OptiLink HF: Does Implanted Device-Based Impedance Monitoring With Telemedicine Alerts Impact HF Mortality and Morbidity?
Implantable cardioverter defibrillators (ICDs) that send automated alerts when too much fluid accumulates in the lungs did not improve outcomes in heart failure patients, as compared to regular ICDs, according to results of the OPTILINK HF trial presented Sept. 1 during ESC Congress 2015 in London.
The study randomly assigned 1,002 patients with the automated alert ICDS to have the automated transmission turned off or on. Those with the alerts turned on received a call from their physician when an alert occurred and were provided with an exact care-alert questionnaire and therapies were increased or medical action was taken if necessary.
According to investigators, there were 1,748 "fluid threshold crossings" that triggered alerts during the course of the study period. Three quarters (76 percent) of these alerts were successfully transmitted from the patient's ICD to the physician, with the remaining 24 percent deemed unsuccessful because the patient was either already in the hospital, on vacation without the monitor, or offline. Medical action was taken by physicians for 30 percent of the successful transmissions, most of which involved medication changes. After 18 months of follow up, no significant difference in all-cause death or cardiovascular hospitalization was observed between the two groups (45 percent/Alert vs. 48.1 percent/No-Alert).
The obstacles to ICD-based heart failure telemonitoring identified in OptiLink HF would likely be even more pronounced in a real-life clinical setting, noted the study's principal investigator Michael Böhm MD, from Saarland University Hospital in Homburg, Germany, "Improved outcomes would require better patient adherence in terms of being online all the time."
"Given the considerable, and largely unmitigated burden of heart failure, the potential for telemonitoring to improve the management of patients with heart failure is substantial," Böhm explains. "However, in our trial, ICD-based telemonitoring did not increase appropriate interventions, despite intensive instruction of patients and physicians in the clinical trial setting."
< Back to Listings