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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.

(Source: http://www.cdc.gov/ncbddd/pediatricgenetics/pulse.html)

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

undetected.

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.

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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

rkoppel@nshs.edu

718-470-3440

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