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      The Practicing Parent: Newborn Heart Test

      30% of infant deaths in the U.S. are because of congenital heart defects. There's a new test for newborns which can help detect deadly heart

      problems, it's called Pulse-Oximetry.

      A light source and sensor measure the blood oxygen levels of the newborn. A healthy saturation is 96% or greater.

      Cohen Children's Medical Director Dr. Robert Koppel says it gives parents peace of mind. "Although we can't be absolutely certain that the baby doesn't have an

      underlying potentially lethal problem, we know that that's far less likely than it was a generation ago," Koppel said.

      There is some fear it can also lead to false positive results that are costly and stressful for the family, but a study out of Britain showed a false positive

      rate of 1 in 3,000 cases.

      Dr. Koppel believes early detection outweighs any negatives. "Treatment is so effective at saving lives," he said.

      Studies show 1 in 6 babies who die from critical congenital heart disease are underdiagnosed and unrecognized cases. An estimated 1,200 babies a

      year could be diagnosed sooner and infant deaths could be prevented if the Pulse Oximetry was routinely used.

      For hospitals that do have the Pulse Oximetry machine, the only additional cost is for use of the probe, which is about one dollar per reusable probe or

      $7-$8 for a single-use probe.

      More information:

      A pulse oximetry screening is now being performed on newborns

      across the U.S. with the exception of a few states. Newborns are tested for

      heart defects in hospitals just moments after birth to detect any potential or

      current heart complications. Before performing the screening, doctors place a

      probe on the infant's foot then they begin the screening. The blood oxygen

      level is measured by light source and sensors which determine how healthy the

      heart is. The test screens for the seven most vital heart diseases to save the

      lives of newborns and prevent further complications. This procedure provides

      comfort and relief to parents as they feel that their child is in good health.


      Depending on the severity of the disease, a child may or may not

      need to be treated. If treatment is needed, then a catheter or surgery can

      repair the irregularity. If the disease cannot be treated with the use of a

      catheter, then doctors perform open-heart surgery to fix the defect.

      Robert Koppel, MD, Medical Director, Regional Perinatal Center, Cohen

      Children's Medical Center of New York, and Associate Professor of Pediatrics,

      Hofstra North Shore - LIJ School of Medicine, talks about the test:

      What is pulse oximetry?

      Dr. Koppel: Pulse oximetry is a technology that's been around for quite a long

      time, it was developed in the 1970s. It's a noninvasive way of measuring the

      oxygen saturation of a patient's blood. And it relies on transmitting a

      specific wave length of red light through an extremity, such as a hand or foot

      or a fingertip. The device is able to interpret the amount of light that passes

      through the extremity and convert that in to a percentage of red blood cells

      that are carrying oxygen. It displays a number that's called oxygen saturation.

      Why is it needed?

      Dr. Koppel: Well it's very useful for all patients in terms of a vital sign

      that gives us an assessment of the oxygen status of the patient. And what we've

      known for some time now is that it can also be useful as a screening test to

      detect subtle degrees of decreased oxygen in babies who may have critical

      congenital heart disease. These are babies that may look pink to us when we

      just look at them using our eyes but in fact our eyes can deceive us. Although

      the babies look pink to us their oxygen levels may be slightly low and that

      might be an indication that they have a critical congenital heart defect.

      How easy is the procedure?

      Dr. Koppel: It's very simple. It's a procedure that's done on patients in the

      hospital very routinely, and is completely painless, and noninvasive. It simply

      involves placing a probe that has a red light on one side and a sensor on the

      other, and a cable that attaches to a device. And it gives us a display that

      tells us the patient's heart rate with the oxygen saturation, and it all can be

      done in less than a minute.

      How long have you been doing this here?

      Dr. Koppel: We were very early adopters of pulse oximetry screening. The

      initial reports came out in the spring of 1995 and by 1998 we undertook a

      clinical trial here at Long Island Jewish Medical Center. So we've been doing

      this for fifteen years. We've published our data and it's been incorporated

      into the collection of world literature that has now reached a point where

      governments, ministries of health, and departments of health have been able to

      endorse the use of pulse oximetry as a screen for critical congenital heart

      disease. It's really very quick; it takes only about a minute to get a reading,

      but we measure in two locations. We measure in the right hand as well as one

      of the feet. So the estimate is that the screen itself takes about five minutes

      from start to finish. It is completely painless; it's nothing more than

      wrapping something that looks like a band aide around the hand or the foot.

      Are all of them the same? I thought one only used the foot.

      Dr. Koppel: The nature of the test is that it can be done in one extremity, in

      which case it should be the foot but the current national recommendation is to

      do the right hand as well. The feeling is that by doing the right hand

      together with one of the feet you can increase your detection of one of the

      more common of the critical heart defects called coarctation of the aorta. The

      problem is that you might increase your risk of having a false positive result

      by doing two measurements. But on balance, the feeling is that if you can

      increase the sensitivity of the test to find the most common defect then it's

      worth the risk of having a few more false positives cases.

      What can be found and can these conditions be deadly?

      Dr. Koppel: The nature of congenital heart disease is that it's quite common;

      there are about one in 100 babies that have some type of heart defect.

      Thankfully, three-quarters of them are not considered critical. They might

      cause problems after a few weeks or months but they're not likely to be lethal.

      However, one in four babies with a heart defect has what's called critical

      congenital heart disease. That's defined as a heart defect that requires some

      type of intervention during the first year of life. So the problems that we're

      screening for with the pulse oximetry are for that category, the critical

      congenital heart disease. Most of those babies can be picked up with pulse

      oximetry because these are conditions that result in a decreased oxygen level.

      But there are some that may not and for that reason pulse oximetry screening

      was never intended to replace the physical examination. Pediatric caregivers

      are still expected to perform a detailed physical examination and discharge

      instructions to families should include instructions on signs to watch out for.

      The signs to watch out for might be blue discoloration or difficulty feeding,

      rapid breathing, etc.

      So mom, or mom and dad come in; tell me how the process works, when do you guys

      tell them about it? And when does this baby get tested?

      Dr. Koppel: Well, this is part of our routine newborn screening process. Which

      New York State has been a leader in since the very beginning when newborn

      screening first started in the 1960s. Most newborn screening is traditionally

      based on the collection of dried blood spots from a heel stick. And the blood

      is sent off to a lab in the state's public health lab where screening is done

      for over 45 different disorders. But more recently, newborn screening has

      expanded to include physiologic testing for conditions such as hearing loss.

      And now pulse oximetry screening is added to that list of other conditions for

      which we screen babies. So the way we do it here at our hospital, is we wait

      until the babies are at the time point where they need to have their blood

      spots collected for the state screening. At that point, we bring the baby back

      to the nursery and before we obtain the blood spots we put the pulse oximetry

      probes on the baby and perform the screening tests at that time. It's

      recommended to wait until after 24 hours for the blood spot collection. And in

      addition, if we delay the pulse oximetry screening beyond 24 hours we minimize

      the risk of having a false positive result. That is the time point at which we

      do the screening.

      How much is the piece of equipment to do it?

      Dr. Koppel: The device itself varies according to manufacture, but it's

      generally on the order of about $2000 per instrument. The probes may either be

      reusable or disposable probes. And the guidance from national agencies is that

      either is acceptable. There can be significant cost savings by using reusable

      probes that just need to be wiped down with alcohol between patients. Other

      hospitals however choose to go with disposable probes. So by using reusable

      probes the per patient cost works out to approximately 50 cents, and disposable

      probes range between six to thirteen dollars each.

      And these are something that you would bill to insurance or if they don't have

      insurance, the patient would be charged for it? How much is it for the test to

      be done?

      Dr. Koppel: National agencies are currently working with the insurance industry

      to try to develop an appropriate system for billing for this procedure. In the

      meantime, governments have mandated that the screening be performed, and it

      often becomes an unfunded mandate which hospitals pick up. But then hospitals,

      in all likelihood, transfer this into other patient costs. There was a paper

      that appeared in a pediatrics journal paper out of the CDC that illustrated how

      cost-effective pulse oximetry screening is compared to many others screening

      mortalities. And in fact, of the costs per patient to perform the screen and

      the cost per quality life year that saved by detecting heart defects, the

      performance of pulse oximetry as a screening test is extremely favorable.

      So you weren't surprised?

      Dr. Koppel: That's right. The report came as no surprise because the test is so

      easy to administer at such a low-cost with excellent performance

      characteristics in terms of sensitivity and specificity. The treatment is so

      effective at saving lives that it was very obvious from the outset that the

      cost-effectiveness data would be favorable. Having said that I should point out

      that in metropolitan regions pediatric echocardiography is widely available.

      There have always been concerns voiced about implementing this type of

      screening in suburban and rural locations across the country where pediatric

      echocardiography may not be as easily available and where abnormal pulse

      oximetry screening test may require ambulance transport of the patient to a

      larger center. But these fears are turning out to be unwarranted because the

      data is being collected from programs all across the country, indicating that

      it's in fact very rare for a baby to have to move by ambulance. And the few

      babies that are moved by ambulance do turn out, in the vast majority of cases,

      to have a critical congenital heart defect that would have required transport

      even if the baby had become symptomatic.

      How much of a lifesaver is the pulse oximetry?

      Dr. Koppel: It's difficult to know because up until this point, where pulse

      oximetry screening has now been recommended for wide split--widespread

      implementation, the data collection mechanisms have been somewhat incomplete.

      But we have estimates that the number of lives that we can expect to be saved

      each year in the United States with universal pulse oximetry screening will be

      somewhere between 20 and 100 babies saved each year. That is, protection of

      somewhere between 20 and 100 babies from death, but that doesn't include the

      expected number of babies who will be protected from severe neurologic injury

      among survivors of the late diagnosis of critical congenital heart disease.

      What's the downside of pulse oximetry?

      Dr. Koppel: Well the downside is that it is not yet at a point where it's able

      to detect all types of critical heart disease. The one that is most common is a

      condition called coarctation of the aorta where there's a narrowing in the

      aorta and we're only able to find about half of those cases using our current

      method. So there is the need for ongoing research to develop additional tests

      to improve our sensitivity for finding babies with coarctation. The only other

      downside is that, like any other screening tests there is the risk of a false

      positive where we think that the baby has disease but ultimately we do

      electrocardiogram in find out, in fact, there is no disease. And conversely,

      there's a risk of a false negative where, as in the case of coarctation, the

      test results are normal but the baby still has the disease that has gone


      Anything else you want to add?

      Dr. Koppel: Well, I would simply say that we're at a point we are able to do so

      much for babies who have congenital heart disease. And it's very disappointing

      if we have a baby that has fallen through multiple layers of safety in terms

      of detection of the critical heart defect. We have a duty to diagnose. And if

      there's anything that we can do to improve our clinical abilities and we have

      to overcome this idea that we're outstanding clinicians that can detect lewd

      discoloration using our eyes only. So we need the help of the pulse oximeter as

      an instrument that aids in the detection of low oxygen levels.

      This information is intended for additional research purposes only. It is not

      to be used as a prescription or advice from Ivanhoe Broadcast News, Inc. or any

      medical professional interviewed. Ivanhoe Broadcast News, Inc. assumes no

      responsibility for the depth or accuracy of physician statements. Procedures or

      medicines apply to different people and medical factors; always consult your

      physician on medical matters.


      If you would like more information, please contact:

      Robert Koppel, MD

      Medical Director

      Regional Perinatal Center

      Cohen Children's Medical Center of New York

      Associate Professor of Pediatrics

      Hofstra North Shore - LIJ School of Medicine