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Mechanical Circulatory
Support
Dr Awadhesh Shrama
LPS Institute of Cardiology
Introduction
• Heart failure (HF) is a complex clinical syndrome characterized by
pulmonary and systemic congestion due to myocardial dysfunction
leading to reduced cardiac output.
• HF is estimated to affect 1%–2% of the adult population with
approximately 1 million new cases per year.
• While HF outcomes have improved with the use and application of
evidenced based therapies, the death rate remains high at
approximately 50% within 5 years of diagnosis.
• Heart failure is a progressive disease with approximately 10% of the
overall HF population having end stage disease with ongoing
symptoms refractory to conventional therapies (American Heart
Association Class D/New York Heart Association Class IIIB–IV).
• Over the last 50 years cardiac transplantation has been established as
the gold standard for the treatment of end stage HF.
• However, cardiac transplantation remains a limited option for a select
number of patients.
• The need for transplant outpaces the availability of donor organs.
• Accordingly, mechanical circulatory support (MCS) in the form of durable
left ventricular assist devices (LVAD) is a central therapeutic alternative to
improve the quality of life and longevity of patients who are either
waitlisted or ineligible for a heart transplant.
• Potentially capable of permanent mechanical support.
• First implantation of LVAD as a BTT –performed by PHILIPS OYER in 1984.
What Are MCS Devices ?
• Mechanical pumps designed to assist / replace the function of either
left / right / both ventricles.
• MCS devices are indicated to provide hemodynamic support to
patients with cardiogenic shock or symptomatic advanced heart
failure (HF) refractory to guideline-directed medical care.
• It decreases the workload of the heart while maintaining adequate
flow and blood pressure.
Common terminology
• Bridge to Recovery (BTR) – [US-FDA approved]
• Potential Reversible Cause (E.G. AMI, Ac. Myocarditis, Post-cardiotomy Cardiogenic Shock)
• Bridge to Bridge (BTB)
• Temporary MCS continued as a bridge to long term LVAD
• Bridge to transplant (BTT) – [US-FDA approved]
• Patient eligible for heart transplant
• “Destination” therapy (DT) – [US-FDA approved]
• Recovery or transplant is not feasible
• Bridge to candidacy (BTC)
• When eligibility unclear at implant or with comorbidities (e.g. CRS, PAH)
• Bridge to Decision (BTD)
• Potential for transplant or recovery unclear
Guidelines For Initiation Of MCS
• Timing of initiation – crucial for pt. outcome
• Generally accepted guidelines (despite use of OMM) :
• Cardiac index < 1.8-2.2 L/min/m2
• SBP < 90 mmHg
• PCWP > 20 mmHg
• RA pressure > 18-20 mmHg
• Evidence of poor tissue perfusion (oliguria, mental status change, cool extremities)
• General C/I for MCS :
• Irreversible renal/hepatic/resp. failure
• Sepsis
• Significant cognitive deficit
Indications For VAD
1.Chronic Heart Failure :
1. LVEF <25%
2. Peak VO2 < 14 cc/kg/min
3. NYHA class IV for 60 days
4. NYHA class III/IV for 28 days and
1. IABP support for 14 days or
2. 2 failed attempts to wean I.V. Inotropes
5. Increasing diuretic requirement
6. Symptomatic despite CRT or ionotropic dependence
2.Acute refractory Cardiogenic Shock
1. Acute fulminant myocarditis
2. AMI with cardiogenic shock
3. PPCM/TTCM
4. Post cardiac surgery
a. Unable to maintain cardiac output
b. Failure to wean from CPB
3. Bridge to Recovery: therapeutic strategy in small subset
Principle:- Mechanical unloading with LVAD-reverse remodelling
-reduction in chamber size
-improvement in end –diastolic pressure-volume relationship
Approx 80% of LVAD implants for BTT
Heidenreich, P. A. et al. (2022). 2022 AHA/ACC/HFSA Guideline for Heart Failure. Circulation.
Durable Mechanical Support with
Left Ventricular Assist Device
SOURCE: https://www.mayoclinic.org/tests-procedures/ventricular-assist-
device/multimedia/left-ventricular-assist-device/img-20006714
INDICATIONS
• Frequent hospitalizations for HF
• NYHA class IIIB to IV symptoms
despite maximal GDMT
• Intolerance of GDMT
• Increasing diuretic requirement
• Symptomatic despite CRT
• Inotrope dependence
• Low peak VO2 (<14-16 ml/kg/m2)
• End-organ dysfunction
attributable to low cardiac output
CONTRAINDICATIONS
Absolute
• Irreversible hepatic, renal or
neurological disease
• Medical non-adherence
• Severe psychosocial
limitations
Relative
• Age >80 years for destination
therapy
• Obesity or malnutrition
• Musculoskeletal disease that
impairs rehabilitation
• Active systemic infection or
prolonged intubation
• Untreated malignancy
• Severe PVD
• Active substance abuse
• Impaired cognitive function
• Unmanaged psychiatric
disorder
• Lack of social support
Abbreviations: CRT indicates cardiac resynchronization therapy; GDMT, guideline-directed medical therapy; LVAD, left ventricular assist device; NYHA, New
York Heart Association; PVD, peripheral vascular disease; and VO2, oxygen uptake.
9
Heidenreich, P. A. et al. (2022). 2022 AHA/ACC/HFSA Guideline for Heart Failure. Circulation.
Mechanical Circulatory Support
Despite improving hemodynamic compromise, positive inotropic agents have not
shown improved survival in patients with HF in either the hospital or outpatient
setting.
COR RECOMMENDATIONS
1
1. In select patients with advanced HFrEF with NYHA class IV symptoms who
are deemed to be dependent on continuous intravenous inotropes or
temporary MCS, durable LVAD implantation is effective to improve
functional status, QOL and survival.
2a
2. In select patients who have NYHA class IV symptoms despite GDMT,
durable MCS can be beneficial to improve symptoms, functional class and
reduce mortality.
2a
3. In patients with advanced HFrEF and hemodynamic compromise and
shock, temporary MCS, including percutaneous and extracorporeal
ventricular assist devices, are reasonable as a ”bridge to recovery” or
“bridge to decision.”
In patients with advanced HFrEF who have
NYHA class IV symptoms despite GDMT,
durable MCS devices provide low to
intermediate economic value based on
current costs and outcomes
Value Statement: Uncertain Value (B-NR)
Abbreviations: GDMT indicates guideline-directed medical therapy; HFrEF, heart failure with reduced ejection fraction; IV, intravenous; LVAD, left ventricular assist
device; MCS, mechanical circulatory support; NR, nonrandomized; NYHA, New York Heart Associations; and QOL, quality of life.
10
Contraindication for VAD Therapy
1. Active systemic infection or major chronic risk for infection.
2. High surgical risk for successful implantation.
3. Recent or eveolving stroke /neurological deficit.
4. Fixed pulmonary or portal hypertension.
5. Intolerance to anticoagulant.
6. Morbid obesity(BMI>45kg/m2)
7. CKD with serum creatinine level >3.0mg/dl
8. Restrictive CM
9. Significant underlying psychiatric illness or lack of support.
Classification of VAD
1. Based on pumping mechanism
• Pulsatile
• Continuous flow
• Axial
• Centrifugal
• Mixed
2. Based on location of pumping chamber
• Intracorporeal
• extracorporeal
3. Based on ventricle supported
• Left ventricle (LVAD)
• Right ventricle(RVAD)
• Both ventricle (BiVAD)
4. Based on duration of support
• Short term (days to weeks)
• Long term (months to years)
Pre-op Assessment
• CAG
• RV function
-ECHO
• Severity of TR
• RV size
• RVEF,FAC
• TAPSE
• Right heart catheterisation (RA pressure,PVR)
Component of VAD
Components Of A VAD
1. Electromechanical Pumps - placed in parallel with the native patient’s circulation
2. Inflow cannula - decompresses the ventricular cavity
• In LVAD: originates in LA or LV
• In RVAD: originates in RA or RV
• In BVAD: originates in both Atriums &/or Ventricles
3. Pump: Provides propulsion to the blood
• Flow can be:
• Pulsatile
• pneumatically or electromechanically driven
• Non pulsatile / Continuous
• Axial / Cetrifugal / Mixed
4. Pump is implanted sub-diaphragmatically to:
1. Preperitoneal position
2. Intra-abdominal position or
3. Para-corporeal position outside the body
5. Outflow cannula returns blood to either
• Ascending aorta (In LVAD) or
• Main pulmonary artery (In RVAD)
6. Controller: Operates pump by receiving and processing information from it.
7. Percutaneous driveline:
• containing the control & power wires, is tunneled through skin of abdominal wall
• connects device to external portable driver consisting of electronic or pneumatic controller &
power supply that may be worn around waist
Schemetic of LVAD
Centrifugal flow pump Axial flow pump
Physiology Of CF-LVAD
• Flow across pump depends on :
• Pump speed – directly proportional
• Afterload across LVAD (Head Pressure) – inversely proportional
• Axial vs. Centrifugal Pumps :
Axial Centrifugal
relationship
between flow and
head pressure
steep and inverse
linear
flatter and more
susceptible to
head pressure
changes
Dependent on Preload Both preload and
afterload
Flow range 3-7 L/min 0-10 L/min
• These hydrodynamic characteristics of centrifugal pumps translate into:
1. More pulsatile waveform;
2. More accurate flow estimation;
3. Lower risk of suction events (e.g, In setting of dehydration,
arrhythmias, or right ventricular failure);
4. More dependency of device flow on loading conditions
Pulsatility Of Device
• Assessed by PUMP INDEX (PI)
• PI = [max flow – min flow] / avg flow
• Low PI suggests
• Hypovolemia
• Pump Obstruction
• Low arterial pulsatility
• cause for several serious adverse effects of CF-LVADs
• LVAD speed modulation
• Used for antithrombotic cycling to prevent pump thrombosis
• Precludes formation of zones of recirculation and stasis within the device
Types Of Mechanical Circulatory Support
• SHORT TERM MCS SUPPORT :
• Temporary MCS is indicated in patients with cardiogenic shock refractory to medical therapy when
rapidly achieved augmentation of cardiac output and reduction of ventricular filling pressures are
required to sustain life.
• When used in the setting of medically refractory myocarditis or Takotsubo cardiomyopathy, temporary
MCS may provide time for spontaneous recovery and discontinuation of MCS.
• When cardiogenic shock complicates longstanding HF, temporary MCS can provide the time needed
for patients, family members, and physicians to make critical decisions about long-term MCS and
heart transplantation.
• Examples :
1) IABP-
• Most commonly used MCS device
2) Extra corporeal life support & Extracorporeal Membrane Oxygenation-
• VV ECMO or VA ECMO
3) Impella – LV to Aorta assist device
• Impeller-driven, axial flow pump, capable of pumping 2.5-5 L/min
4) TandemHeart – LA to Aorta assist device
• Low speed centrifugal continuous-flow pump
• Drains oxygenated blood through a catheter advanced across the IAS to the
LA & pumps it back to one or both femoral arteries
IABP
• The IABP pump remains the most commonly used
MCS device.
• The IABP consists of a balloon catheter and a pump
console to control the timing of balloon inflation
and deflation.
• The catheter is a double- lumen, 7.5- to 8.0- French
(F) catheter with a polyethylene balloon attached at
its distal end, with one lumen of the catheter
attached to the pump and used to inflate the
balloon with gas.
• Helium is used because its low viscosity facilitates
rapid transfer in and out of the balloon, and because
it absorbs very rapidly in blood if the balloon
ruptures.
IABP
• Timing of balloon inflation and deflation is based on electrocardiogram (ECG) or
pressure triggers.
• The balloon inflates with the onset of diastole, which roughly corresponds with
electrophysiologic repolarization or the middle of the T wave on the surface ECG,
or just after the dicrotic notch on the aortic pressure tracing.
• Following diastole, the balloon rapidly deflates at the onset of LV systole, which
is timed electrocardiographically to the peak of the R wave on the surface ECG.
• The IABP increases diastolic blood pressure, decreases afterload, decreases
myocardial oxygen consumption, increases coronary artery perfusion, and
modestly enhances cardiac output
• Efficacy of IABP counterpulsation was recently evaluated in the SHOCK II
clinical trial a randomized, prospective, open- label, multicenter trial
comparing IABP therapy with best available medical therapy for treatment of
acute myocardial infraction (AMI) complicated by cardiogenic shock.
• All patients were expected to undergo early revascularization (by means of
percutaneous coronary intervention or bypass surgery).
• At 30 days, 119 patients in the IABP group (39.7%) and 123 patients in the
control group (41.3%) had died (RR with IABP, 0.96; 95% CI 0.79 to 1.17; P =
0.69).
• No significant differences were found in secondary endpoints or in
process- of- care measures, including the time to hemodynamic
stabilization, the length of stay in the intensive care unit,serum lactate
levels, dose and duration of catecholamine therapy, and renal
function.
• The use of IABP counterpulsation did not significantly reduce 30- day
mortality in patients with AMI complicated by cardiogenic shock for
whom an early revascularization strategy was planned.
• The IABP provides modest ventricular unloading but does increase mean arterial
pressure and coronary blood flow.
• Patients must have some level of LV function and electrical stability for an IABP
to be effective because any increase in cardiac output depends on the work of
the heart itself.
• Optimal hemodynamic effect from the IABP depends on several factors, including
the balloon’s position in the aorta, the blood displacement volume, the balloon
diameter in relation to aortic diameter, the timing of balloon inflation in diastole
and deflation in systole, and the patient’s own heart rate, blood pressure, and
vascular resistance.
Nir Uriel. Circulation: Heart Failure. Clinical Outcomes and Quality of
Life With an Ambulatory Counterpulsation Pump in Advanced Heart
Failure Patients, Volume: 13, Issue: 4, DOI:
(10.1161/CIRCHEARTFAILURE.119.006666) Š 2020 American Heart Association, Inc.
Extracorporeal Life Support and Extracorporeal
Membrane Oxygenation
• ECMO provides cardiopulmonary support for patients whose heart and/or
lungs can no longer provide adequate physiologic support.
• ECMO can be configured for respiratory support (venovenous [VV-ECMO])
or for respiratory and circulatory support (venoarterial [VA-ECMO]).
• In cases of biventricular failure, VA-ECMO is the MCS device of choice for
patients in cardiogenic shock and impaired oxygenation, because it provides
full cardiopulmonary support.
• ECMO may be placed at the bedside without fluoroscopic guidance. ECMO is
similar to a CPB circuit used in cardiac surgery with some modifications.
• VA-ECMO involves a circuit composed of a continuous-flow centrifugal pump
for blood propulsion (most commonly) and a membrane oxygenator for gas
exchange.
• A venous cannula drains deoxygenated blood into a membrane oxygenator for gas
exchange, and oxygenated blood is subsequently infused into the patient through an
arterial cannula. VA-ECMO provides systemic circulatory support with flow capabilities
approximating 4 to 6 L/min depending on cannula size.
• Because of the increase in systemic afterload, however, VA-ECMO alone may not
significantly reduce ventricular wall stress and may result in LV distension in cases
where residual LV function is inadequate to eject against the increase in systemic
afterload.
• This may result in high myocardial oxygen demand (secondary to high filling
pressures and volume). This may have negative consequences on myocardial
recovery unless the LV is unloaded by concomitant IABP, an LV vent, atrial
septostomy, or use of a percutaneous LV-to-aorta VAD. Inadequate LV unloading may
also result in pulmonary hemorrhage.
LV TO AORTA ASSIST DEVICE-IMPELLA
• The Impella is a continuous flow microaxial pump designed to pump blood
from the LV into the ascending aorta, in series with the LV.
• Several versions of the pump are available, including the Impella 2.5, Impella
CP, Impella CP with SmartAssist, Impella 5.0, Impella LD, and Impella 5.5 with
SmartAssist.
• The pumps are U.S. FDA-approved to treat patients with cardiogenic shock.
• A pump specifically designed to support the right ventricle, the Impella RP is
U.S. FDA-approved to treat right HF or decompensation following left VAD
implantation, myocardial infarction, heart transplant, or postcardiotomy failure
to wean from CPB.
• The SmartAssist technology uses optical sensors to assess aortic pressure.
• The devices for LV assist are designed to be placed via the femoral artery, either
percutaneously (Impella 2.5 and CP) or with a surgical cutdown (Impella 5.0 and 5.5).
Alternate access sites such as the subclavian artery have also been described.
• The Impella pumps blood from the LV into the ascending aorta, thereby
unloading the LV and increasing forward flow. It reduces myocardial oxygen
consumption, increases coronary perfusion, improves mean arterial pressure,
and reduces PCWP.
• The Impella 2.5 provides a greater increase in cardiac output than the IABP but less
than the TandemHeart device.
• The more powerful Impella CP and 5.0 devices are comparable to the TandemHeart
device in terms of support.
• Similar to the TandemHeart, adequate RV function or concomitant RVAD is necessary
to maintain LV preload and hemodynamic support during biventricular failure or
unstable ventricular arrhythmias.
• In a prospective, randomized clinical trial comparing the Impella 2.5 to the
IABP, cardiac index was significantly increased in patients with the Impella 2.5
compared with patients supported with an IABP.
• Overall mortality rates at 30 days were similar in both groups, but the study
was not adequately powered to assess for a mortality difference.
• Despite the absence of suitably powered randomized clinical trials
demonstrating a mortality benefit over IABP therapy (which itself has no
proven mortality benefit), the use of temporary MCS devices in patients with
cardiogenic shock is likely to continue.
• In comparison with an IABP, these devices provide a much larger increment in
cardiac output and superior LV unloading.
IMPELLA VAD
LA TO AORTA ASSIST DEVICE- TandemHeart
• The TandemHeart percutaneous ventricular assist device (pVAD) is a paracorporeal
device inserted as a LA–aorta assist device that pumps blood from the left atrium to the
femoral artery through a transseptal positioned LA cannula, thereby entirely bypassing
the LV.
• The TandemHeart system includes a 21F transseptal cannula, a centrifugal pump, a
femoral arterial cannula, and a control console.
• The TandemHeart is approved by FDA to incorporate an oxygenator to the circuit,
allowing for concomitant LV unloading and oxygenation.
• The centrifugal blood pump contains a hydrodynamic bearing that supports a spinning
impeller. The impeller is powered by a brushless direct-current (DC) electromagnetic
motor, rotating between 3000 and 7500 rpm. The external console controls the pump
and provides battery backup in case of power failure.
• A continuous infusion of heparinized saline flows into the lower chamber
of the pump, which provides lubrication and cooling, and prevents
thrombus formation.
• The redirection of blood from the left atrium reduces LV preload, LV
workload, filling pressures, wall stress, and myocardial oxygen demand.
The increase in arterial blood pressure and cardiac output supports
systemic perfusion.
• The flow through the TandemHeart is additive to LV output through the
aortic valve (parallel circulation).
• However, the contribution from the native heart is typically reduced as
MCS support is increased due to changes in LV loading conditions (i.e.,
decrease in preload and increase in afterload)
• Coronary flow is driven by the perfusion pressure (diastolic
pressure−RA pressure). With a parallel circulation, the aorta is
perfused and pressured by both the left ventricle and the
TandemHeart.
• Not infrequently, LV contraction (native heart output) may be
negligible, and systemic perfusion is pump dependent, with a flat
mean arterial pressure curve.
• This situation can result in stasis of blood within the aortic root,
resulting in thrombus formation and stroke.
• In a randomized comparison of the IABP with the TandemHeart, the
TandemHeart provided more effective improvement in cardiac power
index as well as other hemodynamic and metabolic variables
compared to the IABP.
• Moreover, complications, such as severe bleeding and limb ischemia,
were encountered more frequently after TandemHeart VAD support.
• Thirty-day mortality rates were similar between the groups, but the
study was underpowered to compare mortality between groups.
TANDEM HEART VAD
Extracorporeal :
Bio – Medicus
Abiomed – BVS
Thoratec CetriMag Blood Pump
Advantages :
Widely available
Relatively inexpensive
Simple and quick implantation
May be used as
RVAD
LVAD
Part of ECMO circuit
Disadvantages :
Requires systemic anticoagulation
Requires ICU monitoring
Limited mobility
Types of Ventricular Assist Devices
• LONGER TERM ASSIST DEVICES (3 GENERATIONS) :
1. First Generation Or Pulsatile Flow Pumps
2. Second Generation Or Continuous (Axial) Flow Pumps
3. Third Generation Or Continuous (Centrifugal) Flow Pumps
REMATCH TRIAL
• The benefits of MCS for DT, in terms of survival, function, and quality of life,
for the treatment of chronic advanced HF were first established in a
prospective, randomized trial known as REMATCH (Randomized Evaluation of
Mechanical Assistance in the Treatment of Congestive Heart Failure)
• REMATCH evaluated the use of a durable, implantable LVAD compared with
optimal medical management (OMM) for refractory chronic advanced HF.
• LVAD therapy halved the mortality seen in the control population (92% at 2
years) treated with OMM.
• Despite serious adverse events (e.g., stroke, infection, bleeding, and device
malfunction) attributable to MCS, LVAD recipients experienced a better quality
of life than those in the OMM group.
FIRST VS SECOND/THIRD GENERATION LVAD
CHARACTERSTIC OF DEVICE FIRST GENERATION LVAD SECOND /THIRD GENERATION
LVAD
SIZE OF LVAD LARGER SIZE SMALLER SIZE
DURABLITY LESS DURABLE MORE DURABLE
OUTPUT DETERMINANTS PRELOAD PRELOAD AND AFTERLOAD
POSITION OF PUMP INTRA-
ABDOMINAL/PREPERITONEAL IN A
POCKET UNDER RECTUS ABDOMINI
INTRACARDIAC/INTRATHORACIC AT
THE APEX
PUMP CAPACITY 10LIT/MINT 10L/MINT
MOVING PARTS MANY MOTOR
DRIVE LINES THICK AND LESS FLEXIBLE THIN AND FLEXIBLE
BATTERY CAPACITY SHORT DURATION LONG DURATION
THROBOGENICITY HIGH LESS
1. First Generation Or Pulsatile Flow Pumps
• Anticoagulation necessary for all devices, (except HeartMate XVE)
• Noisy and uncomfortable (percutaneous leads are large, stiff & contain air
vent channel)
• Increased risk of hematomas and infections as they are large in
volume,requiring extensive surgical dissection
• Examples :
• HeartMate® I
• HeartMate XVE (Thoratec Corp., Pleasanton, CA)
• Novacor VAD (WorldHeart Inc., Oakland, California, USA
Types of Ventricular Assist Devices
• Heartmate I
• Made of titanium with a polyurethane diaphragm & has a pusher-plate
actuator
• Cannula is placed in the apex of the left ventricle
• Blood flows through a Dacron conduit to the pump,
• Returns into a Dacron outflow graft through another porcine valve to
the ascending aorta
• Resist thrombogenesis d/t titanium microspheres and a fibrillar
textured inner surface
• Can pump 4–10 l/min
Types of Ventricular Assist Devices
2.HeartmateXVE (Thoratec Corp)
• Has a 65 ml stroke volume pumping chamber and two mechanical
valves
• Positioned on the anterior abdominal wall with cannulas crossing
into the chest wall
• Can be used an LVAD, RVAD or BIVAD
• Produces a beat rate of 40–110 bpm & a flow rate of 1.3–7.2 l/min
• Warfarin (international normalisation ratio = 2.5–3.5) & aspirin
anticoagulation required
Types of Ventricular Assist Devices
3. Novacor VAD
• Consists of pump drive unit which is implanted in the left upper quadrant
of the abdomen
• Incorporates a dual pusher plate 70 ml stroke volume
• Contains sac-type blood pump with a smooth blood-contacting surface,
coupled to a pulsed-solenoid energy converter drive
• Inflow cannule is inserted through the diaphragm into the left ventricular
(LV) apex
• Outflow graft anastomosed to the ascending aorta
Second Generation Or Continuous Flow Pumps
• Examples:
• HeartMate 2 VAD (Thoratec Inc.)
• Jarvik 2000 (Jarvik Heart Inc., New York)
• Berlin Heart Incor (Berlin Heart AG)
• Micromed Debakey VAD
Types of Ventricular Assist Devices
1.HeartMate II
• Continuous-flow axial blood pump with internal rotor
with helical blades that curve around central shaft
• Twisted shape of outlet stator vanes converts radial
velocity of blood flow to axial direction
• Can pump up to 10 l/min
• Axial flow design & absence of blood sac eliminate need
for venting
Types of Ventricular Assist Devices
2.Jarvik 2000
• Axial flow, continuous-flow pump having intraventricular position
with whole pump sitting within the LV cavity
• Impeller is only moving componant located in centre of the
titanium housing
• Blood flow is directed through outlet graft by stator blades
located near pump outlet & returns to either ascending or
descending aorta
• Can pump 8 l/min, serious infections rare
Types of Ventricular Assist Devices
3.Berlin Heart Incor
• An axial flow pump
• As blood passes into the Incor, it first passes the inducer that
guides laminar flow onto actual impellar, which is suspended by
a magnetic bearing
• Stationary diffuser behind rotor has specially aligned blades
which reduce the rotational effect of blood flow
• Also creates additional pressure to assist transport of blood in
the outflow cannula to the aorta
Types of Ventricular Assist Devices
4.MicroMed-De-Bakey VAD
• Axial flow rotary pump
• Consists of :
• Elbow-shaped inflow cannula that inserts into LV apex
• Pump housing unit which houses the impeller
• Dacron outflow conduit graft
• Ultrasonic flow probe that encircles the outflow graft
Third Generation Ventricular Assist Device
• Examples :
• VentrAssist VAD (Ventracor Ltd, Chatswood, New SouthWales,
Australia)
• DuraHeart (Terumo, Somerset, New Jersey, USA)
Total Artificial Heart
• Complete support for severe BV failure
• In situations where leaving native heart in place detrimental :
• Cardiac tumours
• Aortic insufficiency or prosthesis
• Arrhythmias
• LV thrombus
• Acquired VSD
• Currently approved
• for BV support as BTT
• Humanitarian use device (HUD) designation for DT
TOTAL ARTIFICIAL HEART
• Adequate intrathoracic space required (fitting criteria)
• BSA > 1.7 m2
• Cardio-Thoracic Ratio > 0.5
• AP distance of Thorax > 10 cm
• LVDD > 66mm
• Combined ventricular volume > 1500 ml
• Strict anticoagulation with warfarin, aspirin and pentoxifylline
• Examples :
• CardioWest TAH (SynCardia systems, Tucson, Ariz)
• AbioCor TAH (Abiomed Cardiovascular Inc, Danvers, Mass)
Complications Of VAD
1. Bleeding Risk
• Acquired von Willebrand’s syndrome
• Small bowel AV malformations
2. Thrombosis – increases stroke risk
3. Hemolysis – VAD destroys blood cells
4. Infection
sepsis is leading cause of death in long-term VAD support
5. Depression/ Adjustment Disorders
Complications Of VAD
Cardiac related :
1. RV dysfunction / failure
2. Closed Aortic Valve – blood stasis and clot formation
3. Aortic Insufficiency
• Lack of valve opening
• LV decompression
• Female Gender
• Small Body Size
4. Ventricular Arrhythmias – contact of inflow cannula with endocardium
Complications Of VAD
LVAD related :
1. Pump Thrombosis – rare but catastrophic
Consider in setting of BV dysfunction
Presents as Ac. Pul. Edema with hypotension
Lab E/O hemolysis
Surges in pump power
Decrease in PI
2. Device failure / malfunction (highly variable by device)
3. Increased LVAD Afterload
Outflow graft kinking or obstruction
Assessed by pullback along the graft or contrast CT angio
4. Suckdown
Low preload causes a nonpulsatle VAD to collapse the ventricle
Leads to acute pump thrombosis
Post-op Surveillance
1. Clinical assessment
2. ECHO
3. Right Heart Catheterization (if required)
4. Adjustment of vasodilators, diuretics and pump parameters.
Prognosis Of LVAD
Landmark Trials
INTERAGENCY REGISTRY OF MECHANICALLY
ASSISTED CIRCULATORY SUPPORT- INTERMACS
• INTERMACS is a national registry currently administered by The Society of
Thoracic Surgeons, and is the largest available data repository for the study
of durable MCS outcomes in USA.
• Since the inception of INTERMACS, the ongoing evolution of strategies for
device application and the types of available devices has continued to
refine the landscape of MCS.
• A major limitation of INTERMACS is the inability to enter patient
information on investigative devices currently in evaluation in the United
States, which represents a barrier for capture of all patients receiving
durable, implantable MCS therapy.
• To date, data on more than 22,000 patients receiving durable MCS
therapy have been reported to INTERMACS.
• The overall survival rate for all patients undergoing primary implantation
of a durable MCS device is approximately 82% at 1 year and 72% at 2
years.
• A competing outcomes analysis demonstrates that at 5 years, 23% of
patients remain alive on support, 34% have undergone heart
transplantation, 39% have died, and 4% underwent device explantation
for myocardial recovery.
• Subjective classification system based on severity of illness, termed
“INTERMACS Patient Profiles,” which range from Profile 1 (critical
cardiogenic shock) to Profile 7 (advanced NYHA Class III HF)
• This classification system has added enhanced resolution of patient outcomes in
the advanced stages of HF or cardiogenic shock beyond that offered by the NYHA
classification system.
• INTERMACS patient profiles are associated with short-term survival following
LVAD implantation and are used to inform appropriate timing of intervention with
durable, implantable MCS devices.
• Patients undergoing implantation of an MCS device who have critical cardiogenic
shock (INTERMACS Patient Profile 1) have worse long-term outcomes than
patients with more stable forms of advanced HF (INTERMACS Patient Profile
levels 2 through 7).
• Patients with significant organ dysfunction at MCS device implantation,
accompanied by a greater degree of hemodynamic compromise, are significantly
more likely to require BiVAD support and are at higher risk for major adverse
events and at significantly higher risk for death during use of MCS devices.
To conclude
• IT IS THE FUTURE OF END STAGE HEART FAILURE
• IMPROVING QUALITY OF LIFE
• IMPROVING SURVIVAL
• EITHER ACTS AS BTR,BTT OR AS A FINAL DESTINATION
THANK YOU

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Mechanical Circulatory Support.pptx

  • 1. Mechanical Circulatory Support Dr Awadhesh Shrama LPS Institute of Cardiology
  • 2. Introduction • Heart failure (HF) is a complex clinical syndrome characterized by pulmonary and systemic congestion due to myocardial dysfunction leading to reduced cardiac output. • HF is estimated to affect 1%–2% of the adult population with approximately 1 million new cases per year. • While HF outcomes have improved with the use and application of evidenced based therapies, the death rate remains high at approximately 50% within 5 years of diagnosis.
  • 3. • Heart failure is a progressive disease with approximately 10% of the overall HF population having end stage disease with ongoing symptoms refractory to conventional therapies (American Heart Association Class D/New York Heart Association Class IIIB–IV). • Over the last 50 years cardiac transplantation has been established as the gold standard for the treatment of end stage HF. • However, cardiac transplantation remains a limited option for a select number of patients.
  • 4. • The need for transplant outpaces the availability of donor organs. • Accordingly, mechanical circulatory support (MCS) in the form of durable left ventricular assist devices (LVAD) is a central therapeutic alternative to improve the quality of life and longevity of patients who are either waitlisted or ineligible for a heart transplant. • Potentially capable of permanent mechanical support. • First implantation of LVAD as a BTT –performed by PHILIPS OYER in 1984.
  • 5. What Are MCS Devices ? • Mechanical pumps designed to assist / replace the function of either left / right / both ventricles. • MCS devices are indicated to provide hemodynamic support to patients with cardiogenic shock or symptomatic advanced heart failure (HF) refractory to guideline-directed medical care. • It decreases the workload of the heart while maintaining adequate flow and blood pressure.
  • 6. Common terminology • Bridge to Recovery (BTR) – [US-FDA approved] • Potential Reversible Cause (E.G. AMI, Ac. Myocarditis, Post-cardiotomy Cardiogenic Shock) • Bridge to Bridge (BTB) • Temporary MCS continued as a bridge to long term LVAD • Bridge to transplant (BTT) – [US-FDA approved] • Patient eligible for heart transplant • “Destination” therapy (DT) – [US-FDA approved] • Recovery or transplant is not feasible • Bridge to candidacy (BTC) • When eligibility unclear at implant or with comorbidities (e.g. CRS, PAH) • Bridge to Decision (BTD) • Potential for transplant or recovery unclear
  • 7. Guidelines For Initiation Of MCS • Timing of initiation – crucial for pt. outcome • Generally accepted guidelines (despite use of OMM) : • Cardiac index < 1.8-2.2 L/min/m2 • SBP < 90 mmHg • PCWP > 20 mmHg • RA pressure > 18-20 mmHg • Evidence of poor tissue perfusion (oliguria, mental status change, cool extremities) • General C/I for MCS : • Irreversible renal/hepatic/resp. failure • Sepsis • Significant cognitive deficit
  • 8. Indications For VAD 1.Chronic Heart Failure : 1. LVEF <25% 2. Peak VO2 < 14 cc/kg/min 3. NYHA class IV for 60 days 4. NYHA class III/IV for 28 days and 1. IABP support for 14 days or 2. 2 failed attempts to wean I.V. Inotropes 5. Increasing diuretic requirement 6. Symptomatic despite CRT or ionotropic dependence 2.Acute refractory Cardiogenic Shock 1. Acute fulminant myocarditis 2. AMI with cardiogenic shock 3. PPCM/TTCM 4. Post cardiac surgery a. Unable to maintain cardiac output b. Failure to wean from CPB 3. Bridge to Recovery: therapeutic strategy in small subset Principle:- Mechanical unloading with LVAD-reverse remodelling -reduction in chamber size -improvement in end –diastolic pressure-volume relationship Approx 80% of LVAD implants for BTT
  • 9. Heidenreich, P. A. et al. (2022). 2022 AHA/ACC/HFSA Guideline for Heart Failure. Circulation. Durable Mechanical Support with Left Ventricular Assist Device SOURCE: https://www.mayoclinic.org/tests-procedures/ventricular-assist- device/multimedia/left-ventricular-assist-device/img-20006714 INDICATIONS • Frequent hospitalizations for HF • NYHA class IIIB to IV symptoms despite maximal GDMT • Intolerance of GDMT • Increasing diuretic requirement • Symptomatic despite CRT • Inotrope dependence • Low peak VO2 (<14-16 ml/kg/m2) • End-organ dysfunction attributable to low cardiac output CONTRAINDICATIONS Absolute • Irreversible hepatic, renal or neurological disease • Medical non-adherence • Severe psychosocial limitations Relative • Age >80 years for destination therapy • Obesity or malnutrition • Musculoskeletal disease that impairs rehabilitation • Active systemic infection or prolonged intubation • Untreated malignancy • Severe PVD • Active substance abuse • Impaired cognitive function • Unmanaged psychiatric disorder • Lack of social support Abbreviations: CRT indicates cardiac resynchronization therapy; GDMT, guideline-directed medical therapy; LVAD, left ventricular assist device; NYHA, New York Heart Association; PVD, peripheral vascular disease; and VO2, oxygen uptake. 9
  • 10. Heidenreich, P. A. et al. (2022). 2022 AHA/ACC/HFSA Guideline for Heart Failure. Circulation. Mechanical Circulatory Support Despite improving hemodynamic compromise, positive inotropic agents have not shown improved survival in patients with HF in either the hospital or outpatient setting. COR RECOMMENDATIONS 1 1. In select patients with advanced HFrEF with NYHA class IV symptoms who are deemed to be dependent on continuous intravenous inotropes or temporary MCS, durable LVAD implantation is effective to improve functional status, QOL and survival. 2a 2. In select patients who have NYHA class IV symptoms despite GDMT, durable MCS can be beneficial to improve symptoms, functional class and reduce mortality. 2a 3. In patients with advanced HFrEF and hemodynamic compromise and shock, temporary MCS, including percutaneous and extracorporeal ventricular assist devices, are reasonable as a ”bridge to recovery” or “bridge to decision.” In patients with advanced HFrEF who have NYHA class IV symptoms despite GDMT, durable MCS devices provide low to intermediate economic value based on current costs and outcomes Value Statement: Uncertain Value (B-NR) Abbreviations: GDMT indicates guideline-directed medical therapy; HFrEF, heart failure with reduced ejection fraction; IV, intravenous; LVAD, left ventricular assist device; MCS, mechanical circulatory support; NR, nonrandomized; NYHA, New York Heart Associations; and QOL, quality of life. 10
  • 11. Contraindication for VAD Therapy 1. Active systemic infection or major chronic risk for infection. 2. High surgical risk for successful implantation. 3. Recent or eveolving stroke /neurological deficit. 4. Fixed pulmonary or portal hypertension. 5. Intolerance to anticoagulant. 6. Morbid obesity(BMI>45kg/m2) 7. CKD with serum creatinine level >3.0mg/dl 8. Restrictive CM 9. Significant underlying psychiatric illness or lack of support.
  • 12. Classification of VAD 1. Based on pumping mechanism • Pulsatile • Continuous flow • Axial • Centrifugal • Mixed 2. Based on location of pumping chamber • Intracorporeal • extracorporeal 3. Based on ventricle supported • Left ventricle (LVAD) • Right ventricle(RVAD) • Both ventricle (BiVAD) 4. Based on duration of support • Short term (days to weeks) • Long term (months to years)
  • 13. Pre-op Assessment • CAG • RV function -ECHO • Severity of TR • RV size • RVEF,FAC • TAPSE • Right heart catheterisation (RA pressure,PVR)
  • 15. Components Of A VAD 1. Electromechanical Pumps - placed in parallel with the native patient’s circulation 2. Inflow cannula - decompresses the ventricular cavity • In LVAD: originates in LA or LV • In RVAD: originates in RA or RV • In BVAD: originates in both Atriums &/or Ventricles 3. Pump: Provides propulsion to the blood • Flow can be: • Pulsatile • pneumatically or electromechanically driven • Non pulsatile / Continuous • Axial / Cetrifugal / Mixed
  • 16. 4. Pump is implanted sub-diaphragmatically to: 1. Preperitoneal position 2. Intra-abdominal position or 3. Para-corporeal position outside the body 5. Outflow cannula returns blood to either • Ascending aorta (In LVAD) or • Main pulmonary artery (In RVAD) 6. Controller: Operates pump by receiving and processing information from it. 7. Percutaneous driveline: • containing the control & power wires, is tunneled through skin of abdominal wall • connects device to external portable driver consisting of electronic or pneumatic controller & power supply that may be worn around waist
  • 18. Centrifugal flow pump Axial flow pump
  • 19. Physiology Of CF-LVAD • Flow across pump depends on : • Pump speed – directly proportional • Afterload across LVAD (Head Pressure) – inversely proportional • Axial vs. Centrifugal Pumps : Axial Centrifugal relationship between flow and head pressure steep and inverse linear flatter and more susceptible to head pressure changes Dependent on Preload Both preload and afterload Flow range 3-7 L/min 0-10 L/min
  • 20. • These hydrodynamic characteristics of centrifugal pumps translate into: 1. More pulsatile waveform; 2. More accurate flow estimation; 3. Lower risk of suction events (e.g, In setting of dehydration, arrhythmias, or right ventricular failure); 4. More dependency of device flow on loading conditions
  • 21. Pulsatility Of Device • Assessed by PUMP INDEX (PI) • PI = [max flow – min flow] / avg flow • Low PI suggests • Hypovolemia • Pump Obstruction • Low arterial pulsatility • cause for several serious adverse effects of CF-LVADs • LVAD speed modulation • Used for antithrombotic cycling to prevent pump thrombosis • Precludes formation of zones of recirculation and stasis within the device
  • 22. Types Of Mechanical Circulatory Support • SHORT TERM MCS SUPPORT : • Temporary MCS is indicated in patients with cardiogenic shock refractory to medical therapy when rapidly achieved augmentation of cardiac output and reduction of ventricular filling pressures are required to sustain life. • When used in the setting of medically refractory myocarditis or Takotsubo cardiomyopathy, temporary MCS may provide time for spontaneous recovery and discontinuation of MCS. • When cardiogenic shock complicates longstanding HF, temporary MCS can provide the time needed for patients, family members, and physicians to make critical decisions about long-term MCS and heart transplantation. • Examples : 1) IABP- • Most commonly used MCS device
  • 23. 2) Extra corporeal life support & Extracorporeal Membrane Oxygenation- • VV ECMO or VA ECMO 3) Impella – LV to Aorta assist device • Impeller-driven, axial flow pump, capable of pumping 2.5-5 L/min 4) TandemHeart – LA to Aorta assist device • Low speed centrifugal continuous-flow pump • Drains oxygenated blood through a catheter advanced across the IAS to the LA & pumps it back to one or both femoral arteries
  • 24. IABP • The IABP pump remains the most commonly used MCS device. • The IABP consists of a balloon catheter and a pump console to control the timing of balloon inflation and deflation. • The catheter is a double- lumen, 7.5- to 8.0- French (F) catheter with a polyethylene balloon attached at its distal end, with one lumen of the catheter attached to the pump and used to inflate the balloon with gas. • Helium is used because its low viscosity facilitates rapid transfer in and out of the balloon, and because it absorbs very rapidly in blood if the balloon ruptures.
  • 25. IABP • Timing of balloon inflation and deflation is based on electrocardiogram (ECG) or pressure triggers. • The balloon inflates with the onset of diastole, which roughly corresponds with electrophysiologic repolarization or the middle of the T wave on the surface ECG, or just after the dicrotic notch on the aortic pressure tracing. • Following diastole, the balloon rapidly deflates at the onset of LV systole, which is timed electrocardiographically to the peak of the R wave on the surface ECG. • The IABP increases diastolic blood pressure, decreases afterload, decreases myocardial oxygen consumption, increases coronary artery perfusion, and modestly enhances cardiac output
  • 26.
  • 27. • Efficacy of IABP counterpulsation was recently evaluated in the SHOCK II clinical trial a randomized, prospective, open- label, multicenter trial comparing IABP therapy with best available medical therapy for treatment of acute myocardial infraction (AMI) complicated by cardiogenic shock. • All patients were expected to undergo early revascularization (by means of percutaneous coronary intervention or bypass surgery). • At 30 days, 119 patients in the IABP group (39.7%) and 123 patients in the control group (41.3%) had died (RR with IABP, 0.96; 95% CI 0.79 to 1.17; P = 0.69).
  • 28. • No significant differences were found in secondary endpoints or in process- of- care measures, including the time to hemodynamic stabilization, the length of stay in the intensive care unit,serum lactate levels, dose and duration of catecholamine therapy, and renal function. • The use of IABP counterpulsation did not significantly reduce 30- day mortality in patients with AMI complicated by cardiogenic shock for whom an early revascularization strategy was planned.
  • 29. • The IABP provides modest ventricular unloading but does increase mean arterial pressure and coronary blood flow. • Patients must have some level of LV function and electrical stability for an IABP to be effective because any increase in cardiac output depends on the work of the heart itself. • Optimal hemodynamic effect from the IABP depends on several factors, including the balloon’s position in the aorta, the blood displacement volume, the balloon diameter in relation to aortic diameter, the timing of balloon inflation in diastole and deflation in systole, and the patient’s own heart rate, blood pressure, and vascular resistance.
  • 30. Nir Uriel. Circulation: Heart Failure. Clinical Outcomes and Quality of Life With an Ambulatory Counterpulsation Pump in Advanced Heart Failure Patients, Volume: 13, Issue: 4, DOI: (10.1161/CIRCHEARTFAILURE.119.006666) Š 2020 American Heart Association, Inc.
  • 31. Extracorporeal Life Support and Extracorporeal Membrane Oxygenation • ECMO provides cardiopulmonary support for patients whose heart and/or lungs can no longer provide adequate physiologic support. • ECMO can be configured for respiratory support (venovenous [VV-ECMO]) or for respiratory and circulatory support (venoarterial [VA-ECMO]). • In cases of biventricular failure, VA-ECMO is the MCS device of choice for patients in cardiogenic shock and impaired oxygenation, because it provides full cardiopulmonary support. • ECMO may be placed at the bedside without fluoroscopic guidance. ECMO is similar to a CPB circuit used in cardiac surgery with some modifications. • VA-ECMO involves a circuit composed of a continuous-flow centrifugal pump for blood propulsion (most commonly) and a membrane oxygenator for gas exchange.
  • 32. • A venous cannula drains deoxygenated blood into a membrane oxygenator for gas exchange, and oxygenated blood is subsequently infused into the patient through an arterial cannula. VA-ECMO provides systemic circulatory support with flow capabilities approximating 4 to 6 L/min depending on cannula size. • Because of the increase in systemic afterload, however, VA-ECMO alone may not significantly reduce ventricular wall stress and may result in LV distension in cases where residual LV function is inadequate to eject against the increase in systemic afterload. • This may result in high myocardial oxygen demand (secondary to high filling pressures and volume). This may have negative consequences on myocardial recovery unless the LV is unloaded by concomitant IABP, an LV vent, atrial septostomy, or use of a percutaneous LV-to-aorta VAD. Inadequate LV unloading may also result in pulmonary hemorrhage.
  • 33.
  • 34. LV TO AORTA ASSIST DEVICE-IMPELLA • The Impella is a continuous flow microaxial pump designed to pump blood from the LV into the ascending aorta, in series with the LV. • Several versions of the pump are available, including the Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, Impella LD, and Impella 5.5 with SmartAssist. • The pumps are U.S. FDA-approved to treat patients with cardiogenic shock. • A pump specifically designed to support the right ventricle, the Impella RP is U.S. FDA-approved to treat right HF or decompensation following left VAD implantation, myocardial infarction, heart transplant, or postcardiotomy failure to wean from CPB. • The SmartAssist technology uses optical sensors to assess aortic pressure.
  • 35. • The devices for LV assist are designed to be placed via the femoral artery, either percutaneously (Impella 2.5 and CP) or with a surgical cutdown (Impella 5.0 and 5.5). Alternate access sites such as the subclavian artery have also been described. • The Impella pumps blood from the LV into the ascending aorta, thereby unloading the LV and increasing forward flow. It reduces myocardial oxygen consumption, increases coronary perfusion, improves mean arterial pressure, and reduces PCWP. • The Impella 2.5 provides a greater increase in cardiac output than the IABP but less than the TandemHeart device. • The more powerful Impella CP and 5.0 devices are comparable to the TandemHeart device in terms of support. • Similar to the TandemHeart, adequate RV function or concomitant RVAD is necessary to maintain LV preload and hemodynamic support during biventricular failure or unstable ventricular arrhythmias.
  • 36. • In a prospective, randomized clinical trial comparing the Impella 2.5 to the IABP, cardiac index was significantly increased in patients with the Impella 2.5 compared with patients supported with an IABP. • Overall mortality rates at 30 days were similar in both groups, but the study was not adequately powered to assess for a mortality difference. • Despite the absence of suitably powered randomized clinical trials demonstrating a mortality benefit over IABP therapy (which itself has no proven mortality benefit), the use of temporary MCS devices in patients with cardiogenic shock is likely to continue. • In comparison with an IABP, these devices provide a much larger increment in cardiac output and superior LV unloading.
  • 38. LA TO AORTA ASSIST DEVICE- TandemHeart • The TandemHeart percutaneous ventricular assist device (pVAD) is a paracorporeal device inserted as a LA–aorta assist device that pumps blood from the left atrium to the femoral artery through a transseptal positioned LA cannula, thereby entirely bypassing the LV. • The TandemHeart system includes a 21F transseptal cannula, a centrifugal pump, a femoral arterial cannula, and a control console. • The TandemHeart is approved by FDA to incorporate an oxygenator to the circuit, allowing for concomitant LV unloading and oxygenation. • The centrifugal blood pump contains a hydrodynamic bearing that supports a spinning impeller. The impeller is powered by a brushless direct-current (DC) electromagnetic motor, rotating between 3000 and 7500 rpm. The external console controls the pump and provides battery backup in case of power failure.
  • 39. • A continuous infusion of heparinized saline flows into the lower chamber of the pump, which provides lubrication and cooling, and prevents thrombus formation. • The redirection of blood from the left atrium reduces LV preload, LV workload, filling pressures, wall stress, and myocardial oxygen demand. The increase in arterial blood pressure and cardiac output supports systemic perfusion. • The flow through the TandemHeart is additive to LV output through the aortic valve (parallel circulation). • However, the contribution from the native heart is typically reduced as MCS support is increased due to changes in LV loading conditions (i.e., decrease in preload and increase in afterload)
  • 40. • Coronary flow is driven by the perfusion pressure (diastolic pressure−RA pressure). With a parallel circulation, the aorta is perfused and pressured by both the left ventricle and the TandemHeart. • Not infrequently, LV contraction (native heart output) may be negligible, and systemic perfusion is pump dependent, with a flat mean arterial pressure curve. • This situation can result in stasis of blood within the aortic root, resulting in thrombus formation and stroke.
  • 41. • In a randomized comparison of the IABP with the TandemHeart, the TandemHeart provided more effective improvement in cardiac power index as well as other hemodynamic and metabolic variables compared to the IABP. • Moreover, complications, such as severe bleeding and limb ischemia, were encountered more frequently after TandemHeart VAD support. • Thirty-day mortality rates were similar between the groups, but the study was underpowered to compare mortality between groups.
  • 43. Extracorporeal : Bio – Medicus Abiomed – BVS Thoratec CetriMag Blood Pump Advantages : Widely available Relatively inexpensive Simple and quick implantation May be used as RVAD LVAD Part of ECMO circuit Disadvantages : Requires systemic anticoagulation Requires ICU monitoring Limited mobility
  • 44. Types of Ventricular Assist Devices • LONGER TERM ASSIST DEVICES (3 GENERATIONS) : 1. First Generation Or Pulsatile Flow Pumps 2. Second Generation Or Continuous (Axial) Flow Pumps 3. Third Generation Or Continuous (Centrifugal) Flow Pumps
  • 45. REMATCH TRIAL • The benefits of MCS for DT, in terms of survival, function, and quality of life, for the treatment of chronic advanced HF were first established in a prospective, randomized trial known as REMATCH (Randomized Evaluation of Mechanical Assistance in the Treatment of Congestive Heart Failure) • REMATCH evaluated the use of a durable, implantable LVAD compared with optimal medical management (OMM) for refractory chronic advanced HF. • LVAD therapy halved the mortality seen in the control population (92% at 2 years) treated with OMM. • Despite serious adverse events (e.g., stroke, infection, bleeding, and device malfunction) attributable to MCS, LVAD recipients experienced a better quality of life than those in the OMM group.
  • 46. FIRST VS SECOND/THIRD GENERATION LVAD CHARACTERSTIC OF DEVICE FIRST GENERATION LVAD SECOND /THIRD GENERATION LVAD SIZE OF LVAD LARGER SIZE SMALLER SIZE DURABLITY LESS DURABLE MORE DURABLE OUTPUT DETERMINANTS PRELOAD PRELOAD AND AFTERLOAD POSITION OF PUMP INTRA- ABDOMINAL/PREPERITONEAL IN A POCKET UNDER RECTUS ABDOMINI INTRACARDIAC/INTRATHORACIC AT THE APEX PUMP CAPACITY 10LIT/MINT 10L/MINT MOVING PARTS MANY MOTOR DRIVE LINES THICK AND LESS FLEXIBLE THIN AND FLEXIBLE BATTERY CAPACITY SHORT DURATION LONG DURATION THROBOGENICITY HIGH LESS
  • 47.
  • 48.
  • 49. 1. First Generation Or Pulsatile Flow Pumps • Anticoagulation necessary for all devices, (except HeartMate XVE) • Noisy and uncomfortable (percutaneous leads are large, stiff & contain air vent channel) • Increased risk of hematomas and infections as they are large in volume,requiring extensive surgical dissection • Examples : • HeartMateÂŽ I • HeartMate XVE (Thoratec Corp., Pleasanton, CA) • Novacor VAD (WorldHeart Inc., Oakland, California, USA
  • 50. Types of Ventricular Assist Devices • Heartmate I • Made of titanium with a polyurethane diaphragm & has a pusher-plate actuator • Cannula is placed in the apex of the left ventricle • Blood flows through a Dacron conduit to the pump, • Returns into a Dacron outflow graft through another porcine valve to the ascending aorta • Resist thrombogenesis d/t titanium microspheres and a fibrillar textured inner surface • Can pump 4–10 l/min
  • 51. Types of Ventricular Assist Devices 2.HeartmateXVE (Thoratec Corp) • Has a 65 ml stroke volume pumping chamber and two mechanical valves • Positioned on the anterior abdominal wall with cannulas crossing into the chest wall • Can be used an LVAD, RVAD or BIVAD • Produces a beat rate of 40–110 bpm & a flow rate of 1.3–7.2 l/min • Warfarin (international normalisation ratio = 2.5–3.5) & aspirin anticoagulation required
  • 52. Types of Ventricular Assist Devices 3. Novacor VAD • Consists of pump drive unit which is implanted in the left upper quadrant of the abdomen • Incorporates a dual pusher plate 70 ml stroke volume • Contains sac-type blood pump with a smooth blood-contacting surface, coupled to a pulsed-solenoid energy converter drive • Inflow cannule is inserted through the diaphragm into the left ventricular (LV) apex • Outflow graft anastomosed to the ascending aorta
  • 53. Second Generation Or Continuous Flow Pumps • Examples: • HeartMate 2 VAD (Thoratec Inc.) • Jarvik 2000 (Jarvik Heart Inc., New York) • Berlin Heart Incor (Berlin Heart AG) • Micromed Debakey VAD
  • 54. Types of Ventricular Assist Devices 1.HeartMate II • Continuous-flow axial blood pump with internal rotor with helical blades that curve around central shaft • Twisted shape of outlet stator vanes converts radial velocity of blood flow to axial direction • Can pump up to 10 l/min • Axial flow design & absence of blood sac eliminate need for venting
  • 55. Types of Ventricular Assist Devices 2.Jarvik 2000 • Axial flow, continuous-flow pump having intraventricular position with whole pump sitting within the LV cavity • Impeller is only moving componant located in centre of the titanium housing • Blood flow is directed through outlet graft by stator blades located near pump outlet & returns to either ascending or descending aorta • Can pump 8 l/min, serious infections rare
  • 56. Types of Ventricular Assist Devices 3.Berlin Heart Incor • An axial flow pump • As blood passes into the Incor, it first passes the inducer that guides laminar flow onto actual impellar, which is suspended by a magnetic bearing • Stationary diffuser behind rotor has specially aligned blades which reduce the rotational effect of blood flow • Also creates additional pressure to assist transport of blood in the outflow cannula to the aorta
  • 57. Types of Ventricular Assist Devices 4.MicroMed-De-Bakey VAD • Axial flow rotary pump • Consists of : • Elbow-shaped inflow cannula that inserts into LV apex • Pump housing unit which houses the impeller • Dacron outflow conduit graft • Ultrasonic flow probe that encircles the outflow graft
  • 58. Third Generation Ventricular Assist Device • Examples : • VentrAssist VAD (Ventracor Ltd, Chatswood, New SouthWales, Australia) • DuraHeart (Terumo, Somerset, New Jersey, USA)
  • 59.
  • 60. Total Artificial Heart • Complete support for severe BV failure • In situations where leaving native heart in place detrimental : • Cardiac tumours • Aortic insufficiency or prosthesis • Arrhythmias • LV thrombus • Acquired VSD • Currently approved • for BV support as BTT • Humanitarian use device (HUD) designation for DT
  • 61. TOTAL ARTIFICIAL HEART • Adequate intrathoracic space required (fitting criteria) • BSA > 1.7 m2 • Cardio-Thoracic Ratio > 0.5 • AP distance of Thorax > 10 cm • LVDD > 66mm • Combined ventricular volume > 1500 ml • Strict anticoagulation with warfarin, aspirin and pentoxifylline • Examples : • CardioWest TAH (SynCardia systems, Tucson, Ariz) • AbioCor TAH (Abiomed Cardiovascular Inc, Danvers, Mass)
  • 62. Complications Of VAD 1. Bleeding Risk • Acquired von Willebrand’s syndrome • Small bowel AV malformations 2. Thrombosis – increases stroke risk 3. Hemolysis – VAD destroys blood cells 4. Infection sepsis is leading cause of death in long-term VAD support 5. Depression/ Adjustment Disorders
  • 63. Complications Of VAD Cardiac related : 1. RV dysfunction / failure 2. Closed Aortic Valve – blood stasis and clot formation 3. Aortic Insufficiency • Lack of valve opening • LV decompression • Female Gender • Small Body Size 4. Ventricular Arrhythmias – contact of inflow cannula with endocardium
  • 64. Complications Of VAD LVAD related : 1. Pump Thrombosis – rare but catastrophic Consider in setting of BV dysfunction Presents as Ac. Pul. Edema with hypotension Lab E/O hemolysis Surges in pump power Decrease in PI 2. Device failure / malfunction (highly variable by device) 3. Increased LVAD Afterload Outflow graft kinking or obstruction Assessed by pullback along the graft or contrast CT angio 4. Suckdown Low preload causes a nonpulsatle VAD to collapse the ventricle Leads to acute pump thrombosis
  • 65. Post-op Surveillance 1. Clinical assessment 2. ECHO 3. Right Heart Catheterization (if required) 4. Adjustment of vasodilators, diuretics and pump parameters.
  • 68.
  • 69. INTERAGENCY REGISTRY OF MECHANICALLY ASSISTED CIRCULATORY SUPPORT- INTERMACS • INTERMACS is a national registry currently administered by The Society of Thoracic Surgeons, and is the largest available data repository for the study of durable MCS outcomes in USA. • Since the inception of INTERMACS, the ongoing evolution of strategies for device application and the types of available devices has continued to refine the landscape of MCS. • A major limitation of INTERMACS is the inability to enter patient information on investigative devices currently in evaluation in the United States, which represents a barrier for capture of all patients receiving durable, implantable MCS therapy.
  • 70. • To date, data on more than 22,000 patients receiving durable MCS therapy have been reported to INTERMACS. • The overall survival rate for all patients undergoing primary implantation of a durable MCS device is approximately 82% at 1 year and 72% at 2 years. • A competing outcomes analysis demonstrates that at 5 years, 23% of patients remain alive on support, 34% have undergone heart transplantation, 39% have died, and 4% underwent device explantation for myocardial recovery. • Subjective classification system based on severity of illness, termed “INTERMACS Patient Profiles,” which range from Profile 1 (critical cardiogenic shock) to Profile 7 (advanced NYHA Class III HF)
  • 71. • This classification system has added enhanced resolution of patient outcomes in the advanced stages of HF or cardiogenic shock beyond that offered by the NYHA classification system. • INTERMACS patient profiles are associated with short-term survival following LVAD implantation and are used to inform appropriate timing of intervention with durable, implantable MCS devices. • Patients undergoing implantation of an MCS device who have critical cardiogenic shock (INTERMACS Patient Profile 1) have worse long-term outcomes than patients with more stable forms of advanced HF (INTERMACS Patient Profile levels 2 through 7). • Patients with significant organ dysfunction at MCS device implantation, accompanied by a greater degree of hemodynamic compromise, are significantly more likely to require BiVAD support and are at higher risk for major adverse events and at significantly higher risk for death during use of MCS devices.
  • 72.
  • 73.
  • 74.
  • 75. To conclude • IT IS THE FUTURE OF END STAGE HEART FAILURE • IMPROVING QUALITY OF LIFE • IMPROVING SURVIVAL • EITHER ACTS AS BTR,BTT OR AS A FINAL DESTINATION

Editor's Notes

  1. The first human-to-human heart transplant operation was performed on December 3, 1967 by surgeon Christiaan Barnard and his team at Groote Schuur Hospital in Cape Town, South Africa. The patient, 53-year-old Louis Washkansky, received the transplant in a groundbreaking historical even
  2. The goal of MCS therapy is to provide hemodynamic support to the patient in one of three clinical scenarios: (1) patients with severe but potentially reversible heart dysfunction until native heart function sufficiently recovers to have the MCS device successfully withdrawn for anticipated long-term survival without MCS (i.e., bridge to recovery, BTR); (2) patients with severe and irreversible heart dysfunction who are failing medical therapy, to allow sufficient time for allocation and transplantation of a donor heart (i.e., bridge to heart transplantation, BTT); or (3) patients with severe and irreversible heart dysfunction who are failing medical therapy but not eligible for heart transplantation, for permanent support (i.e., destination therapy [DT]).
  3. Early inition of LVAD therapy has better prognosis than those with late initiation
  4. Inflow from the heart will be directly going through sewing ring with cudd and inflow cannula- continuing going forward through conduit where from conduit it is driven outside by outflow valve conduit which is connected to the ouflow graft which is usually connected to AS aorta or desending aorta
  5. Inflow part ,pump and outflow part- from pump we have a percutaneous lead which is connected to the controller-and this controller we can control the entire pump. We have two batteries on either side of shoulder which give power to both controller and pump.
  6. Turbine like configuration which pump out
  7. Aortic pressure tracing during IABP support. Balloon counterpulsation is occurring after every other heartbeat (1:2 counterpulsation). With correct timing, balloon inflation begins immediately after aortic valve closure, signaled by the dicrotic notch of the arterial waveform. Compared with unassisted ejection, the pump augments diastolic blood flow by increasing peak aortic pressure during diastole. Balloon deflation before systole decreases ventricular afterload, with lower aortic end-diastolic pressure and lower peak systolic pressure.
  8. The iVAS is an external heart assist device. A fully ambulatory counterpulsation device intended for more prolonged hemodynamic support in the outpatient setting, potentially in less advanced HF patients. It has several components. The intravascular component is a 50-cc displacement pump (similar to an intra-aortic balloon) placed in the descending aorta. The skin interface device (SID) is an electromechanical and pneumatic conduit with a chimney that allows for shuttling of air between the pump and external driver and communication of the captured electrocardiogram (ECG) signals that are transmitted to the driver from 3 subcutaneous electrodes. The SID is placed onto the lower chest cage and connects a driver to an external driveline. An external and wearable drive unit provides compressed ambient air to inflate and deflate the pump.
  9. (a) Veno-venous (V-V) ECMO with a duel site cannulation. Drainage cannula inserted into the right femoral vein and return cannula in the right internal jugular vein. (b) Veno-arterial (V-A) ECMO, with a duel site cannulation, with the drainage cannula inserted into the right femoral vein, and the return cannula to the left femoral artery.
  10. The tip is positioned within the left ventricle, and blood is pumped from the left ventricle into the ascending aorta. B, The tip of the catheter is a flexible pigtail loop that stabilizes the device within the left ventricle. The catheter connects to a cannula that contains the pump inlet and outlet areas, motor housing, and pump-pressure monitor. The proximal end of the catheter is connected to the external pump.
  11. IT IS EXTRACORPOREAL SYSTEM WHICH IS ASSEED THROUGH TRANSFEMORAL APPROACH REQUIRE TRANSEPTAL PUNTURE ONE END IS LEFT INTO THE LA AND AND BLOOD IS PUMPED THEROUGH MOTOR TO FEMORAL ARTERT – LA TO FEMORAL ARTERY BYPASS PROVIDE UPTO 5L/MINT OF BLOOD AND CAN BE USED FOR 14 DAYS
  12. In 1982, the first permanent artificial heart was transplanted into a 61-year-old patient named Barney Clark by surgeons at the University of Utah. Dr. Willem Kolff, who was mentioned earlier, led the team that worked on this artificial heart. JARVIK 7