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DESCRIPTIONA variety of outpatient cardiac hemodynamic monitoring devices have been proposed to decrease episodes of acute decompensation in patients 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.
Patients with chronic heart failure are at risk of developing acute decompensated heart failure, often requiring hospital admission. Patients with a history of acute decompensation have additional risk of future episodes of decompensation, and death. Reasons for the transition from a stable, chronic state to an acute, decompensated state include disease progression, as well as acute coronary events and dysrhythmias. While precipitating factors are frequently not identified, the most common preventable cause is non-compliance with medication and dietary regimens. Strategies for reducing decompensation, and thus the need for hospitalization, are aimed at early identification of patients at risk for imminent decompensation. Programs for early identification of heart failure are characterized by frequent contact with patients to review signs and symptoms with a healthcare provider and with education or adjustment of medications as appropriate. These encounters may occur face-to-face in the office or at home, or via transmission telephonically or electronically of symptoms and conventional vital signs, including weight.
Precise measurement of cardiac hemodynamics is often employed in the intensive care setting to carefully manage fluid status in acutely decompensated heart failure. Transthoracic echocardiography, transesophageal echocardiography, and Doppler ultrasound are noninvasive methods for monitoring cardiac output on an intermittent basis for the more stable patient, but are not addressed in this policy. A variety of biomarkers and radiologic techniques may be utilized in the setting of dyspnea when the diagnosis of acute decompensated heart failure is uncertain.
A number of novel approaches have been investigated as techniques to measure cardiac hemodynamics in the outpatient setting. It is postulated that real-time values of cardiac output or left ventricular end diastolic pressure (LVEDP) will supplement the characteristic signs and symptoms and improve the clinician’s ability to intervene early to prevent acute decompensation. Four methods will be reviewed here: thoracic bioimpedance, inert gas rebreathing, arterial waveform during Valsalva, and implantable pressure monitoring devices.
Inert Gas Rebreathing
LVEDP Estimation Methods
Arterial Pressure During Valsalva to Estimate LVEDP
Pulmonary Artery Pressure Measurement to Estimate LVEDP
The following devices have received specific FDA clearance or approval.
Noninvasive Thoracic Impedance Plethysmography Devices
Multiple thoracic impedance measurement devices that do not require invasive placement have been approved through FDA’s 510(k) process, based on substantial equivalence to predicate devices that are used for peripheral blood flow monitoring. The table below includes a representative list of devices but is not meant to be comprehensive (FDA product code: DSB).
Noninvasive Thoracic Impedance Plethysmography Devices
The NEXTFIN HD Continuous Noninvasive Hemodynamic Monitor (BYMEYE B.V., now Edwards Lifesciences, Irvine, CA) uses an inflatable finger cuff with a built-in photoelectric plethysmograph, which calculates estimated cardiac output from continuous blood pressure monitoring; the monitor was cleared by FDA through the 510(k) process in 2007. Other noninvasive monitors that derive cardiac output estimates from measured parameters exist, but not all are designed to be used in the outpatient setting.
In addition, several manufacturers market thoracic impedance measurement devices that are integrated into implantable cardiac pacemakers, cardioverter defibrillator devices, and cardiac resynchronization therapy devices. With the integrated devices, the electrical resistance of tissue to flow of current is measured using a vector from the right ventricular coil on the lead in the right side of the heart to the implanted cardiac devices; changes in bioimpedance reflect intrathoracic fluid status and are evaluated based on a computer algorithm. These include the CorVue® Thoracic Impedance Monitoring feature (St. Jude Medical, St. Paul, MN) which is integrated in St. Jude Medical’s Unify, Fortify, and Quadra family of cardiac rhythm devices, and the OptiVol® Fluid Status Monitor (Medtronic, Minneapolis, MN), which is integrated into multiple Medtronic cardiac rhythm devices. The CorVue device was approved by FDA in 2012 as a premarket approval (PMA) supplement, and the OptiVol Fluid Status Monitor’s integration into other devices has been approved through multiple PMA supplements since the device’s pivotal trial results in 2008.
Inert Gas Rebreathing Devices
Noninvasive LVEDP Measurement Devices
“The VeriCor is indicated for use in estimating non-invasively, left ventricular end-diastolic pressure (LVEDP). This estimate, when used along with clinical signs and symptoms and other patient test results, including weights on a daily basis, can aid the clinician in the selection of further diagnostic tests in the process of reaching a diagnosis and formulating a therapeutic plan when abnormalities of intravascular volume are suspected. The device has been clinically validated in males only. Use of the device in females has not been investigated.”
FDA product code: DXN.
Implantable Pulmonary Artery Pressure Measurement Devices
Several additional devices that monitor cardiac output through measurements of pressure changes in the PA or right ventricular outflow tract have been investigated in the research setting but have not received FDA approval. These include the Chronicle® implantable continuous hemodynamic monitoring device (Medtronic, Minneapolis, MN), which includes a sensor implanted in the right ventricular outflow tract and, and the ImPressure® device (Remon Medical Technologies, Caesara, Israel), which includes a sensor implanted in the PA.
Note: This policy only addresses use of these techniques in ambulatory care and outpatient settings.
POLICYIn the ambulatory care and outpatient setting, 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 is considered investigational.
POLICY EXCEPTIONSFederal Employee Program (FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity.
This policy refers only to the use of stand-alone cardiac output measurement devices that are designed to be used in ambulatory care and outpatient settings. The use of cardiac hemodynamic monitors or intrathoracic fluid monitors that are integrated into other implantable cardiac devices, including implantable cardioverter defibrillators, cardiac resynchronization therapy devices, and cardiac pacing devices, is addressed in the Biventricular Pacemakers (Cardiac Resynchronization Therapy) for the Treatment of Heart Failure medical policy.
Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
POLICY HISTORY11/11/2010: Approved by Medical Policy Advisory Committee.
08/11/2011: Policy reviewed; no changes.
09/25/2012: Policy reviewed; no changes.
05/07/2013: Removed deleted CPT codes 0104T and 0105T from the Code Reference section.
11/06/2013: Policy reviewed; no changes.
09/15/2014: Policy reviewed; no changes.
07/08/2015: Code Reference section updated for ICD-10.
11/02/2015: Policy description updated regarding devices. Policy statement unchanged. Policy guidelines updated to state that this policy refers only to the use of stand-alone cardiac output measurement devices that are designed to be used in ambulatory care and outpatient settings. Investigative definition updated.
06/06/2016: Policy number added.
SOURCE(S)Blue Cross Blue Shield Association policy # 2.02.24
This may not be a comprehensive list of procedure codes applicable to this policy.