Cardiac Hemodynamic Monitoring for the Management of Heart Failure in the Outpatient Setting
DESCRIPTION
A variety of cardiac hemodynamic monitoring devices for use in the outpatient setting have been proposed to decrease episodes of acute decompensation in individuals with chronic heart failure. Strategies for reducing decompensation, and thus the need for hospitalization, are aimed at early identification of imminent decompensation. These devices operate through a variety of mechanisms, including thoracic bioimpedance measurement, inert gas rebreathing and estimation of left ventricular end diastolic pressure (LVEDP) by arterial pressure during the Valsalva maneuver.
Thoracic Bioimpedance
Bioimpedance is defined as the electrical resistance of tissue to the flow of current. Changes in bioimpedance, measured at each beat of the heart, are inversely related to pulsatile changes in volume and velocity of blood in the aorta. Cardiac output is the product of stroke volume by heart rate, and thus can be calculated from bioimpedance. Cardiac output is generally reduced in individuals with systolic heart failure. Acute decompensation is characterized by worsening of cardiac output from the individual’s baseline status. The technique is also known as impedance plethysmography and impedance cardiography (e.g., TEBCO® [Thoracic Electrical Bioimpedance Cardiac Output], BioZ® Thoracic Impedance Plethysmograph, Performance IQ™ System Cardiac Output Monitor, Sorba Steorra® Non-invasive Impedance Cardiography, Zoe® Fluid Status Monitor, Cheetah NICOM® system, PhysioFlow® Signal Morphology-based Impedance Cardiography (SM-ICG™, ReDS™ Wearable System, Bodyport Cardiac Scale).
Inert Gas Rebreathing
This technique is based on the observation that the absorption and disappearance of a blood-soluble gas is proportional to cardiac blood flow. The individual is asked to breathe and rebreathe from a rebreathing bag filled with oxygen mixed with a fixed proportion of two inert gases, typically nitrous oxide and sulfur hexafluoride. The nitrous oxide is soluble in blood and is absorbed during the blood’s passage through the lungs at a rate that is proportional to the blood flow. The sulfur hexafluoride is insoluble in blood and stays in the gas phase and used to determine the lung volume from which the soluble gas is removed. These gases and carbon dioxide are measured continuously and simultaneously at the mouthpiece (e.g., Innocor®).
Non-invasive Arterial Pressure during Valsalva to estimate LVEDP (left ventricular end diastolic pressure)
Noninvasive measurements of LVEDP have been developed based on the observation that arterial pressure during the strain phase of the Valsalva maneuver may directly reflect the LVEDP. Arterial pressure responses during repeated Valsalva maneuvers can be recorded and analyzed to produce values that correlate to the LVEDP (e.g., VeriCor®).
Implanted Pulmonary Artery Pressure Measurement to estimate LVEDP
LVEDP can purportedly be approximated by direct pressure measurement of an implantable sensor in the pulmonary artery wall. The sensor is implanted via right heart catheterization and transmits pressure readings wirelessly to external monitors (e.g., CardioMEMS™ Champion Heart Failure Monitoring System).
POLICY
Cardiac hemodynamic monitoring for the management of heart failure utilizing thoracic bioimpedance, inert gas rebreathing, arterial pressure/Valsalva, and implantable direct pressure monitoring of the pulmonary artery in the outpatient setting is considered investigational.
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ADDITIONAL INFORMATION
For individuals with heart failure who receive hemodynamic monitoring in the outpatient setting by any of the above stated methods, there is a lack of high-quality comparative evidence to determine improved health outcomes over standard active management. The evidence is insufficient to determine the effects of the technology on health outcomes at this time.
SOURCES
Abraham W., Stevenson L., Bourge R., Lindenfeld J., Bauman J., Adamson P., CHAMPION Trial Study Group. (2016). Sustained efficacy of pulmonary artery pressure to guide adjustment of chronic heart failure therapy: complete follow-up results from the CHAMPION randomised trial. Lancet, 387 (10017), 453-461. Abstract retrieved April 5, 2017 from PubMed database.
Adamson, P., Ginn, G., Anker, S. Bourge, R., and Abraham, W. (2016). Remote haemodynamic-guided care for patients with chronic heart failure: a meta-analysis of completed trials. European Journal of Heart Failure, 19 (3), 426-433. (Level 2 evidence)
American College of Cardiology/American Heart Association/Heart Failure Society of America. (2022). 2022 ACC/AHA/HFSA guideline for the management of heart failure: A report of the American College of Cardiology /American Heart Association Joint Committee on Clinical Practice Guidelines. Retrieved December 16, 2022 from http://circ.ahajournals.org.
BlueCross BlueShield Association. Evidence Positioning System. (7:2023). Cardiac hemodynamic monitoring for the management of heart failure in the outpatient setting (2.02.24). Retrieved January 18, 2024 from https://www.bcbsaoca.com/eps/. (42 articles and/or guidelines reviewed)
Centers for Medicare & Medicaid Services. CMS gov. (2006). NCD for Cardiac output monitoring by thoracic electrical bioimpedance (TEB) (20.16). Retrieved July 31, 2015 from https://www.cms.gov.
Conraads, V.M., Tavazzi, L., Santini, M., Oliva, F., Gerritse, B., Yu, C., et al. (2011). Sensitivity and positive predictive value of implantable intrathoracic impedance monitoring as a predictor of heart failure hospitalizations: the SENSE-HF trial. European Heart Journal, (32), 2266-2273. (Level 2 evidence)
Costanzo, M.R., Stevenson, L.W., Adamson, P.B., Desai, A.S., Heywood, J.T., Bourge, R.C., et al. (2016). Interventions linked to decreased heart failure hospitalizations during ambulatory pulmonary artery pressure monitoring. JACC: Heart Failure, 4 (5), 333-344. (Level 2 evidence)
Curtain, J. P., Lee, M. M. Y., McMurray, J. J., Gardner, R. S., Petrie, M. C., & Jhund, P. S. (2023). Efficacy of implantable haemodynamic monitoring in heart failure across ranges of ejection fraction: a systematic review and meta-analysis. Heart (British Cardiac Society), 109 (11), 823–831. (Level 1 evidence)
Givertz, M., Stevenson, L., Costanzo, M., Bourge, R., Bauman, G., Ginn, G., et al. (2017). Pulmonary artery pressure-guided management of patients with heart failure and reduced ejection fraction. Journal of the American College of Cardiology, 70 (15), 1875-1886. (Level 1 evidence)
Hassan, M., Wagdy, K., Kharabish, A., Selwanos, P., Nabil, A., Elguindy, A., et al. (2017). Validation of noninvasive measurement of cardiac output using inert gas rebreathing in a cohort of patients with heart failure and reduced ejection fraction. Circulation, 10 (3), e003592. (Level 3 evidence)
Heart Failure Society of America. (2017). Remote monitoring of patients with heart failure: A white paper from the Heart Failure Society of America Scientific Statements Committee. Retrieved December 23, 2020 from PubMed database.
Heywood, J., Jermyn, R., Shavelle, D., Abraham, W., Bhimaraj, A., Bhatt, K., et al. (2017). Impact of Practice-Based management of pulmonary artery pressures in 2000 patients implanted with the CardioMEMS sensor. Circulation, 135, 1509-1517. (Level 4 evidence)
Jermyn, R., Alam, A., Kvasic, J., Saeed, O., & Jorde, U. (2017). Hemodynamic-guided heart-failure management using a wireless implantable sensor: Infrastructure, methods, and results in a community heart failure disease-management program. Clinical Cardiology, 40, 170-176. (Level 3 evidence)
Joosten, A., Desebbe, O., Suehiro, K., Murphy, L.S., Essiet, M., Alexander, B., et al. (2017). Accuracy and precision of non-invasive cardiac output monitoring devices in perioperative medicine: a systematic review and meta-analysis. British Journal of Anaesthesia, 118 (3), 298-310. (Level 1 evidence)
Krahnke, J., Abraham, W., Adamson, P., Bourge, R., Bauman, J., Ginn, G., et al. (2015). Heart failure and respiratory hospitalizations are reduced in patients with heart failure and chronic obstructive pulmonary disease with the use of an implantable pulmonary artery pressure monitoring device. Journal of Cardiac Failure, 21 (3), 240-249. (Level 2 evidence)
Minhas, A.M., Ahmed, S., Khan, M.S., Fatima, K., Anwar, M.N., & Constantin, J. (2017). Does hemodynamic-guided heart failure management reduce hospitalization? A systematic review. Cureus, 9 (4), e1161. (Level 2 evidence)
National Institute for Health and Care Excellence. (2018). Chronic heart failure in adults: diagnosis and management. Retrieved December 16, 2022 from www.nice.org.uk/guidance/ipg463.
National Institute for Health and Care Excellence. (2021). Percutaneous implantation of pulmonary artery pressure sensors for monitoring treatment of chronic heart failure. Retrieved December 16, 2022 from www.nice.org.uk/guidance/ipg463.
U. S. Food and Drug Administration. (2004, December). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K041294 (BioZDx™). Retrieved February 15, 2011 from http://www.accessdata.fda.gov.
U. S. Food and Drug Administration. (2009, May). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K090602 (BioZRx™). Retrieved February 15, 2011 from http://www.accessdata.fda.gov.
U. S. Food and Drug Administration. (2014, May). Center for Devices and Radiological Health. Summary of safety and effectiveness data (CardioMEMS™) P100045. Retrieved August 6, 2015 from http://www.accessdata.fda.gov.
Winifred S. Hayes, Inc. Health Technology Assessment. (2023, July). CardioMEMS implantable hemodynamic monitor (Abbott) for managing patients with heart failure. Retrieved January 19, 2023 from www.Hayesinc.com/subscribers.
Zhou, S., Chen, P., Li, H., Zeng, C., Fang, Y., Shi, W., & Yang, C. (2016). Noninvasive measurement of cardiac output during 6-minute walk test by inert gas rebreathing to evaluate heart failure. Acta Cardiologica, 71 (2), 199-203. Abstract retrieved July 21, 2016 from PubMed database.
ORIGINAL EFFECTIVE DATE: 2/1/2004
MOST RECENT REVIEW DATE: 3/14/2024
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