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
yb
lee
din
g
Hem
ato
ma
>5c
m
´
Pro
lon
ged
com
pre
ssi
on
tim
e
Ult
raso
un
d/C
T
Pro
lon
ged
h
osp
Tre
tmen
t m
ore
th
an
com
pre
ssi
on
Ble
ed
ing
Min
or
Hb
-dro
p>
20g
/L
Tra
nsf
usi
on
Pse
ud
o-
aneu
rys
m
Med
dis
con
t’
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