P. Michael Grossman, MD Director, BMC2 PVI Associate Professor

1. P. Michael Grossman, MD Director, BMC2 PVI Associate Professor University of Michigan Hospitals and Health Center October 2013 BLUE CROSS BLUE SHIELD OF MICHIGANCARDIOVASCULAR CONSORTIUMVASCULAR INTERVENTIONS COLLABORATIVE- (BMC2 VIC)

2. Focus for Today • Update on our recent expansion and addition of new sites • Brief overview of data from the PVI part of our Collaborative • History of transfusion in BMC2 • Future direction

3. What is the “Blue Cross Blue Shield of Michigan Cardiovascular Consortium Vascular Intervention Collaborative?” I only have a few minutes, so from now on….. BMC2 VIC

4. What is BMC2 VIC? • Regional, physician-run, multidisciplinary collaboration • Partnership with Blue Cross Blue Shield of Michigan • Assess and improve quality of care and outcomes of PVI patients • Overcome barriers of traditional market and academic competition • Collect, organize, audit, and analyze data • Report procedural variables and outcomes • Individual physician operators • Institutions • Support quality improvement initiatives

5. Which Physicians Participate? Consecutive cases from all vascular interventions in participating hospitals Truly multidisciplinary • Vascular surgery • Interventional radiology • Interventional cardiology

6. 2014 PVI – 47 Participating Hospitals/Outpatient Centers

7. New PVI Outpatient Center Participants • Michigan Vascular Center • Michigan Outpatient Vascular Institute

8. BMC2 PVI/VIC Data Overview

9. PVI Patient Characteristics PVI Patients Have Multiple Co-Morbidities

10. Percent of PVI Procedures by Arterial Bed

11. BMC2 PVI Outcome Trends: 2007 – YTD Q2 2013 23% 38% Percent 14% 44%

12. 6-Month Medication Compliance* 2009 – 2012 RX compliance at 6 months with discharge medications Percent • *Medication Compliance – Patient continues to take the medications as prescribed at discharge after the PVI procedure

13. 6-Month Medication Compliance* Not Discharged with RX: 2009 – 2012 RX use at 6 months for patients not discharged on RX(and no documented contra-indication) • *Medication Compliance – Patient continues to take the medications as prescribed at discharge after the PVI procedure 37

14. Transfusion History in BMC2

15. BMC2 “Historical” Quality Improvement Approach Collect data Audit data Report data to participants Benchmarked to collaborative Good performers congratulated Underperformers scrambled to meet the mark or ignore the reports Communication with physician champions and site data coordinators “Trickle Down” Quality Improvement

16. Early PVI Transfusion Data

17. Early Transfusion Data

18. Quality Improvement Initiative: 2008 • Initiative focused on decreasing peri-procedural bleeding complications and post-procedural transfusion • Weight-based heparin anticoagulation dosing • Initial procedural heparin dose should be ≤ 60 U/kg • Check intra-procedural ACT • Heparin to achieve an ACT of 200 to 250 seconds • Follow guidelines for blood transfusion

19. From “Trickle Down” to “Aim for a Target” “…Setting a target resulted in better performance and significant cost savings (in janitorial services).”

20. Quality Improvement Goals: 2009-2010 Physician Advisory Committee approved creation of numeric PVI goals based on Collaborative data and goal to smooth practice variation across sites and reduce outliers: • ASA at Discharge > 90% • Statin at Discharge >75% • Vascular Complications < 4% • Post PVI Transfusion < 7% • Contrast Induced Nephropathy < 7%

21. A Quality Improvement Team was Created • QI team performed 24 site visits over a 2year time period • Visited sites where outcomes were low • Discussed a detailed questionnaire regarding site processes for peripheral vascular procedures • Obtained site protocols and order sets • Identified and starred the very best practices from these visits • Worked with the QI Team to merge the best practices together into a BMC2 compendium of “Best Practices”

22. QI Site Visit Questionnaire - Transfusion

23. April 2010 BMC2 Meeting • All BMC2 meeting to obtain a comprehensive review of the outcome literature, ways to prevent complications and patient management • Transfusion was one of the areas of focus • “Best Practice” protocols distributed to all sites – transfusion protocols included • Added focus on patients transfused with Hgb >8.0 • Additional quarterly hospital QI Reports were also created with detailed outcome specific information

24. Transfusion as an Adverse Outcome • Independent risk factor for mortality in several cardiovascular studies • Transfusion associated with bleeding • Increased hospital stay • Increased cost • Other risks of transfusion: • RBCs in stored blood act as NO “sinks” • Increase vasoconstriction, platelet aggregation • Stored RBCs are low in 2,3-diphosphoglyceric acid and have high oxygen affinity • Increased inflammatory mediators • Exacerbation of myocardial ischemia

25. Transfusion Literature • ACS Patients who received a blood transfusion had markedly worse 30-day mortality compared with those who did not receive a transfusion. RaoSV, et. al., JAMA 2004; 292:1555–1562 • Patients undergoing lower extremity revascularization; found a higher risk of postoperative mortality, pulmonary, and infectious complications after receiving intraoperative blood transfusion. O’Keeffe SD, et. al. J VascSurg2010; 51:616-21

26. Transfusion Literature (cont.) • Independent association between RBC transfusion and increased risk of 1-year mortality. • PCI Patients receiving blood > 35 days old had significantly worse 1-year survival rates compared with patients receiving blood < 35 days old and patients not transfused. Kim, P., et. al. Clinical Cardiology 2007; 30:II-35-43 • In patients undergoing cardiac surgery, transfusion of red cells that had been stored for more than 2 weeks was associated with a significantly increased risk of postoperative complications as well as reduced short-term and long-term survival. Koch CG et al. N Engl J Med 2008; 358:1229-1239

27. 2010 BMC2 Best Practice Protocols

28. 2010 BMC2 Best Practice Protocols

29. 2010 BMC2 Best Practice Protocols

30. 2008 - 2010 Transfusion Rate – 6% to 7%

31. Results from our Post-Procedure transfusion QI Initiative?

32. 2011 Survey: Value of BMC2 Best Practices 49 Responses: • 75% had obtained the protocols • 66% thought the protocols added value to quality improvement in the BMC2 Collaborative • 46% stated the protocols were used at their site to support quality improvement • Several others mentioned that quality improvements were “in process”

33. BMC2 PVI Outcome Trends for Transfusion: 2007 – YTD Q2 2013 52% Transfusion Rate (%)

34. Transfusion Recent PVI Survey ResultsSeptember/October 201315 respondents

35. Recent PVI Survey Results Do you transfuse at a threshold of:

36. Recent PVI Survey Results Do you use clinical parameters to decide when to transfuse in addition to Hgb? If so:

37. Recent PVI Survey Results Does your hospital employ techs, nurses, PAs or other professionals who obtain femoral artery access in the cath lab?:

38. Recent PVI Survey Results In a patient with a post operative NSTEMI and Hgb= 9.5 would you transfuse?

39. Recent PVI Survey Results In a post procedure patient with CAD and without symptoms of ischemia and a Hgb = 7.5 would you transfuse this patient?

40. Transfusion Future Direction

41. Predictors of PVI Post-Procedure Transfusion All Variables - Excludes hybrid procedures

42. Predictors of PVI Post-Procedure Transfusion (cont.) All Variables - Excludes hybrid procedures

43. Variables: Preliminary Risk Model • Family History of premature CAD • Hyperlipidemia • Hypertension • Diabetes • CHF • Significant Valve Disease • COPD • CVD/TIA • CAD • Prior PCI • Prior MI • Prior CABG • Current/Recent GI Bleed • Afib • Other Atherosclerotic Disease • Renal Failure • Renal Transplant • Gender • Age • BMI • Pre Procedure Aspirin • Pre Procedure Clopidogrel • Pre Procedure Prasugrel • Pre Procedure Statin • Pre Procedure Cilostazol • Pre Procedure Coumadin • Procedure Type: Upper Extremity • Procedure Type: Lower Extremity • Procedure Type: Mesenteric • Procedure Type: Renal • Indication = Claudication • Indication = Limb Ischemia • Pre Procedure Anemia (WHO definition) • Pre Procedure Creatinine >1.5

44. Preliminary Risk Model Includes patient history and pre-procedure variables only – Excludes hybrid procedures

45. Post-Procedure Transfusion: OE Plot (Blinded)

46. Collaborative Post-Procedure Transfusion OE Plot

47. Future Direction • Implementation of risk model for transfusion into quarterly reports • Issuance of “final” 2013 BMC2 Best Practice Protocols this winter – will contain Post op MI, SSI, and transfusion in a surgical setting. • Draft 2013 Best Practices are in your folders today.

48. BMC2 Welcomes Dr. Carson We are looking forward to hearing his presentation later this morning and are grateful to him for joining us today. Jeffrey L Carson, MD Vice Chair, Research Richard C Reynolds Professor of Medicine Chief, Division of General Internal Medicine Rutgers Robert Wood Johnson Medical School New Brunswick, New Jersey 08901