Handle the Scan with Care

Anytime one begins an obstetrical scan, there is a ritual that precedes our privileged access into an otherwise inaccessible place pulsating with life, hope and promise. The trilogy of preparing the patient, applying the gel, and selecting the transducer helps us transition as we open a window to the womb, sharing a highly anticipated and treasured moment with the family.

old windowWhile this privileged access may provide priceless reassurance, it is accompanied by a huge responsibility for the sonologist who is attempting to make sense of what is seen while trying to decide how to share the information with the family.

As diagnosticians, we are taught to be vigilant, careful and meticulous, making note of every single finding. We employ the most sophisticated machines and the importance of being non-paternalistic is deeply engrained in our brains. Yet at the same time, care and caring must come into play if we need to break news that may shatter dreams or induce significant parental anxiety.

Personally I find that the most challenging cases are those in which various isolated sonographic markers may be detected. The struggle between wanting to be scientific, factual and transparent and the fear of labeling an otherwise healthy being and worrying a hopeful parent becomes paramount. This is becoming more commonplace nowadays with the advancing technology as we delve into fetal evaluations with much more detail and at earlier points in gestation. We must not mistake normal developmental findings with pathology. We must be careful with enhanced image resolution and the employment of harmonics as these may increase tissue echogenicity and lead to over diagnosis of physiologic “cysts” in fluid producing structures.

With the continuing advancement of the technological capabilities of this most versatile of medical diagnostic modalities and its evolving portability, the number of probe-handlers globally is increasing exponentially across the disciplines. The problem is that education, training and experience are not uniform. The expertise to discuss the implications of various sonographic findings, particularly soft markers, and to recognize serious abnormalities, may be lacking. Despite the well-established positive impact of prenatal diagnosis, allowing us to prepare families and formulate the optimal plan of care, it may also be a double-edged sword, particularly in inexperienced hands.  As such, and in keeping with the mission of the AIUM and its communities of practice, the importance of proper training cannot be overstated. One must adhere to the basic sonographic teachings, employ the ALARA principle, and implement practice parameters when incorporating sonography into daily clinical practice. Referral to centers of excellence, whenever there may be doubt, is critical. Sound judgment remains the key to utilizing ultrasound first.

A new life is purity in the absolute form: a blank sheet of paper. Much caution must be exercised before any marks are made. Every word uttered has the potential of tainting the page, of taking away hope, of falsely “labeling” this promising life before it has even come into physical being. “First do no harm” should continue to echo in our brains and we must always proceed with caution, and tread with care.

What’s your opinion on the quality issue? Do you see a wide range of quality in ultrasound scanning?  Comment below or let us know on Twitter: @AIUM_Ultrasound.

Reem S. Abu-Rustum, MD, FACOG, FACS, FAIUM, is the Director of the Center For Advanced Fetal Care in Tripoli, Lebanon. She has served the AIUM in several capacities, including her current role on the AIUM Board of Governors.

  • Image adapted from A Practical Guide to 3D Ultrasound. RS Abu-Rustum. CRC Press 2015.

Simulators Role in Ultrasound Training

I believe the future of health care will involve the expanded use of diagnostic ultrasound, which will be accomplished through the use of an enhanced version of today’s handheld ultrasound scanner. I envision this “sono-scope” to be a wireless, lightweight, handheld imaging device with a long battery life and high-quality image capture that will expand the capabilities of the stethoscope.

The compact, portable ultrasoundpedersen_image scanners began entering the medical imaging marketplace around year 2000. Since then the market has grown dramatically, and the portable scanners have bifurcated into two broad groups: (i) The pocket-sized or handheld scanners (HHUS) and (ii) the larger, full-featured point-of-care ultrasound systems (POCUS).

These devices provide doctors with an extension of their senses and augment existing tools. But to be truly transformational, users need to receive ultrasound training from the beginning of their medical career, which will allow them quickly to “rule in” and “rule out” possible diagnoses and lead to earlier treatment decisions and/or more relevant further tests.

I maintain that the main barrier for making the HHUS (and POCUS) every clinician’s examination tool of choice, is not the technology, but rather the lack of opportunity to acquire and develop the needed scanning skills.

Thus, finding training strategies that enable the integration of ultrasound into medical schools is an essential step in overcoming this barrier. If the next generation of doctors had ultrasound for diagnosis and guided procedures as a vital part of their training, they would quickly develop a natural comfort with this tool and, with time, increasing sophistication. A parallel can be drawn regarding the attitude toward acquiring computer skills. As recent as 40 years ago, the operation of computers was thought to be limited to a select, carefully trained group of specialists. Today, nearly everyone is able to operate computers at some level.

Effective training in medical ultrasound requires both clinical knowledge (understanding of anatomy, physiology, and pathology) and scanning skills (psycho-motor skills, which are the integration of motion and the mental processes of recognizing anatomic structures in 3D from the 2D images). While both clinical knowledge and scanning skills are essential, the former is often emphasized at the expense of the latter because clinical knowledge can be delivered cost effectively and in flexible formats through online courses (including MOOCs), self-study, and in traditional classroom courses. Scanning skills, on the other hand, are acquired through hands-on experience, by examining patients, preferably both healthy and with symptoms, under the guidance of an experienced sonographer. Here, the medical educational enterprise does not currently have the capacity to meet this training need. There are too few scanners available for learners to use. There are too few patients or human subjects in general available for scanning. Last but not least, there are too few qualified instructors who can guide the learning.

There exists a potentially effective approach to overcoming this limitation in delivering scanning skills training: The use of ultrasound training simulators. Simulation provides a controlled and safe practice environment to promote learning. The efficacy of the simulator-based training is well-established. For example, human errors related to airline accidents have decreased in large part due to flight simulator training. Likewise, high-fidelity medical simulations have been shown to be educationally effective, as evidenced by the strong correlation between surgical simulator training and improved outcomes. Several studies have demonstrated the learning value of simulator-based training in diagnostic ultrasound.

Just as HHUS and POCUS have proliferated over the last 15 years, so have ultrasound simulator products. Some training simulators cover multiple clinical specialties, while others are designed for a specific application. Typically, the learner scans a physical manikin with a realistic-looking sham transducer, which produces an image on the display corresponding to the position and orientation of the sham transducer on the manikin, along with an anatomy display of the location of the image plane through the body.

An important component of the simulator design is the degree to which the simulator provides structured learning with guidance, interaction, and assessment. While all simulators include educational modules, only a few offer self-paced learning and competence verification. All in all, today’s ultrasound simulators are sophisticated devices that are capable of meeting training needs on basic and even intermediate levels. However, because the purchase price is sufficiently high (from $10K to more than $100K) sonography programs and simulation centers at larger hospitals are typically the only facilities able to acquire this technology.

When the medical community is ready to embrace ultrasound as an imaging modality of first choice for doctors from all specialties, I am convinced that technological innovation will lead to affordable, yet customizable and realistic training simulators. In particular, what is needed are portable and lightweight simulators that run on ordinary, modern PC/laptops, making personal ownership of a simulator possible as well as allowing medical schools to purchase such simulators in large quantities. For individualized training, it is essential that the simulator be task-based and able to verify the acquired skills level. To deliver the best realism, the image material should preferably be acquired directly from human subjects, and to provide the optimal development and assessment of psychomotor skills, the scanning practice on the simulator should resemble actual patient scanning as closely as possible. Such low-cost training simulators can lay the groundwork for building up such ultrasound skills both among practicing specialists and students enrolled in medical schools.

Have you/do you use simulators in your ultrasound training? What are the advantages or disadvantages? What would make simulation training better? Comment below or let us know on Twitter: @AIUM_Ultrasound.

Peder C. Pedersen is Professor of Electrical and Computer Engineering at Worcester Polytechnic Institute.

Ultrasound Can Catch What NIPT Misses

A few months ago a young couple, Michele and Dan, came to my office for a mid-trimester fetal anatomic survey at 21 weeks’ gestation. They were excited to see their fetus in 3D-4D ultrasound, and were wowed by the 3D image of their baby’s face. During the scan the couple related that they were sure their baby was OK “because the blood test came back negative,” and had decided to forego first trimester screening, despite their OB strongly recommending it.

unnamedThe blood tests, nuchal translucency measurement, and other sonographic parameters evaluated in first trimester screening are considered together to provide a risk profile for fetal chromosomal anomaly, particularly the risk of Down syndrome. If there is an increased risk, the parents may be advised to undergo invasive testing, such as chorionic villus sampling (CVS) or amniocentesis. In addition, first trimester screening can raise warning flags for structural anatomic malformations in the fetus, as well as other problems for the pregnancy. If first trimester screening includes a full fetal anatomic survey, it can spot about 40% of fetal malformations at a very early stage.

While I was reassured that Michele and Dan’s results on noninvasive prenatal testing (NIPT) meant the risk of their baby having Down syndrome and certain other aneuploidies was extremely low, I explained that structural malformations were still a much more common concern than chromosomal anomalies, and that a negative NIPT result did not rule out other conditions. Michele protested, “On the Internet it said that the blood test rules out Down syndrome 100%, that we didn’t have to worry.”

“The screening tests only give you a risk profile,” Dan insisted, “they don’t tell you if the baby is really affected. So we thought the blood test was the way to go.”

“I don’t want to have an amnio,” Michele continued, “I had a miscarriage in my last pregnancy,” she continued, as I proceeded to the echocardiography portion of the examination.

“Your baby appears to have a heart defect,” I said, as gently as I could, and began to explain the nature of transposition of the great arteries (TGA).

NIPT is the name applied to new techniques that use a sample of a pregnant woman’s blood to examine her fetus’s chromosomes. As early as 10 weeks of pregnancy there is sufficient fetal genetic material, called cell-free DNA, found in the maternal serum to allow analysis. A negative result from NIPT is a very good test to rule out Down syndrome in the fetus: it is highly specific, meaning that in almost all cases, a negative result is truly negative. NIPT is also highly sensitive, which means that in almost all cases, a positive result is truly positive. However, because there is a chance (however small) of a false positive (a healthy fetus may have a result showing him/her to have Down syndrome), a positive test result always needs to be confirmed with invasive testing, such as CVS or amniocentesis, before any decisions are made regarding the further management of the pregnancy. NIPT has also been found useful in identifying fetuses with other chromosomal anomalies and certain other genetic conditions. NIPT can also be used to determine the fetal sex.

However, while NIPT does a very good job at what it is designed for: looking at fetal chromosomal complement in specific conditions, it does not examine all the fetal chromosomes, nor does it look at the anatomy of the fetus. Fetal anatomy is examined in detail by ultrasound scanning. There is some debate among practitioners regarding the optimal week of pregnancy when full early fetal anatomy scanning should be performed. Some practitioners prefer performing the scan at the time of nuchal translucency screening, 11-13 weeks, while others prefer 14-16 weeks, when the fetal organs are more developed. The important point to remember: a fetus with a normal (negative) NIPT result can have an anatomic structural malformation. It has been shown that while fetuses with malformations may be at increased risk of chromosomal anomaly, the majority have healthy chromosomes. The diagnosis of a malformation by ultrasound should prompt invasive testing such as CVS or amniocentesis. In some centers, more detailed investigation by chromosomal microarray analysis (CMA), which may discover subtle anomalies, will also be ordered. CMA detects duplicated or deleted chromosomal segments and translocations—rearrangements of chromosomal structure, which may not be evident on traditional karyotyping.

NIPT is a very reliable test. But patients may have a false sense of security regarding their baby’s well-being. A negative NIPT result cannot rule out anatomic structural malformations in the fetus, nor does it rule out all chromosomal anomalies. There is ongoing debate surrounding the integration of NIPT into existing screening programs.

I continued to follow Michele and Dan in the weeks and months that followed. They were, of course, shocked and dismayed by their diagnosis. With Michele at 21 weeks, we immediately arranged multidisciplinary consultation with the cardiologists, who explained the procedures the baby would have to undergo, and how Michele’s plans for the birth would have to change. Prenatal diagnosis of TGA can improve the baby’s surgical outcome, and with prompt intervention, prognosis is excellent. They met with a genetic counselor, and despite Michele’s fears, underwent amniocentesis. CMA is performed in all such cases in our center. Testing ruled out genetic syndromes that we suspected based on the anatomic malformation, none of which could have been diagnosed by NIPT.

With comprehensive information in hand about their baby’s prognosis and the options open to them, Michele and Dan decided to continue the pregnancy, despite the difficult road they knew was ahead. They made arrangements for delivery in the tertiary care center where the baby would undergo surgery, so she would not have to be transferred from their community hospital and would be under constant surveillance. “I fell in love when I first saw the baby’s face in 3D,” she told me. “Whatever comes, we’ll handle it together.”

How do you think NIPT should be integrated into prenatal care? How do you advise your patients who ask about NIPT? Have you encountered patients with negative NIPT results whose fetus has a structural anomaly? Have you encountered patients with false negative or false positive NIPT? Comment below or let us know on Twitter: @AIUM_Ultrasound.

Simcha Yagel, MD, is Head of the Division of Obstetrics and Gynecology Hadassah-Hebrew University Medical Centers, Jerusalem, Israel, and Head of the Center for Obstetric and Gynecological Ultrasound at the Hadassah-Hebrew University Medical Centers, Mt. Scopus, Jerusalem. He served as moderator for a panel discussion, “Noninvasive Prenatal Testing and Fetal Sonographic Screening,” that appeared in the March 2015 issue of the Journal of Ultrasound in Medicine.

Why 76811 Accreditation?

Starting in 2013, the AIUM and the Society for Maternal-Fetal Medicine (SMFM) co-led a task force of medical societies to explore what distinguished a 76811 examination from the more routine 76805 examination. The result of that task force was the “Consensus Report on the Detailed Fetal Anatomic Ultrasound Examination,” which was published in the February 2014 edition of the Journal of Ultrasound in Medicine.

aium_accredThe report concludes that the 76811 is a distinct examination that requires special expertise. While many obstetricians and radiologists perform the 76805 on a routine basis, the skills and detail required for a 76811 generally require additional training and expertise—frequently through a Maternal-Fetal Medicine fellowship or similar targeted radiology fellowship.

Unfortunately in practice, what constitutes a “detailed obstetrical ultrasound” (or a 76811 examination) varies tremendously. It was for this reason that the AIUM felt it was critically important to promote standardization of what is required of such an examination and work to ensure that individuals performing these are competent and qualified. Additionally, given the move by some payors to reimburse only examinations performed by accredited practices, the AIUM felt it was prudent to have a mechanism in place to accredit practices that would be qualified to perform these examinations before it was directed by the insurers.

To address these concerns the AIUM developed the 76811 accreditation. This new accreditation is an “adjunctive” accreditation for practices that have, or are seeking, accreditation in 2nd/3rd trimester obstetrical ultrasound. It operates very similarly to how 3-D gynecologic ultrasound accreditation is an adjunct to the basic GYN ultrasound accreditation.

If your practice is performing detailed ultrasound examinations for women at high risk of, or who are suspected of having, an anomaly, you should consider adding the 76811 accreditation.

The structure for this accreditation submission is a little different however. Because the consensus statement provided a long list of “always must show” anatomy, and an additional list of “when clinically indicated” anatomy, the accreditation submission must show all of the “always” anatomy on each of the normals, but only needs to show an example of a selection of the “when clinically indicated anatomy” structures on at least one of the studies. In this way, you can exhibit competence getting the views that are occasionally, but not always, needed without having to add a lot of extra views to all of your study submissions.

This newly added accreditation option is live now. The AIUM is excited about letting you demonstrate your expertise so that you can get the credit and recognition that you deserve. Once again, the AIUM is involved in setting the standards for quality, and we know our members are up to the challenge!

Have questions about this new accreditation option? Comment below or let us know on Twitter: @AIUM_Ultrasound.

Dr. David C. Jones is Director, Univerisity of Vermont Medical Center Fetal Diagnostic Center and Professor, Obstetrics, Gynecology & Reproductive Sciences at the University of Vermont, Department of Obstetrics, Gynecology & Reproductive Sciences, Division of Maternal-Fetal Medicine. He serves as Vice Chair of the AIUM’s Ultrasound Practice Accreditation Council.

The Issue with Keepsake Ultrasounds

Every cousmiling 3rd triple of weeks, the AIUM office receives a call from a reporter asking about keepsake (or entertainment) ultrasounds. Most of these calls result from a keepsake ultrasound facility opening in the community. A number of them came when the FDA reaffirmed its warning against the practice. Occasionally we get the oddball like the one about the ultrasound booth at a flea market.

Regardless of why the AIUM receives the call or inquiry, our response is the same. Since 1999, the AIUM has had the following official position:

“The AIUM advocates the responsible use of diagnostic ultrasound and strongly discourages the non-medical use of ultrasound for entertainment purposes. The use of ultrasound without a medical indication to view the fetus, obtain images of the fetus, or determine the fetal gender is inappropriate and contrary to responsible medical practice. Ultrasound should be used by qualified health professionals to provide medical benefit to the patient.”

AIUM, and a number of other professional associations in the U.S. and other countries, discourage the entertainment use of ultrasound for several reasons, including:

  1. The lack of training of the individuals obtaining the images. When it comes to keepsake ultrasound facilities, there are no regulations governing training requirements for those obtaining the images, either through certification or accreditation.
  2. The concern about potential biological effects that could result from scanning for a prolonged period, inappropriate use of color or pulsed Doppler ultrasound without a medical indication, or excessive thermal or mechanical index settings. As stated in the FDA’s position, “ultrasound can heat tissues slightly, and in some cases, it can also produce very small bubbles (cavitation) in some tissues.”
  3. The potential that pregnant women will visit a keepsake ultrasound facility in lieu of routine prenatal appointments with their medical doctor.

Despite government and medical association warnings against the use of keepsake ultrasounds, the number of facilities performing these scans appears to be increasing. Many theorize that this increase has been driven by the use of 3D ultrasound technology which provides detailed, in-depth images of the fetus and its appeal to expecting parents.

As the number of facilities increases, some states have taken action to ban the practice of keepsake ultrasounds based on the reasons outlined above. In 2009 Connecticut became the first state to ban keepsake ultrasounds. It took 5 years for the second state to take a similar action. Oregon’s law took effect in January of 2014.

Although the issue of keepsake ultrasounds has been around for decades, the recent proliferation of facilities offering this service has prompted action by medical organizations, the federal government, and state governments. Only time will determine the ultimate fate of keepsake ultrasound practices. Until then, the AIUM will continue to advocate for the responsible use of medical ultrasound.

What’s your take on keepsake/entertainment ultrasounds? Comment below or let us know on Twitter: @AIUM_Ultrasound.