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

Disclosures No relevant disclosures

Evolution of registries in cardiology

STS/ACC/TVT Sites

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;101:1483-1493.

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

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

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.

Reporting An Example: Stress Test Level of Detail

Assess Patient Risk

NCDR PCI Risk Score

Registries Influence Devices therapy in Cardiology

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)

EXAMPLE OF poSITIVE SIGNAL

DETECTING NEGATIVE SIGNAL

Registries Support Clinical research

Benchmarking

CathPCI Registry Reports

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

Registries Impact Practice Guidelines

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

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.

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

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; 53:530-553

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

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

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

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

IMPACT ON OUR INSTITUTION

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

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

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