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TRANSCRIPT
H E R Z Z E N T R U M
CoreValve ReValving® Experience
Post-CE Mark Results of
Percutaneous Aortic Valve Replacement (PAVR) Procedures
through 30-April-2009 with
Data Collected through 12-May-2009
Gerhard Schuler
Herzzentrum Leipzig
H E R Z Z E N T R U M
Disclosures: None
CoreValve Technology
Outflow Aspect: low radial force serves to orient system
Inflow Aspect: radial force and elasticity of frame designed to maximize conformation to native annulus while intra-annular sealing skirt minimizes PVL
Valve Region:supra-annular valve function delivers optimal hemodynamics, frame designed to maintain coronary perfusion
18F Delivery Catheter System
12F Shaft
18F Capsule
Over-the-wire 0.035 compatible
Loading/Release Handle
CoreValve Procedure – Deployment
Before annular contact
After annular contact
Before devicerelease
Pat. B.: CoreValve Malpositioning I
Pat. B.: CoreValve Malpositioning II
Pat. B.: CoreValve Device Removal III
Blood Flow During Deployment
Normal blood pressure before annular contact
Reduced blood pressure only between 1/3 & 2/3 of
the deployment
At 2/3 point, BP returns to normal and valve is still
repositionable
Est. CoreValve Post CE Mark Implants
0
500
1,000
1,500
2,000
2,500
3,000
3,500
4,000
4,500
5,000
5,500
2007-
Apr
2007-
May
2007-
Jun
2007-
Jul
2007-
Aug
2007-
Sep
2007-
Oct
2007-
Nov
2007-
Dec
2008-
Jan
2008-
Feb
2008-
Mar
2008-
Apr
2008-
May
2008-
Jun
2008-
Jul
2008-
Aug
2008-
Sep
2008-
Oct
2008-
Nov
2008-
Dec
2009-
Jan
2009-
Feb
2009-
Mar
2009-
Apr
2009-
May
2009-
Jun
2009-
Jul
2009-
Aug
Medtronic CoreValve® Experience (through Aug 2009)
• Over 5000 implants
• 184 centers in 27 countries
H E R Z Z E N T R U M
18F EER192454.5%
Outside 18F EER
160545.5%
Pacific Rim & North American Cases;
2009 Solo Cases & New Centers and
Cases without CRFs
Cases “Captured” with Baseline
& Procedural CRFs
18f Expanded Evaluation Registry
H E R Z Z E N T R U M
Known
148377.8%
Outstanding
42422.2%
18f EER 30-Day Follow-Up(1907 Cases through 31-Mar-2009)
H E R Z Z E N T R U M
In-Training
91861.9%
Solo565
38.1%
Training Status of CentersPts with 30 Day Follow-up
H E R Z Z E N T R U M
In-Training Solo Total EER
Mean ± SD or % N = 918 N = 565 N = 1483
Age (years) 80.8 6.7 81.7 5.9 81.2 6.4
Logistic EuroSCORE (%) 22.2 13.6 23.2 13.7 22.6 13.7
Female 55.8% 54.7% 55.4%
NYHAI-II: 17.2%
III-IV: 82.8%
I-II: 14.4%
III-IV: 85.6%
I-II: 16.1%
III-IV: 83.9%
Aortic Valve Area (cm2) 0.65 0.18 0.61 0.17 0.64 0.18
Peak gradient (mm Hg) 78.3 26.1 81.3 25.8 79.5 26.1
Mean gradient (mm Hg) 48.4 16.4 50.4 16.0 49.2 16.3
LVEF(%) 52.9 13.8 51.4 13.7 52.3 13.8
Patient Demographics
Risks & Mortality
Acute LV Failure
Tamponade
AMI
CVA
Hemorrhage
Renal Failure
Resp. Failure
Infection
LV Failure
Arrhythmias>30 days:
Natural history
30 days24h 6 months
[%]
Su
rviv
al
H E R Z Z E N T R U M
In-Training SoloTotal
EER
Angina 14.4% 17.9% 15.8%
Aortic Aneurysm 3.6% 2.0% 3.0%
Atrial Fib 29.6% 26.0% 28.3%
Carotid AD 13.1% 14.0% 13.4%
CAD 60.2% 59.6% 59.9%
COPD 23.7% 26.3% 24.7%
CHF 16.0% 17.1% 16.4%
Cardiomyopathy 5.9% 6.5% 6.1%
Diabetes Mellitus 25.2% 27.1% 25.9%
Hyperlipidemia 51.1% 48.2% 50.0%
Hypertension 70.2% 65.9% 68.6%
Pulmonary Hypertension 28.2% 28.4% 28.3%
Patient Co-Morbidities
H E R Z Z E N T R U M
98.4% 98.8% 98.5%
0%
20%
40%
60%
80%
100%
In-Training(N = 918)
Solo (N = 565)
Total EER (N = 1483)
Procedural Success
H E R Z Z E N T R U M
Mortality Rate
2.6%1.9%
2.4%
0%
2%
4%
6%
8%
10%
12%
In-Training
(N = 918)
Solo
(N = 565)
Total EER
(N = 1483)
24-Hour
10.7%9.7%
10.3%
0%
2%
4%
6%
8%
10%
12%
In-Training (N = 918)
Solo (N = 565)
Total EER (N = 1483)
30-Day
H E R Z Z E N T R U M
24h Adverse Events
In-Training Solo Total EER
Cardiac† Death 2.2% 1.7% 1.8%
Aortic Dissection 1.0% 0.4% 0.7%
Cardiac Perforation 2.7% 1.6% 2.3%
Cardiac Tamponade 3.7% 1.9% 3.0%
Access Site Bleeding 3.3% 1.6% 2.6%
Major Bleeding 6.0% 3.5% 5.0%
Conversion to Surgery 0.3% 0.5% 0.4%
Myocardial Infarction 0.8% 0.5% 0.7%
Major Arrhythmia 5.7% 5.5% 5.6%
Permanent Pacemaker 6.9% 7.7% 7.2%
Renal Failure 0.9% 0.5% 0.7%
Stroke 1.1% 1.2% 1.1%
TIA 0.3% 0.4% 0.3%
Pat. G.: Major Bleeding
H E R Z Z E N T R U M
30d Adverse Events
In-Training Solo Total EER
Cardiac† Death 6.4% 7.0% 6.7%
Aortic Dissection 1.2% 0.5% 0.9%
Cardiac Perforation 3.0% 2.1% 2.7%
Cardiac Tamponade 4.2% 2.6% 3.6%
Access Site Bleeding 3.5% 1.9% 2.9%
Major Bleeding 8.2% 4.7% 6.9%
Conversion to Surgery 0.5% 1.2% 0.8%
Myocardial Infarction 0.9% 0.9% 0.9%
Major Arrhythmia 16.3% 14.9% 15.7%
Permanent Pacemaker 25.7% 23.9% 25.0%
Renal Failure 2.2% 2.3% 2.2%
Stroke 2.2% 2.3% 2.2%
TIA 0.4% 0.4% 0.4%
AV-Block III°4 days after COREVALVE Implantation
Day 45 post Revalving
H E R Z Z E N T R U M
30-Day* Paired NYHA Class Comparison
0% 1%3%
14%
45%
35%
3%
0% 0%2%
15%
52%
30%
3%0% 0%
2%
15%
47%
32%
3%
0%
10%
20%
30%
40%
50%
60%
Worsened
3 Levels
Worsened
2 Levels
Worsened
1 Level
No Change Improved
1 Level
Improved
2 Levels
Improved
3 Levels
In-Training (N = 576)
Solo (N = 400)
Total EER (N = 976)
H E R Z Z E N T R U M
In-Training Solo Total EER
(N =362) (N = 188) (N = 550)
In-Training Solo Total EER
(N = 320) (N = 162) (N = 482)
76.2
16.9
82.0
17.5
78.1
17.1
0
20
40
60
80
100
120
Peak Gradient (mm Hg)Mean ± SD
47.0
8.8
50.3
9.2
48.1
8.90
20
40
60
80
100
120
Mean Gradient (mm Hg)Mean ± SD
30 Day Paired Gradient Comparison
H E R Z Z E N T R U M
30 Day Paired Echo Data
0.67
1.59
0.60
1.44
0.65
1.55
0.0
0.4
0.8
1.2
1.6
2.0
2.4
Effective Orifice Area (cm2)Mean ± SD
52.155.2
50.8
55.4
51.655.3
0
20
40
60
80
LVEF (%)Mean ± SD
In-Training Solo Total EER
(N = 202) (N = 79) (N = 281)
In-Training Solo Total EER
(N = 461) (N = 252) (N = 713)
Medtronic CoreValve® Upcoming Clinical Studies
Name Description Start Intent Patients/# Sites
CoreValve US PivotalClinical Trial
US IDE for FDA Approval
Early Summer, CY10-CY11
Secure FDA Approval/US Launch
TBDUS Only
CoreValve AdvanceInternational Registry
International Registry to follow EER
Q1 CY2010 Ensure ongoing and robust understanding of the CoreValve patient population
TBD
CoreValve EpicClinical Trial
Prospective clinical study
Fall 2009 Investigate frequency and predictors of conduction disturbances during CoreValve implant
TBD
Conclusions
Despite of a large number of implanted devices
data regarding mortality and clinical status are
far from complete.
Available data indicate that procedural success
is >98% and 30 day mortality ~ 10%.
A new registry with complete data collection is
urgently needed.