Embed Size (px)
Citation preview
SAVR in the Era of TAVR
Vinod H. Thourani, MD
Bernie Marcus Chief of Cardiovascular Surgery
Marcus Heart and Vascular Center and Valve Center
Piedmont Heart Institute
Atlanta, GA, USA
PAR Annual Course
Athens, GA
February, 2020
Disclosures
• Abbott Vascular
– National Co-PI: Mitral in MAC Arm (SUMMIT trial)
– Advisor, Research
• Boston Scientific
– National Co-PI: REPRISE IV trial
– Steering Committee: ACURATE trial
– Advisor, Research
• Cryolife
– Executive Committee, PROACT X trial
• Edwards Lifesciences
– National Co-PI: CLASP IIF
– National PI: Harpoon Trial
• Gore Vascular
– Advisory board
• JenaValve
– Advisory Board
– National Co-PI: EFS trial
4,6668,946
16,301
24,819
38,276
51,303
59,293
255 499 1318 2358 3153 3732
0
10,000
20,000
30,000
40,000
50,000
60,000
70,000
2012 2013 2014 2015 2016 2017 2018
TVT Registry Datamart Data as of 6/6/19
TVT RegistryTAVR and TAVR ViV Procedures
SAVR and TAVR Volumes
29,829 30,275
28,67926,032
25,274
16,308
24,820
38,240
51,271
59,527
51,717
18385 18103 1758515781 15855
2565 2560724
2485 26700
10,000
20,000
30,000
40,000
50,000
60,000
70,000
2014 2015 2016 2017 2018 2019 Q1-3
SAVR TAVR AVR/CABG AVR/MVR
TAVRMedian LOS in Days
(25th and 75th percentiles)10 10
9
8
6
5
44 4 4
3
2 2 2
67
6
4
32
2
0
2
4
6
8
10
12
2012 2013 2014 2015 2016 2017 2018 Q1
TAVR MortalityIn-Hospital, 30 Day, and One Year Mortality
5.7%5.2% 4.1%
2.9% 2% 1.7% 1.6%
7.5% 7%6%
4.4%3.2% 2.9% 2.8%
26.4%
21.8% 21.6%
18.2%
15.3%13.9%
0%
5%
10%
15%
20%
25%
30%
2012 2013 2014 2015 2016 2017 2018 Q1
In Hospital 30 Day 1yr (CMS linked data)
TAVR StrokeIn-Hospital, 30 Day, and One Year Stroke
2.2%2.0% 2.2% 2.0%
1.8% 1.8% 1.8%
2.8% 2.7% 2.8%2.5% 2.4% 2.5% 2.5%
3.9% 3.9%4.2% 4.3% 4.2%
3.9%
0.0%
0.5%
1.0%
1.5%
2.0%
2.5%
3.0%
3.5%
4.0%
4.5%
5.0%
2012 2013 2014 2015 2016 2017 2018 Q1
In Hospital 30 Day One Yr CMS linked
TAVRNew (No PPM pre TAVR)
In Hospital and 30 Day Pacemaker
9.1%
12.9% 13.2%
11.0%
9.9% 9.6%
10.9%
14.8% 15.0%
13.0%12.1% 12.4%
0%
2%
4%
6%
8%
10%
12%
14%
16%
2013 2014 2015 2016 2017 2018 Q1In Hospital Pacemaker 30 Day Pacemaker
TAVR Guidelines (2017)The New AHA/ACC Focused Update
nn
nn
Primary Endpoint
0 3 6 9 12
496 475 467 462 456454 408 390 381 377
Number at risk:
TAVRSurgery
Months after Procedure
451374
TAVRSurgery
Psuperiority= 0.001
HR [95% CI] =
0.54 [0.37, 0.79]
Death
, S
troke, or
Rehosp
(%)
Pnon-inferiority< 0.001
Upper 95% CI of
risk diff = -2.5%
8.5%9.3%
15.1%
4.2%
0
10
20
All StrokeA
ll S
troke (
%)
491 491 489 487454 435 427 423 421
484417
Months from ProcedureNumber at risk:
HR [95% CI] =
0.38 [0.15, 1.00]
496TAVRSurgery
1.2%
2.4% 3.1%
P = 0.04
0
10
20
0.6%0 3 6 9 12
TAVRSurgery
15
0%
2%
4%
6%
8%
10%
0 1 2 3 4 5 6 7 8 9 10 11 12
TAVR
SAVR
Dea
th o
r D
isab
ling
Stro
ke (
%)
Months
30 Days 2.50.7
1 Year4.6 2.7
No. at risk
TAVR 725 718 648 435
SAVR 678 656 576 366
K-M All-Cause Mortality or Disabling Stroke at 1 Year
Log-rank P = 0.065
0%
2%
4%
6%
0 1 2 3 4 5 6 7 8 9 10 11 12
K-M Disabling Stroke at 1 Year
Log-rank P = 0.024
No. at risk
TAVR 725 720 648 435
SAVR 678 656 576 366
Months
Dis
ablin
g St
roke
(%
)
1 Year
2.30.7
Low-Risk Trials: TBD
• Low risk TAVR RCTs did not include young
or BAV patients
• More data is required on:
• TAVR in BAV
• Long-term effects of pacemaker / LBB
• Long-term effects of mild AI
• Consequences of leaflet thrombosis
• TAVR durability
Excellent SAVR Outcomes in
Low Risk AS Patients: STS Database
80% of patients low risk (STS score < 4%)
Thourani et al, Ann Thorac Surg, 2015;99:55-61
Obstacles to TAVR Expansion
• Anatomical Obstacles
–Bicuspid
–LVOT calcium
• Durability / Thrombus
• Conducting system injury
• Paravalvular regurgitation
• Cost
Bicuspid AV Patients!
Courtesy of Joerg Kempfert
Anatomical Differences
for TAVR vs SAVR
The PARTNER 2A TrialStudy Design
Primary Endpoint: All-Cause Mortality or Disabling Stroke at 2 Years
Randomized Patients
n = 2,032Enrollment Dates: Dec. 2011 – Nov. 2013
Symptomatic Severe Aortic Stenosis
ASSESSMENT by Heart Valve Team
Operable (STS ≥ 4%)
TF TAVR
(n = 775)
Surgical AVR
(n = 775)VS.
ASSESSMENT:
Transfemoral Access
1:1 Randomization (n = 1,550)
Yes No
Transfemoral (TF)
TA/TAo TAVR
(n = 236)
Surgical AVR
(n = 246)VS.
1:1 Randomization (n = 482)
Transapical (TA) / TransAortic
(TAo)
0
0.5
1
1.5
2
Baseline 30 Days 1 Year 2 Years 3 Years 4 Years 5 Years
Ao
rtic
Va
lve
Are
a (
cm
2)
899 827 695 572 365 289861 726 590 490 349 259
No. of Echos:
TAVRSurgery
468413
1.67
1.47
1.57
1.42
1.54
1.40
1.54
1.39 1.36
1.48 1.50
1.37
0.700.70
P = 0.001
TAVR
Surgery
Mean ± SE
Aortic Valve Area
VI Population
Thourani, TCT, 2019
0
10
20
30
40
50
Baseline 30 Days 1 Year 2 Years 3 Years 4 Years 5 Years
45.0
44.7
P = 0.23
9.7
10.9 11.5
10.7
11.7
10.8
11.7
10.8
11.4
11.2 10.8
11.4
No. of Echos:
TAVRSurgery
959916
890788
751633
633538
522453
405377
323288
TAVR
Surgery
Mean ± SE
Me
an
Gra
die
nt (m
mH
g)
Mean Aortic Valve Gradient
VI Population
n (%)TAVR
(n = 21)
Surgery
(n = 5)
Reasons for Re-intervention*
Stenosis 10 (48) 0
Regurgitation 11 (52)* 1 (20)
Endocarditis 0 4 (80)
Treatment modality
Repeat TAVR (TAVR-in-TAVR) 17 (81) 0
Valvuloplasty 1 (5) 0
Surgery 3 (14) 5 (100)
In-Hospital Mortality 1 (5) 3 (60)
Aortic Valve Re-intervention
Incidence and Details
*TAVR cohort: 9/10 stenosis cases and 2/11 regurgitation cases were due to SVD. In the SAVR cohort, 1 case of
regurgitation was due to SVD.
P = 0.003
HR: 3.93 [95% CI: 1.48, 10.43]
99.496.8
Fre
ed
om
fro
m R
e-i
nte
rve
nti
on
(%
)
0
25
50
75
100
Months0 12 24 36 48 60
1,011 860 805 699 591 3121,021 802 730 651 565 301
No. at risk:
TAVRSurgery
TAVR
Surgery
Freedom from Aortic Valve Re-intervention
ITT Population
Mod/Severe
Mild
None or trace
0
20
40
60
80
100
TAVR Surgery TAVR Surgery TAVR Surgery
30 Days 2 Years 5 Years
3.8
22.5
0.52.8 8.2
26.9
0.63.5 6.5
26.8
0.45.9
Pa
tie
nts
(%
)
872 609 310757 516 272
73.7
96.7
64.9
95.9
66.8
93.8
No. of Echos:
Paravalvular Regurgitation
VI PopulationP < 0.001 TAVR vs SAVR in all PVR categories at all FU times
Death From Any Cause by PVR Severity
VI TAVR Population
Overall Log-Rank P < 0.001
Mild vs none-trace
P = 0.07
Mild vs mod-severe
P = 0.007
41.1
48.7
64.8
De
ath
(%
)
0
20
40
60
80
Months0 12 24 36 48 60
643 592 557 495 427 225
196 178 170 143 120 6333 25 20 16 11 5
No. at risk:None-trace
MildMod-severe
HR: 0.87 [95% CI: 0.62, 1.22] HR: 1.11 [95% CI: 0.87, 1.42]
12.4
13.9
32.428.9
No. at risk:
De
ath
or
Dis
ab
ling
Str
oke
(%
)
Months
TAVR TF (none-trace PAR)
Surgery TF (none-trace PAR)
0
20
40
60
80
0 12 24 36 48 60
Primary Endpoint: 2-Yr Landmark Analysis
VI TF Population with None-Trace PAR
TAVRSurgery
Months
494 451 437 392 335 174555 491 469 413 359 191
Flow Stagnation / Leaflet Thrombosis
Post-TAVR
Midha et al, Circulation 2017;136:1598-1609
JAMA Network Open 2018
Scenarios That May Require SAVR
• High risk for PVR (calcium in LVOT) or root
rupture
• Bicuspid valve and low risk with or without enlarged
aortic root
• Enlarged root (>4.5 cm or >5.5 cm) requiring
replacement
• Very young pts who want mechanical valves
• Aortic annulus area > 750mm
• Predominantly AI and very little AS
• Short annulus to STJ and worried about root
rupture
• Low coronaries although usually ok if root large
enough
Shared decision making is not
patient education or informed consent
Patient Provider
1. Knowledge transfer
2. Patient preferences
3. Deliberation / consensus
Charles, Whelan, et al. 1999 Soc Sci Med
Conclusions
The growth in TAVR in the US has been
predominantly in intermediate-risk patients
Growth in the next 5 years will most likely be in the
low-risk population
Heart team decision-making should continue utilize
anatomic criteria for optimal patient outcomes
regardless for the procedure type (SAVR or TAVR)
In younger patients, more emphasis should be placed
on the most optimal procedure for long-term success
Share-decision making should be a mainstay of the
discussion with patients
