Know Your Study Enrolling Studies List

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1 Know Your Study Enrolling Studies List Enrolling studies list now available in all Clinic Work Rooms Top studies selected for January by Section/Area Talk with your Section s Research Manager Page 1 of 42

2 Know Your Study Enrolling Studies List If your patient might be eligible, send an in-basket via EPIC Coordinator contact information provided Research study participation offers your patients more options Increased referrals leads to higher enrollment Page 2 of 42

3 CARDIOLOGY GRAND ROUNDS Title: Update on the MHI experience with FFR-CT Speaker: John R. Lesser, MD, FACC, FSCCT, FAHA, FSCAI Senior Consulting Cardiologist, Medical Director CT/CMR Minneapolis Heart Institute at Abbott Northwestern Hospital Adjunct Associate Professor of Medicine, University of Minnesota Date: Monday, January 16, Time: 7:00 8:00 AM Location: ANW Education Building, Watson Room OBJECTIVES At the completion of this activity, the participants should be able to: 1. Understand and review the clinical basis for coronary revascularization using invasive FFR. 2. Define the clinical data supporting the use of FFR-CT in clinical practice. 3. Understand the lessons learned through the implementation of FFR-CT at MHI and discuss next steps or approaches. ACCREDITATION Physician Allina Health is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians. Allina Health designates this live activity for a maximum of 1.0 AMA PRA Category 1 Credit(s) TM. Physicians should only claim credit commensurate with the extent of their participation in the activity. Nurse This activity has been designed to meet the Minnesota Board of Nursing continuing education requirements for 1.2 hours of credit. However, the nurse is responsible for determining whether this activity meets the requirements for acceptable continuing education. DISCLOSURE STATEMENTS Moderator(s)/Speaker(s) Dr. Lesser has disclosed that he does not have a conflict of interest in making this presentation. Planning Committee Dr. Alex Campbell, Dr. Kevin Harris, Rebecca Lindberg, Dr. Michael Miedema, Dr. JoEllyn Carol Moore, Dr. Scott Sharkey, and Jolene Bell Makowesky have declared that they do not have any conflicts of interest associated with the planning of this activity. Dr. David Hurrell declares the following relationship Boston Scientific: Chair, Clinical Events Committee. PLEASE SAVE A COPY OF THIS FLIER AS YOUR CERTIFICATE OF ATTENDANCE Signature: My signature verifies that I have attended the above stated number of hours of the CME activity. Allina Health - Learning & Development Chicago Ave - MR Minneapolis MN Page 3 of 42

4 Background and 1 Year Clinical Experience with FFR-CT at MHI John R. Lesser, MD Minneapolis Heart Institute Presenter Disclosure Information John R. Lesser, M.D. DISCLOSURE INFORMATION: The following relationships exist related to this presentation: None Page 4 of 42

5 Animal Coronary Constrictor vs Human Epicardial Doppler and CA Animal model Human measurements Gould KL. JACC Cardiovascular imaging 2009;2: White CW, et al. N Engl J Med 1984;310: Current Status with CAD Dx ACC NCDR Registry No known prior CAD 663 hospitals, ~ 400,000 pts. 84% had non-invasive testing 38% obstructive disease 39% no CAD at all + Non-invasive test: 41 vs. 35% (no stress test) significant CAD Patel MR, et al. NEJM 2010;362: Page 5 of 42

6 Non-invasive Tests in ACC NCDR Registry Cury RC. JCCT 2014;8:480-2 Standard approach for sorting patients with possible angina is inadequate and inefficient Page 6 of 42

7 Flow Reserve Adenosine (dilates arterioles) Pa Pd Abnormal FFR < 0.75 to 0.8 Physiologic Significance of CAD Stenoses: Relationship of % Stenosis to Invasive FFR, stenoses, n = 2986 QCA Toth G, et al. EHJ 2014;35: Page 7 of 42

8 FFR and MPI: Multivessel CAD n=76 n=201 vessels 42% agreement in vessel territory 36% MPI underestimated 22% MPI overestimated Melikian N et al. JACC Intv 2010;3: Meta-analysis of FFR and Stress MPI with MR, PET, CT(P) Per Patient Per Vessel Stress MPI MRI, PET, CT can R/O severe CAD gatekeeper for CA Stress SPECT, echo not as good Takx RAP, et al. Circ Cardiovasc Imaging. 2015;8:e DOI: /CIRCIMAGING Page 8 of 42

9 The best diagnostic test is associated with improved outcomes Lead to beneficial therapy and/or avoidance of harm What is the evidence for invasive FFR? Courage Trial: Stable CAD Anatomic Assessment (no LM lesion) Anatomic (PCI) vs OMT PCI+OMT OMT Death 7.6% 8.3% MI 13.2% 12.3% ACS 12.4% 11.8% Total: 19.0% 18.5% 4.6 year follow-up Boden W et al. N Engl J Med 2007;356:1503 Page 9 of 42

10 FAME 1 Trial Meta-analysis (DEFER; FAME 1) of FFR studies and outcomes 20% fewer adverse events (vs. anatomy, OMT) 10% better anginal relief (vs. OMT alone) FFR is the clinical standard Johnson N, et al. JACC 2014;64: Page 10 of 42

11 FAME 2 n=441 n=447 Stable angina, multi-vessel CAD FFR < 0.8 PCI + OMT vs OMT 2 year f/u Primary combined endpoint 8.1 vs 19.5% (p< 0.001) Targeted PCI improved outcome De Bruyne B et al. NEJM 2014;371: Cost-Effectiveness of PCI FFR-Guided Tx PCI FFR guided vs maximal medical tx (FAME 2 Trial) Less angina with CAC 2 or > 11.1% versus 28.9%, P< Greater patient utility QOL questionairre (EQ-5D survey) $50,000 per QOL year Fearon WF, et al. Circulation 2013;128: Page 11 of 42

12 Stress or anatomic (invasive or noninvasive) imaging tests serve as a surrogate for the gold standard of invasive FFR FFR Versus QCA, QCT, CCA, and CTCA (FFR invasive physiologic standard) Meijboom, W. B. et al. J Am Coll Cardiol 2008;52: Page 12 of 42

13 FFR: Comparison of CA (QCA) vs CCTA n= 252 pts All with FFR, QCA, and CCTA Defacto trial patients with intermediate severity lesions (30 to 90%) 54% with abnormal FFR per patient (37% per vessel) CA and CCTA no difference in predicting lesion causing ischemia Same result per vessel (not shown) Budoff MJ, et al. JACC Img 2016;9: Rationale for FFR-CT CCTA problems with specificity and PPV QCA and CCTA highly correlated Stenoses > 50% predict ischemia < ½ lesions Stress SPECT poorly identifies specific ischemic coronary territories DEFER, FAME 1, 2 lessen events with targeted PCI based on invasive FFR Better than angio guided PCI or best med tx De Bruyne B, et al. NEJM 2012;367: Pijls NH et al. JACC 2007;49: Tonino PA, et al. NEJM 2009;360: Page 13 of 42

14 Inlet and outlet boundaries Millions of nonlinear differential equations (Navier-Stokes) Myocardial mass Coronary anatomy Form-function principles Standard coronary CTA acquisition Post-processing technique No additional contrast or radiation No additional medications Page 14 of 42

15 Form and Function relationships Mass of an object relates to shape, anatomy, and physiology Coronary flow proportional to myocardial mass (directly measured from CTA) Distal blood vessel size adapts to chronic change in flow in 4 to 6 weeks Vessel feeding territory that is repetitively ischemic will decrease in size Small coronary branches have higher resistance to flow Resistance to flow proportional to number and size of branches Assume a max hyperemic decrease in distal resistance (0.24 of resting resistance) Possible Limitations Extensive coronary calcification Coronary motion Slice misregistration Overestimate lesion importance with presence of microvascular disease No clear information with stents or grafts yet Taylor CA, et al. JACC 2013;61: Page 15 of 42

16 FFR-CT NXT: Accuracy Trial Patients (n=251, 484 vessels) with 30 to 70% stenoses FFR-CT More careful requirements for CT image quality Improved technical and physiologic modeling based on retrospective (machine) learning from prior trials Invasive FFR on all vessels Norgaard BL, et al. JACC 2014;63: Invasive FFR vs n=254 n=484 Page 16 of 42

17 (FN) (FP) Norgaard BL, et al. JACC 2014;63: CCTA and FFR-CT vs FFR Per Patient Per Vessel Norgaard BL, et al. JACC 2014;63: Page 17 of 42

18 PLATFORM Trial: Clinical Application Noninvasive Invasive Compare effectiveness of 2 strategies 11 centers and 6 EU countries Primary Endpoint: Patients with a planned ICA Are patients evaluated using a CTA/FFR CT guided strategy less likely to undergo ICAs that show no obstructive CAD? Douglas PS, et al. EHJ 2015;doi: /eurheartj/ehv444 Platform Trial: Usual Care (stress, CTA) vs FFR-CT (n=204) (n= 380) % pre-test prob in intended cath arm 61% cancelled ICA in CTA/FFRct arm 73% (usual care QCA; 57%, visual) vs 12% CTA/FFR-CT insignificant ds Assessed by QCA or FFR Douglas PS, et al. EHJ 2015;doi: /eurheartj/ehv444 Page 18 of 42

19 After 90d FFR-CT (anatomic and functional) leads to more selective use of resources in invasive arm FFR-CT slightly more cost in noninvasive planned arm but improved QOL Even when assume FFR-CT costs 7X > CTA, there is a 20% (p< ) cost improvement over invasive testing strategy Hlatky MA, et al. JACC 2015;66: Costs of Care at 12 Months P< days 180 days P= days $2,579 $3,049 $12,145 $8,127 Page 19 of 42

20 PLATFORM In the context of other trials: Patients without Obstructive Disease at ICA (site read) NCDR NCDR US VA PROMISE Functional PLATFORM Usual Care PLATFORM FFR CT Guided Douglas, P. S FFR-CT Technical limitations and reproducibility Page 20 of 42

21 Patients Vessels Norgaard BL, et al. JACC Img 2015;8: Invasive FFR: Reproducibility (DEFER trial) 2 repeat measurements 10 min apart 95% measurement certainty if outside 0.75 to 0.85 <80% when 0.77 to 0.83 and 50% at 0.8 Use multiple readings and clinical judgment Petraco R, et al. JACC Intv 2013;6:222 5 Page 21 of 42

22 Gaur S, et al. JCCT 2014;8: FFR-CT: Questions for Clinical Use Pressure on CT image quality, turn-over time for results, cost? How will clinical outcomes reflect study outcomes? Differences in patient population Applicable for acute lesions? How do you relate a continuous variable to a binary choice (FFR < or > 0.8)? Risk linearly increases with severity of FFR result Will clinical routine be unchanged by new test results? Page 22 of 42

23 Our Experience: Expected Use Is the LAD a potentially flow-limiting stenosis? LAD RCA CX CACS= 758; Atrial fib Not flow-limiting Typical Angina: Provisional Use of FFR-CT Would not expect to clinically need FFR-CT in this case May need to provide physiology for payors Page 23 of 42

24 Application: Recurrent new onset CP, R/O in ED, CCTA next day Reluctant to have an invasive test Know the vessel and size to discuss options; med tx vs CA Unique added value of FFR-CT to CCTA Cross check artifact vs disease, disease severity Post Anomalous RCA Button Reimplant Pre Post FFR-CT: 0.97 Page 24 of 42

25 Pre-op Aortic Surgery: Avoid CA Known CAD with prior distal CX occlusion: Are new symptoms from a new or old lesion? LAD Diag OM1 OM2-AV Groove RCA (non-dom.) CACS = 886 Page 25 of 42

26 ICA: 3 years before Normal lexiscan sestamibi with continued pain CCTA to look for a false negative RCA 0.84 LAD 0.65 CX 0.90 CT reader gave result to noninvasive referring cardiologist Elective cath, cared for by PA and interventional MD Page 26 of 42

27 Decision to Cath by FFR-CT FFR-CT LAD = 0.65; RCA 0.84 Visually driven decision for DES to LAD and RCA Different (but Valid) Ways to Assess Atypical chest pain 2 years ago Stress echo, 6 min, peak HR 144 x 164 = DP 23,616 No sxs and neg test New onset intermittent chest pain rest and exercise Regadenoson-sestamibi fixed inferior defect, LVEF 57% CCTA ordered Page 27 of 42

28 LM LAD RCA LM LM luminal area 7 mm2 RCA (PR, LAP) FFR-CT Page 28 of 42

29 IVUS LM: 6.9 mm2 Which approach is best? Post LM, LAD, RCA DES Physiology vs IVUS anatomy in LM? Complete revascularization visually determined Were LM and LAD stents good work or unnecessary risk? Page 29 of 42

30 Cross Check for a New, Distracted, or Weaker CT Reader RCA LAD CX No significant lesion. Will check with FFR-CT FFR-CT Avoided a False Negative Page 30 of 42

31 Elevated Coronary Calcium: CACS = 2,706, Good quality study RCA LAD CX Heavy coronary calcification Cross check for intermediate LAD stenosis No invasive CA Urinary Sepsis and Elevated Troponin: No objective Signs of ACS RCA LAD CX In-hospital patient (more common use of CCTA) Diffuse disease in all vessels No discreet proximal or mid lesion with pressure drop Page 31 of 42

32 New Onset CP: Acute FFR-CT FFR-CT is higher here than expected (ED trial with rapid FFR-CT turn around in planning) Vessel not conditioned by ischemia to decrease size? Problem of Communication, Registration : Exertional CP LAD LAD OM1 OM1 CX CX Cath Report: Normal FFR (of OM), no lesions Page 32 of 42

33 I ordered a coronary CTA and a FFR-CT was 0.71 in the LAD. The invasive FFR was What happened? 63 yo woman New onset chest pressure while sitting Diaphoresis Getting more tired in the past few weeks + F. Hx of CAD; quit smoking 2 years before Coronary CTA performed CAS msv, 70 ml contrast, 0.8 mg SL NTG Page 33 of 42

34 CCTA LAD Diagonal Process Multiple datasets sent for FFR-CT Returned next day and PDF is scanned into medical record CCTA reader clipped the conclusion and sent it to the referring Cardiologist. An invasive CA is recommended Page 34 of 42

35 Page 35 of 42

36 Use Interactive tool Interrogate the coronary bed at any point Insignificant pressure drop across proximal LAD FFR-CT slightly lower than invasive FFR (~0.03) Progressive pressure drop across the entire vessel Page 36 of 42

37 17% without focal lesion but atherosclerosis had FFR < 0.8 De Bruyne B, et al. Circulation 2001;104: Microvascular vs Epicardial vs Both vs None CACS 812 Recurrent CP CCTA equivocal LAD Distal FFR-CT equivocal Invasive LAD FFR 0.8 F/U negative exercise sestamibi 2 months but continued sxs Page 37 of 42

38 Virtual Stenting: FFR-CT Kim K-H, et al. JACC Intv 2014;7:72-8 MHI Experience with FFR-CT Initial exclusions Systolic imaging (required diastole for myocardial mass) often use with HR > 68 Known prior CAD (eg. stent, CABG) Mild or no CAD Current exclusions CABG and stented vessel (can assess non-stented arteries in same patient) 94% of datasets can be analyzed Page 38 of 42

39 FFR-CT: Our Selection Bias Send severe disease (high likelihood of cath) Recheck severe lesion and other vessels Lead to a high PCI rate per FFR-CT sent Tendency for extra motion or calcium that creates interpretation uncertainty Bias against accuracy Some readers do not send visually moderate disease? False sense of confidence in the anatomic technique (similar to CA) MHI Results: Patients sent for FFR-CT 253 of 389 (65%) had epicardial and/or distal vessel abnormality 185 of 389 had an abnormal lesion FFR-CT Epicardial lesion in 67 of 185 (31%) were treated medically without ICA 124 of 389 (32%) pts had an ICA 76 of 124 (61%) with PCI or CABG 17 of 124 (14%) were sent for ICA because FFR-CT data was misread (76 of 107, (71%), assuming proper reading of FFR-CT) 67 of 389 (17%) with abnormal distal FFR-CT only Page 39 of 42

40 Miscellaneous Findings Lesion related abnormal FFR-CT and FFR 13 of 19 were false positive Small number of patients had an anatomy-based PCI when FFR-CT was normal 2 False negative patients, both in setting of an acute lesion Both sent to ICA because of a severe visual stenosis on CCTA Unexpected Findings High number of patients with epicardial lesions were treated medically without invasive CA A modest number with a lesion FFR-CT < 0.8 have an abnormal whole (distal) vessel FFR-CT elsewhere A minority of patients (17%) with a lesion FFR-CT > 0.8 have abnormal whole vessel FFR-CT < 0.8 Page 40 of 42

41 Other Use for FFR-CT QA - provide a random selection of cases per reader Future prediction of lesions at risk for rupture via shear stress analysis Insurance payment for CCTA if a FFR-CT is available Provisional use Conclusions FFR-CT Selective PCI of vessels with an invasive FFR < 0.8 is associated with event-free survival FFR-CT is a post-processing technique that is highly correlated with invasive FFR Improves the specificity of CCTA Lowers the rate of insignificant CA and likely costs Very low FN rate (? acute cases) New clinical option has been introduced into our practice Page 41 of 42

42 Thank You Page 42 of 42