BlueCross BlueShield of Tennessee Medical Policy Manual

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.

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 patients with systolic heart failure.  Acute decompensation is characterized by worsening of cardiac output from the patient’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™).

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 therefore 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 therefore stays in the gas phase and is 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®)

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®).

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

IMPORTANT REMINDERS

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 Foundation/American Heart Association. (2013). A report of the American College of Cardiology Foundation/American Heart Association task force on practice guidelines. Retrieved June 12, 2014 from http://circ.ahajournals.org.

BlueCross BlueShield Association. Evidence Positioning System. (5:2018). Cardiac hemodynamic monitoring for the management of heart failure in the outpatient setting (2.02.24). Retrieved March 21, 2019 from https://www.evidencepositioningsystem.com/.  (26 articles and/or guidelines reviewed)

Centers for Medicare & Medicaid Services. CMS gov. 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)

ECRI Institute. Emerging Technology Evidence Report. (2016, July). Wireless implantable hemodynamic device (CardioMEMS HF System) for monitoring pulmonary artery pressure in heart failure. Retrieved July 21, 2016 from ECRI Institute. (73 articles and/or guidelines reviewed)

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)

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. Abstract retrieved March 27, 2019 from PubMed database.

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)

National Institute for Health and Care Excellence. (2013). Insertion and use of implantable pulmonary artery pressure monitors in chronic heart failure. Retrieved March 27, 2019 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 Brief. (2019, January). CardioMEMS implantable hemodynamic monitor (Abbott) for managing patients with heart failure. Retrieved March 27, 2019 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:  5/9/2019

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