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Historical Perspective

During the past 25 years Dr. DeVore has examined over 100,000 fetuses. Many patients have been referredforRoutine or Screening Ultrasound of the fetus in which the referring physician did not suspect the patient tobe at increased risk for problems. When Dr. DeVore inquired as to whether the patient or her family had anyconcerns, the majority confided that their biggest worry was whether the unborn "baby was healthy." The followingare questions that a pregnant woman should consider.

How Often Do Bir th Defects Occur?

Birth defects occur in1 in 33 newborn babiesand may be readily identified because of the external features of theabnormality. Examples may be a spinal cord defect, missing arm or leg, cleft lip or palate, or abnormal facial orhead features. However, the majority of serious birth defects are silent--- they involve organs which the

pediatrician cannot adequately examine. Examples are:

Early hydrocephaly (water on the brain) or other abnormalities of the brain

Heart defects

Obstruction of the kidneys

Blockage of the stomach or intestines

Abnormalities of the lungs

TheCalifornia Birth Defects Monitoring Program reviews many of the concerns and implications of birth defects.

I f I Wou ld Not Termin ate A Pregnanc y If A Birth Defect Were Identi f ied, What Is The

Adv antage Of Detect ing A Problem Before Bir th?

When birth defects are present, but not identified at birth, the child may not become ill until after it is sent homewith the parents, only to return with a medical emergency. This is especially important with short maternal stays inthe hospital following delivery. It has been demonstrated that the prenatal diagnosis of birth defects may improvethe outcome of the child, especially when the birth defects involve the heart or spine.

What Is A Screening Test?

When one considers whether a screening test should be offered to patients, it is important to use a GoldStandardto compare whether the test which is being considered is equal to or superior to screening testscurrently in use. Examples of screening tests would be the PAP smear for cervical cancer, mammography forbreast cancer, and the maternal serumTriple or QUADscreening test to identify fetuses at increased risk forDown syndrome and other birth defects.

Should Ultrasou nd B e Used As A Screening Test To Detect Bir th Defects?

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From its early inception, fetal ultrasound has been a useful diagnostic tool when utilized by experts to identifyserious birth defects. It has received much attention in the medical literature as well as the public press during thepast 30 years. Numerous textbooks, and thousands of medical articles have been written describing its use toidentify birth defects. Given its diagnostic potential, physicians in the early 1980's advocated the use of ultrasoundto screen for birth defects in women who were low risk; having no family history, or not exposed to drugs orenvironmental toxins. While ultrasound appeared to have promise as a screening tool, it later became apparentthat its potential benefit was limited by the experience of the physician or technologist performing theexamination. Let us explore this in more detail.

The Wall Street Journ al

Over 20 years ago (June 20, 1995), Heidi Evans of the Wall Street Journalwrote an article entitled, Doctors WhoPerform Feta l Sonograms Often Lack Suff ic ient Tra in ing A nd Ski l l . In the article, a prominent Professor ofRadiology, Roy Filly, at the University of California Medical Center in San Francisco stated,

"Sonography is rife with virtually untrained practitioners who are treating this imaging tool like an open cashregister drawer."

The article also stated ,

"In 1975, fewer than 5% of doctors did ultrasound in their offices, according to Harvey Klein, president of KleinBiomedical Consultants Inc. in New York. Instead, obstetricians referred patients to hospital radiologists. Butwhen "real-time" scanning came into the picture in the late 1970's, allowing fetal movement to be observed asit happened, the market boomed. Mr.Klein estimates that today, 75% of the country's 39,000 obstetrician-gynecologists have machines and do the tests themselves."

Representative Pat Schroeder, who co-authored the 1992 Mamm ography Qual i ty Assurance Act, whichrequires physicians and facilities to meet high standards before mammograms can be performed, stated thefollowing about fetal ultrasound, "The only thing worse than not having a sonogram is having a bad one." Inaddition, the article reported that the poor quality of ultrasound imaging was documented in a study in 1992, byU.S. Healthcare, in which they reported that in 141 second-trimester sonograms-the sonogram that is most crucialfor detecting defects in fetal structures-the heart, brain, spine and kidneys were most often poorly or inadequatelyimaged. In 1994, US Healthcare required obstetricians pass a certification program, of only which 36% passed!

In 1993, the Routine An tenatal Diagnostic Imagin g With Ultrasound Stu dy (RADIUS)was published intheAmerican Journal of Obstetrics and Gynecologyin which the benefit of routine fetal ultrasound screening oflow-risk pregnant women was conducted in hospitals and physicians offices throughout the United States. Whencompared to obstetricians or radiologists who practiced in a community hospital, the RADIUS study found thatthere was a significantly higher detection rate of serious birth defects if the ultrasound study was performed byphysicians who had extensive training in fetal diagnosis. For example, if the ultrasound was performed by anobstetrician or radiologist at a non-referral center, 0% of serious heart defects were detected! In another paperanalyzing the implications of theRADIUSstudy, it was reported that if screening ultrasound were performed byexperienced physicians, it was the most cost effective method for detecting birth defects. In this study, the authorproposed matching the cost of the ultrasound to the experience of the physician. If, for example, the obstetricianrarely detected birth defects, as reflected by the results of the RADIUS study, they should only be paid $50 for theultrasound examination. If their detection rate was higher, then they should be reimbursed accordingly. Thisconcept would save patients and insurance companies millions of dollars annually. The most important conclusionfrom the RADIUS study is that if the ultrasound examination is performed by obstetricians, community-basedradiologists, or their technicians, over 85% of major birth defects and virtually all (99%) serious heart defects aremissed! This is due to lack of experience of the physician who must divide his or her clinical activities amongmany different areas, thus precluding the necessary time required to develop expertise in this area of medicine.

What Is The Benef i t Of Having A Fetal Ultrasound Special is t Examine My Unbo rn Baby?

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While obstetricians may use ultrasound to determine the fetal heart beat during the first 12 weeks of pregnancy,or examine the amount of amniotic fluid in the last 12 weeks of pregnancy, serious concern has to be raised ifthey perform an examination of the fetus between 16 and 24 weeks of pregnancy to examine fetal anatomy.Because of the poor performance detecting birth defects as described above, patients should ask themselveswhether they should have their screening examination performed by a physician with expertise in examination offetal anatomy?

What Is Dr. DeVore's Detectio n Rate For Birth Defects ?

Detection Rate For Fetuses With Down Syndrome, Trisomy 13, and Trisomy 18

Since 1991, Dr.DeVore has conducted an ongoing study evaluating his detection rate for birth defects. Over15,000 patients undergoing genetic amniocentesis have been examined with ultrasound using the techniquesdescribed above. The results of Dr. DeVore's study were published in 2000 in Ultrasound in Obstetrics andGynecology. The results demonstrated that 91% of fetuses with Down syndrome were identified usingGeneticUltrasound. In addition, Dr. DeVore has published studies (trisomy 18,all chromosomal defects) in which hehas detected fetuses with other serious chromosomal abnormalities associated with women age 35 and older.

Detection Rate For Congenital Heart Defects

The expected number of children born with severe heart defects is between 2 and 3 per thousand births. In thestudy reported inUltrasound in Obstetrics and Gynecology, Dr. DeVore's detection rate for severe heart defectswas 4/1,000. The following lists some severe heart defects which have been detected during the screeningexamination of the fetus during the past several years.

Hypoplastic Left VentricleHypoplastic Right VentricleTetralogy of FallotAtrioventricular Canal DefectCoarctation Of The AortaDouble Outlet Right VentricleTransposition Of The Great VesselsTruncus Arteriosus

Detection Rate For Major Birth Defects In Low Risk Patients

Dr. DeVore's detection rate for serious birth defects during the second trimester screening ultrasoundexamination is over 20/1,000. This is 5 times higher than the rate reported in theRADIUSstudy for patientswho were examined by their obstetrician or community hospital-based radiologist.

What If My Unbo rn Baby Has A Bir th Defect?

If a birth defect is identified during the ultrasound examination, the findings are discussed with you in detail.Information will be offered to assist your obstetrician in rendering care for you and your unborn child to insure inthe best possible outcome.

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