Safety of a new transpulmonary echocontrast agent (Albunex) in repeated echocardiographic studies in patients.
OBJECTIVE
Multiple contrast-enhanced echocardiographic studies are to be expected in patients with cardiac ischemic disease, but the sonication process used to produce the echocontrast agent Albunex may result in new epitopes that could cause an immunogenic response.


METHODS
Repeated exposures to intravenous Albunex over a period of time long enough to allow development of an eventual immune reaction were performed in 12 patients while monitoring for lymphocyte transformation, microsphere specific IgE and IgG antibodies, and systemic, pulmonary artery, capillary wedge, and right atrial pressures, as well as cardiac output, left ventricular fractional shortening, and blood gases.


RESULTS
No significant 3H-thymidine incorporation and thus no specific blastic transformation of the patients' lymphocytes were observed either for high or low Albunex concentrations, corresponding to the expected hepatic and plasma concentrations of microspheres. No formation of microsphere-specific IgE and IgG antibodies was observed after the first or second Albunex exposure. Furthermore, no clinically significant hemodynamic or respiratory adverse reactions were observed in any patient.


CONCLUSIONS
These results suggest that repeated exposures to intravenous Albunex induce no adverse effect on the cellular and humoral immune systems and on left and right heart hemodynamics in patients.
Geny
B
B
Laboratoire d'Explorations Fonctionnelles du Système Circulatoire, Faculté de Médecine, Université Louis Pasteur, Strasbourg, France.
Bischoff
P
P
Muan
B
B
Piquard
F
F
Thiranos
J C
JC
Epailly
E
E
Lambrechs
M
M
Juelsrud-Vebner
A
A
Eisenmann
B
B
Haberey
P
P
D000418:Albumins / Q000009:adverse effects / Q000276:immunology; D006328:Cardiac Catheterization; D003287:Contrast Media; D004452:Echocardiography / Q000379:methods*; D004562:Electrocardiography; D005260:Female; D006439:Hemodynamics / Q000187:drug effects; D006801:Humans; D007073:Immunoglobulin E / Q000032:analysis; D007074:Immunoglobulin G / Q000032:analysis; D007262:Infusions, Intravenous; D008213:Lymphocyte Activation / Q000276:immunology; D008214:Lymphocytes / Q000276:immunology; D008297:Male; D008863:Microspheres; D008875:Middle Aged; D017202:Myocardial Ischemia / Q000000981:diagnostic imaging* / Q000276:immunology; D011652:Pulmonary Circulation / Q000187:drug effects; D012449:Safety
D000418:Albumins; C060687:Albunex; D003287:Contrast Media; D007074:Immunoglobulin G; D007073:Immunoglobulin E