Results from a clinical trial have produced the first positive, randomized findings for an implantable hemodynamic monitoring device in patients with moderately symptomatic heart failure where the addition of information about pulmonary artery pressure to clinical signs and symptoms allowed for improved heart failure management and led to a reduction in heart failure (HF)-related hospitalizations, according to the CHAMPION study published online Feb. 10 in the Lancet.
William T. Abraham, MD, from the Ohio State University Heart and Vascular Center in Columbus, and colleagues, as the CHAMPION (CardioMEMS Heart Sensor Allows Monitoring of Pressure to Improve Outcomes in NYHA [New York Heart Association] Class III Heart Failure Patients) Trial Study Group, sought to assess whether the use of a wireless device could help clinicians better manage heart failure via the addition of pulmonary artery pressures, and if this method would reduce the rate of heart failure-related hospitalizations.
Patients with NYHA Class III heart failure, irrespective of the left ventricular ejection fraction, and a previous hospital admission for heart failure were enrolled in 64 centers in the U.S. Participants were randomly assigned to management with the wireless implantable hemodynamic monitoring (W-IHM) system or to a control group for at least six months. Two hundred and seventy were in the treatment group while 280 were placed in the control group.
In the treatment group, clinicians used daily measurement of pulmonary artery pressures in addition to standard of care versus standard of care alone in the control group.
“[The W-IHM system is] is a small device about the size of a paperclip that is implanted in the pulmonary artery, which reflects the pressure that builds up and backs up from the heart in congestive heart failure (CHF) patients,” Abraham said in an interview. “[One of the] reasons why patients with CHF have poor quality of life is because of the build-up of those pressures, which cause shortness of breath and limits their ability to do daily activities. [One of the reasons why they might] get hospitalized is because when those pressures build up to a certain point, fluid leaks into the lungs and that requires hospitalization to treat with IV medicine.”
The W-IHM device measures those pressures directly, which helps clinicians keep them consistently in a normal or “more normal” range; thusly alleviating symptoms and reducing the risks of hospitalization, Abraham stated. “Previously, we had a crude way to accept what those pressure levels were by assessing body fluid volumes and daily weight. But these measures haven’t helped us keep [these types of patients] out of the hospitals.”
According to Abraham, the number of hospitalizations related to heart failure has continued to increase relentlessly and noted that last year, there were nearly 1.2 million hospitalizations related to heart failure in the U.S.
At six months, 83 heart failure-related hospitalizations were reported in the treatment group, compared with 120 in the control group. At six months, the rate of heart-related hospitalizations was 30 percent in the treatment group, Abraham reported. “Over the period of follow-up (which ranged up to 30 months and averaged 15 months), the treatment group had a 39 percent reduction in heart-failure-related hospitalization compared with the control group.”
In addition, patients managed in the treatment group experienced significantly shorter lengths of stay than the control group (2.2 days compared with 3.8 days, respectively). Patients in the treatment group had an average quality-adjusted life expectancy of 2.506 with a total cost of $68,919; patients in the control group had an average quality-adjusted life expectancy of 2.200 with a cost of $64,637, the researchers reported. "Thus, the incremental cost-effectiveness ratio of integrating W-IHM into standard of care for management of the heart is estimated to be $13,979 per QALY gained.”
The approach is safe and effective across the board in reducing the rate of hospitalizations and length of stay, and improving quality of life, asserted Abraham.
The CardioMEMS W-IHM device is pending FDA approval and Abraham stated he hopes that the FDA will take action on the system by the end of this year and will eventually into routine clinical practice.
The next steps are exploring expanded indications and developing a model to include patient participation in