ORLANDO, Florida — Use of a pulmonary artery pressure monitor (CardioMEMS, Abbott/St Jude Medical) that allows heart failure medication to be adjusted regularly in line with latest hemodynamic information was associated with a 30% reduction in mortality in a new observational study.
“This real-world data is the strongest evidence to date that hemodynamic management of heart failure in an ambulatory setting can reduce mortality,” study author Jacob Abraham, MD, Providence Heart institute, Oregon, told theheart.org | Medscape Cardiology.
“This result is not definitive because this was a retrospective observational study, but our patients were very closely matched with controls, which makes the data more reliable and refocuses attention to hemodynamic issues in heart failure.”
He added: “There has been so much attention in recent years on the neurohormonal management of heart failure. Our results re-emphasize that heart failure is a hemodynamic disease but we just didn’t have a way of accessing this information before.”
Abraham presented the study here at the recent American College of Cardiology (ACC) 2018 Annual Scientific Session.
The CardioMEMS device is implanted in the pulmonary artery via a percutaneous procedure and then wirelessly transmits data on pulmonary artery pressure to an external sensor connected to a website. A healthcare professional can then advise on medication dose changes.
“This is similar to diabetics taking regular blood glucose measurements and altering their insulin dose accordingly,” Abraham commented. “Similarly, heart failure patients can alter their levels of diuretics or vasodilators based on their pulmonary artery pressure.”
The previous CHAMPION randomized controlled trial showed the CardioMEMS device to be associated with reduced hospitalization rates for heart failure. On this basis the US Food and Drug Administration approved the device in 2014 for use in patients with NYHA class 3 heart failure who had been hospitalized within the past year.
“To really have confidence in this approach, we need to find out if it is reducing mortality,” Abraham added. “A meta-analysis of previous studies measuring pressure in the right ventricle has suggested that reducing pulmonary artery pressure leads to an improvement in survival, but we don’t have mortality data on the CardioMEMS device yet.”
To look at this further, Abraham and colleagues conducted the current study, in which they analyzed Medicare administrative claims data and examined rates of mortality and heart failure hospitalization after implantation of the pulmonary artery pressure sensor compared with a propensity-matched heart failure cohort who received standard of care (controls).
For the comparison, 1087 patients who had received the sensor between 2014 and 2016 were matched 1:1 with controls according to age, sex, race, timing, and number of heart failure hospitalizations in the year prior to implant and a propensity score based on comorbidities, including arrhythmia, hypertension, diabetes, pulmonary disease, and renal disease.
In the year after implantation of the sensor, patients with the device had a mortality rate of 0.22 per patient-year vs 0.30 in controls, for a hazard ratio (HR) of 0.70 (95% CI, 0.59 – 0.83; P < .0001).
Heart failure hospitalizations occurred at a rate of 0.65 per patient-year in the sensor group vs 0.88 in the controls (HR, 0.76; 95% CI, 0.65 – 0.89; P < .001).
Abraham said he hoped these latest data would encourage more physicians to consider using the sensor, but he acknowledged that some payors could still be reluctant to reimburse the cost of the device.
“Many payors still consider this device to be experimental,” he said. “We are hoping our data will encourage them to be more liberal, but we understand that a mortality reduction in a randomized controlled trial is actually what is required, and that trial — known as GUIDE-HF — is now planned.
“If the GUIDE-HF trial confirms a mortality reduction with this approach, that could completely change our approach to treating heart failure,” he added.
Commenting on the study for theheart.org | Medscape Cardiology, James Udelson, MD, chief, Division of Cardiology at Tufts Medical Center, Boston, Massachusetts, said, “Short of a randomized controlled trial, this type of large observational study with clinical and demographic matching can provide useful information, with caveats.”
He thought the device could be useful for patients with heart failure who have been challenging to manage with regard to volume control. “The data from this study, which confirm other recent real-world observational analyses, along with the original randomized trial, do suggest that management based in part on the information may help influence outcomes favorably.”
Udelson also suggested that uptake of the CardioMEMS device had been somewhat slow. “To some degree, that may reflect our fractured system of reimbursement, where the value of a reduction in admissions may not accrue directly to those assuming the costs of the device implant and follow-up work.”
He added that another factor may be the work involved in tracking the information and the follow-up with the patients. “If you implant a lot of these devices, there is a lot of information streaming in that someone has to review and collate, make some clinical decisions about, and then connect with patients. Again, someone is paying to support that work, while the downstream benefits (at least financially) might go elsewhere.”
This study was funded by Abbott. Abraham reports no disclosures.
American College of Cardiology (ACC) 2018 Annual Scientific Session. Presentation 412-16. Presented March 12, 2018.
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