Stefan James, MD, PhDDirector of Interventional Cardiology

Associate Professor of Cardiology

Uppsala Clinical Research Centre

University Hospital Uppsala, Sweden

The Swedeheart registry

Transforming Health Care Delivery through CV Registries

RIKS-HIA SCAAR Hjärtkir SEPHIA

Ålder, kön, etc. x x x x

Tid. sjukdomar x x x

Tid. mediciner x x x

Status x x x

Labvärden x x x x

LVEF x

Komplikationer x x x x

Långtidsuppföljn x x x x

Prevention, QoL x

Journal

x

x

x

x

x

x

x

x

x

Ulf Stenestrand, 2008

Quality registry previously

SwedeheartRIKS-HIA SCAAR Hjärtkir SEPHIA TAVI

Ålder, kön, etc. x x x x x

Tid. sjukdomar x x x x

Tid. mediciner x x x x

Status x x x x

Labvärden x x x x x

LVEF x x

Komplikationer x x x x x

Långtidsuppföljn x x x x x

Prevention, QoL x x

Journal

x

x

x

x

x

x

x

x

x

Modifierad efter Ulf Stenestrand, 2008

Quality registry today

SwedeheartRIKS-HIA SCAAR Hjärtkir SEPHIA TAVI

Ålder, kön, etc. x x x x x

Tid. sjukdomar x x x x

Tid. mediciner x x x x

Status x x x x

Labvärden x x x x x

LVEF x x

Komplikationer x x x x x

Långtidsuppföljn x x x x x

Prevention, QoL x x

Journal

x

x

x

x

x

x

x

x

x

Quality registry tomorrow

Modifierad efter Ulf Stenestrand, 2008

Hospitals No Patients Annual No

Thoracic surgery 100 % 8 100 % 7000

SCAAR (coronary angiography and PCI)

100 % 30 100 % 40000

RIKS-HIA coronary intensive care registry

100 % 73 60% 50000

SEPHIA Secondary Prevention After Myocardial Infarction(<75 yrs)

85% 65 55% 5500

TAVI 100 % 7 100 % 150

Samma information används både i register och journal ökar tillförlitligheten

Färre inmatningar - säkrare / reducerar dubbelarbete Används data aktivt ökar validiteten

Följa egna patienters resultat / komplikationer Intressanta interaktiva on-line rapporter Modul för läkare under utbildning Automatisk rapport till strålfysik

Correct dataStimulate use of data

History is presented and all previously implanted stents have to be checked

Data entry on line by the operator

190 variables:190 variables:Patients characteristicsPatients characteristics

Procedural details Procedural details (lesions, stents, devices etc.)(lesions, stents, devices etc.)

Pharmacological treatmentPharmacological treatmentComplicationsComplications

190 variables:190 variables:Patients characteristicsPatients characteristics

Procedural details Procedural details (lesions, stents, devices etc.)(lesions, stents, devices etc.)

Pharmacological treatmentPharmacological treatmentComplicationsComplications

Interactive immediately available information

Information om tidigare ingrepp

Rätt åtgärd kan vidtas

Dålig teknik, medicin, medicinteknisk utrustning eller sjukvårdsartiklar kan identifieras

RR: 1.03 (0.84,1.26)

0.0 0.5 1.0 1.5 2.0 2.5 3.0

0.0

00

.02

0.0

40

.06

0.0

80

.10

Time (years)

Cu

mu

lative

ris

k o

f d

ea

th

RR: 1.32 (1.11,1.57)

BMS 12880 12473 12354 12228 9298 5966 3199DES 5770 5605 5541 5471 3434 1777 626

RR 1.3 (1.1-1.6)

Future potential increased mortality?

??

5 y

Patients enrolled 2003-2004 and followed max 3 years

N=19 771

N Engl J Med 2007;356:1009-19.

BMS vs DMS

Bare metal stents vs. Death metal stents

“The SCAAR registry is contaminated with fraud data….” M Leon 2007

The SCAAR Scare

“This clearly shows how inappropriate registry studies are….” Kastrati 2007

“What is rotten in the kingdom of Sweden”

P. Serruys 2008

0 1 2 3 4 5

0.0

00

.05

0.1

00

.15

Time (years)

Cu

mu

lative

ris

k o

f d

ea

th

BMSDES

BMS 28286 26843 19429 13592 6682 7

DES 19681 18893 12691 6065 1964 0

RR: 0.82 (0.73, 0.92)

RR: 1.06 (0.97, 1.17)

Patients enrolled 2003-2006 and followed max 5 years

N= 47.867

James, N Engl J Med 2009;360(19):1933-45

Years after PCI

Cu

mu

lati

ve

ra

te o

f d

efi

nit

e s

ten

t th

rom

bo

sis

(%

)

210

2

1

0.5 0.5% early

0

1.5

N=64 979 stents

Unadjusted

BMS, N=38 649

Slope 0.5% per year

DES, N=26 330

Lagerqvist, Circ Cardvasc Int 2009 Oc;2(5):401-8

Stent thrombosis

SCAAR SWEDE HEART

SCAAR

Time (Years after stenting)

543210

Cu

mu

lati

ve r

isk

of

Res

ten

osi

s

0,12

0,11

0,10

0,09

0,08

0,07

0,06

0,05

0,04

0,03

0,02

0,01

0,00

Adjusted

November 8th 2009. Copyright SCAAR.

SCAAR

XienceV / Promus, N=1,849

BS Taxus Liberté, N=16,357

Braun Coroflex Blue, N=3,761

BS Liberté, N=28,735

Other, N=3,654

Stents used <1000 times excluded

N=104,142 stents

Medtronic Endeavor, N=4,891

Medtronic Driver, N=15,954

BS Taxus Express, N=3,165

Sorin Chrono, N=2,465

Abbott Flexmaster Fl, N=1,311

Hexacath Titan2, N=1,974

Cordis Cypher, N=11,513

Abbott Vision, N=8,565

2.3%

1.4%

3.0%

James, Eurointervention 2009

Time (Years after stenting)

543210

Cu

mu

lati

ve r

isk

of

acu

te s

ten

t th

rom

bo

sis

0,02

0,01

0,00

July 18th 2010. Copyright SCAAR.

Medtronic Resolute 1038 (7)

Hexacath Titan2 2225 (50)

Sorin Chrono 2594 (21)

BS Taxus Liberté 17705 (269)

Medtronic Endeavor 5521 (55)

Abbott Flexmaster Fl 1302 (18)

BS Liberté 32630 (377)

BS Taxus Express 3148 (78)

Medtronic Driver 19767 (265)

Cordis Cypher 12240 (264)

Xience V – Promus 3417 (12)

Other 4591 (40)Abbot Vision 9756 (105)

Abbott Xience Prime 1091 (3)

120,893 stents 1,657 events

Stent N < 400 excluded

Stent thrombosis

SCAAR

Braun Coroflex Blue 3868 (93)

Number of stents (events)Adjusted for baseline differences in clinical, lesion and vessel characteristics

New generation DESn-DES vs o-DES: adjusted HR 0.62; 95% CI: 0.53-0.72 n-DES vs BMS: adjusted HR: 0.29; 95% CI: 0.25-0.33 o-DES vs BMS: adjusted HR: 0.46; 95% CI: 0.43-0.51

BMSo-DESn-DES

Adjusted

Sarno et al ESC 2011Sarno et al ESC 2011

n-DES vs o-DES: adjusted HR: 0.50; 95% CI: 0.35-0.71 n-DES vs BMS: adjusted HR: 0.33; 95% CI: 0.23-0.47 o-DES vs BMS: adjusted HR: 0.65; 95% CI: 0.54-0.46

BMSo-DESn-DESAdjusted

n-DES vs o-DES: adjusted HR: 0.77; 95% CI: 0.63-0.95 n-DES vs BMS: adjusted HR: 0.55; 95% CI: 0.46-0.67 o-DES vs BMS: adjusted HR: 0.72; 95% CI: 0.64-0.81

BMS; N=42773o-DES; N=12153n-DES; N= 6425

Adjusted

Over 20 high ranked publications annually

Puncture site

Femoral

Radial

Proportion

0.0% 0.2% 0.4% 0.6% 0.8% 1.0% 1.2% 1.4% 1.6% 1.8% 2.0% 2.2% 2.4% 2.6% 2.8% 3.0% 3.2%

An

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Pro

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on

tim

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Ult

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d/C

T

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osp

Tre

tmen

t m

ore

th

an

com

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Ble

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Min

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Med

dis

con

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Ble

ed

ing

Maj

or

Su

rger

y

Complications in hospital

Adjusted OR (95% CI) 0.78 (0.64-0.96) P= 0.018

Eur Heart J In press

Adjusted Cumulative Risk of death for up to 1 year:transfemoral vs. transradial access site

Proportion

(%)

0

10

20

30

40

50

20

03

20

04

20

05

20

06

20

07

20

08

20

09

20

10

Figur 124. Andel punktioner i armen vid angio/PCI, 2003 - 2011.

Andel(%)

0

10

20

30

40

50

60

70

2003

Figur 124. Andel punktioner i armen vid angio/PCI, 2003 - 2011.

Andel(%)

0

10

20

30

40

50

60

70

2003

Radial procedures 2003-2011.

SCAAR/RIKS-HIA database screened for subjects surviving ST/MI occuring within

6 months of stenting and controls

ST Cases (n=48)VerifyNow P2Y12, VASP

TOPAS

MI Cases (n=30)VerifyNow P2Y12, VASP

Matched controls (n=50, n=28)VerifyNow P2Y12, VASP

Subjects invited by local study sites (n=12) if ST/MIoccured while subject on dual antiplatelet treatment

All subjects on aspirin 75-160 mg o.d. Subjects notalready on clopidogrel were administered 600 mg

clopidogrel 16-26 h prior to PD assessment

Registerbaserade case control studier

Internationella jämförelser

Quality index

Quality index and mortality

till ålder och kön, alla åldrar, 1995-2006.Figur 27g. Utvecklingen av 30-dagarsmortalitet vid hjärtinfarkt i relation

Kvinnor <65 år Kvinnor 65-74 år Kvinnor >=75 årMän <65 år Män 65-74 år Män >=75 år

An

de

l 3

0-d

ag

ars

mo

rta

lite

t

0%

5%

10%

15%

20%

25%

30%

1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006

> 75 years

65-74 years

< 65 years30 d

ay m

ort

aiit

y

Mortality post MI

Reasons for success

Initiated by cardiologists, driven by National and local

enthusiasts (champions)

Highly motiverated users

Immediate benefit in the local unit – on-line-reports, local

variables, local development

Open comparison of hospital performances

All hospitals part of the same system

Published studies in high ranked journal

Vlaar, P.J. et al. NEJM 2008, 371: 1915

SWEDE HEART

SCAAR

TAPAS, total mortality at 1 year

SWEDE HEART

SCAARProportion thombus aspirationin Sweden

SWEDE HEART

SCAAR

Patients with suspected STEMI referred to primary PCIN = 5000

STEMI diagnosis confirmed at coronary angiography. Informed consent obtained

Online 1:1 randomization in SCAAR, guidewire advancement, i.c. nitroglycerin

Thrombus aspiration and PCI PCI alone

Immediately after PCI: TIMI flow grade

30 days: all-cause death

1, 2, 5 and 10 years: all-cause death and additional secondary endpoints

TASTE trial flow chart

Fröbert et al, AHJ 2009

Thrombus Aspiration in ST-Elevation myocardial infarction in Scandinavia

Two questions need to be answered:

Is the patient informed verbally and accepts participation?

Are inclusion and no exclusion criteria met?

SWEDE HEART

SCAARTASTE

Thrombus Aspiration in ST-Elevation myocardial infarction in Scandinavia

Randomized

All primary PCI:s

New concept for clinical research

Combines the advantages of a clinical registry and randomized study

Ideal for studies with a simple hypothesis that can be evaluated with

hard reliable endpoints

Only clinically relevant questions can be addressed

No substitute for RCT but a complement

SWEDE HEART

SCAAR

Randomized Clinical Registry studies- RRCT

Treatment support Propose treatments and strategies according to guidelines Suggest discontinuation of therapies when risk for complications

Automatic Syntax score calculation for stabil angina and more than 1 vd

Calcualate CHADS-VASC score Warn about bleeding in ACS patients with high risk; high age,

female sex, low body weight, reduced renal function

PROM- Patient related outcome measures

Development

Acreditation for users Web based course for handling regsitries for all new staff

i required for access of user name and password Automatic annual control for all users

Acreditation

Aim and goal

StefanJamesChairman SCAAR

Course Content

About quality registries

Final case

Certification andEvaluation

Communication

News

Events

Science

Questions

The Swedish Health and Medical ServiceA system of national quality registries has been established in the Swedish health and medical services in the last decades. There are about 70 registries and four competence centres that receive central funding in Sweden. Definition of quality registers in SwedenA national quality registry contains individualised data concerning patient problems, medical interventions, and outcomes after treatment; within all healthcare production. It is annually monitored and approved for financial support by an Executive Committee.

VisionThe vision for the quality registries and the competence centres is to constitute an over-all knowledge system that is actively used on all levels for continuous learning, quality improvement and management of all healthcare services.

About Quality Registries Test Case

50 years old man with history of hypertension:

-Chest pain 2 hours-St – elevations in inferior leads-Bp 160/100 mmHg-HR 48/min

Ambulance Treatment:-ASA 320mg-Clopidogrel 600mg-Morphine 2 x 5mg-Oxygen

1

Certification and

evaluation

Certification and

evaluationFinal CaseFinal CaseAim and goal Background

The quality certification process. The user have to pass a test in step two, to be able to get to step three. In step three the user have to pass the final case to get a certificate.

Certification and

evaluation

Certification and

evaluation

Final CaseFinal CaseAim and goalAbout Quality

Registries

Content:

-Aim of Quality Registries

-Purpose with certification process

-Common concepts

-Multiple chocie

Content:

-National work with Quaity Registries

-Atricels related to Cardiology

-SCCAR Quality Registry

-Test Case

Content:

Final Case for achieving certification. The case highlight important pieces of information in the Quality Register.

Content:

-The certificate

-Certifikation is recorded in a database

-User can evaluate the course

Monitoring of a larger proportion of variables and patients

Regional cross monitoring of hospital staff Monitoring symposia Automated checks Monitoring of non reported events

Monitoring

Important outcome variables adjudicated by competent staff Ex. Stent thrombosis, Restensis, bleeding, stroke 10% of reported event controlled

Adjudication

PROM Patient Related Outcome Measures