CHIP Complex Higher-risk (and indicated) PCI

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1 CHIP Complex Higher-risk (and indicated) PCI Ziad A Ali MD DPhil Columbia University Medical Center Cardiovascular Research Foundation

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 Grant/Research Support: NIH/NHLBI, Medtronic, St Jude Medical Consulting Fees/Honoraria: St Jude Medical, InfraRedX, Medtronic Shares/Stock/Equity: Shockwave Medical, VitaBx Inc

3 Referred for Angina 1 55 y.o male with HTN, HLD 4 months of exertional angina Nuclear stress test positive for inferior wall ischemia with normal EF c/o D. Karmpaliotis

4 Referred for Angina 2 55 y.o male with HTN, HLD 4 months of exertional angina Nuclear stress test positive for inferior wall ischemia with normal EF Why Do We Treat These So Differently? c/o D. Karmpaliotis

5 COURAGE: A Paradigm Shift Survival Free of Death from Any Cause and Myocardial Infarction 1.0 Optimal Medical Therapy (OMT) PCI + OMT Hazard ratio: % CI ( ) P = Years Number at Risk Medical Therapy PCI Boden WE et al. NEJM 2007;356:

6 No. of Individuals (per 100,000 Residents) COURAGE: Clinical Impact Temporal Trends PCI and CABG in Massachusetts 250 Percutaneous coronary intervention 100 Coronary artery bypass graft surgery 200 Elective PCI 80 Elective CABG 150 PCI for MI CABG for MI Year Year Yeh et al, JAMA Int Med 2015;published online

7 But 35,539 Patients assessed 3,071 (8.6%) met eligibility criteria 32,468 patients were excluded 8,677 Did not meet inclusion criteria 5,155 Had undocumented ischemia 3,961 Did not meet protocol for vessels 6,554 Were excluded for logistic reasons 18,360 Had one or more exclusions 4,513 Had undergone recent (<6 mo) revascularization 4,939 Had an inadequate ejection fraction 2,987 Had a contraindication to PCI 2,542 Had a serious coexisting illness 1,285 Had concomitant valvular disease 1,203 Had class IV angina 1,071 Had a failure of medical therapy 947 Had left main stenosis >50% 722 Had only PCI restenosis (no new lesions) 528 Had complications after MI Boden WE et al. NEJM 2007;356:

8 Crossover Rate COURAGE: Cross-Overs from OMT Arm 50% 45% 40% 35% 30% 25% 20% 15% 10% 5% 0% daily weekly monthly none Baseline SAQ Angina Frequency Score In a matched analysis, MT with 1 st yr crossover was not associated with death, MI, or SAQ but was associated with worse health status and unstable angina admissions (OR 2.78, 95% CI [1.1,7.5], p=0.04) J. Spertus et al, TCT 2010 and Circ CV Qual Outcomes, 2013

9 All-Cause Mortality at Median 2.1 years CONFIRM Association of Revascularization with All-Cause Mortality 15,223 stable patients without known CAD undergoing CTA Revascularization of High-Risk Anatomy (7.3%) was independently associated with 62% lower Mortality at 2.1 yrs (adjusted HR 0.38 [0.18,0.83]) 20% Medical Therapy Revascularization P=0.45 P=0.02 P= % 8.7% 10.5% 3.1% 2.3% 2.4% 3.0% 0% 1 Vessel 2 Vessel 3 Vessel Number of Vessels with Severe (>70%) Stenosis Min JK et al, Eur Heart J 2012

10 AUC: Shifting the SYNTAX scales * Assuming medical treatment only ACC/AHA SIHD Guidelines Patel, JACC 2012;published online

11 NSTEMI with LMCA/3VD: A Role for Medical Management? 41,310 pts from 316 high-volume hospitals in ACTION-GWTG Harskamp et al, AHJ 2014

12 Definition of the CHIP Population: Complex Higher-Risk (and Indicated) Patients Patient Comorbidities / Surgical Ineligibility Hemodynamics / Ventricular Function Complexity of Coronary Anatomy / Distal Targets These patients are undertreated

13 Risk Treatment Paradox Patient Co- Ventricular Morbidities Function/Hem odynamics Anatomic Consideratio ns

14 Complex Higher-Risk (and Indicated) Patients Group 1: Left Main and Multivessel Disease Group 2: Advanced CKD Group 3: Mechanical Circulatory Support for Shock and High-Risk PCI Group 4: Chronic Total Occlusions

15 Dangas et al. Am J Cardiol 2005; 95:13-19 Advanced CKD Development of CIN is associated with Mortality

16 Up to a two line subtitle, generally used to describe the takeaway for the slide Brar et al. Lancet

17 Leung et al. CJASN 2014 Impact of CKD on Medical Therapy AKI is correlated with less use of cardio-protective medications

18 Marini et al. JACC Int 2014; 7:1287 Limited Options Patients who are at highest risk (co-morbidities) and whom would benefit the most from revascularization are undertreated due to CKD. Primary endpoint Angiographyguided IVUS-guided P (n=42) (n=41) Total contrast volume, ml 71.4 ± ± 12.5 <0.001

19 Ali et al. EHJ 2016; In press Zero Contrast PCI First Description of PCI without Radio-contrast utilization

20 Zero Contrast PCI 31 patients Median Cr 4.2mg/dL(IQR ) and egfr 16±8mL/min/1.73 m 2 Z-PCI performed at least 1 week after minimal contrast angiography with CV/eGFR < 1 set as absolute limit. Z-PCI performed using IVUS guidance, with pre- and post-pci measurements of FFR and CFR to confirm physiological improvement Pre FFR Pre CFR Post FFR Post CFR No major adverse cardiovascular events & preservation of renal function without the need for RRT (FU 79 days (IQR )) in all patients. Ali et al. EHJ 2016; In press

21 Zero-contrast PCI in Practice 51 y/o male Former smoker w/ PMH of HLD, Hypertension, CKD V (Cr 6.1mg/dl), CCS II-III Recent NSTEMI 2 weeks prior to his admission during physical activity developed choking sensation and nausea with chest pain. At OSH, troponin 1.3 managed medically due to CKD V. Underwent nuclear SPECT study which showed large area of inferior and moderate area of anterolateral ischemia. SSD = 11 Patient referred to CHIP service at CUMC for further management Physical Exam: HR: 70 - BP: 110/68 - RR: 15 SpO2: 100% No acute distress Neck: no obvious JVD Resp: unremarkable CV: no heart failure signs Aspirin 81mg Rosuvastatin 20mg Ticagrelor 90mgx2 Metoprolol XL 50mg ISMN 60mg Ranolazine 1000mg LVEF >55%

22 Brar et al. POSEIDEN. Lancet 2014 Minimal Contrast Angiography No femoral artery arteriogram Pre-PCI LVEDP guides hydration Radial access avoided LVEDP <13 = 5ml/kg/hr LVEDP ml/kg/hr LVEDP ml/kg/hr

23 Brown J R et al. Circ Cardiovasc Interv 2010;3: Minimal Contrast Angiography The absolute contrast limit is set at egfr/contrast volume ratio of 1 30% 25% Risk-adjusted Crude 20% 15% 10% 5% 0% < >2

24 Minimal Contrast Angiography 3 image acquisitions RCA LAO Cranial, LCA AP Cranial AP Caudal

25 Minimal Contrast Angiography If the CV/eGFR requires dilution of contrast consider 20% dextrose

26 Minimal Contrast Angiography If need for PCI is unclear, FFR without contrast should be performed.

27 Minimal Contrast Angiography Post Angiography LVEDP further guides hydration

28 Zero Contrast PCI Staged Intervention 1 week later Limited echocardiogram to rule out pre-existing effusion

29 Brar et al. POSEIDEN. Lancet 2014 No femoral artery arteriogram Zero Contrast PCI Pre-PCI LVEDP guides hydration LVEDP <13 = 5ml/kg/hr LVEDP ml/kg/hr LVEDP ml/kg/hr

30 Pre-formed loop advanced into LM Guidewire Placement Wires used to create silhouette Standard workhorse wires are used avoiding hydrophilic wires

31 Guidewire Placement Screen mask used for guidance

32 Guidewire Placement Screen mask used for guidance

33 Guidewire Placement The guidewire silhouette and fiduciary markers further guide PCI

34 Pre-PCI Preparation Pre-dilation (2.0x12mm CB) used to facilitate IVUS passage

35 Pre-PCI Preparation Further pre-dilation with 2.5x15 CB to facilitate IVUS passage

36 Distal reference marked by cine IVUS Guidance EEL-EEL measurements guide size 2.73mm 2.54mm

37 Proximal reference marked by cine IVUS Guidance EEL-EEL measurements guide size 2.77mm 2.83mm

38 360 degree calcium Fibrous plaque Ostial disease IVUS Guidance Distal reference (2.73x2.54mm) Proximal reference (2.77x2.83mm) Length 34mm Plaque Morphology LM RI LAD LM RI

39 PCI Distal reference marked by prior cine 2.5x34 mm DES placed

40 Distal reference area MSA Proximal reference area IVUS assessment Distal reference (4.17mm 2 ) Proximal reference (4.43mm 2 ) MSA (3.54mm 2 )

41 2.75x15 NC proximally PCI Optimization 2.5x15 NC distally

42 Distal reference area MSA Proximal reference area IVUS Optimization Distal reference (4.17mm 2 ) Proximal reference (4.43mm 2 ) MSA (3.82mm 2 ) 89% Expansion (MUSIC Criteria)

43 LAD IVUS to assess ostium Post-PCI assessment Precision PCI LM strut RI

44 Cx IVUS to assess ostium Post-PCI assessment Precision PCI LM RI strut

45 Stent and wire assessment

46 Post-PCI Physiological Assessment Pressure Catheter ACIST Navvus FFR Rx FFR 0.93

47 Complete Revascularization - RCA Corsair 130cm + Pilot 50 Uploaded RCA angiogram

48 Corsair advanced through lesion Guidewire placement Pilot 50 exchanged for BMW 300cm

49 Lesion Assessment Pre-dilation (2.0x15mm CB) to facilitate IVUS passage Distal reference IVUS cine flag

50 Pre-dilation (2.5x30mm CB) Lesion Preparation

51 PCI 2.5x38mm DES placed distally using IVUS reference cine for placement

52 PCI Lesion length guided by IVUS and dry cine used for 2mm overlap

53 PCI 3.5x32mm DES placed proximally with IVUS for optimization

54 3.5x32 SB distally at 10atm IVUS Optimization 3.5x20 NC proximally at 20atm

55 Imaging and Physiology Guided PCI IVUS confirms optimal expansion Pressure Catheter FFR = 0.92

56 Completion of PCI procedure Post-PCI LVEDP guides hydration If post-procedure there are; a) Symptoms b) EKG Changes c) CFR <1.8 d) No improvement in FFR e) New effusion Limited angiography is performed. TTE to rule out new effusion LVEDP <13 = 5ml/kg/hr LVEDP ml/kg/hr LVEDP ml/kg/hr Brar et al. POSEIDEN. Lancet 2014

57 Zero Contrast PCI Patient now revascularized and angina free. Post-PCI Cr 5.7mg/dL and stable at 5.9mg/dL at 6 month follow-up. In patients with advanced CKD who require revascularization, PCI may safely be performed without contrast using IVUS and physiological guidance with high procedural success and without complications.

58 Ali et al. EHJ 2016; In press IVUS guided PCI without contrast C E B F C A B A D D

59 A OCT guided PCI without contrast D H G B E F G I G Proximal Reference Minimal Lumen Area Distal Reference C J K Ali et al - Eur Heart J Apr 1;37(13):1059.

60 Rota-PCI without contrast 1.5mm burr 2.75x38 DES Minimal contrast angio Post PCI FFR 0.90 (relieved ischemia), CFR 3.0 (no slow flow, improved prognosis)

61 Jeff Moses Dimitri Karmpaliotis Michael Collins Manish Parikh Ajay Kirtane Martin Leon Ziad Ali

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