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Detection of Resting Myocardial Perfusion Defects by Sonovue Myocardial Contrast Echocardiography

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Detection of Resting Myocardial Perfusion Defects by Sonovue Myocardial Contrast Echocardiography Detection of Resting Myocardial Perfusion Defects by SonoVue Myocardial Contrast Echocardiography Tamanna Nahar, M.D., Peng Li, M.D., Ph.D., Bettina Kuersten, M.D., Sanjay Batra, Ph.D., and Mani A. Vannan, M.B.B.S. Department of Medicine, Division of Cardiology, University of Michigan Health System, Ann Arbor, Michigan Background: SonoVue is a new microbubble contrast agent containing sulfur hexafluoride. We as- sessed the efficacy of SonoVue myocardial contrast echocardiography (MCE) to detect resting perfu- sion abnormalities. Methods: Nineteen adult patients with a wall motion abnormality in a screening echocardiogram were studied. Each patient received up to four bolus injections of 2.0 mL SonoVue (Bracco Diagnostics, Inc.) during echocardiographic examination using either B-mode (n = 12) or power Doppler (n = 7) imaging. Each patient also had SPECT nuclear perfusion imaging performed. Segmental assessment of myocardial perfusion from SonoVue MCE images were compared with corresponding SPECT nuclear images. Results: Using B-mode imaging, the mean number of views obtained with a single SonoVue injection ranged from 1.4 to 1.9, with 2 or 3 injections required for a complete examination. Ninety-four percent of segments were scored as diagnostic. Agreement between B-mode and SPECT images was 72% for segments with a perfusion defect, 86% for normal perfusion, and 80% for segments with either perfusion defect or normal perfusion (all views com- bined). Using power Doppler imaging, the mean number of views obtained with a single SonoVue injection ranged from 1.0 to 1.3, with 2 to 4 injections required for a complete examination. Sixty- eight percent of segments were scored as diagnostic. Agreement between power Doppler and SPECT images was 67% for perfusion defects, 53% for segments with normal perfusion, and 59% for segments with either perfusion defect or normal perfusion (all views combined). Conclusions: SonoVue MCE has the potential to assess myocardial perfusion at rest. B-mode imaging was more accurate than power Doppler imaging when compared with SPECT nuclear imaging. (ECHOCARDIOGRAPHY, Volume 20, August 2003) SonoVue, myocardial perfusion, myocardial contrast echocardiography Myocardial contrast echocardiography vascular ultrasound applications.2−5 It consists (MCE) using newer microbubbles has shown of sulfur hexafluoride-filled microbubbles in a promise in the clinical setting to delineate nor- phospholipid shell. Sulfur hexafluoride (SF6) mal and abnormal myocardial perfusion. It has is a poorly soluble, totally innocuous gas that also been demonstrated that high mechanical does not undergo metabolism and is eliminated index (MI) triggered MCE using can be used in expired air.6 to detect perfusion defects in patients with The purpose of this study was to evaluate coronary artery disease (CAD).1 SonoVue whether SonoVue MCE is able to detect rest- (BR1; Bracco Diagnostics, Inc., Princeton, NJ, ing myocardial perfusion defects. USA) is a new microbubble contrast agent currently being evaluated for cardiac and other Methods Supported in part by a research grant from Bracco Study Population Diagnostics Inc. Nineteen patients were enrolled sequentially Address for correspondence and reprint requests: Mani A. in two groups: the first group of patients was Vannan, MBBS, Drexel University College of medicine, De- = partment of Cardiovascular Medicine and Surgery, 245 N. evaluated using B-mode imaging (n 12) and 15th Street, MS 313, Philadelphia, PA 19102. Fax: (215) 762 the second group using power Doppler imag- 1525; E-mail: [email protected] ing (n = 7). Patients were eligible for the Vol. 20, No. 6, 2003 ECHOCARDIOGRAPHY: A Jrnl. of CV Ultrasound & Allied Tech. 511 NAHAR, ET AL. study if they were at least 18 years of age, optimal PRF was selected for each patient based had a history of ischemic heart disease, had on minimal motion artifact and best myocardial a discrete left ventricular wall motion abnor- contrast effect. mality (ie, two consecutive segments graded A screening noncontrast B-mode examina- as hypokinetic, dyskinetic, or akinetic) on a tion was performed for assessment of wall mo- noncontrast echocardiogram performed within tion abnormalities within 7 days prior to ad- 7 days prior to SonoVue administration, and ministration of SonoVue. Echocardiographic were clinically indicated for a radionuclide views for assessment of wall motion were se- perfusion study. Exclusion criteria included a lected from the following six views: apical technically inadequate imaging window on four-chamber (A4C), apical two-chamber (A2C), screening noncontrast echocardiogram, severe apical long-axis (APLAX), parasternal mid- congestive heart failure, unstable angina, se- short-axis (SAX-PM), parasternal apical-short- vere arrhythmia, a right-to-left circulatory axis (SAX-AP), and parasternal long-axis shunt, pulmonary hypertension, or pregnancy (PLAX) views. SonoVue MCE imaging began and lactation. The study protocol was approved with the echocardiographic view most likely by the institutional review board, and writ- to reveal a myocardial perfusion defect based ten informed consent was obtained from all pa- on the wall motion abnormality seen in the tients prior to enrollment. screening noncontrast echocardiogram. A sec- ond echocardiographic view was selected that anatomically complemented the first view (ie, Study Agent Administration the view that illustrated the same defect or an Patients received up to four intravenous bo- additional defect in the same territory). Addi- lus injections of SF6 microbubbles (SonoVue ) tional views were imaged if they were deemed at a dose of 2.0 mL each, in accordance with essential to detect the perfusion abnormality in the prespecified phase II protocol. The bolus a given patient. was administered over 30 seconds followed by For each injection of SonoVue, echocardio- slow 5-mL normal saline flush. The number graphic imaging (B-mode or power Doppler) of injections each patient received was deter- began 30-seconds prior to SonoVue adminis- mined by the need to obtain a complete MCE tration (minimum of three frames acquired). examination. SonoVue was provided by Bracco Following administration of SonoVue, trig- Diagnostics Inc. as a sterile, pyrogen free, gered images that were gated to an electro- lyophilized powder. A white, milky suspension cardiogram at end-systole, at every cardiac of SF6 microbubbles was obtained by adding 5 cycle (1 : 1) and every fourth cardiac cycle (1 : 4), mL of physiologic saline (0.9% sodium chloride) were obtained. At least three evaluable frames to the powder, using standard clinical aseptic were obtained for each pulsing interval in one techniques followed by hand agitation. After re- view before switching to the next view. Imag- constitution, bubble concentrations are in the ing continued after each injection until virtual range of 1 to 5×108 microbubbles per milliliter. disappearance of the contrast effect from the SonoVue microbubbles range in diameter left ventricle and myocardium. All images were from 1 to 10 µm (mean diameter, 2.5 µm; recorded on SVHS videotape. 90% < 8 µm). Radionuclide Perfusion Imaging B-Mode and Power Doppler Echocardiography The 99m Tc-sestamibi single-photon emission Images were obtained using a commercially computerized tomography (SPECT) imaging available echocardiographic machine ATL 5000 was done in each patient within 4-weeks prior (Bothell, WA, USA). The frequencies of the to or 1-week after administration of SonoVue. probe used for harmonic imaging were 1.8-MHz A standard image acquisition protocol was used transmit and 3.6-MHz receive. Instrument set- 1-hour after administration of 99m Tc-sestamibi. tings were optimized prior to SonoVue admin- The reconstructed data set was reformatted to istration. For B-mode imaging, MI ranged from yield horizontal long-axis views, vertical long- 0.7 to 1.2 for all patients. For power Doppler axis views, and a series of SAX views from apex imaging, MI ranged from 0.7 to 1.3, while pulse to the base of the left ventricle. No percuta- repetition frequency (PRF) ranged from 500 to neous or surgical coronary interventions were 2100. The optimal PRF for SonoVue was not done in any of the patients between the SPECT established at the time of this study. Hence the and MCE studies. 512 ECHOCARDIOGRAPHY: A Jrnl. of CV Ultrasound & Allied Tech. Vol. 20, No. 6, 2003 SONOVUE MCE IN RESTING PERFUSION DEFECTS Efficacy Assessment Methods of Analysis A single reader blinded to the results of the Descriptive statistics were used to sum- SPECT study interpreted all of the echocardio- marize all parameters. Data obtained from graphic images. For each patient, the reader B-mode and power Doppler assessments were recorded the number of SonoVue injections re- analyzed separately. For assessment of echocar- quired for a complete examination, i.e., suffi- diographic images, the frequency of each dis- cient to determine whether or not a perfusion tinct myocardial perfusion score and the cor- defect was present (additional injections, not responding percentage of the total number of to exceed a total of four, may have been ad- segments evaluated were determined based on ministered at the investigator’s discretion). For all echocardiographic views obtained. The per- each bolus injection, the reader recorded the centage of segments with scores indicating di- number of assessable views and pulsing inter- agnostic images (i.e., scores of 0, 1, or 2) was vals. Segmental assessments of myocardial per- also determined. Agreement
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