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