The Effect of Definity on Systemic and Pulmonary Hemodynamics in Patients

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...

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Veröffentlicht in:Journal of the American Society of Echocardiography 2012-05, Vol.25 (5), p.584-588
Hauptverfasser: Wei, Kevin, MD, Main, Michael L., MD, Lang, Roberto M., MD, Klein, Allan, MD, Angeli, Stephen, MD, Panetta, Carmelo, MD, Mikati, Issam, MD, Lee, L. Veronica, MD, Bernstein, Jonathan A., MD, Ahmad, Masood, MD
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container_end_page 588
container_issue 5
container_start_page 584
container_title Journal of the American Society of Echocardiography
container_volume 25
creator Wei, Kevin, MD
Main, Michael L., MD
Lang, Roberto M., MD
Klein, Allan, MD
Angeli, Stephen, MD
Panetta, Carmelo, MD
Mikati, Issam, MD
Lee, L. Veronica, MD
Bernstein, Jonathan A., MD
Ahmad, Masood, MD
description 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.
doi_str_mv 10.1016/j.echo.2012.01.019
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Veronica, MD ; Bernstein, Jonathan A., MD ; Ahmad, Masood, MD</creator><creatorcontrib>Wei, Kevin, MD ; Main, Michael L., MD ; Lang, Roberto M., MD ; Klein, Allan, MD ; Angeli, Stephen, MD ; Panetta, Carmelo, MD ; Mikati, Issam, MD ; Lee, L. Veronica, MD ; Bernstein, Jonathan A., MD ; Ahmad, Masood, MD</creatorcontrib><description>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 &gt; 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.</description><identifier>ISSN: 0894-7317</identifier><identifier>EISSN: 1097-6795</identifier><identifier>DOI: 10.1016/j.echo.2012.01.019</identifier><identifier>PMID: 22365709</identifier><language>eng</language><publisher>United States: Mosby, Inc</publisher><subject>Adult ; Aged ; Aged, 80 and over ; Cardiac Catheterization - methods ; Cardiovascular ; Contrast echocardiography ; Contrast Media - adverse effects ; Dose-Response Relationship, Drug ; Drug Administration Schedule ; Drug Hypersensitivity - diagnosis ; Drug Hypersensitivity - epidemiology ; Echocardiography - methods ; Female ; Fluorocarbons - adverse effects ; Fluorocarbons - pharmacology ; Follow-Up Studies ; Hemodynamics ; Hemodynamics - drug effects ; Humans ; Hypertension, Pulmonary - diagnosis ; Hypertension, Pulmonary - diagnostic imaging ; Image Enhancement - methods ; Male ; Middle Aged ; Monitoring, Physiologic - methods ; Prospective Studies ; Pulmonary artery pressure ; Pulmonary Wedge Pressure - drug effects ; Risk Assessment ; Safety ; Safety Management ; Time Factors</subject><ispartof>Journal of the American Society of Echocardiography, 2012-05, Vol.25 (5), p.584-588</ispartof><rights>American Society of Echocardiography</rights><rights>2012 American Society of Echocardiography</rights><rights>Copyright © 2012 American Society of Echocardiography. 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Veronica, MD</creatorcontrib><creatorcontrib>Bernstein, Jonathan A., MD</creatorcontrib><creatorcontrib>Ahmad, Masood, MD</creatorcontrib><title>The Effect of Definity on Systemic and Pulmonary Hemodynamics in Patients</title><title>Journal of the American Society of Echocardiography</title><addtitle>J Am Soc Echocardiogr</addtitle><description>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 &gt; 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. 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Veronica, MD</creatorcontrib><creatorcontrib>Bernstein, Jonathan A., MD</creatorcontrib><creatorcontrib>Ahmad, Masood, MD</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Journal of the American Society of Echocardiography</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Wei, Kevin, MD</au><au>Main, Michael L., MD</au><au>Lang, Roberto M., MD</au><au>Klein, Allan, MD</au><au>Angeli, Stephen, MD</au><au>Panetta, Carmelo, MD</au><au>Mikati, Issam, MD</au><au>Lee, L. Veronica, MD</au><au>Bernstein, Jonathan A., MD</au><au>Ahmad, Masood, MD</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>The Effect of Definity on Systemic and Pulmonary Hemodynamics in Patients</atitle><jtitle>Journal of the American Society of Echocardiography</jtitle><addtitle>J Am Soc Echocardiogr</addtitle><date>2012-05-01</date><risdate>2012</risdate><volume>25</volume><issue>5</issue><spage>584</spage><epage>588</epage><pages>584-588</pages><issn>0894-7317</issn><eissn>1097-6795</eissn><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 &gt; 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.</abstract><cop>United States</cop><pub>Mosby, Inc</pub><pmid>22365709</pmid><doi>10.1016/j.echo.2012.01.019</doi><tpages>5</tpages></addata></record>
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subjects Adult
Aged
Aged, 80 and over
Cardiac Catheterization - methods
Cardiovascular
Contrast echocardiography
Contrast Media - adverse effects
Dose-Response Relationship, Drug
Drug Administration Schedule
Drug Hypersensitivity - diagnosis
Drug Hypersensitivity - epidemiology
Echocardiography - methods
Female
Fluorocarbons - adverse effects
Fluorocarbons - pharmacology
Follow-Up Studies
Hemodynamics
Hemodynamics - drug effects
Humans
Hypertension, Pulmonary - diagnosis
Hypertension, Pulmonary - diagnostic imaging
Image Enhancement - methods
Male
Middle Aged
Monitoring, Physiologic - methods
Prospective Studies
Pulmonary artery pressure
Pulmonary Wedge Pressure - drug effects
Risk Assessment
Safety
Safety Management
Time Factors
title The Effect of Definity on Systemic and Pulmonary Hemodynamics in Patients
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