OPACIFICATION AND BORDER DELINEATION IMPROVEMENT IN PATIENTS WITH SUBOPTIMAL ENDOCARDIAL BORDER DEFINITION IN ROUTINE ECHOCARDIOGRAPHY - RESULTS OF THE PHASE-III ALBUNEX MULTICENTER TRIAL

Objectives. This study was designed to assess the safety and efficacy of intravenously administered sonicated human serum albumin for enhanc ing echocardiographic delineation of the left ventricular endocardium and improving assessment of wall motion in patients with incomplete de piction of noncontrast echocardiography. Background. Echocardiographic regional wall motion analysis is impaired by incomplete endocardial d efinition in as many as 10% of patients. Sonicated human serum albumin is a stable contrast material that, unlike other agents, opacifies th e left ventricle when administered intravenously. Methods. One hundred seventy-five patients were enrolled at eight centers on the basis of incomplete echocardiographic endocardial depiction. Sonicated 5% human serum albumin, a stable preparation of air filled microspheres (size range 1 to 10 mu m), was administered intravenously in divided doses: 0.08 ml/kg body weight in all patients, followed by 0.14 and 0.08 ml/k g or a single dose of 0.22 ml/kg, depending on the result of the initi al dose. Investigators and independent reviewers blinded to the protoc ol scored the echocardiograms for degree of left ventricular opacifica tion and improvement of endocardial border depiction. Results. Overall , 81% of patients had at least moderate left ventricular chamber opaci fication with at least one contrast dose, and endocardial definition w as improved in 83%; In the subgroup with inadequate left ventricular o pacification from the initial dose, a second, larger dose (0.22 ml/kg) improved endocardial depiction in 64%. No significant side effects oc curred. Conclusions. In patients with incomplete echocardiographic end ocardial definition, sonicated human serum albumin is a safe, effectiv e contrast agent that, when administered intravenously, produces left ventricular chamber opacification, improves endocardial depiction and enhances regional wall motion analysis.