Role of TAVR in Low and Intermediate Risk Patient
Transcript of Role of TAVR in Low and Intermediate Risk Patient
Role of TAVR in Low and Intermediate RiskRole of TAVR in Low and Intermediate RiskPatient
Michael Mack, M.D.
Baylor Scott & White HealthBaylor Scott & White Health
Dallas, TX
Conflict of Interest DisclosureConflict of Interest Disclosure
Co- PI of COAPT Trial of Abbott VascularCo- PI of COAPT Trial of Abbott Vascular
Steering Committee Intrepid Trial of Medtronic
Co-PI of the PARTNER 3 Trial of Edwards Lifesciences
T rial R isk T otal T AVR S AVR
• Partner 1B Inoperable 358 179 179 (Med)• Partner 1B Inoperable 358 179 179 (Med)
• Partner 1A High 699 348 351
• Corevalve High 795 394 401• CorevalveHR
High 795 394 401
• Partner 2A Intermediate 2032 1011 1021
• SURTAVI Intermediate 1800
• Partner 3 Low 1228
• EvolutR-LR Low 1200
4
• T otal 6884
5
T rial R isk O utcom e
• Partner 1B• CoreValve
Extreme Risk
Inoperable TAVR > MedicalTherapy
Extreme Risk
• Partner 1A• CoreValve High
Risk
High Risk TAVR=SAVR
Risk
• Partner 2A• SURTAVI
Intermediate Risk TAVR=SAVR• SURTAVI
• Partner 3• Corevalve EvolutR
Low Risk TAVR vs. SAVR
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• Corevalve EvolutR
80%
100%
60%
80%
20%
40%
0%
20%
20
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Femoral Transapical Transaortic Other
S ource: S T S /ACC T VT R egistry DatabaseasofO ct18,2016
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TVT SitesJan 2012-Sept 2016
TVT SitesJan 2012-Sept 2016
400
476
450
500
252
348
400
250
300
350
400
156
50
100
150
200
0
2012 2013 2014 2015 YT D 2016
S ource: S T S /ACC T VT R egistry DatabaseasofS ept2016S ource: S T S /ACC T VT R egistry DatabaseasofS ept2016
TAVR Centers in USTAVR Centers in US
476Centers
Alaska: 1Hawaii: 1
TAVR Patients in the TVT RegistryTAVR Patients in the TVT Registry
40000
Total ~75,000 Patients
26121
35000
25000
30000
35000
9171
16359
15000
20000
25000
4601
9171
0
5000
10000
2012 2013 2014 2015 Est20162012 2013 2014 2015 Est2016
S ource: S T S /ACC T VT R egistry DatabaseasofA ug2016
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The PARTNER 3 TrialThe PARTNER 3 TrialStudy DesignStudy DesignStudy DesignStudy Design
Symptomatic Severe Calcific Aortic Stenosis
Low Risk ASSESSMENT by Heart TeamLow Risk ASSESSMENT by Heart Team(STS < 4(STS < 4%, TF only)%, TF only)
Low Risk ASSESSMENT by Heart TeamLow Risk ASSESSMENT by Heart Team(STS < 4(STS < 4%, TF only)%, TF only)
PARTNER 3PARTNER 3RegistriesRegistries
PARTNER 3PARTNER 3RegistriesRegistries
1:1 Randomization(n=1,228)
1:1 Randomization(n=1,228)
TF - TAVRTF - TAVR SurgerySurgery
Alternative Access(n=100)
(TA/TAo/Subclavian)
Alternative Access(n=100)
(TA/TAo/Subclavian)TF - TAVR(SAPIEN 3)TF - TAVR(SAPIEN 3)
Surgery(Bioprosthetic Valve)
Surgery(Bioprosthetic Valve)
CT Imaging Sub-Study (n=200)CT Imaging Sub-Study (n=200)
Bicuspid Valves(n=50)
Bicuspid Valves(n=50)
SAVR orTAVR ViV(n=100/25)
SAVR orTAVR ViV(n=100/25)
Actigraphy/QoL Sub-StudyActigraphy/QoL Sub-Study
CT Imaging Sub-Study (n=200)CT Imaging Sub-Study (n=200)
Actigraphy/QoL Sub-StudyActigraphy/QoL Sub-Study
PRIMARY ENDPOINT:PRIMARY ENDPOINT:Composite of allComposite of all--cause mortality, allcause mortality, all strokes,strokes,or reor re--hospitalization at 1 yearhospitalization at 1 year postpost--procedureprocedure
PRIMARY ENDPOINT:PRIMARY ENDPOINT:Composite of allComposite of all--cause mortality, allcause mortality, all strokes,strokes,or reor re--hospitalization at 1 yearhospitalization at 1 year postpost--procedureprocedure
(n=100/25)(n=100/25)
Mitral ViV or ViR(n=50/50)
Mitral ViV or ViR(n=50/50)
Follow-up: 30 days, 6 mos, 1 year and annually through 10 yearsFollow-up: 30 days, 6 mos, 1 year and annually through 10 years
or reor re--hospitalization at 1 yearhospitalization at 1 year postpost--procedureprocedureor reor re--hospitalization at 1 yearhospitalization at 1 year postpost--procedureprocedure
Current Issues About TAVR in Low Risk PatientsCurrent Issues About TAVR in Low Risk Patients
StrokeStroke
Paravalvular Leak
New PacemakerNew Pacemaker
Durability
Leaflet Immobility/Valve Thrombosis
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All Strokes at 30 DaysAll Strokes at 30 DaysEdwards SAPIEN ValvesEdwards SAPIEN Valves
PARTNER I and II TrialsPARTNER I and II Trials
Neurologist evaluations (pre- and post)
SAPIENSAPIEN XT SAPIEN 3
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Primary Endpoint Events (ITT)Primary Endpoint Events (ITT)At 30 Days and 2At 30 Days and 2 YearsYears
Events (%)Events (%)30 Days30 Days 2 Years2 Years
TAVRTAVR SurgerySurgerypp--value*value*
TAVRTAVR SurgerySurgerypp--value*value*
At 30 Days and 2At 30 Days and 2 YearsYears
TAVRTAVR(n = 1011)(n = 1011)
SurgerySurgery(n = 1021)(n = 1021)
pp--value*value*TAVRTAVR
(n = 1011)(n = 1011)SurgerySurgery
(n = 1021)(n = 1021)pp--value*value*
Death (all-cause)and Stroke (disabling)
6.1 8.0 0.11 19.3 21.1 0.33
DeathDeath
All-cause 3.9 4.1 0.78 16.7 18.0 0.45
Cardiovascular 3.3 3.2 0.92 10.1 11.3 0.38Cardiovascular 3.3 3.2 0.92 10.1 11.3 0.38
Neurological Events
All Stroke 5.5 6.1 0.57 9.5 8.9 0.67
Disabling Stroke 3.2 4.3 0.20 6.2 6.4 0.83
TIA 0.9 0.4 0.17 3.7 2.3 0.09
*Event rates are KM estimates, p-values are point in time
T riGuardEm bolicDeflectionDevice(KeystoneHeart)1
S entinelCerebralP rotectionS ystem (ClaretM edical)2
Em brellaEm bolicDeflectorS ystem (Edw ards
L ifesciences)3
US TrialEnrolling
US Trial CompleteFDA Panel
On the ShelfEnrolling FDA Panel
On the Shelf
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Moderate/Severe PVL at 30 DaysModerate/Severe PVL at 30 DaysEdwards SAPIEN ValvesEdwards SAPIEN Valves
PARTNER I and II TrialsPARTNER I and II Trials
SAPIENSAPIEN
XTSAPIEN 3
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Other Clinical Endpoints (ITT)Other Clinical Endpoints (ITT)At 30 Days and 2At 30 Days and 2 YearsYears
Events (%)Events (%)30 Days30 Days 2 Years2 Years
TAVRTAVR SurgerySurgerypp--value*value*
TAVRTAVR SurgerySurgerypp--value*value*
At 30 Days and 2At 30 Days and 2 YearsYears
TAVRTAVR(n = 1011)(n = 1011)
SurgerySurgery(n = 1021)(n = 1021)
pp--value*value*TAVRTAVR
(n = 1011)(n = 1011)SurgerySurgery
(n = 1021)(n = 1021)pp--value*value*
RehospitalizationRehospitalization 6.5 6.5 0.99 19.6 17.3 0.22
MIMI 1.2 1.9 0.22 3.6 4.1 0.56MIMI 1.2 1.9 0.22 3.6 4.1 0.56
Major VascularMajor VascularComplicationsComplications
7.9 5.0 0.008 8.6 5.5 0.006
LifeLife--Threatening /Threatening /Disabling BleedingDisabling Bleeding
10.4 43.4 <0.001 17.3 47.0 <0.001Disabling BleedingDisabling Bleeding
10.4 43.4 <0.001 17.3 47.0 <0.001
AKI (Stage III)AKI (Stage III) 1.3 3.1 0.006 3.8 6.2 0.02
New Atrial FibrillationNew Atrial Fibrillation 9.1 26.4 <0.001 11.3 27.3 <0.001
New PermanentNew PermanentPacemakerPacemaker
8.5 6.9 0.17 11.8 10.3 0.29
ReRe--interventionintervention 0.4 0.0 0.05 1.4 0.6 0.09
EndocarditisEndocarditis 0.0 0.0 NA 1.2 0.7 0.22EndocarditisEndocarditis 0.0 0.0 NA 1.2 0.7 0.22
*Event rates are KM estimates, p-values are point in time
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The PARTNER 3 TrialThe PARTNER 3 TrialStudy DesignStudy DesignStudy DesignStudy Design
Symptomatic Severe Calcific Aortic Stenosis
Low Risk ASSESSMENT by Heart TeamLow Risk ASSESSMENT by Heart Team(STS < 4(STS < 4%, TF only)%, TF only)
Low Risk ASSESSMENT by Heart TeamLow Risk ASSESSMENT by Heart Team(STS < 4(STS < 4%, TF only)%, TF only)
PARTNER 3PARTNER 3RegistriesRegistries
PARTNER 3PARTNER 3RegistriesRegistries
1:1 Randomization(n=1,228)
1:1 Randomization(n=1,228)
TF - TAVRTF - TAVR SurgerySurgery
Alternative Access(n=100)
(TA/TAo/Subclavian)
Alternative Access(n=100)
(TA/TAo/Subclavian)TF - TAVR(SAPIEN 3)TF - TAVR(SAPIEN 3)
Surgery(Bioprosthetic Valve)
Surgery(Bioprosthetic Valve)
CT Imaging Sub-Study (n=200)CT Imaging Sub-Study (n=200)
Bicuspid Valves(n=50)
Bicuspid Valves(n=50)
SAVR orTAVR ViV(n=100/25)
SAVR orTAVR ViV(n=100/25)
Actigraphy/QoL Sub-StudyActigraphy/QoL Sub-Study
CT Imaging Sub-Study (n=200)CT Imaging Sub-Study (n=200)
Actigraphy/QoL Sub-StudyActigraphy/QoL Sub-Study
PRIMARY ENDPOINT:PRIMARY ENDPOINT:Composite of allComposite of all--cause mortality, allcause mortality, all strokes,strokes,or reor re--hospitalization at 1 yearhospitalization at 1 year postpost--procedureprocedure
PRIMARY ENDPOINT:PRIMARY ENDPOINT:Composite of allComposite of all--cause mortality, allcause mortality, all strokes,strokes,or reor re--hospitalization at 1 yearhospitalization at 1 year postpost--procedureprocedure
(n=100/25)(n=100/25)
Mitral ViV or ViR(n=50/50)
Mitral ViV or ViR(n=50/50)
Follow-up: 30 days, 6 mos, 1 year and annually through 10 yearsFollow-up: 30 days, 6 mos, 1 year and annually through 10 years
or reor re--hospitalization at 1 yearhospitalization at 1 year postpost--procedureprocedureor reor re--hospitalization at 1 yearhospitalization at 1 year postpost--procedureprocedure
30 days Post TAVRAsymptomatic
Change Mean Gradient - 12
30 Days Post Coumadin
Change Mean Gradient - 12
405/460 (88%) 4D CT
JACC Online
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JACC Online
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4.69.190%
100%
4.69.1
16.322.4
35
60%
70%
80%
90%
28.830.6
29.8 29.429
30%
40%
50%
60%
29.429
0%
10%
20%
2012 2013 2014 2015 20162012 2013 2014 2015 2016
SAVR TAVR
4.69.190%
100%
4.69.1
16.322.4
34 40 45 55 6560%
70%
80%
90%
28.830.6
29.8 29.429
30%
40%
50%
60%
29.429 27 25 25 25
0%
10%
20%
2012 2013 2014 2015 2016 2017 2018 2019 20202012 2013 2014 2015 2016 2017 2018 2019 2020
SAVR TAVR
The TAVR train has left the station on the way to Low Risk
TAVR is not real surgeryTAVR is not real surgery
Bruce Lytle MD
TMVRTMVR
The decline of big case surgerybegan before we startedtraining, it was always atraining, it was always aproduct of the age in which itdeveloped and that age haspassed, and it will decline
Vince Gaudiani MD
Big Case SurgeryBig Case Surgery
Whipple ProceduresRadical MastectomyOpen AAAOpen AAAOpen Esophagectomy