Il Cuore in Fortezza Savona, 9 Aprile 2015

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1 Il Cuore in Fortezza Savona, 9 Aprile 2015 Alaide Chieffo UO Emodinamica Ospedale San Raffaele, Milano

2 Improvements for treatments of ST elevation myocardial infarction DES and New DES Functional revascularization and reasonable incomplete revascularization Better antiplatelet agents Value of intravascular ultrasound Bioresorbable stents Vulnerable Plaque Structural interventions

3 Improvements for treatments of ST elevation myocardial infarction

4 Time and Myocardial Salvage Mortali ity reduction (%) Extent of myocardial salvage Time for pharmacological and logistic interventions Time from symptom onset to reperfusion therapy (hr) Critical time-dependent period goal: myocardial salvage Time-independent period goal: open infarct-related artery Gersh B et al: JAMA 293:979, 2005

5 DES and New DES

6 Sabaté et al. J A C C, V OL. 7, N O. 1,

7 One-Year Stent Thrombosis Kaplan-Meier curves for the definite/probable stent thrombosis in each of the stent groups Sabaté et al. JACC, Vol. 7, N. 1,

8 Abluminal vs. Conformal Polymer Abluminal coating significantly improves endothelialization % Endothelial Cell (EC) Coverage at 21 Days in Cell Assay P< ,8 72,5 PROMUS PtCr-EES SYNERGY PtCr-EES * * * * * * * * * * * * * * From data presented by Mike Eppihimer, PhD at EuroPCR 2013 IC AE Jan 2014 Page 8

9 Functional revascularization and reasonable incomplete revascularization

10 Can we shift a High Risk Anatomy/Patient with PCI to Intermediate/Low Risk and then treat him/her with Medical Therapy? The shift can take place thanks to: 1) Better diagnosis of critical lesions 2) Conservative approach towards lesions involving vessels supplying medium/small myocardial mass REASONABLE INCOMPLETE REVASCULARIZATION

11 Unreasonable Complete Revascularization FFR 0.89 LAD FFR LA 2.83mm 2 at LCx-ostium

12 Value of intravascular ultrasound

13 All-Cause Mortality (DES patients) According to IVUS Guidance % IVUS-guided Cumulative Incide ence ( %) % No IVUS-guided Log-rank P< Years after treatment S J Park, et al. MAIN COMPARE Registry (n=2311)

14 ADAPT Study: Clinical Outcomes at 1 Year, IVUS observational substudy IVUS (n=3349) 0.52% (17) Definite/probable ST No IVUS (n=5234) 1.03 (53) P value Subacute (1-30 day) Late 0.27%(9) 0.25% (8) 0.56% (29) 0.45% (23) Cardiovascular death 0.99% (32) 1.35% (68) 0.14 Stone GW, Circulation 2014

15 Better antiplatelet agents

16 New and more potent antiplatelet agents will be able to further lower the risk of atherothrombosis. Point of care evaluation may help to find the ideal sweet spot to tailor optimal antiplatelet therapy: lowering thrombosis without increasing the risk of bleeding.

17 Not ideal for potent antiplatelets PRU= P2Y12 reaction units Ideal for potent antiplatelets Mangiacapra et al. JACC Cardiovasc Interv 2012

18 Ticagrelor, Prasugrel or other P2Y12 blockers may become standard of care: One Size Fits All. Measurement of individual response to clopidogrel and individualize therapy

19 Bioresorbable stents

20 Hideo Tamai MD

21 LAD with diffuse disease: No more full metal jacket 28436/12 CCC

22 Diffuse disease of the LAD LAD Treatment Baseline 28436/12 CCC

23 Diffuse disease of the LAD LAD Treatment Predilatation Result after Predilatation 28436/12 CCC

24 First BVS implanted distally LAD Treatment Prox Predilatation First BVS After First LAD BVS 28436/12 CCC

25 Diagonal is treated with DEB LAD Treatment Diag DEB After Diag DEB 28436/12 CCC

26 Two additional 28 mm long BVS LAD Treatment Second LAD BVS Third LAD BVS 28436/12 CCC

27 Very distal dissection or poor outflow LAD Treatment After Third LAD BVS 28436/12 CCC

28 Distal vessel too small for current BVS LAD Treatment After Third LAD BVS Short distal DES 28436/12 CCC

29 DEB 2.5*40mm BVS 3.5*28mm BVS 3.0*28mm BVS 2.5*28mm DES 2.25*12mm

30 LAD Treatment Final Result LAD 28436/12 CCC

31 A Prox. edge OCT findings (15.April 2014) A C DEB 2.5*40mm B BVS 3.5*28mm C BVS 3.0*28mm D Overlap site BVS 2.5*28mm B D DES 2.25*12mm Overlap site Overlap site

32 3, interesting findings by OCT Neointimal pattern = homogeneous pattern The pattern of neointima in BVS is different from that in metallic DES BVS SES

33 Vulnerable plaque

34 Searching for the active lesion: VULNERABLE PLAQUE Cholesterol deposits LipiScan IVUS Coronary Imaging System

35 I maintain skepticism about the possibility for Interventional Cardiology to provide viable and cost-effective solutions to prevent myocardial infarction utilizing a specific treatment for the vulnerable plaque. The interplay of the vulnerable lesion, vulnerable patient and environmental circumstances will make any treatment directed to a coronary lesion to be effective only in a limited subset of patients/lesions Antonio Colombo

36 Structural interventions

37 Transcatheter Aortic Valve Implantation: will become dominant Next generation devices DirectFlow Sadra Sapien 3 Centera

38 Most current limitations will be resolved Residual aortic regurgitation: YES Vascular complications: YES Periprocedural and mid term strokes:? AV block and need for permanent pacemaker:?

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43 Clinical and Echocardiographic Outcomes at 30 Days with the SAPIEN 3 TAVR System in Inoperable, High-Risk and Intermediate-Risk AS Patients Susheel Kodali, MD on behalf of The PARTNER Trial Investigators ACC 2015 San Diego March 15, 2015

44 SAPIEN 3 TAVR System in Inoperable, High-Risk and Intermediate-Risk AS Patients Key Inclusion Criteria Risk determined by STS score and heart team: High Risk / Inoperable (S3HR): STS score > 8 or heart team determination Intermediate Risk (S3i): STS score between 4 and 8 or heart team determination Severe aortic stenosis determined by echocardiography: Valve area < 0.8 cm 2 or Valve area index < 0.5 cm 2 /m 2 and mean gradient > 40mmHg or peak velocity > 4 m/s

45 All-Cause Mortality and Stroke: S3HR At 30 Days (As Treated Patients) Mortality Cardiovascular All Stroke Stroke Disabling 60 % O:E = (STS 8.6%) % ,2 1,4 S3HR 0 1,5 0,9 S3HR

46 All-Cause Mortality and Stroke: S3i At 30 Days (As Treated Patients) Mortality Cardiovascular All Stroke Stroke Disabling O:E = 0.21 (STS 5.3%) % % ,1 0,9 S3i 0 2,6 1.0 S3i

47 All-Cause Mortality at 30 Days Edwards SAPIEN Valves (As Treated Patients) PARTNER I and II Trials TA/TAo Patients Nested Registries SAPIEN SAPIEN XT SAPIEN 3

48 First report of the surgical edge to edge technique in 1998

49 Clip repair in porcine heart (6 months post repair) Suture repair in human heart Percutaneous (4 years post repair) Fann JI, St Goar FG, Komtebedde J, Oz MC, Block PC, Foster E, Butany J, Feldman T, Burdon TA: Beating heart catheter-based-edge-to-edge mitral valve procedure in a porcine model; efficacy and healing response. Circulation 110: , 993, 2004 Privatera et al: Circulation ;106:e173

50 The MitraClip system Percutaneous repair of the MV Beating heart procedure Real time MR assessment Repositioning of the device

51 Procedural Overview General anesthesia in order to continuously monitor TEE Right femoral vein to perform transeptal puncture TEE guided transeptal puncture TEE X plane utilized to direct the clip in the center of the valve at more importantly at the level of the jet (doppler)

52 Procedural Overview The main advantage over surgery is that the procedure is done in beating heart, the results can be evaluated immediately and if needed the position of the clip can be changed or additional clips can be placed

53 MitraClip Therapy Current Global Adoption More than 8000 pts treated Commercial 1. First-time procedures only. Includes commercial patients, ACCESS I and ACCESS II patients. 2. Successful implants only. Investigational Special Access

54 Consensus 2013 MitraClip therapy should be limited to the treatment of symptomatic patients with mitral regurgitation refractory to medical therapy and at high surgical risk or inoperable by surgeons proficient in mitral valve surgery and working in institutions with a high-volume mitral surgical programs. Class IIb C

55 MitraClip Therapy Broad Spectrum of Experience A EVEREST II EVEREST ACCESS EU (Randomized Controlled Trial) (High Risk Cohort^) (Europe) 27% 29% 23% 73% 71% 77% A shift with less degenerative and more functional mitral regurgitation being treated ^ Enrolled by February 28, 2010 Data on file Abbott Vascular, April 12, 2011 Schillinger, W. ESC 2012, ACCESS 1-year results = DMR = FMR

56 Importance of the learning curve The MitraClip learning curve is characterized by 1 : Procedure time reduction: 180min to 55min Acute procedural success* from 80% to 92% Significant device time reduction is observed across the MitraClip centers of excellence

57 Improvements for treatments of ST elevation myocardial infarction DES and New DES Functional revascularization and reasonable incomplete revascularization Better antiplatelet agents Value of intravascular ultrasound Bioresorbable stents Vulnerable Plaque Structural interventions

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