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