Følgende dias er fremlagt ved DCS / DTS

Fællesmøde 13. januar 2011 og alle rettigheder

tilhører foredragsholderen.

Gengivelse må kun foretages ved tilladelse.

Guidelines for myokardiel

revaskularisering

Kirurgens synspunkt

Per Hostrup NielsenÅrhus Universitetshospital Skejby

DCS/DTS Middelfart 13.1.11

Agenda

• Hvem har lavet de nye guidelines

• Baggrund – Syntax

• Hovedpunkter– Patienten i centrum – Informeret samtykke

– Ad hoc PCI

– Heart team

– Institutionelle protokoller

– Fordelingsnøgle – PCI/CABG

– Anbefalede kirurgiske metoder

• Mediko-legale implikationer

• Konklusioner

European Heart Journal (2010) 31, 2501–2555

oCo-operation Cardiology (ESC) og Cardiac Surgery (EACTS)o25 medlemmer fra 13 Europæiske lande (afspejler ‘Heart Team’)

•9 non interventions kardiologer, •8 interventions kardiologer, •8 hjertekirurger

oExtensive reviews – men ikke fra DK

Intended all-comers study design instead of a highly selected patient population

Consensus physician agreement (surgeon & cardiologist) instead of inclusion & exclusion criteria

And, nested registries for CABG only and PCI only to define patient characteristics and outcomes of these two unique treatment options

SYNTAX: Intended All-Comers Design with Nested Registries

Left Main Disease(isolated, +1, +2 or +3 vessels)

3 Vessel Disease(revasc all 3 vascular territories)

SYNTAX Eligible Patients

De novo disease

Limited Exclusion Criteria

Previous interventions

Acute MI with CPK>2x

Concomitant cardiac surgery

Patient Profiling

Local Heart team (surgeon & interventional cardiologist) assessed each patient in regards to :

Patient’s operative risk (EuroSCORE & Parsonnet score)

Coronary lesion complexity (Newly developed SYNTAX score)

Goal: SYNTAX score to provide guidance on optimal revascularization strategies for patients with high risk lesions

Sianos et al, EuroIntervention 2005;1:219-227Valgimigli et al, Am J Cardiol 2007;99:1072-1081Serruys et al, EuroIntervention 2007;3:450-459

BARI classification of coronary segmentsLeaman score, Circ 1981;63:285-299Lesions classification ACC/AHA , Circ 2001;103:3019-3041Bifurcation classification, CCI 2000;49:274-283CTO classification, J Am Coll Cardiol 1997;30:649-656

No. &

Location

of lesionLeft

Main

Tortuosity

3 VesselThrombus

BifurcationCTO

Calcification

SYNTAX

SCORE

Dominance

71% enrolled (N=3,075)

All Pts with de novo 3VD and/or LM disease (N=4,337)

Treatment preference (9.4%)

Referring MD or pts. refused informed consent (7.0%)

Inclusion/exclusion (4.7%)

Withdrew before consent (4.3%)

Other (1.8%)

Medical treatment (1.2%)TAXUSn=903

PCIn=198

CABGn=1077

CABGn=897

no f/un=428

5yr f/un=649

PCIall captured w/

follow up

CABG2500

750 w/ f/uvs

Total enrollment N=3075

Stratification: LM and Diabetes

Two Registry ArmsRandomized Armsn=1800

Two Registry ArmsN=1275

Randomized ArmsN=1800

Heart Team (surgeon & interventionalist)

PCIN=198

CABGN=1077

Amenable for only one treatment approach

TAXUS*

N=903CABG

N=897vs

Amenable for bothtreatment options

Stratification: LM and Diabetes

LM33.7%

3VD66.3%

LM34.6%

3VD65.4%

DM 28.5%

Non DM71.5%

NonDM71.8%

DM28.2%

23 US Sites62 EU Sites +

SYNTAX Trial Design

*TAXUS Express

Staged procedure, % 14.1

Lesions treated/pt, mean ± SD 3.6 ± 1.6

No. stents implanted, mean ± SD 4.6 2.3

Total length implanted, mm ± SD 86.1 47.9

Range, mm 8 – 324

Long stenting (>100 mm), % 33.2

Procedural CharacteristicsPCI Randomized Cohort

TAXUS

N=903Patient-based

CABGN=897

Off-pump surgery, % 15.0

Graft revascularization, %

At least one arterial graft 97.3

Arterial graft to LAD 95.6

LIMA+venous 78.1

Double LIMA/RIMA 27.6

Complete arterial revascularization 18.9

Radial artery 14.1

Venous graft only 2.6

Grafts per patient, mean ± SD 2.8 0.7

Distal anastomosis/pt, mean ± SD 3.2 0.9

Procedural CharacteristicsCABG Randomized Cohort

MACCE to 12 Months

P=0.0015*

0 6 12

10

20

0

Months Since Allocation

Cum

ula

tive E

vent

Rate

(%

)

ITT population

12.1%

17.8%

Event Rate ± 1.5 SE. *Fisher’s Exact Test

TAXUS (N=903)CABG (N=897)

Conclusions:

In the randomized SYNTAX cohort, there were comparable overall safety outcomes (Death, CVA, MI,) in CABG and PCI patients at 12 months (7.7 vs. 7.6 %).

There was a significantly higher rate of revascularization in the PCI group (13.7 vs. 5.9 %), and a significantly higher rate of CVA in the CABG group (2.2 vs. 0.6 %).

Overall MACCE in the PCI group was higher (17.8 vs.12.1 %) due to an excess of redo revascularization compared with CABG.

Per protocol rates of symptomatic graft occlusion and stent thrombosis were similar.

The SYNTAX score will help stratify patients for the appropriate revascularization option.

SYNTAX RCT Results (3 Years): ALL, 3 Vessel, Left Main

ALL (1800)

PCI CABG p

numbers 903 897

Death % 8.6 6.7 (-22%) 0.13

CVA % 2.0 3.4 (+70%) 0.07

MI % 7.1 3.6 (-49%) 0.002

Revasc % 19.4 10.7 (-45%) <0.001

MACCE % 28 20.2(-28%) <0.001

3 vessel (1095)

PCI CABG p

546 549

9.5 5.7 (-40%) 0.02

2.6 2.9 (+12%) 0.64

7.1 3.3 (-54%) 0.005

19.4 10 (-48%) <0.001

28.8 19 (-35%) <0.001

Left Main (705)

PCI CABG p

357 348

7.3 8.4 (+15%) 0.64

1.2 4.0 (+333%) 0.02

6.9 4.1 (-40%) 0.14

20 11.1 (-45%) 0.004

26.8 22.3 (-17%) 0.20

SYNTAX RCT Results (3 Years): Left Main

LM SYNTAX 0-22 (Low severity)

PCI CABG p

numbers 118 104

Death % 2.6 6.0 .21

CVA % 0.9 4.1 .12

MI % 4.3 2.0 .36

Death,CVA,MI % 6.9 11 .26

Revasc % 15.4 13.4 .69

LM 23-32 (Intd)

PCI CABG p

103 92

4.9 12.4 .06

1.0 2.3 .46

5.0 3.3 .63

10.8 15.6 .29

15.9 14.0 .75

LM >33 (High)

PCI CABG p

135 149

13.4 7.6 .10

1.6 4.9 .13

10.9 6.1 .17

20.1 15.7 .34

27.7 9.2 .001

4.1 Patient information

Patient information needs to be:

objective and unbiasedpatient orientedevidence based up-to-datereliableunderstandable accessiblerelevantconsistent with legal requirements

Informed consent requires transparency, especially if there is controversy about the indication for a particular treatment (PCI vs.CABG vs. OMT).

Appendix 1Patient information (cf. chapter 4.1)Dear Madam, Dear Sir,You have been advised to undergo coronary angiography. This examination provides an X-ray image of the coronary arteries, the blood vessels that supply blood to your heart. Coronary angiography reveals the presence of coronary artery disease (CAD), a condition that leads to narrowing or blockage of the coronary arteries. The results of this examination will help your physician to identify the best treatment for you.Please carefully consider the following information and share your thoughts with your referring physician, your family or close friends. Do not hesitate to ask for further information and explanation if needed. The physician who has proposed that you undergo coronary angiography will certainly provide additional information, as desirable. Keep in mind that after the angiogram, there is no time constraint to make a decision regarding further therapy. This brief commentary is aimed at providing you with the elements necessary to make an informed decision before proceeding to the formal informed consent procedure. Both are necessary to give us the opportunity to provide care for you. What is significant about coronary artery disease? (CAD)

The coronary arteries represent a tree of vessels providing blood to the heart itself, which is essentially a muscle pumping blood and oxygen through the body. A disease known as “atherosclerosis” affects the wall of the coronary arteries, and their typically smooth inner surfaces become irregular and thickened by a bulky plaque. In certain areas, this may restrict

Collaborative care requires the preconditions

of communication, comprehension, and trust.

Patients taking an active role throughout the

decision making process have better outcomes.

For patients with stable CAD and multivessel or LM

disease, all relevant data should be reviewed by a

clinical/non-invasive cardiologist

a cardiac surgeon

an interventional cardiologist

to determine the likelihood of safe and effective

revascularization with either PCI or CABG.

Heart Team

CABG

Uafhængig af proximal kompleksitet

Profylaktisk overfor fremtidig progression

PCI

God til ”PCI-egnede” læsioner

Ingen profylakse mod fremtidig progression

Præ- per- post stent stenoser

STEMI: Emergent coronary artery bypass grafting

In cases of unfavourable anatomy for PCI or PCI failure,

emergency CABG in evolving STEMI should only be

considered when a very large myocardial area is in jeopardy

and surgical revascularization can be completed before this

area becomes necrotic (i.e. in the initial 3–4 h).

STEMI:Urgent coronary artery bypass grafting

Current evidence points to an inverse relationship between

surgical mortality and time elapsed since STEMI. When

possible, in the absence of persistent pain or

haemodynamic deterioration, a waiting period of 3–7 days

appears to be the best compromise.

10.2 Surgical procedures

Surgical procedures are complex interactions between

human and material resources. The best performance is

obtained through experience and routine, process control,

case-mix, and volume load.

The surgical, anaesthesiological, and intensive care

procedures are written down in protocols.

Medikolegale overvejelser

Når

”Guidelines for myokardiel revaskularisering”

forvandles til

”almindelig anerkendt klinisk praksis”

Kan patienten klage

-hvis han ikke får et skriftligt informeret samtykke

-hvis …

Federal Report Linking Dr. Mark Midei and Abbott Finds "Potential Fraud, Waste, and Abuse“CTSNet Dec 2010

Probe of Cardiologist Accused of Implanting Unneeded Stents Now Expanding to Other Docs

Dr. Mark Midei may have implanted "unneeded stents“ in 585 out of nearly 2000 patients over a two-year period

Dr Mehmod Patel was given a 10-year prison sentence after being convicted on 51 counts of billing private and government health insurers for unnecessary medical procedures

Medscape.com juni 2010

Konklusioner - kirurgens

• Guidelines implementeres i videst muligt omfang

• Der dannes Heart teams som

– Udfærdiger Institutionsprotokoller m.m. (strategisk)

– Evaluerer enkeltpatienter – Hjertekonf (operationel)

• Reglerne for informeret skriftlig samtykke følges

• Protokoller for procedurer udfærdiges

– Total arteriel revaskularisering – OPCAB - Hybrid

• Nationalt:

– Guidelines og NBV samordnes

– Patoanatomisk fordelingsnøgle KAG registreres i

Dansk HjerteRegister