Percutaneous Coronary Intervention: Update

Transcription

1 Percutaneous Coronary Intervention: Update Alphonse M. Ambrosia, DO, FACC Interventional Cardiologist CardioVascular Associates of Mesa Mesa, Arizona

2 Disclosures Speakers Bureau Boston Scientific Medtronics Vascular Philips/Volcano Corp Novartis Research: Abbott Vascular

3 Objectives Review 2009 Appropriateness guidelines and updates in 2016 Review limitations of angiography and solutions Review functional PCI with cases Review multivessel intervention v. surgery Review data on complete revascularization Review new stents and bioabsorbable scaffold

4 Washington we have a problem $2,159 for a barbecue at Midei s house that included a whole smoked pig and other fixings. 111TH CONGRESS 2nd Session S. PRT STAFF REPORT ON CARDIAC STENT USAGE AT ST. JOSEPH MEDICAL CENTER PREPARED BY THE STAFF OF THE COMMITTEE ON FINANCE UNITED STATES SENATE MAX BAUCUS, Chairman CHUCK GRASSLEY, Ranking Member DECEMBER 2010 Printed for the use of the Committee on Finance

5 2009 Appropriateness Criteria

6 $2,159 for a barbecue at Midei s house that included a whole smoked pig and other fixings. attorney represents 200 (patients) The cases will be tried one by one. procedure has left him chained to medication and at risk of future blockage. but concealed from him that his coronary arteries did not have the requisite degree of stenosis to made the procedure medically necessary.

7 Banner Heart Initiatives 100% review of all PCI Initially cases per month Last review 3/233 cases, only 1/233 could not be justified as appropriate after physician review Appropriate utilization of supplies Right device for right patient Safe Procedure Decrease unnecessary opening of product

8 2009 AUC Problems Based on 1st generation stent data Controversial data on left main intervention Nomenclature pejorative Appropriate, Uncertain, Inappropriate Most cardiologists do not report degree of ischemia (mild, moderate, severe) Data on CTO intervention limited

9 2016 Update Nomenclature: Usually appropriate, may be appropriate, rarely appropriate ICNAEL requirement for degree of ischemia on stress testing Syntax trial results available CTO intervention evolved Functional PCI expanded

10 A good day in our lab When your angiogram matches your stress test

11 Functional PCI The right treatment for each patient Consistent with Appropriate Use Overcoming the limitations of angiography Overcoming discordant stress testing Rethinking surgical revascularization

12 40 years of PTCA

13 Limitations of Angiography Sometimes not so obvious Sometimes it obvious

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15 Angiography gold standard

16 Overcoming limitations of Angiography

17 IVUS Imaging

18 Lesion Characterization Fibro Fatty Fibrous Calcified B E

19 Dissection E

20 Well apposed stents E

21 Incomplete Stent Apposition E

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24 Making IVUS more efficient

25 Physiology: FFR/iFR

26 First Angioplasty recording

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28 Using Pressure to Get Flow Coronary pressure is simple to measure Flow velocity is more challenging Fundamental Equation for relating Pressure and Flow: P = Q x R Pressure = Flow x Resistance or P Q x R Change in Pressure = Change in Flow x Constant Resistance When Resistance is Constant, changes in Pressure are proportional to changes in Flow

29 FAME II Trial Results FFR-guided PCI with drug-eluting stents plus the best available medical therapy, resulted in significantly improved clinical outcomes. > pts. OMT 3.0% p=< ,220 pts. FFR < pts. OMT 12.7% p=<0.001 SIHD with Angiographic 1, 2, or 3 vessel disease Randomized 447 pts. PCI 4.3% p=<0.001 Primary Endpoint was a Composite of Death, MI or Urgent Revascularization 1. De Bruyne B., et al, Fractional Flow Reserve-Guided PCI versus Medical Therapy in Stable Coronary Disease, New England Journal of Medicine, August 28, 2012, ( / NEJMoa ) / De Bruyne B., et al, Fractional Flow Reserve-Guided PCI versus Medical Therapy in Stable Coronary Disease, New England Journal of Medicine, August 28, 2012, ( /NEJMoa )

30 R. V 71 y.o. female with know CAD, class II angina, HTN, PAF, RAS, DM, COPD, colon cancer, hypothyroidism, and glaucoma presents with increasing frequency of classic angina with activity. She is using 4 nitroglycerine a week with relief. She has had no rest pain. She had a Lexiscan nuclear perfusion study 3 months prior which showed no ischemia. Allergies: betadine and shellfish Past CV: DES to distal LAD and BMS to proximal LAD in 2009; DES to LCX into OM branch 10/09; LHC 5/11 with patent stents and distal LAD stenosis managed medically with renal artery intervention 5/11 Medications: clopidogrel 75 mg qd; ASA 325 mg qd; Atorvastatin 40 mg q hs; Glipizide 2.5 mg bid; Ranexa 500 mg bid; hydralazine 25 mg tid; xanax 0.5 mg tid; Trazadone 100 mg q hs; Celexa 20 mg qd; Gabapentin 300 mg tid; Levoxyl 150 mcg qd; Metoprolol 50 mg bid; Protonix 40 mg q hs; Lasix 20 mg q am prn edema

31 R.V. Exam: BP 150/90; HR 83; Sat 95% JVP is normal, no bruit CV: RRR without murmur. diminished pulses bilaterally Lungs: clear bilaterally ECG: NSR with low voltage

32 Left system

33 Right coronary

34 FFR of RCA

35 FFR of LCX

36 Distal to previous stent Proximal to stent Previous stent

37 After dilation and new stent E

38 Limitations of FFR: Vasodilation Definition: Instantaneous pressure ratio, across a stenosis during the wave-free period, when resistance is naturally constant and minimized in the cardiac cycle Wave-free period Pa Pd /001

39 Resistance is Constant in the Wave-Free Period /001

40 Co-efficient of variation ifr Oct 2011 ifr vs. FFR ADVISE study Set the foundations of ifr Pilot study which compared ifr to FFR Wave-Free Period Wave-free resistance p=0.96 Hyperaemic resistance ROC AUC = 0.93 Accuracy = 88% FFR Sen et al J Am Coll Cardiol Apr 10;59(15):

41 Oct 2011 May 2012 ifr vs. FFR Aug 2012 Oct 2012 ADVISE study ADVISE Registry HYBRID strategy RESOLVE study Over 1500 stenoses evaluated, core lab analysis, using Imperial algorithm Algorithm is critical for accurate calculation of ifr Confirmed previous studies VERIFY clear outlier Sen et al J Am Coll Cardiol Apr 10;59(15): LBCT TCT 2011 Petraco et al. Eurointervention, August LBCT EuroPCR 2012 Park et al, International J Cardiol Petraco et al. Eurointervention, December ESC 2012 Jeremias et al. J Am Coll Cardiol, 2014 Apr 8; 63(13):

42 Functional Lesion Assessment of Intermediate stenosis to guide Revascularisation Study Objectives: Determine safety and efficacy of PCI-guided ifr vs. FFR Determine if ifr is non-inferior to FFR to guide PCI Primary Endpoints: Major adverse cardiac events (MACE) rate in the ifr and FFR groups at 1 year MACE (combined endpoint of death, nonfatal MI, or unplanned revascularization) Largest Physiology Study to Date n= Sites, 17 countries /002

43 JC 59 y.o. female seen for the first time on May 15th with a 4 month history of exertional angina. Epigastric to low chest, only with exertion and resolves with rest in 5-10 minutes. PMH: HTN, HLP, irregular heart rate not diagnosed, no family history Meds: Lisinopril 40 mg qd, Pravastatin 20 mg q hs, amlodipine 5 mg qd, Cymbalta 60 mg qd, Trazadone 50 mg q hs, Ibuprofen prn, Acyclovir prn BP 120/70 HR 73 Sat 97% on RA, wt 201# Exam otherwise negative ECG: SR with anterior T wave inversion Rx: ASA 81 mg daily, Bystolic 5 mg daily (samples), Effient 10 mg daily Set up for LHC (radial)

44 ifr measured at 9:05 am

45 ifr measured post stent at 9:06:30 am

46 Making the Right Call

47 Angiography versus FFR in the FAME study Proportions of functionally diseased coronary arteries in patients with angiographic 3 vessel disease 3-VD 14% 0-VD 9% 3-VD 1-VD 34% 2-VD 43% P. Tonino et al ESC 2009

48 Angiography versus FFR in the FAME II study Proportions of functionally diseased coronary arteries in patients with angiographic 3 vessel disease 9% with no stenosis with FFR <0.8 34% with 1 stenosis with FFR <0.8 43% with 2 stenoses with FFR <0.8 14% with 3 stenoses with FFR <0.8 43% of my patients I treated in the past I sent for CABG that could have been treated with PCI with less cost and comorbidity P. Tonino et al ESC /001

49 /001

50 Complete v. Incomplete Revascularization

51 Multivessel Disease Treated with functional PCI 70 y.o. with decreased exercise tolerance over the past year. PCP ordered coronary calcium score and it was Seen in office and had coronary CTA which suggested multi vessel disease. Had Exercise nuclear study in 2014 that was normal with average exercise tolerance PMH: dyslipidemia, HTN; no diabetes and nonsmoker BP: 132/92 HR 86, exam negative Meds: ASA 81 mg qd, Valsartan 160 mg qd, Simvastatin 40 mg q hs

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56 Summary 3v disease with one critical lesion and several intermediate lesions No stress test abnormality and non-classic symptoms What do you do: Call a surgeon Fix the right coronary Fix RCA and LAD Fix all visible lesions

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61 Stent Update

62 BRS Case 58 y.o. with HTN and HLP with frequent PVC s and family history of CAD. Presented with a month of classic angina with dyspnea. Episodes up to minutes in duration, resolve with rest Meds: Lisinopril 20 mg qd, Zoloft 100 mg qd VS 130/68 HR 84 96% on RA Exam negative ECG: NSR with nonspecific ST and T wave abnormalities started on ASA 325 mg qd, Systolic 5 mg qd, Crestor 20 mg qd and set up for LHC, radial

63 Left system

64 ifr 0.95 ifr 0.83 ifr 0.84 Left system

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66 LAD post 2.5 x 28 Xience and 3.0 x 28 Xience dilated with 2.5 NC to 18 atm

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69 Predilation

70 Post Stent Implant

71 Post NC Dilation to 18 atm

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73 Struts

74 Conclusion Coronary intervention has reached its 40th year AUC highlighted discordance between technology advance and patient care Invasive tools are available and advancing to overcome limitations of angiography Our goal should be complete revascularization Thoughtful consideration and use of tools can provide All the patient needs and nothing they don t

75 Doctors of the Future