FACT vs. HYPE: You make the call

FACT vs. HYPE:
You make the call
lves”
ted Mitroflow Va
ilure in Explan
ough
Fa
th
of
en
es
ev
od
,
“M
ay
negative w
a
d colleagues,
in
an
u
ny
yo
tany
ta
to
Bu
Bu
d
r.
h
r. Jagdis
valves” D
or presente
ical study by D
n of “over 600
be interpreted
og
em
io
ol
ay
th
at
m
ph
of
rv
y
or
se
ve
er
m
ob
Fi
rg
nt
r
D.
A rece
oracic Su
g a 10 -yea
fied as SV
e Annals of Th
positive. Durin
nnot be classi
itis, and
rd
ca
ry
ca
ts
ve
do
e
an
pl
ar
en
e
ex
published in th
ith
lv
va
infected w
ever, all 12
the Mitroflow
p.1623) were
explants. How
rditis cases is
the results for
oflow Valves,”
e five endoca
ors studied 12
itr
th
at
M
ig
of
d
st
se
on
ve
ci
iti
in
os
Ex
w
sp
and his fello
gic Findings of
to SVD, the di
mar y of Histolo wn.” (p.1621)1 With respect
(Table 2: “Sum
no
nk
“u
n
ere listed as
sive of infectio
follows:
two of them w
ed valve (exclu
at
Guidelines as
er
S
op
ST
e
e
th
th
g
in
in
2
defined
tion involv
(p.1490)
ion or deteriora
udes dysfunct
investigation.”
cl
al
in
ic
n
in
tio
cl
ra
or
rio
y,
autops
dings.
lve dete
“Structural va
D histologic fin
by reoperation,
seven non- SV
SVD
of
, as determined
l
s)
er
ta
si
nt
to
bo
ce
a
m
r
tifo
ro
ul
th
m
or
enomenal
two unknowns
ph
e
a
th
ts
ith
en
w
es
g
pr
on
The data re
excluded al
600 patients.
e must also be
explants out of
d
Thus, these fiv
te
la
re
elv
ly five va
Indeed,
This leaves on
ear period.
oflow valves.
explanted Mitr
8% over a 10 -y
e
0.
th
es was
of
lv
of
e
va
e
nc
fiv
rn
r
rre
occu
the to
res evident fo
3,4 All but one of
ilu
fa
e
e of
lv
.
va
te
es
al
t the exis nc
hetic valv
e structur
that there wer
ardial bioprost
uncertain abou
e
s
ric
ut
hich
pe
w
em
sp
di
in
of
se
l
lf
s,
no
ca
ar
se
is
pi
te
m
There
ed are ty
Butany hi
had cusp
ilures describ
of our valves
cation
docarditis. Dr.
ifi
5)
lc
en
=
ca
ith
(n
if
w
e
%
is
ed
42
ct
the types of fa
rm
infe
is series,
cult to su
one was also
ification): “In th
tation, it is diffi
calcified, and
related to calc
ges. At explan
un
ed
s
ar
ar
te
te
e
e.
th
(i.
at
n
primar y tears
with calcificatio
Heart
as associated
5)
62
®
.1
(p
all except 1 w
”
rtic Pericardial
s.
ar
Mitroflow Ao
llowed the te
ented
rin
fo
es
So
or
pr
e
ed
ce
th
ed
en
of
ec
id
pr
performance
thors, the ev
ic
au
e
am
th
yn
by
od
m
provided
ural and he
e conclusion
rostheses.
ng-term struct
5,6 Contrary to th
Mitroflow biop
d.
The proven lo
e
th
he
lis
of
y
ab
lit
st
bi
l-e
ra
el
du
w
l
na
en
io
be
pt
s
Valve ha
f of the exce
. is further proo
by Butany et al
ay Con
To Whom It M
cern:
Sincerely,
Sorin Group
–1628.
2011;92:1621
Mayer J, Ly tle
n Thorac Surg.
ial Valves. An
ian D, Hagl S,
ah
ard
Sh
ric
D,
Pe
s
w
am
flo
Ad
tro
Mi
E,
d
art
nte
tch
pla
Bu
Ex
T,
of Failure in
90 -1495.
07;22:7-12.
enberg J, David
Nair V. Modes
rg. 20 08;85:14
J Card Surg. 20
meier G, Takk
References
Law K, Suri R,
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Ann Thorac Su
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Feng T, Luk A,
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Interventions.
os N, Blacksto
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Fin
uk
lve
art
al
ho
Va
He
gic
uc
J
ac
.
Ko
olo
rdi
1. Butany J,
ion
M,
rph
Ca
the Aortic Posit
nt Valves – Mo
ller DC, Turina
Morbidit y Af ter
prosthesis in
y
wards Perimou
Mortality and
2. Akins C, Mi
Peric ardial Bio
esis: Durabilit
for Reporting
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ntier- Edwards
G, Feindel C.
B. Guidelines
ardial bioprosth
or
rpe
So
Ca
S,
the
g
of
on
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des
V, Le
ir
Mo
the
h
Na
re
J,
ilu
wit
t
y
Fa
en
tan
E.
3. Bu
ckstone
valve replac em
ric ardial
Smedira N, Bla
tzer R. Aortic
of Mitroflow pe
4. Roselli E,
tre evaluation
Siniawski H, He
28.
-year, multic en
Detschades C,
20
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J,
a
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88
Ste
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i
TH
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ive results (IS
Pasic M, Musc
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5. Yankah C,
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years. J Thora
dy on the Mitro
results up to 21
The Italian stu
rs.
ato
.
tig
-26
es
US Inv
11;39:18
6. The ISTHM Eur J Cardiothorac Surg. 20
bioprosthesis.
Heart Valves
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