paravalvular leak (pvl) in tavi...predictors of pvl post-tavi • prosthesis annulus mismatch...
TRANSCRIPT
ParaValvular Leak (PVL) in TAVI
Angelos Papanikolaou, MD, MEAPCI
Consultant, Interventional Cardiologist,
1st University Dpt Cardiology, GHA “Hippokration”
~2013 JACC reviewincidence of AR in real world registries
9,5%
17,5%
17,2%
13,6%
14,9%
54,9%
55,1%
47,4%
85,1%
27,6%
27,7%
39,0%
40,1%
0% 20% 40% 60% 80% 100%
Eltchaninoff et al
Zahn et al
German Registry
UK Registry
FRANCE II Registry
None < moderate ≥ moderate
40% to 67% for upto mild7% to 30% for >2+AR
Athappan G, et al. Incidence, Predictors, and Outcomes of AR After TAVI. Meta-Analysis and Systematic
Review of Literature. JACC 2013; 61:1585-95.
impact of PVL on mortality
PVL ≥ 2 after TAVI isan independent predictor of mortality
S3-TAVR
N = 1050
SAVR
N = 856
XT-TAVR
N = 856
30 Day Complications
Disabling/life-threatening bleeding 4.3% 47.3% 9.8%
Acute kidney injury 0.5% 3.4% 1.3%
Major vascular complication 5.9% 5.4% 7.7%
1 Year Complication
Disabling Stroke 2.1% 5.6% 4.7%
New atrial fibrillation 5.9% 29.2% 10.3%
Moderate or severe aortic
regurgitation
1.3% 0.2% 3.0%
New permanent pacemaker insertion 10.6% 9.1% 10.2%
PARTNER 3
impact of PVL on mortality
Kodali SK et al. N Engl J Med. 2012;366:1686-95CoreValve ADVANCE Registry: Presented at ACC 2012
FRANCE II Registry: Van Belle et al, TCT 2012
ADVANCE Registry
France 2 Registry
P<0.0001
PVL and Outcome after TAVI
Hayashida et al. JACC Interv. 2012; 12:1247-56
PARTNER 2 TRIAL
PARTNER:3 year outcomes after TAVI or sAVR
Kodali et al., N Engl J Med 2012;366:1686-95
Athappan et al. JACC, Volume 61, Issue 15, 2013, 1585 - 1595
Impact of Moderate or Severe AR on Overall Mortality
25 studies: Sapien: 7,279 SAPIEN pts and CoreValve: 5,261 pts
Para-Valvular Leak after TAVI
predict (ie minimize) by imaging
predict (ie minimize) by valve type
minimize and treat during procedure
Para-Valvular Leak after TAVI
predict (ie minimize) by imaging
predict (ie minimize) by valve type
minimize and treat during procedure
EVALUATION OF AR
Predictors of PVL post-TAVI
• Prosthesis annulus mismatch (annulus > prosthesis)
• Cover index
• Ca2+ and Agatston score
• Depth from NCC
• Implantation depth
• Larger annulus size
• Bicuspid and/or eccentric valve anatomy
Detaint D et al., JACC Cardiovascular interventions 2009;2:821-7.
Samim M et al., The Journal of thoracic and cardiovascular surgery 2012.
Haensig M et al., European journal of cardio-thoracic surgery : 2012;41:1234-40;
Willson AB et al., Journal of the American College of Cardiology 2012;59:1287-94.
Jilaihawi H et al., Journal of the American College of Cardiology 2012;59:1275-86.
Latsios G et al , JACC Cardiovascular interventions 2010;3:233-43
John D et al., JACC Cardiovascular interventions 2010;3:233-43
Schultz C et al.,. EuroIntervention 2011;7:564-72.
Rates of PVL According to MSCT Nominal Area Oversizing
Significant reduction of PAR:Sapien XT: MDCT area oversizing > 10% Sapien 3: MDCT area oversizing ≤ 4.17%
Yang et al. JACC Cardiovascular interventions 2015;3:462–71
Impact of correct MSCT sizing on PVL
M. Drakopoulou, K. Toutouzas, G Latsios et al., in press
Latsios G, Spyridopoulos Th, Toutouzas K et al. Hellenic J Cardiol. 2017 Oct 28.
over-Sizing in ~ 14%
↓PVL and ↓ mortalityn= 152
Impact of correct MSCT sizing on PVL
Perimeter
Area
Diameters
MSCT“Annulus-Sizing concept”
RCS
LCS
NCS
coronal
sagittal
MSCT measurements
J. Leipsic, J. Webb et al. TCT 2012
Change in valve sizeusing CT sizing
compared with TEE
PVL in patients where CT recommended
a larger valve
44% are under or over sized
MSCT sizing:more precise - can predict PVL
TAVI StrategyAgreement
with TTEAgreement
with TEE23mm Device
26mm Device
No Implant
n (%) n (%)
Echo
TTE 5 29 11 - 37 (83)
TEE 6 25 14 37 (83) -
MSCT
Long-axis 0 10 35 16 (36) 19 (42)
Short-axis 16 21 8 21 (47) 19 (42)
Mean 4 24 17 28 (62) 28 (62)
3-chamber view 7 25 13 27 (60) 26 (58)
Multimodal Assessment of theAortic Annulus Diameter
Messika-Zeitoun D. J Am Coll Cardiol. 2010;55(3):186-94.
Imaging Modality Determines Treatment Strategy
MSCT would have modified the TAVI strategy in around 40% of patients
Latsios G, Gerckens U, et al. Catheter Cardiovasc Interv. 2010 Sep 1;76(3):431-9Latsios G, Gerckens U, et al . JACC Cardiovasc Interv. 2010 Feb;3(2):233-43.
AoV Landing Zone and LVOT Ca++
↑ PVL
Grade Imild
Grade IIIsevere
Grade IVmassive(+outreaching in to the LVOT)
Grade IImoderate
AgS and DLZ-CaScore
correlated with PVL
angio PVL:
AgS r=0.25, P=0.011;
DLZ-CS r=0.24, P=0.016
TTE PVL:
AgS r=0.34, P=0.001;
DLZ-CS r=0.30, P=0.002
AoV Landing Zone and LVOT Ca++
↑ PVL
Buellesfeld L et al. TVT 2013
Para-Valvular Leak after TAVI
predict (ie minimize) by imaging
predict (ie minimize) by valve type
minimize and treat during procedure
The new devicesand their characteristics to reduce PVL
The new devicesand their characteristics to reduce PVL
• Sealing rings to prevent aortic regurgitation
• Repositionable, fully retrievable
• Allows hemodynamic assessment before final
detachment
• Adaptive seal
• Repositionable & retrievable
• High radial force
• Allows hemodynamic assessment before final
detachment
• Outer skirt minimizes paravalvular leak
• High radial strength for circularity
• More consistent radial force and
• Optimized cover index to reduce PVL
• Resheathable, recapturable, repositionable and
retrievable
• Allows hemodynamic assessment before final detachment
Emergency conversion to open heart surgery
9.251 patients from 46 studies: 1.1%
Eggebrecht H, EuroIntervention. 2012 Nov 8
PVL rates @ 30 days
Meredith IT, et al REPRISE II. JACC Cardiovasc Interv. 2016 Feb 22;9(4):376-
384
PVL rates @ 30 days
PVL rates @ 30 days
Adams et al., ACC, 2014; Popma, et al., JACC 2017; Forrest, et al., ACC, 2017
% P
atie
nts
wit
h M
od
/Sev
ere
PV
L
24,2
16,9
14,2
11,49,0
4,0 3,4 3,41,4 0,6
0
5
10
15
20
25
30
SAPIEN XTPARTNER II, Inop1
SAPIENPARTNER II Inop1
CoreValveADVANCE2
CoreValveExtreme Risk3
CoreValveHigh Risk4
Portico
CE Study5
SAPIEN 36
Evolu R
CE Study9
LOTUS REPRISE II & EXT8
N=236 N=225 N=639 N=412 N=356 N=75 N=116
N=74 N=177
1Leon M, ACC 2013, 2Linke A, PCR 2014. 3Popma J, JACC 2014; 63(19): 1972-81, 4Adams D, N Engl J Med 2014; 370: 1790-98. 5Manoharan, et al. TCT 2014. 6Webb J, EuroPCR2014. 7Schofer, JACC 2013. 8Ian Meredith, London Valves 2014. Results from different studies not directly comparable. Information provided for educational purpose only.
1 Month Moderate & Severe PVL TAVI Clinical Trials
EVOLUTION OF DEVICES
Direct Flow
DISCOVER7
9Meredith IT,ACC. March 14, 2015.
REPRISE II Ext. Cohort (N=250) 1.8
DISCOVER (CE Mark) (n=75) 1
SALUS (IDE US) (n=30) 0
Real-World Reg. (n=105) 2
S3HR Overall (n=583) 2.9
S3i Overall (n=1076) 4.2
Evolut™ R CE Study (N=60) 3.4
Valve AR 2+(%)
the New Devicesmoderate / severe AR
~ 1 – 4%
Para-Valvular Leak after TAVI
predict (ie minimize) by imaging
predict (ie minimize) by valve type
minimize and treat during procedure
Mechanisms of PVLafter CoreValve TAVI
Sinning et al JACC, 2012
Calcifications of
the cusps of the
native valve
Too shallow
valve
malposition
Too deep
valve
malposition
Annulus-prosthesis-
size mismatch
insufficient expansion – post-dilate
Balloon Post-Dilation after CoreValve TAVI
22%
78%
3.532 pts
Harrison JK, et al CoreValve US Clinical Investigators JACC Cardiovasc Interv. 2017 Jan
23;10(2):168-175.
AR due to ‘too deep’- Snare© pull
from femoralunsuccessful
from radial
TAVI “malposition”novel solutions
40