ICOR 2021

Yeah. Hi, my name is Milton Alfonso and I'm here

to talk to you about Ike or the international cardio

sell outcomes registry.

I'm a surgeon at the Queensland Children's Hospital in Brisbane

in Australia.

I moved here in June 2012 from all the children's

hospital in Liverpool in England.

And soon after the movie, I was requested by my

former colleague Tom Karl to consider using calm yourself.

My only condition at the time was that we collect

prospective data and the prospective data collection continues to this

day and has now expanded into something more ambitious namely

I car.

Yeah. Yeah.

So what is cut yourself kill yourself is bovine pericardium

that has been subjected to the adapt and the calcification

process. The adaptive process transforms the bovine pericardium into an

a cellular, strong pliable collagen scaffold all the notices for

calcification including nucleic acids, alpha gal episodes, cells and cell

remnants. And forceful methods are removed.

The pericardium is then strengthened by cross linkage with mon

America Blue Rally hype.

The final step of the process and was detoxification by

removal of the residual value add careers health comes stored

in sailing and is available in different sizes off the

shelf based on our experience with carry yourself over the

past nine years.

We have published three peer reviewed articles on its results.

This was our first paper published in the seminars of

thoracic and cardiovascular surgery in 2017.

This was a purely histological study using conventional and immuno

history chemical staining on six X plants, none of which

were related to call yourself.

And the study demonstrated that there was no calcification in

any of the six implants.

But there were signs of early remodeling with new fibroblasts,

collagen deposition, new and timor formation and new revascularization.

Yeah. This was our first clinical Paper published in the

interactive cardiovascular and thoracic surgery journal in 2018.

It involved 135 patients all from our center.

And every patient in the study had completed 24 months

of flour.

The freedom from re intervention was 96 of two years

and 95 of three years.

There was no difference in performance in the systemic versus

the pulmonary circulation and between units, infants and older Children.

He then went on to publish a multi center study

in the annals of Thoracic surgery in 2019.

The study involved three centers to in Australia, Brisbane, Melbourne

and one in the UK.

The study involved 377% 377 patients.

The freedom from the intervention at three and 5 years,

96 percent.

Yeah. And once again there was no difference in performance

in the systemic opinion, every position or between the inmates,

infants and all the Children.

Which cardio cell was first developed by a company named

Admiral. Is that is based in Malaga in both in

western Australia.

The factory is still in Malaga.

I have been to the factory.

All the bovine pericardium is sourced locally And 95 of

this bovine pericardium is rejected because they focus on obtaining

patches with uniform thickness.

It's an absolute priority for the company.

And our histological study demonstrated that the cardio, which was

uniformly 400 migrants and thickness carousel nears even thinner.

They select the tennis parts of the pericardium.

It's uniformly 200-300 microns in thickness, making it a good

match for pulmonary artery and wild repairs, especially in the

younger Children.

Uh huh.

I said I alluded to earlier.

We first began using carrier school in October 2012.

2 centers that began using it at the same time.

One was asked the other was the Royal Children's Hospital

in Melbourne in Australia.

Call yourself is used under the T.

J. The therapeutics Good Administration's special access scheme.

Yeah. Currently it's used in over 25 countries across the

world and it's becoming increasingly recognized as a viable alternative

to other mainstream materials for reconstruction in congenital heart defects.

Mhm. As of today, cardio cell is being used in

prison, pull it Melbourne in Australia.

And the starship turned into hospital which is the only

Children's hospital in New Zealand.

Yeah. So now moving on to I call what distinguishes

the registry is supposed to regional statistics in a registry.

You collect some information on all patients in a research

elevation, collect all the information want some patients in the

registry. Where a systematic collection of a clearly defined set

of health and demographic data that is held in a

central database and its very nature makes it more powerful

than multi center studies.

Yeah. From the perspective of using cardio.

So what is that?

We would like to see from my core the collection

of demographic details diagnosis, risk factor, operative details, morbidity, mortality,

follow up three interventions and any possible astrology from England

on the entire cardio self family.

The data should be collected prospectively and ideally we'd like

longer term follow up.

There are to be entered into icon periodically.

Our vision is to foster systematic multi center collection of

data relating to the implantation of cardio self because people

have large numbers in different economic locations.

This will enable meaningful statistical comparison between groups and then

we can use this knowledge taylor and improve outcomes.

In order for I call to work.

It needs to be based modern technology and huge approved

to a large extent.

Okay, we need a secure online application for building databases.

The application must be highly versatile, must have customizable reporting

functions must walk across various platforms.

Both Mac and hand Roy.

And the data must be exportable into a wide range

of formats so that you can prepare reports or conduct

research studies.

There are several obvious benefits to having a registry of

this nature to describe the use of cardio sail across

several centers.

We can produce annual reports.

Daniel reports will give us basic demographic data uh information

about the utilization of cardio sale in different centers in

different anatomical locations.

Okay. Mhm.

We will be able to determine the early and late

outcomes after surgery using card yourself from a research perspective,

prospectively collected data is very valuable.

Yeah. Okay.

The large numbers of patients and different anatomical locations, different

age groups makes for meaningful statistical comparison.

All this information we'll give true meaning to the word

informed consent.

Yeah, yeah, importantly, the analysis will enable us okay from

a surgical perspective to understand what cardio self doesn't perform

as well as expected and we can tailor our surgical

strategies as necessary.

Okay. From the developers, person developers perspective this is more

like a dream.

Okay, that's good.

And there's another major intangible benefit.

Ah That's a very small subspecialty.

And with I call we get to make friends.

I call already has a government structure in place.

There is a steering committee and the steering committee will

always have either the director or nominated surgeon from each

of the contributing billets.

There's a management team.

Um the data custodian for the database Jessica sooner is

a clinical research manager.

General Johnson is a clinical data manager.

KIM Bets is the statistician, helps generate the reports and

do all the research work that comes out of icon.

It is the responsibilities of the management committee primarily to

communicate with participating centres, provide advice and help with committing

ethics or completing ethics and governance applications, designing content forms

for each institute, validating data as best as possible, generating

an annual report, facilitating research projects and for purely logistic

reasons. We plan to focus on Australia and new Zealand

and the countries in the AsIA pacific region in the

first instance.

But there are no barriers.

Any unit across the world that is using Cardio self

wants to submit.

That is very welcome to join.

Icahn requires ethics approval at the various centers and for

all the units that are currently contributing data.

We not only have ethics are proven, but we have

data sharing agreements across borders.

one big advantage of setting all this up up front

is that it makes engaging in multi center research projects

fairly uncomplicated from a governance perspective.

Okay. Yeah.

From a database standpoint has been developed in Red Cap.

The research electronic data capture.

Red Cap is a secure web application for building and

managing online surveys and data bases.

It was developed by a team at the Vanderbilt University

in Nashville in Tennessee and while it can be used

to virtually collect any type of data in any environment,

it is specifically geared to support online and offline data

capture for research studies.

Okay. The current time, the red crab consortium, which is

a vast support network of collaborators, is composed of 5000

active institutional partners in 141 countries With 1.7 million users.

And this data is accurate.

As of April 2021.

Red gap has several advantages.

From an I cord perspective, it's highly versatile, it's very

user friendly.

I it's free for any users.

All we do is pay a small annual field uh

for housing the server, uh Children's health Queensland or rather

in our hospital.

It works across all platforms and across all devices.

It works on any computer, It works on any laptop,

it works on any mobile phone.

The data is very easily exportable into a wide range

of formats.

You can run customizable creation simply export those queries into

Excel. For example, I wanna really very good example of

an existing international, existing bi national registry that has been

very, very successful uh, is the Australian new Zealand Fontaine

registry. Red Cap my I call is housed on a

secure Children Children's health Queensland.

So we're here in Brisbane as of now, as the

management team.

We are we are moving to face for the Red

Cap database has been designed and tested.

We have all the ethics approvals and network agreements for

data sharing amongst the Australian centers and they a few

international centers.

We completed a pilot data envy data export and generation

of an annual report and we are now ready for

a wider rollout.

Okay, okay.

But Brisbane and Melbourne actively contribute to icon.

Sydney has not started using Cardio sellers yet.

New Zealand has recently started using Cardio cell and has

joined the corners of April 2021.

We have contributions from the university hospital in Leicester, Children's

Hospital in Kuala Lumpur in Hong kong in Singapore.

You're walking through data sharing agreements as of April 2020

money but they have committed to participating in icon.

What is it that we are looking to collect an

icon? It's all fairly straightforward.

basic demographic.

There are like age, gender, primary diagnosis and country, right?

Primary and secondary procedure.

The type of patch the size of the patch, whether

it's cardio, sailor, Carlos, Phil neal.

How many patches, what locations the patches were used.

That whether or not the patient at any re operation

related to call yourself during the first admission from a

follower perspective, what people really like as if the patient

at any re intervention, be it an interventional procedure of

a surgical procedure related to carry yourself whether there are

existing problems at the site of uh Gardasil implantation that

haven't yet met criteria for intervention.

What imaging modalities have been used to diagnose these problems

and any details around the explanation.

Yeah, yeah.

If you're planning to use card yourself, you would strongly

encourage you to join a car and set up a

system for prospective data entry.

We have endeavored to make the process as straightforward as

possible. All you have to do is Union Canal johnson,

she's the data manager and request a startup back.

She sends you out a couple of funds to complete.

And most of this information relates who is actually going

to be using cardio self, not just people that are

going to need a password for access to the database

once you complete the forms and she receives them, she

will grant you access to a dropbox folder which contains

all the registry agreements.

It contains all the ethics approval documents that contains the

actual study protocol, which we needed to submit for ethics

approval. It has all the steering committee minutes, it has

all the papers that have been published, not only about

cardio, sorry, not only for my unit, but from every

other uh, center in the world.

Right, Okay.

And then red cap contacts you directly with the user

name and you set your own password.

And that's really all you need to begin entering that

up. You will simply have to go to the red

cap, the red cap on site via the you are

a search field in any browser, select your project and

your username and password.

And we can entering data.

Now we strongly suggest that you get local ethics approval

for I call and in this respect, if you send

us the forms and give us the names of any

individuals uh in your research governance office, we can help

you with completing and submitting them.

Okay. Okay.

Yeah. We haven't caught their as yet because a considerable

amount of manpower is necessary to maintain and monitor continuous

online presence.

And and for a start, I don't even have a

facebook or to the regard, but hopefully we'll get there

someday. If there's any information you need or if you

think there's any way we can help you join and

contribute to I call or you have, if you have

any new ideas, please don't hesitate to get in touch.

Emailing anyone of us is the same thing as emailing

all of us.

Mm Thank you very much for listening.

ICOR 2021

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