a way to improve heart-failure outcomes.
"If we give simple instructions to the patient and the primary-care physicians, maybe there is very little room left to change the natural course of the disease itself," she told heartwire . "Maybe we will be able to handle [the patients] without including complicated devices if we can diminish the disease with medication and education."
Speaking from the audience after Soran's presentation of the study, Dr John GF Cleland (University of Hull, UK) characterized the way in which the researchers' conclusions were framed as "pessimistic." The findings, he said, are in line with earlier trials, which together show a significant fall in mortality of about 40% with telemonitoring devices but no effect on hospitalization [ 2]. The mortality outcomes Soran was reporting, he observed, show a nonsignificant but nearly 40% decrease with the device.
"So I think this is an underpowered trial but highly consistent with the rest of the data showing a substantial reduction in mortality with these systems," Cleland said.
Soran's trial randomized 315 patients hospitalized for heart failure within the previous six months who were in NYHA class 2-3, had medically refractory symptoms, and were under the care of primary-care physicians in the community. The population excluded any with "significantly symptomatic" ischemic heart disease or on dialysis or receiving inotropic therapy.
By design, enrollment tilted toward women, Hispanics, and African Americans, who made up about 65%, 27%, and 47% of the population, respectively.
Prior to randomization, all patients and providers received special instruction in evidenced-based medical therapy and other heart-failure management issues. Patients were followed up by telephone at 30 days and three months by personnel, blinded to randomization, from the otherwise-hands-off heart-failure disease-management program running the study,Soran said.
The intervention group was also trained in and received a DayLink telemonitoring system, which is directly wired to a digital bathroom-type scale and linked to primary-care providers over telephone lines. Activated with the push of a button, the device, in addition to monitoring for changes in weight, presents the patient with yes-or-no questions about symptom status and relays the responses to a database and, as appropriate, the care providers, according to Soran.
Noteworthy data from the patient prompted a call from the provider to confirm and follow up, so it's likely the intervention group had more individualized contact with providers compared with the control group, Soran said.
Six months after randomization, however, the two groups showed no significant difference in the study's primary composite end point, "treatment failure," defined as cardiovascular death or hospitalization for heart failure, she reported. Hospital length of stay, she said, was a primary end point for any hospitalized patient.
Outcomes at six months with and without DayLink telemonitoring
|Outcome||With telemonitoring, n=160||Without telemonitoring, n=155|
|Primary end point* (%)||21||29|
|All-cause mortality (%)||7.0||11.2|
|Mean length of stay (d)||10||9.3|
*Cardiovascular death or hospitalization for heart failure
No significant differences
There were also no differences in any prospectively defined secondary end points, including the composite end point's components, number of emergency-department visits, change in functional status, and quality of life.
Although some forms of telemonitoring have made significant contributions to care in clinical trials, the current findings caution against generalizing those results to all heart-failure outpatients, according to Soran. Those favorable results, she said, "don't mean that those devices are universally effective. We need to try to understand which groups really respond to this treatment." In the current study, she emphasized, the device didn't work as expected in a predominantly female, predominantly minority population.
"If we focus our attention on educating the primary-care physicians and try to manage heart failure by adjusting the medications and following the guidelines, then we will be able to treat those patients with the same effectiveness as using sophisticated devices."
Soran reports that the study was funded by the US Centers for Medicare and Medicaid Services and that she has no relevant financial relationships. Cleland reports receiving research grants and honoraria from Medtronic.
Soran ZO, Piña IL, Lamas GA, et al. Randomized clinical trial of the clinical effects of enhanced HF monitoring using a computer-based telephonic monitoring system in older minorities and women. Heart Failure Society of America 2007 Scientific Meeting; September 19, 2007; Washington, DC. Recent and Late Breaking Trials.
Clark RA, Inglis SC, McAlister FA, et al. Telemonitoring or structured telephone support programmes for patients with chronic heart failure: systematic review and meta-analysis. BMJ 2007; 334:942. Abstract
Heartwire from Medscape © 2007 Medscape
Cite this: Steve Stiles. Home Telemonitoring Shows Limited Clinical Impact on Heart Failure in Primary-Care Setting - Medscape - Sep 26, 2007.