Show Me The Evidence

Guest: Dr Jorio Mascheroni, biomedical engineer, with a Master's in Technology Enhanced Learning and a PhD on how best to implant cardiac resynchronisation therapy (CRT) devices. Jorio has spent his career in the medical device industry, where he develops and validates training for cardiac device implanters. 

Interviewed by: Professor Anthony G. Gallagher 

Topic: Moving the Learning Curve Away from the Patient: Proficiency-Based Progression for Cardiac Device Implantation 

Episode Summary 
Professor Tony Gallagher talks with Dr Jorio Mascheroni, a friend and collaborator of around 20 years, about a career spent trying to make device training safer and more effective. Jorio was there when cardiac resynchronisation therapy was introduced and saw early on that getting specific steps right, and avoiding specific mistakes, decided whether a procedure went well. 
The conversation traces how training moved from knowledge-based courses and "learning on patients", through the early days of virtual reality simulators, to a proficiency-based progression (PBP) programme with validated metrics and a benchmark that every trainee must reach before moving on. Jorio shares what his randomised trials found, why the approach does not take longer or cost more over time, and why he would change one thing above all: everyone should start in a protected environment and only then move to the operating room. 

Key Topics Covered 
Introducing Dr Jorio Mascheroni (0:00) 
  • An engineer who moved into education, with a Master's in Technology Enhanced Learning and a PhD on optimal CRT implantation
  • Twenty years of working together

From Engineer to Educator: The Arrival of CRT (0:34)
 
  • Witnessing the introduction of cardiac resynchronisation therapy, a completely new type of procedure
  • Working with the pioneers and realising that performing certain steps properly and avoiding mistakes determined success
  • Early involvement in building a virtual reality simulator for CRT, and the chance to move training away from the patient

Training 25 Years Ago: Impression, Not Data (2:55)
 
  • Training was mostly knowledge-based and theoretical
  • Physicians learning a new procedure were, and still often are, learning on patients
  • Different experts taught different content and techniques for the same procedure
  • Nobody measured what trainees had actually learned: "we had an impression that people were getting better"

Simulators: From Room Decoration to a Standard Workflow (6:51)
  • Early simulators were often "the attraction of the training event"
  • Use ranged from decoration to the first attempts at standardising a procedural workflow
  • Bringing the pioneers together to agree an optimal approach, and why a group of experts beats a single speaker telling their own story
Was Simulation Seen as a Magic Bullet? (10:04)
  • Industry valued simulation for demonstrating product workflow in a safe setting
  • Effectiveness depended on the faculty delivering the training
  • "Simulators by themselves don't teach much if there is no solid curriculum around"
Shared Shortcomings Across Industry and Medicine (11:54)
  • Underestimating the size of skill gaps and taking foundational skills for granted
  • Training differed from one hospital to the next, even for the same therapy
  • Speaker-centred training: "listening to an expert does not mean that you become an expert"
  • Learning curves happening on patients in the clinical environment
An Accumulation of Evidence (15:04)
  • No single turning point: evidence built up that different techniques produced different patient outcomes
  • The way you teach someone to do something may determine the outcome for the patient
  • Reading Tony's work on minimally invasive surgery and realising the approach could apply to device implantation
  • The aggregation of marginal gains, and why it sits at the core of proficiency-based progression

Related reading: Gallagher AG, Ritter EM, Champion H, et al. Virtual reality simulation for the operating room: proficiency-based training as a paradigm shift in surgical skills training. Annals of Surgery, 2005; 241(2): 364 to 372
 
What Pacing and CRT Are (21:22)
  • Treatments for selected patients with cardiac rhythm abnormalities
  • A generator placed under the skin of the chest, connected to the heart through implanted leads
  • Permanent pacing has been around for about 70 years; CRT for 25 to 30 years

Where Device Training Fell Short (23:41)
  • Challenge one: training or coaching in the cath lab is too late, and it is not fair for the learning curve to happen on a patient
  • Challenge two: many interpretations of optimal implantation, never compared, varying between countries and even neighbouring hospitals
  • Licensed physicians finishing training with wide variability in performance
  • Complications that looked like technology problems were often a suboptimal use of the technology
  • Tony on the surgical side of device procedures: femoral access complications in carotid stenting at Emory in 2003, and the same complications two decades later with TAVR

Publication: Mascheroni J, Stockburger M, Patwala A, Retzlaff H, Gallagher AG. Beyond the badge: quantitative insights of skill gaps in licensed early-career cardiac device implanters and evidence-based pathways to proficiency. Journal of Interventional Cardiac Electrophysiology, 2026; 69: 267 to 276. Most licensed early-career implanters did not meet the proficiency benchmark on a simulated assessment.
 
What a PBP Programme for Device Implantation Involves (28:26)
 
  • A structured, consensus-based description of how the procedure should be performed
  • Metrics, and a proficiency benchmark set from experienced operators
  • A blended curriculum: trainees must pass a knowledge benchmark before hands-on training
  • Faculty training is critical: "If you stick to the methodology the results are generally very predictable"

Publication: Mascheroni J, Mont L, Stockburger M, Patwala A, Retzlaff H, Gallagher AG, et al. International expert consensus on a scientific approach to training novice cardiac resynchronization therapy implanters using performance quality metrics. International Journal of Cardiology, 2019; 289: 63 to 69. Experts broke the procedure into 13 phases, 196 steps, 122 errors and 50 critical errors, agreed through a Delphi process with an international panel.
 
Why Validation Matters, and How Trainees Respond (31:44)
  • Validation makes the approach objective, so it is not "the opinion of 10 people"
  • The metrics must be objective, transparent and fair for trainers and trainees
  • Trainees have responded very positively because they know exactly what is expected
  • "Proficiency-based progression is not meant to fail people": it gives each person the time they need to reach the benchmark
  • The assessment exists to give explicit, formative feedback; reaching the benchmark is non-negotiable
What the Data Show (38:44)
  • PBP-trained implanters made significantly fewer errors than peers trained on the same simulators with the same content using traditional methods
  • Jorio reports 93% of PBP trainees reached the lead implantation benchmark in the trial, compared with none in the traditional group
  • Skills transferred to real procedures, with far better adherence to optimal technique
  • The benchmark is set in advance from the average performance of experienced practitioners: realistic, not perfection

Publication: Mascheroni J, Stockburger M, Patwala A, et al. Effect of metrics-based simulation training to proficiency on procedure quality and errors among novice cardiac device implanters: the IMPROF randomized trial. JAMA Network Open, 2023; 6(8): e2322750. Trainees trained to proficiency made 77% fewer objectively assessed intraoperative errors than peers trained traditionally.

Publication: Mascheroni J, Stockburger M, Patwala A, et al. Surgical skill simulation training to proficiency reduces procedural errors among novice cardiac device implanters: a randomized study. EP Europace, 2024; 26(9): euae229. PBP trainees made 61% fewer critical errors; 73% reached the benchmark compared with 20% in the simulation group.

Publication: Mascheroni J, Stockburger M, Patwala A, Retzlaff H, Gallagher AG. From simulator to patient: transfer of procedural skills to practice in cardiac device implantation. European Heart Journal Open, 2026; 6(4): oeag120. PBP-trained operators showed 60% fewer procedural deviations in real procedures than simulation-trained peers.
 
Does PBP Take Longer? (42:31)
  • Training should not be tied to a fixed time, because people learn at different speeds
  • Over the same two days, most PBP trainees reached the end goal while others were still working towards it
  • More effective, and more efficient
How the Evidence Has Been Received (43:51)
  • A big change of mindset: early adopters, people thinking about it, and some "still in denial"
  • Some are surprised by the size of the difference, or question the simulation and methodology
  • "Today I don't know a better alternative", and Jorio would support a better one if the data showed it
Publication: Mazzone E, Puliatti S, Amato M, et al. A systematic review and meta-analysis on the impact of proficiency-based progression simulation training on performance outcomes. Annals of Surgery, 2021; 274(2): 281 to 289
 
Is PBP More Expensive? (46:13)
  • Higher investment up front than "putting together a few PowerPoint slides"
  • The break-even point comes quickly when training is a programme rather than a one-off event
  • Tony on Stefano Puliatti's robotic surgery data: break-even at 25 trainees, not the hundreds he expected
Publication: Puliatti S, Rodriguez Peñaranda N, Amato M, et al. Randomised trial on the economic impact of proficiency-based progression vs conventional robotic surgical training. BJU International, 2026; 137: 493 to 501
 
Agree the Finish Line Before You Compare (49:06)
  • The hidden assumption: that everyone wants trainees to reach a predefined, quantitative performance benchmark
  • Without a defined goal, any training looks successful "because there is no finish line"

Knowing Is Not Doing (50:39)
  • Smart, well-qualified clinicians who know a procedure cannot always perform it to a benchmark
  • Tony's shift from "have you done it many times?" to "show me"
  • What PBP offers beyond a good educational experience: an evidence-based pathway, consensus and validation, immediate feedback and a clear performance goal
  • Credit to the open-minded clinicians who gave their time to improve training for the next generation
Is Today's Training Better Than Before? (54:59)
  • Jorio would not sleep well if the training he offers today were worse than what was offered in the past
  • Data, not opinion or impression, makes the comparison possible
  • "Data shortens the discussion"
Where Device Training Goes Next (56:12)
  • The quality of training should match the quality of the technology
  • Moving from training that experts say is good to training proven effective with data
  • Tony on good devices that failed in the market because of how clinicians used them
  • Trainees are motivated; it is the education system that needs to improve
Take-Home Messages (1:00:43)
  • Never give up: there is a path to better training and safer healthcare
  • Not every training is good training; do not assume years of training equal proven skill
  • Sceptics should try it and look at their own data
  • If Jorio could change one thing: everyone starts in a protected environment, then moves to supervised cases in the operating room, "and not the other way around"

Connect & Follow
 
Show Me The Evidence Podcast

Professor Anthony G. Gallagher, KU Leuven and Ulster University: Tony Gallagher on LinkedIn Tony Gallagher on Google Scholar

Dr Jorio Mascheroni: Jorio Mascheroni on LinkedIn.

Timestamps

Topic Time

Introducing Dr Jorio Mascheroni | 0:00
From engineer to educator: the arrival of CRT | 0:34
Training 25 years ago: impression, not data | 2:55
Simulators: from room decoration to a standard workflow | 6:51
Was simulation seen as a magic bullet? | 10:04
Shared shortcomings across industry and medicine | 11:54
An accumulation of evidence | 15:04
What pacing and CRT are | 21:22
Where device training fell short | 23:41
What a PBP programme for device implantation involves | 28:26
Why validation matters, and how trainees respond | 31:44
What the data show | 38:44
Does PBP take longer? | 42:31
How the evidence has been received | 43:51
Is PBP more expensive? | 46:13
Agree the finish line before you compare | 49:06
Knowing is not doing | 50:39
Is today's training better than before? | 54:59
Where device training goes next | 56:12
Take-home messages | 1:00:43

What is Show Me The Evidence?

Most training is sold on confidence. Show Me The Evidence is built on data.
In every episode we take a single study, clinical trial, or systematic review and work through what it found, how it was designed, and what it means for the way we teach and assess skill. We focus on metrics-based training and proficiency-based progression, the approach that asks learners to demonstrate measurable competence before moving on, and we trace its results across surgical, medical, and professional education.
This is a podcast for learning professionals and medical educators who want more than opinion. Expect plain-language breakdowns of the research, honest discussion of what the evidence does and does not support, and conversations with the people behind the studies.
If you make decisions about how people are trained, we think you deserve to see the evidence first.

Today I'm joined by Dr. Jorio
Mascheroni

I've known Jorio
for about 20 years.

Jorio is an engineer who
subsequently did

a Masters in Technology
Enhanced Learning

and a PhD in how optimally to
implant a CRT device.

Jorio has worked in industry
certainly since

I have known him and Jorio
is very welcome.

Hello Tony.

Jorio, can I start out with,
okay you've worked

in the medical device sector
for quite some time

certainly alongside known
you. So what

got you interested in educational
training?

Yes, thanks Tony. I got interested in

education from the early
days of my career

medical industry. I had the
privilege to to

witness the introduction
of one of the most

successful therapies of the
last 30 years in

cardiac pacing which is cardiac
resynchronisation

therapy. It's a therapy
for cardiac rhythm

abnormalities. Maybe we can
talk about that

more specifically later and
because it was a

totally new approach and a
new type of procedure

there were a lot of challenges
from the

pioneers that started with that
therapy and I had the

privilege to work with some
of them go through

the challenges and I realised
that the ability to

perform certain steps properly
and avoid

mistakes was a determinant for
success. So at the time I

also had the possibility to work on

developing some training programs
for these new

implanters new to therapy
at least and that's

how I started getting involved
with education.

The second aspect was in the
few years at the

beginning of this therapy
we had the chance to

start working with the beginning
of simulation

with virtual reality and we
had the chance to

get involved in the development
of simulator

for teaching cardiac resynchronization
therapy

procedure and so that was
also interesting for

me because it opened more
possibilities to move

training away from the patient and to

experiment how to do things outside
the operating room.

So all those years ago when
you started I mean

you talk about simulation you
talk about education

so how was education and
training approached

back then? Well I think there
was no single way

there were multiple degrees
of quality and

quantity as well and in general
if I compare

to what happens and I see
today what I do

training was certainly more knowledge
based at that time

and the lack of simulation
tools of course made

it more theoretical and at
the time the reality

was and still today that
most of those

physicians learning a new procedure
or a new skill

were and are learning on patients
and so I have

to say also that we were looking
more at technical

aspects at that time and
I found looking

backwards that there were
multiple ways

experts suggested to do
training and of

course that meant that there
were also different

training contents and different
teaching

ways even for the same for
the same procedure.

So there was a lot of variability
in terms of

recommendation of how to do
it there was a limited

chance to experiment outside
the training room

sorry the operating room and
certainly we were not

really measuring what at the
end of the training

people learned we had an idea
we had an impression

that people were getting better
but how far they

went it was unclear. So from
a personal perspective

you know somebody relatively
new to the

training education training was
the impression I'm not

about you know your views
today but looking

back at the time did you
think the approach

that was used for training
and education

do you think was it effective
and you know

why would you say that? I can say we
believed it was effective it was

based on impression more
than data and again

there were many different
ways of delivering

training we tried at least
in our group to do

the best with what was available
at that time.

My background as you mentioned at the

beginning was biomedical engineering
at that time so I

feel I was more focusing
on the technical

aspects of the devices of tools
that were used for the

procedure but there was
still a lot of

variability in the way each training
was conducted. I think

since then the journey has been
long and certainly

it's not over I personally learned
a lot from what

I did at the beginning I
believe that was

a successful approach I would
say today but

it would be difficult to
prove that was

effective or as effective as what
we are doing today.

So the impression was that
it was helpful and

people who knew very little at
least could practice

a little bit outside the
operating room and

that's certainly an advantage
at that time

thanks to the simulation. The use of

simulation was not probably the
best at different levels

from the very first simulator
created a lot

of interest many times they
were considered

the attraction of the training
event how well

they were used and I would
say it went through

spectrum from room decoration
to probably at

least the first attempts
of standardising a

procedural workflow so there
was no consistency

in the use of training and simulation
at that time

but I have to say also that
there were at

least on our side many efforts
to do better with

consistency so we started
at that time

especially because very few people
at the beginning knew

how to do things we tried
to find a bit of

consensus of how optimally
we should perform

procedure and there were some
people that the

very first pioneer which I
admire because they

figured out an optimal way
to perform the cases

and when I saw them getting together
and discussing

how to do things I realised
that probably the

power of having a group together
of people who

genuinely tried to help
the patients that

power was unbeatable and of
course was much more

effective than having a single
individual showing

up and telling his own way or
his own story so we

started getting experts
together and we

started having more consistency
in the way we trained

novices on a certain procedure. Again

looking back 25 years probably
we were ineffective

compared to where we should
be and we have

no data to say what people
learned at the end.

It was a it was already a paradigm
shift to be able to take people

outside the operating room
because again

going back to that those early
days of the therapy

people were taught how to perform
the procedure

in front of the patient and
at least the basics

with the first simulator simulators
available at

least the basics were done
outside the room and

discussions could happen outside
the operating

room that was a big change
although yes without

metrics without benchmarks without

standards at that time but it
was an important step

on the journey. And do you
think that the

industry and other training
centres did they

see simulation as some sort
of magic bullet? I

think there was a lot of attention
to simulation

because simulation could help
industry explaining

or I would say at that time
demonstrating the use

of the product at least the
workflow of the use

of the product in a safe protected
environment and

of course that is difficult
to do in the

operating room. At the same time
the simulation was

used in multiple ways and I
would say not always

in the most effective and many
times it depended

on the on the training team
on the experts

that were delivering the training
so there was

inconsistency in the way
it was used so

participants trainees were attracted
by the simulator

themselves because they believed
they gave them

the opportunity to do something
safer but also

was the novelty that attracted
them. Now we

know that simulators by themselves
don't teach much

if there is no solid curriculum
around so maybe

the technology was there maybe
the use was up to

the individual trainer to make it

effective and so you could see
multiple versions of

good or bad use of simulation. So the

shortcomings that you saw in
industry training,

I mean for me it always
struck me as an

educational experience but industry
was doing training on

simulation and as you know
I'm a huge fan of

virtual reality simulation. So
were the shortcomings

just in industry or were they in other
sectors as well such as the

scientific societies or universities?

What's your observation? I
think it's difficult

to generalise if I have to
give my perspective

I think there were many
common aspects

between what happened in industry,
what happened in

the medical field and one of them was
we sometimes underestimated the

how large the gaps were in
certain areas or

we gave for granted some skills
that were not

instead demonstrated. So
trying to build

new skills on a weak foundation
was not always

simple. So before simulators
and that's when

I started before simulator
of course training

happened mostly in the operating
room and that is

definitely not the safest and
most effective way

to do it. We also saw common
aspects with lack

of standardization so training
delivered in one

hospital was different from
training delivered in

the hospital maybe next door
although the therapy

was the same and sometimes
also this happened

depending on which experts
or consultants were

delivering training on a simulator
so this was a

common aspect and so there
was also tendency of

having more speaker-centred
training so the

learner was there to listen
to these pioneers

which of course had experience
that were admired

for what they did but listening
to an expert does

not mean that you become an
expert and so this

was probably a misunderstanding
that was happening

at the same at that time and
by the end of the

training people were satisfied
with the training

but not sure how much they
could do the same as

the speaker that was teaching.
To summarise

I mean I would say common
aspects I think the

most challenging and critical
was the fact that the

learning curve was happening
on patients in the

clinical environment so that
was something that

looking backwards would still
worry me. So I mean

you so you observed all this
for a number of years

at what point did you come
to the conclusion

that a different approach to
training was required

because you seemed to have
all the right

bits in place I mean you had
a structured course

you had a training on
simulation which

allowed training outside the
OR but you seemed to

move beyond that so you must
have come to the

conclusion at some point a
different approach

training was required. What
drove that? I think

in my experience for myself
I was no one single

turning point I think it
was an accumulation

of evidence and there are
some moments when

you wake up in the morning
and you put

together those pieces and bites
and say it's okay that

maybe there is something we can do
and I think it moved from

analyzing more critically
how different

techniques that were adopted in
the operating room and

given in training as well
we're generating

different outcomes so you
start realising that

actually it's not only the
way you apply the

technology it's also the way
the patient benefits

or benefit less from the technology
and you see

that the way you taught somebody
doing something

may determine the outcome
of the patient so

I think I learned that you
needed to pay more

attention to the gaps to be able
to analyse exactly

what the gaps were and try to
find solution to get

people at a certain level
I think if I have

to say and we have known each
other for so long

I think there were moments
like when I

first got across one of
your publication

in our group training group and when
I read that I was at that point

already a few years in my
training position

and I realised that everything
I read there

made sense to me although
was still mostly

applied to minimal invasive
surgery but the

approach made sense for other
types of procedure

as well so at that point I said
okay not only we are

realising that gaps exist
but also there may

be a potential solution that
can be applied to

fill those gaps the challenge
is the gaps were

very variable depending on where
you were looking

and so also the degree of
improvement required

was different at different levels
but that was one

of the moments where you
said okay I may be

novice in education and training
but I could learn from

experienced more experienced
practitioners

that you don't have to reinvent
the wheel

but you can apply something
that has been

validated and proven working
already and maybe

this could help in our sector
as well so that was

a moment I remember very well
and that's probably

the moment we started getting
in touch and I

thought okay there is a direction
the direction

is pretty clear and there is
something we can do

more I have to say I've learned
every year that

there is something else we
can do better and I

think we haven't got to the
point where I said

we have done everything there
is still a long

journey but I think I think
we or I personally

had to go through the different
steps at the

pace that was required to come
to the conclusion or

partial conclusion that we
needed to move one

step forward and I think we've
gone through a long

journey and there is still
a lot of room for

improvement so multiple moments
where accumulation

of evidence showed us that
we needed to move

one step forward and one step
after the other

I think we progressed a lot
it would be easy

to say now we could have skipped
that phase or

skipped the steps but probably
we would not be

here without all the stops we
made on the journey

yeah no I agree with you
I mean it's about

learning the science of this
approach because

it's an entirely different
approach to

conventional training so I think
if I may if I made only

I think I learned one thing
that probably drives

most of the innovation I think
if you genuinely

believe that you want to improve
training every

day and your purpose is to
make healthcare safer

and more effective I think you are motivated
to look for improvements

there was a time we discussed about

accumulation of marginal gains
I think life has been

this type of journey for me
and sometimes the gain

was big sometimes was small
but every small piece

made the construction I totally
agree with you

about that whole approach to
the aggregation of

marginal gains and to a large
extent that's

at the core of proficiency
based progression

so over the last number
of years you've

developed and validated a proficiency
based progression

approach to training of cardiac
pacing and cardiac

resynchronisation therapy can
you briefly explain

what pacing and CRT are?
Yes absolutely so

I've always been involved from
my early years in

medtech on the cardiology
side and pacing

cardiac pacing and cardiac resynchronisation
therapies

are treatments that are offered
to selected

patients who have some cardiac
rhythm abnormalities

and pacing has been cardiac
pacing permanent

cardiac pacing has been around
for about 70

years already cardiac resynchronisation
is more

recent or relatively very recent
because it's about

25 years old maybe almost
30 but all these

therapies require an implantation
of a cardiac

consists typically on a
generator which is

placed in the chest under the
skin and the generator

contains the battery and contains
the circuit

that decides what therapy
and when the therapy

should be delivered and they
are connected to

the heart rhythm where they can
listen to the heart

and deliver therapy to
the heart through

implanted leads inside the heart
and this is the most

traditional way of delivering
cardiac pacing

and recircurization in the recent
years there are

alternative ways that have
been suggested but in

general the therapies are delivered
for patients

who are suffering from any
cardiac abnormalities

and have certain criteria so
this is in summary

what we do and we train physicians
to make sure

they can use the technology
for the safest and

most effective approach to
have a better patient

outcome. So it's okay you're
working in the sector

and the education and the
training did you

think there were major issues
in the education

and training of these procedures
or were you

happy with how it was being
done? I think again

going back to what we discussed
before I think

the first challenge I observed
at the beginning was

that if training or observation
or coaching

happens in the OR, the laboratory
room or in the

cat lab, I think that's definitely
too late and

it's not certainly fair that
the learning curve

happens on a patient so that
that was for me

challenge number one. Challenge
number two was

there were a lot of different
interpretations

of what optimal therapy, optimal
implantation

of the cardiac device consisted
of and nobody

ever compared all those approaches
and of course

depending where you learn
the approach you

could be a very good or a
less good operator

and not only in different
countries there were

different approaches but even
in the same country

sometimes in different hospitals
they were

applying different techniques
with different

level of success and so I
would say the system

the medical education system
was not optimal because

at the end of their training
physicians had

a large variability of performances
despite

being licensed to perform
the procedures so

those were the aspects that
I considered the most

challenging and the most critical
at that time.

Were these simply catheter
wire performance or

was there other aspects of
the procedure that

you considered okay this is
not done optimally?

I think I've learned the clinical
side of the

therapy by working with very
smart clinicians

and I learned at the beginning
at my time I was

mostly focusing on the technology
and the aspects

that of the procedure that
required the

technology to be implemented but
if you look at the entire

procedure I realized over time
that were parts of

the procedure we gave for granted
or were assumed

to be conducted without the
problem instead

skills involves specific domains
were not certainly

guaranteed and that's when
we had to start

looking at gaps not only related
to the device but also

what two complications that
would ultimately lead

to a system a technology malfunction
but was not

were not strictly related to
the technology but

were related many times to
a suboptimal use of

a technology so that's when
we realised that

actually gaps may happen
at multiple levels

at all phases of the procedure.
I remember

Hartwick Redslaff took me to a
hospital in Dublin in 2006

I think it was. It showed
me the first pacing

procedure I ever saw and I
go this is a surgical

procedure what's the cardiologist
doing it and it

turns out that most or well
a significant number

of the complications to do
with cardiovascular

devices are to do with the
surgical end of it

and on the courses that
I observed there

seemed to be very little attention
paid to those

I mean when I was at Emory in 2003 we

were working with the carotid
artery stenting

and one of the highest complications
was on

the femoral axis there was
infections there was

hepatomas and so on and
like two decades

later I was working with
the TAVR procedure

and turns out that the complications
still

existed, so you've developed
a proficiency-based

progression approach to
pacing and CRT

devices so what does that training
program involve?

Okay so I'll start by saying
that it's not

just an interesting educational
experience as you

normally call it. It involves
from the very

beginning a very structured
approach to how

the procedure should be performed
according

to certain standards what
metrics need to be

checked to ensure that trainees
progress and

demonstrate that they can
do the procedure at

a certain level proficiency
benchmark that need to

be defined based on experience
operator performing

the same approach and it requires
after a good

investment into the development
and validation

of everything you created it
requires an extreme

rigour in the implementation
of what this science

has generated. A rigour that starts

certainly with trainers. The
trainers need to be

proficient in applying this
rigorous methodology

and need to demonstrate that
they can consistently

transfer those knowledge
and skills to the

students and they also need
to make sure that

not only in the first second
or third training

they perform but over time
they don't decrease

the level of attention they
have to the details

of a procedure when teaching
and they make sure

that trainees only progress when they

demonstrate all those details. So
it's attention to details

it requires multiple components
in fact it's not

a training event where people
get together around

it starts with it's a
blended learning

curriculum it starts with a knowledge
component which is

usually delivered by a learning
participants have

to demonstrate the proficiency
benchmark on their

knowledge before being able
to advance to a

hands-on training. So faculty
training I think

is critical you need to have
consistency you

have to have very solid agreement
about how the

procedure is performed and
taught to the people

and you need to be very disciplined
in the way

you train and assess the performance.
If you stick

to the methodology the results
are generally very

predictable if you deviate
even lightly from

the methodology you may encounter
some surprises.

Can I just back up a bit why is
the validation important?

I mean surely you develop
a depth restriction

you'll use them why is the
validation important?

I think because you want to make this

approach bulletproof you
want to make it

you want really to make it
as objective as you

can and nobody can come back
and say that's your

opinion that's the opinion of
10 people you need to

make sure that what you have
chosen is what works.

Yeah yeah no I totally
agree with you I

think it has to be objective
transparent and fair

for both the trainers
and the trainees

because this is a different
approach medicine

particularly procedure-based
medicine is not

accustomed to their performance
being assessed

to reach some quantitatively defined

performance benchmark and I think
the onus is on us

to demonstrate okay this
is objective it's

transparent and it's fair
and if somebody's

failed you know they don't
demonstrate

proficiency you can show them why
but the good thing is they

can do it again and they can
do it as many times

as they like but the the rule
is you don't progress

if I may add something to what you

said for the people listening
is sometimes

probably myself as well at
the beginning were

afraid of how participants
how trainees would

react to such a strict methodology
and actually

the the recipients have been
extremely positive

because as you said it is
very transparent

so they know what they are
expected to do

they are not afraid of
having different

individuals evaluating them depending
on the day of the week

or depending on the place
they come from they

know that if they do what they
are supposed to do

they will get where they are supposed

to get and proficiency-based
progression

I insist with that aspect
which is not always

very clear to people is not
meant to fail people

it is meant to take the right
amount of time

people need individually to
get to the benchmark

you expect so we are actually
helping people

finding their way with a very
structured approach

to the level of performance
they expect

themselves to reach and sometimes
they are afraid that they

can't get there and they
get conflicting

information and recommendation
about how to proceed

and here instead is very transparent
so it's been

well received we haven't had
any objection about

why do I have to do this who
says that this is

the best way they have been
looking at ways to get

better to demonstrate that
they could reach the

objective and the great majority
of them get to

where they need to get

yeah yeah, I mean I think

that's an important point because
the whole point

of proficiency-based progression
I mean

everyone concentrates on the metrics
and the assessment

and they think it's the assessment
is the most

important the assessment is
only important to give

the trainee objective transparent
feedback on

their performance and to coach
them how to pass

I remember giving a professor
a lecture in

Leuven and somebody stood up and
said hold on a second

you're educating them what
to do what the tasks

are before they get to the skills
lab and I'm going

yep and they can do it as
many times as they

like go yep and then they get
to the skills lab and

coaching them what to do and
they can fail that

and they get as many goes so
that's not the way

we do things today and I go
our job is to help

them get to the benchmark what's
non-negotiable

is to get to the benchmark
and I know I'm not

checking or we're not checking
how smart they

are I already know that
they've got into

medical school they've progressed
through the system

so the the idea is that
we help them the

metrics are there to help them
and that's one of the

I think the most powerful aspects of

proficiency-based progression it's
about the the objective

explicit formative feedback they get

about performance and my
experience is that

my experience is that they
received that

approach better than what I expected
at the beginning I

thought some people may question
or challenge

or be critical about the rigor
the methodology

requires but at the end
they are all very

compliant and and successful
in what they do

yeah but I think they pick
up fairly quickly

that we're on our side I mean
we'll help them

get to the benchmark I mean
there's no tricks

about that but what's non-negotiable
is to get

to the benchmark and Stefano
pulled out that

we get everybody to the benchmark

especially in a situation the
people I meet we train

international people from
mostly Europe they

come and their biggest challenge
today or one of

the biggest challenges is the
lack of systematicity

and they have to find their
way to navigate

through the system to get
the learning they

expect to get but is not provided
to them in a

structured way so they have
to to get it somehow

and here is pre-packed very
systematic and

they can go this is the comment
they often make

it's probably one of the
first time they can

go from A to Z through everything
they need

receiving feedback and being able to

observe and confirm their
own progression

and they always say it the
majority depending of

course again from where they
come from where they

learn but the majority of
them complain today

about the access to consistent
structure training

in the order they need in
the moment they

would need and with proficiency
based progression

training that is actually very
clear the pathway

is very clear so they appreciate
the transparency

and the objectivity of that
so over the last few

years you've been working on
a proficiency based

progression approach to device
implantation

what does the data show you
published this in

peer-reviewed high impact
peer-reviewed

journals so what's the data show

so the data our data

showed consistently that
people trained

with a proficiency based progression
approach

outperformed significantly
in an objective

standardised assessment
what people train

still train still with simulation
still with

same content but with the traditional
methodology

and our data showed that there
was a reduction

in procedural errors in lead
implantation of 77%

and there was a reduction in surgical

skills the surgical task related
to the device

implantation of 61% and and
we also showed more

recently that those skills
were transferred to

the real world because the
adherence to optimal

performance in in real procedures
was far superior

in people that were trained
with proficiency

based progression approach
compared to people

that were trained traditionally
so they they

reach the proficiency benchmark
not only they

perform better making fewer
errors they also

have higher chances to demonstrate
the proficiency

benchmark that is required in in a

reasonable amount of time compared
to their peers the

difference we had in the
two trials for lead

implantation we had 93 of
the students in the

PBP group demonstrating
the proficiency

benchmark and none of the other
group demonstrated the

benchmark and in the surgical
skills was 73

compared to 20% so not only
you make fewer errors

you are able also to progress to the

benchmark more efficiently
and more effectively

and the proficiency benchmark
was based

on the class average or
something else

no the proficiency benchmark is
defined up front and

the way we set the proficiency
benchmark is having

experienced practitioners going
through exactly

the same task the same procedure
that you train

participants at and you'd
measure the average

performance the average score
of the experienced

practitioner performing exactly
the same task we

know that's not perfection
we are not asking for

perfection but at least it's
a realistic real

world benchmark that these people
should at least

achieve in simulation before
moving on and

when i say moving on it doesn't
mean we make them

experts right away they
will still need to

probably practice under supervision
but at least

they will start from a demonstrated
fundamental

skill set that their supervisor
can trust because

it's been proven and the part
of the learning

curve that is typically happening
on patients

the early learning curve
which implies risks

higher risk than later is
moved away from the

patient and is now happening
on a simulator

with a systematic approach

so does the PBP approach

take longer than what you
would do normally

I think

Sorry I'm not
talking about the

development of the metrics I'm
just talking about

the the training program because
you normally train

what one two three days so
does the PBP approach

does it take longer?

So at the end it doesn't take

longer because if we compared
on the same

amount of time and we know that
proficiency based

progression should be not
should not be tied

to a fixed amount of time
because individual

different individuals learn
at different speed so

everyone should have the right
amount of time to

get to the benchmark that's
the ultimate

goal but if you have a determined
fixed time you

goal but if you have a determined
fixed time you

you compare the the progression
of the students

in the two groups as we did in
the randomised trial

You realise that actually
not only they

get more likely to the benchmark
but they also do it

faster i say or the majority
of them over the

two days of the training could
reach the end goal

and the others who are still
struggling with

getting there so you could
say that not only

is more effective but is also
more efficient so

that leads into my next question
so you publish

the results in high impact
peer review journals

so how has the data been received
by the clinicians

not just the people that
do the training

but also by your colleagues
in industry

I think it's a it's a big change of
mindset i mean some people

and luckily I had the privilege
to meet

quite some very open-minded
realise that

based on data there is a better way to
do things so you consider changing

you cannot say everyone
agrees with that

some people are surprised
by the magnitude

of the difference question
the simulation

question the methodology
have doubts that

the current system does
not work maybe

maybe will require several years
before a critical

mass of people accept that
it's time for change

but I think and this is true
inside outside the

industry there are early adopters
and people who

are thinking about and people
that will probably

join later however today i
don't know a better

alternative there may be one
alternative one day

if based on data we see that
there is an even

better way I would certainly
support that today

what we see is that a different
approach to

training as the one we propose
with proficiency

based progression leads to
better outcomes and

this is data driven and it's
not just opinion

so some people have understood
very quickly

some people are thinking about
some people at the

moment are still in denial
but the evidence

accumulated will probably
lead everyone to be

inevitable which is change
is needed to get

better patient outcome through
better performances of

operators

So is PBP more expensive?

So the data we

have and this is not data we
could collect on our

research but the data is
probably cross

therapies you require of course
with proficiency based

progression and a higher
investment at the

beginning of course you have
to invest more

than putting together
a few powerpoint

slides obviously however
because of the

more effective and more
efficient approach

once you implement you will
get quickly to the

break even so the research
you did showed that

you don't need so many trainees
to process to get to

that level that pays off
so the initial

investment was paid off after 25
students were trained and

and that means yes upfront
it looks like oh okay

I have to invest more here
but if your training

is not a one event only
but it's a program

that you want to consistently
deliver over time

the return will be most important
of course

better performances of the
people but also

the cost of the investment
will not be as

big as you believe at the beginning

Yeah, I mean

Stefano Puliatta's data honestly
surprised me

they gave me a huge fan of simulation
and obviously

I'm quite fond of proficiency
based progression

but I thought it would take
us we were talking

about a robotic surgical
skills task I

thought it would take us hundreds
till we got to the

break even point but as you
quite rightly pointed

out took 25 I think
shows that it's a much

more efficient and effective
approach to

training and I would have thought
that it was something

that the industry would they
would embrace that idea

I think it will come it's
it's it's something

despite you've been working
on this for probably

30 years I think we we
probably have to

create more awareness
of what you have

achieved over time and the
power of proficiency

based progression I think
the actual cost or

number of trainees will depend
on the therapy

on the resources that are
invested may vary

with the therapy but the result
will not change

so most likely the number
of trainees needed

to reach the break even will
be lower than what

you expect and your investment
in training

will pay off soon I think there
is an important

assumption we are making here
and that's something

that sometimes I find myself
to discuss with people

after a few minutes and
not at the very

beginning I think our assumption
is that we all agree

that we want people we want
trainees to reach a

predefined performance benchmark
so if you agree

whatever the training approaches
so if you agree

with that assumption then you
can start comparing

but sometimes I found myself
discussing with

people about the performance
benchmark and the

assumption was not correct
so I assume that

we all want the people to
reach a quantitative

performance benchmark but in
others people mind

this quantitative performance
benchmark is not

very clearly defined and so
then you can probably

get to some kind of learning
with the power point

although if you haven't defined
where you want

to end up of course you will
be successful because

there is no finish line but
you need to agree

first on what your goal is and
how you measure it

and then you can start comparing
the different

training approaches but this
assumption I learned

needs to be clarified at the
very beginning so

do we all agree that we want
people to reach a

predefined performance benchmark
and then we

can compare the approaches otherwise
no comparison

will survive

I mean one of the problems I find

I've worked with medicine
now for 40 odd years

and one of the problems I mean these

individuals are smart I mean they've
demonstrated that by

getting into college but
the assumption that

everybody else and they make
is because you know

how to do something or you
know about something

you can do it one of the things
i've learned over

the decades is that you can
get somebody really

smart and they really know
how to do something

but they're the correlation
between them being

able to do it well is not
a strong correlation

and I mean like 20 years
ago I would or 30

years ago I would ask okay do
you know about this

procedure yes do you know how
to do it yes have

you done it many times yes
I would have stopped

there today i say okay show
me and frequently what

I find is that they're not really
able to do it to

a performance level so you've
developed and

validated this approach to
proficiency based

progression for the the crt
procedure is what

you're offering just a better
education experience

or are you offering something
more?a

I think

offering a a good educational
experience

I don't say it's easy it's all and I

don't say it's easy to offer
but it's probably

easier than offering a structured
training

with a guaranteed outcome so
what we offer here is

if you first of all it's
evidence-based so

you know what you get and
how far you can go

second you know that this
is not only the

opinion of somebody that is there
today to teach you

but this actually comes from a very

structured consensus and validation
so again as we said

before I don't say bullet
proof but it's

quite rigorous and then once
you enter open-minded

in this training mode then
you see that you

indeed progress and you
indeed receive the

receive the feedback immediate
feedback that you

need in the moment you need
to make sure that you

correct yourself and proceed
to the next so what

we are offering is actually
a very clear pathway

with very transparent mechanisms
and a very clear

performance goal so you know
what you get from the

very beginning you just it's
not that easy but

you just have to follow that
path to get to where

you expect to get so you
will be happy with

probably much less but you will
not be performing

as well if you get something
less and I

I have to say

over the years another
thing I learned I

had the privilege to work
with very talented

open-minded clinicians and
also colleagues that

believe that there is always
a better way to do

things so we have improved
because we never

stopped with what we had
it was a journey

clinicians believe despite
they've been doing

the same job for many many years
with new therapies

of course but these people I
had the privilege to

work with have realised quickly
that there is room

for improvement and we're
talking about big

improvement and they have
dedicated their time

and efforts to make sure that
their fellows

their students and clinicians
in general of the

next generation can have
better access to

structured training and
leading to better

performances and ultimately
of course we expect

better patient outcomes

Okay, can I be bold and

ascii does the training you
offered today do you

think it's better than what
we've offered in the past

Yes I would not be I would
not sleep well

if I would offer today training
that is worse of

what we offered in the past
I think it's better

I think definitely better
I think I can say it

because we now have data and
we didn't have data

before I think having data
makes a difference in

terms of what you compare
with and based on

your own data you can always
do better but you have

to start from somewhere which
is not an opinion

which is not an impression
so we are here today

because we went through the
journey we have

accumulated evidence that
shows that the the

path we took is the right
path

Yeah, I mean I

totally agree with you data shortens
the discussion

because uh before you have
data it's all

qualitative it's your opinion
versus my opinion

but once you have scientific data published
in peer-reviewed journals

that changes the conversation
significantly.

So where does education and
training for the use

of new medical devices stand?

And where does it stand now

and where do you think we
need to go next?

I think I, I mean, the place I work,

I think there is a commitment
to patients

to make sure that every aspect from
the design of a device

to the training, to the collaboration
with clinician

leads to better outcomes.

So I think we have made over
the years effort

to provide training that generally
produces better outcomes.

I think we have improved and showed

that it is possible to do moving
from a good training

where you have an impression
that is a good training

where some experts say is
a good training.

Now we have moved to proving
with data

that the training is effective.

I think it is important
in all domains

that the quality of the training
should match

the quality of the technology
we provide

and the quality of the technology
investment

in the med tech is high.

And I believe that training should
match that quality

to be able to provide healthcare
with a better package

to optimize what the patient
could get.

And yes, we are not done yet.

I think we are on the
right trajectory

and I see things moving.

Maybe not as fast as people
would expect,

but actually faster than what
the general public today

is going to consider good enough.

Yeah, I mean, the number of
devices I've seen fail

in the marketplace and the devices,

I mean, from what I could see
were perfectly good,

but the application of the devices,

the use, the clinicians using them,

some of them were suboptimal

and some devices failed in
the marketplace,

not because of the device,

but because of the clinicians
actually using it.

And that's not something that's
been recognised,

well, publicly recognised
within medicine,

but the data basically now shows
across all specialties

that we have a group of clinicians

that perform sub-optimally in comparison
to their colleagues.

And I think if I may add
something, Tony,

I think the great majority
of trainees

I have a chance to meet are
really looking forward

to learning in a more effective,
more efficient way.

So they are genuinely open to ways

that would lead them to
more confidence

and better performance.

So I think they feel the need.

I think the system, it's the system,

that education system that
needs to improve

to make sure that those motivated
individuals

reach the level they are
set to reach,

and they're probably capable to reach

within a reasonable timeframe

and with very clear pathway
to a precise goal.

So the individuals are motivated,

the system needs to make
an extra effort

to provide those motivated
individuals

with the tools that are required
to make them successful.

Yeah, no, I totally agree with it.

I mean, our goal should be to
help those trainees

to get to that performance level,

but the performance level has to
be quantitatively defined.

It shouldn't be an attritional
system.

I mean, we basically, the whole point
of deliberate practice

is you help them get to
the benchmark,

but reaching the benchmark's
non-negotiable,

because what we believe is, and what
the data, I think, shows

is that your performance level

will impact on patient outcomes.

So you've been working on this now
more or less for 20 years.

So what would you say are the
major take-home messages

from your work, your experience,
your research,

your publications over the
last 20 years?

Yes, to summarise, so I think
you are an example

of the first recommendation
I want to give,

so never give up.

There is a path to make
training better,

make healthcare more successful,

and it's not only related to the
successful treatments

that are introduced or new therapies,

but it's also related to how
we train people.

So attention to the quality of
training is essential.

Not every training is
a good training,

and you should not give for granted

that after going through some
years of training,

you reach a certain level if you
haven't proven that.

The summary is also showing
me that, yes,

if you are motivated and interested
in doing a better job,

there is certainly a way
that is proposed

that could get you better results.

And I would invite people that are
still skeptical to try,

and once they will see
their own data,

they will probably find that
there is no other way

from the traditional approach
that can match,

at least from the data we have
shown over the years,

there is no traditional approach

that matches the outcomes
that we reach

with a very rigorous systematic
metric based training.

I think we need to have
people that are,

genuinely interested in moving
the learning curve

away from patient.

That's what is my number
one concern today.

And I think the operating room
at a certain point

will certainly become, or becomes,

an important environment where
you can observe

and you can be supervised
and perform,

but this should not be the
first thing you do.

I believe that there is a lot
that can be moved

into a safer environment for learning

and reducing the number of
errors you can make

by trying and retrying and
receiving feedback

until you demonstrate that
you have reached

a safer level with your skills.

And at that point, of course,

exposure to patient is absolutely
necessary.

But I think my recommendation
be if I could change

one thing today is that everybody
starts first

in a protected environment and
then moves to the OR,

performing cases in vivo
under supervision

and not the other way around.

That's a very good summary, Jorio.

You've been doing this
for a long time

and I've been with you for
a good part of it.

And thank you for sharing
your wisdom today.

It's always a pleasure
to talk to you.

Thank you.

It's been a pleasure working with you

and showing that there are better
ways of doing training

and of course, the journey, as
I said at the beginning,

doesn't stop here.

We're trying to make it always
better and better

and having more people involved
in this type of approach.

Thanks, Tony, for the discussion.

Thank you.