Enhanced External Counterpulsation on Medically Refractory Angina Patients

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Enhanced External Counterpulsation on Medically Refractory Angina Patients

Summary and Introduction

Summary


Patients with refractory angina often suffer from erectile dysfunction. Enhanced external counterpulsation (EECP) decreases symptoms of angina, and increases nitric oxide release. This study evaluated the effect of EECP on sexual function in men with severe angina. The International Index of Erectile Function (IIEF) was used to assess erectile function of severe angina patients enroled in the International EECP Patient Registry. Their symptom status, medication use, adverse clinical events and quality of life were also recorded before and after completing a course of EECP. A cohort of 120 men (mean age 65.0 ± 9.7) was enroled. The men had severe coronary disease with 69% having a prior myocardial infarction, 90% prior coronary artery bypass graft or percutaneous coronary intervention, 49% with three vessel coronary artery disease, 86% were not candidates for further revascularisation, 71% hypertensive, 83% dyslipidaemia, 42% diabetes mellitus, 75% smoking and 68% using nitrates. Functional status was low with a mean Duke Activity Status Inventory score of 16.6 ± 14.8. After 35 h of EECP anginal status improved in 89%, and functional status in 63%. A comparison of the IIEF scores pre- and post-EECP therapy demonstrated a significant improvement in erectile function from 10.0 ± 1.0 to 11.8 ± 1.0 (p = 0.003), intercourse satisfaction (4.2 ± 0.5 to 5.0 ± 0.5, p = 0.009) and overall satisfaction (4.7 ± 0.3 to 5.3 ± 0.3, p = 0.001). However, there were no significant changes in orgasmic function (4.2 ± 0.4 to 4.6 ± 0.4, p = 0.19) or sexual desire (5.3 ± 0.2 to 5.5 ± 0.2). The findings suggest that EECP therapy is associated with improvement in erectile function in men with refractory angina.

Introduction


Enhanced external counterpulsation (EECP) is a non-invasive treatment used for patients with angina refractory to medical therapy who are poor revascularisation candidates. The system consists of three sets of cuffs wrapped around the calves, lower and upper thighs of the patient. The pneumatic cuffs are sequentially inflated at the onset of diastole; providing diastolic augmentation, increasing venous return, cardiac output and coronary blood flow. Cuff deflation occurs at the end of diastole, providing left ventricular unloading and further increasing cardiac output. EECP is commercially available in the United States, Europe and Asia. The Food and Drug Administration has cleared EECP devices for use in unstable and stable angina pectoris, acute myocardial infarction (MI), congestive heart failure and cardiogenic shock. It was approved for coverage by the Centers for Medicare and Medicaid Services for patients who have been diagnosed with disabling angina with Canadian Cardiovascular Society (CCS) classification class III or class IV.

Enhanced external counterpulsation has acute haemodynamic effects on the systemic circulation that include a reported 88% increase in infrarenal abdominal aortic blood flow and a 144% increase in internal iliac flow. EECP therapy is also associated with progressive increase in nitric oxide levels that persist beyond the immediate course of therapy and are associated with decreased systemic resistance and normalisation of endothelial function as assessed by reactive hyperaemia-peripheral artery tonometry. By increasing nitric oxide production, EECP potentially augments penile arterial vasodilation and may enhance erections. Potential cardiac mechanisms contributing to the benefits of EECP therapy include relief of exertional angina, improvement of cardiac output and reserve, decrease in myocardial ischaemic burden. The improvement in physical health demonstrated with EECP, such as a decrease in angina class and improved exercise tolerance, has also been shown to benefit psychosocial functioning with a third of patients reporting improved sexual activity in an earlier small study.

A small study of 13 patients with a primary diagnosis of erectile dysfunction (ED) treated with EECP demonstrated dramatic improvement in the signs and symptoms of ED with therapy. After completing the 20-h course of treatment with EECP there was an 88% increase in penile artery peak systolic flow, and an improvement in erectile function (1.5-2.3 on a scale of 0-3). Post-EECP 84% of the patients demonstrated improvement in ED, with 40% having complete resolution.

However, whether the cardiac patients with refractory angina will realise similar benefits is uncertain, particularly given the high diabetic comorbidity and chronic need for medications such as beta blockers, antihypertensives and diuretics impacting on ED. To investigate the effect of EECP on sexual function in men with severe medically refractory angina a substudy, code named Mens Health, was performed using patients enroled in the International Enhanced External Counterpulsation Patient Registry 2 (IEPR 2).

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