Transforming Health Care Delivery through CV Registries
The Swedeheart registry
Stefan James, MD, PhD
Director of Interventional Cardiology
Associate Professor of Cardiology
Uppsala Clinical Research Centre
University Hospital Uppsala, Sweden
Quality registry previously
RIKS-HIA
SCAAR
Hjärtkir
SEPHIA
Journal
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
LVEF
x
Komplikationer
x
x
x
x
x
Långtidsuppföljn
x
x
x
x
x
x
x
Prevention, QoL
x
x
Ulf Stenestrand, 2008
Quality registry today
Swedeheart
RIKS-HIA
SCAAR
Hjärtkir
Ålder, kön, etc.
x
x
x
Tid. sjukdomar
x
Tid. mediciner
Journal
SEPHIA TAVI
x
x
x
x
x
x
x
x
x
x
x
x
Status
x
x
x
x
x
Labvärden
x
x
x
x
x
LVEF
x
x
x
Komplikationer
x
x
x
x
x
x
Långtidsuppföljn
x
x
x
x
x
x
x
x
x
Prevention, QoL
x
Modifierad efter Ulf Stenestrand, 2008
Quality registry tomorrow
Journal
Swedeheart
RIKS-HIA
SCAAR
Hjärtkir
Ålder, kön, etc.
x
x
x
Tid. sjukdomar
x
Tid. mediciner
SEPHIA TAVI
x
x
x
x
x
x
x
x
x
x
x
x
Status
x
x
x
x
x
Labvärden
x
x
x
x
x
LVEF
x
x
x
Komplikationer
x
x
x
x
x
x
Långtidsuppföljn
x
x
x
x
x
x
x
x
x
Prevention, QoL
x
Modifierad efter Ulf Stenestrand, 2008
SCAAR
SWEDE
HEART
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
Correct data
Stimulate use of data
 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
SCAAR
Data entry on line by the operator
SWEDE
HEART
190 variables:
Patients characteristics
Procedural details
(lesions, stents, devices etc.)
History is presented and all previously
implanted stents
have to be checked
Pharmacological
treatment
Complications
Interactive immediately available information
SCAAR
SWEDE
HEART
Information om tidigare ingrepp
Rätt åtgärd kan vidtas
Dålig teknik, medicin, medicinteknisk
utrustning eller sjukvårdsartiklar kan
identifieras
Patients enrolled 2003-2004 and
followed max 3 years
N=19 771
0.08
0.06
0.04
Future potential increased mortality?
0.02
RR: 1.03 (0.84,1.26)
RR: 1.32 (1.11,1.57)
RR
1.3 (1.1-1.6)
0.00
Cumulative risk of death
0.10
??
0.0
0.5
1.0
1.5
2.0
2.5
3.0
9298
3434
5966
1777
3199
626
5y
Time (years)
BMS 12880
DES 5770
12473
5605
12354
5541
12228
5471
N Engl J Med 2007;356:1009-19.
The SCAAR Scare
“The SCAAR registry is contaminated with fraud
data….” M Leon 2007
“This clearly shows how inappropriate registry studies
are….” Kastrati 2007
“What is rotten in the kingdom of Sweden”
P. Serruys 2008
BMS vs DMS
Bare metal stents vs. Death metal stents
Patients enrolled 2003-2006 and
followed max 5 years
0.10
BMS
DES
0.05
RR: 0.82 (0.73, 0.92)
0.00
Cumulative risk of death
0.15
N= 47.867
RR: 1.06 (0.97, 1.17)
0
1
2
3
Time (years)
4
5
James, N Engl J Med 2009;360(19):1933-45
Stent thrombosis
SCAAR
SWEDE
Slope 0.5% per year
2
Cumulative rate of definite stent thrombosis (%)
SCAAR
N=64 979 stents
1.5
DES, N=26 330
Unadjusted
1
BMS, N=38 649
0.5% early
0.5
0
0
1
2
Years after PCI
Lagerqvist, Circ Cardvasc Int 2009 Oc;2(5):401-8
HEART
SCAAR
0,12
Stents used <1000 times excluded
Adjusted
0,11
Braun Coroflex Blue, N=3,761
Hexacath Titan2,
0,10
N=1,974
Abbott Flexmaster Fl, N=1,311
0,09
Medtronic Driver,
N=15,954
Sorin Chrono,
N=2,465
BS Liberté,
N=28,735
Abbott Vision,
N=8,565
Other,
N=3,654
0,08
0,07
3.0%
Cumulative risk of Restenosis
0,06
0,05
Medtronic Endeavor, N=4,891
1.4%
0,04
BS Taxus Express,
N=3,165
Cordis Cypher,
N=11,513
BS Taxus Liberté,
N=16,357
XienceV / Promus,
N=1,849
0,03
2.3%
0,02
0,01
N=104,142 stents
0,00
November 8th 2009. Copyright SCAAR.
0
1
2
Time (Years after stenting)
3
4
5
James, Eurointervention 2009
Stent thrombosis
Cumulative risk of acute stent thrombosis
SCAAR
Number of stents (events)
Adjusted for baseline differences in
clinical, lesion and vessel characteristics
Braun Coroflex Blue 3868 (93)
Hexacath Titan2 2225 (50)
BS Taxus Express 3148 (78)
0,02
Cordis Cypher 12240 (264)
Medtronic Driver 19767 (265)
BS Liberté 32630 (377)
BS Taxus Liberté 17705 (269)
Abbott Flexmaster Fl 1302 (18)
Sorin Chrono 2594 (21)
0,01
Other 4591 (40)
Abbot Vision 9756 (105)
Medtronic Endeavor 5521 (55)
Medtronic Resolute 1038 (7)
Xience V – Promus 3417 (12)
Abbott Xience Prime 1091 (3)
0,00
120,893 stents
0
1
2
3
4
Time (Years after stenting)
5
1,657 events
Stent N < 400 excluded
July 18th 2010. Copyright SCAAR.
New generation DES
n-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
Adjusted
BMS
n-DES vs o-DES: adjusted HR: 0.50; 95% CI: 0.35-0.71
o-DES
n-DES vs BMS: adjusted HR: 0.33; 95% CI: 0.23-0.47
n-DES
o-DES vs BMS: adjusted HR: 0.65; 95% CI: 0.54-0.46
BMS
o-DES
n-DES
Adjusted
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
Adjusted
BMS; N=42773
o-DES; N=12153
n-DES; N= 6425
Sarno et al ESC 2011
Over 20 high ranked publications annually
3.2%
3.0%
2.8%
2.6%
2.4%
2.2%
2.0%
1.8%
1.6%
1.4%
1.2%
1.0%
0.8%
0.6%
0.4%
0.2%
0.0%
Surgery
Bleeding
Major
Med discont’
Proportion
Pseudoaneurysm
Transfusion
Hb-drop
>20g/L
Tretment more than
compression
Bleeding
Minor
Prolonged
hosp
Ultrasound/CT
´ Prolonged
compression time
Hematoma
>5cm
Any
bleeding
Complications in hospital
Puncture site
Femoral
Radial
Adjusted Cumulative Risk of death for up to 1 year:
transfemoral vs. transradial access site
Adjusted OR (95% CI)
0.78 (0.64-0.96)
P= 0.018
Eur Heart J In press
Radial procedures 2003-2011.
Proportion
Andel
(%)
70
50
60
40
50
30
40
(%)
30
20
20
10
Figur 124. Andel punktioner i armen vid angio/PCI, 2003 - 2011.
2010
2009
2011
20102008
2009
2007
2008
2007
2006
2006
2005
2005
2004
2004
0
2003
0
2003
10
Registerbaserade case control studier
TOPAS
SCAAR/RIKS-HIA database screened
for subjects surviving ST/MI occuring within
6 months of stenting and controls
Subjects invited by local study sites (n=12) if ST/MI
occured while subject on dual antiplatelet treatment
All subjects on aspirin 75
-160 mg o.d. Subjects not
already on clopidogrel were administered 600 mg
clopidogrel 16-26 h prior to PD assessment
ST Cases (n=48)
VerifyNow P2Y12, VASP
MI Cases (n=30)
VerifyNow P2Y12, VASP
Matched controls (n=50, n=28)
VerifyNow P2Y12, VASP
Internationella jämförelser
Quality index
Quality index and mortality
Mortality post MI
Andel
mortaiity
30 day 30-dagarsmortalitet
30%
25%
> 75 years
20%
15%
65-74 years
10%
< 65 years
5%
0%
1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006
Kvinnor <65 år
Män <65 år
Kvinnor 65-74 år
Män 65-74 år
Figur 27g. Utvecklingen av 30-dagarsmortalitet vid hjärtinfarkt i relation
till ålder och kön, alla åldrar, 1995-2006.
Kvinnor >=75 år
Män >=75 år
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
SCAAR
TAPAS, total mortality at 1 year
Vlaar, P.J. et al. NEJM 2008, 371: 1915
SWEDE
HEART
Proportion thombus aspiration
in Sweden
SCAAR
SWEDE
HEART
TASTE
trial flow chart
SCAAR
SWEDE
HEART
Thrombus Aspiration in ST-Elevation myocardial infarction in Scandinavia
Patients with suspected STEMI referred to primary PCI
N = 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
Fröbert et al, AHJ 2009
Two questions need to be
answered:
Is the patient informed verbally
and accepts participation?
Are inclusion and no exclusion
criteria met?
TASTE
SCAAR
SWEDE
HEART
Thrombus Aspiration in ST-Elevation myocardial infarction in Scandinavia
All primary PCI:s
Randomized
SCAAR
Randomized Clinical Registry studies- RRCT SWEDE
HEART
 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
Development
 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
Acreditation
 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
1
Stefan
James
Chairman SCAAR
About Quality Registries
Test Case
Course Content
Aim and goal
About quality
registries
Final case
Certification and
Evaluation
Communication
News
Events
Science
Questions
The Swedish Health and Medical Service
A 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 Sweden
A 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.
Vision
The 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.
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
Certification
Aim 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.
Final Case
and
evaluation
Aim and goal
About Quality
Registries
Final Case
Content:
Content:
Content:
Content:
Final Case for
achieving certific
ation. The case
highlight
important pieces
of information in
the
Quality Register.
-The certificate
-Aim of Quality
Registries
-Purpose with
certification
process
-National work
with Quaity
Registries
-Atricels related
to Cardiology
-Common
concepts
-SCCAR Quality
Registry
-Multiple chocie
-Test Case
Certification
and
evaluation
-Certifikation is
recorded in a
database
-User can
evaluate the
course
Monitoring
 Monitoring of a larger proportion of variables and
patients
 Regional cross monitoring of hospital staff
 Monitoring symposia
 Automated checks
 Monitoring of non reported events
Adjudication
 Important outcome variables adjudicated by competent
staff
 Ex. Stent thrombosis, Restensis, bleeding, stroke
 10% of reported event controlled
PROM Patient Related Outcome Measures