Update 2012 Herzchirurgie
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1 Update 2012 Herzchirurgie Prof. Dr. Jürg Grünenfelder Klinik für Herz- und Gefässchirurgie UniversitätsSpital Zürich
2 Themenübersicht - update Koronarchirurgie - Syntax 5 Jahre - Freedom 5 Jahre - update Klappenchirurgie - TAVI vs. chirurgische AKE - transapikal vs. transfemoral - neue Techniken
3 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?
4 Probability of 10y event-free survival among patients in the MASS II-Trial (OMT vs CABG vs PCI) Hueb W Circulation 2010
5 MASS II-Trial (OMT vs CABG vs PCI) Hueb W Circulation 2010
6 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
7 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 realworld population seen by the surgeon and the interventional cardiologist in their daily practice.
8 SYNTAX Trial Design 62 EU Sites + 23 US Sites Heart Team (surgeon & interventionalist) Total enrollment Amenable for both treatment options N=3075 Stratification: Stratification: LM LM and and Diabetes Diabetes Amenable for only one treatment approach Randomized Arms N=1800 Randomized Arms CABG n=1800 TAXUS* vs N=897 n=897 N=903 n=903 vs 3VD 66.3% LM 33.7% 3VD 65.4% LM 34.6% Two Registry Arms CABG PCI 2500 N=1077 n=1077 N=198 n= w/ f/u 5yr f/u n=649 Two Registry Arms no f/u n=428 N=1275 all captured w/ follow up
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15 SYNTAX 3VD at 4 years PCI CABG p All cause death Cardiac death Myocardial infarction Stroke ns Death/MI/Stroke Repeat revasc <0.001 MACCE <0.001
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17 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
18 Freedom Trial: Primary Outcome Death, MI, Stroke Farkouh ME, NEJM 2012
19 Freedom Trial: Death Farkouh ME NEJM 2012
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21 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
22 Is non adherance with Guidelines an exception?
23 Indications for CABG versus PCI in stable patients with lesions suitable for both procedures and low predicted surgical mortality
24 Conclusions: DES use in clinical practice was associated with a significant overall increase in PCI to treat patients with class I indications for CABG.
25 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
26 16142 catheter lab patients in New York 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 Hannan EL, Circ 2010
27 Routine non-adherance with guidelines 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, Circ 2010
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29 Hannan EL, JACC 2012
30 Hospital rates for inappropriate PCI procedures 0-40%! Hannan EL, JACC 2012
31 What can we surgeons do better?
32 Technical recommendations for CABG DGTHG Statitsics 2011
33 Total arterial revascularization in Germany Only 22% in 2011!
34 Technical recommendations for CABG
35 OPCAB in Germany DGTHG Statitsics 2011
36 Stroke rate in Kyoto-Credo II Study No difference in stroke rate (63% OPCAB!) Shiomi H ESC 2011
37 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
38 TAVI in 2012
39 TAVI penetration rate
40 TAVI market prediction
41 Aortic valve replacement in Germany Isolierte Aortenklappenchirurgie ohne kathetergeführte Eingriffe + (2000?) unreported Kunstklappe Xenograft Letalität Kunstklappe Letalität Xenograft ,8% 3,6% 4,6% 3,3% 4,7% 3,0% 5,0% 3,1% 3,8% 2,8% 3,6% 2,8% 4,1% 2,6% 4,1% 3,2% 4,1% 2,7% 3,8% 2,4% 3,8% 2,5% 4,4% 4,1% 2,5% 2,6% 4,2% 2,9% 3,7% 2,0% 3,2% 3,3% 1,7% 1,5% 0
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45 Access routes according to anatomic characteristics
46 Frequency distribution of access routes Courtesy of A. Khattab
47 Stroke TA: PARTNER (n=104) versus continued access (n=822) 40% % % % 0.1 TAVR AVR PARTNER TF (n=492): Stroke 29.1% 25.3% 23.6% No. at Risk 0% 0 Stroke 30d 1yr AVR PMA-TA NRCA-TA
48 TA: consistently lower stroke risk n 3236 TF Log. EuroScore Stroke / TIA 30-days MCV 22 % 3.1 ±2.2 % 1733 TF ES 26 % 4.2 ±2.2 % 2482 TA ES 29 % 2.7 ±1.4 % Eurointervention 2012; 7-online publish ahead of print- February 2012
49 TAVI Patient: risk is a continuum
50 TAVI Patient: risk is a continuum
51 Risk assessment
52 Risk assessment: porcelain aorta
53 Risk assessment: hostile chest
54 Risk assessment: frailty
55 Preop planning with CT
56 Annulus measurement with CT
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58 New devices in clinical practice / trials Device Status Features JENAVALVE (Jenavalve) ENGAGER (Medtronic) ACURATE (Symetis) PORTICO (SJM) SAPIEN 3 (Edwards) CE - TA Devel. TF MC trial -TA no TF CE - TA Clin.trial TF Clin.trial - TF Devel. - TA Clin. Trial -TF+TA - anatomical orientation - partial repositioning - anatomical orientation - partial repositioning - anatomical orientation - partial repositioning - intuitive positioning - partial repositioning - PV leak prevention
59 PV leak matters AI > 1 => increased mortality
60 FRANCE II Registry rate of PVL Transfemoral Transapical 10 0 Grade 0 Grade 1 Grade 2 Grade 3 Gilard M, NEJM 2012
61 TA will become a percutaneous procedure 26H>K=5` %( H%4??1OH: 46%>K8K=1: G%H=% 1: 85=Q5: OH: %=5gK1=5?` % YT%9 1: K85>%4d5=%=59 HQ46%Hb%?1648H=%4:?%GK1?5I 1=5%fK>8%L =1H=%8H% Spontaneous Closure 16 APICA Permaseal
62 TA will become a percutaneous procedure EnTourage CardiApex
63 FIH closure device Apica
64 Sutureless aortic valve implantation through minithoracotomy
65 Sutureless aortic valve implantation Sorin Perceval
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67 New techniques for the treatment of mitral insufficiency - Percutaneous implantation of mitral ring - Percutaneous implantation of mitral valve
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