Diapositiva 1

TAVR and SAVR:
Argentinean Registries
Dr. Miguel O. Payaslian
Argentina´s TAVR Registry Coordinator
Chief of Interventional Cardiology
Juan A Fernandez General Hospital
Buenos Aires, Argentina
All faculty disclosures are available on
the CRF Events App and online at
www.crf.org/tct
Argentinean Registry TAVR: 35 Institutions
CORDOBA
•
•
•
•
•
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SANATORIO ALLENDE
HOSPITAL PRIVADO DE LA COMUNIDAD
FUSAVIM
HOSPITAL DE CORDOBA
SANATORIO VELEZ SARSFIELD
CLINICA SUCRE
SANTA FE
•
INSTITUTO DE DIAGNOSTICO SANTA FE
•
SANATORIO GARAY
ROSARIO
•
INSTITUTO CARDIOVASCULAR ROSARIO
•
•
SANATORIO PLAZA
HOSPITAL ITALIANO
CORRIENTES
•
INSTITUTO DE CARDIOLOGIA CABRAL
BUENOS AIRES
•
•
•
•
•
•
•
FUNDACION FAVALORO
HOSPITAL ALEMAN
HOSPITAL BRITANICO DE BS AS
HOSPITAL ESPAÑOL DE BS AS
HOSPITAL ESPAÑOL DE LA PLATA
HOSPITAL JUAN A FERNANDEZ
HOSPITAL ITALIANO DE BS AS
•
•
INSTITUTO CADIOVASCULAR DE BS AS
INSTITUTO MOD. DE ALTA COMPLEJIDAD
•
•
•
•
•
•
•
•
•
•
•
•
ANATORIO BURZACO
SANATORIO GUEMES
SANATORIO OTAMENDI
HOSPITAL DEL CRUCE
HOSPITAL DEL SUR BAHIA BLANCA
CLINICA SAN CAMILO
CLINICA ADVENTISTA
CLINICA SAGRADA FAMILIA
INSTITUTO FLENI
SANATORIO LAS LOMAS
SANATORIO TRINIDAD PALERMO
HOSPITAL UNIVERSITARIO UAI
Evaluation Time:
Echocardiographic & Clinical Variables
30 D
6M
1Y
2Y
3Y
680 patients were included in the Registry
509 patients were studied for this presentation
Retrospective / Prospective Registry
Consecutive TAVRs since March 2009 until today
www.tavi.org.ar
In Argentina we implant self expanding prothesis with porcine
pericardium.
The Registry is independent from sponsors
INTERANNUAL VARIATION
INTERANNUAL VARIATION
800
800
600
680
600
400
680
400
200
200
0
0
29
29
2009
2009
265
146
87
146
87
265
2010
2010
sep-11
sep-11
Sep-11 to AprApr-12 to 2014
12
Sep-11 to AprApr-12 to 2014
12
Cirugza cardiovascular
REVISTA ARGENTINA DE CARDIOLOGIA, ENERO-FEBRERO 2001, VOL. 69, N° 1
Estudio Multicentrico de Cirugia Cardiaca.
Pacientes valvulares
uibles a su enfermedad; si fuese corona1. Endocarditis infecciosa activa (EIA): Cuando
demostrar la presencia de isquemia sipresentaba al menos uno de los siguientes criterios
empo libre de sintomas es limitado, este
en los dos ultimos meses previos a la cirugia: hemose considera asintomatico y se incluye
cultivos positivos, cultivo de pieza quirurgica posirupo sintomatico que corresponda.
tivo y/o identification de microorganismos por miI nvestigadores ESMUCICA*
6nlco estable (ACE): Paciente que precroscopic en la pieza quirurgica.
de la misma clase funcional por un tiem2. Endocarditis infecciosa curada (EIC): Cuando
r de 3 meses. (2)RESUMEN
Clase funcional segun
no cumplia con ningun criterio de endocarditis actin de la Canadian Cardiovascular Society
va pero con antecedentes objetivos de endocarditis
Objetivo
n (CCSC).
infecciosa.
El objetivo del presente trabajo es el de determinar las caracteristicas poblacionales, valorar la
nestable: Se incluyen
en este
item los
incidencia
de complicaciones
y de mortalidad de los pacientes sometidos a cirugia cardiaca
ue presentan cuadros
inestables, como
Complicaciones posoperatorias
valvular.
eciente comienzo, angina progresiva,
a) Hemorragia posoperatoria
Material
y
metodo
AM segun clasificacion de Bertolasi y
Perdida de sangre mayor de 300 ml/h por el terSe incluyeron en forma prospectiva,
y an6nima 2.125
pacientes
de cuatro
minoconsecutiva
de 3 horas consecutivas
o bien
a la perdida
de instituciones de
Republica
Argentina,
que de
fueron
cirugia cardiaca
incluyeron infartos
Q ylano
Q, de mas
y
mas
1.200sometidos
ml en las aprimeras
12 horas.entre
(9) agosto de 1996 y
julio de 1997.
e 30 dias de evolution.
Causa: Quirurgica (si fue solucionada quirurgincia cardiaca (ICC):
Se
requirio
uno
de
Resultados
camente) o medica (si no fue solucionada quirurgis criterios para considerar
quepacientes
el pacien-incluidos,
camente).
De los 2.125
395 (18,6%) fueron sometidos a cirugia valvular, de los cuales
a6rtica, el 27% mitral y el 12% doble valvular. Las caracor de ICC: (3) el 61% correspondi6 a cirugia valvular
b) Hemodinamicas
teristicas
operatorios
varian de(3,
acuerdo
con la patologia
6n de eyeccion (Fey)
del poblacionales
ventriculo iz- y los datosBajo
gasto cardfaco:
4) Hipotensi6n
arterialtratada y se
analizan separadamente.
deHg)
complicaciones
fuepalidel 61,5% en la
evaluada por angiografia,
ecocardiogra- La incidencia
(< 90 mm
sostenida deposoperatorias
mas de una hora,
del de
51,8% endez
la estenosis
delmal
51,8%
en lacapilar,
insuficiencia
a6rtica y del
a gamma menorestenosis
del 40%a6rtica,
o fraction
y frialdadmitral,
cutanea,
relleno
obnubi54,5% menor
en la insuficiencia
mitral. La mortalidad intrahospitalaria de2 los pacientes a6rticos fue
o por ecocardiograma
del 25%.
Population Characteristics in TAVR and SAVR
TAVR
2009-2014
TAVR Registry
509 Patients
35 Centers
SAVR
2007-2008
1996-1997
CONAREC 16
ESMUCICA
359 Patients
177 Patients
49 Centers
4 Centers
Age
81,4
64,8
65,8
Femenine Sex
52,0%
36,8%
47%
Hypertension
89,0%
64,6%
N/D
Hypercholesterolemia
73,0%
36,7%
N/D
Diabetes
24,0%
17,5%
9,0%
23%
30%
N/D
20,84%
3.5% - 6.5%
Parsonnet Score
Current Smoker
Euro Score
Cardiovascular Comorbilities in TAVR and SAVR
TAVR
TAVR Registry
509 Patients
SAVR
CONAREC 16
ESMUCICA
359 Patients
177 Patients
Peripheral Artery Disease
29,5%
2,51%
-
Highly calcified aorta
7,5%
-
-
Previous Stroke
6,0%
4,74%
5%
LVEF % < 30
13,2%
Previous AMI
15,0%
Previous CABG
14,5%
CONAREC- 16
RVA + CABG
312 Patients
3,86%
11%
Age
69,8
2,23%
Femenine Sex
Euro Score
Coronary Disease
54,0%
-
-
25,6%
6,51% - 8,37%
-
Procedures by age grouping
84 - 85
SAVR
TAVR
81,4
SAVR
Arg Registry
Argentinean Registry TAVR
Non-Cardiovascular Comorbidities in TAVR vs SAVR
SAVR
TAVR
TAVR Registry
509 Patients
CONAREC 16
359 Patients
65,0%
-
-
18,0% / 2,0%
7,8% / 0,8%
2,8%
27% / 9%
8,3%
-
Cirrhosis
3,0%
-
-
Chest Irradiation
1,5%
-
-
Pulmonary Hypertension
Chronic Renal Failure / Dialysis
EPOC
ESMUCICA
177Patients
Characteristics in TAVR
100.0%
12.3%
90.0%
30.0%
80.0%
Emergency
70.0%
60.0%
Urgency
55.0%
Scheduled procedures
50.0%
FV
40.0%
ICC
30.0%
Asympthomatic
20.0%
10.0%
0.0%
31.0%
Syncope
Angina
FC II
FC III
FC IV
Methodology: TAVR
120.0%
100.0%
Direct Aortic
Transapical
Subclavian
80.0%
Femoral
Neuroleptoanalgesya
60.0%
General
98.0%
95.0%
CX
82.0%
40.0%
LC
26,7%
RC
DA
20.0%
VIV
Native Valve
0.0%
Aortic
Stenosis
Previus PCI
Anesthesia
Vascular
Access
Results: TAVR
III
3.0%
3.0%
BCRI
100.0%
17.0%
II
90.0%
BAV
80.0%
FC III
70.0%
FC II
60.0%
97.0%
59.0%
I
50.0%
FC I
40.0%
Without
18,4% PM
30.0%
2.4%
20.0%
21.0%
0
10.0%
16.0%
No
Yes
0.0%
Success
Leak
Pacemarker
44% of pacemakers were implanted on patients with previous RBBB
Transvalvular Gradient Post TAVR
160
140
120
100
81.24
80
60
40
7
12
14
15
20
0
Pre
Post
30 dias
6 meses
12 mese
Mortality & Morbidity at 30 Days
Argentinean Registry TAVR
10.0%
9.0%
8.0%
7.0%
6.0%
5.0%
4.0%
3.0%
2.0%
1.0%
0.0%
9.4%
4.8%
4.9%
3.9%
0.4%
5.3%
EuroScore Related Mortality
Population x EuroScore
100%
90%
80%
70%
60%
50%
40%
Mortality x EuroScore
Global
Mortality
4,43%
30%
24,22%
10,20%
20%
10%
INOPERABLE
5,21%
3,57%
0%
< 10
10 a 19
>20 a 29
> 30
EuroScore EuroScore EuroScore Euroscore
TAVR PARTNER B LIKE
TAVR SELF EXPANDING
INOPERABLE LIKE
Comparison of Argentinean Resgistries:
TAVR – SAVR
SAVR Mortality > to
70.0%
Predicted EuroScore
60.0%
50.0%
40.0%
10.0%
61.5%
TAVR Mortality is
Similar to the SAVR
Low & Moderate Risk
20.2%
8.9%
8.6%
5.0%
0.0%
Argentinean
Registry (TAVR)
2009/2014
Mortality
Linear (Mortality)
22.3%
9.4%
EuroScore
Complications
29.3%
30.0%
20.0%
Less Complication
Rate in TAVR vs SAVR
CONAREC (SAVR) ESMUSICA (SAVR)
2003/2008
(2010)
1996/1997
(2001)
Argentinean TAVR Registry: 2 year Follow Up
Argentinean Registry: TAVR
Preliminary Outcome
In-Hospital and 30 days FU
Any death
9,4%
Myocardial Infarction
0.6%
Stroke
3.9%
Permanent Pacemaker
18.4%
2.1 +/- 1.3 yrs of Follow-up
Any death
17.3%
Myocardial Infarction
0.8%
Any Stroke
4.1%
Death+Stroke
21.4%
All cause of Mortality
30 days
10
9
9.4%
8
7
6
7.8%
7.1%
5
4
3
3.4%
2
1
0
UK-TAVI(1)
Partner(2)
Metanalysis(3)
1-NE Moat et al. J Am Coll Cardiol. 2011 Nov
8;58(20):2130-8.
2-RS Smith et al. N Engl J Med 2011;364:2187-98.
3-P Genereux et al. J Am Coll Cardiol 2012;59:2317–26.
Arg Reg
Stroke (major&minor)
30 days
6
5
4.9%
4
4.6%
4.1%
4.0%
3.9%
3
2
1
0
UK-TAVI(1)
Adams et al(2)
Partner(3)
Metanalysis(4)
1-NE Moat et al. J Am Coll Cardiol. 2011 Nov
8;58(20):2130-8.
2-DH Adams et al. N Engl J Med. 2014 May
8;370(19):1790-8.
3-RS Smith et al. N Engl J Med 2011;364:2187-98.
4-P Genereux et al. J Am Coll Cardiol 2012;59:2317–26.
Arg Reg
Myocardial Infarction
30 days
2
1.5
1
1.3%
1.1%
0.5
0
UK-TAVI(1)
0.0
%
Partner(2)
0.6%
Metanalysis(3)
1-NE Moat et al. J Am Coll Cardiol. 2011 Nov
8;58(20):2130-8.
2-RS Smith et al. N Engl J Med 2011;364:2187-98.
3-P Genereux et al. J Am Coll Cardiol 2012;59:2317–26.
Arg. Reg.
Permanent Pacemaker
30 days
25
20
21%
19.8%
15
18.4%
16.3%
13.9%
10
5
0
Koos et al(1)
UK-TAVI(2)
Adams et al(3) Metanalysis(4)
1-R Koos et al. J Heart Valve Dis. 2011 Jan;20(1):83-90
2-NE Moat et al. J Am Coll Cardiol. 2011 Nov
8;58(20):2130-8.
3-DH Adams et al. N Engl J Med. 2014 May
8;370(19):1790-8.
4-P Genereux et al. J Am Coll Cardiol 2012;59:2317–26.
Arg Reg
All cause of Mortality
2 years Follow-up
40
35
33.9%
30
25
20
26.3%
15
17.3%
10
5
0
UK-TAVI(1)
Partner(3)
1-NE Moat et al. J Am Coll Cardiol. 2011 Nov
8;58(20):2130-8.
3-SK Kodali et al. N Engl J Med 2012;366:1686-95.
Arg Reg
Heart Team should includ:
• Patient Decision
•Factors
Institutional
Expertise
in Patients
with High
& Moderate
such as sex,
race, availability,
experience,
and institutional
commitment
to Surgical
managingRisk
very high-risk patients, technical skills, local results, referral
patterns, and patient preference all may have an impact on the decision-making
process and should be taken into account by this multidisciplinary team.
suchCardiologist
a Team would be comprised of the Patient’s Primary Cardiologist
•Ideally,
Primary
Conclusions
 The Argentinean TAVR Registry shows a significant decrease in mortality on
high-risk and inoperable patients.
 Argentina lacks SAVR and TAVR randomized data.
 Medium-Term follow-up showed a similar survival between the two technics
 TAVR needs better devices to reduce severe (3%) and moderate (16%) valvular
leak.
 The final decision between TAVR and SAVR should take into account:
 Local experience
 Local mortality and morbidity
 Patient preferences
 Primary cardiologist´s opinion
FIRST TAVR IN ARGENTINA.
5 year later
FIRST TAVR IN
ARGENTINA.
5 year later
Other Complications
4.50%
4.05%
4.00%
3.50%
3.00%
2.50%
1.92%
2.00%
1.50%
1.06%
1.06%
1.00%
0.42%
0.50%
0.00%
Convertion to
SAVR
Prothesis
Migration
Pericardium
Bleeding
Annulus
Rupture
Aortic
Disection
Implant Technique
80%
70%
69%
60%
50%
40%
31%
30%
20%
Post-Dilatation
17,70%
Post-Dilatation
36,30%
10%
0%
Con Valvuloplastia
Sin Valvuloplastia
ALTURA DEL IMPLANTE
RELACIONADO A NECESIDAD DE
MARCAPASO
ALTURA DEL IMPLANTE
100%
90%
80%
70%
60%
50%
40%
30%
20%
10%
0%
87%
13%
OPTIMA
BAJA
0%
ALTA
CAUSAS DE MORTALIDAD
PARO CARDIACO / MUERTE SUBITA
TAPONAMIENTO POR PERFORACION DE VI/VD
CIRUGIA CARDIOVASCULAR DE URGENCIA
IAM
FIBRILACION VENTRICULAR
DISFUNCIÓN VENTRICULAR SEVERA
ANESTESIA GENERAL
DISECCION DE AORTA
ACV HEMORRAGICO/ISQUEMICO
OCLUSION VASCULAR PERIFERICA
INFARTO MESENTERICO
HEMORRAGIA DIGESTIVA
CRISIS BLASTICA
SEPSIS
NEUMONIA INTRAHOSPITALARIA
INSUFICIENCIA RENAL AGUDA
EuroScore Related Mortality
37.66%
40.00%
% Mortality x
EuroScore
35.00%
23.80%
30.00%
19.69%
25.00%
18.83%
20.00%
15.00%
10.00%
5.00%
0.93%
1.74%
1.76%
5.02%
0.00%
< 10%
10 to 20 %
> 20 to 30%
> 30 %
% Total Patients
x EuroScore
Methodology: TAVR
120.0%
23mm
100.0%
80.0%
3.0%
Two Valves
31 mm
31.0%
One Valve
26mm
60.0%
23 mm
97.0%
40.0%
69.0%
31 mm
29mm
20.0%
26 mm
0.0%
29 mm
Valvulaplasty
Valve Diameter
Valve Qty
Depth of
Implant
No
Yes
All cause of Mortality
1 year Follow-up
30
25
24.3%
20
22.1%
21.4%
15
14.2%
14.1%
10
5
0
UK-TAVI(1)
Adams et al(2)
Partner(3)
Metanalysis(4)
1-NE Moat et al. J Am Coll Cardiol. 2011 Nov
8;58(20):2130-8.
2-DH Adams et al. N Engl J Med. 2014 May
8;370(19):1790-8.
3-SK Kodali et al. N Engl J Med 2012;366:1686-95.
4-P Genereux et al. J Am Coll Cardiol 2012;59:2317–26.
Arg Reg