The Evolving ACC-NCDR Programs: What you need to know for your practice

Transcription

1 The Evolving ACC-NCDR Programs: What you need to know for your practice John S. Rumsfeld, MD PhD FACC Chief Science Officer and Chair, American College of Cardiology National Cardiovascular Data Registry (NCDR) Programs National Director of Cardiology, US Veterans Health Administration Professor of Medicine, University of Colorado School of Medicine Science tells us what we can do; Guidelines tell us what we should do; Registries tell us what we re actually doing. ~Lukas Kappenberger, MD 1

2 Practice Research Technology Mission To improve the quality of cardiovascular patient care by providing information, knowledge and tools; implementing quality initiatives; and supporting research that improves patient care and outcomes. 2

3 9 national programs > 2000 hospitals > 2500 cardiologists 40 million clinical records 2 additional programs LAAO and AFAR in 2015/16 NCDR Data Quality Program The overall accuracy of data abstraction for the CathPCI, ICD, and ACTION-GWTG registries were, respectively, 93.1%, 91.2%, and 90.0%. Messenger JC et al. J Am Coll Cardiol 2012 Oct 16;60(16):

4 NCDR Collaborations NCDR: Not Just Data Standard data elements and definitions Clinical Data Database Quality Assessment Quality Improvement Clinical Research Meaningful Role in Clinical Practice / U.S. Healthcare Reform Bufalino VJ, Masoudi FA, et al. Circulation. 2011;123:

5 QCDR and MACRA 5

6 NCDR: Quality Feedback & Benchmarking Evidence to Practice (E2P) Evidence / Guidelines Practice Implications Practice Improvement NCDR Rapid Registry Response NCDR Evidence in Action 6

7 Maddox TM et al. J Am Coll Cardiol May 26, 2015; vol 65; pp Evidence In Action (EIA) Track ACC guidelines / documents: pre-publication assessment and planning Tailored alert to NCDR practices / hospitals: Show their current practice Highlight key guideline change Link to ACC resources Track performance; Share best practices Update data fields and quality metrics 7

8 Dashboards Site, Physician, Corporate, C-suite /CV Director Key Metrics ACTION Registry CathPCI Registry ACTION: Overall AMI Performance Composite CathPCI: PCI In-hospital Risk Adjusted Mortality (All Patients) ICD: Incidence of Death or Major Adverse Event (Implant Procedures) Site Admissions STEMI: 90 NSTEMI: 39 Procedure Volumes Diagnostic Cath: PCI: Registry Metric Type Measure Value Percentile Change Performance ACTION CathPCI AUC CathPCI AUC CathPCI AUC CathPCI Performance Measures Performance Measures Time from ED arrival at STEMI referral facility to Primary PCI at STEMI receiving facility among transferred patients Patients with Acute Coronary Syndrome: Proportion of evaluated PCI procedures that were inappropriate Patients without Acute Coronary Syndrome: Proportion of evaluated PCI procedures that were inappropriate Proportion of PCI procedures not classifiable for AUC reporting Composite: Discharge medications in eligible PCI patients 98 75% 0 0% 90% % % 90% +5 99% 90% 0 8

9 Clinical registries provide knowledge about clinical effectiveness Basic biomedical science Clinical efficacy knowledge Clinical effectiveness knowledge Improved health care quality and value and population health NIH Roadmap: JAMA 2008;299: ; T1-T4 Research: Nature Medicine 2012;18:35 41 Role of Clinical Registries: Rumsfeld JS et al. U.S. Cardiology 2009;11-15 NCDR Publications 9

10 U.S. Institute of Medicine domains of high quality healthcare Effective Efficient Equitable Safe Timely Patient- Centered Institute of Medicine. Crossing the Quality Chasm: A New Healthcare System for the 21 st Century. National Academy Press 2001 Effective + Safe Care 10

11 Do clinical trial benefits extend to clinical practice? Compare real-world outcomes after ICD implantation with MADIT-II and SCD-HeFT Trials 5,816 propensity matched patients from ICD Registry from Median follow up: 35 months Al-Khatib S et al. JAMA. 2013;309:55-62 Similar outcomes between trials and practice. Al-Khatib S et al, JAMA. 2013;309(1):

12 A similar effectiveness story for TAVR in the U.S. Mack MJ et al. JAMA 2013;310: Comparative effectiveness and safety 829 hospitals; 22,778 dialysis patients; 22.3% received a contraindicated antithrombotic Tsai TT et al. JAMA 2009;302:

13 Acute MI registry data highlight major bleeding complication rates Mortality Bleeding Roe M et al. J Am Coll Cardiol 2010; Vol. 56, No. 4: Anticoagulant medication overdosing is a problem * Infusion (> 15 units/kg/hr) or bolus (> 70 units/kg) # Initial dose (> 1.05 mg/kg) or total 24 hr dose (> 10 mg over recommended) NCDR ACTION Registry-GWTG Data: July 1, 2009 June 30, 2010 Alexander KP, et. al. JAMA 2005;294(24):

14 Medication dosing is now a quality metric in hospital feedback reports Masoudi FA et al. Cardiovascular Care Facts: A Report from the NCDR: 2011 J Am Coll Cardiol 2013;62: Device safety: post-market studies and surveillance VasoSeal withdrawn from U.S. market VasoSeal had higher risk of vascular complications compared with manual compression (OR=2.38, p=0.0004) Tavris DR et al. J Invasive Cardiol. 2005;17:

15 Efficient Care Can PCI patients be discharged on the same day as the procedure? 107,018 patients 65 y/o undergoing elective PCI procedures at 903 hospitals Rao SV et al. JAMA. 2011;306(13):

16 Patients can be safely discharged, thus improving efficiency of care Complications rare 2 day and 30 day complication rates similar between groups Rao SV et al.jama. 2011;306(13): Rao SV et al. JAMA. 2011;306(13):

17 500,154 PCIs from 1091 hospitals Overall 4.1% inappropriate PCI rate Among non-acute PCIs:11.6% inappropriate Chan PS et al. JAMA 2011;306:53-61 Hospital variation in inappropriate non-acute PCIs Chan PS et al. JAMA 2011;306:

18 Timely Care Door to balloon times were slow and unchanging in the U.S. 18

19 Six strategies were identified among the best performing hospitals Bradley EH et al. N Engl J Med Nov 30;355(22): The ACC launched a national quality initiative 19

20 There were significant increases in D2B strategies used by hospitals Bradley EH et al. J Am Coll Cariol 2009; 54 (25): There was a significant improvement in D2B times nationally > 75% of patients with STEMI had D2B times within 90 min by Bradley EH et al. J Am Coll Cariol 2009; 54 (25):

21 Menees D. et al. NEJM 2013;369: Menees D. et al. NEJM 2013;369:

22 55% increase in the number of patients undergoing primary PCI (expanded indications) Secular trend toward more complex cases, changing case-mix. Within each year, shorter D2B times associated with significantly lower mortality Nallamothu BK et al. Lancet 2014 Nov 19. doi: /S (14) [Epub ahead of print] SCAAR: Swedish Coronary Angiography And Angioplasty Registry 22

23 Registry clinical trial infrastructure Baseline data Site recruitment Clinical Registry Program Clinical trial Post-trial surveillance The evolution of research using clinical registries Basic biomedical science Clinical efficacy knowledge Clinical effectiveness knowledge Improved health care quality and value and population health JAMA 2008;299: and Nature Medicine 2012;18:

24 The 21st Century Cures Act Pre-Market Post-Market Evolving Role for NCDR Programs Phase 1 Phase 2 Phase 3 Phase 4 Post- Post- Approval Market Studies Surveillance Clinical Registries Clinical Trials Clinical Practice 24

25 Post-Approval Studies (PAS) Edwards Post Approval Studies TVT Registry Abbott Post Approval Studies TVT Registry Boston Scientific Post Approval Study ICD Registry Medtronic Post Approval Study TVT Registry Boston Scientific Post Approval Study LAAO Registry Practice Research Technology 25

26 At 3pm Friday, local autocrat C. Montgomery Burns was shot following a tense confrontation at Town Hall. Burns was rushed to a nearby hospital where he was pronounced dead. He was then transferred to a better hospital where doctors upgraded his condition to alive. --Kent Brockman Newscaster, The Simpsons Thank you John.Rumsfeld@ucdenver.edu 26