Post on 10-Jun-2020
TAVI VS. OFFENER KLAPPENERSATZ: PRO
Berner Tage der Klinik
8 -11. November 2017, Bern, Switzerland
Stephan Windecker
Department of Cardiology
Swiss Cardiovascular Center
Bern University Hospital, Switzerland
10 YEARS OF TAVI - FIRST TAVI PROCEDURE IN
SWITZERLAND, INSELSPITAL, BERN – AUGUST 2007
THE SWISS TAVI REGISTRY CTU BERN
0
50
100
150
200
250
300
350 2013-2014 2014-2015 2015-2016
1197
2087
3309
4756
0
1000
2000
3000
4000
5000
6000
2013 2014 2015 2016
TOTAL NUMBER OF PROCEDURES
(2013-2016)
NUMBER OF PROCEDURES
BY SITES
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TAVI superior to medical Rx
TAVI noninferior or superior to SAVR
TAVI noninferior or superior
(TF access) to SAVR
THE EVOLUTION OF CLINICAL EVIDENCE
TIME (MONTHS)
TAVI VS. CONSERVATIVE TREATMENT: INOPERABLE-EXTREME PATIENTS
PARTNER 1B: 5-Year Follow-up
CoreValve Extreme-Risk: 2-Year Follow-up
TIME (MONTHS)
Kapadia SR et al. Lancet 2015 Yakubov SJ et al. J Am Coll Cardiol 2015
All-Cause Mortality N=358 N=489
93.6%
71.8%
Number Need to Treat= 4 (2-year); 5 (5-year)
TAVI VS. SAVR: HIGH-RISK PATIENTS
TIME (MONTHS) TIME (MONTHS)
Mack MJ et al. Lancet 2015 Deeb M et al. J Am Coll Cardiol 2016
PARTNER 1A: 5-Year Follow-up
CoreValve High-Risk: 3-Year Follow-up
N=699
All-cause Mortality All-cause Mortality
62.4%
67.8%
N=797
N=1,746
TAVI VS. SAVR: INTERMEDIATE-RISK PATIENTS
TIME (MONTHS) TIME (MONTHS)
PARTNER 2A - Edwards SURTAVI - CoreValve
N=699
All-cause Mortality
62.4%
67.8% N=1746
Leon MB et al. N Engl J Med 2016 Reardon MJ et al. NEJM 2017
PARTNER 1A
US CoreValve
NOTION
PARTNER 2A
116/348 114/351
85/391 99/359
11/145 14/135
166/1011 170/1021
0.90 (0.71-1.15)
0.79 (0.61-1.01)
0.72 (0.33-1.59)
0.92 (0.74-1.13)
0.87 (0.76-0.99), P=0.038 Overall
Trial TAVR SAVR HR (95% CI)
All-cause Mortality at 2 years 4 randomized trials (N =3,806)
TAVI VS. SAVR
Subgroup Trials τ2 HR (95% CI) P-inter
Siontis et al. Eur Heart J. 2016 Dec 14;37(47):3503-3512
PROCEDURE
EARLY PERI-PROCEDURE
-50
-40 -40
-60
-40
-20
0
ATRIAL FIBRILLATION
MAJOR BLEEDING
RENAL FAILURE
MORTA
L I T
Y
-20%
OPEN THORACOTOMY CARDIOPULMONARY BYPASS OROTRACHEAL INTUBATION
GENERAL ANESTHESIA PROLONGED VENTILATION
TAVI vs. SAVR
ADVANTAGES OF TRANSCATHETER VS. SURGICAL AORTIC VALVE INTERVENTIONS
VALVE INSERTION: EDWARDS SAPIEN 3
IMPLANTATION SEQUENCE
VALVE IMPLANTATION RESULT
IMPLANTATION SEQUENCE
ACCESS SITE CLOSURE
IMPLANTATION SEQUENCE
STRATEGIES TO MITIGATE
PARAVALVULAR REGURGITATION
Advanced sealing: External Wrap
Internal skirts, external cuffs, sleeves
Imaging Tools:
Device Selection
Repositionability:
Partial or Full
95 99
5 1
0%
20%
40%
60%
80%
100%
EdwardsSAPIEN XT
EdwardsSAPIEN 3
moderate/severe AR
no/mild AR
p=0.04
N=598
Binder RK et al, Circ Cardiovasc Interv 2015
90 92
10 8
0%
20%
40%
60%
80%
100%
MedtronicCoreValve
MedtronicEvolut R
p=ns
N=995
Noble S et al, EuroIntervention 2017
BALLOON-EXPANDABLE SELF-EXPANDING
PARAVALVULAR REGURGITATION WITH EARLY AND
NEWER GENERATION TAVI PROSTHESES
TAVI VS. SAVR ECHOCARDIOGRAPHIC OUTCOMES
MEAN AORTIC VALVE AREA AND TRANSVALVULAR GRADIENT
Leon MB et al. N Engl J Med 2016;374:1609-1620
PARTNER 2A SURTAVI
Reardon MJ et al, N Engl J Med. 2017 Jul 13;377(2):197-198
PARTNER 1A
US CoreValve
NOTION
PARTNER 2A
116/348 114/351
85/391 99/359
11/145 14/135
166/1011 170/1021
0.90 (0.71-1.15)
0.79 (0.61-1.01)
0.72 (0.33-1.59)
0.92 (0.74-1.13)
0.87 (0.76-0.99), P=0.038 Overall
Trial TAVR SAVR HR (95% CI)
All-cause Mortality at 2 years (N =3,806)
Subgroup Trials τ2 HR (95% CI) P-inter
Siontis et al. Eur Heart J. 2016 Dec 14;37(47):3503-3512
TAVI VS. SAVR:
MORTALITY IN FEMALE PATIENTS
Balloon-expandable THV
Self-expandable THV
Siontis et al Eur Heart J. 2016 Dec 14;37(47):3503-3512
Meta-analysis of RCTs
Comparing TAVI vs. SAVR
PERMANENT PACEMAKER IMPLANTATION
0%
10%
20%
30%
40%
50%
0 6 12 18 24
All-
Cau
se M
ort
alit
y
Months Post-Procedure No. at Risk
PPI Prior to Procedure With New PPI Without New PPI
P-value (log-rank) = 0.32
10.5%
16.3%
10.1%
Reardon MJ et al N Engl J Med. 2017 Apr 6;376:1321-1331
SURTAVI
PROGNOSTIC IMPACT OF PACEMAKER IMPLANTATION
BALLOON-EXPANDABLE TRANSCATHETER AORTIC
VALVES AND PACEMAKER IMPLANTATION
PARTNER 2A
8.5
9.9
6.9
8.9
0
5
10
15
30-day 1-year
TAVI SAVR
%
P=0.17 P=0.43
Leon MB et al. N Engl J Med 2016
COREVALVE NOTION TRIAL:
LONG-TERM HEMODYNAMIC DATA Søndergaard L, EuroPCR 2017
TAVI SAVR
TAVI VS. SAVR:
TOTAL COSTS
Presented by Cohen D at TCT 2017
0
20000
40000
60000
80000
100000
120000
140000
SAVR XT-TAVR
Follow-up
Index Hosp
0
20000
40000
60000
80000
100000
120000
140000
SAVR S3-TAVR
PARTNER 2A- 2-YEAR SAPIEN 3 IR- 1-YEAR
$ 114,132
$ 55,857
$ 58,545
$ 107,716
$ 46,284
$ 61,433
$ 96,489
$ 38,238
$ 58,250
$ 80,977
$ 26,861
$ 54,117
∆= $ 6,416 (p= 0.014)
∆= $ 15,511 (p<0.001)
Valve costs based on current acquisition costs: TAVI $ 32,500, SAVR $ 5,000
TAVI VS. SAVR:
COST-EFFECTIVENESS @ 2 YEARS
Presented by Cohen D at TCT 2017
PARTNER 2A SAPIEN 3 IR
WILL TAVI REPLACE SURGERY? TAVI HAS THE POTENTIAL TO BECOME A PROCEDURE FOR (NEALRY) ALL PATIENTS WITH AORTIC STENOSIS
SAVR
TAVI
PATIENT – PROSTHESIS MISMATCH
NEW-ONSET AFIB
SAVR
TAVI
STROKE SAVR
TAVI
INVASIVENESS SAVR
TAVI
PACEMAKER SAVR
TAVI
COST EFFECTIVENESS
SAVR
TAVI
AORTIC REGURGITATION
SAVR
TAVI
SIMILAR OR LOWER RISK
NEW GENERATION TAVI DEVICES
BALLOON-EXPANDABLE DEVICES LOWER RISK IN LOW RISK PATIENTS
TAVI=Transcatheter aortic-valve implantation. New York Times. Building a Better Valve (June 20, 2015). Available from http://www.nytimes.com/2015/06/22/health/heart-failure-aortic-valve-disease-tavr.html?_r=0 (Accessed October 2015).
TAVI
Henry Kissinger, 92, the former secretary of state, has had the procedure (TAVI).
“I was getting out of breath more easily, and my cardiologist said something had to
happen,” he said in a telephone interview. “He said I would be in a wheelchair if I didn’t
have it, and my survival rate in a year would be only 50–50.”
“I am more energetic, people tell me I look better, and I feel much less tired,” Mr. Kissinger
said. He described the procedure as easier and less debilitating than the open-heart
bypass surgery he had previously. “There’s no comparison.”