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Medical Policy

Policy Num:       02.002.012
Policy Name:     Enhanced External Counterpulsation
Policy ID:          [02.002.012]  [Ar / B / M- / P-]  [2.02.06]

Last Review:       July 15, 2024
Next Review:      Policy Archived

Related Policies: 

07.001.056 Transmyocardial Revascularization

Enhanced External Counterpulsation 

Summary

Description

Enhanced external counterpulsation (EECP) is a noninvasive treatment used to augment diastolic pressure, decrease left ventricular afterload, and increase venous return. EECP has been studied primarily as a treatment for patients with refractory angina and heart failure.

Summary of Evidence

For individuals who have chronic stable angina who receive EECP, the evidence includes randomized controlled trials (RCTs), observational studies, and systematic reviews. Relevant outcomes are overall survival, symptoms, morbid events, and functional outcomes. There is a single-blind RCT that includes clinical outcomes, and it reported benefit on only 1 of 4 main angina outcomes. Additional small RCTs have reported changes in physiologic measures associated with EECP but did not provide relevant evidence on clinical efficacy. Because of the variable natural history of angina, the multiple confounding variables for cardiac outcomes, and the potential for a placebo effect, more RCT evidence is needed. Observational studies, including registry studies with large numbers of patients, add little to determinations of efficacy. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals who have heart failure who receive EECP, the evidence includes RCTs, observational studies, and systematic reviews. Relevant outcomes are overall survival, symptoms, morbid events, and functional outcomes. One RCT that reported on clinical outcomes found a modest benefit with EECP on some outcomes but not others. A second RCT reported improvements on the 6-minute walk test with EECP but had methodologic limitations; RCT findings ultimately proved inconclusive. The observational studies on EECP in heart failure have limited ability to inform the evidence on EECP due to the multiple confounding variables for cardiac outcomes and the potential for a placebo effect. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals who have other conditions related to ischemia or vascular dysfunction who receive EECP, the evidence includes RCTs, registry studies, and systematic reviews. Relevant outcomes are overall survival, symptoms, morbid events, and functional outcomes. Two RCTs have assessed use of EECP for treatment of central retinal artery occlusion; both trials had methodologic limitations. Registry studies of erectile function have reported improvements for some outcomes with ECCP but design shortcomings limit conclusions drawn. EECP has also been used to treat acute ischemic stroke, but the evidence base in is not robust. EECP has been used in a small RCT to treat type 2 diabetes. Reported follow-up was short term. The evidence is insufficient to determine the effects of the technology on health outcomes.

Objective

The objective of this evidence review is to determine whether the use of enhanced external counterpulsation improves the net health outcome in individuals who have chronic stable angina, heart failure or other cardiovascular conditions.

Policy Statements

Enhanced external counterpulsation is considered investigational for all indications, including but not limited to, treatment of chronic stable angina pectoris, heart failure, erectile dysfunction, or ischemic stroke.

Policy Guidelines

This policy only addresses outpatient uses of enhanced external counterpulsation (EECP), such as for the treatment of chronic stable angina or heart failure. This policy does not address its use for unstable angina pectoris, acute myocardial infarction, or cardiogenic shock.

Please see the Codes table for details.

Coding

See the Codes table for details.

Benefit Application

BlueCard/National Account Issues

State or federal mandates (eg, Federal Employee Program) may dictate that certain U.S. Food and Drug Administration-approved devices, drugs, or biologics may not be considered investigational, and thus these devices may be assessed only by their medical necessity. 

Benefits are determined by the group contract, member benefit booklet, and/or individual subscriber certificate in effect at the time services were rendered.  Benefit products or negotiated coverages may have all or some of the services discussed in this medical policy excluded from their coverage.

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. The proposed mechanism of action is the augmentation of diastolic pressure by displacement of a volume of blood backward into the coronary arteries during diastole when the heart is in a state of relaxation and 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. Also, when the left ventricular contracts, it faces reduced aortic counterpressure, because 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 acute myocardial infarction. In contrast, EECP is thought to provide a permanent effect on the heart by enhancing the 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 a week. The multiple components of the procedure include the use of the device itself, finger plethysmography to follow the blood flow, continuous electrocardiograms to trigger inflation and deflation, and optional use of pulse oximetry to measure oxygen saturation before and after treatment.

Regulatory Status

A variety of EECP devices have been cleared for marketing by the U.S. Food and Drug Administration (FDA) through the 510(k) process. Examples of EECP devices with FDA clearance are outlined in Table 1. FDA product code: DRN.

Table 1. FDA-Cleared EECP Devices

EECP: enhanced external counterpulsation; FDA: Food and Drug Administration; Vo2: oxygen consumption.

Rationale

This evidence review was created in January 1998 and has been updated regularly with searches of the PubMed database. The most recent literature update was performed through March 12, 2024.

Evidence reviews assess the clinical evidence to determine whether the use of a technology improves the net health outcome. Broadly defined, health outcomes are length of life, quality of life, and ability to function-including benefits and harms. Every clinical condition has specific outcomes that are important to patients and to managing the course of that condition. Validated outcome measures are necessary to ascertain whether a condition improves or worsens; and whether the magnitude of that change is clinically significant. The net health outcome is a balance of benefits and harms.

To assess whether the evidence is sufficient to draw conclusions about the net health outcome of a technology, 2 domains are examined: the relevance and the quality and credibility. To be relevant, studies must represent 1 or more intended clinical use of the technology in the intended population and compare an effective and appropriate alternative at a comparable intensity. For some conditions, the alternative will be supportive care or surveillance. The quality and credibility of the evidence depend on study design and conduct, minimizing bias and confounding that can generate incorrect findings. The randomized controlled trial (RCT) is preferred to assess efficacy; however, in some circumstances, nonrandomized studies may be adequate. RCTs are rarely large enough or long enough to capture less common adverse events and long-term effects. Other types of studies can be used for these purposes and to assess generalizability to broader clinical populations and settings of clinical practice.

Promotion of greater diversity and inclusion in clinical research of historically marginalized groups (e.g., People of Color [African-American, Asian, Black, Latino and Native American]; LGBTQIA (Lesbian, Gay, Bisexual, Transgender, Queer, Intersex, Asexual); Women; and People with Disabilities [Physical and Invisible]) allows policy populations to be more reflective of and findings more applicable to our diverse members. While we also strive to use inclusive language related to these groups in our policies, use of gender-specific nouns (e.g., women, men, sisters, etc.) will continue when reflective of language used in publications describing study populations.

Population Reference No. 1

Chronic Stable Angina

Clinical Context and Therapy Purpose

The purpose of enhanced external counterpulsation (EECP) is to provide a treatment option that is an alternative to or an improvement on existing therapies, such as guideline-directed medical management, in individuals with chronic stable angina.

The following PICO was used to select literature to inform this review.

Populations

The relevant population of interest is individuals with chronic stable angina.

Interventions

The therapy being considered is EECP. EECP is a noninvasive treatment used to augment diastolic pressure, decrease left ventricular afterload, and increase venous return.

Comparators

Comparators of interest include guideline-directed medical management.

Outcomes

The general outcomes of interest are overall survival (OS), symptoms, morbid events, and functional outcomes.

Available literature has followed patients for up to 3 years..

Study Selection Criteria

Methodologically credible studies were selected using the following principles:

• To assess efficacy outcomes, comparative controlled prospective trials were sought, with a preference for RCTs.

• In the absence of such trials, comparative observational studies were sought, with a preference for prospective studies.

• To assess long-term outcomes and adverse events, single-arm studies that capture longer periods of follow-up and/or larger populations were sought.

• Studies with duplicative or overlapping populations were excluded.

The literature base consists of a low number of RCTs, some of which have reported relevant clinical outcomes, and others that have reported intermediate or physiologic outcome measures. Also, there are a large number of observational studies, including publications from EECP registries and case series, that have generally reported pretreatment and posttreatment measures of EECP effectiveness.

Review of Evidence

Randomized Controlled Trials

Arora et al (1999) presented results of the Multicenter Study of Enhanced External Counterpulsation (MUST-EECP) trial.^1,The MUST-EECP trial applied a randomized controlled, double-blinded protocol that compared active treatment with placebo (inactive counterpulsation sham treatment) among 139 individuals with Canadian Cardiovascular Society (CCS) Classification Scales (a functional assessment tool based on the level of exertion that elicits symptoms) class I, II, or III chronic, stable angina. Four outcomes were examined: (1) self-reported frequency of angina, analyzed 2 ways; (2) self-reported use of on-demand nitroglycerin; (3) exercise duration tolerance testing; and (4) time to exercise-induced ischemia (defined as time to depression of ≥ 1 mm in the ST segment on an electrocardiogram).

All patients underwent the same 35-hour protocol, followed by an exercise tolerance test within 1 week of completing therapy. Follow-up beyond the treatment period was not conducted. Intention-to-treat analyses were reported for the angina count and nitroglycerin usage outcomes only. There was a statistically significant difference (P =.01) between groups in the change in time to ≥ 1 mm or greater ST-segment depression. Patients in the EECP group had an average difference of 37 seconds longer time to ST-segment depression than the sham-treated group. There was no significant difference between treatment groups in the change in exercise duration from baseline to the posttreatment period (P <.31). Also, there were no statistically significant differences between groups concerning angina counts (P <.09) or nitroglycerin use (P >.1).

In addition to methodologic limitations found in the design, execution, and reporting of this trial, the magnitude of the benefit reported was not large. Of the 4 endpoints of interest, only time to ST-segment depression differed statistically in the EECP group compared with the sham group. The clinical significance of a 37-second improvement in time to ST-segment depression is unknown, but because it occurred while the other 3 endpoints were statistically unchanged with therapy should not suggest that this anomaly marks improvement. That both groups showed increased exercise duration suggests a degree of placebo effect; exercise duration possesses a motivational component that time to ST-segment depression does not.

Arora et al (2002) published a 12-month follow-up to the MUST-EECP trial.^2, Only 71 (54%) of the original 139 subjects in the study. Subjects treated with EECP reported greater improvement in several quality of life scales. However, such findings could not be correlated with treatment responses reported in the first study (because of data limitations). The findings were further limited by the small sample size and a potentially biased sample of the original subject pool.

Bondesson et al (2011) published a small unblinded RCT that addressed a single health outcome (change after 7 weeks in CCS angina class), along with multiple intermediate outcomes.^3, Twenty patients with refractory angina (CCS class III) were randomized to EECP or no EECP. Mean CCS class was significantly improved in the EECP group but not in the no-EECP group. At the 7-week follow-up, soluble interleukin-2 receptor (a potential indicator of lymphocyte activation in atherosclerosis) measurements significantly increased in the EECP group and significantly decreased in the no-EECP group. There were no differences between groups at 7 weeks in resting cutaneous microvascular blood flow or response to acetylcholine, sodium nitroprusside, or local heating.

Additional RCTs have reported on intermediate, or physiologic, outcomes. Gloekler et al (2010) published one such RCT (N = 20), which compared intracoronary blood flows in patients treated using EECP with those treated using a sham procedure.^4, This trial was designed to detect statistically significant differences in collateral flow rates by angiography, not anginal symptoms. After 7 weeks of treatment, collateral flow index increased significantly in the EECP group compared with sham treatment. Buschman et al (2009) noted similar findings in a comparative study et al (2009) of 23 patients.^5,

Two publications reported on a single trial evaluating blood flow and other measures of arterial function.^6,7, This trial randomized 42 patients with coronary artery disease and chronic angina to EECP or sham EECP. EECP improved flow-mediated dilation in the brachial and femoral arteries and improved numerous serum markers of blood flow and inflammation. The same trial also reported that measures of arterial stiffness were improved in the EECP group.

Shakouri et al (2015), in a randomized pilot study, reported on intermediate outcome measures, including plasma nitric oxide, endothelin 1, and high-sensitivity C-reactive protein levels, as well as quality of life, in patients with coronary artery disease allocated to 20 sessions of EECP (n = 21) or cardiac rehabilitation (n = 21).^8, There were no statistically significant improvements in the physiologic markers and quality of life over time in either group and no statistically significant between-group differences in change in any of the parameters evaluated.

Systematic Review

This evidence review was informed by a TEC Assessment (1999) on EECP for chronic stable angina, which was updated in 2002 and again in 2005.^9, These Assessments concluded that the evidence was insufficient to determine whether EECP improved the net health outcome or was as beneficial as any established alternatives in patients with chronic stable angina.

Specifically, the 2005 Assessment offered the following observations and conclusions regarding EECP for chronic stable angina^9,:

• The results of the single RCT, the MUST-EECP trial, must be interpreted with caution given the following factors: (1) the high subject dropout rate; and (2) the uncertain clinical significance of the reported improvement in physiologic measures, especially when intention-to-treat analysis was applied.^1,2,

• Comparative studies of EECP did not address the hard outcomes of cardiac death or recurrent cardiac events, such as myocardial infarction and revascularization procedures.^10,11,

• Several case series and registry-based studies have reported the outcomes of large numbers of patients treated in a number of different institutions. There were several problems with this kind of evidence:(1) these studies, while contributing to the body of knowledge of EECP, did little to address the efficacy or durability of EECP treatment; and (2) the lack of comparison groups made it impossible to rule out either placebo effect or spontaneous recovery among patients with milder disease.

Section Summary: Chronic Stable Angina

Data on use of EECP in chronic stable angina are insufficient to form conclusions about the efficacy of this treatment. The single randomized trial (MUST-EECP) that included relevant clinical outcomes reported a benefit on 1 of 4 main angina-related outcomes, and the magnitude of this benefit was of uncertain clinical significance. RCTs that have reported on intermediate outcomes offer evidence on possible physiologic mechanisms underlying EECP treatment but do not themselves provide evidence of health outcome benefits. Observational studies (eg, registry data, case series) offer little evidence on the efficacy of this procedure due to the variable natural history of angina, the multiple confounders of cardiac outcomes, and the potential for a placebo effect.

For individuals who have chronic stable angina who receive EECP, the evidence includes RCTs, observational studies, and systematic reviews. Relevant outcomes are overall survival, symptoms, morbid events, and functional outcomes. There is a single-blind RCT that includes clinical outcomes, and it reported benefit on only 1 of 4 main angina outcomes. Additional small RCTs have reported changes in physiologic measures associated with EECP but did not provide relevant evidence on clinical efficacy. Because of the variable natural history of angina, the multiple confounding variables for cardiac outcomes, and the potential for a placebo effect, more RCT evidence is needed. Observational studies, including registry studies with large numbers of patients, add little to determinations of efficacy. The evidence is insufficient to determine the effects of the technology on health outcomes.

Population Reference No. 2

Heart Failure

Clinical Context and Therapy Purpose

The purpose of EECP is to provide a treatment option that is an alternative to or an improvement on existing therapies, such as guideline-directed medical management, in individuals with heart failure.

The following PICO was used to select literature to inform this review.

Populations

The relevant population of interest is individuals with heart failure.

Interventions

The therapy being considered is EECP. EECP is a noninvasive treatment used to augment diastolic pressure, decrease left ventricular afterload, and increase venous return.

Comparators

Comparators of interest include guideline-directed medical management.

Outcomes

The general outcomes of interest are OS, symptoms, morbid events, and functional outcomes.

The limited available literature has followed patients for up to 6 months..

Study Selection Criteria

Methodologically credible studies were selected using the following principles:

• To assess efficacy outcomes, comparative controlled prospective trials were sought, with a preference for RCTs.

• In the absence of such trials, comparative observational studies were sought, with a preference for prospective studies.

• To assess long-term outcomes and adverse events, single-arm studies that capture longer periods of follow-up and/or larger populations were sought.

• Studies with duplicative or overlapping populations were excluded.

Review of Evidence

The 510(k) approval of the Vasomedical devices stated that objective measures, such as peak oxygen consumption, exercise duration, and preload-adjusted maximal left ventricular power, are improved following EECP therapy, as are subjective measures of patient response to therapy, such as quality of life and functional ability.^12, However, no clinical details of these studies were provided in the U.S. Food and Drug Administration (FDA) summary, and these data were not from controlled trials.

The 2005 TEC Assessment included heart failure in its analysis and concluded the evidence supporting the role of EECP as an effective treatment for heart failure was lacking in both quantity and quality.^9, A single randomized, multicenter study has compared EECP with usual care in 187 optimally medically managed patients with New York Heart Association (NYHA) functional class II or III heart failure who had an ejection fraction of 35% or less of ischemic or idiopathic etiology.^13, This study, the Prospective Evaluation of EECP in Congestive Heart Failure (PEECH trial), was mostly inconclusive. Feldman et al (2005) published the trial design and methodology by Feldman et al (2005).^12,Feldman et al (2006) also reported on the PEECH trial results, (2006), indicating statistically improved, but modest, changes in exercise duration and improved functional class but not in quality of life or peak oxygen consumption.^13,

A 2006 subgroup analysis of the PEECH trial showed that subjects aged 65 years and older treated with EECP (n = 41) were more likely to meet the exercise duration (35% vs. 25% increased by ≥ 60 seconds) and peak oxygen consumption (30% vs. 11% increased by ≥ 1.25 mL/kg/min) improvement thresholds compared with those undergoing sham treatment (n = 45); there was no difference at 6 months in NYHA class.^14,

Rampengan et al (2015) reported on a double-blinded RCT evaluating EECP in patients with congestive heart failure treated in Indonesia.^15, Patients with NYHA functional class I or II symptomatic heart failure of various causes were included. Patients were randomized to active EECP (n = 56) or sham EECP (n = 56), which involved the use of the EECP device at only 77 mm Hg of pressure versus the standard 300 mm Hg. The analysis was per protocol, excluding 6 and 7 patients who dropped out of the active and sham groups, respectively. Postintervention, active EECP group patients were more likely to have a 6-minute walk distance of 300 meters or greater (98.0% vs. 32.7%; P<.01). The change in 6-minute walk distance was greater (improved) for the active EECP patients (192.6 meters) than for the sham control patients (–9 meters; P<.05).

A small, open-label, ongoing RCT conducted in Russia by Belenkov et al (2024) randomized patients with ischemic heart disease and heart failure to optimal drug therapy alone (n=40), optimal drug therapy plus 1 course of EECP per year (n=40), or optimal drug therapy plus 2 courses of EECP per year (n=40).^16, The total duration is anticipated to be 3 years. At 12 months, the percentage of patients achieving at least a 20% increase in 6-minute walk test was greater in the EECP groups than optimal drug therapy alone (97.5% and 72.5% vs 7.7% ). Longer-term follow-up from this ongoing study may help clarify the role of EECP; however, the open-label nature and limited sample size of the study will limit the applicability of the findings.

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.^17,18,19,20, Soran et al (2002) conducted a single-arm study indicating that patients showed some improvements, but the lack of a comparison arm precluded inferences about the true effects of therapy.^21,

McKenna et al (2009), in their previously described review,^22, included the only trial of EECP for heart failure available at that time, the 2006 PEECH study.^13, Reviewers concluded that the studies did not provide firm evidence of the clinical effectiveness of EECP in heart failure and that high-quality studies would be required to investigate the benefits of EECP and whether they outweigh the common adverse events.

Section Summary: Heart Failure

The evidence for the use of EECP in heart failure includes 2 RCTs that reported on clinical outcomes. One study reported modest improvements for some outcomes and none for others. A second study reported improvements in the 6-minute walk test but had methodologic limitations that, in turn, limited the conclusions that could be drawn from the study. The observational studies added little to the evaluation of efficacy due to the variable natural history of heart failure, the multiple confounding variables for cardiac outcomes, and the potential for a placebo effect. Further high-quality RCTs would be needed to determine whether EECP is a useful treatment for heart failure.

For individuals who have heart failure who receive EECP, the evidence includes RCTs, observational studies, and systematic reviews. Relevant outcomes are overall survival, symptoms, morbid events, and functional outcomes. One RCT that reported on clinical outcomes found a modest benefit with EECP on some outcomes but not others. A second RCT reported improvements on the 6-minute walk test with EECP but had methodologic limitations; RCT findings ultimately proved inconclusive. The observational studies on EECP in heart failure have limited ability to inform the evidence on EECP due to the multiple confounding variables for cardiac outcomes and the potential for a placebo effect. The evidence is insufficient to determine the effects of the technology on health outcomes.

Population Reference No. 3

Other Conditions Related to Ischemia or Vascular Dysfunction

Clinical Context and Therapy Purpose

The purpose of enhanced EECP is to provide a treatment option that is an alternative to or an improvement on existing therapies, such as guideline-directed medical management, in patients with other indications related to ischemia or vascular dysfunction.

The following PICO was used to select literature to inform this review.

Populations

The relevant population of interest is individuals with other indications related to ischemia or vascular dysfunction.

Interventions

The therapy being considered is EECP. EECP is a noninvasive treatment used to augment diastolic pressure, decrease left ventricular afterload, and increase venous return.

Comparators

Comparators of interest include guideline-directed medical management.

Outcomes

The general outcomes of interest are overall survival, symptoms, morbid events, and functional outcomes.

The limited available literature has followed patients for up to 6 months; in practice, length of follow-up would depend upon the condition being treated.

Study Selection Criteria

Methodologically credible studies were selected using the following principles:

• To assess efficacy outcomes, comparative controlled prospective trials were sought, with a preference for RCTs.

• In the absence of such trials, comparative observational studies were sought, with a preference for prospective studies.

• To assess long-term outcomes and adverse events, single-arm studies that capture longer periods of follow-up and/or larger populations were sought.

• Studies with duplicative or overlapping populations were excluded.

Review of Evidence

The use of EECP for other conditions associated with ischemia or vascular dysfunction has been investigated. Lin et al 2023 evaluated interventions for central retinal artery occlusion in a Cochrane review.^23, The authors identified one prospective study ^24, that failed to find benefit in retinal reperfusion or visual acuity when EECP was added to hemodilution.

Published registry studies have also demonstrated improvements in erectile function. Lawson et al (2007) showed improved erectile function in a study of 120 men prospectively enrolled from 16 centers.^25, Three of 5 domains of the International Index of Erectile Function were statistically improved with EECP treatment (erectile function, intercourse satisfaction, overall satisfaction), and the total score improved from 28 to 32, a statistically significant improvement. The noncomparative design of this study makes drawing conclusions on treatment efficacy difficult.

Preliminary studies from Asia have also reported on early results using EECP to treat the lower extremities after acute ischemic stroke.^26,Lin et al (2012), in a Cochrane review, assessed 2 RCTs of EECP in acute ischemic stroke and concluded that the methodologic quality of the studies was poor, and reliable conclusions could not be reached from this evidence.^27,

Sardina et al (2016) reported on an RCT that allocated 30 patients with type 2 diabetes in a 2:1 ratio to EECP (n=20) or standard care for diabetes (n=10), and reported results out to 3^28, and 6 months.^29, At 6-month follow-up, patients in the EECP group had significant decreases in a variety of biomarkers of advanced glycation end products, inflammation, and oxidative stress; the percent change in advanced glycation end products and receptor of advanced glycation end products differed significantly between groups (p<.05). Nagendra et al (2023) compiled the 12-week results of Sardina et al (2016) with 2 smaller RCTs (N=71) in patients with prediabetes or type 2 diabetes.^30, Patients received standard diabetic care and were randomized to EECP or placebo/passive control. Although improvements in hemoglobin A1c with EECP were noted at 7 to 12 weeks after therapy completion (mean difference, -0,98%; 95% CI, -1.22 to -0.74; p<.00001), there was high risk of detection and other biases. This, along with the small number of enrolled patients, short duration of follow-up, and unclear standard of care, limits the application of these findings.

Section Summary: Other Conditions Related to Ischemia or Vascular Dysfunction

An RCT assessed use of EECP for treatment of central retinal artery occlusion and failed to find clinical benefit.. Registry studies of erectile function have reported improvements for some outcomes with EECP but design shortcomings limit conclusions drawn. EECP has also been used to treat acute ischemic stroke, but the evidence base is not robust. EECP has been used in several small RCTs to treat type 2 diabetes. Reported follow-up was short-term, and trials had methodologic limitations.

For individuals who have other conditions related to ischemia or vascular dysfunction who receive EECP, the evidence includes RCTs, registry studies, and systematic reviews. Relevant outcomes are overall survival, symptoms, morbid events, and functional outcomes. Two RCTs have assessed use of EECP for treatment of central retinal artery occlusion; both trials had methodologic limitations. Registry studies of erectile function have reported improvements for some outcomes with ECCP but design shortcomings limit conclusions drawn. EECP has also been used to treat acute ischemic stroke, but the evidence base in is not robust. EECP has been used in a small RCT to treat type 2 diabetes. Reported follow-up was short term. The evidence is insufficient to determine the effects of the technology on health outcomes.

SUPPLEMENTAL INFORMATION

The purpose of the following information is to provide reference material. Inclusion does not imply endorsement or alignment with the evidence review conclusions.

Clinical Input From Physician Specialty Societies and Academic Medical Centers

While the various physician specialty societies and academic medical centers may collaborate with and make recommendations during this process, through the provision of appropriate reviewers, input received does not represent an endorsement or position statement by the physician specialty societies or academic medical centers, unless otherwise noted.

In response to requests, input was received from 3 academic medical centers while this policy was under review in 2008 and 2010. Reviewers agreed with the conclusion that enhanced external counterpulsation was investigational. Some reviewers commented on the potential use of enhanced external counterpulsation in those with angina not amenable to surgical interventions.

U.S. Preventive Services Task Force Recommendations

Not applicable.

Ongoing and Unpublished Clinical Trials

A search of ClinicalTrials.gov in April 2022 did not identify any ongoing or unpublished trials that would likely influence this review.

Practice Guidelines and Position Statements

Guidelines or position statements will be considered for inclusion in ‘Supplemental Information’ if they were issued by, or jointly by, a US professional society, an international society with US representation, or National Institute for Health and Care Excellence (NICE). Priority will be given to guidelines that are informed by a systematic review, include strength of evidence ratings, and include a description of management of conflict of interest.

Joint Guidelines from the American College of Cardiology Foundation, American Heart Association et al

In 2012, the American College of Cardiology Foundation, American Heart Association, and 5 other medical societies published joint guidelines that recommended: "[patients with stable ischemic heart disease who indicate for enhanced external counterpulsation (EECP)] may be considered for relief of refractory angina." This recommendation was class IIb, based on level B evidence (ie, the efficacy of the intervention is not well established, and further studies would be helpful).^31,

In 2014, the American College of Cardiology Foundation and American Heart Association updated these joint guidelines. ^32, Based on this review, the groups did not change their recommendation on EECP from the 2012 guidelines.

The 2022 American College of Cardiology Foundation, American Heart Association, and Heart Failure Society of America guidelines on the management of heart failure do not address EECP. ^33,.

Medicare National Coverage

Medicare has published a national coverage decision on EECP that mandates coverage for the following indications^34,:

"Coverage is provided for the use of ECP [external counterpulsation] 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 percutaneous transluminal coronary angioplasty or cardiac bypass because: 1) Their condition is inoperable, or at high risk of operative complications or post-operative failure; 2) Their coronary anatomy is not readily amendable to such procedures; or 3) They have co-morbid states which create excessive risk."

Medicare's coverage decision also noted that while the U.S. Food and Drug Administration has cleared EECP "for use in treating a variety of cardiac conditions, including stable or unstable angina pectoris, acute myocardial infarction and cardiogenic shock, the use of this device to treat cardiac conditions other than stable angina pectoris is not covered…."

Ongoing and Unpublished Clinical Trials

Some currently unpublished trials that might influence this review are listed in Table 2.

Table 2. Summary of Key Trials

References

1. Arora RR, Chou TM, Jain D, et al. The multicenter study of enhanced external counterpulsation (MUST-EECP): effect of EECP on exercise-induced myocardial ischemia and anginal episodes. J Am Coll Cardiol. Jun 1999; 33(7): 1833-40. PMID 10362181
2. Arora RR, Chou TM, Jain D, et al. Effects of enhanced external counterpulsation on Health-Related Quality of Life continue 12 months after treatment: a substudy of the Multicenter Study of Enhanced External Counterpulsation. J Investig Med. Jan 2002; 50(1): 25-32. PMID 11813825
3. Bondesson SM, Edvinsson ML, Pettersson T, et al. Reduced peripheral vascular reactivity in refractory angina pectoris: Effect of enhanced external counterpulsation. J Geriatr Cardiol. Dec 2011; 8(4): 215-23. PMID 22783308
4. Gloekler S, Meier P, de Marchi SF, et al. Coronary collateral growth by external counterpulsation: a randomised controlled trial. Heart. Feb 2010; 96(3): 202-7. PMID 19897461
5. Buschmann EE, Utz W, Pagonas N, et al. Improvement of fractional flow reserve and collateral flow by treatment with external counterpulsation (Art.Net.-2 Trial). Eur J Clin Invest. Oct 2009; 39(10): 866-75. PMID 19572918
6. Braith RW, Conti CR, Nichols WW, et al. Enhanced external counterpulsation improves peripheral artery flow-mediated dilation in patients with chronic angina: a randomized sham-controlled study. Circulation. Oct 19 2010; 122(16): 1612-20. PMID 20921442
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29. Sardina PD, Martin JS, Dzieza WK, et al. Enhanced external counterpulsation (EECP) decreases advanced glycation end products and proinflammatory cytokines in patients with non-insulin-dependent type II diabetes mellitus for up to 6 months following treatment. Acta Diabetol. Oct 2016; 53(5): 753-60. PMID 27278477
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34. Center for Medicare & Medicaid Services (CMS). National Coverage Determination for external counterpulsation (ECP) therapy for severe angina (20.20). 2006; https://www.cms.gov/medicare-coverage-database/view/ncd.aspx?ncdid=97&ncdver=2 Accessed March 12, 2024.

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