PHILADELPHIA – A heart failure management strategy guided by home lung fluid measurements from the remote dielectric sensing (ReDS) system can significantly reduce recurrent hospitalizations, as long as the technology is used as intended.
A ReDS-directed management strategy did not significantly reduce recurrent hospitalizations for acute decompensated heart failure (ADHF) in the traditional intent-to-treat analysis of the randomized, controlled SMILE trial,of the Ohio State University, Columbus, said at the annual scientific meeting of the Heart Failure Society of America.
However, use of the Food and Drug Administration–cleared thoracic fluid status monitoring system to guide treatment changes did cut such hospitalizations by 58% in a modified intent-to-treat population that excluded patients who failed to take daily measurements at home and who didn’t receive modified treatment despite actionable readings, Dr. Abraham reported in an oral presentation.
“These observations may support an adherence-based approach to the utilization and reimbursement of ReDS-guided management in recently discharged ADHF patients,” he said.
The ReDS system consists of a device that, within about 90 seconds, provides a measurement of lung fluid via a focused electromagnetic radar beam that passes through the right lung, Dr. Abraham said. Clinicians access data from measurements patients initiate at home through a secure, cloud-based system, and then initiate changes to heart failure management as warranted based on a ReDS-specific treatment algorithm, Dr. Abraham said.
The postmarketing SMILE study of the ReDS system was stopped early because of an administrative decision by the sponsor, according to Dr. Abraham. However, 268 patients enrolled at 43 U.S. sites continued to the end of the study, with an average follow-up of about 6 months, while readmissions were collected and adjudicated by an independent clinical events committee.
A total of 135 patients were randomized to a ReDS-based management strategy, while 133 were randomized to standard of care, the investigator said.
Most of the medication changes made in response to ReDS measurements were increased diuretics because of high lung fluid volume measurements, or decreased diuretics in response to low measurements, though some changes in vasodilator medications were also made, Dr. Abraham said.
The ReDS-directed management approach yielded a “highly nonsignificant” 19% reduction in recurrent or cumulative heart failure readmissions (P = .36); by contrast, after removing nonadherent, noncompliant cases, there were 11 hospitalizations in 91 treatment patients, compared with 43 hospitalizations in 133 control patients, yielding a hazard ratio of 0.42 (95% CI, 0.22-0.82; P = .01).
“This comes back to the adage that, if you don’t use it, you can’t improve clinical outcomes,” he said, explaining that this study’s modified intent-to-treat population was defined by excluding patients who took no ReDS measurements for more than 20 consecutive days; or by clinicians who received at least eight notifications of out-of-range ReDS values yet didn’t implement the ReDS treatment algorithm.
There were no adverse events reported as being definitely related to the use of the device, and five adverse events reported as possibly related to the device, Dr. Abraham said.
SMILE was sponsored by Sensible Medical Innovations. Dr. Abraham reported disclosures (consultant/advisory board) related to Sensible Medical Innovations, Abbott, Boehringer Ingelheim, Victorious Medical, V-Wave Medical, and others.