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Percutaneous  Management  of  Aortic  

Stenosis:  TAVI  Update

Alexander  (Sandy)  Dick,  MD

ACC  Rockies,  2018


Disclosures

• Consulting  fees/Honoraria
– Medtronic
– Edwards  Lifesciences
What  is  New  and  Exciting  for  TAVI  
Teams?
Hokkaido,  Japan
Risk
6.2% High  Risk  (  STS  >8%) +++  Data

Intermediate  Risk
13.9% (STS  4-­8%) Partner  II
SURTAVI

79.9% Low  Risk


(STS  <4%) Evolut Low  Risk
Partner  III

Durability
Full  Steam  Ahead
• SURTAVI  -­ STS  <4%
• Minimalist  Clinical  Pathway
– 3M  TAVI  Trial
• New  Indications/Strategies
– Bicuspid,  AR,  Asymptomatic,  Fracking
• HALT
– Hypoattenuating leaflet  thickening,  PPM
Guideline  Update

2017  AHA/ACC  Focused  Update


David  Cohen
Jenavalve
Valve  in  Valve  TAVI
Courtesy  Jessica  Forcillo
Time  to  Event  Based  on  
Surgical  Valve  Size

Dvir,  JAMA  2014


In  the  pipeline…

• Inspiris Resilia (Edwards)


In  the  pipeline
• BASILICA

Lederman,  NIH
Pacemaker  Post  TAVI
Circulation.  2017;;136:1049–1069.
HALT
The n e w e ng l a n d j o u r na l of m e dic i n e

Original Article

European Heart Journal (2016) 37, 2263–2271 CLINICAL RESEARCH


Possible Subclinical Leaflet Thrombosis doi:10.1093/eurheartj/ehv526 TAVI

in Bioprosthetic Aortic Valves


R.R. Makkar, G. Fontana, H. Jilaihawi, T. Chakravarty, K.F. Kofoed, O. De Backer, Early hypo-attenuated leaflet thickening
F.M. Asch, C.E. Ruiz, N.T. Olsen, A. Trento, J. Friedman, D. Berman, W. Cheng,
M. Kashif, V. Jelnin, C.A. Kliger, H. Guo, A.D. Pichard, N.J. Weissman, S. Kapadia,
JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY
in balloon-expandable transcatheter aortic VOL. 68, NO. 19, 2016
E. Manasse, D.L. Bhatt, M.B. Leon, and L. Søndergaard
ª 2016 BY THE AMERICAN COLLEGE OF CARDIOLOGY FOUNDATION

PUBLISHED BY ELSEVIER heart valves ISSN 0735-1097/$36.00

http://dx.doi.org/10.1016/j.jacc.2016.08.010 Articles
A BS T R AC T Gregor Pache1*, Simon Schoechlin2, Philipp Blanke3, Stephan Dorfs2, Nikolaus Jander2,
Transcatheter Aortic Valve Thrombosis
BACKGROUND
Chesnal D. Arepalli3, Michael Gick2, Heinz-Joachim Buettner2, Jonathon Leipsic3,
Mathias Langer1, Franz-Josef Neumann2, and Philipp Ruile2
A finding of reduced aortic-valve leaflet motion was noted on computed tomogra- The authors’ full names, academic de-
Incidence, Predisposing Factors, and Clinical Implications grees, and affiliations are listed in Bad
Articles
the Krozingen 79189, Germany; Department of Cardiology & Angiology II,
phy (CT) in a patient who had a stroke after transcatheter aortic-valve replacement
1 2
Department of Radiology, Section of Cardiovascular Radiology, University of Freiburg, Südring15,
3
University Heart Center Freiburg-Bad Krozingen,Appendix.
Bad Krozingen,Address
Germany; andreprint requests to
Center for Heart Valve Innovation, St. Paul’s Hospital & University of British Columbia,
(TAVR) during an ongoing clinical trial. This finding raised
Nicolaj C. Hansson, MD, a
Erik L. Grove, MD, P D, a,b
Henning
sible subclinical leaflet thrombosis and prompted further
H
Vancouver,
R. Andersen,Subclinical leaflet thrombosis in surgical and transcatheter
a concern
Canada
investigation.
Received
MD,
about pos- Dr. Makkar at the Department of Interven-
DMS C ,a
Jonathon Leipsic,
tional
16 April 2015; revised 27 July 2015; accepted
MD,
Cardiology,
18 September
c
2015; Cedars–Sinai Heart In-
online publish-ahead-of-print 7 October 2015

bioprosthetic aortic valves: an observational study


Ole N. Mathiassen, MD, PHD,a Jesper M. Jensen, MD, PHD,a Kaare T. Jensen, MD, PHD,a Philippstitute,
Blanke, MD,
8700 c
Beverly Blvd., Los Angeles,
See page 2272 for the editorial comment on thisor
CA 90048, article (doi:1093/eurheartj/ehv742)
at makkarr@
METHODS
Tina Leetmaa, MD,a Mariann Tang, MD,d Lars R. Krusell, MD,a Kaj E. Klaaborg, MD,d Evald H. Christiansen, MD, PHD,a cshs.org.
We
Kimanalyzed
Terp, MD,data
d obtained
Christian from 55MD,
J. Terkelsen, patients
DMSC,ain a clinical
Steen H. Poulsen, trial MD, of TAVR DMSC,aand John from Webb,This MD,article c

two
Hanssingle-center registries
Erik Bøtker, MD, DMSC, that
a,b Tarun
included
Bjarne
Chakravarty, Lars
132 patients
L. Nørgaard, MD, PHDwho a Subclinical
Søndergaard, were John Friedman,
undergoing leaflet
Ole De
either Backer, thrombosisDaniel
2015, at Berman,
NEJM.org. Klaus inF Kofoed,
was published on October 5,
surgical Hasan Jilaihawi, and transcatheter Takahiro Shiota,
Yigal Abramowitz, Troels H Aims Tanya Rami, Sharjeel
Jørgensen, We sought to evaluate the frequency of early hypo-attenuated leaflet thickening (HALT) of the SAPIEN 3 transcatheter
Israr, Gregory Fontana, Martina de Knegt, Andreas Fuchs, Patrick Lyden,
TAVR or surgical aortic-valve bioprosthesis implantation.bioprosthetic We obtained four-dimen- aortic aortic valve (S3). N valves:
Engl J Med 2015;373:2015-24. an observational study
Alfredo Trento, Deepak L Bhatt,. .Martin
. . . . . . . . . B. .Leon,
. . . . . . . . Raj
. . . . . R. . .Makkar,
. . . . . . . . . . .on
. . . .behalf
. . . . . . . . of
. . . the
. . . . . RESOLVE
. . . . . . . . . . . . .and
. . . . . SAVORY
. . . . . . . . . . . . Investigators*
. . . . . . . . . . . . . . . . . . . . . . .....................................................................
sional, volume-rendered CT scans along with data on anticoagulation and clinical DOI: 10.1056/NEJMoa1509233
ABSTRACT Methods
Tarun Chakravarty, Lars Søndergaard, Of 249John patientsFriedman, who
Copyright Olehad De
© Backer,undergone
2015 Daniel Berman,
Massachusetts S3 implantation,KlausSociety.
Medical F Kofoed, weHasan studied 156Takahiro
Jilaihawi, consecutive
Shiota, patients (85 women, median age
outcomes (including strokes and transient ischemic attacks [TIAs]).
Summary
and results 82.2 + 5.5 years) by electrocardiogram (ECG)-triggered dual-source computed tomography angiography (CTA) after
Yigal Abramowitz, Troels H Jørgensen, Tanya Rami, Sharjeel Israr, Gregory Fontana, Martina de Knegt, Andreas Fuchs, Patrick Lyden,
Alfredo Trento,
Background Subclinical leaflet Deepak L Bhatt,
thrombosis a Martin
of medianB Leon,
of 5 Raj
bioprosthetic R Makkar,
days aortic onvalves
behalf of the
post-transcatheter RESOLVE
aortic
after and SAVORY
valve
transcatheter Investigators*
implantation.
valveThe prosthesis was
replacement assessed Lancet
(TAVR) for HALT. Apart
2017; 389: from
2383–92
RESULTS
BACKGROUND There are limited data on the incidence, clinical implications, and predisposing factors of transcatheter
and surgical aortic valve replacement (SAVR) heparin,
has peri-interventional
been found antithrombotic
with CT imaging.therapy
The consisted
objectiveof single-
of (aspirin
this 29%)was
study or dual-
to (aspirin plus clopidogrel
Published Online
Reduced leaflet
heart valve (THV)motion wasfollowing
thrombosis noted on CT in 22aortic
transcatheter of 55valve
patients
Summary (40%)(TAVR).
replacement in the71%) clinical
antiplatelet therapy. Hypo-attenuated leaflet thickening was found in 16 patients [10.3% (95% confidence
report the prevalence ofBackground
subclinical leaflet thrombosis in ofsurgical and aortic
transcatheter aortic valves and the effect of March 19, 2017 interval
trial and in 17 of 132 patients (13%) in the two registries. Reduced Subclinical
leafletleaflet thrombosis
motion bioprosthetic valves after transcatheter valve replacement (TAVR) Lancet 2017; 389: 2383–92
(CI) 5.5 – 15.0%)] of the patients. None of the baseline and procedural variables were significantly associated with
http://dx.doi.org/10.1016/
HALT
• CT  is  increasingly  being  used  peri-­ and  
post-­procedurally
– Prosthesis  position  and  function
– Leaflet  anatomy
• Better  spatial  resolution  than  TTE,  less  
invasive  than  TEE  (and  less  operator  
dependence  of  interpretation)
• Has  led  to  the  identification  of  unforeseen  
findings:
– Hypoattenuating leaflet  thickening,  reduced  
leaflet  motion
HALT
• Hypoattenuated thickening,  +/-­
rigidity/restriction,  of  one  or  more  leaflets  
identifiable  in  at  least  2  different  MPR  
projections  and  2  different  reconstruction  
time  intervals
• Often  subclinical  (incidentally  detected  on  
CT)
• Involve  the  periphery  and  base  of  the  leaflet  
with  variable  extension  to  the  edge  of  the  
leaflet  in  the  centre  of  the  bioprosthetic frame
• Speculated  that  leaflet  thrombosis  is  the  
underlying  cause
HALT
• Potential  mechanisms:
– Traumatic  injury  to  the  leaflets  with  
deployment  of  valve
– Leaving  native  aortic  valve  cusps  in  situ  may  
alter  flow  dynamics
– Incomplete  expansion  or  over-­expansion  
could  alter  mechanical  stress  on  the  leaflets
– Increased  on-­clopidogrel platelet  activity  in  an  
elderly  population  may  predispose  to  
thrombosis
HALT

• Potential  clinical  implications:


– Increased  risk  of  stroke?
– Increased  risk  of  obstruction  causing  HF?
– Reduced  long-­term  valve  durability?
HALT

• Most  data  comes  from  2  single-­centre  


registries  (RESOLVE,  SAVORY)  designed  
to  study  reduced  bioprosthetic leaflet  
motion  in  TAVI  and  SAVR
– 752  patients  with  TAVI  that  had  routine  CT  
imaging  done  (not  performed  at  a  pre-­
specified  time  – median  time  58  days,  IQR  
32-­236)
HALT
• 13%  of  TAVI  had  subclinical  leaflet  
thrombosis  (4%  of  SAVR)
• Less  frequent  among  patients  on  
anticoagulation  (4%)  vs DAPT  (15%)
• Among  those  on  anticoagulation,  there  
was  no  difference  between  NOAC  (3%)  
and  warfarin (4%)
• Resolved  in  100%  of  patients  treated  with  
anticoagulation
HALT
A B C D

E F G H

I J K L

M N O P
HALT

• Rates  of  elevated  AV  gradients  were  low,  


but  higher  proportion  seen  in  those  with  
subclinical  leaflet  thrombosis  (14%)  than  in  
those  with  normal  leaflet  motion  (1%)
• Associated  with  more  strokes/TIAs
– TIA  significant:  4.18  vs 0.60  per  100-­person  
years,  p=0.0005
– Trend  in  CVA:  4.12  vs 1.92  per  100-­person  
years,  p=0.10
CENTRAL I LL USTRATI O N CT Evaluation of Subclinical Leaflet Thrombosis

Jilaihawi, H. et al. J Am Coll Cardiol Img. 2017;10(4):461–70.


anticoagulation in patients
Supplement 6. undergoing On-X AVR showed
equivalent outcomes, but the
HALT bleeding rate in the control group
was unusually high.
In patients without risk factors who receive a mechanical On-X aortic heart valve (On-X Life Technologies
Inc., Austin, Texas), a lower INR target of 1.5 to 2.0 (in conjunction with aspirin 81 mg daily) may be
considered for long-term management, beginning 3 months after surgery. Warfarin dosing is targeted to an
INR of 2.5 (range 2.0 to 3.0) for the first 3 months after surgery (209). This is based on a single RCT of
lower- versus standard-intensity anticoagulation in patients undergoing On-X AVR, showing equivalent
outcomes. The control arm did have a bleeding rate of 3.2% per patient-year (209).
Anticoagulation with a VKA to achieve an INR NEW: Studies have shown that
IIb B-NR of 2.5 may be reasonable for at least 3 months valve thrombosis may develop in
after TAVR in patients at low risk of bleeding patients after TAVR, as assessed
(203,210,211). by multidetector computerized
See Online Data tomographic scanning. This valve
Supplement 6. thrombosis occurs in patients who
received antiplatelet therapy alone
but not in patients who were
treated with VKA.
Several studies have demonstrated the occurrence of prosthetic valve thrombosis after TAVR, as assessed
by multidetector computerized tomography, which shows reduced leaflet motion and hypo-attenuating
opacities. The incidence of this finding has varied from 7% to 40%, depending on whether the patients are
from a clinical trial or registry and whether some patients received anticoagulation with VKA
(203,210,211). Up to 18% of patients with a thrombus formation developed clinically overt obstructive

© 2017 by the American Heart Association, Inc., and the American College of Cardiology Foundation 27
Subclinical  Leaflet  Thrombosis

• Proper  randomized  trials:


– RETORIC  (Jan  2019):
• 200  patients
• Single  anti-­platelet  +  OAC  vs standard  of  care
• Assess  incidence/predictors  of  reduced  leaflet  
motion  and  valve  thrombosis  post-­TAVI  using  CT,  
TEE,  TTE  and  incidence  of  stroke/TIA  (MRI)
Subclinical  Leaflet  Thrombosis

• Proper  randomized  trials:


– ATLANTIS  (Apr  2019):
• 1510  patients
• Apixaban vs standard  of  care
• Composite  clinical  endpoint  of  death,  MI,  
stroke/TIA/systemic  embolism,  intracardiac or  
bioprosthesis thrombus,  DVT/PE,  bleeding
Subclinical  Leaflet  Thrombosis

• Proper  randomized  trials:


– GALILEO  (Dec  2018):
• 1520  patients
• Rivaroxaban vs standard  of  care
• Clinical  endpoints:  death/first  thromboembolic
event,  bleeding
Thoughtful  Full  Steam  Ahead
• Low  Risk
– Partner  III,  Evolut low  risk
• Minimalist  Clinical  Pathway
– 3M  TAVI  Trial
• New  Indications/Strategies
– Bicuspid,  AR,  Asymptomatic,  Fracking
• HALT

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