Whether noninvasive telemonitoring helps keep individuals with heart failure (HF) alive and out of the hospital may depend less on the particulars of the telemonitoring and overall disease-management program than on the patients themselves.
Especially important to success, for example, is the patient's symptom severity and level of engagement in the telemonitoring program, propose researchers based on their randomized study with more than 600 patients.
Their patients assigned to a noninvasive telemonitoring strategy, compared with those on standard care, showed no overall difference in the primary end point of death from any cause or hospitalization over 18 months. However they did benefit with a significant 21% drop in the secondary end point of unplanned HF hospitalization, the group reported.
There were also significant declines in rates of both the primary and secondary end points with telemonitoring for several prespecified patient subgroups.
The primary end point dropped significantly with telemonitoring for both patients in NYHA functional class 3 to 4 and those with at least 70% compliance with the daily weight and symptom checks on which the strategy depended.
And there were significantly fewer unplanned HF hospitalizations for telemonitored patients in those two subgroups, for rates that were 29% lower for those in NYHA class 3 to 4 and 37% lower for the most adherent; as well as among such patients who were socially isolated, who showed a 38% reduced rate.
"This trial showed evidence of a heterogeneous response to treatment, with potential benefit in certain subgroups," Atul Pathak, MD, PhD, Princess Grace Hospital, Monaco, said when presenting the results of Optimisation de la Surveillance Ambulatoire Des Insuffisants Cardiaques Par Télécardiologie (OSICAT) June 15 in an HFA Discoveries Late-Breaking Science Session.
"Our data strongly imply that one size might not fit all when considering telemonitoring solutions in heart failure patients," he said. And that, Pathak added, points to a need to individualize and tailor telemonitoring solutions to individual types of patients with HF in order for them to be successful for disease management.
HFA Discoveries is the online substitute for the annual scientific meeting of the Heart Failure Association (HFA) of the European Society of Cardiology. The traditional HFA sessions, which had been slated for Barcelona were canceled this year because of the COVID-19 pandemic.
Noninvasive telemonitoring is likely to be increasingly important for HF management in this pandemic era, but "we still struggle a lot" in trying to identify the best and most effective telemonitoring processes within disparate healthcare systems, observed invited discussant Tiny Jaarsma, PhD, Linköping University, Sweden, after Pathak's presentation.
Based on the study, she said, "it's important to select the right patients, but also to get them to do the telemonitoring, maybe over the long-term," and to implement the telemonitoring process with that in mind.
Pathak agreed, emphasizing that OSICAT didn't necessarily address whether a specific HF telemonitoring process would be applicable across regions with healthcare systems that vary in terms of reimbursement, whether HF is treated by physician generalists or specialists, the role of nursing, or other ways.
"In our trial, the message we are sending is that whatever the tools, what is more important is what type of patient should be offered the therapy," said Pathak in the follow-up question-and-answer portion of the presentation.
The entry criteria of the study at 38 centers in France cast a wide net; it entered patients with HF who had been hospitalized for decompensation in the preceding 12 months and had internet access. The randomization assigned 305 patients to the telemonitoring group and 327 to a control standard-care group that completed 18 months of follow-up.
Overall at baseline, their mean age was about 70 years, with more than 80% in NYHA functional class 2 to 3, about half with coronary artery disease, about one-third with atrial fibrillation, and about one-third with diabetes. Approximately 60% had a left-ventricular ejection fraction less than 40%.
The baseline rate of beta blocker use was about 70%, and about 75% were on ACE inhibitors or angiotensin-receptor blockers and 46% on an aldosterone inhibitor; 13% had an implantable defibrillator.
As Pathak described, patients in the telemonitoring group daily were supposed to weigh themselves on an electronic scale that automatically transmitted the data to a centralized facility and to answer questions regarding their symptom status on an internet-linked tablet computer.
Nurses at a central facility would review the transmitted data and determine whether any passed preset thresholds that would trigger the involvement of a primary care physician, who had the option of adjusting medications.
Whether or not changes in volume status or symptoms led to physician intervention, all patients received regular phone calls from nurses who provided personalized educational guidance "to improve their knowledge and skills" about HF self-care, Pathak said.
Standard care for the control group consisted of conventional follow-ups and consultations with general practitioners.
Over 18 months, the adjusted hazard ratio (HR) for the primary end point, telemonitoring versus control, was 0.97 (95% CI, 0.77 - 1.23; P = .80) across all patients.
However, the HR was significantly reduced for the prospectively defined subgroups of those in NYHA class 3 to 4 at baseline (P = .03) and who adhered to the daily telemonitoring schedule at least 70% of the time (P = .04).
The adherence rate early in the study was only about 50%, but that quickly climbed to a mean of 74% in months 6 to 12 and remained at about that level for the rest of the follow-up. Overall mean adherence to the telemonitoring strategy was 60%; the median was 74.6%.
The intervention was more consistently successful for the secondary end point, unplanned HF hospitalization, across all patients (HR, 0.79; 95% CI, 0.62 - 0.99; P = .044), and for three subgroups:
NYHA class 3 to 4 (HR, 0.71; 95% CI, 0.53 - 0.95; P = .02)
At least 70% adherence (HR, 0.63; 95% CI, 0.45 - 0.88; P = .006)
Socially isolated (HR, 0.62; 95% CI, 0.39 - 0.98; P = .043)
"We were disappointed by the effects on the primary outcome," Pathak said, "but a telemonitoring trial is probably not the same as a drug trial." Perhaps, he said, telemonitoring trials should not be judged solely on mortality and morbidity outcomes. They should also aim to improve body-weight measurement practices, compliance to drugs, exercise, and other behaviors, such as calling the doctor for dosage adjustments when necessary.
"Our hope is that the coaching part of the trial, a regular phone call aiming to motivate patients to stick to their treatment, to answer questions, and to improve [care] skills, was probably as effective as just measuring data on these patients," Pathak said.
"I think that combining something that measures data with direct interactions between a human and a human, a nurse or dedicated person, to help the patient to cope with this disease, is probably very important."
The study was sponsored by Air Liquide, from which Pathak discloses receiving fees for consulting and travel. Jaarsma had no disclosures.
HFA Discoveries 2020 from the Heart Failure Association (HFA) of the European Society of Cardiology. Presented June 15, 2020.
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Medscape Medical News © 2020
Cite this: Keys to Heart Failure Telemonitoring Success: Insights From OSICAT - Medscape - Jun 17, 2020.