Artificial Heart

B. Meyns Cardiale Heelkunde UZ Gasthuisberg Leuven

• Het klinisch probleem - Chronisch hart falen • Huidige status van ‘Ventricular Assist Devices’ • Onderzoek en ontwikkeling

1. Het Klinisch Probleem Hartfalen

Schatting prevalentie Westerse wereld
Number of Patients (millions)
No Symptoms on Exertion Symptoms on Exertion

5 4 3.79m 3 2 1 3.62m 3.11m

Symptoms at Rest

0.79m 0
CRT 300,000

0.40m

LVADS 3,000

I

II

IV Shock IIIb early NYHA Disease Severity Class

III

Chronisch Hartfalen • Oorzaken – – – – Ischemisch lijden Gedilateerde cardiomyopathie Myocarditis … • Behandeling – Medicamenteuze ondersteuning – Resynchronisatie (pace-maker) – Transplantatie = Meest efficiënt .

Ector.KUL patient survival 91 100 90 80 70 60 50 40 30 20 10 0 0 86 73 52 % 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 years 01/01/10 the expert help of H. MD. PhD is gratefully acknowledged .

NUMBER OF HEART TRANSPLANTS REPORTED BY YEAR 4500 4000 Number of Transplants 3500 3000 2500 2000 1500 1000 500 0 Other Europe North America 01/01/10 ISHLT 2009 .

heart transplantation in Belgium 154 127 108 93 80 130 124 115 98 116 111 96 91 84 81 80 87 .44% 71 6969 70 74 67 37 2 8 4 19 '82 '84 '86 '88 '90 '92 '94 '96 '98 '00 '02 '04 '06 '08 1 01/01/10 3 4 5 6 7 N active centers .

Huidige status van Ventricular Assist Devices .2.

Het kunsthart voor hartchirurgie .

Hartpompen • Verplaatsingspompen – Slag volume – Kleppen • Rotatie pompen – Centrifugaal – Axiaal – Diagonaal .

Korte termijn (1week) centrifugaal pomp ECMO Hemopomp .Hartpompen 1. Middenlange termijn (3 maanden) Medos Thoratec Berlin Heart Plotse shock 3. Lange termijn (>3 maanden) Heartmate Incor Chronisch hartfalen .Impella Abiomed Indicatie Postcardiotomie Post -infarct 2.

Voorbeeld korte termijn pomp Impella .

Motor Cannula P ventricle Differential pressure sensor 6 P aorta P1 P2 P3 P4 P5 P6 P7 P8 P9 5 4 flow [l/Min] 3 2 1 0 0 30 60 90 120 150 180 differential pressure [mmHg]. PAorta-PVentrikel .

Impella LP2.5 L/min • 12 Fr vascular access .5 • Ease of Placement • 2.

Gebruik korte termijn pomp • Therapie bij hartfalen na acute problemen • Hartrecuperatie is nog mogelijk in de eerste dagen • Afhankelijk van de indicatie kan in 30 – 50 % de hartfunctie gerecupereerd worden .

Voorbeeld medium term Plotse shock ‘Bridging to transplantation’ .

Thoratec .

Berlin Heart Excor -verschillende ventrikels -poly-urethaan kleppen en mechanische kleppen -Silicone cannules -Minder thrombus thv kleppen .

controle pannel .

Lange termijn pompen .

Novacor .

.

DCMP Acromegaly. DCMP Implant 6 Jun 2000 Permanent support Pump exchange 05/04 • • • • Female. 50 y/o. 55 y/o.3 Novacor Recipients ongoing >4y (Berlin Heart Center) • • • • • Male. HIT II Implant 8 May 2000 Permanent support . tumor. 40 y/o. DCMP Implant 7 Jul 2000 Permanent support Pump exchange 08/02 Now BTT • • • • Male.

IT (courtesy G. Chronic HF (13 yr) High TPG. bearing wear and inflow valve incompetence) Eligible for Transplant Transplant after 2220 days (6. Faggian) .08 yr) • • Patient from Verona. severe COPD Elective pump replacement (1487 days.First patient >6y • • • 56 y/o.

power pack. compliance chamber. implanted controller. charger/supply • Not available .Arrow LionHeart 2000 • Totally implantable left ventricular assist device system • Blood pump and cannulae. power transmitter.

minder invasief • Geen kleppen • Minder complicaties (minder thrombusvorming) • Mechanische ‘bearings’ • Magnetische ophanging .Evolutie naar rotatiepompen • Kleiner.

Incor .

Jarvik 2000® .

.

NEJM 2007 • Geaccepteerde therapie in transplant centra • Belangrijkste nevenwerkingen – Bloeding – CVA door bloedklonters – Kabel poort infectie .Lange termijn pompen • Voornamelijk rotatie pompen • Overleving belangrijk verbeterd 68% at 1 year Miller et al.

% 45 40 35 30 25 20 15 10 5 0 '88 '90 '92 '94 '96 '98 '00 '02 '04 '06 '08 01/01/09 .

‘Destination therapy’ ??? Eerste klinische studies lopen Grote chirurgie Complicaties Geen terugbetaling Implementatie ? .

KUL VAD aantal patiënten 70 60 50 40 30 20 10 0 ECMO VAD .

.

sensing Transcutane energie Totaal artificieel hart . Ontwikkelingen Onderzoek • • • • • Kleiner.3. minder invasief Recuperatie eigen hartfunctie ? Pump control .

1 Kleiner – minder invasief Partial support – The concept • Pace-maker pocket • Outflow to subclavian artery • Inflow from left atrium (thoracotomy) • Cable tunneled to abdomen .3.

2 mm • Length: 49 mm • Priming volume: 1. flow rate: 4 L / min.5 L/min • Power consumption: 6-9W • Mechanical –hydrodynamic bearing . rot.The pump 250 20000 22000 24000 26000 28000 200 p [m Hg] m 150 100 50 0 0 1 2 flow [l/min] 3 4 • Outer diameter: 13. speed: 28.000 rpm • max. 80mmHg • design point: 2.9 ml • max.

Inflow cannula and batteries .

2. Tunnel cable to abdomen No ECC 2nd ICS Pocket Incision 4th ICS Thoracotomy Outflow Graft Intended Pump Position .Implantation procedure 1. 3. 5. Incision under clavicle Small right thoracotomy Two purse strings on LA Seldinger insertion cannula Tunneling cannula to pacemaker pocket 6. 4. Suture graft to subclavian artery 7.

Two purse strings on left atrium .

Seldinger insertion inflow cannula .

.

Suture graft to subclavian artery Connect pump .

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Technical details Graft connector Magnetic coupling Inflow cage Impeller Motor Ball bearing Pump housing .

Bearing configuration Axial bearing: mechanical / magnetic Radial bearing: magnetic / hydrodynamic .

Prevention of clott formation Washout holes Secondary flow path .

Rotor Designs Original Washout (OWR) Enlarged Washout (EWR) Heart Shaped (HSR) .

Particle Image Velocimetry (PIV) Experimental Setup 3.1. In-vivo testing (animals) .Computational fluid dynamics 2.

PIV Original Washout (OWR) Enlarged Washout (EWR) Heart Shaped (HSR) Flow-visualisation 10:1 24krpm 3.Rotor Design .3L/min 52 .

Berlin Heart Center – .3.Harefield protocol with ‘clenbuterol’ • Depends of underlying disease • Current research focuses on – Effect of unloading on the heart function – Window of opportunity to treat with medication .2 Recuperatie van de hartfunctie • Rare clinical data of weaning (not reproduced) – .

• • • • • 150 papers Different changes during support The heart does show reverse remodeling No prove of better function Pump allows interaction with other drugs .

3 Sensors – Pump control • Algorhytms for pump speed reduction based on motor current. • Opportunity .3.

3.4 Transcutane energie Abdominale kabel Permanente kabel .

3.5 Totaal artificieel hart • • • • Oude droom In ontwikkeling– technical challenge Maximaal invasief Momenteel alleen als bridge .

Home management • Home monitoring anticoagulatie • VAD nurses • E-Health – Automatische controle van pomp stroom verbruik – Automatische controle van patiënt parameters Implementatie met minimale inzet van zorgverleners .6.3.