1. The impact of registries on clinical practice in the united states
Firas Zahr, M.D., FACC, FSACI
Section Head, Interventional Cardiology
Oregon Health & Science University

2. Disclosures
No relevant disclosures

3. Evolution of registries in cardiology

4. STS/ACC/TVT Sites

6. Performance measures
Represent a meaningful outcome to patients and society
Be valid, reliable, and readily measured
Have the ability to be adjusted for patient variability
Be modifiable through improvements in care processes
Be practical to measure
Quality of Care
Circulation 2000
P1485
Left column
Quality of Care and Outcomes Research in CVD and Stroke Working Groups. Circulation. 2000;101:

7. Outcome Measures
Outcome measures are changes in the patient’s health status due to the care delivered Risk adjusted mortality -Risk adjusted morbidity -Functional status -Patient satisfaction -Cost

8. What is the NCDR CathPCI Registry?
NCDR CathPCI is a registry of diagnostic cardiac catheterization and PCI data; more than 1000 US sites
Provides reports containing practice patterns, demographics, and outcomes of diagnostic procedures and therapies
Quarterly reports to institutions that are provider-specific; many parameters besides AUC data (fluoroscopy time, D2B, % normal cath rate, etc)
Supported by ACCF and SCAI, among others
Implemented the Appropriate Use Criteria 2009

9. The Mission of the NCDR™ is …
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.

10. Reporting An Example: Stress Test Level of Detail

11. Assess Patient Risk

12. NCDR PCI Risk Score

13. Registries Influence Devices therapy in Cardiology

14. How Are Registries Used Along the TPLC
Development and Pre-Clinical- Early Clinical
IDE Pivotal Trial
PMA Review - Approved
Post Approval Studies Surveillance (UDI tracking)
Device Iterations, OPC, Practice Guidelines, Payer, Safety Signals, Labeling Updates
Post-Market
Pre-Market
ACC/ NCDR Registries – TVT, CATH PCI, LAAO
Follow device through TPLC -Pre/Post Market Balance
Avoid duplicate data collection
Increase operational efficiencies
Decrease costs/time developing/conducting trials
PAS- timely completion & longitudinal surveillance (CRN - linked databases)

15. EXAMPLE OF poSITIVE SIGNAL

16. DETECTING NEGATIVE SIGNAL

17. Registries Support Clinical research

24. Benchmarking

25. CathPCI Registry Reports

26. CathPCI Registry Reports
10th Percentile
25th Percentile
Median
75th
Percentile
90th Percentile

27. Registries Impact Practice Guidelines

28. Clinical Practice Guidelines
30 years ago: Physicians relied upon experience and intuition to guide patient care
20 years ago: ACC/AHA/SCAI efforts began to provide Guidelines/standards of care
Rely on evidence-based care/randomized trials
If no evidence available, expert opinion
Generally speaking, ignore costs
Today: Appropriate Use Criteria (AUC)
A supplement to ACC/AHA/SCAI guidelines
Designed to improve efficient use of medical resources, to monitor utilization, to improve patient care and health outcomes

29. AUC Coronary Revascularization Background
Approximately 600,000 PCIs are performed in the US each year, at a cost that exceeds $12 billion.
Regional utilization variance has been noted by CMS.
Patients who undergo PCI are exposed to risks of peri-procedural complications and long-term bleeding and stent thrombosis.
Given the cost and invasiveness of PCI, determining the extent to which PCI procedures are performed for appropriate and inappropriate indications could identify procedural overuse and areas for quality improvement and cost savings.

30. AUC Coronary Revascularization Prototypical Patient Scenarios
180 clinical scenarios involved different combinations of:
Clinical Presentation
ACS, Stable CAD, prior CABG
Symptom severity
CCS angina class
Ischemia severity
Low, intermediate, high on noninvasive functional testing
High risk clinical features
Left ventricular dysfunction, ventricular arrhythmia
Intensity of anti-ischemic medical therapy
Extent of coronary anatomical findings on angiography
Significant 1-, 2-, 3-vessel coronary artery disease with or without disease of proximal LAD, LM or bypass graft

31. AUC Coronary Revascularization: The Key Variables Gradient
Clinical Presentation
Stable
Angina
STEMI
Severity of Angina
ASx, CCS Class I
CCS Class IV
Ischemia Tests/Prognostic Factors*
None,
Low Risk
High Risk
None
Max
Medical Therapy
No Sig. CAD
LM + 3v CAD
Anatomic Disease A U I
* CHF, DM, Low LVEF
Patel, et al. JACC 2009; 53:

32. AUC PCI Chart Example
Patel, et al. JACC 2012; 59:

33. PPCI for STEMI: Access Site and LOS
Shorter length of stay for STEMI patients undergoing primary PCI with radial access
RADIAL
FEMORAL
NCDR
N=6,159
N=84,720
<0.0001
Less than 2d
0.93%
1.23%
Between 2 and 4d
48.7%
40.5%
≥ 4 d
50.4%
58.3%
Unpublished data, personal communication from S Rao
RIFLE
N=500
N=501
CCU 3d 4d
<0.001
Total 5d 6d
0.008
Romagnoli E, et al. J Am Coll Cardiol 2012;60:2481–9

34. Impact of Bleeding Avoidance StrategY use on bleeding rates
Bleeding Avoidance Strategies as a hospital performance measure N~2.4 million PCI pts from CathPCI registry
Impact of Bleeding Avoidance StrategY use on bleeding rates
Hospitals that use BAS (e.g. radial approach)
in ≥ 80% of patients realize bleeding reduction
Vora AN, et. al. JACC Intv 2016

35. Significant cost savings with conversion to TRA and same day discharge
Matched medical records from NCDR and CMS
Magnitude of per-case savings ranges from $900 for TR PCI to $3500 for TR PCI with SDD
Programmatic conversion to TR access and/or SDD will result in more substantial cost savings
J Am Coll Cardiol Intv 2017;10:342–51

36. IMPACT ON OUR INSTITUTION

37. BUT! Initial challenge with radial artery thrombosis
Protocol for radial care and assure RA patency prior to discharge
Training and competencies in the TR band
$$$ keep pushing
Less femoral means less familiarity with the groin
Puncture site
Closure devices
Groin management especially for larger sheaths
One Ultrasound fits all

38. Conclusion
Voluntary national data registry system assisting hospitals (and physicians) with the ability to measure, understand, and improve quality of cardiovascular care.
Providing risk-adjusted outcomes and other process measures to participants.
It helps advancing medicine, changing clinical practice and heavily influence device therapies

39. Thank You