Should TAVR be the Standard for Bicuspid Aortic Stenosis , or Do We Need a Randomized Clinical Trial ? Raj R. Makkar, MD Director, Interventional Cardiology & Cardiac Catheterization Laboratories Associate Director, Cedars - Sinai Heart Institute Professor of Medicine, University of California, Los Angeles Stephen Corday Chair in Interventional Cardiology
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Should TAVR be the Standard for Bicuspid Aortic Stenosis ... · Raj R. Makkar, MD Director, Interventional Cardiology & Cardiac Catheterization Laboratories Associate Director, Cedars-Sinai
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Should TAVR be the Standard for Bicuspid
Aortic Stenosis, or Do We Need a Randomized
Clinical Trial?
Raj R. Makkar, MDDirector, Interventional Cardiology & Cardiac Catheterization Laboratories
Associate Director, Cedars-Sinai Heart Institute
Professor of Medicine, University of California, Los Angeles
Stephen Corday Chair in Interventional Cardiology
Disclosures
Consultant and research grant from Edwards LifeSciences,
Medtronic, Abbott, Boston Scientific and Jena Valve
What is the competition for TAVR vs.
SAVR trials?
• Aortic Regurgitation
• Failed surgical bioprosthetic valves
• Mixed valvular heart disease-AS+MS/MR
• Failed TAVR valves
My 5 key arguments for a randomized trial for
Bicuspid AS• Bicuspid AS will be encountered with greater frequency as
TAVR use expands in the younger patients-50% of SAVR
in young are bicuspid
• The available observational data are limited by treatment
bias..perhaps only favorable anatomies were treated
• Surgical outcomes in young Bicuspid AS patients are
excellent; reasonable to expect robust evidence for TAVR to
replace SAVR
• Anatomically heterogeneous group with frequent
aortopathy-unlike what has been treated in previous IDE
studies
• The precedent for label expansion in TAVR in last decade
has been IDE randomized clinical trials
In low risk Bicuspid AS
Is TAVR=SAVR?
• Low risk trials: (Mack et al, NEJM; Popma et al, NEJM)
TAVR equal/better than SAVR
• STS/ACC-TVT registry: (Makkar et al, JAMA 2019)
1 year Death/Stroke
Bicuspid AS =Tricuspid AS
Prevalence of Bicuspid Aortic Valve
20- 30- 40- 50- 60- 70- 80-
Fre
qu
en
cy o
f B
AV
(%
)
Roberts WC et al. Circulation. 2005;111:920-925
33
6064
69
60
42
28
0
10
20
30
40
50
60
70
80
Age (years)
Prevalence of bicuspid valve in patients undergoing
isolated AVR-almost 50%!
Roberts WC. et al. Circulation 2005
Operatively excised, stenotic aortic valves from 932 patients
aged 26 to 91 years
Prevalence of bicuspid aortic valve in TAVR
studies is less than SAVR studies
• Less than 7% of patients
with bicuspid aortic valve
in TAVR registries
• Septugenerians undergoing
SAVR: 41.7%
• Octogenerians undergoing
SAVR: 27.5%
Zhao ZG. et al. Nature Reviews in Cardiology 2015
Pivotal Randomized Trials
Inoperable
High Risk
Intermediate Risk
Low Risk
Key Anatomic Exclusion Criteria
• Aortic annulus diameter < 16mm or 28mm
• Bicuspid valve (CT imaging)
• Severe AR or MR
• Severe LV dysfunction
• Severe calcification of aortic valve complex
• Vascular anatomy not suitable for safe femoral access
• Complex CAD: LM, Syntax score>32
• Low coronary takeoff
Outcomes of TAVR for Bicuspid vs Tricuspid AS
• 546 pairs of patients with bicuspid and tricuspid AS were created with PS-
matching
• Bicuspid had more frequent aortic root injury with Sapien XT and PVL with
CoreValve, but no differences in complications with Sapien 3/Evolut R/Lotus
• No difference in 1-year mortality between bicuspid and tricuspid AS
Yoon et al: J Am Colle Cardiol 2017;69:2579-89
Contemporary TAVR for Bicuspid vs Tricuspid AS
STS/ACC TVT Registry
Makkar et al: JAMA 2019;321:2193-202
22
Characteristic% or mean ± SD
Bicuspid AS(n=2691)
Tricuspid AS(n=2691)
p-value
Device success 96.5 96.6 0.87
Procedure Time, min 100.7 ± 51.80 98.2 ± 52.09 0.08
Fluoroscopy Time, min 18.5 ± 10.96 17.1 ± 10.17 <0.0001
• CT assessment of morphology in bicuspid aortic stenosis helps assess anatomical risk of TAVR
• In absence of randomized clinical trial data in treating Bicuspid Aortic Stenosis, CT based anatomical assessment may identify patients favorable for TAVR and in conjunction with surgical risk help triage patients to TAVR vs. SAVR
Clinical Implications
Pivotal Randomized Trials have been the standard
for indication expansion for TAVR
Inoperable
High Risk
Intermediate Risk
Low Risk
Meta-Analysis
Systemic Reviews
Randomized Controlled Trial
Cohort Studies
Case Control Studies
Case Report/ Case Series
Background Information & Expert Opinion
Hierarchy of Evidence and Research Designs
In low risk Bicuspid AS
Is TAVR=SAVR?
• Low risk trials: (Mack et al, NEJM; Popma et al, NEJM)
TAVR equal/better than SAVR
• STS/ACC-TVT registry: (Makkar et al, JAMA 2019)
1 year Death/Stroke
Bicuspid AS =Tricuspid AS
Why infer? Let us do the randomized clinical trial!
Practical considerations..
• Be careful of unfavorable anatomical features on CT: excessive
calcium, raphe type especially calcified raphe
• Some degree of undersizing (compared to tricuspid) is appropriate
• Positioning is harder than the tricuspid valve. Cross check with
echo. TEE guidance is is preferable due to higher rates of AI and
risk of aortic root rupture
• Predilation is generally a good idea; avoids difficult crossing and
stresses on aorta which may be diseased; also can help with sizing.
• Post dilation and rarely valve in vavle may be needed to optimize
the expansion and procedural outcomes.
Conclusions
• Though the mortality may be “similar” to the tricuspid TAVR, the acute
outcomes in the published literature are worse with respect to AI, and
pacemaker implantation with the first generation devices
• The data with Sapien 3 valve are excellent, no comparative studies are
available with other next generation valves (Evolut R, Lotus, Portico)
• While Bicuspid TAVR is justifiable in higher surgical risk patients, high
risk anatomical features (extreme calcium, heavy-calcified raphe),
concomitant aortopathy should prompt consideration for surgical AVR in
low risk patients
• Randomized trials/prospective registries especially in patients with lower