ASE issues echocardiography contrast consensus statement

The American Society of Echocardiography (ASE) has released a consensus statement on the clinical applications of echocardiography contrast agents.

The statement, published in the November issue of the Journal of the American Society of Echocardiography, provides details on how and when echocardiography contrast agents should be used and also reviews the roles of physicians, sonographers, and nurses. The statement also examines ways to efficiently integrate the use of contrast agents into the echocardiography laboratory, and it discusses the recent labeling changes by the U.S. Food and Drug Administration (FDA) (J Am Soc Echocardiogr, November 2008, Vol. 21:11, pp. 1179-1201).

The panel said they made their recommendations based on a critical review of the existing medical literature, including prospective clinical trials. Where no significant study data were available, recommendations were based on expert consensus opinion, according to the panel led by Dr. Sharon Mulvagh of the Mayo Clinic in Rochester, MN.

The consensus guidelines suggest the use of ultrasound contrast in the following echocardiography applications:

  • In difficult-to-image patients presenting for rest echocardiography with reduced image quality:
    • To enable improved endocardial visualization and assessment of left ventricular (LV) structure and function when ≥ 2 contiguous segments are not seen on noncontrast images
    • To reduce variability and increase accuracy in LV volume and LV ejection fraction (LVEF) measurements by 2D echocardiography
    • To increase the confidence of the interpreting physician in LV functional, structure, and volume assessments
  • In difficult-to-image patients presenting for stress echocardiography with reduced image quality:
    • To obtain diagnostic assessment of segmental wall motion and thickening at rest and stress
    • To increase the proportion of diagnostic studies
    • To increase reader confidence in interpretation
  • In all patients presenting for rest echocardiographic assessment of LV systolic function (not solely difficult-to-image patients):
    • To reduce variability in LV volume measurements through 2D echocardiography
    • To increase the confidence of the interpreting physician in LV volume measurement
  • To confirm or exclude the echocardiographic diagnosis of the following LV structural abnormalities, when nonenhanced images are suboptimal for definitive diagnosis:
    • Apical variant of hypertrophic cardiomyopathy
    • Ventricular noncompaction
    • Apical thrombus
    • Complications of myocardial infarction, such as LV aneurysm, pseudoaneurysm, and myocardial rupture
  • To assist in the detection and correct classification of intracardiac masses, including tumors and thrombi
  • For echocardiographic imaging in the intensive care unit when standard tissue harmonic imaging does not provide adequate cardiac structural definition:
    • For accurate assessment of LV volumes and LVEF
    • For exclusion of complications of myocardial infarction, such as LV aneurysm, pseudoaneurysm, and myocardial rupture
  • To enhance Doppler signals when a clearly defined spectral profile is not visible and is necessary to the evaluation of diastolic and/or valvular function

Of course, it's hard to have a discussion about ultrasound contrast these days without covering the safety of the agents. Among other notes on current research evaluating the safety of the agents, the consensus statement mentions that current FDA documents for both the Optison (GE Healthcare, Chalfont St. Giles, U.K.) and Definity (Lantheus Medical Imaging, North Billerica, MA) agents state that the products are not to be administered to patients in whom the following conditions are known or suspected:

  • Right-to-left, bidirectional, or transient right-to-left cardiac shunts
  • Hypersensitivity to perflutren
  • Hypersensitivity to blood, blood products, or albumin (applies to Optison only)

Intra-arterial injection of these agents is also contraindicated.

"Importantly, additional monitoring of vital signs, electrocardiography, and cutaneous oxygen saturation (for 30 minutes) is not required in all patients but is now limited to patients with pulmonary hypertension (degree not specified) or unstable cardiopulmonary conditions," the authors wrote.

Contrast enhancement is an essential part of a modern, quality-driven echocardiography laboratory, and administration of contrast agents is most effectively achieved by establishing a sonographer-initiated decision-making process guided by a physician standing order that clearly describes the precise indications and contraindications for contrast-enhanced studies, according to the authors.

"The successful implementation of contrast agent use requires the effort of a team, optimally composed of physicians, sonographers, and nurses," they wrote.

The consensus statement also recommends the appropriate and efficient use of contrast agents to promote their cost-effectiveness.

"To ensure quality control and maximize benefit to patients, the ASE recommends that appropriately trained cardiac sonographers and physicians with level 2 or level 3 training, and the laboratories at their institutions, establish an effective system to enable use of contrast enhancement," the authors concluded.

While it's difficult to predict the effects of consensus statements, Lantheus Medical Imaging senior medical director of global medical affairs, Dr. Mark Hibberd, Ph.D., said he hopes it will have a positive effect on contrast utilization.

"We applaud the American Society of Echocardiography for showing the leadership necessary to come out with a statement with the right kinds of uses for ultrasound contrast," he said.

GE strongly supports the ASE consensus statement and believes it will help the market, a spokesperson told AuntMinnie.com.

"As [ASE president Dr. William Zoghbi] pointed out, the addition of contrast changes a nondiagnostic test to a relevant diagnostic test 95% of the time," the GE spokesperson said. "It is, often times, the only noninvasive option available and, as Dr. Zoghbi has reassured the public, the potential diagnostic benefit outweighs the risk."

By Erik L. Ridley
AuntMinnie.com staff writer
November 11, 2008

Related Reading

New society aims to secure bright future for ultrasound contrast, September 25, 2008

FDA updates ultrasound equipment guidance, September 18, 2008

Definity echo contrast agent lands on FDA drug safety list, September 8, 2008

FDA formally updates echo contrast black box warning, July 18, 2008

FDA ultrasound contrast safety meeting sparks discussion, hope for the future, July 10, 2008

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