Transcript Three-year clinical and echocardiographic follow-up of aortic stenosis patients implanted with a self-expending bioprosthesis Sabine Bleiziffer German Heart Center, Munich, Germany Johan Bosmans University Hospital.

Three-year clinical and echocardiographic
follow-up of aortic stenosis patients
implanted with a self-expending
bioprosthesis
Sabine Bleiziffer German Heart Center, Munich, Germany
Johan Bosmans University Hospital Antwerp, Antwerp, Belgium
Ulrich Gerckens Gemeinschaftskrankenhaus Bonn, Bonn, Germany
Peter Wenaweser University Hospital Bern, Bern, Switzerland
Stephen Brecker St. George’s Hospital, London, United Kingdom
Corrado Tamburino Ferrarotto Hospital, University of Catania, Catania, Italy
Axel Linke University of Leipzig Heart Center, Leipzig, Germany
(on behalf of the ADVANCE Investigators)
ADVANCE
| Background
• Transcatheter aortic valve implant (TAVI) enables
treatment of aortic valve stenosis using
interventional techniques.
• The CoreValve ADVANCE study evaluated the clinical
benefits of TAVI using the CoreValve system in a fully
monitored, “real world” trial.
• This presentation reports for the first time the
complete 3-year patient outcomes from the
ADVANCE study.
CoreValve ADVANCE Study
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ADVANCE
| Background
Medtronic CoreValve® System
• Porcine pericardial tissue valve
sutured to a self expanding nitinol
frame
• Supra-annular valve position
preserves circularity at the level of
valve function
• 18F catheter delivery system, with
AccuTrak Stability Layer available in
later cases
• 2 valve sizes were used in this study:
26 mm and 29 mm
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ADVANCE
| Methods
Patients Enrolled
N = 1,015
• 1,015 patients enrolled from
March 2010 to July 2011
– 5 year follow-up planned
• 44 centres in 12 countries in
Western Europe, Asia, and South
America
• All centres conducted at least 40
TAVI procedures prior to the
study and had a Heart Team in
place
• Clinical endpoints reported
according to VARC 1
• As-treated analysis on attempted
patients
19 – No Implant Attempted
 2 – deaths
 17 – exits
Patients Attempted Implant
N = 996
52 – Deaths
1 – Withdrawal
30-Day Follow-Up
943/944 (99.9%)
119 – Deaths
16 – Withdrawals
4 – Other Exits
1-Year Follow-Up
804/825 (97.5%)
78– Deaths
2 – Withdrawals
1 – Other Exits
2-Year Follow-Up
723/747 (96.8%)
69– Deaths
2 – Withdrawals
1 – Other Exits
3-Year Follow-Up
651/678 (96.0%)
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ADVANCE
| Endpoints
• Primary Endpoint- Major Adverse Cardiac & Cerebrovascular
Events (MACCE) at 30 days post procedure
• MACCE defined as a composite of
•
•
•
•
All-cause Mortality
Myocardial Infarction (Q-wave and non-Q-wave)
Emergent Cardiac Surgery or Percutaneous Re-intervention
Stroke
• Additional Clinical Endpoints (VARC I)
•
•
•
•
•
Cardiovascular Mortality
Bleeding
Vascular Complications
Acute Kidney Injury
New Pacemaker Implantation
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ADVANCE
| Study Oversight
• 100% of all patients monitored
• Primary endpoint events adjudicated by an independent clinical
events committee consisting of TAVI-experienced interventional
cardiologists and cardiac surgeons using VARC I definitions
• All cerebrovascular events adjudicated by an independent
neurologist
• Adjudication utilized all available relevant source documents, including
neuroimaging and systematic NIH Stroke Scale assessments
• Core laboratory evaluation of all EKGs and procedural angiograms
• Site reported echocardiographic data
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ADVANCE
| Baseline Characteristics
Characteristics
N=1015
Age (yrs)
Male
Logistic EuroSCORE (%)
% or
mean ± SD
%
81.1 ± 6.4
Prior MI
16.4
49.4
Prior PCI
31.5
Permanent Pacemaker
12.9
19.4 ± 12.3
NYHA III or IV
79.6
Prior CABG
21.5
Diabetes
31.4
Cerebrovascular Disease
13.1
CAD
57.8
COPD
22.7
PVD
19.7
Pulmonary Hypertension
13.1
Atrial Fibrillation
33.4
Renal Failure
14.9
LVEF (%)
53.3 ± 13.7
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ADVANCE
| Procedural Results
Procedural Parameters
N=996
%
Successful vascular access, delivery & deployment of device &
successful retrieval of the delivery system
97.5
Correct position of the device in the proper anatomical location
98.7
Mean aortic valve gradient < 20 mmHg (discharge echo)
96.2
One valve used
96.0
Major Complications, Valve Related
N=996
%
Annulus Rupture
0.0
Valve Embolization
0.2
Conversion to open AVR
0.1
Coronary Compromised
0.1
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ADVANCE
Endpoint
| Primary Endpoint
1 Month
1 Year
2 Years
3 Years
N=996
%*
%*
%*
%*
MACCE
8.0
21.0
30.1
38.5
All-cause Mortality
4.5
17.6
25.5
33.7
Myocardial Infarction
0.2
0.9
2.5
2.6
Emergent Cardiac Surgery or
Percutaneous Re-intervention
1.3
1.6
1.9
2.4
Stroke
3.0
4.4
5.6
6.5
Minor
1.8
2.3
3.0
3.3
Major
1.2
2.1
2.9
3.5
*Kaplan-Meier Estimates
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ADVANCE
| Additional VARC 1 Endpoints
Endpoint
1 Month
1 Year
2 Year
3 Year
N=996
%*
%*
%*
%*
Cardiovascular Mortality
3.4
11.6
16.7
22.3
Bleeding
29.0
32.0
33.8
35.3
Life Threatening or Disabling Bleeding
4.0
4.9
5.6
6.1
Major Bleeding
9.7
11.2
12.5
12.7
Minor Bleeding
17.4
19.3
20.1
21.1
20.7
21.8
22.0
22.0
Major
10.9
12.0
12.3
12.3
Minor
10.2
10.3
10.3
10.3
Acute Kidney Injury—Stage III†
0.4
0.6
0.6
0.6
New Pacemaker Implantation
26.3
29.1
30.5
31.4
Vascular Complications
*Kaplan-Meier Estimates
†New AKI that occurred outside of the 72 hr post-TAVI window are included
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ADVANCE
| 3-Year Survival
ADVANCE
| Survival by log EuroSCORE
ADVANCE
| 3-Year Stroke
ADVANCE
| NYHA Symptom Status
ADVANCE
p-values are results of McNemar's test.
| NYHA Paired Comparisons
ADVANCE
| Valve Performance
ADVANCE
| Aortic Regurgitation
ADVANCE
| Paravalvular Leak
ADVANCE
| Paired Paravalvular Leak
ADVANCE
| Transvalvular Leak
ADVANCE
| Survival by Aortic Regurgitation
P-value (log rank) Overall Comparison = 0.009
Mild vs. Moderate/Severe = 0.069
AR-Mild vs. None = 0.669
Moderate/Severe vs. None = 0.004
Based on echo at discharge
ADVANCE
| Summary and Conclusions
• ADVANCE is a large “real world” multicenter TAVI study
reporting 3 year outcomes.
• Mortality remains low at 3 years and when stratified
relative to EuroSCORE, patients with a EuroSCORE > 20
had only a 7.7% increase in mortality relative to all
patients in the study
• Additional outcomes at 3 years continue to demonstrate:
– excellent valve performance (large EOAs and low mean gradients)
– low stroke rates
– sustained moderate PVL rates and a trend towards mild PVL
reducing over time
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