Transcript Presentation to FDA Medical Imaging Division Regarding New

Event Rates for Commonly Performed
Cardiovascular Procedures
Procedure
Event Rate
Event
Coronary
Angiography
1:1000
Death
Exercise Treadmill
Testing
1:2500
MI or Death
SPECT Exam or
Radionuclide
Ventriculography
1:1000 to
1:10,000
Fatal Malignancy
Contrast
Echocardiography
1:500,000
Death
Complete List of Contraindications to
Ultrasound Contrast Agents







Right-to-left, bi-directional, or transient right-to-left
cardiac shunts
Worsening or clinically unstable heart failure
Acute myocardial infarction or acute coronary syndromes
Serious ventricular arrhythmias or high risk for
arrhythmias due to prolongation of the QT interval
Respiratory failure, as manifest by signs or symptoms of
carbon dioxide retention or hypoxemia
Severe emphysema, pulmonary emboli or other
conditions that cause pulmonary hypertension due to
compromised pulmonary arterial vasculature
Hypersensitivity to perflutren
Complete List of Absolute
Contraindications to Cardiac
Catheterization
“The only absolute
contraindication to cardiac
catherization is refusal of a
mentally competent patient to
consent to the procedure”
Grossman W. Current practice standards. In: Baim DS and Grossman W,
editors. Cardiac Catheterization, Angiography and Intervention. Baltimore,
MD: Williams and Wilkins, 1996:9-16
Pseudocomplication
Complications occurring after any
medical pocedure may be attributable to
 the
procedure itself
 progression of underlying disease state
(pseudocomplication)
Pseudocomplication
Event
-24 hour to cath
Cath +72 hour
SAE
0.81%
0.81%
Death
0.24%
0%
Hildner et al. Pseudocomplications of cardiac catherization. Chest
1973;63:15-17
Serious adverse events are relatively common in patients
who are “sick enough” to warrant invasive testing
ACC/AHA/ASE 2003 Guidelines Update for the
Clinical Application of Echocardiography
ACC/AHA/ASE 2003 Guidelines Update for the
Clinical Application of Echocardiography
Contrast Echocardiography is Superior to
Tissue Harmonics for Assessment of Left
Ventricular Function in Mechanically
Ventilated Patients
%
90
80
70
60
50
40
30
20
10
0
Conversion of non-diagnostic
to diagnostic study
Harmonics
Kornbluth et al. Am Heart J 2000;140:291-6
Contrast
Contrast Echocardiography is Superior to Tissue
Harmonics for Assessment of Left Ventricular
Function in Mechanically Ventilated Patients
%
100
90
80
70
60
50
40
30
20
10
0
Wall motion scoring possible
1/5 of mechanically ventilated
patients will require TEE if
contrast contraindicated
Fundamental
Harmonics
Kornbluth et al. Am Heart J 2000;140:291-6
Contrast
Contrast Echocardiography Clarifies
Uniterpretable Wall Motion in Intensive
Care Unit Patients
25
20
% of patients with uniterpretable left ventricular function
15
%
10
5
0
Fundamental
Harmonic
Reilly JP et al. J Am Coll Cardiol 2000;35:485-90
Contrast
Diagnostic Accuracy and Cost-Effectiveness of
Contrast Echocardiography on Evaluation of Cardiac
Function in Technically Very Difficult Patients in the
Intensive Care Unit
100
90
80
70
60
50
40
30
20
10
0
Excellent or Adequate Endocardial Visualization
%
Fundamental
Harmonic
Contrast
Yong et al. Am J Cardiol 2002;89:711-718
TEE
Complications of Transesophageal
Echocardiography
Seward JB et al. J Am Soc Echocardiogr 1992;5:228
Complications of Transesophageal
Echocardiography
Daniel WG et al. Circulation 1991;83:17-821