Transcatheter Aortic Valve Implantation (TAVI): Current ... · Evidence 3. TAVI Learning Curve ....
Transcript of Transcatheter Aortic Valve Implantation (TAVI): Current ... · Evidence 3. TAVI Learning Curve ....
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Transcatheter Aortic Valve Implantation (TAVI):
Current Evidence Davy C. H. Cheng, MD MSc FRCPC FCAHS CCPE
Distinguished University Professor & Chair / Chief
Department of Anesthesia & Perioperative Medicine
Professor, Critical Care Medicine, Department of Medicine
Western University
London, Ontario, Canada
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Department of Anesthesia & Perioperative Medicine www.uwoanesthesia.ca
LHSC (UH-VH) $1.1 Billion
SJHC London $500 Millions
42 OR (3-4 Cardiac OR/d,
1,350 cardiac surgery/yr)
68 ICU beds (14 CSRU)
88 Anesthesia Faculty
20 Fellows
47 Residents
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DISCLOSURE
No Industries Conflict of Interest
Ministry of Health and Long-Term Care AFP
Innovation Fund (MOHLTC)
Canadian Institutes of Health Research
Co-Chair ISMICS Consensus Conferences
Co-Chair ECTS Consensus Conference
Acknowledgement: Janet Martin
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OBJECTIVES
1. Consensus Conference in TAVI
versus SAVR and Medical
Management
2. TAVI Outcomes and Current
Evidence
3. TAVI Learning Curve
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AVR in Octogenarians
Author City n 30 day
Mort. %
Journal (2007-8)
Melby SJ St Louis 245 9 Annals Thorac Surg
Roberts WC Dallas 196 10 Am J Cardiol
Bose AK Newcastle 68 13 J Cardiothorac Surg
Urso S San
Sebastian 100 8 J Heart Valve Dis
Kolh P Liege 220 9 Eur J Cardiothor Surg
Mohr FW Leipzig 282 9.2 Eur J Cardiothor Surg, submitted
Conventional SAVR surgery
is the ‘Gold Standard’
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Surgery was denied in 33% of elderly
patients with severe, symptomatic AS
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Homograft – 1962
Porcine valve, 1965
Pericardial tissue valve, 1969
1950 1960 2002 1970 2004 2005
First CoreValve Transcatheter AVR by
Retrograde Approach
Laborde, Lal, Grube – July 12, 2004
First PVT Transcatheter AVR
by Antegrade Approach
Alain Cribier - 2002
Surgery
Transvascular
Aortic Valve Replacement
2006
First CoreValve Percutaneous AVR
by Retrograde Approach – Oct 12, 2006
Serruys, DeJaegere, Laborde
First Edwards/PVT Transapical
Beating Heart AVR
Webb, Lichtenstein – Nov 29, 2005
2001 2000
First PVT animal
implantation
A. Cribier
First Corevalve
animal implantation
JC. Laborde
2007
PARTNER Trial
First plastic ball
valve - TDA, 1952
Charles Hufnagel
Mechanical aortic valve, 1962
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Transcatheter Aortic Valve
Implantation (TAVI)
8
Trans Femoral approach
Trans Apical
Trans Subclavian
Trans Subclavian
Trans Aorta
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INTERNATIONAL SOCIETY FOR
MINIMALLY INVASIVE
CARDIOTHORACIC SURGERY
ISMICS 2012 EXPERT CONSENSUS PANEL MEMBERS
Paris – April 20-22, 2012 Gregory Fontana, Chair New York, USA
Davy Cheng, Co-Chair London, Canada
Janet Martin London, Canada
Anson Cheung Vancouver, Canada
Todd Dewey Dallas, USA
Gino Gerosa Padova, Italy
John Knight Adelaide, Australia
Francesco Maisano Milano, Italy
Raj Makkar LA, USA
Ganesh Manoharen Belfast
Alan Menkis Winnipeg, Canada
Nicolo Piazza Montreal, Canada
Carlos Ruiz New York, USA
Vinod Thourani Atlanta, USA
Thomas Walther Bad Nauhaim, Germany
Olaf Wendler London, UK
Mat Williams New York, USA
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TAVI vs SAVR CC Objectives
1. TAVI vs SAVR
To assess TAVI (TF and TA) improves
clinical and resource-related outcomes in
AS patients eligible for conventional open
SAVR
2. TAVI vs MM
To assess TAVI (TF) improves clinical and
resource-related outcomes compare with
medical management (MM) in AS patients
ineligible for open SAVR
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N = 179
N = 358 (B)
Inoperable
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 VS
VS
N = 248 N = 104 N = 103 N = 244
The 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 = 699 (A)
High Risk
ASSESSMENT:
Transfemoral
Access
Transapical (TA) Transfemoral (TF)
1:1 Randomization 1:1 Randomization
Yes No
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N Engl J Med 2010;363:1597-1607.
Partner B Trial
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N Engl J Med 2011;364:2187-98.
Partner A Trial
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N Engl J Med 2012 May
Partner B Trial Follow up
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N Engl J Med 2012 May
Partner A Trial Follow up
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Citations Screened:
N = 3630 (up to April 2012)
Potentially Relevant Level A/B
Retrieved:
N = 986 Potentially -relevant Trials
Excluded after Retrieval:
n = 491
Relevant Level A/B studies:
N = 495
Relevant trial Excluded from
after retrieval: n = 335 Included Level A/B studies
N = 44 (3 RCTs, 41 NRCTs)
Non-relevant Trials Excluded
before Retrieval: n = 3136
Meta-Analysis of TAVI: Level A/B
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TAVI vs SAVR
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Group byComparison
Study name Subgroup within study Comparison Outcome Statistics for each study Odds ratio and 95% CI
Odds Lower Upper ratio limit limit p-Value
N Dallas_Dewey 08 MIXED N death, 30d 1.58 0.13 19.12 0.72
N Paris_Descoutures 08 TF N Death, 30d 9.67 0.89 104.82 0.06
N Malaga_CaballeroBorrego 11 TF N death, 30d 0.47 0.05 4.66 0.52
N Catania-Pedara_Tamburino12 MIXED N Death, 30d 1.48 0.74 2.98 0.27
N Vancouver_Higgins11 unmatched TA N death, 30d 6.61 2.47 17.67 0.00
N Pisa_DeCarlo 10 TF N death, 30d 0.54 0.09 3.15 0.49
N Milan-Pisa_Ranucci 10 MIXED N death, 30d 5.71 3.08 10.60 0.00
N Rotterdam-Cali-Bogota_Nuis 12 TF N death, 30d 1.02 0.22 4.67 0.98
N Cleveland_Kapadia 09 vs SAVR MIXED N death, 30d 3.34 0.13 87.52 0.47
N Salzburg_Motloch 12, all MIXED N death, 30d 5.12 0.59 44.74 0.14
N Bern-Rotterdam_Piazza 09 MIXED N death, 30d 4.57 2.17 9.65 0.00
N Bochum_Strauch 12 TA N Death, 30d 1.65 0.50 5.43 0.41
N Bern_Amonn 12 TA N Death, 30d 1.05 0.29 3.76 0.95
N 2.44 1.46 4.07 0.00
RCT STACCATO_Nielson 12 TA RCT Death, 30d 8.11 0.40 163.12 0.17
RCT PARTNER A_Smith 11, all MIXED RCT Death, 30d 0.53 0.26 1.10 0.09
RCT 1.39 0.11 17.66 0.80
Y Hamburg_Conradi 12 MIXED Y Death, 30d 0.85 0.27 2.63 0.77
Y Monzino Milan_Fusari 12, matched MIXED Y Death, 30d 0.13 0.01 2.61 0.18
Y Frankfurt_Zierer 09 TA Y Death, 30d 1.50 0.27 8.28 0.64
Y Milan-Pisa_Guarracino10 TF Y Death, in-hospital 3.22 0.32 32.89 0.32
Y Aachen_Stohr11 MIXED Y Death, 30d 1.70 0.82 3.51 0.15
Y Leipzig_Holzhey12 TA Y death, in hospital 0.76 0.36 1.58 0.46
Y Vancouver_Higgins11, matched TA Y death, 30d 1.58 0.41 6.00 0.51
Y Nord_Steigen 11 MIXED Y Death, 30d 4.57 0.47 44.17 0.19
Y BERMUDA triangle MIXED Y Death, 30d 1.12 0.58 2.17 0.74
Y 1.17 0.83 1.66 0.37
Overall 1.48 1.11 1.97 0.01
0.01 0.1 1 10 100
Lower with TAVI Lower with SAVR
TAVI vs SAVR: All-Cause Mortality at 30 days
I2=61%
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Group byComparison
Study name Subgroup within study Comparison Outcome Statistics for each study Odds ratio and 95% CI
Odds Lower Upper ratio limit limit p-Value
N Dallas_Dewey 08 MIXED N Stroke, 30d 6.24 0.30 130.07 0.24
N Catania-Pedara_Tamburino12 MIXED N CVA 0.83 0.28 2.42 0.73
N Vancouver_Higgins11 unmatched TA N CVA, postop 3.52 0.81 15.31 0.09
N Essen_Kahlert 10, TF TF N stroke/TIA, 30d 0.21 0.01 5.41 0.35
N London SGH_Jahangiri 11 vs SAVR MIXED N stroke/TIA, 30d 4.95 0.54 45.48 0.16
N Salzburg_Motloch 12, all MIXED N stroke, 30d 3.11 0.12 77.37 0.49
N Bochum_Strauch 12 TA N Stroke, 30d 0.28 0.03 2.52 0.25
N Bern_Amonn 12 TA N Stroke, 30d 1.10 0.25 4.80 0.90
N 1.36 0.66 2.80 0.41
RCT STACCATO_Nielson 12 TA RCT stroke, 30d 3.39 0.33 34.27 0.30
RCT PARTNER A_Smith 11, all MIXED RCT Stroke, any, 30d 2.07 0.87 4.89 0.10
RCT 2.19 0.98 4.92 0.06
Y Hamburg_Conradi 12 MIXED Y Stroke, 30d 1.00 0.14 7.27 1.00
Y Leipzig_Holzhey12 TA Y cerebral ischemia, postop 0.56 0.16 1.95 0.36
Y Vancouver_Higgins11, matched TA Y CVA, postop 0.19 0.01 4.10 0.29
Y Nord_Steigen 11 MIXED Y Stroke, 30d 0.32 0.01 8.25 0.49
Y 0.55 0.21 1.43 0.22
Overall 1.28 0.80 2.05 0.30
0.01 0.1 1 10 100
Favours TAVI Favours SAVR
TAVI vs SAVR: Stroke at 30 days
I2=8%
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OUTCOMES: TAVI vs SAVR
SIMILAR INCREASED DECREASED
Mortality Stroke A Fibrillation
MI AR Bld Tx
ARF PPM Reexploration
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Stroke (TA and TF)
Miller et al. J Thorac Cardio Surg 2012: 143: 832-43
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• Major VC were frequent after TF-TAVI in the
PARTNER trial using first-generation devices
and were associated with high mortality.
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N Engl J Med 2012;366:1705-15
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May 2014
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TAVI vs SAVR
TAVI vs SAVR
Outcomes
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TAVI vs Medical Management
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Senile Aortic Valve Stenosis
Medical managed patients – survival
rate (62% 1-yr, 32% 5-yr, 18% 10-yr).
It is worse in the presence of
advanced age, LV dysfunction, heart
failure, and renal failure
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A Tradeoff between Stroke and Death “For every 100 patients treated with TAVI instead of
medical mgt, there will be 20 additional survivors at 1 year, but at a cost of 6 more stroke/TIAs …”
↑ 6 strokes/TIAs ↓ 20 deaths ↑ 33 symptom-free survival
↓ 6 stroke/TIA ↑ 20 deaths ↓ 33 symptom-free survival
MM (+/-BAV)
TAVI
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Cost-Effectiveness Analysis at LHSC
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Incremental Cost-Effectiveness Ratio of TAVI vs Medical Management?
COST QALY ICER
TAVI $192,639 4.48
$ 38,448 ($32,000 - 44,000)
STD CARE $ 78,837 1.52
ICER = ∆C/ ∆E = ($192,639 - $78,837) = $38,448/QALY
(4.48 – 1.52)
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ISMICS Recommendation:
TAVI vs MM
• In severe AS patients who are
ineligible for SAVR, it is
reasonable to perform TAVI. The
choice between TAVI and MM
involves a trade off between the
increased risk of stroke with
TAVI vs improved 1 yr survival,
clinical status and resource
utilization. [Class IIa, level B]
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TAVI vs MM
TAVI vs MM
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Learning Curve & Death at 30d
Within increasing experience, 30-day all-cause mortality declines
(p=0.00016)
Regression of Experience on Logit event rate
Experience
Lo
git
ev
en
t ra
te
-29.00 9.40 47.80 86.20 124.60 163.00 201.40 239.80 278.20 316.60 355.00
0.80
0.12
-0.56
-1.24
-1.92
-2.60
-3.28
-3.96
-4.64
-5.32
-6.00
Martin J, Chu M, Cheng D, et al 2012
50 75 5 25 100 125 150 125 175 200 225 250 275 300 400
p=0.00016
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Take Home Messages
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TAVI: LHSC Hybrid Operating Room (with Fluoroscopy )
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LHSC: TAVI (Total 168, May 2015)
TransFemoral 92 – Core Valves (Medtronic)
TransApical 55 – Sapiens (Edwards),
Accurate TA valves (Symetis), Engagers
(Medtronic)
Direct Aortic 19 - Core Valves (Medtronic)
TransAxillary 2 – Core Valves (Medtronic)
Total mortality : 8.9%
LOS in Hospital 7.1± 6.2
47
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TAVI vs SAVR
TAVI vs SAVR
Outcomes
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TAVI vs MM
TAVI vs MM
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Slide Title Goes Here