Background: Nearly five million Americans experience heart failure (HF) with greater than 250,000 dying annually. The prevalence has continued to increase with HF now being the leading cause of hospitalization among adults >65 in the United States. Despite remarkable improvements in medical therapy, the prognosis of patients with HF remains poor. This project seeks to assess if the use of non-invasive hemodynamic (HD) monitoring technologies (ClearSight/Nexfin, Edwards Lifesciences, Irvine CA), which are currently used in the perioperative and critical care settings, can provide additional patient benefit when used longitudinally for outpatient management. This HD monitor provides information on cardiac output, stroke volume, dp/dt, mean arterial pressure and systemic vascular resistance.
The aim of this multi-phase study is to assess if using this HD monitor longitudinally to patients with NYHA classification 3 or greater during their HF clinic visits will result in less patient hospitalizations and complications. Currently, this study is in its first phase designed to evaluate patient and provider satisfaction with the use of the HD monitor as well as begin evaluating associations of the HD parameters to the patients’ electronic medical record (EMR) data.
Methods: After IRB approval and collaborative agreement with the heart failure group, patients with classification of NYHA classification 3 or greater were approached to be involved in the study. Patients were consented and had the HD device placed for 2 minutes. The patient was then surveyed regarding level of discomfort during data capture. Averaged data was then displayed to the HF expert who were subsequently surveyed regarding the utility of the device and its data. The patients’ EMR were also reviewed to evaluate for overall improvement or decline in the patients’ cardiovascular status. All HD data was recorded (values captured every second) for analytics and patient EMR comparisons.
Results: To date, 42 patients have been enrolled. Recent results suggest that none of the participants had discomfort while wearing the device. Provider surveys indicate a high level of interest in the device data and its correlation to the patients’ clinical picture (Table 1). Comparisons of patients (n=9) who reported to have worsened in cardiovascular status since last clinic visit demonstrated a statistically significant reduction in dp/dt values vs. those who reported stability or an improvement (n=33), p = 0.03. Similarly for patients (n=5) who have been evaluated for multiple clinic visits, alterations of HD data correlated to alterations in the patients cardiovascular status captured in the EMR, R=0.73.
Conclusions: Use of flow guided cardiovascular function technologies have not been evaluated for its potential impact on outpatient management of patients with HF. This study highlights the promising first phase of a project seeking to evaluate the impact of implementing these technologies for the outpatient management of heart failure patients.
