Medical Policy



Subject: Extracorporeal Carbon Dioxide Removal
Document #: SURG.00146 Current Effective Date:    03/29/2017
Status: New Last Review Date:    02/02/2017

Description/Scope

This document addresses the use of extracorporeal carbon dioxide removal (ECCO2 R), a minimally invasive, low-flow veno-venous or venous-arterial procedure used to treat acute hypercapnic respiratory failure or as an alternative to standard extracorporeal membrane oxygenation (ECMO).

Position Statement

Investigational and Not Medically Necessary:

Extracorporeal carbon dioxide removal is considered investigational and not medically necessary for all conditions, including but not limited to acute hypercapnic respiratory failure.

Rationale

The Hemolung Respiratory Assist System (RAS) (ALung Technologies, Inc, Pittsburgh, PA, USA) is currently being evaluated as an ECCO2 R device. The ultimate goal of ECCO2 R or ECMO is to prevent or minimize the use of invasive ventilation. Hemolung is not currently U.S. Food and Drug Administration (FDA) approved. The device did receive expedited access pathway in November 2015. Currently, there are trials underway to evaluate clinical outcomes associated with use of the ECCO2 R, including studies specific to Hemolung.

The safety and feasibility of low-flow veno-venous ECCO2 R treatment using Hemolung RAS was evaluated in a small, prospective study involving 15 individuals with moderate acute respiratory distress syndrome (ARDS) who were mechanically ventilated (Fanelli, 2016). The authors aimed to study lower tidal volumes in combination with ECCO2 R in an attempt to reduce the likelihood of ventilator induced lung injury. Individual tidal volumes (VT) were reduced from 6 mg/kg/predicted body weight (PBW) to 4 mg/kg/PBW; positive end-expiratory pressure (PEEP) was increased from 23 to 25 cm H2 O. ECCO2 R began when individuals developed respiratory acidosis at pH < 7.25 and PaCO2 > 60 mmHg. The potential for weaning from ultra-protective ventilation and ECCO2 R was assessed daily. Participants who remained stable for at least 12 hours with plateau pressure (Pplat) < 25 cmH2 O and PaCO2 < 50 mmHg (allowing for respiratory rate (RR) up to 30-35/min) were discontinued from ECCO2 R and the venous catheter removed. At baseline, all participants had a PaO2 /FiO2 ≤200 and they were ventilated with a conventional protective ventilation strategy. After initiation of ECCO2 R, a VT of 4.29 ± 0.5 mL/kg was achieved and respiratory acidosis was significantly corrected, with pH and PaCO2 returning to within 10% of baseline values obtained at VT=6 mL/kg. The median number of days on ECCO2 R was 3 (range, 2-4). The reduction in VT was associated with a significant reduction in Pplat from 27.7 ± 1.6 to 23.9 ± 1 cmH2 O (p<0.05) at day 1 and this difference remained significant throughout the study period. Two study-related adverse events were reported including intravascular hemolysis and kinking of the ECCO2 R catheter. The overall mortality at day 28 was 47%. Among the 8 survivors, 6 were successfully weaned from both ECCO2 R and mechanical ventilation while 2 were still dependent on ventilator support at 28 days. Larger, more comprehensive randomized clinical trials are needed in order to further evaluate the feasibility, safety and efficacy of ECCO2 R therapies.

In a prospective, randomized trial, Bein and colleagues (2013) evaluated the use of arteriovenous extracorporeal CO2 -elimination (avECCO2 -R) with low tidal volume ventilation in individuals with ARDS. A total of 79 individuals with established ARDS with moderate hypercapnia enrolled. Forty individuals were randomized to receive avECCO2 -R with mechanical ventilation at a low tidal volume rate of 3 ml/kg/PBW. Thirty-nine control-group individuals received only mechanical ventilation at a rate of 6 ml/kg/PBW. The primary outcome was the proportion of ventilator-free days (VFD) at 28 and 60 days. There were no statistical differences between the groups in VFD-28 (10.0 ± 8 days, 9.3 ± 9 days in the control group; p=0.779) or VFD-60 (33.2 ± 20 days, 29.2 ± 21 days in the control group; p=0.469). Mortality rates were low (17.5% in the treatment group, 15.4% in the control group) and did not differ between the groups. In the treatment group, ECCO2 -R-related complications graded as temporary and moderate occurred in 3 individuals. The authors concluded that the use of low tidal volume ventilation combined with ECCO2 -R was safe and feasible but was not associated with a significant reduction in the duration of mechanical ventilation needed.

In 2015, Sklar and associates performed a systematic review on ECCO2 R use to treat hypercapnic respiratory failure in chronic obstructive pulmonary disease (COPD) exacerbations. A total of 10 studies, primarily case series, with 87 individuals were included. In an analysis of the potential of ECCO2 R plus noninvasive ventilation (NIV) to prevent intubation, there was a success rate of 92.8% (65/70 individuals). In those 17 individuals already receiving invasive mechanical ventilation (IMV), the rate of successful extubation was 52.9% (9/17 individuals). Results reported in three studies regarding hospital mortality were mixed, with two studies reporting positive results while one retrospective review showed no significant difference in mortality at 28 days. There were a total of 11 major complications (major bleeding, venous performation, pneumothorax or death) and 30 minor complications reported amongst eight studies. While the studies reported high success rates overall, the quality of the evidence is considered low given the potential selection bias associated with case series data. The authors concluded that randomized controlled trials are needed to further evaluate the use of ECCO2 R in COPD exacerbations.

There have been a limited number of articles, primarily pilot studies, case studies and retrospective reviews, published in the peer-reviewed literature addressing the use of ECCO2 R in treating acute hypercapnic respiratory failure (Abrams, 2013; Bermudez, 2015; Bonin, 2013; Burke, 2013; Moss, 2016). In a review of the technology, Camporota and colleague (2016) note that "At present ECCO2 R should be considered a research tool, rather than an accepted clinical procedure. There is a clear need for further robust research, particularly prospective, randomized, controlled studies."

Background/Overview

Approximately 24 million adults in the United States (U.S.) show evidence of impaired lung function (ACCP, 2015). The American Lung Association (ALA) reported that in the U.S., 11 million individuals have been diagnosed with COPD and approximately 200,000 ARDS cases are reported each year (ALA, 2016). These conditions can result hypercapnic respiratory failure.

Hypercapnic respiratory failure occurs when there is a failure to remove carbon dioxide from the body. The partial pressure of carbon dioxide in arterial blood levels (PaCO2 ) is elevated and typically is present along with hypoxemia. Current standard treatments to oxygenate the blood as well as removing carbon dioxide include EMCO or mechanical ventilation.

ECCO2 R therapy has been proposed as an alternative treatment, and is designed to provide CO2 removal at lower blood flow rates (350-550 mL/min) than ECMO. This low flow rate allows for significant CO2 removal but only minimal blood oxygenation. However, these lower blood flow rates permit the use of smaller catheters. The goal of ECCO2 R is to reduce ventilation requirements in individuals who are either failing NIV or to minimize ventilator associated morbidity.

ECCO2 R circuits always consist of two cannulas, drainage and return cannulas, and a membrane lung in which the gas exchange takes place. These circuits can be venovenous (VV) or arteriovenous (AV) systems. In the AV system, the individual's blood pressure provides the pump to move the blood across the membrane. In the VV system, a pump must be included in the circuit (Camporota, 2016).

The HEMOLUNG RAS is noted to be the first fully-integrated system for respiratory dialysis, to provide partial extracorporeal support. This system is not yet FDA approved.

Definitions

Acute respiratory distress syndrome (ARDS): A rapidly progressive disease in which the alveoli fill with fluid, making breathing and gas exchange very difficult. ARDS occurs when there is direct or indirect trauma to the lungs.

Extracorporeal life support (ECLS): Life supporting procedures which are carried out outside the body and include cardiopulmonary support extracorporeal CO2 removal, and ECMO.

Extracorporeal membrane oxygenation (ECMO): An invasive technique used to provide total respiratory support by bypassing the heart and lung and providing oxygenation and CO2 removal. ECMO is generally considered a surgical procedure and performed in the intensive care setting.

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: 

CPT  
37799 Unlisted procedure, vascular surgery [when specified as extracorporeal carbon dioxide removal]
   
ICD-10 Procedure  
  For the following codes when specified as extracorporeal carbon dioxide removal:
5A0935Z Assistance with respiratory ventilation, less than 24 consecutive hours
5A0945Z Assistance with respiratory ventilation, 24-96 consecutive hours
5A0955Z Assistance with respiratory ventilation, greater than 96 consecutive hours
   
ICD-10 Diagnosis  
  All diagnoses
   
References

Peer Reviewed Publications:

  1. Abrams DC, Brenner K, Burkart KM, et al. Pilot study of extracorporeal carbon dioxide removal to facilitate extubation and ambulation in exacerbations of chronic obstructive pulmonary disease. Ann Am Thorac Soc. 2013; 10(4):307-314.
  2. Bein T, Weber-Carstens S, Goldmann A, et al. Lower tidal volume strategy (≈3 ml/kg) combined with extracorporeal CO2 removal versus 'conventional' protective ventilation (6 ml/kg) in severe ARDS: the prospective randomized Xtravent-study. Intensive Care Med. 2013; 39(5):847-856.
  3. Bermudez CA, Zaldonis D, Fan MH, et al. Prolonged use of the Hemolung Respiratory Assist System as a bridge to redo lung transplantation. Ann Thorac Surg. 2015; 100(6):2330-2333.
  4. Bonin F, Sommerwerck U, Lund LW, Teschler H. Avoidance of intubation during acute exacerbation of chronic obstructive pulmonary disease for a lung transplant candidate using extracorporeal carbon dioxide removal with the Hemolung. J Thorac Cardiovasc Surg. 2013; 145(5):e43-e44.
  5. Burki NK, Mani RK, Herth FJF, et al. A novel extracorporeal CO2 removal system: results of a pilot study of hypercapnic respiratory failure in patients with COPD. Chest. 2013; 143(3):678-686.
  6. Camporota L, Barrett N. Current applications for the use of extracorporeal carbon dioxide removal in critically ill patients. Biomed Res Int. 2016; 2016:9781695.
  7. Combes A, Brodie D, Bartlett R, et al.; International ECMO Network (ECMONet). Position paper for the organization of extracorporeal membrane oxygenation programs for acute respiratory failure in adult patients. Am J Respir Crit Care Med. 2014; 190(5):488-496.
  8. Del Sorbo L, Fan E, Nava S, Ranieri VM. ECCO(2)R in COPD exacerbation only for the right patients and with the right strategy. Intensive Care Med. 2016; 42(11):1830-1831.
  9. Del Sorbo L, Pisani L, Filippini C, et al. Extracorporeal Co2 removal in hypercapnic patients at risk of noninvasive ventilation failure: a matched cohort study with historical control. Crit Care Med. 2015; 43(1):120-127.
  10. Fitzgerald M, Millar J, Blackwood B, et al. Extracorporeal carbon dioxide removal for patients with acute respiratory failure secondary to the acute respiratory distress syndrome: a systematic review. Crit Care. 2014; 18(3):222.
  11. Kluge S, Braune SA, Engel M, et al. Avoiding invasive mechanical ventilation by extracorporeal carbon dioxide removal in patients failing noninvasive ventilation. Intensive Care Med. 2012; 38(10):1632-1639.
  12. Lund LW, Federspiel WJ. Removing extra CO(2) in COPD patients. Curr Respir Care Rep. 2013; 2:131-138.
  13. Moss CE, Galtrey EJ, Camporota L, et al. A retrospective observational case series of low-flow venovenous extracorporeal carbon dioxide removal use in patients with respiratory failure. ASAIO J. 2016; 62(4):458-462.
  14. Pisani L, Corcione N, Nava S. Management of acute hypercapnic respiratory failure. Curr Opin Crit Care. 2016; 22(1):45-52.
  15. Rodenstein D. The human CO2 market. Respirology. 2016; 21(7):1150-1151.
  16. Shekar K, Mullany DV, Thomson B, et al. Extracorporeal life support devices and strategies for management of acute cardiorespiratory failure in adult patients: a comprehensive review. Crit Care. 2014; 18(3):219.
  17. Sklar MC, Beloncle F, Katsios CM, et al. Extracorporeal carbon dioxide removal in patients with chronic obstructive pulmonary disease: a systematic review. Intensive Care Med. 2015; 41(10):1752-1762.
  18. Ventetuolo CE, Muratore CS. Extracorporeal life support in critically ill adults. Am J Respir Crit Care Med. 2014; 190(5):497-508.

Government Agency, Medical Society, and Other Authoritative Publications:

  1. American College of Chest Physicians (ACCP). Executive Summary: Prevention of Acute Exacerbation of COPD: American College of Chest Physicians and Canadian Thoracic Society Guideline. April 2015. Available at: http://journal.publications.chestnet.org/article.aspx?articleID=1918413. Accessed on February 2, 2017.
  2. Extracorporeal Life Support Organization (ELSO). General Guidelines for all ECLS Cases. Version 1.3 November 2013. Available at: https://www.elso.org/Portals/0/IGD/Archive/FileManager/929122ae88cusersshyerdocumentselsoguidelinesgeneralalleclsversion1.3.pdf . Accessed on February 2, 2017.
Websites for Additional Information
  1. American Lung Association. Lung Health & Diseases. Available at: http://www.lung.org/lung-health-and-diseases/lung-disease-lookup/. Accessed on February 2, 2017.
    • Acute Respiratory Distress Syndrome (ARDS)
    • Asthma
    • COPD
  2. American Thoracic Society. Fact Sheets: Topic Specific. Reviewed July 2016. Available at: https://www.thoracic.org/patients/patient-resources/topic-specific/ . Accessed on February 2, 2017.
  3. National Heart, Lung, and Blood Institute. What is Respiratory Failure? Updated December 19, 2011. Available at:  https://www.nhlbi.nih.gov/health/health-topics/topics/rf . Accessed on February 2, 2017.
Index

Hemolung
Respiratory dialysis

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
New 02/02/2017 Medical Policy & Technology Assessment Committee (MPTAC) review. Initial document development.