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%)

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

EF=15%

Mitral Valve: moderate to severe regurgitation

Metallic Aortic Valve: normal function

CORONARY ANGIOGRAPHY

RCA: normal AVR: normal

CORONARY ANGIOGRAPHY

severe heavily calcified distal LMS ostial LAD

ostial CX (MEDINA 1,1,1)

ΕΠΙΛΟΓΕΣ

CABG – αποκλειόμενη από χειρουργούς STS score >10

PCI – Rotablation χωρίς υποστήριξη

PCI – Rotablation με μηχανική υποστήριξη

ΑΠΟΦΑΣΗ

PCI – Rotablation με μηχανική υποστήριξη

Goals of Percutaneous Circulatory SupportDepend 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 optimizerecovery•

Decrease myocardial work and oxygen consumption while optimizing myocardial perfusion

• High Risk PCI– Maintain BP and CO during proximal coronary occlusion to maximize CBF to other myocardial regions

and blood flow to the body

• Myocardial Salvage in Setting of AMI

– Reduce LV workload (and oxygen demand) to minimize necrosis and optimize myocardial recovery

Metrics for Comparing Different Methods ofPercutaneous 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)

Right Ventricle

Left Ventricle

Varying Mechanisms of Hemodynamic Support

Intra-Aortic Balloon Pump

- Pros and ConsPROs:

• 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

LV dysfunction

LM occlusion

IABC

IMPELLA

Thiele H et al, N Engl J Med 2012;367:1287-96.

IABP SHOCK II Trial: 1-year Mortality

Thiele H et al. Lancet 2013; 382:1638-45

52%51%

30-day Survival in Patients with Cardiogenic ShockTreated in the Impella-EUROSHOCK Registry

46%43.7%

24.5%18.2%

Lauten A et al, Circ Heart Fail. 2013;6;23-30

Selected Trials of Circulatory Device Therapy and Indications

Trial Study Device Indication Primary Outcome

IABP SHOCK IABP Cardiogenic ShockNo difference in 30-day

mortality or secondaryendpoints

CRISP IABPAcute Anterior Myocardial

Infarction

Trend toward higher infarctsize and vascular

complications with IABP

PROTECT IIvsImpella 2.5

IABPHigh Risk PCI

No difference in 30-day MAE;halted for futility and DSMBconcerns for safety trends

BCIS IABP High Risk PCINo difference in in-hospitalMACCE; improved 5-year

survival

IMPRESSImpella CP vs

IABPCardiogenic Shock

No difference in 30-daymortality or secondary

endpoints

TandemHeart PV Loop Performance

The combination of left atrial cannulation with a high-flowcentrifugal pump enables up to 80% work reduction

On File, Cardiac Assist, Inc.

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%

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

DECISION

PCI – Rotablation with MECHANICAL SUPPORT

IABP: Inadequte support

IMPELLA: Non applicable (AVR)

ECMO

PILOT 50 LAD - FINECROSS IVUS CANNOT CROSS

PTCA: Rotablation LAD, CX, CULOTTE technique

ROTAWIRE THROUGH FINECROSS ROTABURR 1.25mm 140000rpm

PTCA: Rotablation LAD, CX, CULOTTE technique

ROTABURR 1.5mm 140000rpm POST ROTA LAD

PTCA: Rotablation LAD, CX, CULOTTE technique

ROTABURR 1.5 mm CX 140000rpm POST ROTA CX

PTCA: Rotablation LAD, CX, CULOTTE technique

BALLOON LAD BALLOON CX

PTCA: Rotablation LAD, CX, CULOTTE technique

STENT CX WIRE LAD

PTCA: Rotablation LAD, CX, CULOTTE technique

FIRST KISSING STENT LAD

PTCA: Rotablation LAD, CX, CULOTTE technique

STENT LAD DEPLOYED FINAL KISSING

PTCA: Rotablation LAD, CX, CULOTTE technique

PTCA: Rotablation LAD, CX, CULOTTE technique

FINAL POT 4.5 BALLOON 26 Atm

PTCA: Rotablation LAD, CX, CULOTTE technique

FINAL RESULT

PTCA: Rotablation LAD, CX, CULOTTE technique

FINAL IVUS RESULT

DAY 1: patient completely dependent on ECMO –

pressure tracing direct line – iv inotropes

DAY 1: patient completely dependent on ECMO – pressure

tracing direct line – iv inotropes

DAY 5: ECMO REMOVED

DAY 8: PATIENT DISCHARGED – NYHA I – EF 35%

MR improved grade II

PRE POST

EF

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

Sintek and Joseph et al J Card Fail 2015

The more dysfunction the ventricle,

the less functional an IABP becomes

Counterpulsation Requires Native Left Ventricular Pulsation

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

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

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

Rota-Kurs Gaul I/2002

Rotablator:

Catheter Components

drive shaft

guide wire

diamond coated burr1.25 mm - 2.5 mm

(0.25 mm increments)

sheath 4.3 french O.D.

• Differential Cutting

• The Orthogonal Displacement of Friction

Key Principles of Operation for the

Rotablator System

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

Differential Cutting

Elastic Tissue In-elastic Tissue

Rotablator

Micro

Particles

Rotablator

Micro

Particles

Red Blood CellsRed Blood Cells

5 Micron Bead5 Micron Bead

tt

ss

Plaque is ablated

into small particles

removed by RES

RotablatorTM: 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

Rotablator: Benefits

post-PTCA procedure post-Rotablator® procedure

System

Components

Overview

Disposable’s and Hardware

Rotablator System Components

Disposables:

• Advancer

• Burr Catheter

• WireClip Torquer

• Guide Wire

Rotablator System

ComponentsHardware

• Air Supply

Compressed Air

Compressed Nitrogen

• Console

• Dynaglide Foot Pedal