tavr-update · leon et al. transcatheter or surgical aortic valve replacement in intermediate risk...
TRANSCRIPT
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TAVR-UpdateAndrzej Boguszewski MD, FACC, FSCAI
Vice Chairman, Cardiology Mid-Michigan Health
Associate Professor Michigan State University, Central Michigan University
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Disclosure Chiesi Pharma- Consultant
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Objectives Review where TAVR is now
Current Challenges
TAVR Updates
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Background Aortic valve stenosis
• 15,000 deaths per year in North America
• 85,000 valve procedures
• AVR is indicated for severe AS and either symptoms
or LV dysfunction
• Over 500 TAVR programs open
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2017 40th Anniversary of PCI
• September 1977
15th Anniversary of TAVR
• April 2002
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Two TAVR Options• Edwards Sapien Valve
• Cobalt Chromium frame-balloon expandable (bovine)
• More Aortic Regurg, less AV block/PPM
• Better for severe bulky calcification.
• Medtronic CoreValve
• Nitinol Frame-self expanding
• Less Aortic Regurg, More heart block/PPM
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N = 179
N = 358Inoperable
Standard
Therapy
ASSESSMENT:
Transfemoral
Access
Not In Study
TF TAVR
Primary Endpoint: All-Cause Mortality
Over Length of Trial (Superiority)
Co-Primary Endpoint: Composite of All-Cause Mortality
and Repeat Hospitalization (Superiority)
1:1 Randomization
VS
Yes No
N = 179
TF TAVR AVR
Primary Endpoint: All-Cause Mortality at 1 yr
(Non-inferiority)
TA TAVR AVR
VSVS
N = 248 N = 104 N = 103N = 244
PARTNER Study Design
Symptomatic Severe Aortic Stenosis
ASSESSMENT: High-Risk AVR Candidate
3,105 Total Patients Screened
Total = 1,057 patients
2 Parallel Trials: Individually Powered
N = 699High
Risk
ASSESSMENT:
Transfemoral
Access
Transapical (TA)Transfemoral (TF)
1:1 Randomization1:1 Randomization
Yes No
Cohort A Cohort B
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Cohort B Survival
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N = 179
N = 358Inoperable
Standard
Therapy
ASSESSMENT:
Transfemoral
Access
Not In Study
TF TAVR
Primary Endpoint: All-Cause Mortality
Over Length of Trial (Superiority)
Co-Primary Endpoint: Composite of All-Cause Mortality
and Repeat Hospitalization (Superiority)
1:1 Randomization
VS
Yes No
N = 179
TF TAVR AVR
Primary Endpoint: All-Cause Mortality at 1 yr
(Non-inferiority)
TA TAVR AVR
VSVS
N = 248 N = 104 N = 103N = 244
PARTNER Study Design
Symptomatic Severe Aortic Stenosis
ASSESSMENT: High-Risk AVR Candidate
3,105 Total Patients Screened
Total = 1,057 patients
2 Parallel Trials: Individually Powered
N = 699High
Risk
ASSESSMENT:
Transfemoral
Access
Transapical (TA)Transfemoral (TF)
1:1 Randomization1:1 Randomization
Yes No
Cohort A Cohort B
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TAVR 348 298 261 239 222 187 149
AVR 351 252 236 223 202 174 142
Cohort A: All-Cause Mortality
No. at Risk
HR [95% CI] =
0.93 [0.74, 1.15]
p (log rank) = 0.483
26.8%
24.3%
34.6%
33.7%
44.8%
44.2%
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N Engl J Med 2016; 374:1609-1620
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Core Valve
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N Engl J Med 2016; 374:1609-1620
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Recurrent Theme:
TAVR
More vascular complications
More pacemakers
More PVL
Lower gradients and better EOA
SAVR
More Bleeding
More atrial fibrillation
Acute kidney injury
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Equipoise
Mortality, Stroke, MI, Aortic re-
interventions?, durability (5 years)
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Is TAVR now for everyone? Evidence base:
• Inoperable patients
• Extreme Risk patients
• High Risk patients
• Intermediate Risk patients
On going Trials:
• Low Risk Patient
Uncertain Benefit
• “Cohort C” Futility
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TAVR
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JACC.2017;70(2):252-89
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79.9%
13.9%
High risk
(STS >
8%)Intermediate
risk (STS 4-
8%)
Low risk
(STS
<4%)
6.2%
STS database 2002-2010(141,905 pts)
Courtesy of N. Piazza
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What about Low Risk Patient? Notion Trial I and II
Partner 3
CoreValve Low Risk Trial
• Sub-studies
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JACC 2015(65)20:2184-94
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JACC 2015(65)20:2184-94
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NOTION Trial (low Risk)
Mortality Stroke
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JACC 2015(65)20:2184-94
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NOTION Trial
NYHA Classification PVL
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JACC 2015(65)20:2184-94
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JACC 2015(65)20:2184-94
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Clinical Outcomes
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28PCRonline.com
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Potential Pitfalls in a low risk patient Need for PPM
• Potential for TR regurgitation and RV dysfunction
Stroke and embolic protection
Future CAD and need for PCI
• Won’t usually present to TAVI centers
Durability question
Bicuspid AV and aortopathy
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The PARTNER 3 Trial
Study Design
CT Imaging Sub-Study (n=200)
1:1 Randomization
(n=1228)
TF - TAVR
(SAPIEN 3)
Surgery
(Bioprosthetic Valve)
Follow-up: 30 days, 6 mos, 1 year and annually through 10 years
CT Imaging Sub-Study (n=200)
Low Risk ASSESSMENT by Heart Team(STS < 4%, TF only)
Symptomatic Severe Calcific Aortic Stenosis
PRIMARY ENDPOINT:
Composite of all-cause mortality, all strokes,
or re-hospitalization at 1 year post-procedure
Bicuspid Valves
(n=100)
ViV (AV and MV)
(n=100)
PARTNER 3
Registries
Alternative Access
(n=100)
(TA/TAo/Subclavian)
Actigraphy/QoL Sub-Study (n=200) Actigraphy/QoL Sub-Study (n=200)
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1200 low-risk patients randomized to TAVR vs
SAVR
Primary end point of mortality and stroke at 2
years
400 patient sub-study on leaflet mobility
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Strokes and Embolic protection
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Strokes post AVR Likely underestimated
Diffusion Weight MRI showed up 80% new
ischemic lesion post AVR
“Silent infarct”
• 2-4 fold increase in future strokes
• >3 fold increase in mortality
• >2-fold increase in dementia
• Cognitive decline
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Tay et al. JACC 2011;4(12):1290-97
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Van Mieghem et al. JACC 2015;8(5):718-24
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Embolic protection Devices
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42% reduction in
median new lesion
volume
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CLARET Device
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Durability
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Durability Bio-prosthetic aortic valve degeneration
• <1% at 1 year
• 10-30% at 10 years
• 20-50% at 15 years
Trans-catheter Valve --?
• Dvir et al. EuroPCR
• ? 50% TAVI degenerate at 8 years (2/3 AI)
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Interact Cardiovasc Thorac Surg 2014;19:36-40.
Pibarot P et al. Circulation 2009;119:1034-48.
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TAVR degeneration Moderate AI and/or mean gradient >20 mmHg not
present at 30 days post procedure (not
comparable to definition of surgical valve
degeneration)
Sub-clinical leaflet immobility
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Patient prosthesis mismatch (PPM)
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Dvir et al. JAMA 2014;312920:162-170
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RESOLVE and SAVORY Registries
• Assess prevalence of subclinical leaflet thrombosis
• 931 patients had 4D CT, ECHO
• 13% vs 4% thrombosis on TAVR vs SAVR (p=0.001)
• Resolution on anticoagulation (warfarin or NOAC)
• No stroke difference but more TIA
• Aortic gradients >20 mmHg or increase gradient >10
mmHg were seen more frequently in pts with leaflet
thrombosis then not. 14% vs 1% p=<0.0001)
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Ring fracturing
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Circ Cardiovasc Inter. 2015;8:e002667
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Asymptomatic aortic stenosis True asymptomatic
Under reported (Sx attributed to normal aging)
Risk of SCD 1-2% vs surgery 1-5% mortality
• No EQUIPOISE if considering SAVR
Stress stress testing is indicated
• ~5-6% doctors give stress tests (fear?)
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JACC 2012:59(3):235-43
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SAPIEN 3 Trial
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Kodali et al. European Heart J 2016
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Taniguchi et al. JACC 2015;66:2827-38
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EARLY TAVR Trial Test the hypothesis that early TAVR will be
superior to watchful waiting in patients with
asymptomatic severe aortic stenosis
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Early intervention with moderate AS
and reduced EF?
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Duke echo database identified 1634 pts with LV systolic dysfunction (EF ≤
50%) and AS; 1090 (67%) with moderate AS (mean AV gradient ≥ 25-39
mmHg, mean AVA 1.08 cm2) and 544 (33%) with severe AS (mean AVA 0.72
cm2)
• Mean age 75yo and major co-morbidities included CAD 61%, DM 33%,
and cerebrovascular disease 20%
• Pts followed at least 5 years after the index echo
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TAVR UNLOAD 600 pts, 1:1 randomization
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TAVR Categories(risk is a continuum)
Operable AS patients
TAVR in 2018
TAVR
preferred
Extr
Risk*
* Extreme (prohibitive) risk = “inoperable”
Low
Risk
Surgery (AVR)
Evaluation in
progress
~65%
Moderate
Risk¿
Safe for TAVR
But surgery also
a good option
~25%
High
Risk
TAVRor
AVR
OK
~10%
Fu
tile
No
Too
Sick
Current TAVR
Clinical Use
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TAVR Over 500 TAVR programs in the US
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JACC.2017;70(2):252-89
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Aortic Replacement Guidelines
62
Valvular heart disease Focused Updated.
JACC.2017;70(2):252-89
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Questions:
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Intervention for asymptomatic aortic valve
replacement is indicated:
a. When mean valvular gradient falls by 20% with
exercise
b. Resting peak velocity of >5 m/sec
c. Prior to moderate risk surgery
d. New onset atrial fibrillation
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Intervention for asymptomatic aortic valve
replacement is indicated:
a. When mean valvular gradient falls by 20% with
exercise
b. Resting peak velocity of >5 m/sec
c. Prior to moderate risk surgery
d. New onset atrial fibrillation
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Sentinel Trial: The CLARET Device has shown to:
a. Reduce mortality
b. Statistically reduce major strokes
c. Reduced major lesion volume by MRI
d. Increase in vascular complication
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In the intermediate risk TAVR clinical trial
SURTAVI: TAVR patients experienced more..
a. life threatening or disabling bleeding
b. atrial fibrillation
c. more acute kidney injury
d. vascular complications
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References:
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Leon et al. Transcatheter or surgical aortic valve replacement in Intermediate risk
patiens. N Engl J Med 2016; 374:1609-1620
2017 AHA/ACC Focused Update of the 2014 AHA/ACC Guidelines for
Management of Patients with Valvular Heart Disease. JACC.2017;70(2):252-89
Kapadia et al. Protection against embolism during transcatheter aortic valve
replacement. JACC 2017;69:367-77