Post PCI functional testing and imaging: case based lessons from FFR React

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1 Post PCI functional testing and imaging: case based lessons from FFR React Joost Daemen, MD, PhD, FESC Optics in Cardiology 2018 April 21st, h

2 Disclosure Statement of Financial Interest Within the past 12 months, I or my spouse/partner have had a financial interest/arrangement or affiliation with the organization(s) listed below. Affiliation/Financial Relationship Institutional Research Support Consulting Fees/Honoraria Major Stock Shareholder/Equity Royalty Income Ownership/Founder Intellectual Property Rights Other Financial Benefit Company Medtronic, St. Jude Medical/Abbott, Acist, Boston Scientific, Pie Medical Pythagoras, ReCor Medical, Acist Medical N/A N/A NA N/A N/A

3 Why post PCI FFR? Strong predictor of MACE during follow-up Meta-analyses 10 studies / 970 lesions 574 patients SA/ACS Johnson N, et al. JACC (16): Agarwal S, et al. JACC Cardiov. Interv. 2016;9(10):

4 Why post PCI FFR? Meta-analysis of randomized controlled trials MACE Odds Ratio 4.95 Meta-analyses 10 studies / 970 lesions 574 patients SA/ACS Wolfrum et al. BMC Cardiovascular Disorders (2016) 16:177

5 Why post PCI FFR? Meta-analysis of randomized controlled trials Mortality Odds Ratio patients SA/ACS MI Odds Ratio TVR Odds Ratio 4.42 Wolfrum et al. BMC Cardiovascular Disorders (2016) 16:177

6 FFR-SEARCH: Stent Evaluated at Rotterdam Cardiology Hospital Objective: determine impact of FFR values post PCI on (long-term) clinical outcome Patients: consecutive all-comer patients with that were successfully treated with PCI Intervention: FFR assessment using ACIST NAVVUS rapid exchange FFR micro catheter after PCI Outcome: Primary: A composite of MACE (including all-cause mortality, myocardial infarction, any 30-days, 1 year, 2 years and 5 years Secondary: All separate endpoints, also including TLR, TVR, stent thrombosis

7 Post PCI FFR assessment Navvus Microcatheter P3 P4 P2 P1 P1: 20 mm distal of stent P2: distal stent edge P3: proximal stent edge P4: ostium (drift) FFR values: P1: 0.96 P2: 1.00 P3: 1.00 P4: 1.00 (drift 0)

8 FFR SEARCH Cumulative % per 0.01 FFR increment Percentage of lesions lesions (56.7%) > lesions (43.3%) patients lesions (19.8%) (8.9%) with 1 lesion lesions (7.7%) patients (22%) with 1 lesion FFR value (N = 1165 lesions) Diletti R. et al. EuroPCR 2017

9 Post PCI FFR Why are our results suboptimal? A: geographical miss (diseased reference segment); B: stent mal-apposition; C: under-expansion; D: intrastent plaque-protrusion/thrombus; E: edge dissection. Wolfrum et al. BMC Cardiovascular Disorders (2016) 16:177

10 FFR SEARCH - IVUS substudy Focal lesion (proximal*) FFR 0.85 (n=100) MLA Mean (SD) (n =120) 29 (29%) 2.9 (0.9) Focal lesion (distal) 30 (30%) 2.1 (0.5) Lumen compromising hematoma 3 (3%) 1.8 (0.6) Focal lesion (any) 54 (54%) - Underexpansion 4 68 (68%) 4.5 (1.9) Malapposition 23 (23%) - Spasm 9 (9%) *) MLA<4mm2 4) De Jaegere et al. MUSIC study Eur Heart J 1998 van Zandvoort et al. Submitted for publication

11 Distal stent edge Proximal stent edge Example of a proximal focal lesion Male, 63 years, non STEMI, LAD. Post PCI FFR 0, Lumen area = 7.9 MLA = 3.0 Lumen area = 7.6 0,94 0,90 0,83 Pre procedure Post procedure

12 Distal stent edge Proximal stent edge Example of underexpansion Male, 679 years, STEMI, LAD. Post PCI FFR 0, Stent area = 3.2 MLA = 2.0 Lumen area = Pre procedure Post procedure

13 PCI optimization feasible? In the presence of a persistently ischemic, or if not ischemic, unsatisfactory (as determined by the operator) post-pci FFR, a subsequent intervention was performed in many cases which may have included additional post dilation, further stenting, intravascular ultrasound (IVUS), optical coherence tomography (OCT), or a combination depending on the operator s discretion. A total of 137 (20%) lesions underwent a subsequent procedure based on a suboptimal post-pci FFR. Achieved by: Additional post dil 42% Additional stent 33% Postdil + additional stent 18% IVUS/OCT 9% Agarwal et al. JACC cardiovasc interv 2016

14 FFR REACT Trial To assess if FFR guided PCI optimization directed by high-definition IVUS improves patient outcome. Prospective single center randomized controlled trial 290 patients randomized (1:1) Assuming 45% post <0.90 ±640 patients to be included Primary endpoint - Target vessel failure at 1 year (Card death, target vessel MI, clinically driven TVR)

15 FFR REACT Case I To assess if FFR guided PCI optimization directed by high-definition IVUS improves patient outcome. Age: 50y Clinical presentation: Risk Factors: unstable angina Smoker, hypercholesterolemia Medical History: NSTEMI 2013 PCI RCA and LCX Residual lesion OM(50%)

16 FFR REACT Case I Left coronary system LAD: intermediate stenosis, diffuse disease LCX: Stent patent

17 FFR REACT Case I Right coronary RCA: significant in-stent restenosis mid and stenosis at bifurcation

18 FFR REACT Case I Predilatation 2.5x15 Pantera SC, 2x 20 atm Osiro DES 3.0x40, 16 atm Post dilatation 3.5x15 Pantera NC, 2x 18 atm

19 FFR REACT Case I Post PCI Pd/Pa Distal: 0.97 Distal stent edge: 0.98 Prox stent edge: 0.99 Ostium: 1.00 Post PCI FFR Distal: 0.88 Distal stent edge: 0.93 Prox stent edge: 0.94 Ostium:

20 FFR REACT Case I Treatment arm B: HD-IVUS No distal stent egde disease or dissection Mild underexpansion in mid-stent Proximal, severe underexpansion, MLA =3.0 Proximal stent edge fibro fatty plaque

21 FFR REACT Case I Extra post dilatation proximal stent 3.5x15 Pantera NC, 24 atm

22 FFR REACT Case I Final IVUS No proximal underexpansion, LA = 6.8

23 FFR REACT Case I Final post PCI Pd/Pa Distal: 0.98 Distal stent edge: 0.99 Prox stent edge: 0.99 Ostium: 0.98 Final post PCI FFR 1.00 Distal: 0.95 Distal stent edge: 1.00 Prox stent edge: 1.01 Ostium:

24 FFR REACT Case I Final angio

25 FFR REACT Case II To assess if FFR guided PCI optimization directed by high-definition IVUS improves patient outcome. Age: 66y, male Clinical presentation: Risk Factors: stable angina Stopped smoking one year ago, no other risk factors Medical History: No cardiac history

26 FFR REACT Case II Diagnostic angio LAD

27 FFR REACT Case II Placing 3.5x8mm Onyx DES

28 FFR REACT Case II Post PCI angiographic result

29 FFR REACT Case II Post PCI FFR using Navvus microcatheter a b c Pd/Pa FFR a. Equalization point b. Proximal stent edge c. Distal stent edge d. 20 mm distal from the stent d FFR= 0.88 (<0.90 randomization)

30 FFR REACT Case II IVUS MLA in stent = 7.79 mm² Organized thrombus MLA = 4.79 mm² Plaque burden = 71.5%

31 FFR REACT Case II Additional 4.0x18mm Onyx DES

32 FFR REACT Case II Final result 0.99/ / 0.97 Pd/Pa / FFR 1.00/ / 0.87

33 FFR REACT Case II Final IVUS

34 FFR REACT Case II Final angiographic result

35 Conclusions Post procedural FFR has a high diagnostic accuracy in detecting suboptimal procedural results After angiographic successful PCI, around 7.7% of lesions have a persistent ischemic FFR 0.80 and 43.3% of lesions have an FFR 0.90 Residual treatable focal lesions can be found in 54% of the patients with a post PCI FFR 0.85 More data on the use of post-pci FFR values, their association with intravascular findings and clinical outcome is warranted. (FFR REACT)

36 Thank you!

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