My name is Santiago Garcia,
I'm the director of the structural heart programme
at The Christ Hospital in Cincinnati, Ohio,
and the topic for discussion today
is the safety and efficacy
of valve-in-valve TAVR procedures
with and without bioprosthetic valve fracture
using the balloon-expandable SAPIEN 3 and ultra platform.
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Well, this procedure is, as you know,
the use of bioprosthetic valve has increased,
not only in the United States, but also around the world.
And the rationale for that is that patients and doctors
wanted to avoid, if possible, all the risk
of long-term anticoagulation that is
associated with the use of mechanical valves.
However, the downside of bioprosthetic valves is that
eventually all of them will degenerate
and there will be a need for a second procedure.
Valve-in-valve transcatheter aortic valve replacement
has emerged as a very reasonable alternative
to redo surgery.
And it's increasingly used in the US to treat
degenerative surgical valves.
And one of the rationales
for doing bioprosthetic valve fracture as an agent
to these procedures is to try to mitigate the risk
of patient-prosthetic mismatch with these procedures
which is particularly important in patients
who have small surgical prosthesis.
Well, it's one of the most commonly used
transcatheter of our platforms,
balloon-expandable valves in the United States.
And the rationale is to avoid a redo surgery,
a redo operation that is associated with significant risk.
These patients who already have one operation to treat
aortic valve pathology and now, you know,
5, 10, 15 years later, they need another intervention
because the surgical valve is failing.
So it makes sense to try to deliver the second valve
from the groin to avoid a second scenario.
Well, so this is an observational study
using data from the TVT Registry
which has been capturing
data on the use of bioprosthetic valve fracture now
for a couple of years.
So this is the largest study today.
Looking at the outcomes of patients
with bioprosthetic valve fracture
versus those patients who had valve-in-valve TAVR procedures
without fracture.
And the rationale was that we wanted to really assess
the safety of this procedure
and also the efficacy in terms of gradings reduction
and so forth.
Well, the main outcomes are that,
in relationship to patients
who have valve-in-valve TAVR procedures without fracture,
those patients who had a valve-in-valve TAVR with fracture
were an increased risk of in-hospital and 30-day mortality,
the risk almost doubled.
The possible mediators of this increased risk
are number one, life-threatening bleeding
which was significantly more commonly seen
in the group of patients
who had bioprosthetic valve fracture,
and also major vascular complications were higher.
So clearly a safety signal
was seen in the study.
With regards to the efficacy of the procedure,
we saw a modest reduction in gradients
of approximately four millimetres of mercury
which is significantly less
than what has been previously reported.
And also a modest increase in the aortic valve area
of approximately 0.2 centimetre squares,
which is also significantly less than
what has been previously reported.
Well, the clinical significance of these findings is that
this procedure provides some
benefits in terms of hemodynamics,
is also associated with some risk.
We did some additional analysis
because the bioprosthetic valve fracture procedure
can be performed either before the valve-in-valve TAVR
or after valve-in-valve TAVR,
and we noted a significant difference
between the two in terms of both safety and efficacy.
The performance of bioprosthetic valve fracture
after valve-in-valve TAVR is safer and more effective,
and therefore, one of the conclusions so far,
is that the timing of bioprosthetic valve fracture
is very important.
And that's one of the messages that we want to send to the
interventional cardiology community
performing these procedures.
In contrast, those patients who had
bioprosthetic valve fracture performed
prior to the valve-in-valve TAVR
had significant higher risk of death
and life-threatening bleeding,
which we need to better understand.
But there is a clear signal here
for both better safety and efficacy
when the BVF procedure is performed
after the valve-in-valve TAVR.
Well, some of the restrictions that we have
in accessing the TVT Registry with regards to
all the surgical valves,
we had information on the true internal dimension
of only the Edwards Lifescience's surgical valves
which was approximately a third of the cohort.
I think it will be nice to have that information
for all surgical valves,
so one can do more sophisticated analysis
and the data could be more granular
with regards to gradients and changes in aortic valve area.
But that's one of the limitations of the registry.
The second consideration is the adjudication
of what a successful bioprosthetic valve fracture looks like
was done by individual sites.
There was no core lab in our analysis
and this can be sometimes challenging
because not all the valves have fluoroscopic markers,
and not all the valves are created the same way.
So that's one of the limitations,
it was site adjudicated
and not adjudicated by an independent core lab.
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