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
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