PASSION for Coronary Stents

1. PASSION for Coronary Stents

2. Diabetes • 2500 hospitals • 2500 cardiologists • 35M clinical records PVI 1998 2004 2005 2006 2007 2008 2009 2010 2012 2014 2015 AF Ablation in 2016

3. NCDR collaborations

4. As of 6/4/2014

5. CathPCI Registry • QI Activities • PCI-RAM, RAB and AKI models reported in Outcome Reports • AUC updated in Outcome Report • Physician Dashboard live via Cardiosource • Reporting Collaborations • States – MA, WV, MI, MD, CA, WA • Payers – United, BCBSA, WellPoint • Health Systems – Tenet, HCA, CHW • Prospective Research Projects • TRANSLATE • SAFE-PCI – Results at NCDR.14

6. NCDR Data Acquisition Software Vendors Benchmark Reporting Quality Improvement NCDR Home grown systems Clinical Research ACC’s web tool EHR

7. Data Quality • Training and Clinical Support Team • Orientation webinars • Online FAQs • Live customer support • Email • Monthly webinars • Annual meeting with case reviews, etc. • Data Entry Integrity • Software value checks • Field level range parameters • Parent:Child fields • Data Completeness • Completeness monitoring reports • Data Accuracy • Up to 650 records audited annually. • Adjudication

8. NCDR Data Quality Brief • Self reported • Accuracy JACC 2012;60:1484-88.

9. Registry PlatformClinical Research Studies Using a National Clinical Registry as a platform for research • Larger patient volumes • Can use central randomization mechanism • Ongoing data capture • Economical • Reduces data entry burden • Real world population • Consecutive patients

10. An example… SAFE-PCI for Women

11. “FDA believes that national and international registries in selected product areas and electronic health information containing unique device identifiers (UDI) should serve as the foundation of our National Medical Device Surveillance System.”