Abstract T P51: Tolerability and Safety of External Counterpulsation (ECP) in Acute Ischemic Stroke: Final Results of the Counterpulsation to Upgrade Forward Flow in Stroke (CUFFS) Trial

Anne W Alexandrov,Andrei V Alexandrov,David S Liebeskind,Thomas M Hemmen,Reza B Shahripour,Karen Rapp,Rema Raman,Brett C Meyer,Sidney Starkman,Kristian Barlinn,Ileana D Grunberg,Karin Ernstrom,Kama Z Guluma,April Sisson

doi:10.1161/str.45.suppl_1.tp51

Abstract

Background/Purpose: External counterpulsation (ECP) has been cited as a method that may improve brain perfusion and functional outcome in ischemic stroke. We sought to understand the tolerability and safety of ECP within 48 hours of ischemic stroke. Methods: A randomized, patient-blinded design was used in MCA strokes ineligible for reperfusion arriving within 46 hours of stroke onset at 3 CSCs. A 1-hour ECP session (ViaCare, Scottcare Inc.) was provided with 200-300 mm Hg pressures in treatment group patients, and the lowest device pressure with air-leak cuffs in shams. TCD and NIHSS measures were collected before, during and after ECP; patients were followed for 30-days post-treatment. Results: 23 patients were randomized (13 treatment; 10 sham); age (mean 58+12), race (78% White; 74% non-Hispanic) and gender (65% male) were similar between groups, baseline NIHSS was 6 in treatment cases and 6.5 in sham patients (p=ns), and all other baseline measures were similar between groups. There was no difference in time to ECP between groups. During ECP, an unexpected increase in sham group PSV, EDV, MFV, and proportional velocity change (PVC) was observed, with very little augmentation of MFV or PVC observed in the treatment group (Table). Tolerability was 100% in shams vs. 92% in the treatment group, with 54% sustained tolerance during high pressure. A >2 point NIHSS decrease during ECP occurred in 70% of shams vs. 38% of treatment group patients, and persisted at 30 days; mRS and Barthel indices at 30-days were similar between groups (Figure). One adverse event (AE) occurred in each group, and 1 treatment group patient had 3 serious AEs. No sICH, new ischemic strokes, or deaths occurred. Conclusions: ECP is safe in acute ischemic stroke, although 60-minute sustained tolerance of higher pressures remains questionable. The ViaCare device did not augment MFV compared to our experience with other ECPs. Sham arms should be cautiously undertaken in the future designs of ECP studies.

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