Enhanced External Counterpulsation in Patients With Heart Failure: A Multicenter Feasibility Study

Ozlem Soran, MD, Bruce Fleishman, MD, Theresa Demarco, MD, William Grossman, MD, Virginia M. Schneider, RN, Karen Manzo, RN, Paul-André de Lame, MD, Arthur M. Feldman, MD, PhD

Disclosures

CHF. 2002;8(4) 

In This Article

Adverse Events

The population available for safety analysis consisted of the 32 patients enrolled in the study, 26 of whom received one or more EECP treatment sessions. Overall, there were 844 treatment sessions performed during which the safety of EECP was assessed by monitoring oxygen saturation and cardiac condition. Except for three instances in the same subject of a worsening of preexisting arrhythmia, there were no cases of worsening of heart condition, particularly heart failure, as a result of the application of EECP in this patient population. As described in Table II , there were 46 adverse events reported in 23 patients; 22 occurred during the treatment period (i.e., between the first treatment session and the first follow-up 1 week after the end of treatment), and 24 during 6-month follow-up. Of these 46 adverse events, 14 were classified as serious (led to hospitalization) and involved eight patients. One occurred during the baseline period; three occurred during the treatment period and, although serious, none were related to the EECP device. Ten cardiovascular adverse events occurred during the 6-month follow-up period.

Of the 22 adverse events that occurred during the treatment period, 10 occurred during the actual application of EECP (treatment session), and 12 outside a treatment session. Two of the 10 adverse events that occurred during a session resulted in treatment discontinuation. One subject was discontinued from the study after 22 treatment sessions for worsening back pain; the other was hospitalized twice for worsening of heart failure and discontinued from the study after the second episode. A third subject had increased frequency of arrhythmia requiring treatment discontinuation after 23 sessions; this subject remained in the study and had follow-up evaluations.

None of the adverse events reported during the 6-month post-treatment follow-up period were related to direct or indirect effects of EECP therapy. No significant changes in clinical laboratory values were identified.

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