Pending Policies - Medicine


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

Number:MED202.058

Effective Date:08-15-2017

Coverage:

*CAREFULLY CHECK STATE REGULATIONS AND/OR THE MEMBER CONTRACT*

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; or

Optimization of atrioventricular (A/V) interval for patients with A/V sequential cardiac pacemakers; or

Monitoring of continuous inotropic therapy for patients with terminal congestive HF; including patients waiting at home for a heart transplant; or

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/or unproven in the ambulatory care and outpatient setting, 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 stand-alone cardiac output measurement devices that are designed to be used in ambulatory care and outpatient settings. For information on the use of cardiac hemodynamic monitors or intra-thoracic fluid monitors that are integrated into other implantable cardiac devices, including implantable cardioverter defibrillators, cardiac resynchronization therapy devices, and cardiac pacing devices, refer to Medical Policies Automatic Implantable Cardioverter Defibrillator (AICD) and Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) – SUR707.003 or Biventricular Pacing – MED202.054.

Description:

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

Background

Patients with chronic HF are at risk of developing acute decompensated HF, 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. (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 the office or at 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. Transthoracic echocardiography (TTE), transesophageal echocardiography (TEE), and Doppler ultrasound (U/S) 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 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 are reviewed here: thoracic bioimpedance, inert gas rebreathing, arterial waveform during Valsalva maneuver, and implantable pressure monitoring devices.

Thoracic (Electrical) Bioimpedance (TEB)

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 during 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 2 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.

Left Ventricular End Diastolic Pressure (LVEDP) Estimation Methods

Pulmonary Artery (PA) Pressure Measurement to Estimate LVEDP

LVEDP can also be approximated by direct pressure measurement of an implantable sensor in the PA wall or right ventricular outflow tract. The sensor is implanted via right heart catheterization and transmits pressure readings wirelessly to external monitors. One device, the CardioMEMS™ Champion Heart Failure Monitoring System, has approval from the U.S. Food and Drug Administration (FDA) for the ambulatory management of HF patient. The CardioMEMS™ device is implanted using a heart catheter system fed through the femoral vein and generally requires patients have an overnight hospital admission for observation after implantation.

Arterial Pressure During Valsalva Maneuver 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.

Regulatory Status

Noninvasive Thoracic (Electrical) (Bio)Impedance (TEB) Plethysmography 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 because the FDA determined that this device was substantially equivalent to existing devices for use for peripheral blood flow monitoring. Table 1 includes a representative list of devices but is not meant to be comprehensive. FDA product code: DSB.

Table 1: Noninvasive Thoracic (Electrical) (Bio)Impedance (TEB) Plethysmography Devices

Device

Manufacturer

Year of FDA Clearance

TEBCO® (Thoracic Electrical Bioimpedance Cardiac Output)

Hemo Sapiens Inc. (Irvine, CA)

1996

BioZ® Thoracic Impedance Plethysmograph

SonoSite (Bothell, WA)

1997

IQ™ System Cardiac Output Monitor

Renaissance Technology (Newtown, PA)

1998

Sorba Steorra® Non-Invasive Impedance Cardiography

Sorba Medical Systems Inc. (Milwaukee, WI)

2002

Zoe® Fluid Status Monitor

Noninvasive Medical Technologies LLC (Las Vegas, NV)

2004

Cheetah NICOM® System

Cheetah Medical Inc. (Tel Aviv, Israel)

2008

Physioflow® Signal Morphology-based Impedance Cardiography (SM-ICG™)

Vasocom Inc., now Neumedx Inc. (Bristol, PA)

2008

Table Key:

FDA: U.S. Food and Drug Administration.

In 2007, the NEXFIN HD™ Continuous Noninvasive Hemodynamic Monitor (BYMEYE, now Edwards Lifesciences, Irvine, CA), which uses an inflatable finger cuff with a built-in photoelectric plethysmograph that calculates estimated cardiac output from continuous blood pressure monitoring, was cleared for marketing by the FDA through the 510(k) process. 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 TEB measurement devices 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. They 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. In 2012, the CorVue® device was cleared for marketing by the FDA through a premarket approval (PMA) supplement, and, previously (2008), the OptiVol® Fluid Status Monitor’s integration into other devices was cleared for marketing by the FDA through multiple PMA supplements.

The following are other types of measurement devices available for marketing:

Inert Gas Rebreathing Devices. 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. FDA product code: BZG.

Noninvasive LVEDP Measurement Devices. 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.” FDA product code: DXN.

Implantable PA Pressure Measurement Devices. In May 2014, the FDA approved the CardioMEMS™ Champion Heart Failure Monitoring System (CardioMEMS™, now St. Jude Medical, St. Paul, MN) through the PMA process. This device consists of an implantable 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. (3) The device originally underwent FDA review in 2011, at which point the Circulatory System Device Panel decided that there was not reasonable assurance that the discussed monitoring system is effective, particularly in certain subpopulations, although most panel members agreed that that the discussed monitoring system is safe for use in the indicated patient population. (4)

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.

Rationale:

This policy was created in 2005 based on scientific peer-reviewed literature. Periodic literature searches of the MedLine database through July 2016 have been done. The following is a summary of the literature reviewed.

Evaluation of a diagnostic technology typically focuses on the following 3 characteristics:

1. Technical 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.

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

Accuracy of TEB Measurements

A number of early studies evaluated the accuracy of thoracic bioimpedance compared with other methods of cardiac output measurements, in both the inpatient and outpatient settings. In 2002, the Agency for Healthcare Research and Quality published a technology assessment on TEB, which concluded that limitations in available studies did not allow meaningful conclusions concerning the accuracy of TEB compared with other hemodynamic parameters. (2)

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 et al. 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. (5) There was a high degree of correlation between cardiac output as measured by TEB and other invasive measures. Shoemaker et al. reported on a multicenter trial of TEB compared with thermodilution in 68 critically ill patients. (6) Again, the changes in cardiac output, as measured by TEB closely tracked those measured by thermodilution. In contrast, Sageman and Amundson reported a poor correlation between thermodilution and bioimpedance for postoperative monitoring in a study of 50 patients post-coronary artery bypass surgery, primarily due to the postoperative distortion of the patient’s anatomy and the presence of endotracheal, mediastinal, and chest tubes. (7) In a study of 34 patients undergoing cardiac surgery, Doering et al. also found that there was poor agreement between TEB and thermodilution in the immediate postoperative period. (8) The COST case series has been published only in abstract form. (9) In this study, cardiac output estimates using thermodilution methods and TEB were performed in 96 patients undergoing right heart catheterization for a variety of clinical indications. Linear regression analysis revealed an overall correlation of r (Pearson’s correlation coefficient, 0.76).

TEB and Heart Failure (HF) Outcomes

Several studies have assessed the association between TEB measurements and HF-related outcomes.

In a subanalysis of 170 subjects from the ESCAPE study, a multicenter randomized trial to assess PA catheter-guided therapy in patients with advanced HF, Kamath et al. compared cardiac output estimated by the BioZ device with subsequent HF death or hospitalization and to directly-measured hemodynamics from right heart catheterization in a subset of patients (n=82). (10) There was modest correlation between ICG and invasively measured cardiac output (r range, 0.4-0.6), but no significant association between ICG measurements and subsequent HF death or hospitalization.

Packer et al. reported on use of ICG to predict decompensation in patients with chronic HF. (11) In this study, 212 stable patients with HF and a recent episode of decompensation underwent serial evaluation and blinded ICG testing every 2 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 3 ICG parameters was a predictor of an event during the next 14 days (p<0.001). 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 with patients at intermediate risk.

In 2011, Anand et al. reported results of the Multi-Sensor Monitoring in Congestive Heart Failure (MUSIC) Study, a nonrandomized prospective study designed to develop and validate an algorithm for the prediction of acute HF decompensation using a clinical prototype of the MUSE system, multisensory system that includes intrathoracic impedance measurements, along with electrocardiographic and accelerometry data. (12, 13) The study enrolled 543 patients (206 in the development phase, 337 in the validation phase) with HF with ejection fraction less than 40% and a recent HF admission, all of whom underwent monitoring for 90 days with the MUSE. There was a high rate of study dropout: 229 patients (42% of the total; 92 development, 137 validation) were excluded from the analysis, primarily due to withdrawal of consent or failure of the prototype device to function. Subjects were assessed for the development of an acute HF decomposition event (ADHF), which was defined as any of the following:

Any HF-related hospitalization, emergency department or urgent care visit that required administration of IV diuretics, inotropes, or ultrafiltration for fluid removal;

A change in diuretic directed by the health care provider that included 1 or more of the following: a change in the prescribed diuretic type; an increase in dose of an existing diuretic; or the addition of another diuretic;

An ADHF event for which death was the outcome.

Data from the 206 subjects in the development phase were used to generate a multiparameter algorithm to predict outcomes that incorporated fluid index, a breath index, and personalization parameters (age, sex, height, weight). When the algorithm was applied to the validation cohort, it had a sensitivity of 63%, specificity of 92%, and a false-positive rate of 0.9 events per patient-year. The algorithm had a mean advance detection time of 11.5 days, but there was wide variation in this measure, from 2 to greater than 30 days, and it did not differ significantly from less specific algorithms (e.g., based on fluid index alone). The high rate of study dropout makes it difficult to generalize these results.

A number of studies have evaluated the impact of TEB devices that are integrated into implantable cardioverter defibrillator (ICD), cardiac resynchronization therapy (CRT), or cardiac pacing devices. These include the Fluid Accumulation Status Trial (FAST), a prospective trial to evaluate the use of intrathoracic impedance monitoring with ICD or CRT devices in patients with HF, (14) and the Sensitivity of the InSync Sentry for Prediction of Heart Failure (SENSE-HF) study, which evaluated the sensitivity of the OptiVol fluid trends feature in predicting HF hospitalizations. (15) The DEFEAT-PE study used an algorithm to estimate TEB from several different impedance vector measurements from various ICD or CRT device leads. (16) This study reported low sensitivity for bioimpedance monitoring in predicting HF events. TEB devices that are integrated into implantable cardiac devices are addressed in the Biventricular Pacing medical policy, MED202.054.

Section Summary: Noninvasive TEB/IC

The evidence on TEB devices consists of nonrandomized studies that correlate measurements with other measures of cardiac function and studies that use bioimpedance measurement as part of an algorithm for predicting future HF events. No studies were identified that determined how TEB measurements are associated with changes in patient management or in patient outcomes. Prospective studies that evaluate whether prediction of HF decomposition through TEB allows earlier intervention or other management changes are needed to demonstrate that outcomes are improved.

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. (17-20) No studies were identified that examined how inert gas rebreathing may be used to improve patient management in the outpatient setting.

Noninvasive Left Ventricular End Diastolic Pressure (LVEDP) Estimation Methods

Studies have shown high correlation between invasive and noninvasive measurement of LVEDP. For example, McIntyre et al. reported a comparison of pulmonary capillary wedge pressure (PCWP) measured by right heart catheter and an arterial pressure amplitude ration during Valsalva maneuver. (21) The 2 techniques were highly correlated in both stable and unstable patients (R2 [coefficient of determination] range, 0.80-0.85). Sharma et al. performed simultaneous measurements of the LVEDP based on 3 techniques in 49 patients scheduled for elective cardiac catheterization: direct measurement of LVEDP, considered the criterion standard; indirect measurement using PCWP; and noninvasively using the VeriCor® device. (22) 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 with the criterion standard. In 2012, Silber et al. reported on finger photoplethysmography during Valsalva maneuver performed in 33 patients before cardiac catheterization. (23) LVEDP greater than 15 mm Hg was identified by finger photoplethysmography during Valsalva maneuver with 85% sensitivity (95% confidence interval [CI], 54% to 97%) and 80% specificity (95% CI, 56% to 93%). However, literature searches did not identify any published articles that evaluated the role of noninvasive measurement of the LVEDP on the management of the patient. Therefore, the evidence is inadequate to permit scientific conclusions on the clinical utility of this technology.

Implantable Direct Pulmonary Artery (PA) Pressure Measurement Methods

CardioMEMS™ Device

The CHAMPION (CardioMEMS™ Heart Sensor Allows Monitoring of Pressure to Improve Outcomes in NYHA [New York Heart Association] Class III Patients) Trial Study was a prospective, single-blind, randomized controlled trial (RCT) conducted at 64 centers in the United States. (24) This trial was designed to evaluate the safety and efficacy of an implanted, passive, wireless, PA pressure monitor developed by CardioMEMS™ for the ambulatory management of HF patients.

The CHAMPION study enrolled 550 patients who had at least 1 previous hospitalization for HF in the past 12 months and were classified as having NYHA class III HF for at least 3 months. (24) Left ventricular ejection fraction (LVEF) was not a criterion for participation, but patients were required to be on medication and stabilized for 1 month before participating in the study if LVEF was reduced. All enrolled patients received implantation of the CardioMEMS™ PA 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), in which treating providers used data from the PA pressure sensor in patient management or the control group (n=280), in which providers did not incorporate PA pressure sensor data into patient management. All patients took daily PA but were masked to their treatment groups for the first 6 months.

The trial’s primary efficacy outcome was the rate of HF-related hospitalizations in the 6 months after implantation. (25) The primary safety outcomes were device-related or system-related complications and pressure-sensor failures. The investigators reported a statistically significant reduction in readmissions for HF at 6 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 to 0.84; p<0.001). This benefit was maintained over the entire randomized follow-up (mean, 15 months) (153 hospitalizations versus 253 hospitalizations, respectively) (HR=0.64; 95% CI, 0.55 to 0.75; p<0.001). The primary safety outcome, freedom from device-related complications, was 98.6% with no occurrences of pressure-sensor failure. However, 15 adverse events occurred including 8 which were device-related and 7 which were procedure-related. Additionally, length of stay for these hospitalizations was significantly shorter in the treatment group compared with the control group (2.2 days versus 3.8 days, respectively, p=0.02). There was also benefit reported for other secondary outcomes. There were improvements in the secondary outcomes of mean pulmonary pressure and quality of life at 6 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 6 months (HR=0.77; 95% CI, 0.40 to 1.51; p=0.45). During the randomized portion of the trial, the device was generally safe: freedom from device or system-related complications was 98.6%, with a 95.2% lower confidence bound of 97.3%.

In the Summary of Safety and Effectiveness Data for the CardioMEMS™ 2014 application, the U.S. Food and Drug Administration (FDA) noted that “trial conduct included subject-specific treatment recommendations sent by nurses employed by the CardioMEMS to the treating physicians. These subject-specific recommendations were limited to subjects in the treatment arm of the study. The possible impact of nurse communications was determined to severely limit the interpretability of the data in terms of effectiveness.” (3) In response, the manufacturer continued to follow all patients implanted with the device during an open access period, in which all patients were managed with PA pressure monitoring, and no nurse communication occurred. Follow-up data were available for 347 patients. For these patients, the following comparisons in HF-related hospitalization rates were reported to attempt to ensure that outcomes with the CardioMEMS™ device during the open access period (“Part 2”) were similar to those in the randomized period (“Part 1”):

Former Control versus Control -- To determine whether the HFR [heart failure rate] hospitalization rate was lower in the Former Control group than the Control group, when physicians of Former Control patients received access to PA [pulmonary artery] pressures (neither had nurse communications).”

Former Treatment to Treatment – To evaluate whether HFR hospitalization rates remain the same in subjects whose physician’s access to PA pressures remained unchanged, but no longer received nurse communications.”

Former Control to Former Treatment -- To demonstrate that the rates of HFR hospitalizations were similar during Part 2 when both groups were managed in an identical fashion (access to PA pressure and no nurse communications).”

Change in HFR hospitalization rates in the control group (Part 2 versus Part 1) compared to the change in HFR hospitalization rates in the treatment group (Part 2 versus Part 1) -- To demonstrate that the magnitude of change in HFR hospitalization rates after the transition from Control to Former Control (Part 1 versus Part 2, initiation of physician access to PA pressures in Part 2) was greater than the magnitude of change in HFR hospitalization rates after the transition from Treatment to Former Treatment (Part 1 versus Part 2, no change in physician access to PA pressure).”

The FDA concluded that these longitudinal analyses indicated that HF hospitalization rates in Former Control patients in Part 2 of the study decreased to levels comparable with the HF hospitalization rates in treatment group patients whose PA pressures were available throughout the study.

A follow-up report of the CHAMPION trial was published in 2016. (26) It included data on 13 months of open-label follow-up for 347 (63%) of the original 550 randomized patients. For patients originally randomized to the control group, information from the monitoring device was available during this phase. The rate of hospitalizations was significantly lower in this group (HR=0.52; 95% CI, 0.40 to 0.69; p<0.001) compared to the period when no monitoring information was available.

In 2015, Kranke et al. published a subgroup analysis of the CHAMPION trial evaluating outcomes for HF patients with chronic obstructive pulmonary disease (COPD). (27) Of the total study population, 187 were classified as having COPD; these patients were more likely to have coronary artery disease and a history of myocardial infarction, diabetes, and atrial fibrillation. COPD-classified patients in the intervention group (0.55) had lower rates of HF hospitalization than those in the control group (0.96; HR=0.59; 95% CI, 0.44 to 0.81; p<0.001). Rates of respiratory hospitalizations were lower in COPD-classified patients in the intervention group (0.12 versus 0.31; HR=0.38; 95% CI, 0.21 to 0.71; p=0.002). Rates of respiratory hospitalizations did not differ significantly between intervention and control group patients for non-COPD patients.

The results of the BEAT-HF (Better Effectiveness After Transition-Heart Failure) were published in 2016 by Ong et al. (28) The objective was to evaluate the effectiveness of a care transition intervention using remote patient monitoring in reducing 180-day all-cause readmission among a broad population of older adults hospitalized with HF. The 2-year study of 1437 patients randomized to the interventional arm (n=715) or the usual care arm (n=722). The interventional care treatment included health coaching telephone calls and telemonitoring. Centralized nurses conducted telemonitoring reviews, protocol-followed actions, and telephone calls. The authors reported the intervention and usual care arms did not differ significantly in readmissions for any cause 180 days after discharge, which occurred in 50.8% (363 of 715) and 49.2% (355 of 722) of patients, respectively (adjusted HR, 1.03; CI, 0.88-1.20, p<0.74). In a secondary analysis, there were no significant differences in 30-day readmissions or 180-day mortality, but there was a significant difference in 180-day quality of life between the interventional group compared to the usual care group.

Other Implantable Devices

Stevenson et al. and Bourge et al. reported on the Chronicle Offers Management to Patients with Advanced Signs and Symptoms of Heart Failure (COMPASS-HF) randomized trial. (29, 30) 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 1 HF-related event within the 6 months before 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 6 months postimplantation. 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 reported 100 (38%) of 261 patients from both treatment groups had HF-related events during the 6 months of 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 PA 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. The Medtronic Chronicle Hemodynamic Monitor was denied FDA approval in March 2007.

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 ICD coupled with an implantable hemodynamic monitoring (IHM) system. (31) 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 1300 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 previously discussed, the treatment group of 202 patients received HF management that incorporated pressure monitoring information from the IHM compared with 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 to 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.

Section Summary: Implantable Direct PA Pressure Measurement Methods

There are several RCTs of IHM systems. One of these trials (CHAMPION trial) used an FDA-approved monitor and was powered to report on clinical outcomes. This trial reported a decrease in hospitalizations for patients using the monitor as part of HF management compared with usual care. However, this trial had some methodologic limitations, one of which was 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. A second limitation was the unequal intensity of treatment between groups, with the implantable monitor group having greater frequency of contact with study nurses. The recent published results of the BEAT-HF study revealed that among patients hospitalized for HF, combined health coaching telephone calls and telemonitoring did not reduce 180-day readmissions. Because of these limitations, further high-quality trials are needed to determine whether health outcomes are improved.

Ongoing and Unpublished Clinical Trials

Some currently unpublished trials that might influence this policy are listed in Table 2.

Table 2. Summary of Key Trials

NCT No.

Trial Name

Planned Enrollment

Completion Date

Ongoing

NCT01121107

Left Atrial Pressure Monitoring to Optimize Heart Failure Therapy (LAPTOP-HF)

730

Jun 2017

Unpublished

NCT00409916a

Prevention of Heart Failure Events with Impedance Cardiography Testing (PREVENT-HF)

500

Dec 2012

Table Key:

NCT: national clinical trial;

a: denotes industry-sponsored or cosponsored trial.

Practice Guidelines and Position Statements

American College of Cardiology Foundation and American Heart Association (ACCF/AHA)

The 2013 ACCF/AHA Guideline for the Management of Heart Failure offers no recommendations for use of ambulatory monitoring devices. (32, 33)

National Institute for Health and Clinical Excellence (NICE)

The 2010 update of the NICE clinical guideline on chronic HF management does not include outpatient hemodynamic monitoring as a recommendation. (34) This clinical guideline is scheduled for review in March 2015; as of August 29, 2016 updates have not been published.

Centers for Medicare and Medicaid Services (CMS)

In November 2006, the CMS issued a decision memorandum on the second reconsideration of its coverage policy for TEB. (35) CMS’s national coverage determination found TEB to be reasonable and necessary for the following indications:

1. Differentiation of cardiogenic from pulmonary causes of acute dyspnea;

2. Optimization of atrioventricular interval for patients with A/V sequential cardiac pacemakers;

3. Monitoring of continuous inotropic therapy for patients with terminal HF;

4. Evaluation for rejection in patients with a heart transplant as a predetermined alternative to myocardial biopsy; and

5. 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 noncovered due to inadequate evidence.

CMS also specified that TEB is noncovered “in the management of all forms of hypertension (with the exception of drug-resistant hypertension…).” CMS specified in its covered indications that:

“Contractors have discretion to determine whether the use of thoracic bioimpedance for the management of drug-resistant hypertension is reasonable and necessary. Drug-resistant hypertension is defined as failure to achieve goal BP [blood pressure] in patients who are adhering to full doses of an appropriate three-drug regimen that includes a diuretic.”

There is no national CMS coverage decision regarding inert gas rebreathing, arterial pressure with Valsalva, or implantable direct pressure monitoring.

Other Professional Society Guidelines

No other professional society guidelines were found that address TEB, inert gas rebreathing, arterial pressure/Valsalva, or IDP monitoring of the PA in the outpatient setting for the management of HF.

Summary of Evidence

While the evidence for TEB for treatment of HF may be insufficient, CMS’s national coverage determination found TEB to be reasonable and effective for specific indications. However, outside of those indications, CMS has determined that utilization of TEB would be non-covered.

For the use of other types of outpatient hemodynamic monitoring for patients with HF, the available evidence consists of case series that report physiologic measurement-related outcomes. RCTs, as well as studies that specifically address use of ambulatory cardiac hemodynamic monitoring compared with current care, are lacking for inert gas rebreathing and arterial pressure/Valsalva techniques. The available published evidence is insufficient to determine that other types of outpatient hemodynamic monitoring devices improve the net health outcome for patients with HF.

For outpatient monitoring for HF, the largest body of evidence is for direct pulmonary pressure monitors, such as the CardioMEMS™ device, which has FDA approval. Evidence from RCTs for various PA pressure monitors has demonstrated a correlation between increased pressure readings and increased HF event risk. One RCT (CHAMPION trial) found that the use of PA pressure readings may reduce HF-related hospitalizations, but this study was subject to a number of potential biases. Studies of other implantable direct PA pressure measurement devices have not demonstrated significantly improved outcomes or better than usual care interventions, such as the BEAT-HF study. Definitive evidence that the use of these technologies improves health outcomes over standard active HF patient management is lacking. Therefore, the available published evidence is insufficient to determine that direct pulmonary pressure monitors used in the outpatient setting, including the CardioMEMS™ device, improve the net health outcome for patients with HF.

Contract:

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.

Coding:

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.

CPT/HCPCS/ICD-9/ICD-10 Codes

The following codes may be applicable to this Medical policy and may not be all inclusive.

CPT Codes

93701, 93799, 0293T, 0294T

HCPCS Codes

C2624, C9741

ICD-9 Diagnosis Codes

Refer to the ICD-9-CM manual

ICD-9 Procedure Codes

Refer to the ICD-9-CM manual

ICD-10 Diagnosis Codes

Refer to the ICD-10-CM manual

ICD-10 Procedure Codes

Refer to the ICD-10-CM manual


Medicare Coverage:

The information contained in this section is for informational purposes only. HCSC makes no representation as to the accuracy of this information. It is not to be used for claims adjudication for HCSC Plans.

The Centers for Medicare and Medicaid Services (CMS) does have a national Medicare coverage position.

A national coverage position for Medicare may have been changed since this medical policy document was written. See Medicare's National Coverage at <http://www.cms.hhs.gov>.

NOTE: Refer to Rationale for CMS Coverage details.

References:

1. Opasich C, Rapezzi C, Lucci D, et al. Precipitating factors and decision-making processes of short-term worsening heart failure despite "optimal" treatment (from the IN-CHF Registry). Am J Cardiol. Aug 15 2001; 88(4):382-7. PMID 11545758

2. McAlister FA, Stewart S, Ferrua S, et al. Multidisciplinary strategies for the management of heart failure patients at high risk for admission: a systematic review of randomized trials. J Am Coll Cardiol. Aug 18 2004; 44(4):810-9. PMID 15312864

3. FDA - Summary of Safety and Effectiveness Data (SSED) - CardioMEMS HF System (2014). Available online at: http://www.accessdata.fda.gov (accessed on May 6, 2015).

4. Loh JP, Barbash IM, Waksman R. Overview of the 2011 Food and Drug Administration Circulatory System Devices Panel of the Medical Devices Advisory Committee Meeting on the CardioMEMS Champion Heart Failure Monitoring System. J Am Coll Cardiol. Apr 16 2013; 61(15):1571-6. PMID 23352783

5. Belardinelli R, Ciampani N, Costantini C, et al. Comparison of impedance cardiography with thermodilution and direct Fick methods for noninvasive measurement of stroke volume and cardiac output during incremental exercise in patients with ischemic cardiomyopathy. Am J Cardiol. Jul 15 1996; 77(15):1293-301. PMID 8677869

6. Shoemaker WC, Wo CC, Bishop MH, et al. Multicenter trial of a new thoracic electrical bioimpedance device for cardiac output estimation. Crit Care Med. Dec 1994; 22(12):1907-12. PMID 7988125

7. Sageman WS, Amundson DE. Thoracic electrical bioimpedance measurement of cardiac output in postaortocoronary bypass patients. Crit Care Med. Aug 1993; 21(8):1139-42. PMID 8339577

8. Doering L, Lum E, Dracup K, et al. Predictors of between-method differences in cardiac output measurement using thoracic electrical bioimpedance and thermodilution. Crit Care Med. Oct 1995; 23(10):1667-73. PMID 7587231

9. Raisinghani A, Diaco DN, Sageman SW, et al. The COST study: a multicenter trial comparing measurement of cardiac output by thoracic bioimpedance and thermodilution. American College of Cardiology 47th Annual Scientific Sessions. 1998.

10. Kamath SA, Drazner MH, Tasissa G, et al. Correlation of impedance cardiography with invasive hemodynamic measurements in patients with advanced heart failure: the BioImpedance CardioGraphy (BIG) substudy of the Evaluation Study of Congestive Heart Failure and Pulmonary Artery Catheterization Effectiveness (ESCAPE) Trial. Am Heart J. Aug 2009; 158(2):217-23. PMID 19619697

11. Packer M, Abraham WT, Mehra MR, et al. Utility of impedance cardiography for the identification of short-term risk of clinical decompensation in stable patients with chronic heart failure. J Am Coll Cardiol. Jun 6 2006; 47(11):2245-52. PMID 16750691

12. Anand IS, Greenberg BH, Fogoros RN, et al. Design of the Multi-Sensor Monitoring in Congestive Heart Failure (MUSIC) study: prospective trial to assess the utility of continuous wireless physiologic monitoring in heart failure. J Card Fail. Jan 2011; 17(1):11-6. PMID 21187259

13. Anand IS, Tang WH, Greenberg BH, et al. Design and performance of a multisensor heart failure monitoring algorithm: results from the multisensor monitoring in congestive heart failure (MUSIC) study. J Card Fail. Jan 2012; 18(4):289-95. PMID 22464769

14. Abraham WT, Compton S, Haas G, et al. Intrathoracic impedance versus daily weight monitoring for predicting worsening heart failure events: results of the Fluid Accumulation Status Trial (FAST). Congest Heart Fail. Mar-Apr 2011; 17(2):51-5. PMID 21449992

15. Conraads VM, Tavazzi L, Santini M, et al. Sensitivity and positive predictive value of implantable intrathoracic impedance monitoring as a predictor of heart failure hospitalizations: the SENSE-HF trial. Eur Heart J. Sep 2011; 32(18):2266-73. PMID 21362703

16. Heist EK, Herre JM, Binkley PF, et al. Analysis of different device-based intrathoracic impedance vectors for detection of heart failure events (from the Detect Fluid Early from Intrathoracic Impedance Monitoring study). Am J Cardiol. Oct 15 2014; 114(8):1249-56. PMID 25150135

17. Christensen P, Clemensen P, Andersen PK, et al. Thermodilution versus inert gas rebreathing for estimation of effective pulmonary blood flow. Crit Care Med. Jan 2000; 28(1):51-6. PMID 10667498

18. Durkin RJ, Evans TW, Winter SM. Noninvasive estimation of pulmonary vascular resistance by stroke index measurement with an inert gas rebreathing technique. Chest. Jul 1994; 106(1):59-66. PMID 8020321

19. Stok WJ, Baisch F, Hillebrecht A, et al. Noninvasive cardiac output measurement by arterial pulse analysis compared with inert gas rebreathing. J Appl Physiol. Jul 1993; 74(6):2687-93. PMID 8396105

20. Lang CC, Karlin P, Haythe J, et al. Ease of noninvasive measurement of cardiac output coupled with peak VO2 determination at rest and during exercise in patients with heart failure. Am J Cardiol. Feb 1 2007; 99(3):404-5. PMID 17261407

21. McIntyre KM, Vita JA, et al. A noninvasive method of predicting pulmonary-capillary wedge pressure. N Engl J Med. Dec 10 1992 327(24):1715-20. PMID 1435916

22. Sharma GV, Woods PA, Lambrew CT, et al. Evaluation of a noninvasive system for determining left ventricular filling pressure. Arch Intern Med. Oct 14 2002; 162(18):2084-8. PMID 12374516

23. 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. May 2012; 302(10):H2043-7. PMID 22389389

24. Adamson PB, Abraham WT, Aaron M, et al. CHAMPION trial rationale and design: the long-term safety and clinical efficacy of a wireless pulmonary artery pressure monitoring system. J Card Fail. Jan 2011; 17(1):3-10. PMID 21187258

25. Abraham WT, Adamson PB, Bourge RC, et al. Wireless pulmonary artery hemodynamic monitoring in chronic heart failure: a randomized controlled trial. Lancet. Feb 19 2011; 377(9766):658-66. PMID 21315441

26. Abraham WT, Stevenson LW, Bourge RC, et al. Sustained efficacy of pulmonary artery pressure to guide adjustment of chronic heart failure therapy: complete follow-up results from the CHAMPION randomized trial. Lancet. Jan 30 2016; 387(10017):453-61. PMID 26560249

27. Kranke JS, Abraham WT, Adamson PB, et al. 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. J Card Fail. Mar 2015; 21(3):240-9. PMID 25541376

28. Ong MK, Romano PS, Edgington S, et al. Effectiveness of remote patient monitoring after discharge of hospitalized patients with heart failure: The Better Effectiveness After Transition-Heart Failure randomized clinical trial. JAMA. Mar 2016;176(3):310-8. PMID 26857383

29. Bourge RC, Abraham WT, Adamson PB, et al. Randomized controlled trial of an implantable continuous hemodynamic monitor in patients with advanced heart failure: the COMPASS-HF study. J Am Coll Cardiol. Mar 18 2008; 51(11):1073-9. PMID 18342224

30. Stevenson LW, Zile M, Bennett TD, et al. Chronic ambulatory intracardiac pressures and future heart failure events. Circ Heart Fail. Sep 2010; 3(5):580-7. PMID 20562255

31. 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. Sep-Oct 2011; 17(5):248-54. PMID 21906250

32. Yancy CW, Jessup M, Bozkurt B, et al. 2013 ACCF/AHA Guideline for the Management of Heart Failure: A Report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. J Am Coll Card. Oct 15 2013; 62(16):e147-239. Epub June 5 2013. PMID 23747642

33. Yancy CW, Jessup M, Bozkurt B, et al. 2013 ACCF/AHA Guideline for the Management of Heart Failure: A Report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. Circulation. Oct 15 2013; 128:e240-327. Epub June 5 2013. PMID 23741058

34. 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. Aug 16 2011; 155(4):252-9. PMID 21844551

35. Centers for Medicare and Medicaid Services (CMS). National coverage decision for cardiac output monitoring by thoracic electrical bioimpedance (TEB) (20.16). 2006. Available online at <http: //www.cms.gov> (accessed in June 2010) (confirmed on August 23, 2016).

36. Cardiac Hemodynamic Monitoring for the Management of Heart Failure in the Outpatient Setting. Chicago, Illinois: Blue Cross Blue Shield Association Medical Policy Reference Manual (2016 May) Surgery 2.02.24.

Policy History:

DateReason
8/15/2017 Reviewed. No changes.
10/1/2016 Document updated with literature review. Coverage unchanged.
1/1/2016 Document updated with literature review. Coverage unchanged.
10/1/2014 Document updated with literature review. Coverage unchanged. Description, Rationale, and References significantly revised and reorganized. CPT/HCPCS codes updated.
4/15/2013 Document updated with literature review. Coverage unchanged.
4/1/2012 Document updated with the following changes to the Coverage: The use of left atrial pressure monitoring, as a form of cardiac hemodynamic monitoring in the management of heart failure, is considered experimental, investigational and unproven. Additional revisions to Description, References, and Rationale. CPT/HCPCS codes updated.
9/1/2011 Document updated with literature review. The following topics were added: Thoracic electrical bioimpedance may be considered medically necessary when criteria are met. Inert gas rebreathing is considered experimental, investigational and unproven. These topics were previously addressed on Medical Policy MED202.018, Plethysmography; however, criteria have changed. The title was changed from Non-Invasive Measurement of Left Ventricular End Diastolic Pressure (LVEDP) in the Outpatient Setting, and the document was completely revised.
9/1/2010 Document updated with literature review. Coverage unchanged. This document is no longer scheduled for routine literature review and update.
7/1/2008 Revised/updated entire document
5/15/2005 New medical document originating from a position statement

Archived Document(s):

Title:Effective Date:End Date:
Cardiac Hemodynamic Monitoring for the Management of Heart Failure in the Outpatient Setting07-15-202112-31-2022
Cardiac Hemodynamic Monitoring for the Management of Heart Failure in the Outpatient Setting10-15-202007-14-2021
Cardiac Hemodynamic Monitoring for the Management of Heart Failure in the Outpatient Setting01-15-202010-14-2020
Cardiac Hemodynamic Monitoring for the Management of Heart Failure in the Outpatient Setting10-01-201801-14-2020
Cardiac Hemodynamic Monitoring for the Management of Heart Failure in the Outpatient Setting08-15-201709-30-2018
Cardiac Hemodynamic Monitoring for the Management of Heart Failure in the Outpatient Setting10-01-201608-14-2017
Cardiac Hemodynamic Monitoring for the Management of Heart Failure in the Outpatient Setting01-01-201609-30-2016
Cardiac Hemodynamic Monitoring for the Management of Heart Failure in the Outpatient Setting10-01-201412-31-2015
Cardiac Hemodynamic Monitoring for the Management of Heart Failure in the Outpatient Setting04-15-201309-30-2014
Cardiac Hemodynamic Monitoring for the Management of Heart Failure in the Outpatient Setting04-01-201204-14-2013
Cardiac Hemodynamic Monitoring for the Management of Heart Failure in the Outpatient Setting09-01-201103-31-2012
Non-Invasive Measurement of Left Ventricular End Diastolic Pressure (LVEDP) in the Outpatient Setting09-01-201008-31-2011
Non-Invasive Measurement of Left Ventricular End Diastolic Pressure (LVEDP) in the Outpatient Setting07-01-200808-31-2010
Non-Invasive Measurement of Left Ventricular End Diastolic Pressure (LVEDP) in the Outpatient Setting05-15-200506-30-2008
Non-Invasive Measurement of Left Ventricular End Diastolic Pressure (LVEDP) in the Outpatient Setting01-01-200505-14-2005
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