Transcatheter
tricuspid
valve
repair
could
finally
be
tied
to
improved
hard
outcomes
in
people
with
severe
tricuspid
regurgitation
(TR)
at
high
risk
for
future
heart
failure
(HF)
events,
a
German
trial
found.
With
operators
using
commercially
available
transcatheter
devices,
patients
had
1-year
results
well
surpassing
expectations
for
reduced
all-cause
death
and
hospitalization
for
HF
with
improved
quality
of
life
(win
ratio
2.42
over
medical
therapy
alone,
95%
CI
1.76-3.33),
according
to
Jörg
Hausleiter,
MD,
of
Ludwig-Maximilians-Universität
München,
Germany.
Taking
quality
of
life
out
of
the
equation,
combined
death
from
any
cause
and
HF
hospitalization
at
3
years
still
significantly
favored
transcatheter
repair
for
patients
with
symptomatic
severe
TR
(52.4%
with
tricuspid
repair
vs
21.0%
with
medical
therapy,
HR
0.40,
95%
CI
0.29-0.55).
Hausleiter
presented
the
TRIC-I-HF
trial
results
at
the
European
Society
of
Cardiology
(ESC)
Congress
in
Munich,
Germany,
with
a
simultaneous
publication
in
the
New
England
Journal
of
Medicine.
“These
findings
extend
previous
evidence
from
randomized
trials
by
showing
that
the
benefits
of
an
interventional
strategy
were
not
confined
to
improvements
in
quality
of
life
but
also
translated
into
meaningful
differences
in
hard
clinical
outcomes,”
study
authors
wrote.
“The
findings
also
showed
the
procedural
safety
as
well
as
the
sustained
reduction
in
the
severity
of
tricuspid
regurgitation
when
transcatheter
tricuspid-valve
repair
is
performed
at
experienced
heart-valve
centers.”
Notably,
TRIC-I-HF
showed
that
the
number
needed
to
treat
to
prevent
one
death
or
HF
hospitalization
at
1
year
was
just
four
patients
in
the
hands
of
these
experienced
operators
in
Germany.
“It’s
just
an
incredible
result,”
said
ESC
session
discussant
Rebecca
Hahn,
MD,
of
Columbia
University
Medical
Center
in
New
York
City.
“This
is
a
landmark
study
that
will
inform
patients
and
clinicians
about
the
benefit
of
transcatheter
repair
therapy.
I
congratulate
the
…
investigators
in
proving
for
once
and
for
all
that
TR
reduction
can
result
in
a
mortality
and
heart
failure
hospitalization
benefit.
And
we
eagerly
look
forward
to
subgroup
analyzes
that
may
further
inform
clinicians
about
who,
when,
and
how
to
treat,”
Hahn
told
the
audience.
Hausleiter
and
colleagues
reported
that
tricuspid
repair
led
to
an
early
HF
hospitalization
benefit
—
apparent
as
early
as
1.6
years
on
average
—
that
continued
to
diverge
over
time.
As
for
why
TRIC-I-HF
was
so
successful,
the
investigators
cited
the
sicker
patient
population
of
this
trial
as
well
as
increasing
operator
experience
in
the
real
world.
“Owing
to
the
marked
anatomic
variability
of
the
tricuspid
valve,
the
challenges
of
grasping
thin
leaflets
in
the
presence
of
large
coaptation
gaps,
and
the
complexity
of
intraprocedural
echocardiographic
imaging,
transcatheter
tricuspid
valve
repair
remains
a
technically
demanding
procedure
with
a
pronounced
volume-outcome
relationship,”
Hausleiter’s
group
wrote.
TRIC-I-HF
was
conducted
at
29
high-volume
heart-valve
centers
in
Germany.
Participants
were
360
patients
with
symptomatic
severe
TR
randomized
2:1
to
tricuspid
valve
repair
or
medical
therapy
alone
(mean
age
80.3,
56.4%
women).
At
baseline,
tricuspid
regurgitation
was
graded
as
severe
in
50.8%
of
the
cohort,
massive
in
34.2%,
and
torrential
in
10.3%.
Average
left
ventricular
ejection
fraction
was
54.3%.
Three
in
four
people
had
New
York
Heart
Association
class
III
or
IV
HF;
55.0%
had
been
hospitalized
for
HF
in
year
preceding
enrollment.
Of
those
who
got
transcatheter
tricuspid
intervention,
98.3%
underwent
transcatheter
edge-to-edge
repair
(TEER).
TEER
largely
involved
the
available
CE-marked
Pascal
(65.6%)
and
TriClip
systems
(33.0%).
The
investigators
allowed
crossovers
only
after
the
occurrence
of
severe
HF
decompensation
resulting
in
hospitalization
and
IV
diuretic
therapy.
In
28
of
48
crossovers,
valve
repair
was
performed
during
the
hospitalization
that
constituted
the
primary
endpoint
event,
whereas
the
remaining
crossovers
involved
repair
performed
during
subsequent
hospitalizations.
Major
adverse
events
within
30
days
occurred
in
5.9%
of
cases
after
tricuspid
transcatheter
valve
repair.
TRIC-I-HF’s
results
may
not
necessarily
be
generalizable
to
other
countries,
the
trialists
acknowledged.
Nonetheless,
Hausleiter
noted
that
even
a
boost
in
quality
of
life
alone
is
still
meaningful
and
should
not
be
taken
for
granted
in
TR.
“For
the
patients,
probably
for
most
of
them,
the
quality
of
life
improvement
matters
more
than
than
an
increased
lifespan
because
they’re
usually
already
around
80
years
of
age,”
he
said
during
a
press
conference.
“Quality
of
life
is
important,
but
also
the
impact
of
healthcare
hospitalizations
and
mortality
reduction
will
probably
provide
us
with
more
arguments
to
treat
more
patients
with
such
a
therapy.”
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