title: Acute mortality in hospitalized patients undergoing echocardiography with and without an ultrasound contrast agent: results in 18,671 consecutive studies.
abstract: OBJECTIVE
  We sought to define acute mortality in hospitalized patients undergoing clinically indicated echocardiography with and without use of an ultrasound contrast agent.
  
  
  BACKGROUND
  The U.S. Food and Drug Administration recently issued a boxed warning and new contraindications for the perflutren-containing ultrasound contrast agents following post-marketing reports of 4 patient deaths that were temporally related to Definity (Bristol-Myers Squibb Medical Imaging, Billerica, Massachusetts) administration. To appreciate the incremental risk of any medical procedure, the ambient risk of untoward outcome in the population in question must first be defined. There are no published data on short-term major adverse cardiac events in hospitalized patients undergoing echocardiography, either with or without administration of an ultrasound contrast agent.
  
  
  METHODS
  A retrospective analysis of hospitalized patients undergoing clinically indicated echocardiography between January 2005 and October 2007, within Saint Luke's Health System, Kansas City, Missouri, was performed. Studies were separated into 2 groups, those performed without contrast enhancement (n = 12,475) and those performed with Definity (n = 6,196). Vital status within 24 h of the echocardiographic study was available for all patients using a combination of the Social Security Death Master File and Saint Luke's Health System medical records. Incidence of death within 24 h was compared by chi-square test between Definity and unenhanced procedures.
  
  
  RESULTS
  Of the 18,671 patient events, 72 patients died within 24 h. Of those that underwent unenhanced echocardiography, 46 died within 24 h (0.37%). Of patients receiving Definity during the echocardiogram, 26 died within 24 h (0.42%). There was no statistical difference between these 2 groups (p = 0.60). No patient died within 1 h of the echocardiographic study. In a random sampling from the unenhanced (n = 201) and Definity groups (n = 202), patients who underwent Definity-enhanced echocardiography exhibited higher clinical acuity, and more significant comorbidities.
  
  
  CONCLUSIONS
  Approximately 0.4% of hospitalized patients die within 24 h of echocardiography. There is no increased mortality risk associated with Definity-enhanced examinations, despite evidence for higher clinical acuity and more comorbid conditions in patients undergoing contrast studies.
authors.affiliation: Saint Luke's Mid America Heart Institute, Kansas City, Missouri 64111, USA.
authors.forename: Lisa L
authors.initials: LL
authors.lastname: Kusnetzky
authors.forename: Adnan
authors.initials: A
authors.lastname: Khalid
authors.forename: Taiyeb M
authors.initials: TM
authors.lastname: Khumri
authors.forename: Tabitha G
authors.initials: TG
authors.lastname: Moe
authors.forename: Philip G
authors.initials: PG
authors.lastname: Jones
authors.forename: Michael L
authors.initials: ML
authors.lastname: Main
mesh_terms: D054058:Acute Coronary Syndrome / Q000150:complications / Q000000981:diagnostic imaging* / Q000401:mortality* / Q000503:physiopathology; D000368:Aged; D003287:Contrast Media / Q000009:adverse effects*; D004452:Echocardiography / Q000009:adverse effects*; D005260:Female; D005466:Fluorocarbons / Q000009:adverse effects*; D006333:Heart Failure / Q000139:chemically induced; D017052:Hospital Mortality / Q000639:trends; D006801:Humans; D015994:Incidence; D007297:Inpatients / Q000706:statistics & numerical data*; D008297:Male; D008875:Middle Aged; D012189:Retrospective Studies; D012307:Risk Factors; D013318:Stroke Volume; D018487:Ventricular Dysfunction, Left
chemical_list: D003287:Contrast Media; D005466:Fluorocarbons; C042852:perflutren