Protesis aortica percutanea la experiencia portuguesa

TAVI: the PORTUGUESE EXPERIENCE

PERCUTANEOUS AORTIC PROSTHESIS:

the PORTUGUESE EXPERIENCE Vasco Gama Ribeiro

Department of Cardiology Cardiovascular Interventional Unit Centro Hospitalar de Gaia, Portugal

SEC 2011 Maspalomas GRAN CANARIA

TAVI: the PORTUGUESE EXPERIENCE

::INTRODUCTION ::Aortic Stenosis

The most prevalent valvular heart disease in Europe and the USA. Estimated prevalence in individuals 65y or older is about 2-7% (5-7% > 85 years old) 250 000 US patients with AS are > 85 years of age.

TAVI: the PORTUGUESE EXPERIENCE

::INTRODUCTION ::Natural history

TAVI: the PORTUGUESE EXPERIENCE

::INTRODUCTION

::Treatment Options: Elderly

TAVI: the PORTUGUESE EXPERIENCE

::INTRODUCTION ::Natural history

Survival of patients with severe AS with and without AVR 1yr 87%

Cumulative Survival

1

2yr 78%

P < 0.0001

0.8

AVR n = 80 No AVR n = 197

0.6 0.4

≥ 80 years

5yr 68% 1yr 52% 2yr 40%

0.2

5yr 22%

0 0

2

4

6

8

10

12

Time in Years Number at risk

80 197

63 97

54 67

41 48

33 37

26 29

16 17

8 9

4 6

3 4

2 1

AVR group No AVR group

Varadarajan P, Kapoor N, Bansal RC, Pai RG. Survival in elderly patients with severe aortic stenosis is dramatically improved by aortic valve replacement: results from a cohort of 277 patients aged ≥ 80 years.

Euro J Cardiothorac Surg. 2006;30:722-727.

TAVI: the PORTUGUESE EXPERIENCE

::AORTIC Intervention ::Aortic Stenosis

TAVI: the PORTUGUESE EXPERIENCE

::AORTIC Intervention ::Aortic Stenosis

The standard of care rejects most patients

TAVI: the PORTUGUESE EXPERIENCE

::AORTIC Intervention ::Aortic Stenosis

The standard of care rejects most patients

Aortic valve replacement (AVR) is the standard of care.

Is this still true?

Does it match current reality?

TAVI: the PORTUGUESE EXPERIENCE

::AORTIC Intervention ::TAVI: Where we were...

TAVI: the PORTUGUESE EXPERIENCE

::AORTIC Intervention ::TAVI: Where we are...

These are the common patients.

These are the tough patients!

(Surgery is afraid of theseâ&#x20AC;Ś.)

TAVI: the PORTUGUESE EXPERIENCE

::AORTIC Intervention

::TAVI: Where we will be...

TAVI

TAVI: the PORTUGUESE EXPERIENCE

::AORTIC Intervention: TAVI ::TeamWork is critical!

Anesthesiologist Cardiac-experienced

Surgeon Clinical Cardiologist

High Risk

Patient!

GP, Geriatrist

Interventional Cardiologist Image Specialist

TAVI: the PORTUGUESE EXPERIENCE

::AORTIC Intervention

::TAVI: Partner Trial (A) All-Cause Mortality at 1 year 0.5

HR [95% CI] = 0.93 [0.71, 1.22] P (log rank) = 0.62

TAVR AVR

0.4

26.8

0.3 0.2

24.2

0.1 0 0 No. at Risk

6

12 Months

18

24

TAVI: the PORTUGUESE EXPERIENCE

::AORTIC Intervention

::TAVI: Partner Trial (A) All-Cause Mortality or Stroke HR [95% CI] = 0.95 [0.73, 1.23] P (log rank) = 0.70 28.0 26.5

No. at Risk

Months

TAVI: the PORTUGUESE EXPERIENCE

::AORTIC Intervention

:: CoreValve: Procedure Success 95.8%

98.1%

97.0%

18 Fr S&E1 ANZ2 N = 126 N = 118

Spain3 N = 108

French4 N = 78

Percent of Patients (%)

100%

98.0%

98.7%

99.0%

98.1%

Belgian5 Germany6 UK7 N = 141 N = 588 N = 460

Italian8 N = 772

83.1%* 80% 60% 40% 20% 0%

Procedure Success is not defined consistently across all studies. * Technical Success is reported here.

1.

2.

3.

4.

5.

6.

7.

8.

Medtronic Data on File. COR 2006-02: 18 Fr Safety & Efficacy Study Re-Analysis, August 14, 2009.

Meredith I. VARC-adjudicated Outcomes in Inoperable and High Risk AS Patients. Transcatheter Cardiovascular Therapeutics 2010, Washington, DC. Avanzas P, Munoz-Garcia AJ, Segura J, et al. Percutaneous implantation of the CoreValve速 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.

TAVI: the PORTUGUESE EXPERIENCE

::AORTIC Intervention

TAVI @ Portugal CENTRO HOSPITALAR DE GAIA HOSPITAL DE ST. CRUZ HOSPITAL DE ST. MARTA

TAVI: the PORTUGUESE EXPERIENCE

::AORTIC Intervention ::TAVI: Available Devices

CoreValve

Edwards Sapien XT

#26, #29 and #31 mm

#23, #26 and #29mm

TAVI: the PORTUGUESE EXPERIENCE

::AORTIC Intervention

::@Portugal: Our Experience Total TAVI Procedures:

179

Aug’2007 to Sept’2011

CoreValve: 140 Edwards: 39 Patient age (avg) Male (n)

80 ± 8 years 46%

TAVI: the PORTUGUESE EXPERIENCE

::AORTIC Intervention

::@Portugal: Our Experience BASELINE DATA: COMMORBIDITIES

TAVI: the PORTUGUESE EXPERIENCE

::AORTIC Intervention

::@Portugal: Our Experience BASELINE DATA Past Cardiovascular Disease Coronary AD PCI CABG Periph Artery Disease Cerebrovasc Disease Heart Valve Surg Aortic Valve (bio) Atrial Fibrillation Permanent Pacing

71.8% 9.9% 14.1%

45.1% 25.3% 7.0% 2.8%

39.4% 15.5%

TAVI: the PORTUGUESE EXPERIENCE

::AORTIC Intervention

::@Portugal: Our Experience BASELINE DATA Baseline Functional Status 100%

100%

Class IV

11%

75%

75%

66% Class III

55%

50%

50%

Angina 25%

Class II 0%

25%

34%

0%

45%

TAVI: the PORTUGUESE EXPERIENCE

::AORTIC Intervention

::@Portugal: Our Experience BASELINE DATA LV Function LVEF (Simpson)

50.3% (25-65%)

Aortic Valve Evaluation Valve Area (func)

0.5 Âą 0.1cm2

Aortic Grade Grade Grade

49 (69.0%) 18 (25.3%) 4 (5.6%)

Regurgitation 0-I II III/IV

TAVI: the PORTUGUESE EXPERIENCE

::AORTIC Intervention

::@Portugal: Our Experience SURGICAL REFUSAL CRITERIA Criteria as Clinically Described Surg High Risk 36.7% Comorbilities 33.5% Porcelain Aorta 22.6% Re-Operation 5.7% Tracheal disease 1.5% Risk Stratification Log EuroScore (%) STS Score (%)

21.8 ± 12.6 8.8 ± 12.1

TAVI: the PORTUGUESE EXPERIENCE

::AORTIC Intervention

::@Portugal: Our Experience

VASCULAR ACCESS SITE Trans-aortic Subclavian 14%

1%

Femoral 10%

Femoral 85%

CoreValve

Transapical 90%

Edwards

TAVI: the PORTUGUESE EXPERIENCE

::AORTIC Intervention

::@Portugal: Our Experience FOLLOW-UP 30-day total mortality (any cause)

7.1 %

Acute Coronary Syndrome Stroke/TIA major Vascular compl, major Hemorrhage, major Acute Renal Failure

9.3 % 3.0 % 3.1% 15.7 % 7.9 %

Valve in valve RV Pacing

3.0 % 29.0 %

TAVI: the PORTUGUESE EXPERIENCE

::AORTIC Intervention

::@Portugal: Our Experience COMPLICATIONS HAPPEN: LIKE IT OR NOT

TAVI: the PORTUGUESE EXPERIENCE

::AORTIC Intervention

::@Portugal: Our Experience FOLLOW-UP: MEAN GRADIENT IMPROVEMENT Pre

Post

TAVI: the PORTUGUESE EXPERIENCE

::AORTIC Intervention

::@Portugal: Our Experience FOLLOW-UP: AORTIC REGURGITATION (STABLE)

TAVI: the PORTUGUESE EXPERIENCE

::AORTIC Intervention

::@Portugal: Our Experience FOLLOW-UP: CLINICAL STATUS IMPROVEMENT

TAVI: the PORTUGUESE EXPERIENCE

::AORTIC Intervention ::TAVI Experience 12

1/3 of all mortality occurs in 30 days.

100 90 80 70

8

60 6

50 40

4

30 20

2

0

0 2 4 6 9 11 14 16 22 26 31 33 37 43 52 61 69 78 87 93 106 113 121 151 171 186 201 225 267 283 294 311 349 502 515 709 1007

10

Days of follow-up Petronio, AS. The Italian CoreValve Registry, EuroPCR 2010.

0

% of All Mortality

Number of Deaths

10

TAVI: the PORTUGUESE EXPERIENCE

::AORTIC Intervention

::Cost-Effectiveness (Partner B) Dollars per Life Year or QALY ($thousands)

$300

$250

$200

$150

$100

$50

$0 aspirin MI rosuvastatin prevention high‐CRP

ICD prim prev

CRT‐D v. medical Rx

dabigatran AF

PARTNER Cohort B

AF ablation vs. AAD

dialysis

PCI stable CAD

LVAD destination Rx

TAVI: the PORTUGUESE EXPERIENCE

::AORTIC Intervention

::Quality of Life (Partner B)

TAVI: the PORTUGUESE EXPERIENCE

::AORTIC Intervention ::Future Directions

TAVI has future directions.

Future directions for Surgery is….. ….. a smaller future…..

TAVI: the PORTUGUESE EXPERIENCE

::AORTIC Intervention ::Patient opinion counts!

16th April 2002

TAVI: the PORTUGUESE EXPERIENCE

::Final remarks Rarely, in Medical Research, has so dramatic improvement

in survival been achieved in such short time, with so few interations.

TAVI: the PORTUGUESE EXPERIENCE

::Final remarks TAVI is already the standard-of-care for inoperable patients with severe aortic stenosis.

The PARTNER Study results indicate that TAVI is an acceptable alternative to AVR in selected high-risk operable patients.

Future randomized studies should focus on lower risk patients who are candidates for operation.

TAVI: the PORTUGUESE EXPERIENCE

PERCUTANEOUS AORTIC PROSTHESIS:

the PORTUGUESE EXPERIENCE Vasco Gama Ribeiro

Department of Cardiology Cardiovascular Interventional Unit Centro Hospitalar de Gaia, Portugal

THANK YOU