Coverage Policy Manual
Policy #: 1998046
Category: Medicine
Initiated: February 1998
Last Review: July 2018
  External Enhanced Cardiac Counterpulsation (EECP)

Description:
Enhanced external counterpulsation (EECP) is a noninvasive treatment used to augment diastolic pressure, decrease left ventricular afterload, and increase venous return. It has been studied primarily as a treatment for patients with refractory angina and heart failure, as well as for other indications such as erectile dysfunction and ischemic stroke.
 
Background
Enhanced external counterpulsation (EECP) uses timed, sequential inflation of pressure cuffs on the calves, thighs, and buttocks to augment diastolic pressure, decrease left ventricular afterload, and increase venous return. Augmenting diastolic pressure displaces a volume of blood backward into the coronary arteries during diastole when the heart is in a state of relaxation and the resistance in the coronary arteries is at a minimum. The resulting increase in coronary artery perfusion pressure may enhance coronary collateral development or increase flow through existing collaterals. In addition, when the left ventricle contracts, it faces a reduced aortic pressure to work against, since the counterpulsation has somewhat emptied the aorta. EECP has been primarily investigated as a treatment for chronic stable angina.
 
Intra-aortic balloon counterpulsation is a more familiar, invasive form of counterpulsation that is used as a method of temporary circulatory assistance for the ischemic heart, often after an acute myocardial infarction (MI). In contrast, EECP is thought to provide a permanent effect on the heart by enhancing the development of coronary collateral development. A full course of therapy usually consists of 35 one-hour treatments, which may be offered once or twice daily, usually 5 days per week. The multiple components of the procedure include the use of the device itself, finger plethysmography to follow the blood flow, continuous electrocardiograms (EKGs) to trigger inflation and deflation, and optional use of pulse oximetry to measure oxygen saturation before and after treatment.
 
Regulatory Status
While EECP has been primarily researched as a treatment of chronic stable angina, it has also been used in patients with heart failure. The Vasomedical EECP® Therapy System Model has the following labeled indication under 510(k) clearance from the U.S. Food and Drug Administration (FDA):
 
"The EECP Therapy System Model TS3 with Pulse Oximetry is a non-invasive external counterpulsation device intended for the use in the treatment of patients with heart failure, stable or unstable angina pectoris, acute myocardial infarction, or cardiogenic shock."
 
Cardiomedics, Inc. has FDA 510(k) clearance to market the CardiAssist Counterpulsation System (K022107) and the CardiAssist ECP System (K010261) for the same indications as the Vasomedical EECP® systems.
 

Policy/
Coverage:
External Enhanced Cardiac Counterpulsation (EECP) is a specific contract exclusion in most benefit contracts.
 
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
  
For contracts without a specific exclusion, external counterpulsation meets primary coverage criteria for effectiveness and is covered (Up to 35 one-hour treatments) for the treatment of patients with disabling , NYHA Class III or IV angina (or equivalent CCS classification), who have failed maximal medical therapy and who are not amenable to surgical cardiac intervention such as angioplasty or coronary artery bypass grafting.
 
Maximal medical therapy is defined as:  Failure to adequately control anginal symptoms with a regimen that may consist of optimal dosages of platelet inhibitors, beta-blockers, calcium channel blockers, long-acting nitrates, lipid-lowering drugs, and antihypertensives when these drugs are appropriate and there is no contraindication to any of these drugs.
 
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
  
Repeat courses of EECP do not meet primary coverage criteria for effectiveness and are not covered.  
 
For any diagnoses not specifically addressed above EECP does not meet Primary Coverage Criteria for effectiveness.
 
For any diagnoses not specifically addressed above, or for repeat courses,  and for contracts without primary coverage criteria, EECP is considered investigational.  Investigational services are an exclusion in the member certificate of coverage.

Rationale:
There is insufficient evidence to draw conclusions about the benefits of EECP.  The available evidence is limited by lack of comparison groups in more reported studies. The results of the randomized controlled trial (MUST-EECP) must be interpreted with caution, in view of the high subject dropout rate and uncertainly regarding the clinical significance of the reported improvement in physiologic measures, especially when intent-to-treat analysis is applied.  Most recently, 5 studies have reported the outcomes of large numbers of patients treated in a number of different institutions. There are several problems with this kind of evidence. There is no comparison group, and thus it is impossible to determine whether such improvement is due to EECP.
 
In June 2002, Vasomedical received FDA clearance to market for the use of the EECP Therapy System Model for the treatment of congestive heart failure. This expanded FDA approval was granted through the 510(k) process and was based on the outcomes reported in multi-center, single center, and registry-based clinical investigations. The 510(k) summary states that objective measures such as peak oxygen consumption, exercise duration, and pre-load adjusted maximal left ventricular power are improved following EECP therapy, as well as subjective measures of patient response to therapy, such as quality of life and functional ability measures.  However no clinical details of these studies are provided in the FDA summary, and these studies are not controlled trials. In 2002, Soran and colleagues reported on a feasibility study of EECP as a treatment for congestive heart failure in 26 patients.  In this uncontrolled study, the patients were treated with 35 daily, one-hour sessions and followed up for 6 months after completion of the course of therapy. The study suggests that the treatment was safe and well tolerated. Based in part on the results of this study, a larger, randomized study has been launched, the PEECH trial (Prospective Evaluation of EECP in Congestive Heart Failure).
 
Michaels et. al. reported data for 1,192 pts from 29 sites who completed 35 hours of ECP.  Within 2 yrs 194 pts (18%) underwent repeat course for persistent angina (38%), and increasing angina (62%).  Repeat ECP occurred <=  1 year in 62% of pts.  There is available data on 152 pts who repeat underwent ECP.  Those pts had a decrease in angina and a concomitant decrease in nitroglycerin use after the 2nd course.  At 2 years those pts who underwent a 2nd course had worse angina compared with those who did not undergo a 2nd course.  Patients who underwent repeat ECP did benefit from the 2 courses but they did not sustain the symptomatic improvement.
 
A single, unpublished, randomized, multi-center study of EECP compared to usual care in 187 optimally medically managed patients with NYHA functional class II/III heart failure with EF <=35% of ischemic or idiopathic etiology, the PEECH trial (Prospective Evaluation of EECP in Congestive Heart Failure), was mostly inconclusive. Only the design and methods of the PEECH trial have been published by Feldman et al.  The unpublished results of the PEECH trial, presented at the 2005 American College of Cardiology meeting, found statistically improved, but modest, changes in exercise duration, and improved functional classification but not in quality of life or peak oxygen uptake. Registry studies for heart failure use angina outcomes and contribute little to the body of evidence.  The single-arm study by Soran et al  indicates that patients respond with some improvements, but the lack of a comparison arm precludes inference about the true effects of therapy. Treatment durability for either angina or heart failure has yet to be addressed with long-term studies. Therefore, the evidence is insufficient to determine whether EECP improves the net health outcome or is as beneficial as any established alternatives in patients with chronic stable heart failure.
 
2006 Update
A literature search was performed for the period from August 2005 to October 2006. No new evidence was garnered; however the previously unpublished PEECH trial (Prospective Evaluation of EECP in Congestive Heart Failure) was published.   The results reported in the current publication did not differ from those reported above.
 
The Cochrane Library of Technology Assessments published a 2004 and 2006 review of EECP developed by The Ontario Ministry of Health and Long-Term Care.  The authors concluded "There is insufficient evidence to support the effectiveness of EECP treatment for patients with severe refractory stable angina or for treatment of patients with heart failure.
 
The limited coverage of EECP is based on member benefit certificate Primary Coverage Criteria for effectiveness based on the published review of an independent technology assessment organization (Cochrane, 2004, 2006).
 
March 2008 Update
Review of medical literature from October 2006 through March 2008 does not identify any literature which would recommend a change in policy.
 
2010 Update
The policy was updated with a search of the MEDLINE database through April 2010. The search found no new studies that would prompt a change in the policy statement.  In a 2009 paper, McKenna and colleagues report on a systematic review and economic analysis of EECP for the treatment of stable angina and heart failure (McKenna, 2009). Four studies (1 randomized controlled trial [RCT] and 3 non-randomized comparative studies) comparing EECP treatment with no treatment in adults with chronic stable angina were included in the analysis. The systematic review included a study by Barsheshet et al in which 25 patients (15 EECP and 10 controls) were evaluated at the end of treatment (Barsheshet, 2008). “CCS classification improved with EECP but not with usual care, however statistical analysis of between group differences was not reported and, for CCS classification, the data were treated as continuous data which is inappropriate for this four-category classification.” The authors conclude that the studies do not provide firm evidence of the clinical effectiveness of EECP in refractory stable angina or in heart failure and that high quality studies are required to investigate the benefits of EECP and whether these outweigh the common adverse effects.
 
A registry-based study (the International Enhanced External Counterpulsation Patient Registry) reported long-term (3-year) results on patients with chronic refractory angina for patients in this registry (Loh, 2008).  The registry enrolled 5,000 patients from 99 U.S. and 9 international centers between 1999 and 2001. However, analysis was completed only for those centers that had at least 80% compliance with follow-up data submission; the study reported results on 1,427 patients. In this selective group, 220 patients (15.4%) died, while 1,061 patients (74.4%) completed their follow-up. Immediately post-EECP, the proportion of patients with severe angina (Canadian Cardiovascular Angina Classification [CCS] III/IV) were reduced from 89% to 25%.  This was sustained in 74% of the patients during follow-up. More severe baseline angina and a history of heart failure or diabetes were independent predictors of unfavorable outcome.
 
2012 Update
A search of the MEDLINE database was conducted through September 2012. There was no new information identified that would prompt a change in the coverage statement.
 
2013 Update
A search of the MEDLINE database through August 2013 did not reveal any new information that would prompt a change in the coverage statement.
 
2014 Update
 
A literature search conducted through April 2014 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
The 2012 American College of Cardiology/American Heart Association (ACC/AHA) guidelines on the management of patients with stable ischemic heart disease indicate EECP “may be considered for relief of refractory angina.” This recommendation is based on Class IIb, Level of Evidence: B, which indicates the efficacy of the intervention is not well established and further studies would be helpful (ACC/AHA).
 
This recommendation was based on a single randomized control trial (Fihn, 2012). The authors indicate aadditional data from well-designed RCTs are needed to better define the role of this therapeutic strategy in patients with stable ischemic heart disease (SIHD).  No further studies on the use of EECP for this indication were identified. Therefore, the policy statement is unchanged.
 
2015 Update
 
A literature search conducted through December 2014 did not reveal any new information that would prompt a change in the coverage statement.
 
2016 Update
A literature search was conducted using the MEDLINE database through December 2015. There was no new literature identified that would prompt a change in the coverage statement.     
 
2017 Update
A literature search conducted through January 2017 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
Systematic reviews of the literature have evaluated EECP for chronic stable angina. In 2010, Amin and colleagues published a Cochrane review of major databases through 2008 on evidence of the effectiveness of EECP for chronic angina pectoris (Amin, 2010). The solitary RCT identified was the MUST-EECP trial. The reviewers highlighted patient selection for this study. They noted that limiting the study population to patients with CCS class below IV diminished the trial’s generalizability to patients of interest, ie, patients with the most severe symptoms of chronic angina pectoris
 
Registry Studies
Registry-based studies have reported on relatively large numbers of patients. In 1 registry-based study, 450 patients with left ventricular dysfunction (ejection fraction, ≤40%) and refractory angina had 0.7 fewer emergency department visits and 0.8 fewer hospitalizations 6 months after treatment with EECP compared with the 6 months before EECP; 6-month data were available on only 81 patients (Soran, 2007).  Drawing conclusions from this study is not possible due to lack of a comparison group.
 
Similar to the registry evidence for EECP for angina, registry studies for heart failure have provided relatively little insight into the comparative efficacy of EECP (Soran, 2002). The single-arm study by Soran and colleagues indicated that patients showed some improvements, but the lack of a comparison arm precludes inferences about the true effects of therapy.
 
Ongoing and Unpublished Clinical Trials
A search of ClinicalTrials.gov in December 2016 did not identify any ongoing or unpublished trials that would likely influence this review.
 
Practice Guidelines and Position Statements
Guidelines from the American College of Cardiology Foundation (ACCF), American Heart Association (AHA), and 5 other medical societies in 2012 guidelines on the management of patients with stable ischemic heart disease indicated EECP “may be considered for relief of refractory angina.” This recommendation was based on class IIb, level of evidence: B, which indicates the efficacy of the intervention, is not well established and further studies would be helpful (Fihn, 2012).
 
The 2013 ACCF and AHA guidelines on the management of heart failure do not address EECP. In 2014, ACC and AHA issued a Focused Update on the 2012 guideline on the diagnosis and management of patients with stable ischemic heart disease in which the associations specifically reviewed their recommendation on EECP. Based on this review, the recommendation on EECP remained unchanged from the 2012 guideline (Fihn, 2014).
 
2018 Update
A literature search was conducted through June 2018.  There was no new information identified that would prompt a change in the coverage statement.  

CPT/HCPCS:
G0166External counterpulsation, per treatment session

References: Amin F, Al Hajeri A, Civelek B, et al.(2010) Enhanced external counterpulsation for chronic angina pectoris. Cochrane Database Syst Rev. 2010(2):CD007219. PMID 20166092

Barsheshet A, Hod H, Shechter M et al.(2008) The effects of external counter pulsation therapy on circulating endothelial progenitor cells in patients with angina pectoris. Cardiology 2008; 110(3):160-6.

Bonetti PO, Barsness GW, Keelan PC, et al.(2003) Enhanced external counterpulsation improves endothelial function in patients with symptomatic coronary artery disease. JACC 2003; May 21;41(10):1761-8.

Fihn SD, Blankenship JC, Alexander KP, et al.(2014) 2014 ACC/AHA/AATS/PCNA/SCAI/STS focused update of the guideline for the diagnosis and management of patients with stable ischemic heart disease: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines, and the American Association for Thoracic Surgery, Preventive Cardiovascular Nurses Association, Society for Cardiovascular Angiography and Interventions, and Society of Thoracic Surgeons. J Am Coll Cardiol. Nov 4 2014;64(18):1929-1949. PMID 25077860

Fihn SD, Gardin JM, Abrams J et al.(2012) 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.

Lawson WE, Hui JCK, Soroff HS, et al.(1992) Efficacy of enhanced external counterpulsation in the Treatment of angina pectoris. Am J Card 1992; 70:859-62.

Lawson WE, Jui JCK, Zheng ZS, et al.(1995) Three-year sustained benefit from enhanced external counterpulsation in chronic angina pectoris. Am J Card 1995; 75:840-41.

Loh PH, Cleland JG, Louis AA et al.(2008) Enhanced external counterpulsation in the treatment of chronic refractory angina: a long-term follow-up outcome from the International Enhanced External Counterpulsation Patient Registry. Clin Cardiol 2008; 31(4):159-64.

McKenna C, McDaid C, Suekarran S et al.(2009) Enhanced external counterpulsation for the treatment of stable angina and heart failure: a systematic review and economic analysis. Health Technol Assess 2009; 13(24):1-90.

Michaels AD, Accad M, Ports TA, et al.(2002) Left Ventricular systolic unloading and augmentation of intracoronary pressure and Doppler flow during enhanced external counterpulsation. Circ 2002; Sept 3;106(10):1237-42.

Michaels AD, Barsness GW, et al.(2005) Frequency and efficacy of repeat enhanced external counterpulsation for stable angina pectoris (from the International EECP Patient Registry). Am J Cardiol 2005; 95:394-7.

Michaels AD, Linnemeier G, et al.(2004) Two-year outcomes after enhanced external counterpulsation for stable angina pectoris (from the International EECP Patient Registry [IEPR]). Am J Cardiol 2004; 93:461-4.

Michaels AD, Paisinghani A, et al.(2005) The effects of enhanced external counterpulsation on myocardial perfusion in patients with stable angina: a multicenter radionuclide study. Am Heart J 2005; 150:1066-73.

Soran O, Kennard ED, Bart BA, et al.(2007) Impact of external counterpulsation treatment on emergency department visits and hospitalizations in refractory angina patients with left ventricular dysfunction. Congest Heart Fail. Jan-Feb 2007;13(1):36-40. PMID 17268208

Soran O, Kennard ED, et al.(2006) Two-year clinical outcomes after enhanced external counterpulsation (EECP) therapy in patients with refractory angina pectoris and left ventricular dysfunction (Report from the International EECP Patient Registry). Am J Cardiol 2006; 97:17-20.

Soran O, Kennard ED, Kelsey SF, et al.(2002) Enhanced external counterpulsation as treatment for chronic angina in patients with left ventricular dysfunction: a report from the International EECP Patient Registry (IEPR). Congest Heart Fail. Nov-Dec 2002;8(6):297-302. PMID 12461318


Group specific policy will supersede this policy when applicable. This policy does not apply to the Wal-Mart Associates Group Health Plan participants or to the Tyson Group Health Plan participants.
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