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

Policy number: MP 2.051

Effective date: 9/1/2026

Policy

In the ambulatory care and outpatient setting, cardiac hemodynamic monitoring for the management of heart failure using implantable direct pressure monitoring of the pulmonary artery, thoracic bioimpedance, inert gas rebreathing, and arterial pressure during the Valsalva maneuver is considered investigational. There is insufficient evidence to support a general conclusion concerning the health outcomes or benefits associated with these procedures.

Policy guidelines

This policy refers only to the use of stand-alone cardiac output measurement devices designed for use in ambulatory care and outpatient settings.

Product variations

This policy is only applicable to certain programs and products administered by Capital Blue Cross and subject to benefit variations. Please see additional information below.

FEP PPO - Refer to FEP medical policy manual. The FEP medical policy manual can be found at: FEP medical policy manual.

Description/Background

A variety of outpatient cardiac hemodynamic monitoring devices are intended to improve quality of life and reduce morbidity for patients with heart failure by decreasing episodes of acute decompensation. Monitors can identify physiologic changes that precede clinical symptoms and thus allow preventive intervention. These devices operate through various mechanisms, including implantable pressure sensors, thoracic bioimpedance measurement, inert gas rebreathing, and estimation of left ventricular end diastolic pressure by arterial pressure during the Valsalva maneuver.

Chronic Heart Failure

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 the 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 events such as coronary ischemia and dysrhythmias. While precipitating factors are frequently not identified, the most common preventable cause is noncompliance with medication and dietary regimens.

Management

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 health care provider, education, and medication adjustments as appropriate. These encounters may occur face-to-face in the office or at home, or via cellular or computer technology.

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 herein. A variety of biomarkers and radiologic techniques may be used for dyspnea when the diagnosis of acute decompensated heart failure is uncertain.

The criterion standard for hemodynamic monitoring is pulmonary artery catheters and central venous pressure catheters. However, they are invasive, inaccurate, and inconsistent in predicting fluid responsiveness. Several studies have demonstrated that catheters fail to improve outcomes in critically ill patients and may be associated with harm. To overcome these limitations, multiple techniques and devices have been developed that use complex imaging technology and computer algorithms to estimate fluid responsiveness, volume status, cardiac output, and tissue perfusion. Many are intended for use in outpatient settings but can be used in the emergency department, intensive care unit, and operating room. Four methods are reviewed here: implantable pressure monitoring devices, thoracic bioimpedance, inert gas rebreathing, and arterial waveform during the Valsalva maneuver. Use of the last three is not widespread because of several limitations including use proprietary technology making it difficult to confirm their validity and lack of large randomized controlled trials to evaluate treatment decisions guided by these hemodynamic monitors.

Regulatory Status

Noninvasive Left Ventricular End-Diastolic Pressure Measurement Devices

In 2004, the VeriCor® CVP Diagnostics), a noninvasive left ventricular end diastolic pressure measurement device, was cleared for marketing by U.S. Food and Drug Administration (FDA) through the 510(k) process. The FDA determined that this device was substantially equivalent to existing devices for the following indication:

“The VeriCor is indicated for use in estimating non-invasive, 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.

Thoracic Bioimpedance Devices

Multiple thoracic impedance measurement devices that do not require invasive placement have been cleared for marketing by the FDA through the 510(k) process. The FDA determined that this device was substantially equivalent to existing devices used for peripheral blood flow monitoring. Table 1 presents an inexhaustive list of representative devices (FDA product code: DSB).

Table 1. Noninvasive Thoracic Impedance Plethysmography Devices

Also, several manufacturers market thoracic impedance measurement devices integrated into implantable cardiac pacemakers, cardioverter defibrillator devices, and cardiac resynchronization therapy devices.

Inert Gas Rebreathing Devices

In 2006, the Innocor® (Innovision), an inert gas rebreathing device, was cleared for marketing by the FDA through the 510(k) process. The FDA determined that this device was substantially equivalent to existing inert gas rebreathing devices for use in computing blood flow. FDA product code: BZG.

Implantable Pulmonary Artery Pressure Sensor Devices

In 2014, the CardioMEMS™ Heart Failure Monitoring System (CardioMEMS, now Abbott) was approved for marketing by the FDA through the premarket approval process. This device consists of an implantable pulmonary artery (PA) sensor, which is implanted in the distal PA, a transvenous delivery system, and an electronic sensor that processes signals from the implantable PA sensor and transmits PA pressure measurements to a secure database. The device originally underwent FDA review in 2011, at which point FDA found no reasonable assurance that the monitoring system would be effective, particularly in certain subpopulations, although the FDA agreed this monitoring system was safe for use in the indicated patient population. In 2022, the CardioMEMS™ HF Monitoring System received expanded approval for the treatment of New York Heart Association (NYHA) Class II-III patients who had been hospitalized at least 1 time in the prior year and/or had elevated natriuretic peptides.

In 2024, the Cordella™ PA Sensor System (Endotronix, Inc.) received FDA approval through the premarket approval process. This system consists of an implantable PA sensor placed in the right PA, a catheter delivery system, a handheld patient reader with a dock, calibration equipment, and a data analysis platform that transmits PA pressure measurements to a secure database for clinician review. The device was approved for measuring PA pressure in NYHA Class III heart failure patients who are at home on diuretics and guideline-directed medical therapy, with the goal of reducing hospitalizations for heart failure. The FDA is requiring a post-approval study to collect additional evidence of continued safety and effectiveness in the NYHA Class III patient population.

Several other devices that monitor cardiac output by measuring pressure changes in the PA or right ventricular outflow tract have been investigated in the research setting but have not received FDA approval. They include the Chronicle® implantable continuous hemodynamic monitoring device (Medtronic), which includes a sensor implanted in the right ventricular outflow tract and the ImPressure® device (Remon Medical Technologies), which includes a sensor implanted in the PA.

Note: This evidence review only addresses the use of these technologies in ambulatory care and outpatient settings.

Rationale

Summary of evidence

For individuals with New York Heart Association (NYHA) class II-IV heart failure in outpatient settings who have had a hospitalization in the past year and/or have elevated natriuretic peptides who receive hemodynamic monitoring with an implantable pulmonary artery pressure sensor device, the evidence includes 2 meta-analyses, randomized controlled trials (RCTs), and nonrandomized studies. Relevant outcomes are overall survival, symptoms, functional outcomes, quality of life, morbid events, hospitalizations, and treatment-related morbidity. One implantable pressure monitor, the CardioMEMS device, has U.S. Food and Drug Administration (FDA) approval. The pivotal CHAMPION RCT reported a statistically significant 28% decrease in heart failure hospitalization (HFH) in patients implanted with the CardioMEMS device compared with usual care. However, trial results were potentially biased in favor of the treatment group due to the use of additional nurse communication to enhance protocol compliance with the device. The manufacturer conducted multiple analyses to address potential bias from the nurse interventions. Results were reviewed favorably by the FDA. While these analyses demonstrated the consistency of benefit of the CardioMEMS device, all such analyses have methodologic limitations. Early safety data have been suggestive of a higher rate of procedural complications, particularly related to pulmonary artery injury. While the U.S. CardioMEMS post-approval study and CardioMEMS European Monitoring Study for Heart Failure (MEMS-HF) study reported a significant decrease in HFH with few device- or system-related complications at 1 year, the impact of nursing interventions remains unclear. The subsequent GUIDE-HF RCT failed to meet its primary efficacy endpoint, the composite of HFH, urgent heart failure visits, and death at 1 year. With the approval of the FDA, the statistical analysis plan was updated to pre-specify sensitivity analyses to assess the impact of COVID-19 on the trial. For the 72% of patients who completed follow-up prior to the public health emergency declaration in March 2020, a statistically significant 19% reduction in the primary endpoint was reported, driven by a 28% reduction in HFH. However, lifestyle changes during the COVID-19 pandemic such as changes in physical activity, exposure to infections, willingness to seek medical care, and adherence to medications are unmeasured and add imprecision to treatment effect estimates, as do alterations in provider behaviors. Enrollment of NYHA Class II patients was significantly enriched in the first 500 patients, potentially impacting the pre-COVID-19 analysis. The MONITOR-HF trial, an open-label RCT conducted in the Netherlands, showed that hemodynamic monitoring significantly improved quality of life on the Kansas City Cardiomyopathy Questionnaire (KCCQ) and reduced HFH but did not impact mortality at 1 year follow-up. Overall, the beneficial effect of CardioMEMS, if any, appears to be on the hospitalization outcome of the composite. Both urgent heart failure visits and death outcomes had hazard ratios favoring the control group with wide confidence intervals including the null value in pre-COVID-19, during-COVID-19, and overall analyses of the GUIDE-HF trial. The MONITOR-HF trial found improvement in quality of life on the KCCQ for the CardioMEMS group relative to the control, but no significant differences were observed in secondary quality of life and functional status outcomes in the other included trials. While the HFH reduction of 28% found in the pre-COVID-19 analysis is consistent with findings from the CHAMPION trial, it is unclear whether physician knowledge of treatment assignment biases the decision to hospitalize and administer intravenous diuretics. Evidence for the Cordella System is limited to 3 prospective, single-arm studies. The pivotal PROACTIVE-HF trial was a prospective, multicenter, single-arm study evaluating the Cordella System in NYHA Class III heart failure patients with recent HFH or elevated natriuretic peptides. The trial, which was modified from its original randomized design with FDA input, met its primary endpoint by reporting a 6-month event rate (heart failure hospitalization or all-cause mortality) of 0.15 events per patient, significantly lower than the prespecified benchmark of 0.43, which was derived from a composite of non-contemporaneous control arms from prior CardioMEMS trials. Secondary endpoints showed improvements in KCCQ score, 6-minute walk distance, and NYHA class. Device safety was high, with 99.2% freedom from complications and 99.8% freedom from sensor failure at 6 months. The SIRONA 1 and 2 feasibility studies similarly demonstrated a low rate of adverse events with the Cordella device and an improvement in NYHA class for the majority of participants; however, quality-of-life and functional outcomes did not show significant improvement. The 2 included meta-analyses showed a reduction in HFHs with hemodynamic monitoring in heart failure patients but had discordant findings regarding the impact on mortality. One meta-analysis found no pooled difference in mortality between hemodynamic monitoring and control groups; however, a patient-level meta-analysis revealed a significant 25% decrease in mortality associated with hemodynamic monitoring in patients with heart failure with reduced ejection fraction. Given that the intervention is invasive and intended to be used for a highly prevalent condition and, in light of the conflicting evidence of benefit on mortality and functional outcomes, the lack of periprocedural safety data, and unclear impact of COVID-19 on remote monitoring in the GUIDE-HF trial, the net benefit of the CardioMEMS and Cordella devices remains uncertain. Concerns may be clarified by the ongoing open access phase of the GUIDE-HF RCT and the PROACTIVE-HF trial, as well as the German non-industry-sponsored PASSPORT-HF trial. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have heart failure in outpatient settings who receive hemodynamic monitoring by thoracic bioimpedance, the evidence includes uncontrolled prospective studies and case series. Relevant outcomes are overall survival, symptoms, functional outcomes, quality of life, morbid events, hospitalizations, and treatment-related morbidity. There is a lack of RCT evidence evaluating whether the use of these technologies improves health outcomes over standard active management of heart failure patients. The case series have reported physiologic measurement-related outcomes and/or associations between monitoring information and heart failure exacerbations, but do not provide definitive evidence on device efficacy. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have heart failure in outpatient settings who receive hemodynamic monitoring with inert gas rebreathing, no studies have been identified on clinical validity or clinical utility. Relevant outcomes are overall survival, symptoms, functional outcomes, quality of life, morbid events, hospitalizations, and treatment-related morbidity. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have heart failure in outpatient settings who receive hemodynamic monitoring of arterial pressure during the Valsalva maneuver, a single study was identified. Relevant outcomes are overall survival, symptoms, functional outcomes, quality of life, morbid events, hospitalizations, and treatment-related morbidity. The study assessed the use of left ventricular end-diastolic pressure (LVEDP) monitoring and reported an 85% sensitivity and an 80% specificity to detect LVEDP greater than 15 mm Hg. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Definitions

Cardiac output: is the volume of blood expelled by the ventricles of the heart, equal to the amount of blood ejected at each beat (the stroke output) multiplied by the heart rate per minute/number of beats in the period of time used in the computation. A normal heart in a resting adult ejects from four (4) to eight (8) liters of blood per minute.

Hemodynamic: refers to the study of the forces involved in circulating blood through the body.

Thorax: is the cage of bone and cartilage containing the principal organs of respiration and circulation and covering part of the abdominal organs.

Valsalva’s maneuver: is an attempt to forcibly exhale with the glottis, nose and mouth closed. This maneuver causes increased intrathoracic pressure, slowing of the pulse, decreased return of blood to the heart, and increased venous pressure. If the Eustachian tubes are not obstructed, the pressure on the tympanic membranes also will be increased. When this maneuver is done with just the glottis closed, only intrathoracic pressure will increase.

Disclaimer

Capital Blue Cross’ medical policies are used to determine coverage for specific medical technologies, procedures, equipment, and services. These medical policies do not constitute medical advice and are subject to change as permitted by law or applicable clinical evidence from independent treatment guidelines. Treating providers are solely responsible for medical advice and treatment of members. These policies are not a guarantee of coverage or payment. Payment of claims is subject to a determination regarding the member’s benefit program and eligibility on the date of service, and a determination that the services are medically necessary and appropriate. Final processing of a claim is based upon the terms of contract that applies to the member’s benefit program, including benefit limitations and exclusions. If a provider or a member has a question concerning this medical policy, please contact Capital Blue Cross’ Provider Services or Member Services.

Coding information

Note: This list of codes may not be all-inclusive, and codes are subject to change at any time. The identification of a code in this section does not denote coverage as coverage is determined by the terms of member benefit information. In addition, not all covered services are eligible for separate reimbursement.

Investigational; therefore, not covered:

The following code is investigational when used for ambulatory care and outpatient setting. Inert Gas Rebreathing as outlined in the policy section:

References

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