Abstract
Background Hemodynamic-guided therapy using the CardioMEMS™ system has been shown to reduce heart failure hospitalization (HFH) in both clinical trials and real-world settings. However, the CardioMEMS system requires input from multiple independent elements to achieve its effect, and no studies have been done to investigate those elements. Consistent patient participation and health care provider participation are two of those key elements, and this study sought to assess how they affect HFHs. Methods This was a single-center, retrospective cohort study of patients with the CardioMEMS sensor. The primary outcome was the number of HFH days patients experienced in the 1 year following CardioMEMS sensor implant. The primary independent variables were the average number of days between patient transmissions of data and the average number of days between health care provider reviews of those data. Covariates included patient demographics, medical comorbidities, history of HFHs, and initial pressure response to hemodynamic-guided therapy at 28 days after implant. Data were fit to a zero-inflated negative binomial regression. Results Seventy-eight patients were included in the study. The mean age was 64 ± 15 years, 52 (67%) were male, and 58 (76%) had heart failure with reduced ejection fraction. During the study period, there were 538 cumulative HFH patient-days. Based on the regression model, there was an exponential relationship between HFH days and the mean number of days between patient transmissions (IRR = 1.74, 95% CI: 1.09–2.75, p=0.019). There was also an exponential relationship between HFH days and the mean number of days between health care provider reviews (IRR = 1.03, 95% CI: 1.01–1.05, p=0.013). Conclusions This single-center study suggests that more frequent patient transmissions and health care provider reviews of the CardioMEMS system are associated with a decreased number of HFH days, but larger multicentered studies are required. Further systems-based analyses of the CardioMEMS system may be a useful approach to guiding effective use of the CardioMEMS device.
Highlights
Heart failure (HF) is a leading cause of morbidity and mortality in the United States, mentioned in 1 out of 9 death certificates in 2011, and designated as the underlying cause in 58,309 out of 284,388 deaths [1]. e associated financial burden is massive and expected to double to more than $70 billion in the United States by 2030 [2, 3]
TM e CardioMEMS HF system includes an implantable pulmonary artery pressure (PAP) sensor that was approved for use by the Food and Drug Agency (FDA) in 2014 for New York Heart Association (NYHA) functional class III patients with a prior heart failure hospitalization (HFH) within the preceding 12 months. e CHAMPION (CardioMEMS Heart Sensor Allows Monitoring of Pressure to Improve Outcomes in NYHA Class III Heart Failure Patients) trial, open-access registry, and several subgroup analyses subsequently confirmed a reduction in HFH in patients using this sensor [8,9,10,11]
No study has taken a systems-based approach to understand the impact of the patient-specific and health care provider-specific uses of the TM CardioMEMS HF system on HFH. e purpose of this study was to apply a systems-based approach to examine whether the frequency of patient pressure transmissions and the frequency of health care provider reviews of those data were associated with risk of HFH
Summary
Heart failure (HF) is a leading cause of morbidity and mortality in the United States, mentioned in 1 out of 9 death certificates in 2011, and designated as the underlying cause in 58,309 out of 284,388 deaths [1]. e associated financial burden is massive and expected to double to more than $70 billion in the United States by 2030 [2, 3]. E purpose of this study was to apply a systems-based approach to examine whether the frequency of patient pressure transmissions and the frequency of health care provider reviews of those data were associated with risk of HFH. A health care provider review was defined as a note on the Merlin.net website that documented data reviews and a treatment plan, which could include reminding a patient to transmit data. Patient compliance with transmission, health care provider review, and hospitalization statistics were calculated and presented as percent when classified categorically, mean/standard deviation when normally distributed, and quartiles when nonnormally distributed. E ZINB model was used to project the number of HFH days patients might spend in the year following sensor implant based on a patient’s stewardship and a health care provider’s stewardship of the CardioMEMS sensor. STATA 14.2 was used for all data management and statistical analyses
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