Transcatheter aortic valve implantation. Brazilian reality and perspectives! Fábio S. Brito Jr.,...

Transcatheter aortic valve implantation. Brazilian

reality and perspectives!Fábio S. Brito Jr., MD, PhD

Hospital Israelita Albert Einstein

São Paulo, Brazil

fsbrito@einstein.br

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!!!!!