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.

 

  

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.

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.

 

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).

 

Review of medical literature from October 2006 through March 2008 does not identify any literature which would recommend a change in policy.

 

 

 

 

 

 

 

 

 

 

 

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.     

 

 

 

 

 

 

 

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).