ΑΙΤΙΑ ΕΙΣΑΓΩΓΗΣ ΓΙΑ ΝΟΣΗΛΕΙΑ ΑΝΔΡΑΣ

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2 ΑΙΤΙΑ ΕΙΣΑΓΩΓΗΣ ΓΙΑ ΝΟΣΗΛΕΙΑ ΑΝΔΡΑΣ 61 χρονών, υπερτασικός, μη διαβητικός, με μετρίου βαθμού νεφρική ανεπάρκεια. Καρδιακή ανεπάρκεια: περιφερικό οίδημα και δύσπνοια Ηλεκτρική θύελλα: 3 εκφορτίσεις απινιδωτή για κοιλιακή μαρμαρυγή ΙΑΤΡΙΚΟ ΙΣΤΟΡΙΚΟ 1997 Αντικατάσταση αορτικής βαλβίδας -μεταλλική (σοβαρού βαθμού στένωση δίπτυχης αορτικής βαλβίδας) 1997 Βαλβιδική καρδιακή ανεπάρκεια (EF=35%) 2009 PCI LAD 2011 Εμφύτευση απινιδωτή για πρωτογενή πρόληψη (EF=25%)

3 EF=15%

4 Mitral Valve: moderate to severe regurgitation

5 Metallic Aortic Valve: normal function

6 CORONARY ANGIOGRAPHY RCA: normal AVR: normal

7 CORONARY ANGIOGRAPHY severe heavily calcified distal LMS ostial LAD ostial CX (MEDINA 1,1,1)

8 ΕΠΙΛΟΓΕΣ CABG αποκλειόμενη από χειρουργούς STS score >10 PCI Rotablation χωρίς υποστήριξη PCI Rotablation με μηχανική υποστήριξη ΑΠΟΦΑΣΗ PCI Rotablation με μηχανική υποστήριξη

9 Goals of Percutaneous Circulatory Support Depend on the Clinical Application Cardiogenic shock (±AMI)/ Decompensated heart failure Normalize CO, BP, Cardiac Power Output (CPO= MAP x CO) Decrease PCWP Optimize blood oxygen saturation Bridge to Decision enabling Minimize myocardial damage and optimize recovery Decrease myocardial work and oxygen consumption while optimizing myocardial perfusion Maintain BP and CO during proximal coronary occlusion to maximize CBF to other myocardial regions and blood flow High to the Risk body PCI Myocardial Salvage in Setting of AMI Reduce LV workload (and oxygen demand) to minimize necrosis and optimize myocardial recovery

10 Metrics for Comparing Different Methods of Percutaneous Circulatory Support Amount of hemodynamic support Ability to increase CPO and decrease PCWP Single vs Biventricular Support Degree of myocardial protection Ability to offload the LV while providing support Ease of use: insertion & operation Risk of complications (vascular, valvular, hemolysis ) Contraindications (or limitations)

11 Varying Mechanisms of Hemodynamic Support Left Ventricle Right Ventricle

12 Intra-Aortic Balloon Pump - Pros and Cons PROs: Mature technology Increases Stroke Volume up to 30% Increase Coronary Perfusion Ease of Use Lower Complication rate over time CONs: Does not unload the heart Require a minimum LV function Require a stable rhythm No proven mortality benefit only modestly augments cardiac output and is unable to provide circulatory support if hemodynamic collapse occurs LV diastole LV systole

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15 LV dysfunction

16 LM occlusion

17 IABC

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23 IMPELLA

24 Thiele H et al, N Engl J Med 2012;367:

25 IABP SHOCK II Trial: 1-year Mortality 52% 51% Thiele H et al. Lancet 2013; 382:

26 30-day Survival in Patients with Cardiogenic Shock Treated in the Impella-EUROSHOCK Registry 43.7% 46% 24.5% 18.2% Lauten A et al, Circ Heart Fail. 2013;6;23-30

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28

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30 Selected Trials of Circulatory Device Therapy and Indications Trial Study Device Indication Primary Outcome IABP SHOCK IABP Cardiogenic Shock No difference in 30-day mortality or secondary endpoints CRISP IABP Acute Anterior Myocardial Infarction Trend toward higher infarct size and vascular complications with IABP PROTECT II Impella 2.5 IABP vs High Risk PCI No difference in 30-day MAE; halted for futility and DSMB concerns for safety trends BCIS IABP High Risk PCI No difference in in-hospital MACCE; improved 5-year survival IMPRESS Impella CP vs IABP Cardiogenic Shock No difference in 30-day mortality or secondary endpoints

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32 TandemHeart PV Loop Performance The combination of left atrial cannulation with a high-flow centrifugal pump enables up to 80% work reduction On File, Cardiac Assist, Inc.

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37 Veno-Venous/Arterial Extra Corporeal Membrane Oxygenation Indications Cardiogenic shock Pulmonary support Post cardiotomy Post heart/lung transplant Reported in-hospital survival 24-38% In pediatric patients - up to 80%

38 ECMO Percutaneous femoral cannulation of both the common femoral vein (24 Fr cannula) and artery (18 Fr cannula with added distal leg perfusion branch) the circuit was connected to a third generation (magnetically levitated) centrifugal pump (Centrimag, Levitronix) and to a long term (low pressure) membrane oxygenator (Medtronic) cardiopulmonary support with flows up to 5.5 l/min

39 DECISION PCI Rotablation with MECHANICAL SUPPORT IABP: Inadequte support IMPELLA: Non applicable (AVR) ECMO

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41 PTCA: Rotablation LAD, CX, CULOTTE technique PILOT 50 LAD - FINECROSS IVUS CANNOT CROSS

42 PTCA: Rotablation LAD, CX, CULOTTE technique ROTAWIRE THROUGH FINECROSS ROTABURR 1.25mm rpm

43 PTCA: Rotablation LAD, CX, CULOTTE technique ROTABURR 1.5mm rpm POST ROTA LAD

44 PTCA: Rotablation LAD, CX, CULOTTE technique ROTABURR 1.5 mm CX rpm POST ROTA CX

45 PTCA: Rotablation LAD, CX, CULOTTE technique BALLOON LAD BALLOON CX

46 PTCA: Rotablation LAD, CX, CULOTTE technique STENT CX WIRE LAD

47 PTCA: Rotablation LAD, CX, CULOTTE technique FIRST KISSING STENT LAD

48 PTCA: Rotablation LAD, CX, CULOTTE technique STENT LAD DEPLOYED FINAL KISSING

49 PTCA: Rotablation LAD, CX, CULOTTE technique FINAL POT 4.5 BALLOON 26 Atm

50 PTCA: Rotablation LAD, CX, CULOTTE technique FINAL RESULT

51 PTCA: Rotablation LAD, CX, CULOTTE technique FINAL IVUS RESULT

52 DAY 1: patient completely dependent on ECMO pressure tracing direct line iv inotropes

53 DAY 1: patient completely dependent on ECMO pressure tracing direct line iv inotropes

54 DAY 5: ECMO REMOVED DAY 8: PATIENT DISCHARGED NYHA I EF 35%

55 MR improved grade II

56 EF PRE POST

57 Conclusions (I) PCI in patient with severe hemodynamic compromise is feasible if facilitated by MCS IABP remains the old fashioned gold-standard ECMO is indicated for life threatening pulmonary or cardiac failure, when any other forms of treatment have been failed ECMO provides full hemodynamic support although at the expense of a higher complication rate due to the increased invasiveness of the procedure in the femoral vessels and the presence of an oxygenator which increases the inflammatory response

58 Counterpulsation Requires Native Left Ventricular Pulsation Sintek and Joseph et al J Card Fail 2015 The more dysfunction the ventricle, the less functional an IABP becomes

59 Conclusions (I) PCI in patient with severe hemodynamic compromise is feasible if facilitated by MCS IABP remains the old fashioned gold-standard ECMO is indicated for life threatening pulmonary or cardiac failure, when any other forms of treatment have been failed ECMO provides full hemodynamic support although at the expense of a higher complication rate due to the increased invasiveness of the procedure in the femoral vessels and the presence of an oxygenator which increases the inflammatory response

60

61 Conclusions (II) Identification of high risk patients who most likely will benefit from MCS is crucial Type of MCS depends on: LV-circulatory status type and duration of procedure It is important to utilize the expertise of the surgeons in this field

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63 Conclusions (II) Identification of high risk patients who most likely will benefit from MCS is crucial Type of MCS depends on: LV-circulatory status type and duration of procedure It is important to utilize the expertise of the surgeons in this field

64

65 Rotablator: Catheter Components drive shaft diamond coated burr 1.25 mm mm (0.25 mm increments) sheath 4.3 french O.D. guide wire Rota-Kurs Gaul I/2002

66 Key Principles of Operation for the Rotablator System Differential Cutting The Orthogonal Displacement of Friction

67 Principle of Operation Differential Cutting All diseased plaque is inelastic High speed rotational ablation differentiates healthy elastic vessel wall from plaque High speed rotational ablation preferentially cuts all types of plaque morphology

68 Differential Cutting Elastic Tissue In-elastic Tissue

69 Rotablator TM : Benefits Rotablator Micro Particles s 5 Micron Bead Red Blood Cells t Plaque is ablated into small particles removed by RES

70 Rotablator: Benefits Minimises vessel wall stretch and elastic recoil Eliminates vessel barotrauma Removes all plaque morphologies; Soft, fibrotic, calcified Produces a smooth lumen channel for improved hemodynamic flow

71 post-ptca procedure post-rotablator procedure

72 System Components Overview Disposable s and Hardware

73 Rotablator System Components Disposables: Advancer Burr Catheter WireClip Torquer Guide Wire

74 Rotablator System Components Hardware Air Supply Compressed Air Compressed Nitrogen Console Dynaglide Foot Pedal

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