Authors' objectives:

The aims of this study were: - To assess the effectiveness, and cost effectiveness of enhanced external counterpulsation (EECP) in patients with severe anginal symptoms, secondary to chronic coronary disease, who are unresponsive to exhaustive pharmacotherapy and not candidates for surgical/percutaneous revascularization procedures (e.g., angioplasty, coronary bypass surgery).

- To assess the effectiveness, and cost effectiveness of EECP in patients with heart failure.

Authors' results and conclusions: No controlled study has limited assessment of EECP therapy strictly to patients with severe refractory angina. One randomized controlled trial (RCT) evaluated EECP treatment for patients with angina : - There was significant improvement in an electrophysiologic endpoint for EECP treated patients compared to controls. - No significant difference was noted between the treatment and control group for exercise duration, angina count and nitroglycerin usage. - Significantly more patients in the treatment group reported adverse events than in the control group. - Patients with the most severe angina were excluded from the trial. Only patients with mild to moderate angina were enrolled in the study. - It was not reported whether all the angina patients included in the trial had chronic ischemic symptoms that were unresponsive to exhaustive conventional medical therapy and revascularization techniques, or were not amenable to a revascularization procedure. - The study had methodological limitations including: unclear detail of patient dropouts; subanalyses that the trial was not designed to conduct; large exclusion criteria decreasing generalizability of results; and patient self-reporting of angina counts and drug usage. An extension of the RCT examined quality of life (QoL) between the treatment and control groups with angina up to one year after treatment : - The study revealed significant improvement in some of the selected QoL parameters for EECP treated patients compared to controls. - The study had methodological issues including: lack of baseline data for QoL scores between treatment and control groups; the recording of any changes or events in the patients' statuses was inconsistent and unable to be analyzed; the sample size was determined by power requirements for a previous trial; and there was a low patient response available for analysis. Similar to the methodological limitation in the original study, there is decreased generalizability of the results due to a large initial exclusion criteria. - Angina episodes were not recorded at the one-year follow-up. To date there is scanty, insufficient evidence published on the effectiveness and safety of EECP treatment for heart failure (HF). No RCT has examined EECP in HF patients. It is unclear which HF patients, if any, should receive EECP. It is unknown whether HF patients should receive EECP treatments as refractory stable angina patients, and if they do, the optimal number of treatments is not determined. There were major methodological weaknesses in studies assessing EECP treatment in HF patients.

Authors' recommendations: There is insufficient evidence to support the effectiveness of EECP treatment for patients with severe refractory stable angina. There is insufficient evidence to support the effectiveness and safety of EECP treatment for patients with HF.

Authors' methods: Systematic review

Project Status: Completed

URL for project: http://www.health.gov.on.ca/english/providers/program/mas/tech/techlist_ mn.html

Year Published: 2003

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: Canada

Organisation Name: Medical Advisory Secretariat

Contact Address: Medical Advisory Secretariat, 20 Dundas Street West, 10th Floor, Toronto, ON M5G 2N6 CANADA. Tel: 416-314-1092l; Fax: 416-325-2364;

Contact Name: MASinfo.moh@ontario.ca

Contact Email: MASinfo.moh@ontario.ca

Copyright: Medical Advisory Secretariat, Ontario Ministry of Health and Long-Term Care