MCS 2011

Mechanical Circulatory Support: an overview : 

Mechanical Circulatory Support: an overview Core Colloquia Informali A.O.R.N. “AZIENDA OSPEDALIERA DEI COLLI” Monaldi-Cotugno-CTO

First Successful Artificial Heart Implantation (BTT) : 

First Successful Artificial Heart Implantation (BTT) Pat. 47 years old H.K, LCO after LV aneurysm resection MCS-64 h, died 32 h after HTx Denton Cooley and Dominigo Liotta 1969 Liotta`s artificial heart

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Classifications of MCS : 

Classifications of MCS Type of Support Left/Right Support Biventricolar Support Heart Replacement Type of Flow Continuous Pulsatile Finality Myocardial Unloading (Recovery) End-Organ Perfusion Support Duration Short-term (BTD/BTR) T,W Mid-term (BTR/BTT) M,J Long term (DT) Position Impiantable Paracorporeal Pumping principle Displacement Centrifugal pump Axial flow turbine Diagonal flow turb Energy conversion electro pneumatic - mechanic - magnetic - hydraulic Thermomechanic Energy Trasmission Driveline TET

Incidence of RV Failure after LVAD Implantation : 

Incidence of RV Failure after LVAD Implantation 19% Ramasamy N, Cardiac Surg 1993 43% Kormos R. JTCVS 1996 33% Oz M, Circ 1997 20% Wagner F, Circ 1997 50% Argenziano M, Ann Thorac Surg 1998 10-17% Deng M, Circ 2001 6% McBride L, Ann Thorac Surg 2001 15-26% El-Banayosy A, Ann Thorac Surg 2001 39% N. Dang, JH&LT, 2006 33% S. Puwanant, JH&LT, 2008 35% JC Matthews, JACC, 2008 9-12% DHZB, since 2006, according to INOT 41 criteria

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Type of Support Replacement Heart Replacement

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SynCardia Inc. CardioWest TAH-t

HeartWare BiVAD : 

HeartWare BiVAD

Specifics of different MCSS1. displacement pumps / pulsatile systems : 

Specifics of different MCSS1. displacement pumps / pulsatile systems - long, big bore cannulas (extracorporeal systems: big percutaneous tubes) big pump volume / weight noisy operation, wear - valves (mech.: hemolysis/ biolog.: limited duration) - extracorporal / subperitoneal location physiologic flow afterload-independent operation preload-dependent (“Frank-Starling”) syncronisation possible

Specifics of different MCSS2. rotational blood pumps - axial flow : 

Specifics of different MCSS2. rotational blood pumps - axial flow - LVAD, apical inflow critical suction behaviour no valves (retrograde flow in case of pump stop) no / neglectible wear pre- / afterload depending pump flow (low dependency) thoracic location long apical inflow cannula (exemption: Jarvik2000)

Benefits of a Rotary Device : 

Benefits of a Rotary Device Smaller size 60% Smaller than HeartMate I (XVE) 35 mm diameter 70 mm long 280 grams No requirement for venting 40% reduction in the size of percutaneous lead (Driveline) Enhanced patient comfort Single moving part Smaller Silent, vibration-free operation Ease of surgical implantation Standard sternotomy vs. extended midline excision Smaller preperitoneal pocket Designed for extended durability

Comparison of HM I (XVE) and HM II : 

18 Comparison of HM I (XVE) and HM II * at mean pressure=100 mm Hg HM II with controller and batteries HMI HMII

Small Size = Pericardial Placement : 

19 Small Size = Pericardial Placement May reduce blood loss Potential for short implant time No abdominal surgery No pump pocket Potential to expand treatable patients Fundamental advantages resonating globally Surgical placement – Sternotomy or Thoracotomy

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LVAD, apical inflow more advantageous suction behaviour no valves (retrograde flow in case of pump stop) no / negligible wear pump flow highly dependent of pre- / afterload intrapericardial location small pump, integrated apical inflow (exemption: DuraHeart) Specifics of different MCSS3. rotational blood pumps - radial flow

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Finality Myocardial Unloading (Recovery) End-Organ Perfusion

Recovery : 

Recovery ♦ For selected patients with unloading-induced improvement from chronic HF, VAD explantation is a clinical option with potentially successful results over > 15 years. ♦ With the option of HTx, mortality due to VAD removal-related complications is low and patients’ survival with and without HF recurrence is similar. ♦ Echocardiogr. data obtained at “off pump” trials are reliable for detection of cardiac recovery during mechanical unloading ♦“Off pump” LV size, geometry and EF are predictive for outcome after weaning, especially if history of HF is also considered.

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Finality End-Organ Perfusion

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Aims and Options of Mechanical Circulatory Supportin Patients with End-stage Heart Failure The prediction of clinical outcome in patients in severe cardiogenic shock supported by BVAD is possible in extreme situations only. Rapid re-establishing of adequate body perfusion as a means of gaining time, with subsequent employment of a decision-making algorithm, is necessary in all patients suffering from severe cardiogenic shock and MOF.

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Indications for Short-term VAD Abiomed/Berlin Excor/ Impella/TandemHeart/Levitronix Myocardial recovery in the next few days is anticipated postcardiotomy acute myocardial infarction acute myocarditis poisoning Unclear neurological status (bridge to decision) Profound multiorgan failure (bridge to long-term device if organ recovery occurs)

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Post-cardiotomy heart failure Heart failure within hours or days after cardiac operations. intra-aortic ballon pump = IABP for short-term use pneumaticaly driven bridge to recovery in 3 - 5 % of our patients in 0.3% a VAD has to be implanted

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Post-cardiotomy heart failure Heart failure within hours or days after cardiac operations.

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Post-cardiotomy heart failure Heart failure within hours or days after cardiac operations. Which system to implant? short-term device intermediate-term device long-term device recovery expected? prognosis ? (BTT, DT?) TANDEM HEART Cardiac Assist Inc CentriMag Levitronix Impella LP 2,5 ; 5,0 ;LD

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Support Duration Short-term (BTD/BTR) T,W

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Today clinical available systems Rotational Pulsatile Centrifugal Pump Axial Turbine

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Incor Excor Abiomed Cardiowest Duraheart CorAide LionHeart DeBakey Levitronix Heartmate II Jarvik2000 Ventracor TCI Heartmate Novacor Impella Bücherl TAH Which One In Which Patient??? HeartWare

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Patients with Intermacs I Level and Postcardiotomy Syndrome “crush and burn” Percutaneous ECMO in peripheral hospitals for transport or primary BVAD implantation with Excor cannulas and Levitronix pumps as bridge to decision In special cases (massive acute MI, VSD) – TAH CardioWest

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Patients with Intermacs II - V LevelConcept for implantable devices RV function Primary surgery Redo surgery in non-HTx candidates good LVAD (MS) LVAD (LL) risk for RVF LVAD + temp. RVAD* (MS) LVAD + temp. RVAD* (LL) high risk for RVF impl. HW HVAD with an option for 2nd as an RVAD (MS) BV failure impl. BVAD (2 x HW HVAD through median sternotomy) MS median sternotomy LL left lateral thoracotomy In special cases (cardiac tumor, rejection, massive acute MI or VSD) implantation of TAH CardioWest

Does INTERMACS Profile Matter? : 

Does INTERMACS Profile Matter? Less acutely ill, ambulatory patients in INTERMACS profiles 4-7 had better survival and reduced length of stay compared to patients who were more acutely ill in profiles 1-3. Length of Stay Post-VAD* Actuarial Survival Post-VAD* *Boyle AJ et.al. Clinical outcomes for continuous-flow LVAD patients stratified by pre-operative INTERMACS classification, JHLT, April 2011.

INTERMACS Profiles : 

INTERMACS Profiles 61% of patients in the Post Approval study were in profile 1 or 2. Baseline INTERMACS Profiles

INTERMACS Outcome BTT vs DT : 

37 INTERMACS Outcome BTT vs DT

VAD in Children : 

38 VAD in Children Less death on waiting list Increase of VAD support Figure 1. Percentage of patients with VAD implantation as a bridge to heart transplantation.

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Thrombogenicity Problems bearings apical cannula pump

Thrombo-embolic complications : 

Thrombo-embolic complications

Thrombelastogram (TEG) : 

Thrombelastogram (TEG) Global test Hypocoagulability control

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Anticoagulation Protocol

Prevalence of Driveline Infection : 

Prevalence of Driveline Infection 23% in pulsatile LVAD after median time of 400 days 94% after 1 year 30% progress to a pocket infection (Zierer et al., ATS, 2007) 48% in pulsatile LVAD, half of them during the first month, after median time of 150 days (Monkowski et al., Transpl Inf Des, 2007) 28% in TCI patients (Holman et al., JH&LT, 2004) 1.4% in axial flow pumps (Metaanalysis of published data 2001 - 2005)

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Pedestal of Jarvik 2000

Conclusions : 

Conclusions The evolution of design and materials of Mechanical Circulatory Support Devices and the growing experience in the follow-up permitted to reach excellent results in the treatment of acute and chronic Heart Failure. A multidisciplinary team of surgeons, cardiologists, and intensivists is necessary to achieve good results and standardize the approach to MCS.