title: The effect of Definity on systemic and pulmonary hemodynamics in patients.
abstract: BACKGROUND
  The purpose of this study was to evaluate the pulmonary and systemic hemodynamic effects of Definity in patients with normal as well as those with elevated pulmonary artery pressure at baseline. Secondary objectives of the study were to evaluate safety and determine whether any potential immunologic reactions develop after Definity administration.
  
  
  METHODS
  Patients with normal and elevated pulmonary artery systolic pressure undergoing right-heart catheterization received Definity (10 μL/kg) as a slow bolus over 30 to 60 sec. Multiple sequential measurements of right atrial pressure, pulmonary artery systolic pressure, pulmonary artery diastolic pressure, mean pulmonary artery pressure, cardiac output, and pulmonary capillary wedge pressure were made before and after Definity administration. Vital signs, electrocardiograms, and blood samples were taken at multiple time points. Patients were followed for the development of adverse events.
  
  
  RESULTS
  A total of 32 patients (16 with elevated pulmonary artery systolic pressure > 35 mm Hg) were enrolled. No significant changes in any pulmonary or systemic hemodynamic parameters, vital sign values, electrocardiographic data, or laboratory variables were found for data obtained before versus after receipt of Definity.
  
  
  CONCLUSIONS
  The administration of Definity at the approved dosage does not change pulmonary or systemic hemodynamics in control patients or those with mild to moderate pulmonary hypertension. No significant changes were noted in a wide array of clinical and laboratory safety assessments after patients were exposed to Definity.
authors.affiliation: Oregon Health & Science University, Portland, Oregon 97239, USA. weik@ohsu.edu
authors.forename: Kevin
authors.initials: K
authors.lastname: Wei
authors.forename: Michael L
authors.initials: ML
authors.lastname: Main
authors.forename: Roberto M
authors.initials: RM
authors.lastname: Lang
authors.forename: Allan
authors.initials: A
authors.lastname: Klein
authors.forename: Stephen
authors.initials: S
authors.lastname: Angeli
authors.forename: Carmelo
authors.initials: C
authors.lastname: Panetta
authors.forename: Issam
authors.initials: I
authors.lastname: Mikati
authors.forename: L Veronica
authors.initials: LV
authors.lastname: Lee
authors.forename: Jonathan A
authors.initials: JA
authors.lastname: Bernstein
authors.forename: Masood
authors.initials: M
authors.lastname: Ahmad
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D006328:Cardiac Catheterization / Q000379:methods; D003287:Contrast Media / Q000009:adverse effects; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D004342:Drug Hypersensitivity / Q000175:diagnosis* / Q000453:epidemiology; D004452:Echocardiography / Q000379:methods*; D005260:Female; D005466:Fluorocarbons / Q000009:adverse effects / Q000494:pharmacology*; D005500:Follow-Up Studies; D006439:Hemodynamics / Q000187:drug effects*; D006801:Humans; D006976:Hypertension, Pulmonary / Q000175:diagnosis / Q000000981:diagnostic imaging*; D007089:Image Enhancement / Q000379:methods; D008297:Male; D008875:Middle Aged; D008991:Monitoring, Physiologic / Q000379:methods; D011446:Prospective Studies; D011669:Pulmonary Wedge Pressure / Q000187:drug effects; D018570:Risk Assessment; D017751:Safety Management; D013997:Time Factors
chemical_list: D003287:Contrast Media; D005466:Fluorocarbons; C042852:perflutren