Archived Policies - Medicine
Enhanced External Counterpulsation (EECP)
Enhanced external counterpulsation (EECP) is considered experimental, investigational and unproven for all indications, including but not limited to, treatment of chronic stable angina pectoris, congestive heart failure, erectile dysfunction, or ischemic stroke.
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 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. 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.”
EECP therapy usually consists of 35 one-hour treatments which may be offered once or twice daily, 5 days per week.
EECP was the subject of a 2002 Blue Cross Blue Shield Association – Technology Evaluation Center (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:
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, one-hour sessions and followed up for six 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.
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 8, 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 quality of life (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.
A literature review was performed using MEDLINE through March 2008. Several small scale trials used physiologic endpoints, (e.g., arterial stiffness measures), but not clinical endpoints, and are not considered here. A subgroup analysis from the PEECH trial (for CHF) was published. It showed that subjects aged 65 and older treated with EECP (n=41) were more likely to meet the exercise duration (35% vs. 25% increased by ≥60 seconds) and peak VO2 (30% vs. 11% increased by ≥1.25ml/kg.min) improvement thresholds compared to those undergoing sham treatment (n=45); there was no difference at six months in NYHA class. Several registry studies were published demonstrating, among other outcomes, improvements in erectile function and decreased emergency department (ED) visits. Erectile function was improved in a study of 120 men prospectively enrolled from 16 centers. Three of five domains of the International Index of Erectile function were statistically improved with EECP treatment (erectile function, intercourse satisfaction and overall satisfaction) and the total score improved from 28 to 32, also a statistically significant improvement. In another study, 450 patients with left ventricular dysfunction (EF≤40) and refractory angina had 0.7 fewer ED visits and 0.8 fewer hospitalizations six months after treatment with EECP compared to the six months before EECP, noting that six month data was available on only 81 patients. In addition, preliminary studies from Asia are reporting early results on use of EECP to the lower extremities in the treatment of acute ischemic stroke. However, these small, uncontrolled trials are considered early results, and this indication is added as investigational due to lack of data concerning impact on outcomes. Findings from these studies are not sufficient to change the current coverage statements.
The policy was updated with a search of the MEDLINE database through May 2010. The search found no new studies comparing EECP with established treatments. 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. Four studies (one randomized controlled trial [RCT] and three non-randomized comparative studies) comparing EECP treatment with no treatment in adults with chronic stable angina were included in the analysis; all but one of these reports have been reviewed in previous policy updates. 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. Similar to the previously reviewed Schechter study, “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 single study of EECP for heart failure included in the systematic review, the PEECH study, was also reviewed on a previous update. 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.
In summary, no new information was identified that would prompt reconsideration of the coverage statement. High-quality studies comparing EECP with usual care and reporting data such as cardiac death or myocardial infarction are needed.
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Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive.
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The following codes may be applicable to this Medical policy and may not be all inclusive.
ICD-9 Diagnosis Codes
Experimental, investigational, and unproven for all diagnoses codes only when identified as specific to use of EECP as noted in the coverage section of this medical policy.
ICD-9 Procedure Codes
ICD-10 Diagnosis Codes
ICD-10 Procedure Codes
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The Centers for Medicare and Medicaid Services (CMS) does have a national Medicare coverage position.
A national coverage position for Medicare may have been changed since this medical policy document was written. See Medicare's National Coverage at <http://www.cms.hhs.gov>.
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):461-4.
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.
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.
Feldman, A.M., Silver, M.A., et al. Enhanced external counterpulsation improves exercise tolerance in patients with chronic heart failure. Journal of American College of Cardiology (2006) 48(6):1198-205.
Pettersson, T., Bondesson, S., et al. One year follow-up of patients with refractory angina pectoris treated with enhanced external counterpulsation. BMC Cardiovasc Disord 2006; 6:28.
Loh, P.H., Louis, A.A., et al. The immediate and long-term outcome of enhanced external counterpulsation in treatment of chronic stable refractory angina. Journal of Internal Medicine (2006) 259:276-84.
Abbottsmith, C.W., Chung, E.S., et al. Enhanced external counterpulsation improves exercise duration and peak oxygen consumption in older patients with heart failure: a subgroup analysis of the PEECH trial. Congestive Heart Failure (2006) 12(6):307-11.
Lawson, W.E., Hui, J.C., et al. Effect of enhanced external counterpulsation on medically refractory angina patients with erectile dysfunction. International Journal of Clinical Practice (2007) 61(5):757-62.
Soran, O., Kennard, E.D., et al. Impact of external counterpulsation treatment on emergency department visits and hospitalizations in refractory angina patients with left ventricular dysfunction. Congestive Heart Failure (2007) 13(1):36-40.
Han JH, Leung TW, Lam WW et al. Preliminary findings of external counterpulsation for ischemic stroke patient with large artery occlusive disease. Stroke. 2008; 39(4):1340-3.
Barsheshet A, Hod H, Shechter M et al. The effects of external counter pulsation therapy on circulating endothelial progenitor cells in patients with angina pectoris. Cardiology 2008; 110(3):160-6.
McKenna C, McDaid C, Suekarran S et al. 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.
Enhanced External Counterpulsation (EECP) for Chronic Stable Angina or Congestive Heart Failure. Chicago, Illinois: Blue Cross Blue Shield Association Medical Policy Reference Manual (2010 January) Medicine 2.02.06.
Kitsou, V., Xanthos, T, et al. Enhanced external counterpulsation: mechanisms of action and clinical applications. Acta Cardiol (2010 April) 65(2):239-47.
8/15/2010 Revised/Updated Entire Document. Document updated with literature review. Coverage unchanged and remains experimental, investigational and unproven for all indications. An additional two indications (erectile dysfunction and ischemic stroke) added under examples of experimental, investigational, and unproven indications.
6/15/2008 Revised/Updated Entire Document
4/15/2006 Revised/Updated Entire Document
12/1/2003 Revised/Updated Entire Document
11/2000 Revised/Updated Entire Document
5/2000 Revised/Updated Entire Document
3/2000 Revised/Updated Entire Document
8/1999 Revised/Updated Entire Document
6/1999 Revised/Updated Entire Document
8/1998 New Medical Document
|Title:||Effective Date:||End Date:|
|Enhanced External Counterpulsation (EECP)||08-15-2017||10-14-2018|
|Enhanced External Counterpulsation (EECP)||10-01-2016||08-14-2017|
|Enhanced External Counterpulsation (EECP)||06-01-2015||09-30-2016|
|Enhanced External Counterpulsation (EECP)||08-01-2014||05-31-2015|
|Enhanced External Counterpulsation (EECP)||08-15-2013||07-31-2014|
|Enhanced External Counterpulsation (EECP)||08-15-2010||08-14-2013|
|Enhanced External Counterpulsation (EECP)||06-15-2008||08-14-2010|
|Enhanced External Counterpulsation (EECP)||04-15-2006||06-14-2008|
|Enhanced External Counterpulsation (EECP)||12-01-2003||04-14-2006|