the expansion of tavi patient indications. is open avr ......salus (stopped) portico ide medtronic...
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Robert C. Welsh, MD, FRCPCProfessor of Medicine, University of Alberta
Zone Clinical Department Head, Cardiac Sciences
The Expansion of TAVI Patient Indications.Is Open AVR Soon To Be Replaced?
Inspiring Innovation and KnowledgeLeaders in Patient Care
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2010
2011
2012
2013
2014
2015
2016
Published
Upcoming
LowIntermedi
ateHigh Extreme
NOTION
PARTNER 3US Evolut R
LR
PARTNER 2A
SURTAVI
PARTNER 1A
Corevalve US HR
PARTNER 1B
Corevalve US ER
REPRISE 3
Symptomatic AS: SAVR Risk
SALUS (stopped)
PORTICO IDE
Medtronic CoreValve/Evolut R
Edwards Sapien/Sapien XT/S3
Boston Lotus
Direct Flow Medical Direct Flow
Abbott Vascular Portico
PARTNER 2 S3i
UK TAVI
Any available TAVR system
2017
2018
2019
2017
REBOOT
CHOICE
PARTNER 2 S3
Investigational devices
SOLVE-TAV
Pipeline of TAVR trials across the spectrum of
aortic stenosis
SCOPE 1
Symetis Acurate Neo
SCOPE 2
NOTION 22020
2021
AS with no
symptoms
TAVR UNLOAD
EARLY TAVR
PARTNER 2B
RCT, randomised controlled trialCapodanno D, Leon MB. EuroIntervention 2016; 12:Y51–5; Clinicaltrials.gov
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STS Data base
Prohibitive Risk
High RiskIntermediate
RiskLow Risk
Score STS >8% STS 4-8% STS<4%
Percent SAVR 6% 14% 80%
In-hospital Mortality
11.8% 5.1% 1.4%
Strategy TAVI only Option
TAVI Dominant
TAVI Dominant
?TAVI=SAVR
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PARTNER 2A:Adverse events (30 days)
7.9
10.49.1
5.5
8.5
1.3
5
43.4
26.4
6.1 6.9
3.1
0
5
10
15
20
25
30
35
40
45
50
Major Vasc Comp Life ThreateningBleed
New Afib Stroke Pacemaker Acute KidneyInjury
TAVI Column1 SAVR
Leon MB et al. NEJM 2016
P<0.001
P<0.001
P=0.57
P=0.17
P=0.006
P<0.001%
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Events (%) 30 Days 1 Year
TAVR Surgery TAVR Surgery
Death
All-cause 1.1 4.0 7.4 13.0
Cardiovascular 0.9 3.1 4.5 8.1
Neurological Events
Disabling Stroke 1.0 4.4 2.3 5.9
All Stroke 2.7 6.1 4.6 8.2
All-cause Death and Disabling Stroke
2.0 8.0 8.4 16.6
Unadjusted Clinical EventsAt 30 Days and 1 Year (AT)
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What outcomes do you expect with an intermediate STS Score Risk STS score if you receive
open surgical AVR?
In-hospital Outcome Expected risk
Mortality 6.3%
Morbidity or Mortality 36.4%
Risk of long hospitalization 19%
Disability Stroke 2.4%
Prolonged Ventilation 22.3%
Deep Sternal Wound Infection 0.3%
Renal Failure 13.5%
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TAVR Guidelines (2017)The New AHA/ACC Focused Update
ACA, American College of Cardiology; AHA, American Heart AssociationNishimura RA, et al. J Am Coll Cardiol. 2017; 70:252–289
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Nordic Aortic Valve Intervention (NOTION) Trial
Objective:To compare TAVR vs. SAVR in patients ≥ 70 years eligible for surgery
(all-comers population/consecutive recruitment)
Primary outcome:Composite rate of all-cause mortality, stroke or myocardial infarction
at 1 year (VARC II-defined)
Secondary
outcomes:
Safety and efficacy (NYHA), echocardiographic outcomes (VARC II-
defined)
Design: Prospective, multicenter, non-blinded, randomized trial
Enrollment period: December 2009 - April 2013
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ITT TAVR
n=145
ATT TAVR
n=142
Implanted TAVR
n=139
All randomized
N=280
Died prior to
procedure n=3
Crossover
TAVR to SAVR
n=1
Crossover
SAVR to TAVR
n=1
Crossover
TAVR to SAVR
n=3
ITT SAVR
n=135
ATT SAVR
n=134
Implanted SAVR
n=135
Died prior to
procedure n=1
Not implanted
n=2
Trial Flow
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Baseline Characteristics
Characteristic, % or mean ± SDTAVR
n=145
SAVR
n=135p-value
Age (yrs) 79.2 ± 4.9 79.0 ± 4.7 0.71
Male 53.8 52.6 0.84
STS score 2.9 ± 1.6 3.1 ± 1.7 0.30
STS score < 4% 83.4 80.0 0.46
Logistic EuroSCORE I 8.4 ± 4.0 8.9 ± 5.5 0.38
NYHA class III or IV 48.6 45.5 0.61
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All-Cause Mortality, Stroke, or MI
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All-Cause Mortality, Stroke, or MI:STS<4%
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Aortic Valve Performance
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Reflections on TAVR in Symptomatic Low-Risk Severe Aortic Valve Stenosis Patients
Patient factors
1. Age at time of implant
2. Coexisting medical conditions
3. Patient preference
TAVR team factors
1. Experience and outcomes
2. Process of care
Health Economics
1. Health system perspective
2. Patient perspective
Medical and Technical Advances
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Favors TAVI Favors SAVR
Risk of surgical mortality or morbidity ≥ intermediate +
Advanced age, frailty, limited mobility +
Small annulus requiring a small valve +
Longevity unlikely (minimum 2 years) +
Mediastinal anatomy unfavorable for surgery* +
Aortic root anatomy unfavorable for TAVI** +
Advanced atrio-ventricular block, especially RBBB +
Non-femoral access required +
Congenital bicuspid valve +
Risk of coronary obstruction or coronary access concerns +
Concomitant conditions requiring surgery (e.g. multivalve disease) +
Aortic aneurysm or dissection +
Endocarditis +
*Porcelain aorta, prior thoracotomy, patent grafts, hostile root **inadequate or excessive calcification, annulus size out of range, coronary obstruction risk
Conditions that should be considered by a multidisciplinary Heart Team when determining the recommendation for
transcatheter or surgical aortic valve replacement.
Canadian Cardiovascular Society Position Statement for Transcatheter Aortic Valve Implantation (TAVI)
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The VolumeOutcome
Association
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Operator Volumes for TAVI
‘…individual operator experience is paramount to a successful program. Therefore, it is important to preserve adequate exposure as either primary or secondary TAVI operator to a minimum of 50 cases annually’.
Low Volume Medium High Very High
# Cases/Center 0-50 51-100 101-200 >201
# Total Operators (maximum)
2 2 - 3 3-4 4 or more
# Cases per operator(minimum)
25-50 50 50 50
Table 1. Annual Institutional and Operator Requirements based on TAVI Volumes
Canadian Cardiovascular Society Position Statement for Transcatheter Aortic Valve Implantation (TAVI)
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Aortic Valve Replacement Costs
(days) TAVI Mini AVR Open AVRICU LOS 1.9 3.3 2.4
Ward LOS - 6.6 5.5
Total LOS 1.9 9.9 7.9
Mazankowski Alberta Heart Institute – local costs unpublished data
TAVI Mini AVR Open AVR
Age (years) 86.7 - -
YTD Volumes 51 112 14
Med Surg Cost $23 500 $8093 $7735
ICU Cost $2778 $7733 $5385
Ward Cost - $4188 $3490
Total $26 278 $20 014 $16 610
Cost Per Day Datao CVICU: $2,343.40/elapsed Day (BAS)o CCU: $1,462.28/elapsed Day (BAS)o CV Ward: $634.55/elapsed Day (BAS)
*Current fiscal year data.
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Aortic Valve Replacement CostsPatients referred for TAVI
TAVI Mini AVR Open AVR
Age (years) 86.7 77.9 77.0
Med Surg Cost $23 500 $8093 $7735
ICU Cost $2778 $8905 $10309
Ward Cost - $5072 $5584
Total $26 278 $22 070 $23 628
Mazankowski Alberta Heart Institute – local costs unpublished data
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Risk of Thrombotic and Bleeding Events According to Time After Transcatheter Aortic Valve Implantation
Blue dotted line indicates the risk of a cerebrovascular event, red dotted line indicates the risk of bleedingVranckx P, et al. Eur Heart J. 2017 [Epub ahead of print] DOI: 10.1093/eurheartj/ehx390
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Conclusions
Prohibitive Risk
HighRisk
Intermediate Risk
Low Risk
Score STS >8% STS 4-8% STS<4%
Percent SAVR 6% 14% 80%
In-hospital Mortality
11.8% 5.1% 1.4%
Strategy TAVI TAVI Dominant TAVI Dominant ?TAVI=SAVR
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Robert C. Welsh, MD, FRCPCProfessor of Medicine, University of Alberta
Zone Clinical Department Head, Cardiac Sciences
TAVR in Low-Medium Risk Patients with Aortic Stenosis
Inspiring Innovation and KnowledgeLeaders in Patient Care