Transforming Health Care Delivery through CV Registries The

Transforming Health Care Delivery through CV Registries The Swedeheart registry Stefan James, MD, Ph. D 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 Tid. sjukdomar x x Tid. mediciner x x Status x x Labvärden x x LVEF x Komplikationer x x x Långtidsuppföljn x x x x Prevention, Qo. L 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 Status x x x Labvärden x x x LVEF x x x Komplikationer x x x Långtidsuppföljn x x x x x Prevention, Qo. L 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 Status x x x Labvärden x x x LVEF x x x Komplikationer x x x Långtidsuppföljn x x x x x Prevention, Qo. L x 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

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

Data entry on line by the operator 190 variables: Patients characteristics Procedural detailspresented and all previously (lesions, stents, devices etc. ) History is implanted stents have to be checked Pharmacological treatment Complications

Interactive immediately available information Information om tidigare ingrepp Rätt åtgärd kan vidtas Dålig teknik, medicinteknisk utrustning eller sjukvårdsartiklar kan identifieras

Patients enrolled 2003 -2004 and followed max 3 years N=19 771 ? ? Future potential increased mortality? RR 1. 3 (1. 1 -1. 6) 5 y 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 N= 47. 867 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 Years after PCI 2 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 Titan 2, 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 3. 0% 0, 07 Cumulative risk of Restenosis 0, 06 0, 05 Medtronic Endeavor, N=4, 891 1. 4% BS Taxus Express, N=3, 165 Cordis Cypher, N=11, 513 BS Taxus Liberté, N=16, 357 Xience. V / Promus, 0, 04 N=1, 849 0, 03 2. 3% 0, 02 0, 01 N=104, 142 stents 0, 00 November 8 th 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 Titan 2 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 18 th 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

Surgery Bleeding Major 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% Med discont’ Proportion Pseudoaneurysm Transfusion Hb-drop >20 g/L Tretment more than compression Bleeding Minor Prolonged hosp Ultrasound/CT ´ Prolonged compression time Hematoma >5 cm 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 50 40 30 (%) 20 2010 2009 2008 2007 2006 2005 2004 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 h prior to PD assessment -26 ST Cases (n=48) Verify. Now P 2 Y 12, VASP MI Cases (n=30) Verify. Now P 2 Y 12, VASP Matched controls (n=50, n=28) Verify. Now P 2 Y 12, VASP

Internationella jämförelser

Quality index

Quality index and mortality

Mortality post MI 30 day mortaiity > 75 years 65 -74 years < 65 years

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 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 Ø New concept for clinical research Ø Combines the advantages of a clinical registry and randomized study Ø Ideal for studies with a simple hypothesis that can be evaluated with hard reliable endpoints Ø Only clinically relevant questions can be addressed Ø 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 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 mm. Hg -HR 48/min Ambulance Treatment: -ASA 320 mg -Clopidogrel 600 mg -Morphine 2 x 5 mg -Oxygen

Aim and goal Background Final Case 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

Aim and goal About Quality Registries Final Case 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