Archived Policies - Medicine


Enhanced External Counterpulsation (EECP)

Number:MED202.050

Effective Date:04-15-2006

End Date:06-14-2008

Coverage:

Enhanced external counterpulsation (EECP) is considered experimental, investigational, and unproven for the treatment of congestive heart failure or chronic stable angina pectoris.

Description:

Enhanced external counterpulsation (EECP) is a noninvasive treatment that uses timed sequential inflation of pressure cuffs on the calves, thighs, and buttocks to augment diastolic pressure, decrease left ventricular after load, 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.  In contrast, EECP is thought to provide a permanent effect on the heart by enhancing the development of coronary collateral development.  The multiple components of the procedure include the use of the device itself, finger plethysmography to follow the blood flow, continuous EKGs to trigger inflation and deflation, and optimal use of pulse oximetry to measure oxygen saturation before and after treatment. 

While EECP has been primarily researched as a treatment of chronic stable angina, it has also been used in patients with congestive heart failure.  The Vasomedical EECP® Therapy System Model has the following labeled indication 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 congestive heart failure, stable or unstable angina pectoris, acute myocardial infarction, or cardiogenic shock.”

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.

Rationale:

EECP was the subject of a 2002 TEC Assessment that updated a previous 1999 TEC Assessment.  The TEC Assessment concluded that the evidence was insufficient to determine whether EECP improved the net health outcome or is as beneficial as any established alternatives in patients with chronic stable angina, consistent with the conclusions of the 1999 Assessment. 

Specifically, the TEC Assessment offered the following observations and conclusions:

  • There is insufficient evidence to draw conclusions about the benefits of EECP.
  • The available evidence is limited by lack of comparison groups in reported studies.  The results of the single randomized, controlled trial (MUST-EECP) must be interpreted with caution, in view of the high subject dropout rate and uncertainty regarding the clinical significance of the reported improvement in physiologic measures, especially when intent-to-treat analysis is applied. 
  • Several 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 clearance from the U. S. Food and Drug Administration (FDA) to market the EECP Therapy System Model for the treatment of congestive heart failure.  This expanded FDA approval was granted through the 501(k) process and was based on the case series 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 there are no controlled trials.  In 2002, Soran and colleagues reported on a feasibility study of EECP as a treatment for congestive heart failure (CHF) in 26 patients.  In this uncontrolled study, the patients were treated with 35 daily, 1-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. 

The ACC/AHA 2002 Guideline Update for the Management of Patients with Chronic Stable Angina notes the following specific to EECP:  “…should only be used in patients who cannot be managed adequately by medical therapy and who are not candidates for revascularization (interventional and/or surgical).”   This guideline notes that the studies reviewed found EECP treatment generally well tolerated and efficacious; anginal symptoms were improved in approximately 75% to 80% of patients.  However, additional clinical trial data are necessary before this technology can be recommended definitively.   

2005 Update

As of January 2005, no additional randomized controlled trials have been published regarding EECP for treatment of chronic stable angina.

Results of the PEECH trial were presented March 8th 2005 at the ACC 2005 Annual Scientific Session.  The author of the PEECH trial stated “the addition of a standard regimen of EECP to optimal pharmacologic therapy improved exercise time for at least six months.”  He and his colleagues suggest that the therapy is a suitable adjunct in patient with stable heart failure receiving optimal medical therapy.  Further trials may be warranted to determine the therapy’s exact role in clinical care.

November 2005 TEC Bulletin/ Results and Conclusion:

Results; Indication of Angina:

The only randomized trial of ECP for the treatment of angina (MUST-EECP) showed a statistically significant difference (p=0.01) between groups in the change in time to > 1 mm ST-segment depression.  Patients in the ECP group had an average difference of 34 seconds longer time to ST-segment depression compared to the sham treated group.  There was no significant difference between treatment groups in the exercise duration (p<0.31), angina counts (p<0.09), or nitroglycerin usage (p>0.1).  The ECP group experienced both more device related (p<0.001) and non-device related (p<0.005) events than the sham-treated group.  The clinical significance of a 37-second improvement in time to ST-segment depression, while the other three endpoints were statistically unchanged, is unknown.  Several methodological limitations are noted. 

The single-center and registry studies show an improvement of one or more Canadian Cardiovascular Society (CCS) functional classes in more than 70% of patient who complete therapy, although roughly 15-25% of patients were not evaluable due to either drop out or loss to follow-up.  Several studies found an improvement in exercise duration of roughly 1.5 minutes.  Some level of improvement in various quality of life scores was noted by several authors.  The lack of comparison groups and the possibility of selective dropout make it impossible to rule out either placebo effect or spontaneous recovery among patients with milder disease.

Results; Indication of Heart Failure:

The only randomized trial of ECP for the treatment of heart failure (the “Prospective Evaluation of EECP in Congestive Heart Failure” [PEECH] trial) showed statistical improvement six months after treatment in exercise duration (+25 vs. -10 seconds, p=0.016) and the percentage of patients improving at least one New York Heart Association (NYHA) functional class (31 vs.14%, p<0.01), but not in peak VO2 or quality of life.  Although more people discontinued treatment in the ECP group because of adverse events than in the usual care group, the overall incidence of adverse events was not different.  The clinical significance of the outcomes is unknown. 

Registry and single-arm studies indicate that patients respond with some functional improvement but not with measurable QOL improvements. Most of the reported registry studies used outcomes that are pertinent to angina rather than typical heart failure outcomes, so the results do not inform the efficacy of ECP for heart failure.

No comparative studies of ECP address the hard outcomes of cardiac death or recurrent cardiac events such as myocardial infarction and revascularization procedures. However, symptom improvement, measured by functional classification scales and quality-of-life instruments, is perceived as a positive outcome by patients. The other outcomes reported in the studies of ECP are primarily physiologically based (exercise duration, time to S-T segment depression) and are difficult to interpret clinically.  Although the results of the randomized trial of ECP in angina are consistent with observational studies, the trial does not provide convincing evidence of the efficacy of ECP treatment. This trial found statistically significant results in 1 of 4 primary outcomes; treatment extended the time to ST-segment depression by 37 seconds.  There was no significant difference between treatment groups in the change in exercise duration from baseline to the post-treatment period (p<0.31). In addition, there were no statistically significant differences between groups with respect to angina counts (p<0.09) or nitroglycerin usage (p>0.1).The single-arm case series and Multicenter registry studies provide interesting starting points for research questions that need to be addressed with comparative trials. 

The evidence supporting the role of ECP as an effective treatment for heart failure is lacking in both quantity and quality. A single, unpublished controlled trial was mostly inconclusive. It 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 indicates that patients respond with some improvements, but the lack of a comparison arm precludes inference about the true effects of therapy. Treatment durability has yet to be addressed with long-term studies.

2005 TEC Bulletin Conclusion:  

The available evidence is not sufficient to permit conclusions of the effect of ECP therapy on health outcomes. Both controlled trials had methodological flaws. The case series and observational studies for both indications, while suggestive of a treatment benefit from ECP have shortcomings as well.  The available evidence does not permit conclusions regarding the effect of ECP therapy on the net health outcome or as it compares with alternatives.

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:

None


Medicare Coverage:

Medicare has a national coverage position that allows for the following indications:

“Coverage is provided for the use of EECP for patients who have been diagnosed with disabling angina who, in the opinion of a cardiologist or cardiothoracic surgeon, are not readily amenable to surgical intervention, such as PTCA or cardiac bypass because:

  • Their condition is inoperable, or at high risk of operative complications or post-operative failure.
  • Their coronary anatomy is not readily amendable to such procedures; or
  • They have co-morbid states which create excessive risk.”

The information contained in this section is for informational purposes only.  HCSC makes no representation to its accuracy.  This information is not to be used for claims adjudication for HCSC plans.

References:

External Counterpulsation for Treatment of Chronic Stable Angina Pectoris. Chicago, Illinois: Blue Cross Blue Shield Association – Technology Evaluation Center Assessment Program (2002 October) 17(15): 1-21.

Food and Drug Administration (FDA) – 510(k) Summary – Vasomedical, Inc. EECP® Therapy System Model TS3 with Pulse Oximetry. Amendment #2 to K020857 Premarket Notification. (June 13, 2002).

Gibbons, R. J., Abrams, J., et al. ACC/AHA 2002 Guideline Update for the Management of Patients with Chronic Stable Angina – Summary Article, A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee on the Management of Patients With Chronic Stable Angina). Journal of American College of Cardiology (2003 January 1) 41(1): 159-68.

Michaels, A.D. Linnemeier, G., et al. Two-year outcomes after enhanced external counterpulsation for stable angina pectoris (from the International EECP Patient Registry [IEPR]). American Journal of Cardiology (2004 February 14) 93(4): 461-464.

Michaels, A.D., Barsness, G. W., et al. Frequency and efficacy of repeat enhanced external counterpulsation for stable angina pectoris (from the International EECP Patient Registry). American Journal of Cardiology (2005 February 1) 95(3): 394-7.

Enhanced External Counterpulsation (EECP) for Chronic Stable Angina or Congestive Heart Failure. Chicago, Illinois: Blue Cross Blue Shield Association Medical Policy Reference Manual (2005 April) Medicine 2.02.06.

External Counterpulsation for Treatment of Chronic stable Angina Pectoris and Chronic Heart Failure. Chicago, Illinois: Blue Cross Blue Shield Association – Technology Evaluation Center Bulletin (2005 November) 22(3): 4-7.

Policy History:

Archived Document(s):

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