Transcatheter aortic valve implantation

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Presentation transcript:

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 fsbrito@einstein.br On behalf of the SBHCI TAVI Registry investigators

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

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/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.

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

Inclusion / Center 85% em 5 centros

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

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%)

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

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 %)

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 (%)

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, 2009. 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;63:141-148. 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 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. 13

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

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 2006-02: 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, 2009. 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;63:141-148. 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. 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

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