Reflux1: When
did you know you wanted to be a doctor?
Dr. Noar:
In the fifth
grade. There was no particular event that occurred; however, I
think one reason was because my grandmother was seriously ill at
the time. When I was a kid I was always the one playing the medic
as opposed to the solider. It just felt right for me.
Reflux1: How
did you choose the field of gastroenterology?
Dr. Noar:
When I was in
medical school I did a rotation in gastroenterology. What
impressed me was that was the diseases, diagnosis and treatments
were very logical and physiological. It just felt like the right
thing for me.
Reflux1: Can
you explain some of your inventions?
Dr. Noar:
Well in my early
career I developed a series of medical simulators designed to
teach people to perform endoscopy and gain experience prior to
getting into the actual situation with their patients. This was
quite a lively field in late 80s and early 90s that has
essentially fallen by the wayside. We had a number of simulators
in advanced biliary and pancreatic techniques as well as plain
upper endoscopy and colonoscopy. I was not the only one in the
field. There were a couple of others. We even had a couple of
scientific symposiums that were developed. For the most part the
field is quite small as this point, and there is an ongoing use
now. We’ve moved away from the computer model, which, of course,
was resource intense – it required a plug! And a computer! I went
from simulation to then developing a porcine or live pig models
for instruction. Using this model we ran a number of international
courses to advance biliary and pancreatic techniques. At this
point in time, medical stimulation is now more of a curiosity than
a tool.
Reflux1: What
kinds of changes have you seen in the last five years for the
treatment of reflux and GERD?
Dr. Noar: The last five years have been phenomenal for
treating reflux. Up until five years ago we essentially had two
options, other than lifestyle changes. There was a wonderful class
of multiple medications called proton pump prohibitors and the
surgical procedure called fundoplication for refractory reflux –
although that had its own problems. The biggest change has been
the development of endoluminal or outpatient endoscopic treatment.
Reflux1: Is the
Stretta procedure endoluminal treatment?
Dr. Noar:
Yes. Rather than
using an incision with a laparoscope, endoluminal treatments are
performed by putting an endoscope through the mouth. It’s far less
invasive. There’s no anesthesia required. There’s also no
post-procedure limitation in terms of activity or returning to
work.
Reflux1: How do
you rate the various procedures for treating reflux?
Dr. Noar:
I was the first
to adopt these new practices outside of formal clinical trials,
with particular reference to the Stretta procedure, so I’ve had an
opportunity to evaluate every other technology that has come along
since. With regard to other endoluminal procedures available, I
made a conscious decision to turn away from the Enteryx procedure,
which I did for two reasons. One is that I think the implantation
of foreign bodies, unless we are talking about titanium implants,
is fraught with a number of problems. The human body does not take
well to foreign implants, and it will do whatever it can to remove
them. We know this because we used to use cyanoacrylate, which is
essentially crazy glue, to stop bleeding. The cyanoacrylate would
form a mold of the blood vessel, and within several weeks, the
body would react to and wall that material, after which it was
spontaneously pushed off into the body and end up in the stool.
Back before they had metal surgical clips, gallbladders were
removed with standard sutures placed on the cystic duct. In some
patients we would subsequently have to remove stones from the bile
duct. At times a specific type of stone was found, called a suture
stone because it has multiple arms. When this type of stone is
pulled out, there would be a suture in the center of it, but the
suture never existed inside the bile duct. Instead, the body had
transported the suture into the bile duct, in an effort to remove
it from the environment. Any foreign body implantation is really
problematic since the body will react to it, and it will create an
inflammatory response.
My greatest fear
with Enteryx was that since this was a deeply placed implant below
the submucosa there was going to be an inflammatory response that
would cause erosion in nearby body organs – which is exactly what
happened. While there may be a placement issue also involved, this
was something the body reacted to irrespective to whether it was
placed properly or not. For me it was always a concern.
Gatekeeper was
pulled off the market for reasons that have yet to be made clear.
There have been no extensive trials published so we don’t have
enough information in regard to side effects. To date everyone
treated was within the study but the product was not officially
approved.
Reflux1: What
do you like about the Stretta technique?
Dr. Noar:
One of the things
I like about the Stretta procedure is that it’s not a quick fix.
It’s not something that gives someone instantaneous Relief from
reflux. This is a procedure that is largely dependent on the
reduction in nerves or nerve synapses in the sphincter muscle, and
can take up to a full year before its final effect is seen.
Typically we have patients who get better slowly over time but
with sustained Relief.
What attracted me
as well is that there was a lot of basic science that came before
the device was developed. There was a lot of research about reflux
and the mechanisms of reflux. In order to have muscle contract you
have to have nerves firing. For a sphincter, the normal resting
state is contracted, so there is no nerve action required to
contract the sphincter. In fact, it’s the opposite. You need nerve
action to relax the sphincter. Once that became clear that one of
the problems occurring was too much relaxation taking place, the
development of a device designed to destroy some of those nerves
so the sphincter would stay closed in its natural state more
often, made enormous physiological sense for me.
Reflux1: What’s
the learning curve for the Stretta procedure?
Dr. Noar:
Probably about
five cases. The reason is that we have developed good quality in
vitro models that make it very easy to learn and perform the
procedure. The only way you are permitted to perform a Stretta
procedure, is if you are proctored by an experienced physician who
has done the procedure. There is a great deal of control in the
teaching. So it’s a simple procedure to do and to the
manufacturer’s credit they require training before they will even
sell you the device.
Reflux1: Are
there any side effects from the Stretta procedure?
Dr. Noar:
There are no
sustained side effects. Immediately following the procedure some
people might have some discomfort in the chest area that may last
anywhere from 24 hours, perhaps up to two weeks is the longest I
have seen. There is never any difficulty swallowing. Nausea and
vomiting is not something we usually find. I would say just that
chest discomfort is the most common thing that people report.
There have been no long term side effects.
Reflux1: Do
people need to get the procedure done again?
Dr. Noar:
Not normally, but
it is possible. We do have a subset of patients who actually began
having symptoms again after 2-3 years. We have done second set of
Strettas in a small selective group of these patients, and we find
that as long as they responded to the first treatment, they
respond quite well to the second Stretta. Another group of
patients, who respond extremely well to the Stretta procedure, are
in people who have had the surgical procedure of Nissen
fundoplication and failed. These patients respond virtually 100
percent of the time.
Reflux1: Do you
think we are seeing more reflux disease or have we just become
better at diagnosing it?
Dr. Noar:
I believe there
is more and more reflux disease occurring.
Reflux1: Why is
that?
Dr. Noar:
I think it is due
to a multitude of factors. Certainly one of them is dietary, which
leads to issues of obesity, especially in the Western world where
this disease is becoming rampant. Obesity clearly drives this
disease, as does the overuse of stimulants such as caffeine-based
products. But I think there is another equally important and
frequently overlooked factor and that is stress. When we talk
about the stressful lifestyle there is a significant increase in
acid secretions. People are eating more; there’s a tendency to
swallow more when you are under stress, which promotes reflux.
It’s not unusual at all to see a patient with significant reflux,
and by simply recommending stress reduction techniques – if they
follow them – their reflux can improve significantly.
Reflux1: With
all the Starbucks out there, do you think we are going to see
younger and younger people with reflux?
Dr. Noar:
We already do.
Reflux among younger patients is already present. It is also
important to realize that people who are older and have symptoms
were refluxers when they were young. In my opinion, the only
difference between someone in their 40s and 50s who has to take
medication for their reflux is that when they were in their 20s
they still had reflux but their bodies were young enough to repair
the damage. I suspect we are seeing increased acid production
through stress, overeating and obesity, which once again leads
people to a continued prolonged disease state, which their body as
a difficult time managing over a long period of time.
Reflux1: Are
patients using the proton inhibitors eager to get off the
medication?
Dr. Noar:
There is data
beginning in 1988 that shows extraordinary safety and efficacy for
the proton pump inhibitors. So we are looking at a decade and a
half of safety data for those medications. These drugs are very
safe with regard to the patient. While there is a small group of
patients who don’t want to take medication, most of them are just
as happy – if the medication is working – to take one pill a day.
It doesn’t bother them. As long as they have insurance to pay for
the medication, and it doesn’t cost them too much.
Reflux1: Do you
see the Stretta technique eventually replacing the medications?
Dr. Noar:
I don’t think so.
If we look at the number of refluxers in the country taking daily
proton inhibitors, I think we are looking at approximately 40
million cases. Out of those 40 million adult refluxers, you have
perhaps five or six million who are refractory to their
medication. So they are taking at least two of these proton pump
inhibitors per day and still having significant reflux. Again
that’s in the U.S. alone. Those are large numbers. Even if every
gastroenterologist could perform the Stretta procedure, it would
still take years and years to treat everyone.
Reflux1: That’s
a lot of heartburn!
Dr. Noar:
Well that’s just
in this country alone. In some parts of the world such as the
Middle East, like in Iran or Turkey, 25 percent of the population
has significant reflux. Another vitally important group is
children. This is probably one of the most tragic groups, because
there are really not a lot of options available for them. The
results from the typical procedures, such as the Nissen
fundoplication, are uniformly horrible. Based on recent figures
I’ve seen, there are probably four to five million seriously ill
refluxing children in the U.S. alone.
Reflux1: Are
they too young to have the Stretta procedure because they are
still growing?
Dr. Noar:
From some initial
studies we have performed, it appears that the wall thickness of
the esophagus is pretty much the same in adults and children. So,
we are beginning to look at different subsets of children who
might benefit from the procedure. But I must emphasize that we are
really in the infancy of looking at the pediatric population.
There was one reported study of the treatment of eight or nine
children that was done in the age range of 8-10 in which they have
seen some improvement. We are getting ready to do more extensive
studies.
Reflux1: So is
having an endoscopic treatment a last resort for adult refluxers?
Dr. Noar:
The way I view
the endoscopic treatment is you have to make a good faith effort
to change lifestyle, and then you have to demonstrate that you are
a treatment failure, in terms of medication use. So for me, I
reserve the endoluminal therapy for those people who are still
having significant reflux symptoms despite taking at least two of
the proton pump inhibitors class of medication, and showing a good
faith effort with control of lifestyle.
Reflux1: How
does that go over with patients when they come to see you and you
tell them to lose weight and clean up your lifestyle? Aren’t most
people looking for a quick fix?
Dr. Noar:
Everyone is
looking for a quick fix. Most of the people are never going to
achieve those lifestyle changes. However, those who succeed
usually see significant improvement in their reflux symptoms.
Reflux1: Why is
that?
Dr. Noar:
In a word…
Stress. It’s too difficult to change. In the western world, we
live in the horn-of-plenty, and it’s very difficult for people to
change what has become a habit over the years. Overeating is the
result of trying to satisfy some of those stressors. We live a
very fast-paced lifestyle, and you are expected to have high
productivity. You are expected to do more and more. People are
holding down multiple jobs. It’s hard to stay awake without
stimulants.
Reflux1: Have
you had any patients who followed your advice and no longer needed
the surgery?
Dr. Noar:
Oh yes, and it’s
an interesting group of patients. With some patients who were
actually scheduled for the procedure, I have about half a dozen
who failed to show up the day of the procedure. We never heard
from them. Then about a year or two later, I ran across them, and
asked them what happened. They will tell you that instead, they
changed their diet, controlled the stress, eliminated caffeine,
chocolate, weren’t drinking alcohol any longer, lost a bunch of
weight, and they felt the best they ever had in their entire life
and had no symptoms. So it does happen.
Reflux1: How
knowledgeable are your patients when they come to you?
Dr. Noar:
The vast majority
of them will know a little bit, such as, “I understand there is a
new procedure that doesn’t require surgery to fix my reflux.” But
that is about the extent of it. We use a series of visual aids on
videotape or CD, as well as printed material. Then we spend a lot
of time explaining to them why we are doing this procedure, and
provide them with the expectations of what happens after the
Stretta procedure.
Reflux1: Do you
think we expect more because of all the new technologies being
introduced to the public via the media?
Dr. Noar: I think most people are skeptical when presented
with the possibility of using this technique. The nice thing is
that now when we are looking at the four year data, (we’ve done
the two year and then three year prior to this), we are able to
provide patients with numbers to help adjust their expectations.
Since we don’t know what the five year data is going to look like,
I think that’s why this procedure is not being offered to people
with reflux who can control it with medication. When a patient is
well controlled on medication, doctors are reluctant to offer the
procedure. When the five-year data becomes available, we will have
something more substantial and convincing to show.
Reflux1: What’s
so important about year five data?
Dr. Noar: Five years is kind of where physicians draw the line
in the sand for durability of action. We are about to see enormous
changes take place in this field of reflux and reflux correction,
because at this point, we have the five-year data that shows these
procedures are successful and cost effective. For the refluxing
patient this is a great time, because they will have a number of
alternatives they can turn to. Some people say that it’s bad that
Gatekeeper and Enteryx are gone. In fact it’s actually a natural
vetting of the developmental process. The safe and effective
procedures will survive and rise to prominence. So this is fairly
historic, considering what is about to happen in the field.
Reflux1: Do you
have a favorite piece of technology that makes your job easier?
Dr. Noar:
Just one? I would
say if I had to point to one singular piece of technology that has
made a huge difference is probably the computer. Only because we
have much more rapid access to patient information, data analysis,
and communication. That’s something that has been a huge boon to
us. Just the endoscope alone has been an enormous technological
advance. To be able to look inside non-surgically, and see what’s
wrong without having to guess makes the endoscope a revolutionary
and phenomenal tool.
Reflux1: What
kinds of breakthroughs in the technology would you like to see in
the future?
Dr. Noar:
I would like to
see a greater array of wireless devices that can be temporarily
implanted inside of patients that would give us more information
about what is happening inside the gastrointestinal tract. Now we
take pictures, and we can measure pH. But there is a lot of what
we don’t know about the human gastrointestinal tract and how it is
related to hormones and processes. To be able to map, locate and
document, without having to be morbidly invasive would be a huge
boon.
Reflux1: What
do you consider your biggest challenge in treating reflux?
Dr. Noar:
Nowadays it’s the
current insurance environment or reimbursement environment. There
is a great deal we can do for people whether it be a medication or
one of these endoluminal corrections techniques, but we still have
such enormous reluctance and resistance on the part of the third
party payers to pay for any of that. We have significant number of
patients who can’t find treatment or afford treatment because
their insurance companies will throw up roadblocks.
Reflux1: Is
that because they don’t recognize reflux as a disease?
Dr. Noar:
No I don’t think
it’s that. There has been revolution in the last 10 years in the
medical system in the country and spreading to others, where the
insurance companies simply don’t want to pay for anything. It’s
not just in the field of gastroenterology. The overriding
environment is pay the least possible, if you have to pay anything
at all.
Reflux1: Is
your practice mostly referral?
Dr. Noar:
Yes but there a
number of patients who come to us because they have heard we do
various things they’re interested in. I literally have patients
from around the globe who will call up and want to come in to have
a Stretta procedure. There are probably more procedures done
outside the U.S. overall. I think at this point it’s well over
10,000 worldwide. Perhaps even close to 20,000.
Reflux1: How do
you meet the challenge of staying up to date with all the new
technology?
Dr. Noar:
I think you just
have to read, voraciously, everything that comes out from
different places. I tend to focus on the literature around the
world and literally everything that comes out from around the
world and maintain an open viewpoint towards any new ideas. The
other important thing is to spend a lot of time looking at the
posters at major meetings. Usually the things that are selected
for presentation have been digested for a number of years before
they have reached a certain nexus where they are ready for prime
time. Then they get accepted for presentation and publication. The
new ideas, the new thoughts, which are not ready, are almost
always in the poster sessions. And that’s where you can pick up
some phenomenal understanding of new processes coming along. It
gives you an idea of what’s going to work, what’s not going to
work, and what are some of the issues. It’s much easier to pick
technologies that will work.
Reflux1:
How do you handle the demands of having a practice, doing research
as well making inventions?
Dr. Noar:
It is difficult
to juggle so much. I am just a very high-energy person, who is
excited by new ideas and processes. I admit that I do not sleep
very much, and I just seem to turn the normal daily stress of life
into productive energy. Most important is to surround yourself
with a competent staff, always be open to new ideas, and never
close your mind to anything. I am fortunate in that I don’t seem
to be affected by normal stressors as much as others. I can
honestly say I don’t have any reflux. I don’t have any symptoms or
illnesses. I don’t take any medications. I guess I have different
coping mechanisms. I thrive on it as opposed to being paralyzed by
it.
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