docPASSION for Coronary Stents
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PASSION for Coronary Stents
PASSION for Coronary Stents Diabetes • 2500 hospitals • 2500 cardiologists • 35M clinical records 1998 2004 2005 2006 PVI 2007 2008 2009 2010 2012 2014 2015 AF Ablation in 2016 NCDR collaborations Registry CathPCI (Diag. Cath &PCI) ICD ACTION Registry-GWTG (STEMI & NSTEMI) PVI (CAS, CEA, LLE) IMPACT (Ped & Adult Congenital Intervention) PINNACLE (All CV Outpatient) STS/ACC TVT (Transcatheter Valve Therapy) # Participants # Patient Records % Market Share 1,650 17 million 95% 1,715 1.3 million 100% 1010 700,000 40% 210 350,000 15% 85 40,000 45% 2,500 18 million 15% 380 23,000 98% As of 6/4/2014 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 NCDR Data Acquisition Software Vendors Benchmark Reporting Quality Improvement Home grown systems NCDR P D A S Clinical Research ACC’s web tool EHR 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 NCDR Data Quality Brief • Self reported • Accuracy JACC 2012;60:1484-88. Registry Platform Clinical Research Studies Using a National Clinical Registry as a platform for research • Economical • Reduces data entry burden • Real world population • Consecutive patients • Larger patient volumes • Can use central randomization mechanism • Ongoing data capture An example… SAFE-PCI for Women In a nutshell… • NCRI proof of concept • First multicenter randomized trial comparing radial with femoral access in U.S. • First randomized trial comparing interventional strategies in women • Sponsored by DCRI • Used NCDR CathPCI Registry platform • Estimated 65% per patient workload reduction Programmatic outcomes… • • • • • $750 per patient reimbursement ~ $5 million budget Study start up time cut in half Included research naive sites Wider enrollment spread • 90% sites enrolled at least 1 patient • > 70% sites enrolled at least 10 patients “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.” Radius Self Expanding Stent Boston Scientific Corporation NIR Elite Monorail RE Stent Boston Scientific Corporation NIR Elite OTW Stent Boston Scientific Corporation Multi-Link OTW ZETA Stent Boston Scientific Corporation Multi-Link PENTA Stent Boston Scientific Corporation Multi-Link RX ZETA Stent Boston Scientific Corporation Multi-Link TETRA Stent Boston Scientific Corporation Magic WALLSTENT Self Expanding Stent Boston Scientific Corporation Liberte OTW Stent Boston Scientific Corporation Liberte RE Stent Boston Scientific Corporation Express2 OTW stent Boston Scientific Corporation Express2 RE stent Boston Scientific Corporation Multi-Link Mini Vision OTW Stent Abbott Vascular Devices Multi-Link Mini Vision RX Stent Abbott Vascular Devices Multi-Link Pixel Stent OTW Abbott Vascular Devices Multi-Link Pixel Stent RX Abbott Vascular Devices Multi-Link Ultra Stent - OTW Abbott Vascular Devices Multi-Link Ultra Stent - RX Abbott Vascular Devices Multi-Link Vision OTW Stent Abbott Vascular Devices Multi-Link Vision RX Stent Abbott Vascular Devices Stent - Peripheral (any mfr) Not Specified Jostent Coronary Stent Graft Abbott Vascular Devices BeStent2 w/ Discrete Tech OTW Stent Boston Scientific Corporation R Stent Evolution Orbus Medical Technologies R Stent SVS (small vessel system) Orbus Medical Technologies R Stent Prodigy Medtronic S660 with Discrete Technology OTW Stent Medtronic S670 with Discrete Technology OTW Stent Medtronic S7 with Discrete Technology OTW Stent Medtronic S7 Zipper MX Multi-Exchange Stent Medtronic Micro Driver (OTW) Medtronic Micro Driver MX2 (RX) Medtronic Driver MX2 (RX) Medtronic Driver OTW Coronary Stent Medtronic Driver Zipper MX Coronary Stent Medtronic Bx Velocity OTW Stent Johnson & Johnson Bx Velocity Rx Stent Johnson & Johnson CROSSFLEX LC Stent (OTW) Johnson & Johnson SLK-View Boston Scientific Corporation Teneo coronary stent Biotronik Bx SONIC OTW Stent Johnson & Johnson Presillion Plus CoCr Coronary Stent Rx Cordis Integrity OTW Coronary Stent Medtronic Integrity RX Coronary Stent Medtronic VeriFLEX RX Boston Scientific Corporation VeriFLEX OTW Boston Scientific Corporation Driver RX Medtronic Micro Driver RX Medtronic Multi-Link 8 LL Rx Abbott Vascular Devices Rebel Stent RX Boston Scientific Corporation Rebel Stent OTW Boston Scientific Corporation Self-Apposing Stent BMS STENTYS Bx Velocity RX Stent with HEPACOAT Johnson & Johnson Bx Velocity OTW Stent with HEPACOAT Johnson & Johnson Bx SONIC OTW Stent with HEPACOAT Johnson & Johnson BioDivYsio Stents (phosphorylcholine) Biocompatibles Ltd Rithron-XR Coronary Stent System Biotronik Tenax-XR Amorphous Silicon Carb. Coated Stent Biotronik Jostent GraftMaster OTW Abbott Vascular Devices Symbiot Covered Stent (ePTFE polymer) Boston Scientific Corporation Bare Metal Stent Bare Metal Stent Bare Metal Stent Bare Metal Stent Bare Metal Stent Bare Metal Stent Bare Metal Stent Bare Metal Stent Bare Metal Stent Bare Metal Stent Bare Metal Stent Bare Metal Stent Bare Metal Stent Bare Metal Stent Bare Metal Stent Bare Metal Stent Bare Metal Stent Bare Metal Stent Bare Metal Stent Bare Metal Stent Bare Metal Stent Bare Metal Stent Bare Metal Stent Bare Metal Stent Bare Metal Stent Bare Metal Stent Bare Metal Stent Bare Metal Stent Bare Metal Stent Bare Metal Stent Bare Metal Stent Bare Metal Stent Bare Metal Stent Bare Metal Stent Bare Metal Stent Bare Metal Stent Bare Metal Stent Bare Metal Stent Bare Metal Stent Bare Metal Stent Bare Metal Stent Bare Metal Stent Bare Metal Stent Bare Metal Stent Bare Metal Stent Bare Metal Stent Bare Metal Stent Bare Metal Stent Bare Metal Stent Bare Metal Stent Bare Metal Stent Bare Metal Stent Coated Stent Coated Stent Coated Stent Coated Stent Coated Stent Coated Stent Covered Stent Covered Stent GRAFTMASTER RX Stent Angiosculpt Scoring Balloon Catheter Flextome Cutting Balloon Monorail Flextome Cutting Balloon OTW Cutting Balloon Ultra Monorail Cutting Balloon Ultra OTW Cutting Balloon Ultra2 (OTW) Cutting Balloon Ultra2 Monorail Taxus Liberte Atom - OTW Taxus Liberte Atom - RX Xience V DES - OTW - Multilink Vision Xience V DES - RX - Multilink Vision Xience V DES - OTW - Multilink MiniVision Xience V DES - RX - Multilink MiniVision TAXUS Liberte Long Stent Taxus Liberte Stent - OTW Taxus Liberte Stent - RX Taxus Express2 ATOM - OTW Taxus Express2 ATOM - RX Endeavor Sprint - RX Endeavor Sprint - OTW Promus Element RX Promus Element OTW Xience Prime LL Rx Resolute Integrity Rx Resolute Integrity OTW Promus Element Plus Rx Promus Element Plus OTW Xience Nano Rx Xience Xpedition DES Rx Abbott Vascular Devices Angioscore Boston Scientific Corporation Boston Scientific Corporation Boston Scientific Corporation Boston Scientific Corporation Boston Scientific Corporation Boston Scientific Corporation Boston Scientific Corporation Boston Scientific Corporation Abbott Vascular Devices Abbott Vascular Devices Abbott Vascular Devices Abbott Vascular Devices Boston Scientific Corporation Boston Scientific Corporation Boston Scientific Corporation Boston Scientific Corporation Boston Scientific Corporation Medtronic Medtronic Boston Scientific Corporation Boston Scientific Corporation Abbott Vascular Devices Medtronic Medtronic Boston Scientific Corporation Boston Scientific Corporation Abbott Vascular Devices Abbott Vascular Devices Covered Stent Cutting Balloon Cutting Balloon Cutting Balloon Cutting Balloon Cutting Balloon Cutting Balloon Cutting Balloon Drug Eluting Stent Drug Eluting Stent Drug Eluting Stent Drug Eluting Stent Drug Eluting Stent Drug Eluting Stent Drug Eluting Stent Drug Eluting Stent Drug Eluting Stent Drug Eluting Stent Drug Eluting Stent Drug Eluting Stent Drug Eluting Stent Drug Eluting Stent Drug Eluting Stent Drug Eluting Stent Drug Eluting Stent Drug Eluting Stent Drug Eluting Stent Drug Eluting Stent Drug Eluting Stent Drug Eluting Stent Xience Xpedition DES OTW Abbott Vascular Devices Xience Xpedition LL DES OTW Abbott Vascular Devices Xience Xpedition LL DES Rx Abbott Vascular Devices Xience Xpedition SV DES OTW Abbott Vascular Devices Xience Xpedition SV DES Rx Abbott Vascular Devices Self-Apposing Stent DES STENTYS BioMatrix Flex Biosensors ION Stent OTW Boston Scientific Corporation ION Stent Monorail Boston Scientific Corporation Promus PREMIER OTW Boston Scientific Corporation Promus PREMIER RX Boston Scientific Corporation PRO-Kinetic Energy Stent OTW Biotronik PRO-Kinetic Energy Stent RX Biotronik Absorb Bioresorbable Vascular Scaffold System Abbott Vascular Devices Xience Alpine RX Abbott Vascular Devices Xience Alpine OTW Abbott Vascular Devices Promus PREMIER Boston Scientific Corporation Champion DES (Everlimus) Boston Scientific Corporation Taxus Express 2 Monorail Drug Eluting Stent Boston Scientific Corporation Taxus Express 2 OTW Drug Eluting Stent Boston Scientific Corporation Taxus Liberte Paclitaxel-Eluting Stent Boston Scientific Corporation Tacrolimus Eluting Stent Janus Cypher Sirolimus-eluting Stent (OTW) Johnson & Johnson Cypher Sirolimus-eluting Stent (Rx) Johnson & Johnson Endeavor Stent (OTW) Medtronic Endeavor Stent MX2 Medtronic Endeavor Stent RX Medtronic Promus DES RX Boston Scientific Corporation Promus DES OTW Boston Scientific Corporation Xience DES RX Abbott Vascular Devices Xience DES OTW Abbott Vascular Devices Drug Eluting Stent Drug Eluting Stent Drug Eluting Stent Drug Eluting Stent Drug Eluting Stent Drug Eluting Stent Drug Eluting Stent Drug Eluting Stent Drug Eluting Stent Drug Eluting Stent Drug Eluting Stent Drug Eluting Stent Drug Eluting Stent Drug Eluting Stent Drug Eluting Stent Drug Eluting Stent Drug Eluting Stent Drug Eluting Stent Drug Eluting Stent Drug Eluting Stent Drug Eluting Stent Drug Eluting Stent Drug Eluting Stent Drug Eluting Stent Drug Eluting Stent Drug Eluting Stent Drug Eluting Stent Drug Eluting Stent Drug Eluting Stent Drug Eluting Stent Drug Eluting Stent
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