tavi: transapical procedures
TRANSCRIPT
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TAVI:
Transapical Procedures
Cardiology Update Davos
Volkmar Falk, MD
University Hospital Zürich
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TA-AVI: antegrade, simple, safe
The front door
approach!
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Transapical TAVI
• Technical advantages of TA approach
• Is transfemoral better than transapical ?
• Results of latest generation TA valves
• New devices for acces closure and
percutaneous transapical access
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Transapical TAVI
• Technical advantages of TA approach
• Is transfemoral better than transapical ?
• Results of latest generation TA valves
• New devices for acces closure and
percutaneous transapical access
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Technical Adavtages of TA approach
• Only antegrade access
• Short distance to AV, excellent control
• Facilitates coaxial orientation of implant
• Limited aortic manipulation
• Limited radiation exposue
• No limitations for diameter
- allows for larger, (cuffed) devices
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Direct antegrade vs remote retrograde access
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TA-AVI: Coaxial orientation of implant
antegrade, coaxial
orientation
easy wire adjustments
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Transapical TAVI
• Technical advantages of TA approach
• Is transfemoral better than transapical ?
• Results of latest generation TA valves
• New devices for acces closure and
percutaneous transapical access
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Transapical TAVI
• Technical advantages of TA approach
• Is transfemoral better than transapical ?
- Mortality
- Complications
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No difference in outcomes
Webb J Circ 2009
Canadian experience TF - TA
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Transapical AVI only in case of
poor vascular access – transfemoral first strategy
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Canadian experience TF - TA
JACC 2010;55:1080
TF = 162 TA = 177
Peripheral
vascular disease19% 50%
STS Score 9% 10.5%
30-day mortality 9.5% 11.3%
1 year survival 75% 78%
2 year survival 65% 64%
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Johansson ATS 2011
No difference in
survival for
TF vs TA in
propensity
matched groups.
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TA: PARTNER (n=104) versuscontinued access (n=822)
AVR 92 76 71 70 67
PMA-TA 104 87 82 76 73
NRCA-TA 822 571 370 297 126
No. at Risk
23.6%
25.3%
29.1%
0 3 6 9 12
Stroke
3.9% @ 1yr0
0.1
0.2
0.3
0.4
0.5
0 6 12 18 24
TAVR
AVR
PARTNER TF
(n=492): 22.2 @1yr
Stroke 2% @ 30d
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Ewe ATS 2011
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“Early, midterm, clinical, and
echocardiographic outcomes were
comparable in both approaches.
However, TAA has the additional benefit of
reducing radiation exposure (5 vs 12 min)
and contrast use (173 vs 80ml)
intraoperatively without prolonging the length
of hospital stay.”
Ewe ATS 2011
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Transapical TAVI
• Technical advantages of TA approach
• Is transfemoral better than transapical ?
- Mortality
- Complications
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USZ TAVI Experience: VARC Prosthesis Associated
Complications
transapical
transarterial
Cu
mu
lative
Pro
sth
etic V
alv
e A
sso
cia
ted
Co
mp
lica
tio
ns
Edwards SAPIEN
Medtronic CoreValve
Log-rank p=0.46
Days
Grouped by procedure Grouped by prosthesis
Days
Log-rank p=0.004
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USZ TAVI Experience: VARC Combined Efficacy
Endpoint
Apical
Femoral
p=0.8
Edwards SAPIEN
Medtronic CoreValve
p=0.74
Days
Pa
tien
ts w
ith
eff
ective
TA
VI th
era
py
DaysNo. at Risk
TAP 27 18 14
TF 76 46 30
No. at Risk
CV 61 40 29
ES 42 24 15
Grouped by procedure Grouped by prosthesis
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USZ TAVI Experience: 30-Day (VARC) MACCE Rate
Mortality StrokeBleeding
10.5
0.8
8.5
6
AKI
30-d
ay M
AC
CE
Rate
(%
)
AMI
1.5
11.5
Vascular
Compl.logEuroSc
23
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Vascular complications
Genereux P JACC 2012
Metaanalysis 3519 patients from 16 studies
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1,0%1,6%
11,9%
2,5%
0%
2%
4%
6%
8%
10%
12%
14%
without CABG with CABG transvascular transapical
Vascular complications
n=6517 n=3458 n=2689 n=1177
Data presented by Figulla at TCT 2012
GARY-Registry Results – Procedure
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Vascular complications with TF approach: bleeding
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Vascular complications with TF approach: occlusion
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Vascular complications with TF approach: dissection
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Vascular complications with TF approach
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Transfemoral (Sapien) : Major Vascular/Access
Complications 30 d Source Registry (n=463)
Vascular Complications # events/pts % pts with event
Access Related Complications 91/83 17.9%
Aortic Dissections (AD below) 9/9 1.9%
Non-Access Related 6/5 1.1%
All Vascular Complications
Major (includes aortic dissection) 55/49 10.6%
Minor 51/48 10.4%
0
10
20
30
40
50
Transfemoral Major Vascular / Access
Complication
Transapical Major Vascular / Access
Complication
Death rate in patients without event
Death rate in patients with event
5.6 vs 12.2%
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TA access related complication rate
Source: 0.6%,
Prevail: 0.7%
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TAVI- Stroke
Stroke 2.8 -7.7%1-4
Permanent pacer 9.4 - 39%1-4
Moderate paravalvular AI
independent predictor of late death5
Registry n ES 30d mortality
German1 697 20.5 12.4%
French2 244 25.6 12.7%
French 23 759 22-24 7.8-11.3%
Belgian4 328 28 11%
1 EHJ 2011
2 EHJ 2011
3 unpublished data
4 ICTVS 2011
5 Heart 2011
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TA: consistently lower stroke risk
Eurointervention 2012
n Log.
EuroScoreStroke / TIA
30-days
3236 TF MCV 22 % 3.1 ±2.2 %
1733 TF ES 26 % 4.2 ±2.2 %
2482 TA ES 29 % 2.7 ±1.4 %
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Risk of stroke after TAVI:
a meta-analysis of 10,037 published patients.
•Fifty-three studies including a total of 10,037 patients
•Procedural stroke (<24 h) occurred in 1.5 ± 1.4%
•30-day stroke/TIA was 3.3 ± 1.8%
•Differences in stroke rates were associated with
different approaches and valve prostheses used
•lowest stroke rates after transapical TAVI (2.7 ± 1.4%)
Eggebrecht H Eurointervention 2012
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2,2%
3,6%3,7%
3,5%
0,0%
0,5%
1,0%
1,5%
2,0%
2,5%
3,0%
3,5%
4,0%
without CABG with CABG transvascular transapical
Cerebrovascular Events
Results – Outcome
n=6517 n=3458 n=2689 n=1177
Data presented by HR Figulla @ TCT 2012
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TAVI – permanent pacer
Stroke 2.8 -7.7%1-4
Permanent pacer 9.4 - 39%1-4
Moderate paravalvular AI
independent predictor of late death5
Registry n ES 30d mortality
German1 697 20.5 12.4%
French2 244 25.6 12.7%
French 23 759 22-24 7.8-11.3%
Belgian4 328 28 11%
1 EHJ 2011
2 EHJ 2011
3 unpublished data
4 ICTVS 2011
5 Heart 2011
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4,6% 3,9%
23,7%
9,9%
0%
5%
10%
15%
20%
25%
without CABG with CABG transvascular transapical
GARY-Registry Results – ProcedureNew Pacemaker
n=6517 n=3458 n=2689 n=1177
Data presented by HR Figulla at TCT 2012
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TAVI – paravalvular leakage
Stroke 2.8 -7.7%1-4
Permanent pacer 9.4 - 39%1-4
Moderate paravalvular AI
independent predictor of late death5
Registry n ES 30d mortality
German1 697 20.5 12.4%
French2 244 25.6 12.7%
French 23 759 22-24 7.8-11.3%
Belgian4 328 28 11%
1 EHJ 2011
2 EHJ 2011
3 unpublished data
4 ICTVS 2011
5 Heart 2011
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Effect of paravalvular leakage on survival
PARTNER 2y FU: TAVI group
Kodali SK NEJM 2012
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French II Registry
Data presented at TCT 2012 by E Van Belle
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FRANCE II Registry – rate of PVL
0
10
20
30
40
50
60
Grade 0 Grade 1 Grade 2 Grade 3
Transfemoral
Transapical
Gilard M NEJM 2012
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Conclusion from FRENCH II Registry
Gilard M NEJM 2012
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Transapical TAVI
• Technical advantages of TA approach
• Is transfemoral better than transapical ?
• Results of latest generation TA valves
• New devices for acces closure and
percutaneous transapical access
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EngagerJenaValve Symetis
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Jena Valve - Valve Design• Native porcine aortic valve
• Self-expanding Nitinol stent with flexible stent
posts
• “Feeler” for anatomically correct positionining
• Clipping fixation to leaflets
• Sizes 23, 25, 27 mm
• Device retrieval capability
CE mark as of October 2011
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Step 1
• Unsheating of Feelers
• Orientation of Markers
• Anatomically Correct
Positioning
Step 2
• Clipping on native
leaflets
Step 3
• Final Valve Release
• Correct positioning
• No Rapid Pacing
needed
Jena Valve – Three Step Delivery System
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Medtronic Engager Transcatheter Valve
Scalloped bovine
Pericardial leaflets
Nitinol support
frame
Polyester
skirt
Dedicated
commissural
posts
Nitinol main
frame
• Self-guided, reproducible, intuitive deployment into an anatomically correct
supraannular position
• Relies on axial in addition to radial forces for fixation
• Leaves the coronary ostia unobstructed and accessible
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• Precise Valve Positioning: Control arms provide tactile feedback
and stabilize bioprosthesis during deployment
• Minimal Paravalvular Leak: Control arms capture the native leaflets and the self-expanding frame conforms to the annulus
1 2 3
Control arms are released as the first stage in device deployment and are placed in contact with the native leaflets
Engager Control Arm Function
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STABILIZATION ARCHES
Flexible
Self-aligning
UPPER CROWN
Supra-annular anchoring
Stable positioning
Easy placement
Tactile feedback
LOWER CROWN / PET SKIRT
Minimal stent protrusion into LV
Seals within the native annulus
Symetis AcurateValve (CE 2011)
• porcine aortic valve
non coronary leaflets
• Self-expanding Nitinol
• Sizes 23, 25, 27 mm
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Courtesy T Walther/J Kempfert
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Log ES Survival
30d
Stroke
30d
PVL 2+
or >2+
P mean New PM
Jena (73) 28.4 92.5 3.0 13.6 10.0 10.6
Engager (61) 18.9 90.1 1.8 3.3 11.5 30.2
Symetis (90) 20.2 92.2 3.3 2.9 11.6 11.1
Symetis (250) 22.3 95.2 0.8 3.8* 12.8* 4.8
GARY (1181) 22.4 92.3 3.5 - - 9.9
30 day outcomes
*data from 150 pts.
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Transapical TAVI
• Technical advantages of TA approach
• Is transfemoral better than transapical ?
• Results of latest generation TA valves
• New devices for acces closure and
percutaneous transapical access
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TA: Occlusion devices
Outlook on new transapical companion devices
Spontaneous Closure
16
YT%91:K85>%4d5=%=59HQ46%Hb%%?1648H=%4:?%GK1?5I1=5%fK>8%L=1H=%8H%26H>K=5%̀%(H%4??1OH:46%>K8K=1:G%H=%1:85=Q5:OH:%=5gK1=5?%̀%
Apica Permaseal EnTourage
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CardiocloseTM transapical closure system
Anchored sutures
Potential for percutaneous access and closure
Apica
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FIH „closure device“ – Apica
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TA - larger sheath diameter - advanced prostheses
1 day crimped
=> fragmentation
Kiefer, Walther, et al.:
Ann Thorac Surg 2011
Crimping / sheath diameter may affect structural integrity
Less crimping => improved durability !?
Solutions to reduce PV leak:
Cloth may better seal off against PV leaks.
Hydrophilic coatings
Edwards SAPIEN
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Transapical TAVI
• Safe antegrade approach
• Ease of implantation
• Low complication rate
• Outcomes comparable or better to TF
• No limits with regards to size or design of
prosthesis
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Transapical approach: A window of opportunity!
Aortic valve
Mitral valve
Mechanical Circulatory
Assist systems
Hybrid procedures
...
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