Dr. Moises JACOBS (R)EVOLUTION

Hello, Professor Jacobs. Nice to meet you.

Nice to meet you. Good morning.

Good morning, Professor.

Good afternoon for you.

Yes, right. My name is Umberto Grandi. I'm from Ravenna, the northern part of Italy on the Adriatic Sea.

And I'm here with our close friend, Giorgio Palazzini, in his huge congress of the 34th in a row.

So, thank you so much for staying with us. What are you going to show us?

I implanted more than 150

we need you to keep implanting them

we need you to keep implanting them

I love Italy but I love the Italians even more

so thank you

you're welcome

Moses, what do you think is the best indication for Bariclip?

number one

in my experience

The lower BMIs, BMIs of 45 and so, do very, very well with the clip.

People who have reflux do very, very well with the clip.

And, you know, the new techniques that we're using have diminished the risk of slippage significantly, significantly.

And I think that's going to lead to even better weight loss than we've seen going forward.

So I don't think a BMI of 60 is the best candidate.

it, but a BMI of 40, 45

is a perfect candidate.

Especially if they have reflux and they don't want

a gastric bypass, because

the sleeves obviously create reflux

in a significant amount of patients.

And the clip

doesn't.

I think that's a really good indication too.

Okay, but we missed some

studies on reflux, isn't it?

Well, we

have, we're trying to do more studies

specifically for reflux,

but what I've seen is from your study and from other studies across the world

that the incidence of reflux with the CLIP is probably less than 5%,

closer to between 1% and 3% of de novo reflux.

And people who have reflux, like 90% of them are resolved because of the CLIP.

So that's the indication we're seeing.

We really haven't done any formal studies for reflux,

But in published studies such as yours, we've seen that the incisal reflux is much less than we see with the sleep.

Another good indication is people who want a reversible procedure.

It's reversible. It can be done as an outpatient.

People, once they have this, they may have some discomfort, but most of them don't have pain.

They walk out of the hospital the same day in two or three or four hours, depending.

Not everybody, but a lot of patients do.

and it's just a less mutilating operation it's less invasive it's it's a good starting place

for many many patients and not go to a gastric bypass in patients who can benefit from a clip

because they have reflux the other thing is in the youth in our young patients what are we going to

do with these patients are we going to keep them on medications forever or are we going to start

start them off with a sleeve in five years,

commit them to a severe episode of reflux,

and then change them to a bypass.

And then they're 25 and they're going to live to be 80 or 90.

So what are we going to do with these patients?

So I think the clip in the young adults and teenagers

is also a good indication as a starting place

because we have to take care of these patients for 60, 70 years.

And I think the future is going to be a combination of medications and reflux,

at least in your future maybe 30 years from now 20 years from now 25 and only be medications but

for the next 20 years or so I think it's gonna be a combination okay okay are you going to show

us a video of the procedure I did I didn't know what you wanted me to show you so I have a

presentation what I have but I guess that's not I don't know if you want a video I can get a video

for you is that what you would like no it's up to you it's up to you whatever whatever you feel

more comfortable it's good for us because it's a new procedure and we need

to know we are eager to know the best information that you can give us so well

I I'll do a presentation and I'll show a small video at the end great great can

you see this yes definitely yes okay well good morning I didn't know I was on

and my apologies it is a pleasure it is a pleasure to be here with you all it's uh like i was telling

paulo and it's you know i love it italy but i love the italians and and more than than italy itself

and italians have been very good to us over the years and it is an honor to be able to present

here to this conference today um what i'd like to talk to you about today is a few things number

Number one, what is the clip?

I'd like to show you some evolving results.

I'd like to show you, talk to you about slippages,

which are really the worst thing that can happen with the clip today.

And I would like to talk to you a little bit about the absence of reflux.

If we have time at the end, I'll show you a quick two-minute video.

Firstly, what is the clip?

Number one, what we can see here,

it is a titanium covered with silicone.

silicone uh and it's got an inner titanium um skeleton and this is a 15 centimeter length

device it has openings for suturings uh along the sides that are titanium covered so the sutures

don't give and they don't tear it is 15 centimeters in length um it is 11 millimeters wide

and it has an opening at the inferior end of two and a half centimeters which allows us to study

We studied the whole stomach via endoscopy.

When we designed this device, our main fear, and it still is our fear, was erosions,

because we all know that devices around the stomach lead to erosions.

So we designed this with computer aids to have a very low closing pressure of 4.15 grams per meter squared.

It is a lesser pressure than an insufflator band.

and what we wanted to do was just approximate the anterior and the posterior walls

with minimal pressure not so there would be no ischemia and no perforations and indeed i think

we did that we did that to the point that slippage became a problem not erosion because the pressure

is so low and closing that the stomach can slip through it back and forth and obviously we've

learned that over time and what you can see here is the titanium inside the uh the silicone and

and has the sutures, the spaces for suturing, and the opening at the bottom.

Here you can see the clip opens flat, and it goes through a 12 choker very easily.

What the purpose of the clip is, it separates the stomach into a restricted medial segment

and an excluded lateral segment.

And obviously, this mimics the sleeve, as you can see it coming down.

And that was the intent of our device, to create a reversible sleeve, basically.

There are no adjustments that are required.

This is not a band in any way, shape, or form.

Like I said before, it's a low closing pressure.

We can do an endoscopy and look at the whole stomach.

It is removable.

And as we found out through experience, it has minimal reflux.

This is a view of an endoscopy as we're going down into the esophagus, into the lumen.

and we're reaching the area of the uh of the entrum and here we can see an opening to the

in this video to the right or to the left the straight shot is to the left and in this video

and that is um the entrum and the pylorus as it goes down and you can see that we've created uh

using gastric entroplication we've created a small entrum and significantly reduce the entrum

with the entroplication which is something newer uh part of a newer technique that we've been using

in the last few years um and as we come back from the antrum we have to kind of retroflex

in this video it's very easy it's not sometimes it's not so easy um we retroflex and go into the

excluded segment that's through a two and a half centimeter opening and we now we're in the

excluded segment and we're looking uh uh at the uh level up towards the fundus and if i let the

video, if I were to let it play a little bit longer, you can see the pulsations of the heart

on the cardiac, on the fundus. So we come out, and this is what it looks like

through laparoscopy. We have the scope on the excluded segment, looking at the area of the

fundus. And here we're coming out, and you can see that the lumen that we created is very similar to

to what we can see in a gastric sleeve.

So our purpose was to create a removable sleeve,

and I think we've accomplished that.

This is what an upper GI looks like in these patients.

And again, you have to treat these patients like if they were sleeve patients.

You can't give them too much contrast to drink because it will create reflux.

It will create painfulness.

But the reflux that we see in these patients is not the typical reflux

that we're used to with a sleeve.

But you can see that the lumen that we've created is very small,

and it goes right into the antrum, very similar to what we have with a sleeve.

Now let me tell you about some of the results that we've seen over time.

So we published these results in 2017, six years ago more or less,

and we did 139 patients, and we followed them.

Originally it was for three years.

We ended up following most for close to five years.

And the technique that we used at the time, we were only placing three sutures anteriorly and three sutures posteriorly where the indentation of the titanium was to secure the clip to the stomach.

And, you know, we had good results.

Again, this is a study involved using different devices, different type of devices.

One were 15 millimeters, some were 13 centimeters.

I'm sorry, 15 centimeters, 13 centimeters.

The opening at the bottom went from 2 to 2.5 to 3 and back and forth.

So we were testing out different clips.

But basically the object of our study was to prove that it was safe

and to show that it weighed loss.

And our weight loss at 1, 2, and 3 years was really about 55% excess weight loss.

And it does taper down at years 4 and 5.

so we we think we achieved we're in the process of at that stage in our in our devices career

of achieving what we wanted to achieve that result of 139 patients there were no infections

no transfusions and no deaths thankfully there was a unfortunately seven percent slippages which

to me is very high and we had three rations in those patients and they were all with slippages

So, early on, we really equated slippages as being the major factor in the complications

from the CLIP, and we've seen that all erosions so far, as far as I'm concerned, as far as

I know and my knowledge, have been in patients that have slippages.

So, I'm going to show you two or three more studies.

now i don't want to go through a whole list but since we are talking to dr gentileschi i wanted

to start off with his study and he when he did the study it was an evolution in technique where

we started suturing um anteriorly more because we found out early on that slippages occurred

between the sutures so we with time and over the last years we've modified our technique and this

This is a – it's not the latest technique, I don't believe,

but it's next to the latest technique that Dr. Gentileschi published on.

And he had 50 patients, and he followed them for six months.

And his excess BMI and the total weight loss of six months were 57% and 22% respectively.

And let me remind you that in our own study a few years earlier,

obviously with a different technique, we had 55% at five years –

I'm sorry, at six months, in one and two years,

and Dr. Gentileschi at six months already had a 57% excess weight loss.

So I think the trend is positively going in the positive direction,

especially because of the change in technique.

In his study, Dr. Gentileschi had resolution of hypertension in 50% of the cases,

of sleep apnea in 65% of the cases, and diabetes in 80% of the cases.

cases. And again, he didn't have any mortalities, no infections, no transfusions, and no erosions.

And Dr. Gentileschi, if I'm wrong, if I'm misquoting you, please correct me. There were

three slippages in this study. One was at the second day post-op, and it was repositioned.

And I'm sure that was a slippage, but I don't know if it was a real slippage or it was a technical

misplacement of the clip originally. And there were two patients that required removal

was at 125 and 156 days.

And those are really called the real slippages.

And if you put those two patients over the 50,

we're down to 4% slippage rate.

So our goal was to get down to 0%.

So we started at 7, and with the evolutions in technique,

we're going down and getting better.

This is another study by Dr. Noël from France,

and he compared 176 patients worldwide

worldwide, using the older technique versus a newer technique, which is still a technique

in evolution.

And using the older technique, which was less sutures, the slippage was 4.5%, 4.3%.

And the newer technique, the slippage rate dropped to 2.8%.

And so we learned from the study also, because we figured out that to really get down to

to one or less percentage of slippages,

we had to suture gastro-gastro sutures over the clip,

especially at the superior, the proximal aspect.

That's where all the problems have really occurred with our slippages, superiorly.

So this is a third study, and this is also from Italy, obviously,

Dr. Professor Olmi, who is in the process of publishing this,

and this is a personal communication that I've had with him.

And I don't want to give away too much of his study,

but he had 80 patients, the average age was 46, and the initial BMI was 38, and at 12 months his

BMI of these patients were 26.8 percent. He had less, almost four percent complications,

two bleeds, which really bleeds is not very commonly in my experience, but obviously can

happen, and he had one perforation, and when I looked at the video, and I don't know if Dr.

only is in the audience or not but i'm very grateful to them also um uh when i looked at

the video i think it was a slippage that the patient came in late and it was untreated and

it perforated and and let me um show you uh how that can happen so these are two photos of

slippages um and what happens is you're looking at you're looking towards the uh towards the heart

towards the esophagus approximately and this fundus here should be on this side

it should be on the left side of the patient but it slips right through the

middle of between the sutures that we were using this is an early on video and

this is again the same process and this is the fundus going towards the right

side of the patient and it slips in between the sutures we had placed so these slippage videos

and these slippage photos help us realize that we needed to closely obliterate the spaces between

the sutures especially superior because that was the key to the clip not moving and not having

slippages but i also want to show you an after picture of removing the clip and and you can see

see that the stomach looks perfectly normal and endoscopically I didn't know how much time I had

it endoscopically it's a perfectly normal stomach so there's total reversible total removable

with no damage to the stomach so in summary as far as slippages are concerned this is the first

technique that we used we put three sutures superiorly where the indentations of the

titanium were and we put three inferiorly now we're placing um a total of three sutures in the

first two or three centimeters uh of the of the clip gastro gastro sutures uh and that's really

made all the difference because the slippage rates consistently been decreasing and now we think we're

about the the one percent or less worldwide and we put another suture inferiorly uh gastro gastro

sutures to make sure that the inferior portion of the stomach doesn't slide so we went from using

six sutures three anteriorly and three posteriorly to approximately nine or ten sutures but posteriorly

has always been three and the sutures anteriorly have now increased about six and placing sutures

anteriorly is not difficult posteriorly is much more difficult and that's the key to be able to

do a good place a good clip is you have to be able to suture and especially uh because placing those

three sutures posteriorly is more difficult than anteriorly anteriorly is fairly easy

but most surgeons bariatric surgeons know how to do this and and do this correctly so so basically

uh the evolution has in our knowledge uh slippages occur because the stomach slides between the

place sutures so the solution to this is to close those spaces by using gastro gastro sutures

especially at the superior aspect of the clip all erosions have been related to slippages

and now because we with our newer technique we can control slippages we can get place the clip

closer to the uh lesser curvature and closer to the incisora uh which which leads to uh smaller

lumens and greater restrictions and greater weight loss uh we're we're basically getting

results of weight loss as a sleep, no difference at all.

And we've added antralplication at the bottom to increase the restriction of the stomach

outlet for better weight loss, basically for better weight loss.

The last thing I want to talk to you about is reflux and the clip.

So going back to those studies that I mentioned at the beginning, Dr. Noel also published

to study a year ago where he looked at 35 patients and preoperatively eight patients

had reflux taking daily PPIs.

Postoperatively, only one patient was taking PPIs.

And he had a de novo reflux of one patient, which is for 3.12%.

So this is totally different than we see with the sleeve.

The sleeve, obviously, is the opposite.

it's close to 30 or more percent of reflux and the noble gird is 20 or higher if not more

dr marchesini from brazil and his uh pilot study also followed these patients for six months

and as you can see there's no reflux in any of these patients um up to six months and and that

continues for time if this clip doesn't move there is no and there is no slippage and no movement

there is no dilatation of the lumen of the clip so therefore the weight regain

should not be as severe as we've seen with a sleeve and obviously there is no

reflux either because it doesn't move and the reason that this the lumen of

the clip doesn't dilate with time if the clip is placed properly is because

there's a low pressure system it's a low pressure system unlike the sleeve which

is a high pressure system which makes the stomach dilate itself when we go

back to refer to Dr. Gentileschi's study, there was no incidence of de novo GERD in his study.

Dr. Ohm's study, he had 13 patients with reflux and 11 were on daily PPI. In the 12 months,

there was only one patient taking PPI regularly and no de novo GERD. So the clip is clearly,

clearly an advantage for patients who have reflux versus the sleeve in this regard. And why is it

that we don't see reflux with these patients

and I'm going to show

you here, hopefully it plays well

you can see that the patient

is drinking the

contrast and it goes down

into the antrum

and if they drink too much or too

fast or because there's an antral

placation here, they have to go slower

what we see is the lumen

the contrast coming back

into the excluded segment

therefore

patients do have reflux

but it goes into the excluded segment

and they don't feel it.

They just don't feel it.

We can see the same here

with this one. You can see that

this patient is drinking. They're giving him

a significant amount of contrast and it doesn't

empty completely but it goes back

up into the lumen.

These patients obviously have to eat slowly

and eat small amounts just like

we have to with the CLIP

but the difference is they don't feel the reflux.

To kind of summarize

a little bit, we've placed

1600 clips around the world and to date as far as I know there have been no deaths and that to me

it's important because it's a new it's a very new technique um there's a learning curve involved

in doing this technique and even so um and we're we've been placed in this technique in South

America um in Europe the Middle East uh and all over and so far as far as I know no deaths from

from the implantation of the clip.

And like I was talking a little bit ago to Dr. Gentileschi,

I don't know if I was on camera or not, or on video.

My problem that I have, what's going on in the world today,

is young adults or teenagers.

What are we going to do for these young people?

Are we going to treat them with medications forever?

Are we going to do a sleeve, which is really what we can do today,

and hopefully that they'll work for the rest of their life for 70 years.

We know that the sleeves cause reflux in a significant amount of patients.

We know that the sleeves dilate.

We know that nothing lasts forever.

We know that everything is temporary in some degree of time.

So I think for these patients, not the super, super obese maybe,

but the kids, the BMI is 45 to 50.

I think starting off with a clip and good nutritional counseling

and obviously everything that we do for our patients,

may be the way to start with these young people.

This is a Mexican boy.

He was 17 at the time, and now he's 20, and he's very, very happy.

But you can see the significant amount of weight loss that he's incurred.

And obviously, he receives nutritional counseling and psychological counseling.

And for him, life has been a struggle, but he's extremely happy.

And I'm sure we all have stories like this,

but I think the clip is the way to start in young adults.

I really feel that way, unless there's a contraindication.

So, with time, what we've all known is that, number one, the incidence of bariatric surgery around the world was 1% or 1.5% of all the patients only were being operated.

And I think that comes because people are afraid of surgery, and they want less invasive and less mutilating treatments.

And they want to make sure they don't hurt, they don't want to take any risks.

risks and obviously ozempic and the new drugs from lily have proven that i mean

bariatric surgery has gone down around the world by as much as 25 or 30 percent at least in the

united states it has and i and i think it will continue to decrease and more and more patients

are going to be taking these medications we know that these medications are forever and there's

going to be a pendulum swing back of people who want surgery or the ones that fail or have

complications but people don't want surgery they want less and less invasive surgery with time

and i think the clip is a it's a perfect answer for that uh i really believe that the future if

it's going to be uh some type of surgery and medications in my case the clip

and medications i i think we need to work together it's going to be a joint venture between surgery

and medicines to control these patients and again I want the clip because I'm

biased but I think the future is maybe some type of surgery and medications

going forward and the clip obviously offers the least invasive method and

finally today is Thanksgiving in the United States that's the day of giving

thanks so I like to give you a thank you for the privilege and the honor to be

presenting to you today so happy Thanksgiving to my Italian friends I

don't know if there's a lot of time left or not but if I can show you a very

small very quick video yes no problem at all we are we are eager to see also the

video so let's go ahead thank you so much can you see it no we still see in

those lights no we can't you can't can you see it now no yes okay yes okay so this is a two-minute

video and it's not really educational as such but it gives an indication so the first thing we do

is this is the angle of his and we are trying to create an opening uh by the angle of his uh

uh and medial to the spleen the next thing we do is um we open the greater curvature

and we used to open the greater curvature at the beginning of our of our experience only about four

centimeters today uh as my experience has grown i i make a big wide opening in the greater curvature

because it makes it easier to suture uh and placing the clip posteriorly the biggest problem

with a clip technically is the posterior suturing so we create this greater curvature opening then

we pass the clip retro gastrically and we use our instruments and through the angle of his we pass

the clip through the angle of his and then we close it around the stomach that's a closing

mechanism so now that we've closed it we can go ahead and suture the clip in

place firstly we pass a bougie and today like I mentioned before we try to get

even closer to the lesser curvature we actually pull on the on the

stomach laterally to make sure that we can exclude as much as possible then we

begin the process of suturing the clip and I'm sorry I wasn't prepared to show

a video this is the only video i have on this computer uh i'm not home so i'm traveling and

i apologize um i didn't have this video uh i didn't know you wanted a real video but this

clip shows that uh uh basically what we're suturing in place and this is the poster this

is the most this is the to me the most difficult suture which is the posterior ones uh you can see

we place three sutures posteriorly and then we we this is the the the flap is covering our sutures

that are covering our gastro gastro suture superiorly and this is the gastro gastro suture

inferiorly um basically this is what we have left we basically have a small lumen uh today this is

an older video and the gastric location today we're really putting this clip here here much

closer to the curvature we're actually pulling on the stone can you can you see me or how does

this work it worked the show it played okay yeah yeah we saw it we saw it okay can i can i say

something of course i want you to okay first of all uh congratulations because i think that this

idea of this procedure it's very smart and when I go to conferences to speak

about it many many people ask me but this is like a band I think it has

nothing to do with the lap and nothing nothing nothing it is a it is a vertical

restriction it's not horizontal restriction the prosthesis is much

longer and the restriction is a lot more efficient secondly I want I want to tell

you that I I did three cases of removal of the barry clip and in one stage a

gastric bypass and I have videos of that I'm telling you this because I think

I think that another good indication of the bariclip could be a first stage procedure to downgrade people with severe obesity to a second procedure which could be even more effective than a bariclip.

So I don't think it's only a procedure for low BMIs, but can be a good first stage procedure for people who are scared of having surgery at the first time or people who are at a higher risk for leaks and bleeding.

What do you think?

I agree wholeheartedly.

I never want to portray that there's a second procedure coming.

But we know that in bariatric surgery, everything's temporary.

and the sleeves grow

the bypasses get their own complications

have to be revised

but yes, absolutely

you can downgrade

I'm not saying that it's only

a first stage, I'm saying that it's

also a first stage procedure

I agree with you, it can be used

today we have medicines that can do

that also

today we have medicines that can do that also

yeah, but we are surgeons

yeah, we're surgeons

but we're going to have to play in this market

because people don't want surgery. I agree with you though, we are surgeons.

No, but anyway, it's a very, I mean, what I can say after my experience, I mean, I'm

still learning of course, I can say that it's a very safe procedure, really. I mean,

no leaks, I have to say no bleeding, even though the bleeding rate is reported, but

of course can happen and it's a very quick staying hospital staying

procedure because you don't I mean unless you make big mistakes there is no

chance of having a leak so I think it's a it has to be in the surgeons

armamentarium I think so too and I think people are very much attracted to the

the fact that there is no cutting and there's no removing the stomach and the anatomy stays in it

and if it doesn't work we can go to something else it's removable we haven't burned any bridges by

using this procedure and people are attracted to that patients want lesser and lesser invasive

stuff without a doubt so i think yeah i agree with you wholeheartedly what do you think of the

new guidelines for bariatric surgery we are trying to involve also patients with bmi lower than 35

So that could be a real big shot. Don't you think so?

Absolutely. You know, those criteria were criteria that were set in 1980, and they were with open surgery.

So people were afraid of bariatric surgery back then because of all the complications associated with basically gastric bypass, open gastric bypass.

passed so that's why they they created those criteria plus they wanted to limit the amount

of patients that had the surgery because of money or insurance reasons but those criteria are very

old and i think now we're more much more realistically we can do these procedures

safely in bmis of 30 28 um without any without even thinking twice uh as far as the risk to

the patients are concerned um so yeah i wholeheartedly think that the lower the bmi

the more the clip for sure thank you so much no thank you it's really a privilege and always good

to say hello to you paolo and to all of you thank you thank you sir so professor thank you so much

for staying with us and on behalf of professor palacini i just want to thank you for for your

presentation and for staying with us in italy also today and it has been great to have a second

second moderator, I mean

Paolo Zentileschi is of course

so familiar

and I'm not, that's why I just wanted

to ask you

he already

spoke about it

I was somehow worried about

the possibility of perforation

of this

device towards the

stomach, but I heard that

there is not such a risk

I mean

perforation as such, if there's a slippage

and it becomes like an incarcerated slippage,

like that picture I showed with that big fungus,

that kind of becomes like a semi-emergent situation

that has to be fixed in 12 hours or so or acutely.

But other than that, the risk of perforation is nothing.

So if there's no slippage,

the risk of perforation should not occur,

should not be there.

And erosions without slippages, we haven't seen either.

All the erosions that we have seen have been slippage.

One last thing.

when patients erode when the clip erodes it's not like an erosion with a band that creates an

infection and the port became infected or there was an infection or leaking into the abdominal cavity

because there is no tubing going to the outside so what happens when there's an erosion in these

patients the stomach slowly swallows the clip so with time if you give it six months four six

six months the whole clip is inside the stomach and now it can be removed endoscopically you no

longer have to do surgery on these patients either and there's no infection there's no peritonitis

there's no bleed there's no fever there's no white count there's nothing there's some discomfort to

the patient that's how we know patients lose patients lose restriction and patients have some

mild discomfort but it's nothing no emergencies that can be programmed electively you can even

any weight if you want to until the whole

clip is inside the stomach, and then remove it

endoscopically. That's convincing.

Thank you so much,

Professor. Thank you. Thank you. It's a pleasure

and an honor. Thank you, sir. Hope to meet you

in the near future. Thank you so much. Hopefully

very soon. Thank you.