Download 18 Fr - CRTOnline

CRT 2010
Washington DC, January 21, 2010
Medtronic - Core Valve
Device Evolution, Technique and
Clinical Trial Update
Eberhard Grube, MD, FACC, FSCAI
St.Elisabeth Hospital, Heart Center Rhein-Ruhr, Essen, Germany
Instituto Cardiologico Dante Pazzanese, São Paulo, Brazil
DISCLOSURES
Eberhard Grube, MD
Consulting Fees
– Abbott Vascular, Boston Scientific Corporation, Cordis, a Johnson &
Johnson Company, Medtronic CardioVascular, Inc.
Honoraria
– Biosensors International , Boston Scientific Corporation, Medtronic
CardioVascular, Inc
Ownership Interest (Stocks, Stock Options or Other Ownership
Interest)
– Biosensors International , Medtronic CardioVascular, Inc.
I intend to reference unlabeled/ unapproved uses of drugs or
devices in my presentation.
I intend to reference off-label use of stents and valve prosthesis.
CoreValve Prosthesis
CoreValve : 3 Generations
2004
25 fr
21 fr
2005
2006
18 fr
B.Sauren
18 French Procedural Progress
Evolution to a
« true percutaneous cath lab procedure »
within the first 40 Patients of 18 Fr study
•
•
•
•
•
General anesthesia
Surgical cutdown/repair
Ventricular assistance
Pre-closing with ProStar™
Local Anesthesia
Beating heart in normal sinus rhythm
Valve delivery without rapid pacing
No cardiac assistance
CoreValve 2005
- 24 F 1st Gen CoreValve
- Surgical Prep
- CPB pump
- General anesthesia
CoreValve 2010
- 18 F 3rd Gen CoreValve
- PCI-like procedure
Transcatheter AVR
Clinical Data Sources
CoreValve
Edwards
Transseptal Experience
(RECAST, I-REVIVE; 36 pts)
REVIVE (OUS, TF, 106 pts)
TRAVERCE (OUS, TA, 172 pts)
REVIVAL (US, TF/TA, 95 pts)
PARTNER EU (OUS, TF/TA 125 pts)
SOURCE (OUS, TF/TA, 598 pts)*
PARTNER RCT
(US/OUS, TF/TA 456 pts)
FIRST-in-MAN
25 Fr Transfemoral
Experience (14 pts)
FEASIBILITY
21 and 18 Fr Transfemoral
OUS Experience (177 pts)
CE-APPROVAL
18 Fr Transfemoral OUS
Experience (1,243 pts)*
PIVOTAL RCT
CoreValve US Pivotal Trial
In Planning with FDA
Overall Clinical Experience
Study
N
Follow-ups
Status
18 Fr Safety and
Efficacy Trial
126
4 years
On-going
Australia-New Zealand
Registry
140
2 years
On-going
Italian Registry
514 to
date
6 months
On-going
German Series,
Siegburg
>536 to
date
30 days
On-going
Expanded Evaluation
Registry
1483
Up to 2 years
Completed
French Registry
78 to
date
6 months
On-going
Advance Study
1,000
Up to 10 years
Upcoming
US IDE Study
TBD
TBD
Upcoming
10
Baseline Clinical Characteristics
18 Fr S&E
(N=126)
Siegburg
(N=86)
ANZ
(N=62)
Age (years)
81.9 ± 6.4
82.3 ± 5.9
83.7 ± 5.4
Female
72 (57.1%)
56 (65%)
30 (48.4%)
NYHA Class I and II
NYHA Class III and IV
32 (25.4%)
94 (74.6%)
15 (17%)
71 (83%)
11 (19.3%)
46 (80.7%)
21.7 ± 12.6
18.7 ± 12.9
(N=58)
Logistic EuroSCORE (%) 23.4 ± 13.8
Peak Pressure Gradient
(mmHg)
72.8 ± 23.0
70.9 ± 22.8
18.7 ± 12.9
(N=58)
Mean Pressure Gradient
(mmHg)
47.8 ± 14.3
43.7 ± 15.4
48.6 ± 16.3
Aortic valve area (cm2)
0.73 ± 0.16
0.60 ± 0.16
0.7 ± 0.2
11
Procedural Success
100%
98.5%
96.8%
EER
ANZ
86.5%
80%
60%
40%
20%
0%
18FR
S&E
Procedural success has markedly improved over time
Successful implant defined as no conversion to surgery or device-related mortality during the procedure and proper valve
function immediately post-implant. The 18Fr S&E uses technical success (procedural success in re-adjudicated data was
72.6%).
12
30-Day All-Cause Mortality
N = 126
N = 86
30-day all-cause mortality has improved over time
13
Pre- and Post-operative Gradients
Peak Gradient (mmHg)
Mean Gradient (mmHg)
90
80
60
76.3
75.5
18 F S&E
ANZ
50
70
60
49.6
46.4
18 F S&E
ANZ
40
50
30
40
30
20
17.7
17.0
20
9.3
8.4
10
10
0
0
Baseline
30-Day
Baseline
14
30-Day
Change in NYHA Class
Paired 30-Day NYHA Classification
15
CoreValve long term Outcomes
are quite positive
● In over 7,500 implants, not a
single device migration or
fracture was ever reported
● The higher leaflets are
intended to promote leaflets
long term durability and
performance
● Two-year follow up of 18 Fr
S&E shows 63% survival
● Longest implant to date from
2004; patient still alive and
well.
Number at Risk
Number Failed
Survival (%)
126 107
3 18
97.6 85.7
93
30
76.0
78
35
71.8
45
43
62.7
Source: 18 Fr S & E Study: LongTerm Survival
Siegburg CoreValve TAVI
Experience
Study
Patient n
Time period
25 F
21 F
18 F
18 F
18 F
S&E
2008
2009
10
24
102
187
253
2004
2005
03/2006
01/2008
01/2009
to
to
to
03/2008
12/2008
12/2009
-
Five years, Three generations, 576 patients
In-hospital Events (%)
Siegburg CoreValve TAVI Experience
50
45
40
35
30
25
20
15
10
5
0
Death
Stroke
8.3 8.3
9.8
9.8
5.8
2.9
21 F
18 F 2006
2.9
18 F 2007
2.1
18 F 2008
3.3
0
18 F 2009
CoreValve Clinical Results
HELIOS Heart Center Siegburg
% Survival
100
100
100
95
95
90
90
90
85
85
80
8080
75
75
70
7070
65
65
60
6060
55
55
50
5050
45
45
40
4040
35
35
30
3030
25
25
20
2020
15
15
10
1010
5
5
0
0 0
18F until 08/2009
18F until 03/2008
0
30
90
120
210
240
330
360
00
30 50 60
60
90
120
150
180 250
210
240
270
300
330
360
100
150 150
200 180
300 270
350 300
Number
at
risk
Number at risk
184
180
172
172
171
167
166
163
158
155
152
142
125
114
104
101
184
180
172
172
171
167
166
163
158
155
152
142
125
114
104
10189
89 80
80 80
80 79
79 79
79 78
78 73
73 64
64 46
46
Days
Survival Curves up to 1 Year
CoreValve – The Unsuitable Patient
Severe Calcifications of the Access
Which is the preferred access?
Surgical
Transapical
Subclavian
Interventional
Transfemoral
Complexity /
Invasiveness
Predictors for Procedural Success of TAVI
Procedural predictors
Buellesfeld et al. EHJ 2010 in-press
CoreValve Delivery Profile and
Flexibility are critical
● Truly percutaneous delivery:
minimizes risk of bleeding and
vascular complications
● Easier delivery: for less
experienced physicians
18 Fr
24 Fr
● Treating more patients: delivery
is less hindered by peripheral
artery disease
● Better options for additional
approaches: such as subclavian
and transaortic approaches
Drawn to scale
Low Profile !
Lower profile and flexibility means that CoreValve
has a low rate of Vascular Complications
Vascular Complications
Patrick W. Serruys - PCR'08 Transcatheter aortic valve
implantation: State of the art
REVIVAL II
REVIVE
18Fr
S&E
12%
22%
Vancouver
TF
11%
4%
CoreValve
Edwards
Aortic Regurgitation should be avoided
CoreValve Design:
●
The long sealing tunnel allows the valve to
effectively function within a range of depth
placements
●
The conformability of nitinol allows proper
apposition of the valve to the native annulus
●
The supra annular position of the leaflets is
a design feature that is meant to allow
CoreValve to function better even when the
annulus itself is in an out-of-round position
●
The conformation of the leaflets allow them
to have good coaptation and provide durable
performance
CoreValve is functioning well in Out-ofRound Situations
● CoreValve has been shown to retain a round
mid-section (where the leaflets are), even when
the annulus was out of round
-
“Dual source MSCT demonstrated incomplete and non-uniform expansion of the
CRS frame, but the functionally important mid-segment was well expanded and
almost symmetrical. Anatomical under sizing and incomplete apposition of struts
was seen in the majority of patients.” (09/09) Schultz CJ, Weustink A, Piazza N, Otten A,
Mollet N, Krestin G, van Geuns RJ, de Feyter P, Serruys PW, de Jaegere P. Geometry and
degree of apposition of the CoreValve ReValving system with multislice computed tomography
after implantation in patients with aortic stenosis. J Am Coll Cardiol 2009;54(10):911-918
Aortic Regurgitation(PVL)
18 Fr S&E
100%
6%
6%
5%
9%
3%
0%
32%
39%
90%
80%
70%
42%
33%
32%
52%
Grade 4
Grade 3
Grade 2
Grade 1
none (0)
60%
50%
40%
30%
20%
52%
59%
62%
65%
61%
6 Month
n=60
1 Year
n=60
2 Year
n=33
42%
10%
0%
Procedure Discharge 30 Days
n=75
n=84
n=33
Source: 18Fr S&E
33
There Is a Higher Incidence of Pacemaker
Implant Associated with CoreValve
New Permanent Pacemaker within 30 Days
% patients
40
33
32
30
20
20
19
23
25
10
0
(n=30)
(n=102)
(n=34)
(n=91)
(n=1521)
(n=126)
Calvi (PACE
2009)
Grube (Circ
Interv 2008)
Jilaihawi (Am
Heart J 2009)
Rotterdam
18F EER
18F S & E
Weighted average = 23%
(n=1990 patients)
It is important to remember that Pacemaker
Implantation may not mean Pacing Need
New Permanent Pacemaker within 30 Days
18F Safety and Efficacy Study (n=126)
* 2 centers with < 5 implants excluded from
the presentation; both centers had 0% 30-day
50
permanent pacemakers
60
% patients
50
40
33
30
20
20
10
56
36
25
5
0
A
B
C
D
E
F
G
Participating Centers
Physicians’ decision to prophylactically implant
play a big role in the variability among centers
Depth of Implantation May Play a Role in the
Onset of Rhythm Disturbances
Rotterdam Experience (n=91)
New-onset LBBB acquired
during or after valve
implantation
10.3 mm
No new-onset LBBB or
new-onset LBBB acquired
during procedure but
before valve implantation
7.3 mm
6.0 mm
My Prediction: Repetition of an Old Story
TAVI
PCI
sAVR
CABG
1980’s, 1990’s
2000’s, 2010’s
With the same result…
Thank you for your attention !
Questions ?
Clinical Experience to Date
Over 7,500 implants to date
Over 243 sites in 29 countries
40
Thank you for your attention !