1. Transcatheter aortic valve implantation
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

2. Brazil: Population Pyramid by Age and Gender
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

3. TAVR in Brazil: 618 cases (Jan/2008 - July 2012)
CoreValve-Medtronic
Sapien-Edwards
Inovare-Braile
Approval Jan 2008
410 cases:
395 TF
10 Subclavian
05 TransAo
Approval Sept 2011
42 cases:
37 TF
05 TA
Approval Sept 2011
166 cases:
157 TA
01 Tao
08 TF
This has been the first valve prosthesis that can be implanted percutaneously. As you know Alan Cribier did the first-in-man few years ago and up to now, several centers implanted this device in high-risk patients with severe aortic valve disease. The Cribier Edwards valve is balloonexpandable, can be implanted antegardely and retrogradely and has a valve area of 1.7 cm.
TAVR in Brazil: 618 cases (Jan/ July 2012)

4. Numbers of TAVR in Brazil (Corevalve + Sapien)

5. 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.

6. TAVI Registry: Inclusion
SBHCI TAVI Registry: 50% of all cases in Brazil and 66% of all CoreValve / Sapien

7. Inclusion / Center
85% em 5 centros

8. Brazilian TAVI Registry: Baseline Characteristics
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 %)
* GFR<60ml/min

9. Brazilian TAVI Registry: Procedure Characteristics
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%)

10. Brazilian TAVI Registry:
Echo Results
p=ns
p<0.001
p<0.001

11. Brazilian TAVI Registry:
30 Days Results
Baseline (277 pts):
ICC (NYHA)
I or II, n (%)
50 (18.1 %)
III or IV, n (%)
227 (81.9 %)
30 days (230 pts):
ICC (NYHA)
I or II, n (%)
218 (94.7%)
III or IV, n (%)
12 (5.3 %)

12. Brazilian TAVI Registry:
30 Days Results
n=277
Mortality, 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 (%)
Vascular Complication, n (%)
28 (10.1 %)
15 (5.4 %)
Pacemaker, n (%)
51 (21.5 %)
CoreValve, n (%)
51 (24.1%)
Sapien, n (%)

13. CoreValve Registries: 30-Day All-Cause Mortality
25%
20%
15.2%
15.1%
15%
12.4% %
9.7%
10%
9.0%
7.4%
7.2%
5.5%
5.6% 5%
Medtronic. Data on file.
Meredith IT. A Snapshot from the Ongoing Australia-New Zealand Medtronic CoreValve® Registry. Transcatheter Cardiovascular Therapeutics 2009, September 21-25, San Francisco, CA.
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:
Eltchaninoff. French Registry, TAVI Facts, Figures and National Registries. EuroPCR 2010, Paris, France.
Bosmans. Belgian Registry, TAVI Facts, Figures and National Registries. EuroPCR 2010, Paris, France.
Zahn. German Registry, TAVI Facts, Figures and National Registries. EuroPCR 2010, Paris, France.
Ludman. UK Registry, TAVI Facts, Figures and National Registries. EuroPCR 2010, Paris, France.
Petronio. Italian Registry, TAVI Facts, Figures and National Registries. EuroPCR 2010, Paris, France. 0%
18 Fr S&E1
ANZ2
Spain3
French4
Belgian5
German6
UK7
Italian8
Brazilian
1. Medtronic Data on File. COR : 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:
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. 13

14. COREVALVE REGISTRIES: 30-Day Stroke Rate
20%
15%
9.6%
10%
4.5%
4.3% 5%
4.0%
4.0%
2.6%
2.9%
1.9%
1.7% 0%
18 Fr S&E
ANZ
French
Belgian
German UK
Italian
ADVANCE
Brazilian 14 14

15. COREVALVE REGISTRIES: Pacemaker Implantation
Weighted Average 28.5%
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
Percent of Patients (%)
26.3%
24%
Procedural variability, anatomical differences and clinical practice variation impact pacemaker
implant rates:9,10
Depth of implant may induce conduction disturbances11
Valvuloplasty balloon size may impact conduction system11
Anatomical and patient-related factors may impact conduction disturbances12
Inter-hospital variability due to physician subjectivity, country-based healthcare norms and reimbursement strategies9
1. Medtronic Data on File. COR : 18 Fr Safety& Efficacy Study Re-Analysis, August 14, 2009.
2. Meredith IT. A Snapshot from the Ongoing Australia-New Zealand Medtronic CoreValve® Registry. Transcatheter Cardiovascular Therapeutics 2009, September 21-25, San Francisco, CA.
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:
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. German Registry data on file. New pacemakers with Corevalve 240/565.
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.
ADVANCE
Brazilian 15 15

16. Transcatheter aortic valve implantation
Transcatheter aortic valve implantation. Brazilian reality and perspectives!
Thank you!!!!!