transcatheter aortic valve implantation. brazilian reality and perspectives! fábio s. brito jr.,...
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Transcatheter aortic valve implantation. Brazilian
reality and perspectives!Fábio S. Brito Jr., MD, PhD
Hospital Israelita Albert Einstein
São Paulo, Brazil
On behalf of the SBHCI TAVI Registry investigators
1980 2010 2030
> 75 years: 1,421,000 75 years: 5,027,000
Life Expectancy: 73,5 years
Population: 190,000,000
> 75 years: 11,064,000
Brazil: Population Pyramid by Age and Gender Brazil: Population Pyramid by Age and Gender
Sapien-EdwardsCoreValve-Medtronic Inovare-Braile
Approval Sept 201142 cases:• 37 TF• 05 TA
Approval Jan 2008410 cases:• 395 TF• 10 Subclavian• 05 TransAo
Approval Sept 2011166 cases:• 157 TA• 01 Tao• 08 TF
TAVR in Brazil: 618 cases (Jan/2008 - July 2012)
Numbers of TAVR in Brazil
(Corevalve + Sapien)
Brazilian TAVI Registry
Real World Registry.
Electronic Monitoring: 100%
Adverse Events Committee: Mortality
Endpoints and Complications in
acordance with Valve Academic Research
Consortium Consensus on Event
Definition
CoreValve and Sapien cases.
jun/2011 jul/2011 ago/2011 set/2011 out/2011 nov/2011 dez/2011 jan/2012 fev/2012 mar/2012 abr/2012 maio/2012
jul/20120
50
100
150
200
250
300
350
63 69
87
107
165
207214
229
264 269279
297 299
TAVI Registry: Inclusion
SBHCI TAVI Registry: 50% of all cases in Brazil and 66% of all CoreValve / Sapien
85% em 5 centros
0
20
40
60
8073
68
58
34
23
10 8 6 6 5 5 3
Inclusion / Center
Characteristics (n = 277)Age, years 81.7 (DP 7.6)
Male, n (%) 132 (47.6%)
Logistic EuroScore I, % 20.7 (DP 14.2)
STS Score, % 14.2 (DP 13.2)
Congestive Heart Failure (NYHA)
I or II, n (%) 50 (18.1 %)
III or IV, n (%) 227 (81.9 %)
Diabetes, n (%) 84 (30.3 %)
Renal Failure, n (%)* 216 (77.9 %)
Brazilian TAVI Registry: Baseline Characteristics
* GFR<60ml/min
(n = 277)Access Femoral, n (%) 268 (96.7 %) Subclavian, n (%) 8 (2.8 %) Other, n (%) 1 (0.3%)Valvuloplasty, n (%) 168 (69.1 %)Valve-in-valve 6 (2,1 %)Bioprosthesis Corevalve, n (%) 250 (90.2 %) Sapien XT, n (%) 27 (9.8 %)Post dilatation, n (%) 94 (33.9 %)Device Success, n (%) 241 (87 %)Device Failure, n (%) 35 (13%) Mod/Sev aortic regurgitation 16 (5.7%) 2nd device 15 (5.4%) Other cause 7 (2.5%)
Brazilian TAVI Registry: Procedure Characteristics
LVEF Max Grad Mean Grad
58.6
87.3
52.661
19.310.1
Baseline Post procedure
Brazilian TAVI Registry:Echo Results
p=ns
p<0.001p<0.001
ICC (NYHA)
I or II, n (%) 50 (18.1 %)
III or IV, n (%) 227 (81.9 %)
ICC (NYHA)
I or II, n (%) 218 (94.7%)
III or IV, n (%) 12 (5.3 %)
Brazilian TAVI Registry:30 Days Results
Baseline (277 pts):
30 days (230 pts):
n=277Mortality, n (%) 27 (9.7 %) Cardiovascular Mortality, n (%) 22 (7.9 %)Myocardial Infarction 1 (0.4 %)Stoke 12 (4.3 %)Bleeding, n (%) 43 (15.5 %) Life-threatening, n (%) 13 (4.6 %) Major, n (%) 18 (6.4 %) Minor, n (%) 12 (4.3 %)Vascular Complication, n (%) 28 (10.1 %) Major, n (%) 15 (5.4 %) Minor, n (%) 13 (4.6 %)Pacemaker, n (%) 51 (21.5 %) CoreValve, n (%) 51 (24.1%) Sapien, n (%) 0
Brazilian TAVI Registry:30 Days Results
CoreValve Registries:30-Day All-Cause Mortality
1. Medtronic Data on File. COR 2006-02: 18 Fr Safety & Efficacy Study Re-Analysis, August 14, 2009. 2. Meredith. VARC-adjudicated Outcomes in Inoperable and High Risk AS Patients. TCT 2010, Washington, DC.3. Avanzas P, Munoz-Garcia AJ, Segura J, et al. Percutaneous implantation of the CoreValve® self-expanding aortic valve prosthesis in patients
with severe aortic stenosis: early experience in Spain. Rev Esp Cardiol. 2010;63:141-148.4. Eltchaninoff. French Registry, TAVI Facts, Figures and National Registries. EuroPCR 2010, Paris, France.5. Bosmans. Belgian Registry, TAVI Facts, Figures and National Registries. EuroPCR 2010, Paris, France.6. Zahn. German Registry, TAVI Facts, Figures and National Registries. EuroPCR 2010, Paris, France.7. Ludman. UK Registry, TAVI Facts, Figures and National Registries. EuroPCR 2010, Paris, France.8. Petronio. Italian Registry, TAVI Facts, Figures and National Registries. EuroPCR 2010, Paris, France.
15.2%
5.6%
7.4%
15.1%
9.0%
12.4%
5.5%
7.2%
0%
5%
10%
15%
20%
25%
18 Fr S&E1 ANZ2 Spain3 French4 Belgian5 German6 UK7 Italian8
%
Brazilian
9.7%
COREVALVE REGISTRIES:30-Day Stroke Rate
9.6%
0%
5%
10%
15%
20%
18 Fr S&E French Belgian German UK Italian
4.5%4.0%
2.6%4.0%
1.7%
ANZ
1.9%
Brazilian
4.3%
ADVANCE
2.9%
COREVALVE REGISTRIES:Pacemaker Implantation
35.2%
26.9%23%
42.5%
26%
18.5%
31.3%
40.0%
0%
10%
20%
30%
40%
50%
60%
18 Fr S&E ANZ Spain1 French2 Belgian2 German2 UK2 Italian2
Per
cen
t o
f P
ati
en
ts (
%)
Weighted Average 28.5%
Brazilian
24%
ADVANCE
26.3%
Transcatheter aortic valve implantation. Brazilian
reality and perspectives!
Thank you!!!!!