BlueCross and BlueShield of Montana Medical Policy/Codes
Cardiac Hemodynamic Monitoring for the Management of Heart Failure in the Outpatient Setting
Chapter: Medicine: Tests
Current Effective Date: December 27, 2013
Original Effective Date: October 20, 2010
Publish Date: December 27, 2013
Revised Dates: August 20, 2012; December 10, 2013
Description

Patients with chronic heart failure (HF) are at elevated risk of developing acute decompensated HF, often requiring hospital admission. Patients with a history of acute decompensation have an 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 noncompliance with medication and dietary regimens. (1) 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 HF 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 office or in home, or via transmission telephonically or electronically of symptoms and conventional vital signs, including weight. (2)

Precise measurement of cardiac hemodynamics is often employed in the intensive care setting to carefully manage fluid status in acutely decompensated HF. Echocardiography, transesophageal echocardiography (TEE), 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 HF 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.

Thoracic Electrical Bioimpedance (TEB)/Impedance Cardiography (ICG)

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 HF. 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).

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 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.

Arterial Pressure during Valsalva to Estimate LVEDP

LVEDP is elevated in the setting of acute decompensated HF. While direct catheter measurement of LVEDP is possible for patients 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.

Pulmonary artery pressure measurement to estimate LVEDP

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.

Left Atrial Pressure (LAP) Sensor or Monitor

The LAP sensor device detects pressure changes in the left atrium on a millimeter-by millimeter basis. Elevated pressure in the left atrium is a direct early sign of pulmonary edema, allowing the provider to manage and correct the patient’s HF days or weeks before symptoms appear. The LAP sensor is permanently implanted onto the interatrial septum. The transducer is connected by a wire to a signal processing device, which is in the pectoral region. To obtain a pressure reading, the patient positions a handheld device over the region where the device is implanted. Then the real-time information is activated to wirelessly notify the provider.

At this time, the U.S. Food and Drug Administration (FDA) has not cleared a LAP sensor or monitor or sensor for marketing or commercial use. This includes the HeartPOD™ System or Promote® LAP System, for left atrial pressure measurements to manage HF.

Regulatory Status

The following devices have received specific FDA clearance for marketing through the 510(k) process.

  • In June 1997, the "BioZ®" (SonoSite, Bothell, WA) thoracic impedance plethysmograph was cleared for marketing by the FDA through the 510(k) process. Several other impedance plethysmographs have been approved through the same process. The FDA determined that this device was substantially equivalent to existing devices for use in peripheral blood flow monitoring.
  • In March 2006, the "Innocor®" (Innovision, Denmark) inert gas rebreathing device was cleared for marketing by the FDA through the 510(k) process. Several other inert gas rebreathing devices have been approved through the same process. The FDA determined that this device was substantially equivalent to existing devices for use in computing blood flow.
  • In June 2004, the “VeriCor®” (CVP Diagnostics, Boston, MA) noninvasive LVEDP measurement device was cleared for marketing by the 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-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.”
  • In April 2007, the “Endosure®” (CardioMEMS, Atlanta, GA) wireless abdominal aortic aneurysm (AAA) pressure measurement device was cleared for marketing by the FDA through the 510(k) process. The FDA determined that this device was substantially equivalent to existing devices for use in monitoring endovascular pressure during AAA repair. No devices have been cleared for marketing for the indication of determining LVEDP or managing HF.
Policy

Each benefit plan, summary plan description or contract defines which services are covered, which services are excluded, and which services are subject to dollar caps or other limitations, conditions or exclusions. Members and their providers have the responsibility for consulting the member's benefit plan, summary plan description or contract to determine if there are any exclusions or other benefit limitations applicable to this service or supply. If there is a discrepancy between a Medical Policy and a member's benefit plan, summary plan description or contract, the benefit plan, summary plan description or contract will govern.

Coverage

Cardiac hemodynamic monitoring for the management of heart failure (HF) utilizing thoracic electrical bioimpedance (TEB)/impedance cardiography (ICG) may be considered medically necessary in the ambulatory and outpatient setting when medical history, physical examination, and standard assessment tools provide insufficient information, and the treating physician has determined that TEB/ICG hemodynamic data are necessary for appropriate management of the patient, for any of the following indications:

  • Differentiation of cardiogenic from pulmonary causes of acute dyspnea;
  • Optimization of atrioventricular (A/V) interval for patients with A/V sequential cardiac pacemakers;
  • Monitoring of continuous inotropic therapy for patients with terminal congestive HF; including patients waiting at home for a heart transplant;
  • Evaluation for rejection in patients with a heart transplant as a predetermined alternative to a myocardial biopsy; or
  • Optimization of fluid management in patients with congestive HF.

Cardiac hemodynamic monitoring for the management of HF is considered experimental, investigational and unproven in the ambulatory care and outpatient setting utilizing, including but not limited to the following technologies:

  • Inert gas rebreathing,
  • Arterial pressure/Valsalva,
  • Implantable direct pressure monitoring of the pulmonary artery, and/or
  • Left atrial pressure monitoring.

NOTE: This policy only addresses use of these techniques in ambulatory care and outpatient settings.

Rationale

Originally, this policy was created in 2010 based on peer reviewed literature. Periodic literature searches of the MedLine database, through December 2011, have been done. The following is a summary of the literature reviewed.

Evaluation of a diagnostic technology typically focuses on the following three parameters:

  1. echnical performance;
  2. Diagnostic parameters (sensitivity, specificity, and positive and negative predictive value) in different populations of patients; and
  3. Demonstration that the diagnostic information can be used to improve patient outcomes.

Additionally, when considering invasive monitoring, any improvements in patient outcomes must be outweighed by surgical and device-related risks associated with implantable devices.

Thoracic Electrical Bioimpedance (TEB)/Impedance Cardiography (ICG)

A number of small case series have reported variable results regarding the relationship between measurements of cardiac output determined by TEB and thermodilution techniques. For example, Belardinelli and colleagues compared the use of TEB, thermodilution, and the Fick method to estimate cardiac output in 25 patients with documented coronary artery disease and a previous myocardial infarction. (3) There was a high degree of correlation between cardiac output as measured by thoracic bioimpedance and other invasive measures. Shoemaker and colleagues reported on a multicenter trial of TEB compared to thermodilution in 68 critically ill patients. (4) Again, the changes in cardiac output as measured by TEB closely tracked those measured by thermodilution. In contrast, Sageman and Amundson did not recommend the use of bioimpedance as a postoperative monitoring technique for patients who had undergone coronary artery bypass surgery. (5) In this study of 50 patients, only a poor correlation was found between thermodilution and bioimpedance, due primarily to the postoperative distortion of the patient’s anatomy and the presence of endotracheal, mediastinal, and chest tubes. In a study of 34 patients undergoing cardiac surgery, Doering and colleagues also found that there was poor agreement between TEB and thermodilution in the immediate postoperative period. (6) The largest case series, the COST study, has been published in abstract form only. (7) In this case series, estimations of cardiac output using thermodilution methods and TEB were performed in 191 patients who underwent right heart catheterization for a variety of clinical indications. Linear regression analysis revealed an overall correlation of Pearson’s correlation coefficient (r) r=0.73. The authors concluded that cardiac output can be reliably measured with either thermodilution or TEB and that bioimpedance has the additional value of being noninvasive.

Packer and colleagues reported on use of ICG to predict risk of decompensation in patients with chronic HF. (8) In this study, 212 stable patients with HF and a recent episode of decompensation underwent serial evaluation and blinded ICG testing every two weeks for 26 weeks and were followed up for the occurrence of death or worsening HF requiring hospitalization or emergent care. During the study, 59 patients experienced 104 episodes of decompensated HF: 16 deaths, 78 hospitalizations, and 10 emergency visits. A composite score of three ICG parameters was a strong predictor of an event during the next 14 days (p=0.0002). Patients noted to have a high-risk composite score at a visit had a 2.5 times greater likelihood of a near-term event, and those with a low-risk score had a 70% lower likelihood when compared to ones at intermediate risk. However, the impact of use of these results on clinical outcomes is not known.

While results of more studies of ICG are being published, many studies are limited by small populations and uncertainty about the impact on clinical outcomes. In addition, not all studies have evaluated additional novel markers, such as B-type natriuretic peptide (BNP). In a 2006 review article, Wang and Gottlieb comment that there are limited data concerning improved outcomes using ICG in the clinical setting and that, given the data, ICG use should be limited to the research setting. (9)

Additionally, in 2002, the Agency for Healthcare Research and Quality (AHRQ) published a technology assessment on thoracic bioimpedance, which concluded that limitations in available studies did not allow the agency to draw meaningful conclusions to determine the accuracy of thoracic bioimpedance compared to other hemodynamic parameters. (10, 11) The agency also found a lack of studies focusing on clinical outcomes and little evidence to draw conclusions on patient outcomes for the following clinical areas:

  • Monitoring in patients with suspected or known cardiovascular disease;
  • Acute dyspnea;
  • Pacemakers;
  • Inotropic therapy;
  • Post-heart transplant evaluation;
  • Cardiac patients with need for fluid management; and
  • Hypertension.

In November 2006, the Centers for Medicare and Medicaid Services (CMS) issued a decision memorandum on the second reconsideration of its coverage policy for TEB. (12) CMS’s national coverage determination found thoracic bioimpedance to be reasonable and necessary for the following indications:

  • Differentiation of cardiogenic from pulmonary causes of acute dyspnea;
  • Optimization of atrioventricular interval for patient with A/V sequential cardiac pacemakers;
  • Monitoring of continuous inotropic therapy for patients with terminal HF;
  • Evaluation for rejection in patients with a heart transplant as a predetermined alternative to myocardial biopsy; and
  • Optimization of fluid management in patients with congestive HF.

While CMS allows for coverage of TEB in these conditions, it acknowledges that there is a “…general absence of studies evaluating the impact of using thoracic bioimpedance for managing patients with cardiac disease….” CMS concluded in its reconsideration that TEB use in the management of hypertension is non-covered due to inadequate evidence. Medicare also specified that thoracic bioimpedance is noncovered “in the management of all forms of hypertension (with the exception of drug-resistant hypertension…).”

Thoracic bioimpedance may have an important role in the outpatient management of HF, but "earlier studies have not sought to evaluate the clinical importance of the data generated by impedance cardiography [ICG]. They have not determined whether evaluation of the status of the central circulation by impedance cardiography can predict clinical events and, thus, be used to alter the treatment of patients. Obtaining such information is critical if the use of impedance cardiography is to expand from its present application where it has excelled, in short-term management of acutely ill hospitalized patients, to the long-term outpatient management of recently ill or hospitalized patients with severe chronic disorders." (13)

Inert Gas Rebreathing

In contrast to TEB, relatively little literature has been published on inert gas rebreathing, although a literature search suggests that this technique has been used as a research tool for many years. (14-17) A literature search did not identify any clinical articles exploring how inert gas rebreathing may be used to improve patient management in the outpatient setting.

Arterial pressure/ Valsalva - Left Ventricular End Diastolic Pressure (LVEDP)

Studies have shown high correlation between invasive and non-invasive measurement of LVEDP. For example, McIntyre and colleagues reported a comparison of pulmonary capillary wedge pressure (PCWP) measured by right heart catheter and an arterial pressure amplitude ration during Valsalva. (18) The two techniques were highly correlated in both stable and unstable patients (R2 [coefficient of determination] =0.80–0.85). More recently, Sharma et al. performed simultaneous measurements of the LVEDP based on three techniques: direct measurement of LVEDP, considered the gold standard; indirect measurement using PCWP; and non-invasively using the VeriCor device in 49 patients scheduled for elective cardiac catheterization. (19) The VeriCor® measurement correlated well with the direct measures of LVEDP (r=0.86) and outperformed the PCWP measurement, which had a correlation coefficient of 0.81 compared to the gold standard.

A literature search did not identify any published articles that evaluated the role of non-invasive measurement of the LVEDP on the management of the patient. Therefore, evidence is inadequate to permit scientific conclusions regarding the clinical utility of this technology.

Implantable Direct Pulmonary Artery Pressure - Left Ventricular End Diastolic Pressure (LVEDP) 

The CHAMPION (Cardiomems Heart Sensor Allows Monitoring of Pressure to Improve Outcomes in New York Heart Association [NYHA] Class III Patients) Trial Study was a prospective, single-blind, randomized, controlled, trial (RCT) conducted at 64 centers in the U.S. (20) This trial was designed to evaluate the safety and efficacy of an implanted, passive, wireless, pulmonary artery pressure monitor developed by CardioMEMS for the ambulatory management of HF patients. The CardioMEMS pulmonary artery pressure monitoring device has not yet received U.S. Food and Drug Administration (FDA) approval and is currently under FDA review. The CardioMEMS device is implanted using a heart catheter system fed through the femoral vein and requires patients have an overnight hospital admission for observation after implantation. The CHAMPION study enrolled 550 patients who had at least one previous hospitalization for HF in the past 12 months and were classified as having NYHA Class III HF for at least three months. Left ventricular ejection fraction (LVEF) was not a criterion for participation, but patients were required to be on medication and stabilized for one month before participating in the study if LVEF was reduced. All enrolled patients received implantation of the CardioMEMS pulmonary artery radiofrequency pressure sensor monitor and standard of care HF disease management. HF disease management followed American College of Cardiology (ACC) and American Heart Association (AHA) guidelines along with local disease management programs. Patients were randomized by computer in a 1:1 ratio to the treatment group (n=270), which used data from the pulmonary artery pressure sensor in patient management or the control group (n=280), which did not incorporate pulmonary artery pressure sensor data into patient management. All patients took daily pulmonary artery pressure readings but were masked to their treatment groups for the first six months.

The primary efficacy outcome of this trial was the rate of HF-related hospitalizations in the six months after implantation. The primary safety outcomes were device-related or system-related complications (DSRC) and pressure-sensor failures. (21) The investigators reported a statistically significant reduction in readmissions for HF at six months by 30% in the treatment group (n=83) over the control group (n=120) (hazard ratio [HR] 0.70, 95% confidence interval [CI] 0.60-0.84, p<0.0001). This benefit was maintained over the entire randomized follow-up (mean 15 months) (153 vs. 253 hospitalizations, respectively) (HR 0.64, 95% CI 0.55-0.75, p<0.0001). For the primary safety outcomes, freedom from DSRC was 98.6% with no occurrences of pressure-sensor failure. However, 15 adverse events occurred including eight which were DSRC and seven which were procedure-related. Additionally, length of stay for these hospitalizations was significantly shorter in the treatment group when compared to the control group (2.2 days vs. 3.8 days, respectively, p=0.02). There was also benefit reported for other secondary outcomes. There were also improvements in the secondary outcomes of mean pulmonary pressure and quality of life (QOL) at six months. There was no difference in overall mortality, although the trial was not designed with sufficient power to evaluate mortality benefit. There were 15 deaths in the treatment group and 26 deaths in the control group at six months (HR 0.77, 95% CI 0.40-1.51, p=0.45).

A limitation of the CHAMPION trial is the lack of double-blinding. While the patients were blinded and efforts to maintain patient masking were undertaken, the clinicians were not blinded to treatment assignment. The unblinded clinicians were presumably also making decisions on whether to hospitalize patients, and these decisions may have been influenced by knowledge of treatment assignment. Also, the design of this trial does not allow comparison of the incremental risk of implanting a device compared to no implantation, since all patients had a device implanted.

Stevenson and colleagues reported on the COMPASS-HF (Chronicle Offers Management to Patients with Advanced Signs and Symptoms of Heart Failure Study) randomized trial in 2010. (22) The COMPASS trial evaluated outcomes on 274 patients implanted with a Medtronic hemodynamic monitoring system. Patients enrolled in the study were stabilized NYHA Class III or IV HF patients and had at least one HF-related event within the six months prior to enrollment. LVEF was not a criterion. Similar to the CHAMPION trial, all patients were implanted with the monitoring device and received standard HF disease treatment during the first six months post-implantation. One half of the patients were randomized to incorporate pressure monitoring data into HF management, while information from the other half of patients was not used in treatment decisions. The authors of this article reported 100 of 261 patients (38%) from both treatment groups had HF-related events during the six months follow-up despite weight-guided management. Separate reports on HF events by treatment group were not provided. HF event risk increased with higher readings of chronic 24-hour estimated pulmonary artery pressure and at 18 mm Hg diastolic pressure, event risk was 20% and increased to 34% at 25 mm Hg and to 56% at 33 mm Hg. While pressure readings correlated with event risk, the authors noted optimal filling pressures and needed surveillance for event avoidance have not been established.

Ongoing Clinical Trials

Additional clinical trials registered at online site ClinicalTrials.gov have the potential to add to our understanding for these devices in the management of chronic HF. The Left Atrial Pressure Monitoring to Optimize Heart Failure Therapy (LAPTOP-HF) is a randomized trial to evaluate the safety and clinical effectiveness of an implantable device, the HeartPOD™ System or Promote® LAP System, for left atrial pressure measurements to manage HF (NCT01121107). This trial began in April 2010 and is expected to enroll 730 patients for completion in 2013.

Practice Guidelines and Position Statements

The 2009 ACC Foundation (ACCF)/AHA Guidelines for the Diagnosis and Management of Heart Failure in Adults conclude that no role for periodic invasive or noninvasive hemodynamic measurements has been established in the management of HF, stating “Most drugs used for the treatment of HF [heart failure] are prescribed on the basis of their ability to improve symptoms or survival rather than their effect on hemodynamic variables. (23) Moreover, the initial and target doses of these drugs are selected on the basis of experience in controlled trials and are not based on the changes they may produce in cardiac output or pulmonary wedge pressure.”

Summary

The quality of the evidence to date (July 2011) remains limited. RCTs, as well as studies, that specifically address use of ambulatory cardiac hemodynamic monitoring compared with current care are lacking. Some form of intensive outpatient monitoring and follow-up for patients with HF may be warranted, but convincing evidence of the use of the above mentioned technologies cannot be supported at the present time. Additional clinical trials registered at ClinicalTrials.gov have the potential to add to our understanding for these devices in the management of chronic HF.

Evidence from randomized controlled trials is emerging for invasive pulmonary artery pressure monitoring. One report from the CHAMPION RCT reports that pressure readings may be used to reduce HF-related hospitalizations. However, this trial was single-blinded, and the decision to hospitalize patients may have been influenced by knowledge of group assignment. Also, the surgical risks of pressure monitoring devices must be balanced with improvements in net health outcomes and compared longer-term with outcomes of traditional management. Therefore the technology remains experimental, investigational and unproven.  

2013 Update

A search of peer reviewed literature was completed through February 2013. The following is a summary of the literature reviewed.

Thoracic Electrical Bioimpedance (TEB)/Impedance Cardiography (ICG)

The CMS position on TEB remains unchanged from the 2006 decision memorandum. (12) No additional literature to utilize TEB or ICG for the management of HF was found. Therefore, the coverage remains unchanged.

Inert Gas Rebreathing

No additional clinical trials utilizing inert gas rebreathing to treat HF were found. Therefore, the coverage remains unchanged.

Arterial pressure/ Valsalva - Left Ventricular End Diastolic Pressure (LVEDP)

In 2012, Silber and colleagues reported on finger photoplethysmography during Valsalva performed in 33 patients prior to cardiac catheterization. (24) LVEDP greater than 15 mm Hg was identified by finger photoplethysmography during Valsalva with 85% sensitivity (95% confidence interval [CI]: 54-97%) and 80% specificity (95% CI: 56-93%). The evidence remains inadequate to permit a change in coverage.

Implantable Direct Pulmonary Artery Pressure - Left Ventricular End Diastolic Pressure (LVEDP)

In 2011, Adamson et al. reported on the Reducing Decompensation Events Utilizing Intracardiac Pressures in Patients With Chronic Heart Failure (REDUCEhf ) study that evaluated an implantable cardioverter-defibrillator (ICD) coupled with an implantable hemodynamic monitoring (IHM) system. (25) The REDUCEhf study was a prospective, randomized, multicenter, single-blinded trial of 400 patients with NYHA class II or III symptoms who were hospitalized for HF within the past 12 months and qualified for an ICD. The study had expected to enroll 1,300 patients, but after ICD lead failures had been reported in other studies, enrollment was limited to 400 patients. After the ICD was placed, an IHM sensor was implanted in the right ventricle. Similar to the COMPASS-HF and CHAMPION trials discussed earlier, the treatment group of 202 patients received HF management that incorporated pressure monitoring information from the IHM compared to the control group of 198 patients that did not use pressure monitoring information in treatment planning. After 12 months of follow-up, rates of HF hospitalizations, emergency department visits, and urgent clinic visits did not differ between groups (HR: 0.99, 95% CI: 0.61-1.61, p=0.98). While the study was underpowered to detect differences in these events because of limited enrollment, there were no trends favorable to the monitoring group to suggest that the lack of difference was due to inadequate power. Therefore, the coverage remains unchanged.

Left Atrial Pressure (LAP) Measurement

No additional information was located during search of peer reviewed literature using LAP measurements for the treatment of HF. Therefore, the coverage remains unchanged.

Ongoing Clinical Trials

As of December 2012, the Left Atrial Pressure Monitoring to Optimize Heart Failure Therapy (LAPTOP-HF) is still recruiting patients with an expected completion date of August 2013. The HeartPOD™ System or Promote® LAP System, for left atrial pressure measurements to manage HF is an implantable device. (NCT01121107).

According to the ClinicalTrials.gov database, the Prevention of Heart Failure Events with Impedance Cardiography Testing (PREVENT-HF) trial status is unknown as the last verification was June 2009. This study will evaluate the impact of incorporating ICG readings into treatment planning using the BioZ Dx device in 500 patients. (NCT00409916) The PREVENT-HF trial will follow patients for 24-52 weeks and is expected to be completed in December 2012.

Practice Guidelines and Position Statements

The collaborative 2009 ACCF/AHA Guidelines for the Diagnosis and Management of Heart Failure in Adults has not been changed since the last review of this policy. (23)

The 2011 update of the National Institute for Health and Clinical Excellence clinical guideline on chronic HF management does not include outpatient hemodynamic monitoring as a recommendation. (26)

No other professional society guidelines were found that address thoracic bioimpedance, inert gas rebreathing, arterial pressure/Valsalva, implantable direct pressure monitoring of the pulmonary artery, or LAP measurements in the outpatient setting for the management of HF.

Summary

The evidence is not sufficient to determine that outpatient hemodynamic monitoring of patients with HF improves outcomes. The optimal filling pressures and threshold readings for event avoidance have not been established. The REDUCEhf study was also single-blinded but reported no differences in HF event rates, including hospitalizations, emergency department visits, and urgent clinic visits, despite the inclusion of pressure monitoring readings in treatment planning. Finally, FDA-approval for invasive pulmonary artery pressure monitoring devices has been denied.

For other types of hemodynamic monitoring, there is little available evidence on efficacy. RCTs, as well as studies that specifically address use of ambulatory cardiac hemodynamic monitoring compared with current care are lacking for inert gas rebreathing, arterial pressure/Valsalva, and LAP measurements techniques.

While some evidence suggests that intensive outpatient pulmonary artery pressure monitoring may reduce hospitalizations for patients with HF, convincing evidence that the use of these technologies improves health outcomes over standard, active HF patient management is not available. Therefore, these technologies, with the exception of TEB/ICG, remain experimental, investigational and unproven.

Coding

Disclaimer for coding information on Medical Policies

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive.

The presence or absence of procedure, service, supply, device or diagnosis codes in a Medical Policy document has no relevance for determination of benefit coverage for members or reimbursement for providers. Only the written coverage position in a medical policy should be used for such determinations.

Benefit coverage determinations based on written Medical Policy coverage positions must include review of the member’s benefit contract or Summary Plan Description (SPD) for defined coverage vs. non-coverage, benefit exclusions, and benefit limitations such as dollar or duration caps.

ICD-9 Codes

428.0, 428.1, 428.20, 428.21, 428.22, 428.23, 428.30, 428.31, 428.32, 428.33, 428.40, 428.41, 428.42, 428.43, 428.9

ICD-10 Codes
I50.20, I50.21, I50.22, I50.23, I50.30, I50.31, I50.32, I50.33, I50.40, I50.41, I50.42, I50.43, I50.9
Procedural Codes: 93701, 93799, 0086T, 0293T, 0294T
References
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  21. Abraham WT, Adamson PB, Bourge RC, et al. Wireless pulmonary artery hemodynamic monitoring in chronic heart failure: a randomized controlled trial. Lancet 2011; 377(9766):658-66.
  22. Stevenson LW, Zile M, Bennett TD et al. Chronic ambulatory intracardiac pressures and future heart failure events. Circ Heart Fail 2010; 3(5):580-7.
  23. Jessup M, Abraham WT, Casey DE et al. 2009 focused update: ACCF/AHA Guidelines for the Diagnosis and Management of Heart Failure in Adults: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines: developed in collaboration with the International Society for Heart and Lung Transplantation. Circulation 2009; 119(14):1977-2016 (confirmed 2013 March 12).
  24. Silber HA, Trost JC, Johnston PV et al. Finger photoplethysmography during the Valsalva maneuver reflects left ventricular filling pressure. Am J Physiol Heart Circ Physiol 2012; 302(10):H2043-7.
  25. Adamson PB, Gold MR, Bennett T et al. Continuous hemodynamic monitoring in patients with mild to moderate heart failure: results of The Reducing Decompensation Events Utilizing Intracardiac Pressures in Patients With Chronic Heart Failure (REDUCEhf) trial. Congest Heart Fail 2011; 17(5):248-54.
  26. Mant J, Al-Mohammad A, Swain S et al. Management of chronic heart failure in adults: synopsis of the National Institute For Health and clinical excellence guideline. Ann Intern Med 2011; 155(4):252-9.
  27. Cardiac Hemodynamic Monitoring for the Management of Heart Failure in the Outpatient Setting. Chicago, Illinois: Blue Cross Blue Shield Association Medical Policy Reference Manual (2013 July) Surgery 2.02.24.
History
August 2012  Policy updated with literature review; policy statement unchanged. References 18, 22 and 24 added
December 2013 Policy formatting and language revised.  Policy statement updated from strictly investigational to include medically necessary criteria.  Added codes 0293T and 0294T.  Removed codes 0104T and 0105T.
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Cardiac Hemodynamic Monitoring for the Management of Heart Failure in the Outpatient Setting