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Economic Impact of Routine FFR Measurement

Economic Impact of Routine FFR Measurement. What is FFR?. Fractional Flow Reserve (FFR) is a lesion specific, physiological index determining the hemodynamic severity of intracoronary lesions 1 .

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Economic Impact of Routine FFR Measurement

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  1. Economic Impact of Routine FFR Measurement

  2. What is FFR? Fractional Flow Reserve (FFR) is a lesion specific, physiological index determining the hemodynamic severity of intracoronary lesions1. FFR can accurately identify lesions responsible for ischemia which in many cases would have been undetected or not correctly assessed by angiography or IVUS2. FFR is measured at maximum hyperemia1. 1 De Bruyne B, et al, Heart 2008;94:949-959. 2 Tonino PM, et al. NEJM, 2009; 360:213-224 . 2

  3. How does FFR work? FFRmyo =Pd/Pa at hyperemiaFFRmyo =40/90= 0.44 3

  4. PressureWire The distal pressure in the coronary artery is measured by a miniature pressure sensor located 3 cm from the tip of an 0.014” guidewire, called PressureWireTM. 4

  5. RadiAnalyzer Xpress PressureWire is connected to RadiAnalyzer Xpress, an interface which makes the FFR calculations automatically during the procedure. FFR PressureWire Cathlab recording system IBP input AOtransducer 5

  6. What does the FFR value mean? During conditions of maximum hyperemia, only 71% of normal blood flow is able to reach the myocardium, due to one or more stenoses obstructing the flow in this vessel. 6

  7. Significant or not? The reduction in myocardial blood flow by a stenosis, as indicated by FFR, can be closely correlated to Ischemia. FFR = 1.0  Normal artery FFR > 0.75  Ischemia very unlikely, sensitivity 88% FFR < 0.75  Ischemia, specificity 100% “Measurement of Fractional Flow Reserve to asses the Functional Severity of Coronary Artery Stenoses”, Pijls et al; The New England Journal of Medicine; Vol 334: 1703-1708 (1996)

  8. The FAME Study • The Fractional Flow Reserve (FFR) vs. Angiography for Multivessel Evaluation (FAME) Study demonstrated significantly improved health outcomes at one year in patients randomized to multivessel percutaneous coronary intervention (PCI) guided by FFR compared to those patients guided by angiography alone. • In the FAME Study, 1005 patients with multivessel CAD were randomly assigned to FFR-guided PCI or angiography-guided PCI with DES and followed for one year. • The FAME Study shows that routine FFR measurements significantly improves procedural outcomes and saves cost without prolonging the procedure. • FAME’s primary endpoint was met and confirmed patients assessed with FFR had an overall reduction in MACE (Major Adverse Cardiac Events) rates to 28% at one year.

  9. Study Design

  10. 2-year Survival from Death and MI Tonino P. A. L et al; J. Am. Coll. Cardiol. 2010;55;2816-2821

  11. FAME Study - Cost-Effectiveness Evaluation Circulation. 2010;122:2545-2550.)

  12. Supporting Data on Key Economic Findings Total cost reduction at one-year was $2,066, of which $675 was directly related to direct material cost.

  13. FAME Study Resources Used and Costs Fearon et al, 2010 Circulation Volume122 page 2547.

  14. Overall Health Outcomes and Costs Fearon et al, 2010 Circulation Volume122 page 2548.

  15. FFR Better and Less Costly than Angiography Alone 1 Year Costs Angio $16,700 / patient FFR $14,315 / patient Fearon et al, 2010 Circulation Volume122 page 2548.

  16. Unique Study Results FFR-guided PCI in patients with multivessel diseaseis one of those rare situations in whicha new technology not only improves outcomesbut also saves resources. Fearon et al, 2010 Circulation Volume122 page 2545.

  17. Implementation for FFR Cost Effectiveness

  18. Options • FFR Cost Effectiveness customizable model • Risk Sharing Agreements • Retrospectively • Prospectively

  19. Risk Sharing - Retrospectively • Establish baseline materials used over procedure volume without FFR usage (angiography group) in FAME study criteria patients • Stents, Accessories, Contrast • Implement FFR in same procedure volume measuring materials used (FFR group) in FAME study criteria patients • Stents, Accessories, Contract, PressureWire, Hyperemic Agent • Compare Results between procedure volume groups • St. Jude Medical will reimburse 50% of PressureWire cost if FFR group does not show cost reduction over angiography group

  20. Risk Sharing - Prospectively • Enroll patients per FAME study protocol – randomize to either an angiography only group or FFR group • Measure materials used in each group • At end of patient enrollment or evaluation period, compare materials used in each group • St. Jude Medical will reimburse 50% of PressureWire cost if FFR group does not show cost reduction over angiography group

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