Production Management Application by Aparna Asha. v Saritha Jinto Antony Kurian.
Safety and Efficacy of Commercially Available Ultrasound Contrast Agents in the Clinical Setting...
-
Upload
tyler-ryan -
Category
Documents
-
view
215 -
download
1
Transcript of Safety and Efficacy of Commercially Available Ultrasound Contrast Agents in the Clinical Setting...
![Page 1: Safety and Efficacy of Commercially Available Ultrasound Contrast Agents in the Clinical Setting Melda S. Dolan, MD; Simil Gala, MD; Saritha Dodla, MD;](https://reader033.fdocuments.net/reader033/viewer/2022051819/5514677c550346b0158b4bd4/html5/thumbnails/1.jpg)
Safety and Efficacy of Commercially Available
Ultrasound Contrast Agents in the Clinical Setting
Safety and Efficacy of Commercially Available
Ultrasound Contrast Agents in the Clinical Setting
Melda S. Dolan, MD; Simil Gala, MD; Saritha Dodla, MD; Feng Xie, MD; David Cloutier, MD;
Thomas Porter, MD; Arthur J. Labovitz, MD.
Melda S. Dolan, MD; Simil Gala, MD; Saritha Dodla, MD; Feng Xie, MD; David Cloutier, MD;
Thomas Porter, MD; Arthur J. Labovitz, MD.
![Page 2: Safety and Efficacy of Commercially Available Ultrasound Contrast Agents in the Clinical Setting Melda S. Dolan, MD; Simil Gala, MD; Saritha Dodla, MD;](https://reader033.fdocuments.net/reader033/viewer/2022051819/5514677c550346b0158b4bd4/html5/thumbnails/2.jpg)
ACC DisclosureACC Disclosure
Melda S. Dolan, MD Nothing to disclose
Simil Gala, MD Nothing to disclose
Saritha Dodla, MD Nothing to disclose
Feng Xie, MD Grant
David Cloutier, MD Nothing to disclose
Thomas Porter, MD Grant, Consultant
Arthur J. Labovitz,MD Nothing to disclose
Melda S. Dolan, MD Nothing to disclose
Simil Gala, MD Nothing to disclose
Saritha Dodla, MD Nothing to disclose
Feng Xie, MD Grant
David Cloutier, MD Nothing to disclose
Thomas Porter, MD Grant, Consultant
Arthur J. Labovitz,MD Nothing to disclose
![Page 3: Safety and Efficacy of Commercially Available Ultrasound Contrast Agents in the Clinical Setting Melda S. Dolan, MD; Simil Gala, MD; Saritha Dodla, MD;](https://reader033.fdocuments.net/reader033/viewer/2022051819/5514677c550346b0158b4bd4/html5/thumbnails/3.jpg)
Up To 20-30% of EchoesTechnically Difficult
BackgroundBackground
LargeBody
Habitus
ChestWall
Deformities
SevereChronic
LungDisease
![Page 4: Safety and Efficacy of Commercially Available Ultrasound Contrast Agents in the Clinical Setting Melda S. Dolan, MD; Simil Gala, MD; Saritha Dodla, MD;](https://reader033.fdocuments.net/reader033/viewer/2022051819/5514677c550346b0158b4bd4/html5/thumbnails/4.jpg)
Non Contrast ContrastNon Contrast Contrast
QuickTime™ and aYUV420 codec decompressor
are needed to see this picture.
QuickTime™ and aYUV420 codec decompressor
are needed to see this picture.
![Page 5: Safety and Efficacy of Commercially Available Ultrasound Contrast Agents in the Clinical Setting Melda S. Dolan, MD; Simil Gala, MD; Saritha Dodla, MD;](https://reader033.fdocuments.net/reader033/viewer/2022051819/5514677c550346b0158b4bd4/html5/thumbnails/5.jpg)
BackgroundBackground
Before 1997
Phase III Studies1700 Patients
No Safety Concerns
UCAFDA Approval
1997 2007
Black Box Warning
OnOptison & Definity
![Page 6: Safety and Efficacy of Commercially Available Ultrasound Contrast Agents in the Clinical Setting Melda S. Dolan, MD; Simil Gala, MD; Saritha Dodla, MD;](https://reader033.fdocuments.net/reader033/viewer/2022051819/5514677c550346b0158b4bd4/html5/thumbnails/6.jpg)
Over 2 million Doses Administered
11 Deaths Overall
4 Deaths Within 30 min.
![Page 7: Safety and Efficacy of Commercially Available Ultrasound Contrast Agents in the Clinical Setting Melda S. Dolan, MD; Simil Gala, MD; Saritha Dodla, MD;](https://reader033.fdocuments.net/reader033/viewer/2022051819/5514677c550346b0158b4bd4/html5/thumbnails/7.jpg)
Black box WarningNew Contraindications
Black box WarningNew Contraindications
RL, bi-directional, or transient RL cardiac shunts
Clinically unstable or recent worsening congestive heart failure
Acute Coronary Syndrome Serious ventricular arrhythmias or at high risk for
arrhythmias due to QT prolongation Respiratory failure Severe emphysema, pulmonary emboli or other
conditions that compromise pulmonary arterial vasculature
RL, bi-directional, or transient RL cardiac shunts
Clinically unstable or recent worsening congestive heart failure
Acute Coronary Syndrome Serious ventricular arrhythmias or at high risk for
arrhythmias due to QT prolongation Respiratory failure Severe emphysema, pulmonary emboli or other
conditions that compromise pulmonary arterial vasculature
![Page 8: Safety and Efficacy of Commercially Available Ultrasound Contrast Agents in the Clinical Setting Melda S. Dolan, MD; Simil Gala, MD; Saritha Dodla, MD;](https://reader033.fdocuments.net/reader033/viewer/2022051819/5514677c550346b0158b4bd4/html5/thumbnails/8.jpg)
Aim of StudyAim of Study Define overall incidence
of events after contrast administration in the short and longer term.
Outline risk versus benefits profile of contrast use during echocardiograpic exams transthoracic and stress.
Define overall incidence of events after contrast administration in the short and longer term.
Outline risk versus benefits profile of contrast use during echocardiograpic exams transthoracic and stress.
Risks
Benefits
![Page 9: Safety and Efficacy of Commercially Available Ultrasound Contrast Agents in the Clinical Setting Melda S. Dolan, MD; Simil Gala, MD; Saritha Dodla, MD;](https://reader033.fdocuments.net/reader033/viewer/2022051819/5514677c550346b0158b4bd4/html5/thumbnails/9.jpg)
Patient CharacteristicsPatient CharacteristicsRetrospectively
Analyzed
23659 Consecutive Patients with resting EchoFrom Saint Louis University and University of Nebraska
Short TermFollow-Up
24 Hrs.
Non-Fatal Myocardial Infarctions&
Death From All Causes
30 Min.
![Page 10: Safety and Efficacy of Commercially Available Ultrasound Contrast Agents in the Clinical Setting Melda S. Dolan, MD; Simil Gala, MD; Saritha Dodla, MD;](https://reader033.fdocuments.net/reader033/viewer/2022051819/5514677c550346b0158b4bd4/html5/thumbnails/10.jpg)
Patient Characteristics Patient Characteristics
N=23659
59%
54%
49%
38%
9%
66%
56%
0% 20% 40% 60% 80%
Age >50
Male
Diabetes ty 1
Diabetes type 2
Smoking
Hyperlipidemia
Hypertension
![Page 11: Safety and Efficacy of Commercially Available Ultrasound Contrast Agents in the Clinical Setting Melda S. Dolan, MD; Simil Gala, MD; Saritha Dodla, MD;](https://reader033.fdocuments.net/reader033/viewer/2022051819/5514677c550346b0158b4bd4/html5/thumbnails/11.jpg)
ResultsResultsRetrospectively
Analyzed
23659 Consecutive PatientsCONTRAST Resting Echo
From Saint Louis University and University of Nebraska
Short TermFollow-Up
30 Min. 24 Hrs.
No Events 3 Non-Fatal MI and 1 Death
![Page 12: Safety and Efficacy of Commercially Available Ultrasound Contrast Agents in the Clinical Setting Melda S. Dolan, MD; Simil Gala, MD; Saritha Dodla, MD;](https://reader033.fdocuments.net/reader033/viewer/2022051819/5514677c550346b0158b4bd4/html5/thumbnails/12.jpg)
Results: Contrast Echo Short Term Follow up
Results: Contrast Echo Short Term Follow up
23655
3
10
5000
10000
15000
20000
25000
Death
Events
MI
No Events
EventsMINo Events
N= 23659
![Page 13: Safety and Efficacy of Commercially Available Ultrasound Contrast Agents in the Clinical Setting Melda S. Dolan, MD; Simil Gala, MD; Saritha Dodla, MD;](https://reader033.fdocuments.net/reader033/viewer/2022051819/5514677c550346b0158b4bd4/html5/thumbnails/13.jpg)
ResultsResultsRetrospectively
Analyzed
5900 Consecutive PatientsNON CONTRAST Resting Echo
From Saint Louis University and University of Nebraska
Short TermFollow-Up
30 Min. 24 Hrs.
No Events 7 Non-Fatal MI and 1 Death
![Page 14: Safety and Efficacy of Commercially Available Ultrasound Contrast Agents in the Clinical Setting Melda S. Dolan, MD; Simil Gala, MD; Saritha Dodla, MD;](https://reader033.fdocuments.net/reader033/viewer/2022051819/5514677c550346b0158b4bd4/html5/thumbnails/14.jpg)
Baseline DemographicsBaseline DemographicsResting Echo
Quality
ContrastNonDiagnostic
N=23659
No ContrastDiagnostic
N=5900P
Male 66.4% 60.2 % NS
Hypertension 59% 54.3% NS
DM 38% 32% NS
Hyperlipidemia 54% 51% NS
Smoking 49% 41% NS
Previous MI 16% 12% NS
Previous CABG 9% 7% NS
Previous PTCA 18% 14% NS
![Page 15: Safety and Efficacy of Commercially Available Ultrasound Contrast Agents in the Clinical Setting Melda S. Dolan, MD; Simil Gala, MD; Saritha Dodla, MD;](https://reader033.fdocuments.net/reader033/viewer/2022051819/5514677c550346b0158b4bd4/html5/thumbnails/15.jpg)
Results: NonContrast Echo Short Term Follow up
Results: NonContrast Echo Short Term Follow up
5892
7
10
2000
4000
6000
Events
Death
MI
No Events
DeathMINo Events
N= 5900
![Page 16: Safety and Efficacy of Commercially Available Ultrasound Contrast Agents in the Clinical Setting Melda S. Dolan, MD; Simil Gala, MD; Saritha Dodla, MD;](https://reader033.fdocuments.net/reader033/viewer/2022051819/5514677c550346b0158b4bd4/html5/thumbnails/16.jpg)
DSECONTRAST vs. NON CONTRAST
DSECONTRAST vs. NON CONTRAST
4011 Patients Who Received
Contrast for SuboptimalImages
Versus
SpecificitySensitivity Angiography
Accuracy
Angiography
1923Matched Patients
With Optimal Image Quality Without Contrast
![Page 17: Safety and Efficacy of Commercially Available Ultrasound Contrast Agents in the Clinical Setting Melda S. Dolan, MD; Simil Gala, MD; Saritha Dodla, MD;](https://reader033.fdocuments.net/reader033/viewer/2022051819/5514677c550346b0158b4bd4/html5/thumbnails/17.jpg)
Baseline DemographicsBaseline DemographicsDSEQuality
ContrastNonDiagnostic
No ContrastDiagnostic P
Male 61.4% 58.2 % NS
Hypertension 56% 52% NS
DM 32% 29% NS
Hyperlipidemia 48% 54% NS
Smoking 39% 36% NS
Previous MI 14% 10% NS
Previous CABG 10% 7% NS
Previous PTCA 16% 12% NS
![Page 18: Safety and Efficacy of Commercially Available Ultrasound Contrast Agents in the Clinical Setting Melda S. Dolan, MD; Simil Gala, MD; Saritha Dodla, MD;](https://reader033.fdocuments.net/reader033/viewer/2022051819/5514677c550346b0158b4bd4/html5/thumbnails/18.jpg)
DSE DataDSE DataDSEImage Quality
ContrastNonDiagnostic
No ContrastDiagnostic P
Normal 61.7% 63.8% NS
Fixed 10.8% 9.8% NS
Ischemia 13.8% 12.1% NS
Fixed & Isch 14.1% 12.8% NS
Target HR 84.2% 83.7% NS
Rest EF 56.9+ 10.2% 58.2+8.7% NS
Chest Pain 12.6% 13.7% NS
Dyspnea 6.8% 7.6% NS
![Page 19: Safety and Efficacy of Commercially Available Ultrasound Contrast Agents in the Clinical Setting Melda S. Dolan, MD; Simil Gala, MD; Saritha Dodla, MD;](https://reader033.fdocuments.net/reader033/viewer/2022051819/5514677c550346b0158b4bd4/html5/thumbnails/19.jpg)
Angiographic DataAngiographic DataDSEImage Quality
ContrastNonDiagnostic
No ContrastDiagnostic P
Stenosis Severity
74+ 10 % 70+14 % NS
Single Vessel 58% 54% NS
2 Vessel 21% 25% NS
3 Vessel 12% 11% NS
LAD 49% 54% NS
CX 24% 19% NS
RCA 22% 20% NS
![Page 20: Safety and Efficacy of Commercially Available Ultrasound Contrast Agents in the Clinical Setting Melda S. Dolan, MD; Simil Gala, MD; Saritha Dodla, MD;](https://reader033.fdocuments.net/reader033/viewer/2022051819/5514677c550346b0158b4bd4/html5/thumbnails/20.jpg)
ResultsResults
DSEImage Quality
ContrastNonDiagnostic
No ContrastDiagnostic P
Sensitivity 81 % 73 % NS
Single Vessel 74 % 68 % NS
Multivessel 85 % 83 % NS
Accuracy 82 % 76 % NS
![Page 21: Safety and Efficacy of Commercially Available Ultrasound Contrast Agents in the Clinical Setting Melda S. Dolan, MD; Simil Gala, MD; Saritha Dodla, MD;](https://reader033.fdocuments.net/reader033/viewer/2022051819/5514677c550346b0158b4bd4/html5/thumbnails/21.jpg)
Myocardial PerfusionMyocardial Perfusion
6075Patients Analyzed to
Determine Added BenefitOf Myocardial Perfusion Imaging
With Respect to Long Term Follow-Up
![Page 22: Safety and Efficacy of Commercially Available Ultrasound Contrast Agents in the Clinical Setting Melda S. Dolan, MD; Simil Gala, MD; Saritha Dodla, MD;](https://reader033.fdocuments.net/reader033/viewer/2022051819/5514677c550346b0158b4bd4/html5/thumbnails/22.jpg)
ResultsResults
Long TermFollow-Up
6075 Patients
2-92 Months
237 Non-Fatal MI273 Deaths
![Page 23: Safety and Efficacy of Commercially Available Ultrasound Contrast Agents in the Clinical Setting Melda S. Dolan, MD; Simil Gala, MD; Saritha Dodla, MD;](https://reader033.fdocuments.net/reader033/viewer/2022051819/5514677c550346b0158b4bd4/html5/thumbnails/23.jpg)
ResultsResults
6075Patients Analyzed to
Determine Added BenefitOf Myocardial Perfusion Imaging
With Respect to Long Term Follow-Up
4251 Normal Studies
1824 Abnormal Studies
AdverseEventsN=133(3.7%)
AdverseEventsN=377(20.6%)
![Page 24: Safety and Efficacy of Commercially Available Ultrasound Contrast Agents in the Clinical Setting Melda S. Dolan, MD; Simil Gala, MD; Saritha Dodla, MD;](https://reader033.fdocuments.net/reader033/viewer/2022051819/5514677c550346b0158b4bd4/html5/thumbnails/24.jpg)
510 EVENTS
ResultsResults
133Normal WMNormal MP
291 Abnormal WM Abnormal MP
86Normal WMAbnorm MP
![Page 25: Safety and Efficacy of Commercially Available Ultrasound Contrast Agents in the Clinical Setting Melda S. Dolan, MD; Simil Gala, MD; Saritha Dodla, MD;](https://reader033.fdocuments.net/reader033/viewer/2022051819/5514677c550346b0158b4bd4/html5/thumbnails/25.jpg)
95%
80%
69%
0%
20%
40%
60%
80%
100%
Normal MP and WM
Abn. MP and Normal WM
Abn. MP and Abn. WM
5 Year Event Free Survival
Stress Contrast Myocardial Perfusion
*
**
*p<0.05
![Page 26: Safety and Efficacy of Commercially Available Ultrasound Contrast Agents in the Clinical Setting Melda S. Dolan, MD; Simil Gala, MD; Saritha Dodla, MD;](https://reader033.fdocuments.net/reader033/viewer/2022051819/5514677c550346b0158b4bd4/html5/thumbnails/26.jpg)
![Page 27: Safety and Efficacy of Commercially Available Ultrasound Contrast Agents in the Clinical Setting Melda S. Dolan, MD; Simil Gala, MD; Saritha Dodla, MD;](https://reader033.fdocuments.net/reader033/viewer/2022051819/5514677c550346b0158b4bd4/html5/thumbnails/27.jpg)
QuickTime™ and aCinepak decompressor
are needed to see this picture.
QuickTime™ and aCinepak decompressor
are needed to see this picture.
![Page 28: Safety and Efficacy of Commercially Available Ultrasound Contrast Agents in the Clinical Setting Melda S. Dolan, MD; Simil Gala, MD; Saritha Dodla, MD;](https://reader033.fdocuments.net/reader033/viewer/2022051819/5514677c550346b0158b4bd4/html5/thumbnails/28.jpg)
Univariate Predictors
Multivar.
Predictors
Variables RR(95%CI) p RR(95% p
Age>70 1.5(1.0-2.4) 0.05 NSHyperlipid 0.6(0.5-1.0) 0.31 NSHyperten. 0.8(0.5-1.0) 0.12 NSDM 1.2(0.9-1.6) 0.92 NSPre CABG 2.2(1.3-3.8) 0.001 NSPre MI 2.1(1.2-3..4) 0.001 0.6(0.4-0.9) 0.01EF<50 1.6 (0.7-4.1) 0.001 1.4(1.0-1.8) 0.01Abn WM 3.9(2.9-5.7) 0.001 NSAbn MP 5.0(3.4-8.7) 0.001 2.4(1.0-5.9) 0.001
![Page 29: Safety and Efficacy of Commercially Available Ultrasound Contrast Agents in the Clinical Setting Melda S. Dolan, MD; Simil Gala, MD; Saritha Dodla, MD;](https://reader033.fdocuments.net/reader033/viewer/2022051819/5514677c550346b0158b4bd4/html5/thumbnails/29.jpg)
Summary Summary
1. The risk of both short-term and long-term events, defined as non-fatal myocardial infarction and death, following contrast administration during resting echo is very low.
• Not different from non-contrast studies.
1. The risk of both short-term and long-term events, defined as non-fatal myocardial infarction and death, following contrast administration during resting echo is very low.
• Not different from non-contrast studies.
![Page 30: Safety and Efficacy of Commercially Available Ultrasound Contrast Agents in the Clinical Setting Melda S. Dolan, MD; Simil Gala, MD; Saritha Dodla, MD;](https://reader033.fdocuments.net/reader033/viewer/2022051819/5514677c550346b0158b4bd4/html5/thumbnails/30.jpg)
SummarySummary
2. In patients undergoing DSE, the risk of an adverse event in a patient that received contrast was comparable to patients that did not receive contrast
2. In patients undergoing DSE, the risk of an adverse event in a patient that received contrast was comparable to patients that did not receive contrast
![Page 31: Safety and Efficacy of Commercially Available Ultrasound Contrast Agents in the Clinical Setting Melda S. Dolan, MD; Simil Gala, MD; Saritha Dodla, MD;](https://reader033.fdocuments.net/reader033/viewer/2022051819/5514677c550346b0158b4bd4/html5/thumbnails/31.jpg)
SummarySummary
3. The benefits of contrast use in patients with suboptimal images are significant and outweigh the possible risks.
– Making suboptimal studies equivalant to optimal studies
– Preventing additional costly tests
3. The benefits of contrast use in patients with suboptimal images are significant and outweigh the possible risks.
– Making suboptimal studies equivalant to optimal studies
– Preventing additional costly tests
![Page 32: Safety and Efficacy of Commercially Available Ultrasound Contrast Agents in the Clinical Setting Melda S. Dolan, MD; Simil Gala, MD; Saritha Dodla, MD;](https://reader033.fdocuments.net/reader033/viewer/2022051819/5514677c550346b0158b4bd4/html5/thumbnails/32.jpg)
SummarySummary
4. Myocardial perfusion assessment with contrast echo
– Adds significant prognostic value
4. Myocardial perfusion assessment with contrast echo
– Adds significant prognostic value
![Page 33: Safety and Efficacy of Commercially Available Ultrasound Contrast Agents in the Clinical Setting Melda S. Dolan, MD; Simil Gala, MD; Saritha Dodla, MD;](https://reader033.fdocuments.net/reader033/viewer/2022051819/5514677c550346b0158b4bd4/html5/thumbnails/33.jpg)
ConclusionConclusion
In light of these findings regarding safety and benefits, the FDA should reconsider the black box warning placed on contrast agents used during echocardiography.
In light of these findings regarding safety and benefits, the FDA should reconsider the black box warning placed on contrast agents used during echocardiography.
![Page 34: Safety and Efficacy of Commercially Available Ultrasound Contrast Agents in the Clinical Setting Melda S. Dolan, MD; Simil Gala, MD; Saritha Dodla, MD;](https://reader033.fdocuments.net/reader033/viewer/2022051819/5514677c550346b0158b4bd4/html5/thumbnails/34.jpg)
THANK YOU FOR YOUR
ATTENTION
THANK YOU FOR YOUR
ATTENTION