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TAVI in Europe
Hendrik Treede, MD
University Heart Center Hamburg, Germany
Potential conflicts of interest
Speaker’s name Hendrik Treede, MD
X
I have the following potential conflicts of interest to report:
X Research/Proctor contracts (Medtronic, Biotronik, Jenavalve,
Symetis)
X Consulting (Medtronic, JenaValve, Biotronik)
Employment in industry
Stockholder of a healthcare company
Owner of a healthcare company
Other(s)
I do not have any potential conflict of interest
Outline
• Current Practice in US
• TAVR in Europe
• New Devices / New Indications
• New Accessories
• Summary
First generation TAVI
FDA
approved
Edwards Sapien
Edwards Sapien XT
CoreValve
Valve release
Balloon-expandable
Balloon- expandable
Self- expandable
Stent material
Stainless Steel
Cobalt Chronium
Nitinol
Profile
Low Profile
Low Profile
High profile
Leaflets
Bovine pericardium
Bovine pericardium
Porcine pericardium
Available sizes
23mm/26mm
23mm/26mm/29mm
23mm/26mm/29mm/
31mm
TF sheath
22/24 Fr
16 Fr expandable
18F, only TF
available
TA sheath
26 Fr
22 F
-
TAVI Complications
•
•
•
•
•
Strokes
Access Site Complications / Bleeding
New Pacemakers
Para-Valvular Reguritation
Others
Strokes and TAVI
Pacemakers and TAVI
Paravalvular Regurgitation
Mechanisms of Peri-Prosthetic
Aortic Regurgitation After TAVI:
- under-expansion of the
prosthesis stent frame
- valve malposition
- annulus-prosthesis-size
mismatch
Paravalvular AR and
Mortality after TAVI
Outline
• Current Practice in US
• TAVR in Europe
• New Devices / New Indications
• New Accessories
• Summary
TAVI Devices 2013
Human Implants: > 60.000 worldwide
ia
bb
h
i
c
j
d
k
e
f
l
m
g
n
CE Approved:
Edwards
Sapien XT
Medtronic
CoreValve
CoreValve JenaValve Symetis
Acurate
Evolut 23 TA
Direct Flow
Medical
St. Jude
Portico 23
Medtronic
Engager
SAVR / TAVI Ratio in Germany
German Society for Thoracic and Cardiovascular Surgery GTCVS
???
Conventional AVR
TAVI
20XX
AVR / TAVI ratio from 2000 until 2012:
From < 1 % to 35% with further increase ...
TAVI
Experience at UHC Hamburg 05/2013
847 procedures
526
119
18
77
63
44
procedures
procedures
procedures
procedures
procedures
procedures
Edwards Sapien
CoreValve
Direct Flow
JenaValve
Symetis
Acurate
Medtronic
Engager
10 V-in-V
231 TF
295 TA
49 TA
14 TF
25 V-in-V
03/05/2013
Outline
• Current Practice in US
• TAVR in Europe
• New Devices / New Indications
• New Accessories
• Summary
Next Generation Devices in
Transapical TAVI
Edwards Sapien 3
Investigational
Symetis Acurate
Medtronic Engager
JenaValve
Edwards Sapien 3
Ongoing CE Mark Trial in 2013
Balloon Expandable
 Designed to further reduce PV leaks
 Lower profile valve delivered through a
14 Fr expandable Sheath
 External sealing skirt
 Treated bovine pericardial tissue leaflets
 Dramatically reduced profile for the
transapical approach: 18 Fr.
 23, 26 and 29mm sizes
ACURATE TA™ Implant Procedure
•
•
•
•
•
•
•
Self-expanding Nitinol stent
Porcine leaflets
PET-skirt for reinforcement
Annulus-centering
Self-positioning
Transapical delivery
Three sizes for annuli from
21–27mm
Symetis Acurate TA™
n=90: Kaplan-Meier Curve
1
0.9
30 Day:
n=83 92.2%
% Survival
0.8
0.7
6 Months
n=75 83.3%
0.6
0.5
0.4
0.3
0.2
0.1
0
0
30
60
90
120
150
180
Time (Days)
PV Leak
100%
80%
60%
4+
3+
40%
2+
1+
20%
0 (None/Trace)
0%
30D
6M
JenaValveTM TAVI System
The JenaValve
• Porcine aortic root valve
• Self-expanding Nitinol stent with
flexible stent posts
• Unique anatomical positioning
feelers with clipping mechanism
• Sizes 23, 25, 27 mm
“Cathlete” Delivery System
• Sheathless delivery system
• No rapid pacing needed during
prothesis implantation
• Easy 3 step implantation
JV Clinical Implantation
• Lateral
minithoracotomy
• Apical pledgeted pursestring sutures
• Valvuloplasty 23mm
ballon under rapid
pacing
• Implantation 25 mm
valve w/o rapid pacing
under flouro and TEE
control
JV Trial @ 12 month
All cause death / cardiac death
96.9%
92.5%
84.6%
68.2%
Paravalvular Leak
Medtronic EngagerTM TAVI System
• Self-expanding nitinol frame with selfpositioning technology allows for controlled
release and accurate positioning
• Bovine pericardial tissue valve with supraannular valve function
• Available in 23mm and 26mm device
diameters.
• 29Fr Delivery system c for accurate
anatomical positioning
• FIM and Feasability trial completed,
CE-Mark trial ongoing
Implant Procedure
Engager Experience
Engager CE Pivotal
Procedural Results
* one patient withdrew consent in trial on Day 11 and second patient had trace AR at 30-day visit
Engager CE Pivotal
Paravalvular Leak
Independent Echo Core Lab Evaluation
Next Generation Devices in
Transfemoral TAVI
Edwards
Centera
Heart Leaflet
Technologies
Edwards
Sapien 3
Boston Sadra Lotus
Symetis Acurate TF
JenaValve TF
Symetis Acurate TF
STABILIZATION ARCHES
SELF-EXPANDING NITINOL
Flexible and designed for selfalignment of bioprothesis
Anatomic conformability to
the native annular shape
Porcine Pericardium
LEAFLETS
WAIST
Area for native leaflet capture
• Conforms to native
annulus
• Atraumatic implantation
• Supra-annular valve position
SYMETIS Acurate TF
• Step-by-step
• Angio Alignment
• Ballooning
• Insertion
• Initial Alignment
• Upper Crown
• Slight Push
• Stabilization Arches
• Full release
• Delivery System Removal
SYMETIS Acurate TF
• Step-by-step
• Angio Alignment
• Ballooning
• Insertion
• Initial Alignment
• Upper Crown
• Slight Push
• Stabilization Arches
• Full release
• Delivery System Removal
• Final result
New Indication: Valve-in-Valve
26 mm Sapien XT valve-in-valve 27 mm Carpentier Edwards Porcine
Valve-in-valve Implantation Mitral
pre
post
Outline
• Current Practice in US
• TAVR in Europe
• New Devices / New Indications
• New Accessories
• Summary
Apical Access Closure Devices
Apical Access Closure Devices
APICA Device
Percutaneous Apical
Access Device
CardiApex Device
• Performing TA TAVI
• Percutaneous procedure
Robust
Sealing
Future of TA
Access and Closure Devices
Outline
• Current Practice in US
• TAVR in Europe
• New Devices / New Indications
• New Accessories
• Summary
Conclusion
2nd generation TAVI
 Next generation devices are safe in high-risk patients with severe
aortic stenosis
 Good clinical and functional outcomes
 Most obvious advantages:
 Degree of paravalvular leakage
 Ease of implantation
 Availability of different types of prostheses may allow for tailormade, patient-centered treatment
 Further studies are needed to determine which device is suited best
for which patient
Engager CE Pivotal
30-Days & 6-Month Outcomes
Valve-in-Valve Concept
J Thorac Cardiovasc Surg 2011;141:711-5.
JACC Cardiovasc Interv. 2011;4(11):1246-7.
European Journal of Cardio-t horacic Surgery 39 (2011) 1054—1056
www.elsevier.com/ locat e/ ej ct s
Case report
JACC Cardiovasc Interv. 2012;5(3):341-9.
First -in-man implant at i on of a t rans-cat het er aort ic valve in a mit ral
annuloplast y ring: novel t reat ment modalit y for failed mit ral valve repair §
Arend de Weger a,*, See H. Ewe b, Vict oria Delgado b, Jeroen J. Bax b
a
Depar t ment of Cardio-Thoracic Surger y, Leids Universit air Medisch Cent rum, Albi nusdreef 2, 2300 RC, Leiden, The Net herlands
b
Eur J Cardiothorac Surg. 2011 Jun;39(6):1054-6.
TAVI Global Market Share
2011
5%
2018
7%
5%
7%
17%
13%
14%
42%
22%
51%
12%
Total Revenue
488 M$
Estimated Revenue
2,596 M$
Source: Global Data