BlueCross BlueShield of Tennessee Medical Policy Manual

Cardiac Hemodynamic Monitoring for the Management of Heart Failure in the Outpatient Setting

DESCRIPTION

A variety of outpatient setting cardiac hemodynamic monitoring devices have been proposed to decrease episodes of acute decompensation in individuals with heart failure and thus improve quality of life and reduce morbidity.  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 Valsalva or use of an implantable pressure sensor.

Bioimpedance is defined as the electrical resistance of tissue to the flow of current.  For example, when small electrical signals are transmitted through the thorax, the current travels along the blood-filled aorta, which is the most conductive area.  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 alternatively known as impedance plethysmography and impedance cardiography (ICG).

Examples of FDA approved thoracic impedance measurement devices that do not require invasive placement are:  TEBCO® (Thoracic Electrical Bioimpedance Cardiac Output), BioZ® Thoracic Impedance Plethysmograph, IQ™ System Cardiac Output Monitor, Sorba Steorra® Non-invasive Impedance Cardiography, Zoe® Fluid Status Monitor, Cheetah NICOM® system and 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 patient 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.

The Innocor® (Innovision, Denmark) inert gas rebreathing device was cleared for marketing by FDA in 2006.

LVEDP is elevated in the setting of acute decompensated heart failure.  While direct catheter measurement of LVEDP is possible for an individual undergoing cardiac catheterization for diagnostic or therapeutic reasons, its invasive nature precludes outpatient use. 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.

In 2004, the VeriCor® (CVP Diagnostics, Boston, MA) noninvasive LVEDP measure device was cleared for marketing by FDA.

LVEDP can also 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.

In May 2014, FDA approved the CardioMEMS™ Champion Heart Failure Monitoring System (CardioMEMS, now St. Jude Medical, St. Paul, MN). 

POLICY

IMPORTANT REMINDERS

ADDITIONAL INFORMATION

In the absence of well-designed clinical trials, no conclusions can be drawn about whether 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 has an effect on health outcomes.

SOURCES 

Abraham, W. T., Adamson, P. B., Bourge, R. C., Aaron, M. F., Costanzo, M. R., Stevenson, L. W., et al. (2011). Wireless pulmonary artery haemodynamic monitoring in chronic heart failure: A randomised controlled trial. Lancet, 377 (9766), 658-666. (Level 2 evidence - Industry sponsored)

Abraham W., Stevenson L., Bourge R., Lindenfeld J., Bauman J., Adamson P., CHAMPION Trial Study Group (2016, January) 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): 453-61. Abstract retrieved April 5, 2017 from PubMed database.

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. Medical Policy Reference Manual. (5:2016). Cardiac hemodynamic monitoring for the management of heart failure in the outpatient setting (2.02.24). Retrieved July 21, 2016 from BlueWeb. (34 articles and/or guidelines reviewed)

Centers for Medicare & Medicaid Services. CMS gov. NCD for Cardiac output monitoring by thoracic electrical bioimpedance (TEB) (100.3). 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)

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)

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. (2005, June). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K051228. 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. 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 (SSED). P100045. Retrieved August 6, 2015 from http://www.accessdata.fda.gov.

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:  5/11/2017

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