Medical Policies - Medicine


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

Number:MED202.058

Effective Date:10-01-2018

Coverage:

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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 interval for patients with atrioventricular 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 1: 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 (TEB) measurement, inert gas rebreathing, and estimation of left ventricular end diastolic pressure (LVEDP) 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)

Management

Strategies for reducing decompensation, and thus the need for hospitalization, are aimed at early identification of patients at risk for imminent decompensation. Programs for early identification of HF are characterized by frequent contact with patients to review signs and symptoms with a health care provider, education, and medication adjustments as appropriate. These encounters may occur face-to-face in the office or at home, or via cellular or computed technology. (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 used for dyspnea when the diagnosis of acute decompensated HF is uncertain.

The criterion standard for hemodynamic monitoring is pulmonary artery catheters and central venous pressure catheters. However, they are invasive, inaccurate, and inconsistent in predicting fluid responsiveness. Several studies have demonstrated that catheters fail to improve outcomes in critically ill patients and may be associated with harm. To overcome these limitations, multiple techniques and devices have been developed that use complex imaging technology and computer algorithms to estimate fluid responsiveness, volume status, cardiac output and tissue perfusion. Many are intended for use in outpatient settings but can be used in the emergency department, intensive care unit, and operating room. Four methods are reviewed here: implantable pressure monitoring devices, TEB, inert gas rebreathing, and arterial waveform during the Valsalva maneuver. Use of the last 3 is not widespread because of several limitations including use of proprietary technology making it difficult to confirm their validity and lack of large randomized controlled trials to evaluate treatment decisions guided by these hemodynamic monitors.

Thoracic (Electrical) Bioimpedance (TEB)

Bioimpedance is defined as the electrical resistance of current flow through tissue. 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 cardiography (ICG).

Inert Gas Rebreathing

Inert gas rebreathing is based on the observation that the absorption and disappearance of a blood-soluble gas are proportional to cardiac blood flow. The patient is asked to breathe and rebreathe from a 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 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.

Pulmonary Artery Pressure Measurement to Estimate LVEDP

LVEDP can be approximated by direct pressure measurement of an implantable sensor in the pulmonary artery 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 with 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. The FDA determined that this device was substantially equivalent to existing devices used for peripheral blood flow monitoring. Table 1 presents an inexhaustive list of representative devices (FDA product code: DSB).

Table 1. Noninvasive Thoracic Impedance Plethysmography Devices

Device

Manufacturer

Year of FDA Clearance

BioZ® Thoracic Impedance Plethysmograph

SonoSite (Bothell, WA)

2009

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

ReDS™ Wearable System

Sensible Medical Innovations (Trenton, NJ and Netanya, Israel)

2015

Table Key:

FDA: U.S. Food and Drug Administration.

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

Inert Gas Rebreathing Devices

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

Noninvasive LVEDP Measurement Devices

In 2004, the VeriCor® (CVP Diagnostics), a non-invasive 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 2014, the CardioMEMS™ Champion Heart Failure Monitoring System (CardioMEMS™, now St. Jude Medical) was cleared for marketing by the FDA through the premarket approval process. This device consists of an implantable pulmonary artery sensor, which is implanted in the distal pulmonary artery, a transvenous delivery system, and an electronic sensor that processes signals from the implantable pulmonary artery sensor and transmits pulmonary artery pressure measurements to a secure database. (3) The device originally underwent FDA review in 2011, at which point the FDA found no reasonable assurance that the monitoring system would be effective, particularly in certain subpopulations, although the FDA agreed this monitoring system was safe for use in the indicated patient population. (4)

Additional Devices

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

Rationale:

This policy was created in 2005 and is based on published scientific peer-reviewed literature and updated regularly with searches of the MedLine database. The most recent search was performed through August 2018. The following is a summary of the key literature reviewed.

For the cardiac hemodynamic monitoring for the management of heart failure (HF) using implantable direct pressure monitoring of the pulmonary artery indication, because there is direct evidence from a large randomized controlled trial (RCT), our focus on it was to assess the evidence it provides on clinical utility. Medical policies assess the clinical evidence to determine whether the use of a technology improves the net health outcome. Broadly defined, health outcomes are length of life, quality of life, and ability to function--including benefits and harms. Every clinical condition has specific outcomes that are important to patients and to managing the course of that condition. Validated outcome measures are necessary to ascertain whether a condition improves or worsens; and whether the magnitude of that change is clinically significant. The net health outcome is a balance of benefits and harms.

To assess whether the evidence is sufficient to draw conclusions about the net health outcome of a technology, 2 domains are examined: the relevance and the quality and credibility. To be relevant, studies must represent one or more intended clinical use of the technology in the intended population and compare an effective and appropriate alternative at a comparable intensity. For some conditions, the alternative will be supportive care or surveillance. The quality and credibility of the evidence depend on study design and conduct, minimizing bias and confounding that can generate incorrect findings. The RCT is preferred to assess efficacy; however, in some circumstances, nonrandomized studies may be adequate. RCTs are rarely large enough or long enough to capture less common adverse events and long-term effects. Other types of studies can be used for these purposes and to assess generalizability to broader clinical populations and settings of clinical practice.

For the other indications, our focus was to assess the evidence as a medical test. Medical policies assess whether a medical test is clinically useful. A useful test provides information to make a clinical management decision that improves the net health outcome. That is, the balance of benefits and harms is better when the test is used to manage the condition than when another test or no test is used to manage the condition.

The first step in assessing a medical test is to formulate the clinical context and purpose of the test. The test must be technically reliable, clinically valid, and clinically useful for that purpose. Medical policies assess the evidence on whether a test is clinically valid and clinically useful. Technical reliability is outside the scope of these reviews, and credible information on technical reliability is available from other sources.

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

The purpose of TEB in patients who have HF in an outpatient setting is:

1. To guide volume management,

2. To identify physiologic changes that precede clinical symptoms and thus allow preventive interventions, and

3. To prevent hospitalizations.

The question addressed in this medical policy is: Does use of TEB/ICG improve health outcomes in individuals with HF in the outpatient setting?

The following PICOTS (patients, interventions, comparators, outcomes, timing, and setting) were used to select literature to inform this policy (see Table 2):

Table 2. PICOTS to Assess TEB/ICG

PICOTS

Review Assessment

Patients

The relevant population of interest is patients with chronic HF who are at risk of developing ADHF.

Interventions

The test being considered is TEB.

Comparators

The comparator of interest is standard clinical care without testing. Decisions on guiding volume management are being made based on signs and symptoms.

Outcomes

The general outcomes of interest are the prevention of decompensation episodes, reductions in hospitalization and mortality, and improvements in quality of life.

Timing

Trials of using TEB in this population were not found. Generally, demonstration of outcomes over a 1-year period is meaningful for interventions.

Setting

Patients will receive treatment in the outpatient setting.

Table Key:

PICOTS: patients, interventions, comparators, outcomes, timing, setting;

TEB: thoracic bioimpedance;

ICG: impedance cardiography;

HF: heart failure;

ADHF: acute decompensated heart failure.

Technically Reliable

Assessment of technical reliability focuses on specific tests and operators and requires review of unpublished and often proprietary information. Review of specific tests, operators, and unpublished data are outside the scope of this evidence review, and alternative sources exist. This medical policy focuses on the clinical validity and clinical utility.

Clinically Valid

A test must detect the presence or absence of a condition, the risk of developing a condition in the future, or treatment response (beneficial or adverse).

Several studies were excluded from the evaluation of the clinical validity of the TEB testing because they did not include information needed to assess clinical validity. (5-7)

Packer et al. (2006) reported on use of ICG measured by BioZ ICG monitor to predict 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 2 weeks for 26 weeks and were followed for the occurrence of death or worsening HF requiring hospitalization or emergent care. Results are summarized in Table 3. A composite score of 3 ICG parameters was a predictor of an event during the next 14 days (p<0.001).

Table 3. Clinical Validity of 3-Level Risk Score for BioZ Impedance Cardiography Monitor

Author

Initial N

Final N

Excluded Samples

Prevalence of Condition

Clinical Validity: Mean Probability of Outcome (95% CI), %

Low-

Risk

Medium- Risk

High- Risk

Packer

et al. (2006) (8)

212

212

None

59 patients had 104 episodes of decompensated HF including 16 deaths, 78 hospitalizations, 10 ED visits

1.0 (0.5 to 1.9)

3.5 (2.4 to 4.8)

8.4 (5.8 to 11.6)

Table Key:

CI: confidence interval;

ED: emergency department;

HF: heart failure;

N: number.

Section Summary: Clinically Valid

The clinical validity of using TEB for patients with chronic HF who are at risk of developing acute decompensated heart failure (ADHF) has not been established. Association studies are insufficient evidence to determine whether TEB can improve outcomes patients with chronic HF who are at risk of developing ADHF. There are no studies reporting the clinical validity regarding sensitivity, specificity, or predictive value.

Clinically Useful

A test is clinically useful if the use of the results informs management decisions that improve the net health outcome of care. The net health outcome can be improved if patients receive correct therapy, or more effective therapy, or avoid unnecessary therapy, or avoid unnecessary testing.

Direct Evidence

Direct evidence of clinical utility is provided by studies that have compared health outcomes for patients managed with and without the test. Because these are intervention studies, the preferred evidence would be from RCTs.

Amir et al. (2017) reported on results of a prospective study in which 59 patients recently hospitalized for HF was selected for ReDS-guided treatment for 90 days. The number of HF hospitalizations during 90-day ReDS-guided therapy were compared with hospitalizations in the preceding 90 days before enrollment and the 90 days following discontinuation of ReDS monitoring. (9) During treatment, patients were equipped with the ReDS wearable vest, which was worn once a day at home to measure lung fluid content. Study characteristics and results are summarized in Tables 4 and 5. The rate of HF hospitalizations was lower during the ReDS-guided follow-up compared with pre and post-treatment periods. Interpretation of results is uncertain due to the lack of concurrent control and randomization, short-term follow-up, large confidence intervals (CIs), and lack of clarity about lost-to-follow-up during the post-ReDS period. An RCT comparing ReDS monitoring with standard of care (SMILE; NCT02448342) was initiated but terminated before its completion.

Table 4. Summary of Key Nonrandomized Study Characteristics

Author

Study Type

Country

Dates

Participants

Treatment

Mean FU (SD), days

Amir et al. (2017) (9)

Pre-post prospective cohort

Israel

2012-2015

Patients ≥18 years with stage C - HF, regardless of LVEF (n=59)

ReDS Wearable System

83.0 (25.4)

Table Key:

FU: follow-up;

HF: heart failure;

LVEF: left ventricular ejection fraction;

n: number;

SD: standard deviation.

Table 5. Summary of Key Nonrandomized Study Results

Study

HF-Related Hospitalizations

(events/patient/3 months)

Deaths

Amir et al. (2017) (9)

50

50

Pre-90-day period (control)

0.04

0

90-day treatment period

0.30

2

Post-90-day period (control)

0.19

2

HR (95% CI); p

0.07 (0.01 to 0.54); 0.01a

0.11 (0.014 to 0.88); 0.037b

Table Key:

CI: confidence interval;

HR: hazard ratio;

HF: heart failure;

a: Treatment versus pre-treatment period;

b: Treatment versus post-treatment period.

Chain of Evidence

Indirect evidence on clinical utility rests on clinical validity. If the evidence is insufficient to demonstrate test performance, no inferences can be made about clinical utility. Because the clinical validity of using TEB has not been proved, a chain of evidence to support its clinical utility cannot be constructed.

Section Summary: Clinical Utility

The clinical utility of using TEB for patients with chronic HF who are at risk of developing ADHF has not been established. One prospective longitudinal study reported that ReDS-guided management reduced HF readmissions in ADHF patients recently discharged from the hospital. However, interpretation of results is uncertain due to the lack of concurrent controls and randomization, short-term follow-up, large CIs, and lack of clarity about lost-to-follow-up during the post-ReDS monitoring period. An RCT comparing ReDS monitoring with standard of care was initiated but terminated before its completion.

Section Summary: Noninvasive Thoracic (Electrical) Bioimpedance (TEB)/Impedance Cardiography (ICG)

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 clinical validity and utility for patient management or in patient outcomes. RCTs 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

Clinical Context and Test Purpose

The purpose of inert gas breathing in patients who have HF in an outpatient setting is:

1. To guide volume management,

2. To identify physiologic changes that precede clinical symptoms and thus allow preventive interventions, and

3. To prevent hospitalizations.

The question addressed in this medical policy is: Does use of inert gas breathing improve health outcomes in individuals with HF in the outpatient setting?

The following PICOTS were used to select literature to inform this policy (see Table 6):

Table 6. PICOTS to Assess Inert Gas Breathing

PICOTS

Review Assessment

Patients

The relevant population of interest is patients with chronic HF who are at risk of developing ADHF.

Interventions

The test being considered is inert gas breathing.

Comparators

The comparator of interest is standard clinical care without testing. Decisions on guiding volume management are being made based on signs and symptoms.

Outcomes

The general outcomes of interest are the prevention of decompensation episodes, reductions in hospitalization and mortality, and improvements in quality of life.

Timing

Trials of using inert gas breathing in this population were not found. Generally, demonstration of outcomes over a 1-year period is meaningful for interventions.

Setting

Patients will receive treatment in the outpatient setting.

Table Key:

PICOTS: patients, interventions, comparators, outcomes, timing, setting;

HF: heart failure;

ADHF: acute decompensated heart failure.

Technically Reliable

Assessment of technical reliability focuses on specific tests and operators and requires review of unpublished and often proprietary information. Review of specific tests, operators, and unpublished data are outside the scope of this evidence review, and alternative sources exist. This medical policy focuses on the clinical validity and clinical utility.

Clinically Valid

A test must detect the presence or absence of a condition, the risk of developing a condition in the future, or treatment response (beneficial or adverse). 

No studies on the clinical validity were identified that would establish how the use of inert gas rebreathing measurements helps detect the likelihood of decompensation.

Section Summary: Clinically Valid

The clinical validity of using inert gas breathing for patients with chronic HF who are at risk of developing ADHF has not been established.

Clinically Useful

A test is clinically useful if the use of the results informs management decisions that improve the net health outcome of care. The net health outcome can be improved if patients receive correct therapy or more effective therapy, or avoid unnecessary therapy, or avoid unnecessary testing.

Direct Evidence

Direct evidence of clinical utility is provided by studies that have compared health outcomes for patients managed with and without the test. Because these are intervention studies, the preferred evidence would be from RCTs.

No studies were identified that determined how the use of inert gas rebreathing measurements is associated with changes in patient management or evaluated the effects of this technology on patient outcomes.

Chain of Evidence

Indirect evidence on clinical utility rests on clinical validity. If the evidence is insufficient to demonstrate test performance, no inferences can be made about clinical utility. Because the clinical validity of using inert gas breathing has not been proved, a chain of evidence to support clinical utility cannot be constructed.

Section Summary: Clinically Useful

No studies of clinical utility were identified that determined how the use of inert gas breathing measurements in managing HF affects patient outcomes. It is unclear how such devices will improve patient outcomes.

Section Summary: Inert Gas Breathing

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. (10-13) 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

Clinical Context and Test Purpose

The purpose of noninvasive LVEDP in patients who have HF in an outpatient setting is:

1. To guide volume management,

2. To identify physiologic changes that precede clinical symptoms and thus allow preventive interventions, and

3. To prevent hospitalizations.

The question addressed in this medical policy is: Does use of noninvasive LVEDP improve health outcomes in individuals with HF in the outpatient setting?

The following PICOTS were used to select literature to inform this policy (see Table 7):

Table 7. PICOTS to Assess LVEDP

PICOTS

Review Assessment

Patients

The relevant population of interest is patients with chronic HF who are at risk of developing ADHF.

Interventions

The test being considered is noninvasive LVEDP.

Comparators

The comparator of interest is standard clinical care without testing. Decisions on guiding volume management are being made based on signs and symptoms.

Outcomes

The general outcomes of interest are the prevention of decompensation episodes, reductions in hospitalization and mortality, and improvements in quality of life.

Timing

Trials of using noninvasive LVEDP in this population were not found. Generally, demonstration of outcomes over a 1-year period is meaningful for interventions.

Setting

Patients will receive treatment in the outpatient setting.

Table Key:

PICOTS: patients, interventions, comparators, outcomes, timing, setting;

HF: heart failure;

ADHF: acute decompensated heart failure;

LVEDP: left ventricular end diastolic pressure. 

Technically Reliable

Assessment of technical reliability focuses on specific tests and operators and requires review of unpublished and often proprietary information. Review of specific tests, operators, and unpublished data are outside the scope of this evidence review, and alternative sources exist. This medical policy focuses on the clinical validity and clinical utility.

Clinically Valid

A test must detect the presence or absence of a condition, the risk of developing a condition in the future, or treatment response (beneficial or adverse).

Silber et al. (2012) reported on finger photoplethysmography during the Valsalva maneuver performed in 33 patients before cardiac catheterization. (14) LVEDP was measured via a catheter placed in the left ventricle and used as the reference standard. For identifying LVEDP greater than 15 mm Hg, finger photoplethysmography during the Valsalva maneuver was 85% sensitive (95% CI, 54% to 97%) and 80% specific (95% CI, 56% to 93%).

Section Summary: Clinically Valid

Only 1 study was identified assessing the use of LVEDP monitoring in this patient population; it reported an 85% sensitivity and an 80% specificity to detect LVEDP greater than 15 mm Hg.

Clinically Useful

A test is clinically useful if the use of the results informs management decisions that improve the net health outcome of care. The net health outcome can be improved if patients receive correct therapy, or more effective therapy, or avoid unnecessary therapy, or avoid unnecessary testing.

Direct Evidence

Direct evidence of clinical utility is provided by studies that have compared health outcomes for patients managed with and without the test. Because these are intervention studies, the preferred evidence would be from RCTs.

No studies were identified that determined how the use of noninvasive LVEDP estimation is associated with changes in patient management or evaluated the effects on patient outcomes.

Chain of Evidence

Indirect evidence on clinical utility rests on clinical validity. If the evidence is insufficient to demonstrate test performance, no inferences can be made about clinical utility.

Because the clinical validity of using noninvasive LVEDP estimation has only been demonstrated in a small, single study, a chain of evidence to support clinical utility cannot be constructed.

Section Summary: Clinically Useful

No studies of clinical utility were identified that assessed how the use of noninvasive LVEDP estimation in managing HF affects patient outcomes. A chain of evidence on the clinical utility of noninvasive LVEDP estimation cannot be constructed because it is unclear how these devices will improve patient outcomes.

Section Summary: Noninvasive LVEDP

In contrast to prior test methods, relatively little literature has been published on noninvasive LVEDP, the clinical validity rests on 1 small study of 33 patients and no studies on clinical utility. Therefore, no studies were identified that examined how noninvasive LVEDP may be used to improve patient management in the outpatient setting.

Implantable Direct Pulmonary Artery Pressure Measurement Methods

CardioMEMS™ Device

Abraham et al. (2011, 2016) have reported on the results of 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 RCT in which all enrolled patients were implanted with the CardioMEMS™ device. (15, 16) Patients were randomized to the CardioMEMS™ group, in which daily uploaded pulmonary artery pressures were used to guide medical therapy, or to the control group, in which daily uploaded pressures were not made available to investigators and patients continued to receive standard of care management, which included drug adjustments in response to patients’ clinical signs and symptoms. An independent clinical end points committee, blinded to the treatment groups, reviewed abstracted clinical data and determined if hospitalization was related to HF hospitalization. The randomized phase ended when the last patient enrolled completed at least 6 months of study follow-up (average, 18 months) and was followed in an open-access phase during which investigators had access to pulmonary artery pressure for all patients (former control and treatment group). The open-access phase lasted for an average of 13 months. In the randomized phase of the trial, if the investigator did not document a medication change in response to an abnormal pulmonary artery pressure elevation, a remote CardioMEMS™ nurse could send communications to the investigator related to clinical management. No such activity occurred in the nonrandomized phase. Trial characteristics and results are summarized in Tables 8 and 9. The trial met its primary efficacy end point, with a statistically significant 28% relative reduction in the rate of HF?related hospitalizations at 6 months. However, members of the U.S. Food and Drug Administration (FDA) advisory committee in 2011 were unable to distinguish the effect of the device from the effect of nurse communications, and so the FDA denied approval of CardioMEMS™ and requested additional clarification from the manufacturer. (4) Subsequently, the FDA held a second advisory committee meeting in 2013 to review additional data (including open-access phase) and address previous concerns related to impact of nurse communication on the CHAMPION trial. (4)

The 2 major limitations in the early data were related to the potential impact of nurse communication and lack of treatment effect in women.

The sponsor conducted multiple analyses to address the impact of nurse intervention on HF-related hospitalizations. These analyses included:

1. Independent auditing of all nurse communication to estimate quantitatively the number of hospitalization that could have been influenced by nurse communication;

2. Using a propensity-based score to match patients in the CardioMEMS™ group who did not receive nurse communications with those in the control base;

3. Comparing whether the new knowledge of pulmonary arterial pressure in the former control during the open-access phase led to reductions in HF-related hospitalizations;

4. Comparing whether the ongoing access to pulmonary artery pressures in the treatment group during the open-access phase was accompanied by continued reduced rates of HF hospitalizations; and,

5. Comparing whether if similar access to pulmonary artery pressures in the former control group and treatment group during the open-access phase was associated with similar rates of HF-related hospitalizations. (4)

The FDA concluded that all such analyses had methodologic limitations. Propensity matching cannot balance unmeasured characteristics and confounders, and therefore conclusions drawn from propensity analysis were not definitive. (4) While the FDA concluded that the third-party audit of nurse communication was valid, it was difficult to estimate accurately how many HF-related hospitalizations were avoided by the nurse communications. The FDA stated that the longitudinal analyses (see points 3 to 5 above) were the most useful regarding supporting device effectiveness. Therefore, only data from analyses 3 to 5 are summarized in Table 10 and discussed next. It is important to acknowledge that all such analyses were post hoc and were conducted with the intent to test the robustness of potentially biased RCT results and therefore results from these analyses should be evaluated to assess consistency and not as an independent source of evidence to support efficacy. As indicated in Table10, the longitudinal analyses of individual patient data showed that the device appears to be associated with reducing HF-related hospitalization rate. However, there are important trial limitations, notably, subject dropouts were not random, and patient risk profiles could have changed from the randomized phase to the open-access phase. In the open-access phase, 93 (34%) of 270 subjects in the treatment group and 110 (39%) of 280 subjects in control group, remained in the analysis.

According to the FDA documents, the apparent lack of reduction in HF-related hospitalization in women resulted from a greater number of deaths among women in the control group early in the trial and this early mortality resulted in a competing risk for future HF hospitalizations. While both the FDA and sponsor conducted multiple analyses to understand device effectiveness in women, the FDA statisticians concluded that such analyses did clearly delineate the limited treatment effect in women. (4) The effectiveness of CardioMEMS™ in women may be clarified when results of a postmarketing study, currently ongoing and proposed to enroll at least 35% (n=420) women of the enrollment (n=1200), are published.

Other subgroup analysis of CHAMPION trial in patients with reduced ejection fraction, (17) preserved ejection fraction, (18) Medicare-eligible patients, (19) and chronic obstructive pulmonary disease (20) are out of scope and not discussed in this medical policy.

Table 8. Summary of Key RCT Characteristics

Author

Countries

Sites

Dates

Participants

Interventions

Active

Comparator

Abraham et al. (2011, 2016) (15, 16); CHAMPION

United States

64

2007-2009

At least 1 previous HFH in the past 12 months and NYHA class III HF for at least 3 months

40% patients from academic setting and 60% from community setting

Disease management by daily measurement of pulmonary artery pressures (via CardioMEMS™) plus standard of care (n=270)

Disease management by standard of care alone (n=280)

Table Key:

HF: heart failure;

HFH: heart failure hospitalization;

NYHA: New York Heart Association;

n: number;

RCT: randomized controlled trial.

Table 9. Summary of Key RCT Results

Author

HFH, n (events per patient)

Device- or System-Related Complications, n (%)

Pressure-Sensor Failures at 6 or 12 Months

At 6

Months

At 12 Months

At 6 Months

At 12 Months

Abraham et al. (2011, 2016)

(15, 16); CHAMPION

550

550

550

550

550

CardioMEMS™

84 (0.32)

182 (0.46)

3 (1)

0

0

Control

120 (0.44)

279 (0.68)

3 (1)

0

0

HR (95% CI)

0.72

(0.60 to 0.85)

0.67 (0.55 to 0.80)

NA

NA

NA

NNT (95% CI)

8 (NR)

4 (NR)

NA

NA

NA

Table Key:

CI: confidence interval;

HR: hazard ratio;

HFH: heart failure hospitalization;

NA: not applicable;

NR: not reported;

n: number;

NNT: number needed to treat;

RCT: randomized controlled trial.

Table 10. Summary of Additional Analyses of the CHAMPION RCT

Trial Period

Randomized Group

CardioMEMS™

Data Available

Nurse Communication

COMP

HR for HFH (95% CI)

Randomized Access

Treatment

Yes

Yes

Former control to control

0.52

(0.40 to 0.69)

Control

No

No

Former treatment to treatment

0.93

(0.70 to 1.22)

Open Access

Former Control

Yes

No

Former control to former treatment

0.80

(0.56 to 1.14)

Former Treatment

Yes

No

Table Key:

Adapted from Abraham et al. (2016) and FDA (2013); (4, 16)

CI: confidence interval;

COMP: comparison;

HR: hazard ratio;

HFH: heart failure hospitalization;

RCT: randomized controlled trial.

The purpose of the gaps tables (see Tables 11 and 12) is to display notable gaps identified in each study. This information is synthesized as a summary of the body of evidence following each table and provides the conclusions on the sufficiency of evidence supporting the position statement.

Table 11. Relevance Gaps

Study; Trial

Populationa

Interventionb

Comparatorc

Outcomesd

Follow-Upe

Abraham et al. (2011, 2016)

(15, 16); CHAMPION

1. Delivery not similar intensity as comparator.

2. Treatment group received additional nurse communication for enhanced protocol compliance.

3. Trial intention was to assess physician’s ability to use pulmonary artery pressure information and not capabilities of sponsor’s nursing staff to monitor and correct physician-directed therapy.

Table Key:

The evidence gaps stated in this table are those notable in the current review; this is not a comprehensive gaps assessment;

a: Population key: 1. Intended use population unclear; 2. Clinical context is unclear; 3. Study population is unclear; 4. Study population not representative of intended use;

b: Intervention key: 1. Not clearly defined; 2. Version used unclear; 3. Delivery not similar intensity as comparator; 4.Not the intervention of interest;

c: Comparator key: 1. Not clearly defined; 2. Not standard or optimal; 3. Delivery not similar intensity as intervention; 4. Not delivered effectively;

d: Outcomes key: 1. Key health outcomes not addressed; 2. Physiologic measures, not validated surrogates; 3. No CONSORT reporting of harms; 4. Not establish and validated measurements; 5. Clinical significant difference not prespecified; 6. Clinical significant difference not supported;

e: Follow-Up key: 1. Not sufficient duration for benefit; 2. Not sufficient duration for harms.

RCT: randomized controlled trial.

Table 12. Study Design and Conduct Gaps

Study; Trial

Allocationa

Bindingb

Selective Reportingc

Follow-Upd

Powere

Statisticalf

Abraham et al. (2011, 2016)

(15, 16); CHAMPION

Physicians not blinded to treatment assignment but outcome assessment was independent and blinded

Table Key:

The evidence gaps stated in this table are those notable in the current review; this is not a comprehensive gaps assessment;

a: Allocation key: 1. Participants not randomly allocated; 2. Allocation not concealed; 3. Allocation concealment unclear; 4. Inadequate control for selection bias;

b: Blinding key: 1. Not blinded to treatment assignment; 2. Not blinded outcome assessment; 3. Outcome assessed by treating physician;

c: Selective Reporting key: 1. Not registered; 2. Evidence of selective reporting; 3. Evidence of selective publication;

d: Follow-Up key: 1. High loss to follow-up or missing data; 2. Inadequate handling of missing data; 3. High number of crossovers; 4. Inadequate handling of crossovers; 5. Inappropriate exclusions; 6. Not intent to treat analysis (per protocol for noninferiority trials);

e: Power key: 1. Power calculations not reported; 2. Power not calculated for primary outcome; 3. Power not based on clinically important difference;

f: Statistical key: 1. Intervention is not appropriate for outcome type: (a) continuous; (b) binary; (c) time to event; 2. Intervention is not appropriate for multiple observations per patient; 3. Confidence intervals and/or p values not reported; 4. Comparative treatment effects not calculated.

Nonrandomized Studies

Desai et al. (2017) published a retrospective cohort study of Medicare administrative claims data for individuals who received the CardioMEMS™ device following the FDA approval. (21) Of 1935 Medicare enrollees who underwent implantation of the device, 1114 were continuously enrolled and had evaluable data for at least 6 months before, and following, implantation. A subset of 480 enrollees had complete data for 12 months before and after implantation. Study characteristics and results are summarized in Tables 13 and 14. The cumulative incidence of HF-related hospitalizations was significantly lower in the post-implantation period than in the preimplantation period at both 6- and 12-month follow-ups. Limitations of this pre-post retrospective study include lack of data on medical history, ejection fraction, indication for implantation and possible confounding due to amplified touchpoints with the health care system necessitated by the device’s implantation.

Vaduganathan (2017) analyzed mandatory and voluntary reports of device-related malfunctions reported to the FDA to identify CardioMEMS™ HF System-related adverse events within the first 3 years of the FDA approval. (22) From among the more than 5500 CardioMEMS™ implants in the first 3 years, there were 155 adverse event reports covering 177 distinct adverse events for a rate of 2.8%. There were 28 reports of pulmonary artery injury/hemoptysis (0.5%) that included 14 intensive care unit stays, 7 intubations, and 6 deaths. Sensor failure, malfunction, or migration occurred in 46 cases, of which 35 required recalibrations. Compared with a reported 2.8% event rate, the serious adverse event rate in CHAMPION trial was 2.6% with 575 implant attempts, including 1 case of pulmonary artery injury and 2 deaths. Limitation of the current analysis primarily included lack of adjudication and limited clinical data. Tables 13 and 14 summarize the characteristics and results of this 2017 study.

Table 13. Summary of Key Nonrandomized Study Characteristics

Author

Study Type

Country/ Institution

Dates

Participants

Treatment

Follow-Up

Desai et al. (2017) (21)

Retrospective cohort

United States/ Medicare

2014-2015

Individuals with inpatient CPT codes consistent with use of procedure

CardioMEMS™ implant

2 cohorts: 6-month pre-implant and post-implant data (n=1114)

12-month pre-implant and post-implant data (n=480)

Vaduganathan et al. (2017) (22)

Post-marketing surveillance study

United States/

FDA and Abbott

2014-2017

Individuals reporting Cardio-MEMS™-related adverse event

CardioMEMS™ implant

Not applicable

Table Key:

CPT: Current Procedural Terminology;

FDA: U.S. Food and Drug Administration;

n: Number.

Table 14. Summary of Key Nonrandomized Study Results

Study

HFH at 6 Months

HFH at 12 Months

Safety

Desai et al. (2017) (21)

1114

480

-

Pre-implant number

1020

636

-

Post-implant number

381

300

-

HR (95% CI); p-value

0.55 (0.49 to 0.61); <0.001

0.66 (0.57 to 0.76); <0.001

-

Vaduganathan et al. (2017) (22)

-

-

Estimated 5500 received CardioMEMS™

Adverse event cohort identified from MAUDE database

-

-

155 (2.8%) adverse events; 28 pulmonary artery injury or hemoptysis (0.5%), and 2 (0.4%) deaths

Table Key:

CI: confidence interval;

HFH: heart failure hospitalization;

HR: hazard ratio;

MAUDE: Manufacturer and User Facility Device Experience (from U.S. Food and Drug Administration).

Case Series

Heywood et al. (2017) reported pulmonary artery pressure data for the first 2000 consecutive patients with at least 6 months of follow-up who were implanted with CardioMEMS™. No clinical data were reported except for pulmonary artery measurement. (23) Study characteristics and results are summarized in Tables 15 and 16. The mean age of the cohort enrolled was 70 years and the mean follow-up period was 333 days. There was a median of 1.2 days between remote pressure transmissions and greater than 98% weekly use of the system, demonstrating a high level of adherence.

Table 15. Summary of Key Case Series Characteristics

Author

Country

Participants

Treatment Delivery

Follow-Up (SD)

Heywood et al. (2017) (23)

United States/Abbott

First 2000 individuals who received CardioMEMS™ with follow-up data for a minimum of 6 months

CardioMEMS™

333 (125) days

Table Key:

SD: standard deviation.

Table 16. Summary of Key Case Series Results

Author

Treatment

AUC (mm Hg day)

Adherence

Heywood et al. (2017) (23)

CardioMEMS™ device

-32.8 mm Hg/day (1 month)

-156.2 mm Hg/day (3 months)

-434.0 mm Hg/day (6 months)

Median days between transmissions: 1.07 days (first 30 days) and 1.27 days (after 6 months)

Use of the system: 98.6% (IQR, 82.9%-100.0%)

Table Key:

AUC: area under the curve;

IQR: interquartile range;

mm Hg: millimeters of mercury.

ECRI Product Brief Assessment

ECRI Product Brief (2018) was based on the identification of 3 studies (n=3190 patients) from January 1, 2016 to April 23, 2018, (24) 2 of which were discussed earlier from Desai et al., (21) and Heywood et al. (23) Both Desai and Heywood studies were single-arm, whereas the third study included by ECRI, from Jermyn et al. (2016) was a non-randomized comparative study. (25) Seventy-six patients with a NYHA class III HF categorization were either implanted with CardioMEMS™ or treated with best standard-of-care monitoring. After 90 days, 61.8% of the monitored patients had a NYHA class improvement, compared to 12.5% of the control group. After the implantation, the monitored group (19.4%) had ≥ 1 HF hospitalization, compared with 100% who had been hospitalized in the year prior to implantation. The reviewers concluded “hemodynamic-guided HF management leads to significant improvements and HF hospitalization rate in a real-world setting, compared with usual care delivered in a comprehensive disease-management program”. However, ECRI concluded that the CardioMEMS™ HF System may have reduced HF-related hospitalizations and increased cardiovascular improvements when comparing to best-of-care treatment at 6-months and longer; the studies assessed too few patients to assess all-cause mortality and quality of life. ECRI noted that studies published since the 2016 evidence report, were at high-risk of bias because of the lack of randomization, lack of blinding, and lack of controls. ECRI concluded the evidence is somewhat favorable and future clinical trials (i.e., 3 RCTs [n=3680], the largest concluding in 2023) may partially address evidence gaps.

Section Summary: Implantable Direct Pulmonary Artery Pressure Measurement Methods

The pivotal CHAMPION RCT reported a statistically significant decrease in HF-related hospitalizations in patients implanted with CardioMEMS™ device compared with usual care. However, trial results were potentially biased in favor of the treatment group due to use of additional nurse communication to enhance protocol compliance with the device. The trial intended to assess the physician’s ability to use pulmonary artery pressure information and not the capabilities of the sponsor’s nursing staff to monitor and correct physician-directed therapy. The manufacturer conducted multiple analyses to address the potential bias from the nurse interventions. These analyses were reviewed favorably by the FDA. While these analyses demonstrated the consistency of benefit from the CardioMEMS™ device, all such analyses have methodologic limitations. With greater adoption of this technology, it is likely to be used by a broader group of clinicians with variable training in the actual procedure and used in patients at a higher risk compared with those in the CHAMPION trial. Early safety data have been suggestive of a higher rate of procedural complications, particularly related to pulmonary artery injury. Given that the intervention is invasive and intended to be used for a highly prevalent condition, in the light of limited safety data, lack of demonstrable mortality benefit, and pending questions related to its benefit for reduction in hospitalization, the net benefit remains uncertain. Many of the concerns may be clarified by an ongoing post-marketing study that proposes to enroll 1200 patients (at least 35% women) is reported.

Ongoing and Unpublished Clinical Trials

Some currently unpublished trials that might influence this policy are listed in Table 17.

Table 17. Summary of Key Trials

NCT No.

Trial Name

Planned Enrollment

Completion Date

Ongoing

NCT03387813

Hemodynamic-GUIDEd Management of Heart Failure (GUIDE-HF)

3600

Apr 2023

NCT02788656

Pulmonary Artery Pressure Reduction with ENTresto (Sacubitril/Valsartan) (PARENT)

20

Mar 2019

NCT03030222

Empagliflozin Impact on Hemodynamics in Patients with Diabetes and Heart Failure (EMBRACE-HF)

30

Jan 2019

Unpublished

NCT01121107

Left Atrial Pressure Monitoring to Optimize Heart Failure Therapy

486

Apr 2015

(completed)

NCT00409916a

Prevention of Heart Failure Events with Impedance Cardiography Testing (PREVENT-HF): Device BioZ Dx

500

Dec 2012

(unknown)

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 2017 joint guidelines from the ACCF/AHA, and Heart Failure Society of America on the management of HF offered no recommendations for the use of ambulatory monitoring devices. (26)

European Society of Cardiology (ESC)

The ESC guidelines on the diagnosis and treatment of acute and chronic HF stated the following: “Monitoring of pulmonary artery pressures using a wireless implantable hemodynamic monitoring system (CardioMEMS™) may be considered in symptomatic patients with HF [heart failure] with previous HF hospitalization in order to reduce the risk of recurrent HF hospitalization” (class IIb, level B recommendation). (27)

National Institute for Health and Clinical Excellence (NICE)

The updated 2010 guidance from the NICE on chronic HF management did not include outpatient hemodynamic monitoring as a recommendation. (28) This guidance is under review and update and is expected in August 2018; as of the August 7, 2018, the update has not been published.

In 2013, the Institute issued guidance on the insertion and use of implantable pulmonary artery pressure monitors in chronic HF. (29) The recommendations concluded that “Current evidence on the safety and efficacy of the insertion and use of implantable pulmonary artery pressure monitors in chronic heart failure is limited in both quality and quantity.”

Centers for Medicare and Medicaid Services (CMS)

In 2014, CMS’s released its 2006 decision memorandum on TEB. (30) 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 atrioventricular 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 permits coverage of TEB in these conditions, it has acknowledged that there is a “…general absence of studies evaluating the impact of using thoracic bioimpedance for managing patients with cardiac disease….” CMS does not cover the use of TEB in the management of hypertension due to inadequate evidence.

CMS has also specified that TEB is not covered for “the management of all forms of hypertension (with the exception of drug-resistant hypertension…).” Further, CMS specified that:

“[Contractors] have discretion to determine whether the use of TEB [thoracic bioimpedance] for the management of drug-resistant hypertension is reasonable and necessary. Drug resistant hypertension is defined as failure to achieve goal blood pressure in patients who are adhering to full doses of an appropriate 3-drug regimen that includes a diuretic.”

There is no CMS national coverage determination on implantable direct pressure monitoring, inert gas rebreathing, and arterial pressure with Valsalva.

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 thoracic bioimpedance (TEB) for treatment of heart failure (HF) may be insufficient, Centers for Medicare and Medicaid Services’ (CMS) 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 individuals who have HF failure in outpatient settings who receive hemodynamic monitoring by TEB, with inert gas rebreathing, or of arterial pressure during the Valsalva maneuver, the evidence includes uncontrolled prospective studies and case series. Relevant outcomes are overall survival, symptoms, functional outcomes, quality of life, morbid events, hospitalizations, and treatment-related morbidity. There is a lack of randomized controlled trial (RCT) evidence evaluating whether the use of these technologies improves health outcomes over standard active management of HF patient. The case series have reported physiologic measurement-related outcomes and/or associations between monitoring information and HF exacerbations, but do not provide definitive evidence on device efficacy. The evidence is insufficient to determine the effects of the technology (other types of outpatient hemodynamic monitoring devices) on health outcomes.

For individuals who have HF in outpatient settings who receive hemodynamic monitoring with an implantable pulmonary artery pressure sensor device, the evidence includes RCTs. Relevant outcomes are overall survival, symptoms, functional outcomes, quality of life, morbid events, hospitalizations, and treatment-related morbidity. One implantable pressure monitor, the CardioMEMS™ device, has U.S. Food and Drug Administration (FDA) approval. The pivotal CHAMPION RCT reported a statistically significant decrease in HF-related hospitalizations in patients implanted with CardioMEMS™ device compared with usual care. However, trial results were potentially biased in favor of the treatment group due to use of additional nurse communication to enhance protocol compliance with the device. The manufacturer conducted multiple analyses to address potential bias from the nurse interventions. Results were reviewed favorably by the FDA. While these analyses demonstrated the consistency of benefit from the CardioMEMS™ device, all such analyses have methodologic limitations. Early safety data have been suggestive of a higher rate of procedural complications, particularly related to pulmonary artery injury. Given that the intervention is invasive and intended to be used for a highly prevalent condition, in the light of limited safety data, lack of demonstrable mortality benefit, and pending questions related to its benefit in reducing hospitalizations, the net benefit remains uncertain. Many of the concerns may be clarified by an ongoing postmarketing study that proposes to enroll 1200 patients (at least 35% women) is reported. The evidence is insufficient to determine the effects of the technology on health outcomes.

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:

There are no specific CPT codes for implantable direct pressure monitoring of the pulmonary artery, inert gas rebreathing measurement, or left ventricular end diastolic pressure. The unlisted code 93799 would be used.

There is a specific CPT code for bioimpedance – 93701.

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 versus. 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

33289, 93264, 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 3: 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 at: http://www.accessdata.fda.gov (accessed on August 7, 2018).

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. 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

6. 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

7. 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

8. 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

9. Amir O, Ben-Gal T, Weinstein JM, et al. Evaluation of remote dielectric sensing (ReDS) technology-guided therapy for decreasing heart failure re-hospitalizations. Int J Cardiol. Aug 1 2017; 240:279-84. PMID 28341372

10. 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

11. 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

12. 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

13. 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

14. 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

15. 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

16. 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

17. Givertz MM, Stevenson LW, Costanzo MR, et al. Pulmonary artery pressure-guided management of patients with heart failure and reduced ejection fraction. J Am Coll Cardiol. Oct 10 2017; 70(15):1875-86. PMID 28982501

18. Adamson PB, Abraham WT, Bourge RC, et al. Wireless pulmonary artery pressure monitoring guides management to reduce decompensation in heart failure with preserved ejection fraction. Circ Heart Fail. Nov 2014; 7(6):935-44. PMID 25286913

19. Adamson PB, Abraham WT, Stevenson LW, et al. Pulmonary Artery Pressure-Guided Heart Failure Management Reduces 30-Day Readmissions. Circ Heart Fail. Jun 2016; 9(6). PMID 27220593

20. Krahnke 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

21. Desai AS, Bhimaraj A, Bharmi R, et al. Ambulatory Hemodynamic Monitoring Reduces Heart Failure Hospitalizations in "Real-World" Clinical Practice. J Am Coll Cardiol. May 16 2017; 69(19):2357-65. PMID 28330751

22. Vaduganathan M, DeFilippis EM, Fonarow GC, et al. postmarketing adverse events related to the CardioMEMS HF System. JAMA Cardiol. Nov 1 2017; 2(11):1277-9. PMID 28975249

23. Heywood JT, Jermyn R, Shavelle D, et al. Impact of Practice-Based Management of Pulmonary Artery Pressures in 2000 Patients Implanted With the CardioMEMS Sensor. Circulation. Apr 18 2017; 135(16):1509-17. PMID 28219895

24. ECRI Institute. CardioMEMS HF System (Abbott) for Wireless Monitoring of Pulmonary Artery Pressure in Heart Failure; 2018 May. 13 p. (Health Technology Assessment Information Service).

25. Jermyn R, Alam A, Kvasic J, et al. Hemodynamic-guided heart-failure management using a wireless implantable sensor: Infrastructure, methods, and results in a community heart failure disease-management program. Clin Cardiol. Mar 2017; 40(3):170-6; epub ahead of print Nov 23 2016. PMID 27878990

26. Yancy CW, Jessup M, Bozkurt B, et al. 2017 ACC/AHA/HFSA Focused Update of the 2013 ACCF/AHA Guideline for the Management of Heart Failure: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Heart Failure Society of America. J Am Coll Cardiol. Aug 8 2017; 70(6):776-803. PMID 28461007

27. Ponikowski P, Voors AA, Anker SD, et al. 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure. Rev Esp Cardiol (Engl Ed). Dec 2016; 69(12):1167. PMID 27894487

28. 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

29. NICE – Insertion and use of implantable pulmonary artery pressure monitors in chronic heart failure [IPG463] (2013). National Institute for Health and Care Excellence (NICE). Available at: <https://www.nice.org.uk> (accessed August 7, 2018).

30. Centers for Medicare and Medicaid Services (CMS). National coverage decision for cardiac output monitoring by thoracic electrical bioimpedance (TEB) (20.16) (November 24, 2006). Available at: <http: //www.cms.gov> (accessed in June 2010) (confirmed on August 7, 2018).

31. Cardiac Hemodynamic Monitoring for the Management of Heart Failure in the Outpatient Setting. Chicago, Illinois: Blue Cross Blue Shield Association Medical Policy Reference Manual (2018 May) Surgery 2.02.24.

Policy History:

Date Reason
10/1/2018 Document updated with literature review. Coverage unchanged. References 9, 17-19, 21-27, and 29 were added; numerous were removed.
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

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