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Severe Aortic Stenosis: TAVI
My Patient Needs Cardiac Intervention: Should I Advise him Open or Endo?
SSC/SSCS Joint Annual Meeting Zürich, 10. Juni 2015
Kardiologie
Raban Jeger
Cardiology University Hospital Basel
My Patient Needs Cardiac Intervention: Should I Advise him Open or Endo?
PTCA vs. CABG TAVI vs. SAVR
Highest level of achievement
Non-inferiority levelHighest level of achievement
Superiority level
Surgery vs. Intervention:A Robust Clinical Evidence
SOS Trial
BARI Trial
SYNTAX Trial
PRECOMB Trial
MAIN COMPARE Trial
ERACI II Study
ARTS Trial
MASS II Study
PARTNER Trials
CoreValve US Pivotal Trial
Adapted from Laborde JC
Smith CR et al, N Engl J Med 2011;364:2187-98
STS = 11
PARTNER A: High-Risk Patients
Leon MB et al, N Engl J Med. 2010 Oct 21;363(17):1597-607
STS = 11
PARTNER B: Inoperable Patients
Aortic Valve Mean Gradient
TAVR 310 219 156 106 79 56
SAVR 299 158 123 86 61 48
Error Bars = ± 1 Std Dev
No structural valve deterioration that
required re-intervention.
p < 0.0001
Adams DH et al, N Engl J Med 2014;370:1790-8
STS = 7
CoreValveU.S. Pivotal Trial
Adapted from Head SJ et Kappetein P, EuroIntervention 2010;6:560-561
117
COREVALVE
4
STS-Score: <4 Low Risk >8 High Risk4-8 Interm. Risk
TAVI Slowly Moving Towards Lower-Risk Patients...
S&E Post
Market
Surv.
(early)
FIM
Time
Broader application
reveals downsides,
issues, complications
Early enthusiasm,
“exploding“ interest
A A: Lack of convincing
evidence leads to low
penetration (niche) or
end
B B: Acceptance in daily
practice with specific
proven clinical
indication; alternative
options still indicated
C C: Gold Standard,
replacing established
therapies
Benefit/Concern
reassessment
Post Market
Surv.
(late)
2015
Implants
2010
TAVIDevice Adoption and Experience
Adapted from Laborde JC
Improved
Outcome
Increasing
Experience
Patient
Selection
Improved
Visualization/
Measure-
ment
Second
Generation
Valves
Embolic
Protection
Devices
Smaller
Catheter
Size
TAVIRoom for Improvement?
Vasa-Nicotera M et al, J Am Coll Cardiol Intv 2012;5:858–65
Sinning JM et al, J Am Coll Cardiol. 2012;59(13):1134-1141
AR index =
[(DBP-LVEDP)/SBP]x100
Paravalvular Leakage:Severe Aortic Regurgitation
Moderate/Severe PVL at 30 DaysEdwards SAPIEN Valves
PARTNER I and II Trials
SAPIENSAPIEN
XTSAPIEN 3
Czerwinska-Jelonkiewicz K et al, J Thromb Thrombolysis (2014) 37:490–498
TAVIVascular Complications
2002
Cribier-
Edwards
2006
SAPIEN
2009
SAPIEN XT
2013
SAPIEN 3
TAVI Sheath Diameter
Nombela-Franco L et al, Circulation. 2012 Dec 18;126(25):3041-53
MRS = Modified
Rankin Scale
TAVIStrokes
ACC 2014All Stroke
17
Cerebral Protection System:Claret Medical Sentinel™
SAVR Edwards CoreValve New Valves
Procedure Success (VARC) >99% <95% <95% >99%
Valve Embolization 0 0.1-1% <0.1% 0
Annulus Rupture <0.1% 0.1-1% <0.1% 0
Coronary (Sub-)Occlusion <0.1% 0.1-1% 0.1% <0.1%
Valve Dislodgement 0 <0.1% 1-3% 0
Need for Additional Valves 0 2-3% 3-5% 0
Paravalvular Leakage ≥2 <3% >10% >10% <5%
Pacemaker 2-9% 5-10% 10-35% 5-10%
Major Vascular Complications <5% 15% 10% <5%
Stroke 1-4% 2-6% 2-4% <3%
Adapted from Bonow RO et al, Circulation 2006;114;e84-e231
TAVIRoom for Improvement!
My Patient Needs Cardiac Intervention: Should I Advise him Open or Endo?
Based on randomized trial evidence, TAVI has become an established
alternative to surgical AVR in a high-risk and high-to intermediate risk
population; results for intermediate-risk patients are on the way
Durability results look very promising
There has been improvement regarding paravalvular leakage, pacemaker
rates, vascular access complications, and stroke rates which are addressed
by new devices and valve types
My Patient Needs Cardiac Intervention: Most Patients have Chosen Already...
Mohr FW, Nature Reviews Cardiology 11, 637–638 (2014).
Aortic Valve Therapy in Germany
Mohr FW, Nature Reviews Cardiology 11, 637–638 (2014).
Aortic Valve Therapy in Germany
Vielen Dankfür Ihre Aufmerksamkeit
Kardiologie