Medical Policy

 

Subject: Outpatient Cardiac Hemodynamic Monitoring Using a Wireless Sensor for Heart Failure Management
Document #: MED.00115 Publish Date:    02/28/2018
Status: Reviewed Last Review Date:    01/25/2018

Description/Scope

This document addresses the use of a wireless implantable hemodynamic system for ambulatory monitoring of heart failure, specifically the CardioMEMS HF System (St. Jude Medical Inc., Atlanta, GA) that received approval from the U.S. Food and Drug Administration (FDA) in May, 2014. This system utilizes a wireless pressure sensor that is permanently implanted via a right heart catheterization surgical procedure for the purpose of cardiac hemodynamic monitoring of individuals with heart failure in a non-clinical outpatient setting.

Note: For information regarding other technologies used for hemodynamic monitoring, see:

Position Statement

Investigational and Not Medically Necessary:

The implantation of a pressure sensor into the pulmonary artery for the purpose of wireless ambulatory monitoring of heart failure and all other indications is considered investigational and not medically necessary. 

Rationale

In May 2014, the FDA approved the CardioMEMS HF System through the premarket approval (PMA) process. The system utilizes a pulmonary artery sensor device and is indicated for measuring pulmonary artery pressure and heart rate in individuals who have undergone hospitalization for NYHA Class III heart failure in the past year. The CardioMEMS HF System allows the hemodynamic data to be transmitted wirelessly to clinical staff that are monitoring and managing heart failure, with the specific intent to reduce hospitalizations due to heart failure. The system is contraindicated for individuals who are unable to take antiplatelet or anticoagulants for 1 month following the implantation procedure.

Abraham and colleagues (2011) evaluated individuals with New York Heart Association (NYHA) Class III heart failure, who had been hospitalized for heart failure at least once in the previous 12 months in a prospective, single-blinded, multi-center study known as the CHAMPION (CardioMEMS Heart Sensor Allows Monitoring of Pressure to Improve Outcomes in NYHA Class III Heart Failure Patients) trial. After implantation of the pressure sensor, study participants (n=550) were randomized either to the treatment group that consisted of wireless pulmonary artery pressure monitoring and standard of care (n=270) or into a control group that consisted of participants who received only standard of care (n=280); the control arm’s device measurements were not made available to investigators for monitoring and management. The primary outcome measure was the rate of hospitalization due to heart failure in the first 6 months following implantation with the device. Quality of life (QOL) measures were included as secondary outcomes. Additional safety outcomes included complications associated with the device or sensor, and pressure-sensor failures. Participants were trained to take daily pulmonary artery pressure measurements at home, and were blinded to their treatment group. Follow-up assessments were scheduled at 1, 3, and 6 months, and subsequently every 6 months afterward. Study results indicated a statistically significant 30% reduction in the primary outcome of hospital readmissions for heart failure at the 6-month follow-up in the treatment group compared with the control group (hazard ratio [HR]=0.72; 95% confidence interval [CI], 0.60 to 0.85; p=0.0002). Additionally, the length of hospital stay for heart failure-related admissions was significantly shorter in the treatment group compared with the control group (2.2 days compared with 3.8 days, respectively; p=0.02). The QOL score, using the Minnesota Living with Heart Failure Questionnaire (MLHFQ) Total Score, was significantly improved in the treatment group compared with controls (p=0.02), when assessed at 6 months follow-up. A total of 15 adverse events occurred, 8 of which were considered complications related to the device or system (n=3 treatment group; n=3 control group; n=2 not enrolled). None of the 550 participants experienced sensor-related failures during the entire follow-up period (average of 15 months).

In 2015, Abraham and colleagues published follow-up data to the CHAMPION trial. After completion of the initial randomized access period (average of 18 months), investigators were granted access to pulmonary artery pressure for subjects in both study arms (open access period) for an average of an additional 13 months of follow-up. Over the randomized access period, the reduction in hospital admission rates related to heart failure were sustained, and found to be 33% lower in the treatment group compared to the control group (HR=0.67, 95% CI, 0.55-0.80; p<0.0001). During the open access period, rates of hospital admission related to heart failure for the former control group were reduced by 48% (HR=0.52, 95% CI, 0.40-0.69; p<0.0001) compared to admission rates during the random access period. Heart failure-related mortality and all-cause mortality were not significantly different between the two study arms during the random access period or the open access period. No additional device-related failures were reported.

Despite the early positive results of using the outpatient wireless pressure sensor device for heart failure management, the manufacturer-sponsored randomized controlled trial (RCT) was hampered by methodological weaknesses. The safety and durability of treatment effect are unknown since the study's follow-up period was limited to an average of 31 months (2.6 years). In addition, the primary outcome of 6-month hospital admission rates, while important, is a surrogate measure for more clinically meaningful outcomes, such as mortality-related data which the device monitoring reportedly did not significantly impact. Well-designed RCTs with extended follow-up periods and mortality-related primary outcome measures are necessary to establish the safety and efficacy of outpatient cardiac hemodynamic monitoring using a wireless pressure sensor for the routine management of heart failure.

In December of 2015 the final report was published from the California Technology Assessment Forum (CTAF) evaluating the safety and efficacy of the CardioMEMS HF System. The CTAF concluded the following:

…while post-hoc analyses have been presented illustrating reductions in cardiovascular mortality with CardioMEMS, there have been no published data from trials powered to detect mortality differences. It seems reasonable to surmise that ongoing post-marketing trials evaluating the device may demonstrate a wide variety of outcomes, from substantial net health benefit to a small likelihood of overall “negative” benefit given the potential harms associated with device placement. Therefore, we judge the current body of evidence on CardioMEMS to be “promising but inconclusive” using the ICER Evidence Rating framework.

Desai (2017) published a retrospective cohort study of Medicare administrative claims data for individuals who received the CardioMems device following FDA approval. Out of 1935 Medicare enrollees who underwent implantation of the device, there were 1114 who were continuously enrolled and had evaluable data for at least 6 months prior to, and following, implantation (a subset of 480 enrollees had complete data for 12 months before and after implantation). There were 1020 heart failure-related hospitalizations in the 6 months before implantation, relative to 381 hospitalizations in addition to 17 ventricular assisted device (VAD) implantations or transplants, and 139 deaths in the 6-month post implantation follow-up period. The cumulative incidence of hospital-related heart failure was significantly lower than in the 6 months prior to implantation (HR=0.55; 95% CI: 0.49-0.61; p<0.001). Similarly, amongst the 480 individuals with 12-month follow-up data, there were 696 heart failure-related hospitalization in the 12 months prior to implantation, compared to 300 heart failure-related hospitalizations following implantation. There were also 15 VAD implantations or transplants, and 106 deaths. The cumulative incidence of heart failure-related hospitalizations was also significantly lower in the 12-month post implantation cohort (HR=0.66; 95% CI: 0.57-0.76; p<0.001). Despite the trial’s positive outcomes, claims data limitations include that it is not possible to rule out confounding due to medication changes/adjustments, or correlate outcomes to direct intervention based on pulmonary artery pressure data. The primary outcome, reduction in hospital-related heart failure, may be related to the device or simply the amplified touch-points with the healthcare system necessitated by the device’s implantation, and the limited follow-up period in addition to the lack of a control cohort leave the safety and efficacy of the CardioMems device still uncertain.

In 2017, Heywood and colleagues published retrospective data from a de-identified cohort of the first 2000 individuals who received the CardioMEMS device and had available follow-up data for a minimum of 6 months (general-use cohort). The primary outcome of interest was trends in remotely monitored pulmonary artery pressures. The mean age of the cohort enrolled was 70 years (standard deviation [SD]=12 years) and the mean follow-up period was 333 days (SD=125 days). Relative to the previously described CHAMPION clinical trial, general-use cohort in this study had a trend of a higher baseline mean arterial pressure (34.9 ± 10.2 mm Hg vs. 31.6 ± 10.7 mm Hg for the CHAMPION cohort; p<0.05). The pulmonary artery pressure reductions in the general-use cohort from this study were significantly higher compared with the CHAMPION trial treatment cohort (p-value unreported) who had an AUC of -150.1 mm Hg-days after 6 months of pressure-guided care whereas the general-use cohort had an AUC of -434 mm Hg-days after 6 months and mean pulmonary artery pressure was reduced from 34.9 ± 10.2 to 31.6 ± 10.4 mm Hg after 6 months (p<0.0001). In this ‘real-world’ cohort, there was a median of 1.2 days between remote pressure transmissions and > 98% weekly use of the system, demonstrating a high-level of adherence. However, similar to the limitations cited in the CHAMPION trial, safety and efficacy conclusions are precluded by the lack of mortality-related data and lack of long-term follow-up data. Further, the registry data of this study cannot rule out medication changes/adjustments as a potential confounding variable.

Other devices that monitor cardiac output through the implantation of a pulmonary sensor to measure pulmonary artery pressure have been investigated in clinical trials, but thus far, none have received FDA approval.

In summary, the current evidence base is insufficient to support the use of ambulatory cardiac hemodynamic monitoring using an implantable pulmonary artery pressure measurement device in individuals with heart failure in an outpatient setting. Additional well-designed and high quality RCTs are necessary to establish whether health outcomes are significantly improved relative to standard of care for heart failure management.

Background/Overview

Individuals with chronic heart failure are at increased risk of developing acute decompensated heart failure, which often requires hospitalization. Hence, early identification of individuals at greatest risk of imminent heart failure is important. Current risk management strategies involve frequent clinical assessment of signs and symptoms and continual cardiac hemodynamic monitoring in a clinical setting. Changes in cardiac hemodynamics may be indicative of change or progression of heart disease (FDA, 2014).

Several novel approaches have been investigated as techniques to measure cardiac hemodynamic variables in an outpatient setting. One such proposed technique involves the implantation of a wireless pressure sensor in the pulmonary artery during a right heart catheterization procedure to measure pulmonary artery pressure and heart rate in individuals with heart failure. Pressure readings are transmitted wirelessly to an external monitor and database where information may be used by clinicians and clinical staff to guide treatment decisions, and monitor individuals from their home or other non-clinical setting.

The CardioMEMS HF System has been approved by the FDA for individuals with heart failure, classified as NYHA Class III. The CardioMEMS HF System consists of an implantable pulmonary artery sensor, delivery system, and Patient Electronics System (PES). The implantable sensor is permanently implanted in the pulmonary artery during a right heart catheterization procedure. The sensor is roughly the size of a small paper clip and does not require external batteries or wires for operation (FDA, 2014).

Definitions

Cardiac catheterization: A general term describing the use of a thin catheter that is advanced into the bloodstream through an artery at the groin, arm or neck, followed by injection of a contrast agent (dye) that visualizes the coronary arteries and chambers of the heart. Cardiac catheterization, which can be done for diagnostic or therapeutic/interventional purposes or both, can be used to describe imaging of the coronary arteries, (also referred to as coronary angiography), or the heart chambers.

Heart failure: A condition in which the heart no longer adequately functions as a pump. As blood flow out of the heart slows, blood returning to the heart through the veins backs up, causing congestion in the lungs and other organs.

Hemodynamic/Haemodynamic: Study of blood flow or circulation.

New York Heart Association (NYHA) Definitions: The NYHA classification of heart failure is a 4-tier system that categorizes subjects based on subjective impression of the degree of functional compromise. The four NYHA functional classes are as follows:

Right heart: Describes the two chambers on the right side of the heart; the right atrium, which receives the blood returning from the rest of the body, and the right ventricle that pumps this blood to the lungs.

Coding

The following codes for treatments and procedures applicable to this document are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

When services are Investigational and Not Medically Necessary:
When the code describes a procedure indicated in the Position Statement section as investigational and not medically necessary.

CPT

 

93799

Unlisted cardiovascular service or procedure [when specified as implantation of a wireless pressure sensor in the pulmonary artery]

 

 

HCPCS

 

C2624

Implantable wireless pulmonary artery pressure sensor with delivery catheter, including all system components

C9741

Right heart catheterization with implantation of wireless pressure sensor in the pulmonary artery, including any type of measurement, angiography, imaging supervision, interpretation, and report

 

 

ICD-10 Diagnosis

 

 

All diagnoses

References

Peer Reviewed Publications:

  1. Abraham WT, Adamson PB, Bourge RC, et al.; CHAMPION Trial Study Group. Wireless pulmonary artery haemodynamic monitoring in chronic heart failure: a randomized controlled trial. Lancet. 2011; 377(9766):658-666.
  2. 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. 2016; 387(10017):453-461.
  3. 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. 2014; 7(60):935-944.
  4. Adamson PB, Abraham WT, Stevenson LW, et al. Pulmonary artery pressure-guided heart failure management reduces 30-day readmissions. Circ Heart Fail. 2016; 9(6):e002600. Available at: http://circheartfailure.ahajournals.org/content/9/6/e002600.long. Accessed on December 21, 2017.
  5. Adamson PB, Ginn G, Anker SD, et al. Remote haemodynamic-guided care for patients with chronic heart failure: a meta-analysis of completed trials. Eur J Heart Fail. 2017;19(3):426-433.
  6. Costanzo MR, Stevenson LW, Adamson PB, et al. Interventions linked to decreased heart failure hospitalizations during ambulatory pulmonary artery pressure monitoring. JACC Heart Fail. 2016; 4(5):333-344.
  7. Desai AS, Bhimaraj A, Bharmi R, et al. Ambulatory hemodynamic monitoring reduces heart failure hospitalizations in "real-world" clinical practice. J Am Coll Cardiol. 2017; 69(19):2357-2365.
  8. 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. 2017; 135(16):1509-1517.
  9. 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. 2017; 40(3):170-176.
  10. Raina A, Abraham W, Adamson P, et al. Limitations of right heart catheterization in the diagnosis and risk stratification of patients with pulmonary hypertension related to left heart disease: insights from a wireless pulmonary artery pressure monitoring system. J Heart Lung Transplant. 2015; 34(3):438-447.

Government Agency, Medical Society, and Other Authoritative Publications:

  1. Bashore TM, Balter S, Barac A, et al. 2012 American College of Cardiology Foundation/Society for Cardiovascular Angiography and Interventions (ACCF/SCAI) expert consensus document on cardiac catheterization laboratory standards update: a report of the American College of Cardiology Foundation Task Force on Expert Consensus documents developed in collaboration with the Society of Thoracic Surgeons and Society for Vascular Medicine. J Am Coll Cardiol. 2012; 59(24):2221-2305.
  2. Centers for Disease Control (CDC). Million Hearts: Strategies to reduce the prevalence of leading cardiovascular disease risk factors. United States, 2011. MMWR. 2011; 60(36):1248-1251.
  3. European Society of Cardiology (ESC). Task force for the diagnosis and treatment of acute and chronic heart failure. 2016 ESC guidelines for the diagnosis and treatment of acute and chronic heart failure. Available at: https://academic.oup.com/eurheartj/article/37/27/2129/1748921. Accessed on December 21, 2017.
  4. Fihn SD, Gardin JM, Abrams J, et al. 2012 ACCF/AHA/ACP/AATS/PCNA/SCAI/STS Guideline for the diagnosis and management of patients with stable ischemic heart disease: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines, and the American College of Physicians, American Association for Thoracic Surgery, Preventive Cardiovascular Nurses Association, Society for Cardiovascular Angiography and Interventions, and Society of Thoracic Surgeons. J Am Coll Cardiol. 2012; 60(24):e44-e164.
  5. Nishimura RA, Otto CM, Bonow RO, et al. 2014 AHA/ACC guidelines for the management of patients with valvular heart disease: executive summary: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2014; 63(22):e57-e185.
  6. O’Gara PT, Kushner FG, Ascheim DD, et al. 2013 ACCF/AHA guideline for the management of ST-elevation myocardial infarction: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. Circulation. 2013; 127(4):e362-e425.
  7. Scanlon PJ, Faxon DP, Audet AM, et al. ACC/AHA guidelines for coronary angiography: a report of the American College of Cardiology/American Heart Association Task Force on practice guidelines (Committee on Coronary Angiography) Developed in collaboration with the Society for Cardiac Angiography and Interventions. J Am Coll Cardiol. 1999; 33(6):1756-1824.
  8. Ollendorf D, Sandhu A, Heidenreich P, et al. CardioMEMS™ HF System (St. Jude Medical) and Sacubitril/Valsartan (Entresto™, Novartis) for Management of Congestive Heart Failure. Effectiveness, Value, and Value-Based Price Benchmarks. California Technology Assessment Forum (CTAF). Available at: https://icer-review.org/wp-content/uploads/2016/01/CHF_Final_Report_120115.pdf. Accessed on December 21, 2017.
  9. St. Jude Medical. CardioMEMS HF system post approval study. NLM Identifier: NCT02279888. Last updated on October 19, 2017. Available at: https://www.clinicaltrials.gov/ct2/show/NCT02279888. Accessed on December 21, 2017.
  10. U.S. Food and Drug Administration (FDA). Center for Devices and Radiologic Health (CDRH). Summary of Safety and Effectiveness and labeling: CardioMEMS HF System. Premarket approval application No. P100045. Rockville, MD: May 2014. Available at: https://www.accessdata.fda.gov/cdrh_docs/pdf10/P100045B.pdf.  Accessed on December 21, 2017.
  11. Yancy CW, Jessup M, Bozkurt B, et al. 2013 ACCF/AHA guidelines for the management of heart failure: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. Circulation. 2013; 128(16):e240-e327.
Websites for Additional Information
  1. American Heart Association. Classes of Heart Failure. May 28, 2017. Available at: http://www.heart.org/HEARTORG/Conditions/HeartFailure/AboutHeartFailure/Classes-of-Heart-Failure_UCM_306328_Article.jsp#. Accessed on December 21, 2017.
Index

Cardiac hemodynamic monitoring
CardioMEMS HF System
Heart failure
Wireless implantable hemodynamic system

The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

Document History

Status

Date

Action

Reviewed

01/25/2018

Medical Policy & Technology Assessment Committee (MPTAC) review. Updated Rationale and References sections.

Reviewed

02/02/2017

MPTAC review. Updated Rationale and References sections.

Reviewed

02/04/2016

MPTAC review. Updated Description, Rationale, Background, References, Websites and Index sections. Removed ICD-9 codes from Coding section.

Reviewed

05/07/2015

MPTAC review. Updated Description, References and Index sections.

New

02/05/2015

MPTAC review. Initial document development.