beispiel haupttitel einer präsentation. arial 48 punkt farbe cd-blau · • is cabg or pci better...
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Prof. Dr. Jürg Grünenfelder
Klinik für Herz- und Gefässchirurgie
UniversitätsSpital Zürich
Update 2012 Herzchirurgie
Themenübersicht
- update Koronarchirurgie
- Syntax 5 Jahre
- Freedom 5 Jahre
- update Klappenchirurgie
- TAVI vs. chirurgische AKE
- transapikal vs. transfemoral
- neue Techniken
Questions
• Is CABG or PCI better for the treatment of
patients with multivessel diesease including LM?
• Are the current ESC/EACTS Guidelines correct?
• Are we sticking to the guidelines?
• What can we surgeons do better?
Probability of 10y event-free survival among patients
in the MASS II-Trial (OMT vs CABG vs PCI)
Hueb W Circulation 2010
MASS II-Trial (OMT vs CABG vs PCI)
Hueb W Circulation 2010
Selection-Bias in historical trials
• Strong patient selection in MVD
(good LVF, no chronic occlusions, no LMS, no
bifurcation lesions), 95% exclusion!!
• Low percentage of 3-VD in all studies (40%)
(2/3 2-VD; good LVF -> known limited value of CABG)
Despite a lack of evidence
extrapolation of results to all
patients with 3-VD
Purpose of SYNTAX
“The SYNTAX randomized trial is an attempt
to provide an evidence base to determine the
best treatment option for patients in a real-
world population seen by the surgeon and the
interventional cardiologist in their daily
practice.“
23 US Sites 62 EU Sites +
SYNTAX Trial Design
TAXUS n=903
PCI n=198
CABG n=1077
CABG n=897
no f/u n=428
5yr f/u n=649
PCI all captured w/
follow up
CABG 2500
750 w/ f/u vs
Total enrollment N=3075
Stratification: LM and Diabetes
Two Registry Arms
Randomized Arms n=1800
Two Registry Arms N=1275
Randomized Arms N=1800
Heart Team (surgeon & interventionalist)
PCI N=198
CABG N=1077
Amenable for only one treatment approach
TAXUS* N=903
CABG N=897
vs
Amenable for both treatment options
Stratification: LM and Diabetes
LM 33.7%
3VD 66.3%
LM 34.6%
3VD 65.4%
SYNTAX 3VD at 4 years
PCI CABG p
All cause death 11.9 7.3 0.01
Cardiac death 7.4 3.8 0.004
Myocardial infarction 9.0 3.3 0.001
Stroke 3.4 2.8 ns
Death/MI/Stroke 18.6 12.6 0.009
Repeat revasc 22.8 10.2 <0.001
MACCE 33.7 21.0 <0.001
Future REvascularization Evaluation in patients
with Diabetes mellitus: Optimal management of
Multivessel disease (FREEDOM Trial)
• Type 1 or 2 DM
• 83% 3-VD
• LM excluded
• SES 51%
Placitaxel 43%
Farkouh ME, NEJM 2012
Freedom Trial: Primary Outcome Death, MI, Stroke
Farkouh ME, NEJM 2012
Freedom Trial: Death
Farkouh ME NEJM 2012
• Comparative effectiveness of CABG and PCI on hard outcomes
remains similar whether PCI is performed without stents, with BMS, or
with DES.
• Mortality has been consistently reduced by CABG, as compared with
PCI, in more than 4000 patients with diabetes who have been
evaluated in 13 clinical trials.
• The results of FREEDOM add to the consistent evidence base
supporting CABG as the preferred strategy for patients with diabetes
and multivessel CAD. The controversy should finally be settled.
Hlatky MA, NEJM 2012
Is non adherance with Guidelines
an exception?
Indications for CABG versus PCI in stable patients with lesions suitable
for both procedures and low predicted surgical mortality
Conclusions: DES use in clinical practice was associated
with a significant overall increase in PCI to treat patients
with class I indications for CABG.
Increasing number of pts with class I indication
for CABG undergoing PCI
*quarterly slope of increase was 2-fold greater in the DES than the DES diffusion
and pre-DES eras. *p = 0.03 versus pre-DES era Frutkin AD, JACC Int 2009
Hannan EL, Circ 2010
16142 catheter lab patients in New York 2005-07
Treatment decision made by cath lab cardiologist
alone in 64%
Conclusion: Patients receive more
recommendations for PCI and fewer indications
for CABG than indicated by ACC/AHA guidelines
Routine non-adherance with guidelines
Hannan EL, Circ 2010
92% of PCI procedures ad hoc (no time for real choice/
genuine consent)
Large variation in % of patients who had indication for
CABG but were recommended PCI (range 4%-91%)
Hannan EL, JACC 2012
Hospital rates for inappropriate PCI procedures
Hannan EL, JACC 2012
0-40%!
What can we surgeons
do better?
Technical recommendations for CABG
DGTHG Statitsics 2011
Total arterial revascularization in Germany
Only 22% in 2011!
Technical recommendations for CABG
OPCAB in Germany
DGTHG Statitsics 2011
Stroke rate in Kyoto-Credo II Study
Shiomi H ESC 2011
No difference in stroke rate (63% OPCAB!)
„… increasing underuse of CABG surgery
between 2001 and 2008 because patients who
would have been optimally treated with CABG
surgery were instead treated with PCI.”
Epstein AJ, JAMA 2011
TAVI in 2012
TAVI penetration rate
TAVI market prediction
Aortic valve replacement in Germany
Isolierte Aortenklappenchirurgie
1994 - 2010
4.9
70
5.1
88
5.4
24
5.2
94
5.3
44
5.3
81
5.2
09
4.6
67
4.4
91
4.1
66
4.0
71
3.4
42
3.2
22
2.8
14
2.5
55
2.1
46
1.8
40
1.7
13
2.2
29
2.6
99
3.1
08
4.4
12
5.5
40
5.9
67
6.8
09
7.5
35
8.3
35
9.2
60
9.6
73
9.6
88
9.7
04
4.8
09
4.0
76
3.5
41
2,0%
1,5%
3,7%
3,2% 3,3%2,9%
2,6%2,5%2,5%2,4%2,7%
3,2%
2,6%2,8%2,8%3,1%3,0%
3,3%3,6%
1,7%
4,2%4,4%4,1%
3,8%3,8%4,1%4,1%4,1%
3,6%3,8%
5,0%4,7%4,6%
5,8%
0
1.000
2.000
3.000
4.000
5.000
6.000
7.000
8.000
9.000
10.000
94 95 96 97 98 99 00 01 02 03 04 05 06 07 08 09 10
0%
1%
2%
3%
4%
5%
6%
7%
8%
9%
10%
Kunstklappe Xenograft Letalität Kunstklappe Letalität Xenograft
ohne kathetergeführte Eingriffe
+ (2000 ?) unreported
Access routes according to anatomic characteristics
Courtesy of A. Khattab
Frequency distribution of access routes
TA: PARTNER (n=104) versus continued access (n=822)
AVR 92 76 71 70 67
PMA-TA 104 87 82 76 73
NRCA-TA 822 571 370 297 126
No. at Risk
23.6%
25.3%
29.1%
0%
10%
20%
30%
40%
0 3 6 9 12
Str
oke
Stroke
3.9% @ 1yr 0
0.1
0.2
0.3
0.4
0.5
0 6 12 18 24
TAVR
AVR
PARTNER TF
(n=492): 22.2 @1yr
Stroke 2% @ 30d
TA: consistently lower stroke risk
Eurointervention 2012; 7-online publish ahead of print- February 2012
n Log.
EuroScore Stroke / TIA
30-days
3236 TF MCV 22 % 3.1 ±2.2 %
1733 TF ES 26 % 4.2 ±2.2 %
2482 TA ES 29 % 2.7 ±1.4 %
TAVI Patient: risk is a continuum
TAVI Patient: risk is a continuum
Risk assessment
Risk assessment: porcelain aorta
Risk assessment: hostile chest
Risk assessment: frailty
Preop planning with CT
Annulus measurement with CT
New devices in clinical practice / trials Device Status Features
JENAVALVE (Jenavalve)
CE - TA Devel. –TF
- anatomical orientation
- partial repositioning
ENGAGER (Medtronic)
MC trial -TA no TF
- anatomical orientation
- partial repositioning
ACURATE (Symetis)
CE - TA Clin.trial –TF
- anatomical orientation
- partial repositioning
- intuitive positioning
PORTICO (SJM)
Clin.trial - TF Devel. - TA
- partial repositioning
SAPIEN 3 (Edwards)
Clin. Trial
-TF+TA - PV leak prevention
PV leak matters … AI > 1° => increased mortality
FRANCE II Registry – rate of PVL
0
10
20
30
40
50
60
Grade 0 Grade 1 Grade 2 Grade 3
Transfemoral
Transapical
Gilard M, NEJM 2012
TA will become a percutaneous
procedure
APICA
Spontaneous Closure
16
YT%91:K85>%4d5=%=59HQ46%Hb%%?1648H=%4:?%GK1?5I1=5%fK>8%L=1H=%8H%26H>K=5%̀%(H%4??1OH:46%>K8K=1:G%H=%1:85=Q5:OH:%=5gK1=5?%̀%
Permaseal
TA will become a percutaneous
procedure
EnTourage CardiApex
FIH „closure device“ – Apica
Sutureless aortic valve implantation
through minithoracotomy
Sutureless aortic valve implantation
Sorin Perceval
New techniques for the treatment
of mitral insufficiency
- Percutaneous implantation of mitral ring
- Percutaneous implantation of mitral valve