Professional Documents
Culture Documents
Open chest type and closed chest type- Principle and problems
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LIST OF IMPORTANT QUESTIONS
PART - A
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PART - B
1. Explain in detail about left ventricular by-pass pump procedure.(A/M 19)
2. Explain in detail about right ventricular by-pass pump procedure. (A/M 19)
3. Describe the working and its effects of IABP. (N/D 2019)(A/M 2017) (Or) Explain
the operation and physiologic effects of Intra Aortic Balloon Pump. (M/J 2016).
(Or) Describe about intra aortic balloon pumping-IABP(A/M 19) (or) what are the
pathological conditions that lead to use of IABP procedure? (Or) discuss the
requirements and procedure for conducting IABP. Or Describe the principle,
methodology and working of IABP (A/M 2018) (or) Discuss the principle and
problems associated with intra aortic balloon pump with suitable diagrams. (N/D
2018)
4. Explain the types of biomaterials and their characteristics used in heart valve
construction. (N/D 2019)(A/M 2018) or Elaborate the classification and
characteristics of biomaterials. Also explain the testing procedure in the
development of biomaterials.(A/M 2019) (N/D 2018)
5. Explain about prosthetic cardio valves (or) Discuss the different types of artificial
Heart valve with neat diagram.(A/M 19) (A/M 2017) or Discuss in detail about
heart valve prosthesis? (M/J 2016)
6. What are the signs and symptoms of prosthetic cardiac valve malfunction?
Explain its diagnostic and treatment approaches. (N/D 2016)
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PART-A
2. List the materials used for making prosthetic cardiac valves.(N/D 2019) (N/D 2018)
Most artificial valves are made of titanium, graphite, pyrolytic carbon, and
polyester. The titanium is used for the housing or outer ring, graphite coated with pyrolytic
carbon is used for the bileaflets, and 100% pyrolytic carbon is used for the inner ring.
The pyrolytic carbon is sometimes impregnated with tungsten so that the valve can
easily be seen following implantation).
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6. What is LVAD? Or Illustrate the functions of left ventricular assist device.(A/M 2018)
An (Left Ventricular Assist Device) LVAD is a surgically implanted mechanical pump
that is attached to the heart. An LVAD is different from an artificial heart.
An artificial heart replaces the failing heart completely whereas an LVAD works with
the heart to help it pump more blood with less work.
It does this by continuously taking blood from the left ventricle and moving it to the
aorta, which then delivers oxygen-rich blood throughout the body.
7. What are the problems faced by artificial heart valves? (A/M-2017)
There are some cases in which the blood leaks around the insertion site causing a small
In some cases at the mitral site, the blood is slowly squeezing out which results clotting of
blood.
8. What is meant by open chest and closed chest type? (A/M-2017)
Closed heart surgery
Closed heart surgery refers to the type of surgery in which heart lung machine or
bypass machine is not used. The surgeon’s works on the structures located in the exterior
area of the heart.
Open Heart Surgery
Open heart surgery refers to a type of surgery in which the chest wall is surgically
opened and heart is exposed. This surgery is performed on the muscles, valves, or
arteries of the heart.
9. Define cardiac output and venous return.(N/D-2016)
The cardiac output is simply the amount of blood pumped by the heart per minute.
Necessarily, the cardiac output is the product of the heart rate, which is the number of
beats per minute, and the stroke volume, which is amount pumped per beat. The cardiac
output is usually expressed in liters/minute.
CO = HR X SV
Venous return is the rate of blood flow back to the heart. It normally limits cardiac
output. Superposition of the cardiac function curve and venous return curve is used in one
hemodynamic model.
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10. What is known as temporary bypass of left ventricle? (N/D-2016)
The LVAD is the most common type of VAD. It helps the left ventricle pump blood
to the aorta. The aorta is the main artery that carries oxygen-rich blood from your heart to
your body.
11. What are requirements of biocompatibility? (M/J-2016)
Should not produce allergic reaction.
Should not be a carcinogenic.
Easy to use.
Cost effective.
12. What is IABP and how does it work? (M/J-2016)
The IABP reduces the workload on your heart, allowing your heart to pump more
blood. The IABP is placed inside your aorta, the artery that takes blood from the heart to
the rest of the body.
Here's how an IABP works:
After your left ventricle has finished contracting, the balloon inflates. This inflation
helps increase blood flow to the heart and the rest of the body.
As your left ventricle is about to pump out blood, the balloon deflates. This
deflation creates extra space in the aorta, allowing the heart to pump out more blood. This
decreases the workload on the heart.
13. Compare pulsatile and non-pulsatile devices.
Pulsatile:
Most device employ pneumatic pumps to drive pusher plates or compress
polyurethane sacs giving stroke volumes of upto 85ml. but some electric devices, like
novacor, Heartmate XVE are also pulsatile.
Non-pulsatile:
Devices may be axial, centrifugal, or bearing less magnetic levitators and are
generally smaller with fewer moving parts and less surface area in contact with blood, and
therefore less thrombogenic, less prone to driveline infections, quiter and more durable
than pulsatile devices.
14. What is VAD?
A ventricular assist device (VAD) — also known as a mechanical circulatory
support device — is an implantable mechanical pump that helps pump blood from the
lower chambers of your heart (the ventricles) to the rest of your body. A VAD is used in
people who have weakened hearts or heart failure.
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15. Give the situations where an IABP is required.
Cardiogenic shock when used alone as treatment for myocardial infarction. 9-22%
survives the first year.
Reversible intracardial mechanical defects complicating infarction, i.e. acute mitral
regurgitation and septal perforation.
Post cardiothoracic surgery
Percutaneous coronary angioplasty
In high risk coronary artery bypass graft surgery where cardiopulmonary bypass
time was shortened, as well as during intubation period and hospital stay.
16. Mention few contraindications of IABP.
The following conditions will always exclude patients for treatment:
Severe aortic valve insufficiency
Aortic dissection
Severe aortoiliac occlusive disease and bilateral carotid stenosis
Prostheticvascular grafts in the aorta
Aortofemoral grafts
Sepsis
17. What are the complications of IABP?
The device is placed in the femoral artery and aorta it could provoke ischemia, and
compartment syndrome. The leg is at highest risk of becoming ischemic if the
femoral artery it is supplied by becomes obstructed.
Placing the balloon too distal from the aortic arch may induce occlusion of the renal
artery and subsequent kidney failure.
Other possible complications are cerebral embolism during insertion, infection,
dissection of the aorta or iliac artery, perforation of the artery and bleeding in the
mediastinum.
Mechanical failure of the balloon itself is also a risk which entails vascular surgery
to remove under that circumstance.
18. Mention the biomaterial characteristics and testing.
Biocompatibility
Toxicity
Corrosion resistance
Material degradation
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Modulus of elasticity
Poisson’s ratio
Yield and ultimate strength
Creep and visco-elasticity characteristics
19. Sketch the aortic pressure curve in the presence of an intra-aortic balloon pump.
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PART-B
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Fig 1. Left Ventricular Assist Device
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RISKS:
Blood clots. As your blood moves through your VAD, blood clots may form. Blood
clots can slow or block normal blood flow through your heart, which can lead to stroke or
heart attack, or cause your VAD to stop working.
Bleeding. Implanting a VAD requires open-heart surgery. Having open-heart
surgery can increase your risk of bleeding during or after your procedure. Taking blood-
thinning medications to reduce your risk of blood clotting also increases your risk of
dangerous bleeding into the gastrointestinal tract and the brain.
Infection. Because the power source and control unit for your VAD are located
outside your body and are connected through a port in your skin, there's an increased risk
of germs getting in the port and causing a serious infection.
Device malfunctions. It's possible that your VAD may stop working properly after
it's implanted. The pumping action of the device might not work correctly, making it so not
enough blood pumps through your heart.
Right heart failure. If you have an LVAD implanted, it will pump more blood from
the left ventricle of your heart than what your heart might have been used to
The doctor will also evaluate patient condition and ensure that you're healthy enough for
surgery to implant a VAD.
The doctor may order several tests, including:
Echocardiogram. In an echocardiogram, sound waves are used to produce a
video image of the heart.
Chest X-ray. An X-ray image helps your doctor to see the size and shape of your
heart and lungs.
Blood tests. Your doctor may order blood tests to check your liver, kidney and
thyroid function before surgery to implant a VAD.
Electrocardiogram (ECG). An electrocardiogram records the electrical activity of
your heart. An ECG measures the timing and duration of each electrical phase in your
heartbeat.
Cardiac catheterization. In this test, a doctor inserts a thin, flexible tube (catheter)
into a vein or artery in your upper leg (groin), arm or neck and guides it to your heart
using X-ray imaging.
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Procedure:
A surgical team of heart (cardiac) surgeons, surgical nurses, doctors trained in
giving medication that causes you to sleep during surgery (anesthesiologists) and others
work together to perform your surgery.
The procedure to implant a ventricular assist device (VAD) is typically an open-
heart surgery that generally takes four to six hours. You'll be asleep during the procedure,
so you shouldn't feel any pain during the procedure.
You'll be connected to a machine that helps you breathe (ventilator) during your
surgery. A tube will be run down your throat to your lungs and connected to the ventilator.
You may need to remain connected to the ventilator for several days after your surgery.
In this procedure, your surgeon will make an incision down the center of your
chest. Your surgeon will separate your chest bone (sternum) and open your rib cage so
that he or she can operate on your heart.
Your heart may be stopped using medications during the surgery. You'll be
connected to a heart-lung bypass machine that keeps oxygenated blood flowing through
your body during surgery if your heart is stopped during surgery.
Your surgical team will implant your VAD during surgery. An implanted left
ventricular assist device (LVAD) has many parts. A tube carries blood from the left
ventricle of your heart to a pump. The pump delivers blood through another tube to the
aorta — the artery that leads out to the body from the heart — which then delivers blood
to the body. A cable inserted through the skin connects the pump to the control unit and
battery pack outside your body.
After your VAD is implanted and working properly, your doctors will take you off the
heart-lung bypass machine so that the VAD can begin pumping blood through your heart.
Certain types of VADs pump blood similar to the way your heart does, using a
pumping action. They help pump blood from one or both lower chambers of your heart
(ventricles) and on to the rest of your body.
Other types of VADs — continuous flow devices — are smaller. These devices
allow a continuous stream of blood to flow through your heart. If you have a continuous
stream of blood flowing through your LVAD, you or your doctor may not be able to check
your pulse or your blood pressure using standard methods. Doctors may use other tests
to check your heart rate and rhythm and to measure your blood pressure.
Certain types of VADs have pumps located outside of the body. These VADs may
have external pumps connecting to a large console, while some have smaller external
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pumps located next to the body that are connected to portable devices. These VADs may
be used for a temporary period of time, such as during or after heart surgery, but some
may be used while waiting for a heart transplant or a longer-term VAD.
In one type of short-term VAD, the pump is inserted through a catheter in the leg,
neck or armpit, which doctors guide through the arteries to the heart. Another type uses
catheters to access the heart, but the pump is located outside the body.
Complications:
Bleeding - most common reason for ED visit, most common in first month
after implant (frequency 42%)
Lack of pulsatile flow → AV malformations in GI tract
Passive hepatic congestion secondary to biventricular failure,
Infection - driveline and pocket are most common sites
Inadequate anticoagulation and/or antiplatelet treatment
Arrhythmia - very common
2. Explain in detail about right ventricular by-pass pump procedure. (A/M 19)
Right ventricular bypass pump:
A ventricular assist device helps your heart pump blood when the pumping muscle
has become weak. A right ventricular assist device (RVAD) pumps blood from your right
ventricle or right atrium into your pulmonary artery and to the lungs.
Your doctor implants the pump close to your heart. The power source is located
outside of your body. It is connected to the pump through a small hole in your abdomen.
Both the pump and the power source of some temporary ventricular assist devices are
located outside of your body. Tubes connect the pump to your heart through small holes
in your abdomen.
Your surgeon implants the device during open-heart surgery. During this
procedure, he or she redirects the major arteries that take blood in and out of your heart,
to the pump. The pump, in turn, pushes the blood through your heart and out to the rest of
your body.
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It is recommended,
A ventricular assist device stabilizes your heart function after injury, such as a
heart attack. It's also used if you have severe heart failure that does not improve with
medicines.
It can also keep your heart working while you wait for a heart transplant. This may
be called “bridge” therapy. For most people, an RVAD is temporary. Your surgeon usually
places it after implanting a left-ventricular assist device (LVAD) or doing another type of
heart surgery.
Your doctor also uses an RVAD to stabilize your condition during an emergency,
while your medical team evaluates your health and the best option for treatment.
Risks for RVAD implantation
RVAD implantation is major surgery and requires general anesthesia (which puts you to
sleep). Any general anesthesia carries the risk of heart or brain injury. Major surgery also
carries the risk of blood clots forming during or after surgery. These clots can break free
and travel to your lungs (pulmonary embolism) or brain (stroke).
Other risks of this surgery include:
Infection
Bleeding
Device failure
Abnormal heart rhythm
Endocarditis (an infection of your heart tissue)
Kidney damage
Procedure:
A surgical team of heart (cardiac) surgeons, surgical nurses, doctors trained in
giving medication that causes you to sleep during surgery (anesthesiologists) and others
work together to perform your surgery.
The procedure to implant a ventricular assist device (VAD) is typically an open-
heart surgery that generally takes four to six hours. You'll be asleep during the procedure,
so you shouldn't feel any pain during the procedure.
You'll be connected to a machine that helps you breathe (ventilator) during your
surgery. A tube will be run down your throat to your lungs and connected to the ventilator.
You may need to remain connected to the ventilator for several days after your surgery.
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In this procedure, your surgeon will make an incision down the center of your
chest. Your surgeon will separate your chest bone (sternum) and open your rib cage so
that he or she can operate on your heart.
Your heart may be stopped using medications during the surgery. You'll be
connected to a heart-lung bypass machine that keeps oxygenated blood flowing through
your body during surgery if your heart is stopped during surgery.
Your surgical team will implant your VAD during surgery. An implanted Right
ventricular assist device (RVAD) has many parts. A tube carries blood from the Right
ventricle of your heart to a pump. The pump delivers blood through another tube to the
aorta — the artery that leads out to the body from the heart — which then delivers blood
to the body. A cable inserted through the skin connects the pump to the control unit and
battery pack outside your body.
After your VAD is implanted and working properly, your doctors will take you off the
heart-lung bypass machine so that the VAD can begin pumping blood through your heart.
Certain types of VADs pump blood similar to the way your heart does, using a
pumping action. They help pump blood from one or both lower chambers of your heart
(ventricles) and on to the rest of your body.
Other types of VADs — continuous flow devices — are smaller. These devices
allow a continuous stream of blood to flow through your heart. If you have a continuous
stream of blood flowing through your RVAD, you or your doctor may not be able to check
your pulse or your blood pressure using standard methods. Doctors may use other tests
to check your heart rate and rhythm and to measure your blood pressure.
Certain types of VADs have pumps located outside of the body. These VADs may
have external pumps connecting to a large console, while some have smaller external
pumps located next to the body that are connected to portable devices. These VADs may
be used for a temporary period of time, such as during or after heart surgery, but some
may be used while waiting for a heart transplant or a longer-term VAD.
In one type of short-term VAD, the pump is inserted through a catheter in the leg,
neck or armpit, which doctors guide through the arteries to the heart. Another type uses
catheters to access the heart, but the pump is located outside the body.
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3. Describe the working and its effects of IABP.(N/D 2019) (A/M 2017) (Or) Explain the
operation and physiologic effects of Intra Aortic Balloon Pump. (A/M 2019)(M/J
2016). (Or)Describe about intra aortic balloon pumping-IABP (or) what are the
pathological conditions that lead to use of IABP procedure? (Or) discuss the
requirements and procedure for conducting IABP. (or) Describe the principle,
methodology and working of IABP (A/M 2018) (or) Discuss the principle and
problems associated with intra aortic balloon pump with suitable diagrams. (N/D
2018)
An intra-aortic balloon pump (IABP) is a type of therapeutic device. It helps your
heart pump more blood. You may need it if your heart is unable to pump enough blood for
your body.
The IABP consists of a thin, flexible tube called a catheter. Attached to the tip of
the catheter is a long balloon. This is called an intra-aortic balloon, or IAB.
The other end of the catheter attaches to a computer console. This console has a
mechanism for inflating and deflating the balloon at the proper time when your heart
beats.
Heart pumps oxygenated blood and nutrients to all parts of your body. Blood
leaves the heart through the arteries, the blood vessels that carry oxygenated blood.
The outer walls of the heart also contain arteries. These are called the coronary
arteries. Through these vessels, the heart receives the oxygen and nutrients it needs.
When the heart contracts, it sends blood out to the body. As it relaxes, blood flows
into the coronary arteries to bring oxygen to the heart.
An IABP allows blood to flow more easily into your coronary arteries. It also helps
your heart pump more blood with each contraction.
The balloon is inserted into your aorta. The aorta is the very large artery leaving
your heart. In many cases, this procedure is done through a small cut on the inside of
your upper leg.
Healthcare provider will insert the balloon pump catheter into an artery in your leg
and then guide it to your aorta.
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Fig 3.A) When IABP is inflated B) When IABP is deflated
From there, the IABP can start to do its work. The balloon is set to inflate when the
heart relaxes. It pushes blood flow back toward the coronary arteries. They may not have
been receiving enough blood without the pump.
When the heart contracts, the balloon deflates. That allows the heart to pump more
blood out to the body while using less energy. The device continues to inflate and deflate
until it is removed.
An IABP is a short-term treatment. You may need it until your heart condition
improves or until you can receive a more permanent treatment.
Indications for its use include:
Cardiogenic shock.
Heart failure.
Acute heart attack.
Unstable angina
Certain abnormal heart rhythms.
The IABP has two parts:
1. A large bore catheter with a long sausage-shaped balloon at the distal tip, and
2. A console containing a pump that inflates the balloon.
The balloon is designed to sit in the proximal descending aorta. It comes in various
lengths according to body height, with balloon volumes of about 30-50 mL. The balloon is
usually filled with helium gas, and when inflated should fill up 80-90% of the aortic
diameter.
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The IABP works by inflating and deflating at different phases of the cardiac cycle.
Balloon inflation augments diastolic blood pressure
Balloon deflation decreases after load during systole.
Balloon inflation in early diastole (usually triggered by the R wave on the ECG)
increases diastolic blood pressure.
This in turn increases systemic perfusion and coronary perfusion (at least in the
hypotensive patient).Balloon inflation thus displaces blood both proximally and distally.
The increase in coronary perfusion increases myocardial oxygen supply.Balloon
deflation occurs at the end of diastole resulting in a decreased end diastolic blood
pressure.
This reduces the aortic pressure at the start of systolic ejection, thus decreasing
the after load that the heart has to pump against. This decreases myocardial oxygen
demand and improves systemic perfusion during systole.
IABP Procedure
IABPs are usually inserted using the Seldinger technique via the femoral artery so
that the tip of the catheter is advanced proximally into the aorta.
Heparinise patient prior to insertion of catheter providing there are no
contraindications such as recent surgery.
Prepare the skin.
Fully collapse balloon applying 30 ml vacuum with 60 ml syringe.
Insert needle into femoral artery at 45° and pass it through both walls of artery.
Withdraw needle until strong pulsatile jet of blood is obtained.
Pass guide wire through needle and advance until tip is in thoracic aorta. Wire
should pass very easily.
Pass sheath over wire in similar manner to insertion of PA catheter sheath.
Pass balloon over guide wire through sheath. Must be inserted to at least the level
of the manufacturer’s mark (usually double line) to ensure that entire balloon has
emerged from sheath.
Balloon should be positioned so that the tip is about 1 cm distal to the origin of the
left subclavian artery.
Remove wire. Return of blood via central lumen confirms that the tip is not
subintimal and has not caused a dissection.
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Flush central lumen with heparin saline and connect to transducer to monitor intra-
aortic pressure (the outer lumen transmits helium gas to the balloon)
Monitor Doppler ankle pressures and compare with preinsertion value.
Once the balloon has been inflated, even if it is then deflated, it must not be
removed through the sheath for any reason – the sheath must be removed first.
After correct placement of the IAB in the descending aorta with its tip at the distal
aortic arch (below the origin of the left subclavian artery) the balloon is connected
to a drive console. The console itself consists of a pressurized gas reservoir, a
monitor for ECG and pressure wave recording, adjustments for inflation/deflation
timing, triggering selection switches and battery back-up power sources.
The gases used for inflation are either helium or carbon dioxide .The advantage of
helium is its lower density and therefore a better rapid diffusion coefficient.
Whereas carbon dioxide has an increased solubility in blood and thereby reduces
the potential consequences of gas embolization following a balloon rupture.
Inflation and deflation are synchronized to the patients’ cardiac cycle. Inflation at
the onset of diastole results in proximal and distal displacement of blood volume in
the aorta. Deflation occurs just prior to the onset of systole.
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USES
The primary goals of IABP treatment are to increase myocardial oxygen supply
and decrease myocardial oxygen demand. Secondary, improvement of cardiac output
(CO), ejection fraction (EF), an increase of coronary perfusion pressure, systemic
perfusion and a decrease of heart rate, pulmonary capillary wedge pressure and systemic
vascular resistance occur 10, 11, 12.
Elastic Modulus
Elastic modulus is simply defined as the ratio of stress to strain within the
proportional limit. Physically, it represents the stiffness of a material within the elastic
range when tensile or compressive load are applied.
It is clinically important because it indicates the selected biomaterial has similar
deformable properties with the material it is going to replace. These force-bearing
materials require high elastic modulus with low deflection.
As the elastic modulus of material increases fracture resistance decreases. It is
desirable that the biomaterial elastic modulus is similar to bone.
Hardness
Hardness is one of the most important parameters for comparing properties of
materials. It is used for finding the suitability of the clinical use of biomaterials. Biomaterial
hardness is desirable as equal to bone hardness. If higher than the biomaterial, then it
penetrates in the bone.
Fracture strength
Strength of materials is defined as the maximum stress that can be endured before
fracture occurs. Strength of biomaterials (bioceramics) is an important mechanical
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property because they are brittle. In brittle materials like bioceramics, cracks easily
propagate when the material is subject to tensile loading, unlike compressive loading.
Fatigue
Fatigue is defined as failure of a material due to repeated/cyclic loading or
unloading. It is also an important parameter for biomaterial because cyclic load is applied
during their serving life. In this cyclic loading condition, micro crack/flaws may be
generated at the interface of the matrix and the filler.
Applications
Biomaterials are used in:
Joint replacements
Bone plates
Intraocular lenses
Bone cement
Dental implants
Blood vessel prostheses
Heart valves
Cochlear replacements
Classification of biomaterials
1. Natural
2. Synthetic
o Metals
o Polymers
o Ceramics
o Composite
Metals
Metals and alloys are used as biomaterials due to their excellent electrical and
thermal conductivity and mechanical properties. Metals are used as load bearing implants
and internal fixation devices.
Commonly used alloys include austenitic stainless steel, cobalt-chrome alloys
including molybdenum-based alloys, tantalum and titanium and its alloys.
Requirements for metallic implant materials
Must be corrosion resistant
Mechanical properties must be appropriate for desired application
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Areas subjected to cyclic loading must have good fatigue properties
Applications
Bone and Joint Replacement
Dental Implants
Maxilla facial reconstruction
Cardiovascular devices
Heart valves, and for intra-vascular stents.
External Prostheses
Surgical instruments
Ceramics
A ceramic is an inorganic compound, non-metallic, solid material comprising metal,
non-metal or metalloid atoms primarily held in ionic and covalent bonds. Ceramics are
used as biomaterials due to their high mechanical strength and biocompatibility.
Some elements, such as carbon or silicon, may be considered ceramics. Ceramic
materials are brittle, hard, strong in compression, weak in shearing and tension. They
withstand chemical erosion that occurs in other materials subjected to acidic or caustic
environments.
Ceramics generally can withstand very high temperatures, such as temperatures
that range from 1,000 °C to 1,600 °C. Glass is often not considered a ceramic because of
its amorphous (non crystalline) character.
Properties
Elasticity / plasticity,
Tensile strength,
Compressive strength,
Shear strength,
Fracture toughness&ductility
Applications In orthopedics:
Femoral head
Bone screws and plates
Porous coatings for femoral stems
Knee prosthesis
Dental: crowns and bridges
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Polymers
Polymers are classified into two types nmely, natural polymers and synthetic
polymers. Natural polymers are derived from the living creatures. Some of the natural
polymers are collagen, chitosan, dextrans and cellulose.
Synthetic polymers are human-made polymers. Some of the synthetic polymers are
polytetrafluroethylene (PTFE), poly ethylene, poly propylene, poly methyl methaacrylate
(PMMA).
Synthetic polymeric materials have been widely used in medical disposable supply,
prosthetic materials, dental materials, implants, dressings, extracorporeal devices,
Polymeric drug delivery systems, tissue engineered products.
Applications
Blood and solution bag, surgical
packaging, IV sets, dialysis devices,
Polyvinylchloride (PVC)
catheter bottles, connectors, and
cannulae
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Some applications of composites in biomaterial applications are
Dental filling composites,
Reinforced methyl methaacrylate bone cement and ultra-high molecular weight
polyethylene, and
Orthopedic implants with porous surfaces.
Types of biomaterials used in the design of cardiac devices
Biomaterials that have been used in the cardiovascular system include processed
biological substances, metals and polymers. Materials of biologic origin include structures
such as pericardia, arteries, veins and heart valves. Devices can also include biological
substances for example, coatings, such as collagen and heparin.
Metals such as titanium, stainless steel, nitinol and cobalt-chrome alloys are used in
many devices. Generally, these are metals with passive surfaces, or surfaces that can be
passivated. Silver has been used as a coating designed to resist infection.
Glassy carbons have also have used as coatings to render surfaces thrombo
resistant. Pyrolytic carbon structures or coatings on graphite have been utilized in the
fabrication of Bileaflet heart valves.
Polymeric materials that have been used in the cardiovascular system include
polytetrafluroethylene and polyethylene terephthalate are used extensively as fabrics for
repair of vasculature and larger vessel replacement.
TESTING OF BIOMATERIALS
The testing program for any medical devices can be divided into four phases: 1)
biocompatibility, 2) short-term bench, 3) long-term bench tests, 4) Animal studies.
Biocompatibility testing must measure the effects of the material on blood and
tissue, as well as the effects of the organism on the material.
ISO 10993 standards prescribe a series of tests, the selection of which depends
upon the length of time that the device will be in contact with the body.
For implant devices contacting blood for more than days, the following tests are
required: cytotoxicity, sensitization, irritation or intracutaneous reactivity, acute system
toxicity, sub chronic toxicity, gene toxicity and hemocompatibility.
For devices in contact with blood for less than 24 hours, subchronic toxicity and
genotoxicity are not required.
The tests required for implanted cardiovascular devices that do not contact blood
require the same type of testing program except for the hemocompatibility requirement
and for the implantation tests for devices in use for less than 24 hours.
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For long-term devices, either external or implants, chronic toxicity and
carcinogenicity testing may also be required.
Short-term bench testing
Short-term bench (in vitro) testing includes material identification, surface
characterization, mechanical properties, etc. material identification tests characterize the
bulk properties of the material.
Tests chosen depend upon the type of material. Chemical formula, molecular
weight, percentage crystallinity,melting or softening point and degree of cross-linkage
may all be important to characterize a polymer.
Mechanical properties of the material will determine if a device will suffer an early
failure. Tensile strength and elastic modulus can be measured by a simple tensile test. If
the device could be subjected to impact loading, an impact type test can be performed.
Tear tests are important for materials in sheets such as fabrics and films.
Long term bench testing
For long term devices, endurance testing is required. In general, simple tensile or
bending tests can be performed on the basic material. Frequently, however, the device
itself is tested in some simulated loading condition.
Such a test includes the effects of processing, sterilization and shelf life on the
material. It also allows designer to calculate reliability.
There are test and reliability standards for some cardiovascular devices. Vascular
grafts, heart valves, stents and left-ventricular assist devices, among others have
reliability requirements and recommendations for the types of tests that can be employed.
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5. Explain about prosthetic cardio valves (or) Discuss the different types of artificial
Heart valve with neat diagram. (A/M 19)(A/M 2017) (or) Discuss in detail about heart
valve prosthesis? (M/J 2016)
An artificial heart valve is a device implanted in the heart of a patient with valvular
heart disease. When one of the four heart valves malfunctions, the medical choice may
be to replace the natural valve with an artificial valve.
This requires open-heart surgery. Valves are integral to the normal physiological
functioning of the human heart. Natural heart valves are evolved to forms that perform the
functional requirement of inducing unidirectional blood flow through the valve structure
from one chamber of the heart to another.
Natural heart valves become dysfunctional for a variety of pathological causes.
Some pathologies may require complete surgical replacement of the natural heart valve
with a heart valve prosthesis.
Types
Different types of artificial heart valves.
There are two main types of artificial heart valves: the mechanical, the biological
(tissue engineered) valves.
Mechanical heart valve
Ball and cage
Tilting disk
Single leaflet and Bi-leaflet
Tissue (biological) heart valves
Allograft
Xenograft
Mechanical valves
Mechanical heart valves (MHV) are prosthetics designed to replicate the function of
the natural valves of the human heart. The human heart contains four valves: tricuspid
valve, pulmonic valve, mitral valve and aortic valve.
Their main purpose is to maintain unimpeded forward flow through the heart and
from the heart into the major blood vessels connected to the heart, the pulmonary artery
and the aorta.
As a result of a number of disease processes, both acquired and congenital, any
one of the four heart valves may malfunction and result in either stenosis (impeded
forward flow) and/or backward flow (regurgitation).
27
Either process burdens the heart and may lead to serious problems including heart
failure. A mechanical heart valve is intended to replace a diseased heart valve with its
prosthetic equivalent.
There are three major types of mechanical valves – caged-ball, tilting-disk and
bileaflet valve– with many modifications on these designs.
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Fig 6. Caged Ball
Tilting disc
Tilting disk valves have a single circular occluder controlled by a metal strut. They
are made of a metal ring covered by an ePTFE fabric, into which the suture threads are
stitched in order to hold the valve in place.
The metal ring holds, by means of two metal supports, a disc which opens and
closes as the heart pumps blood through the valve. The disc is usually made of an
extremely hard carbon material (pyrolytic carbon), in order to allow the valve to function
for years without wearing out.
Monoleaflet Valves
Monoleaflet valves are composed of a single disk secured by lateral or central metal
struts. The opening angle of the disk relative to valve annulus ranges from 60° to 80°,
resulting in 2 distinct orifices of different sizes.
29
Fig 8. Monoleaflet Valves
Bileaflet Valves
Bileaflet valves are made of 2 semilunar disks attached to a rigid valve ring by small
hinges. The opening angle of the leaflets relative to the annulus plane ranges from 75° to
90°, and the open valve consists of 3 orifices: a small, slit-like central orifice between the
2 open leaflets and 2 larger semicircular orifices laterally.
30
There are some risks associated with a xenograft such as the human body's
tendency to reject foreign material. Medication can be used to retard this effect, but is not
always successful.
Allograft and Homograft
Implantation of valves from same species is called allograft. (one human being to
other human being). Homograft means implantation valves from the same person.
(Donor of the same species as the recipient).
6. What are the signs and symptoms of prosthetic cardiac valve malfunction? Explain
its diagnostic and treatment approaches. (N/D 2016)
Primary valve failure may occur abruptly from the tearing or breakage of
components or from a thrombus suddenly impinging on leaflet mobility. More commonly,
valve failure presents gradually from calcifications or thrombus formation.
Bioprostheses are less thrombogenic than mechanical valves, but this advantage is
balanced by their diminished durability when compared with mechanical valves. Although
30-35% of bioprostheses will fail within 10-15 years, it can be anticipated that most
mechanical valves will remain functional for 20-30 years.
Stenosis or incompetence of prosthetic valves occurs and may be due to a tear or
perforation of the valve cusp, valvular thrombosis, pannus formation, valve calcification,
or stiffening of the leaflets.
Primary failure of mechanical valves may be caused by suture line dehiscence,
thrombus formation, or breakage or separation of the valve components. Acute valvular
regurgitation or embolization of the valve fragments may result.
When the mitral valve acutely fails, rapid left atrial volume overload causes
increased left atrial pressure. Pulmonary venous congestion and, ultimately, pulmonary
edema occur.
Cardiac output is decreased because a portion of the left ventricular output is being
regurgitated into the left atrium. The compensatory mechanism of increased sympathetic
tone increases the heart rate and the systemic vascular resistance (SVR).
This may worsen the situation by decreasing diastolic filling time and impeding left
ventricular outflow, thereby increasing the regurgitation.
Acute failure of a prosthetic aortic valve causes a rapidly progressive left ventricular
volume overload. Increased left ventricular diastolic pressure results in pulmonary
congestion and edema. The cardiac output is reduced substantially.
31
The compensatory mechanism of an increased heart rate and a positive inotropic
state, mediated by increased sympathetic tone, partly helps to maintain output. However,
this is hampered by an increase in SVR, which impedes forward flow.
Increased systolic wall tension causes a rise in myocardial oxygen consumption.
Myocardial ischemia in acute aortic regurgitation may occur, even in the absence of
coronary artery disease.
Biological prosthetic valves often slowly degenerate over time, become calcified, or
suffer from thrombus formation. These events result in the slowly progressive failure of
the valve.
The presentation is usually that of gradually worsening congestive heart failure, with
increasing dyspnea. Alternatively, patients may present with unstable angina or systemic
embolization, or they may be entirely asymptomatic.
The first TAVI device for use in the United States was approved in November 2011.
Subsequently, not enough time has passed to gather data concerning longevity and use.
Vascular complications and strokes related to the procedure are decreasing with
improved delivery techniques and equipment.
Complications related to the conduction system requiring permanent pacemaker
implantation occur in 14% of patients. This risk is increased with the use of the CoreValve
prosthesis.
Signs and symptoms
Signs and symptoms of prosthetic heart valve malfunction depend on the type of
valve, its location, and the nature of the complication. Presentations may include the
following:
Acute prosthetic valve failure: Sudden onset of dyspnea, syncope, or precordial
pain.
Acute aortic valve failure: Sudden death; survivors have acute severe dyspnea,
sometimes accompanied by precordial pain, or syncope.
Subacutevalvular failure: Symptoms of gradually worsening congestive heart
failure; they also may present with unstable angina or, at times, may be entirely
asymptomatic.
Embolic complications: Symptoms related to the site of embolization (eg, stroke,
myocardial infarction [MI], sudden death, or symptoms of visceral or peripheral
embolization).
Anticoagulant-related hemorrhage: Symptoms related to the site of hemorrhage.
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A history of fever should raise the possibility of prosthetic valve endocarditis
(PVE).
On physical examination, normal prosthetic heart valve sounds include the following:
Mechanical valves: Loud, high-frequency, metallic closing sound; soft opening
sound (tilting disc and bileaflet valves); low-frequency opening and closing
sounds of nearly equal intensity (caged ball valves).
Tissue valves: Closing similar to those of native valves, low-frequency early
opening sound in the mitral position.
Prosthetic heart valve murmurs noted include the following:
Aortic prosthetic valves: Some degree of outflow obstruction with a resultant
systolic ejection murmur (loudest in caged ball and small porcine valves); low-
intensity diastolic murmur (tilting disc and bileaflet valves).
Mitral prosthetic valves: Low-grade systolic murmur (caged ball valves); short
diastolic murmur (bioprostheses and, occasionally, St. Jude bileaflet valves).
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Imaging studies that may be helpful include the following:
Chest radiography: This can help in delineating the valvular morphology and
determining whether the valve and occluder are intact; each of the most
commonly used valve types has its own characteristic radiographic
appearance.
Echocardiography (2-dimensional, Doppler, transesophageal [the study of
choice for a suspected prosthetic valve complication], transthoracic).
Cinefluorography: This may detect impaired occluder movement but often
cannot readily determine the etiology.
Computed tomography: A consensus statement from the Society of
Cardiovascular Computed Tomography (SCCT) states that CT should be
performed as part of the evaluation of all patients being considered for
transcatheter aortic valve implantation (TAVI)/transcatheter aortic valve
[3, 4]
replacement (TAVR), except those in whom CT is contraindicated, and
that the CT images should be interpreted with a member of the TAVI/TAVR
team or reviewed with the operator before the procedure.
Treatment
In patients with acute valvular failure, diagnostic studies must be performed
simultaneously with resuscitative efforts.
Treatment approaches to primary valve failure include the following:
Emergency valve replacement
Concomitant adjunctive therapy
Afterload reduction and inotropic support
In selected cases, intra-aortic balloon counterpulsation.
Treatment approaches to PVE include the following:
Intravenous antibiotics administered as soon as 2 sets of blood cultures are
drawn
Cessation of warfarin until central nervous system involvement is ruled out
and invasive procedures are determined to be unnecessary.
Consideration of anticoagulation.
Consideration of emergency surgery in patients with moderate to severe
heart failure or with an unstable prosthesis noted on echocardiography or
fluoroscopy.
34
Treatment approaches to thromboembolic complications include the following:
Anticoagulation (if it has not already been initiated or if the patient has a
subtherapeutic INR)
Assessment of valve function
Note: US dabigatran prescribing information now includes a contraindication
in patients with mechanical prosthetic valves.
Treatment approaches to prosthetic valve thrombosis include the following:
Surgery (historically the mainstay of treatment but associated with a high
mortality)
Thrombolytic therapy (appropriate for selected patients with thrombosed
prosthetic valves): Should always be performed in conjunction with
cardiovascular surgical consultation
In cases of major anticoagulant-related hemorrhage, reversal of
anticoagulation
7. (i)Define Angina Pectoris. Explain the method of external counter pulsation
techniques. (N/D 2016) (ii) Write short notes on open chest type bypass. (N/D 2016)
Angina pectoris is the medical term for chest pain or discomfort due to coronary
heart disease. It occurs when the heart muscle doesn't get as much blood as it needs.
This usually happens because one or more of the heart's arteries is narrowed or blocked,
also called ischemia.
Angina pectoris can be quite painful, but many patients with angina complain of
chest discomfort rather than actual pain: the discomfort is usually described as a
pressure, heaviness, tightness, squeezing, burning, or choking sensation.
Three electrodes are applied to the skin of the chest and connected to an
electrocardiograph (ECG) machine. The ECG will display the heart's rhythm during
treatment. Blood pressure is also monitored.
A set of cuffs is wrapped around the calves, thighs and upper thighs. These cuffs
attach to air hoses that connect to valves that inflate and deflate the cuffs. Patients
experience a sensation of a strong "hug" moving upward from calves to thighs to
upper thighs during inflation followed by the rapid release of pressure on deflation.
Inflation and deflation are electronically synchronized with the heartbeat and blood
Working of ECP
The ECP treatment gently but firmly compresses the blood vessels in the lower
limbs to increase blood flow to your heart. Each wave of pressure is
electronically timed to the heartbeat, so that the increased blood flow is
delivered to your heart at the precise moment it is relaxing.
When the heart pumps again, pressure is released instantaneously. This lowers
resistance in the blood vessels in the legs so that blood may be pumped more
easily from your heart.
ECP may encourage blood vessels to open small channels that become extra
branches. These channels or collaterals may eventually become "natural
bypass" vessels to provide blood flow to heart muscle. This contributes to the
relief of angina symptoms.
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Fig 11 .Steps involved in ECP procedure
Patients who are accepted for treatment must undergo 35 hours of EECP therapy.
Treatment is administered 1-2 hours a day, five days a week, for 7 weeks.
Benefits
Less need for anti-anginal medication.
Decrease in symptoms of angina.
Increased ability to do activities without onset of symptoms.
Ability to return to enjoyable activities.
(ii) Write short notes on open chest type bypass. (N/D 2016)
Open heart surgery refers to a type of surgery in which the chest wall is surgically
opened and heart is exposed. This surgery is performed on the muscles, valves, or
arteries of the heart.
Used for heart Valve Replacement, Coronary Artery Bypass Grafting, and several
other congenital and acquired heart problems.
37
Some of the risks involved in the surgery -
Stroke
Excessive bleeding
Heart attack
Arrhythmias
8. Discuss the principle of using Synchronous Counter Pulsation Technique with its
pathological conditions. (Or) Describe how counter pulsation technique is used as
cardiac assist procedure.
Assisted circulation has as its goal the support of the failing circulatory system
using extracorporeal devices. In general, the various types of assisted circulation
advanced over the past 5 years may be divided into the two broad categories of
synchronous and asynchronous.
Counter pulsation was the first method of synchronous assistance and was
introduced by Clausset in 1961. Counter pulsation reduces the pressure against which
the left ventricle contracts, and hence the oxygen consumption of the left ventricle, while
maintaining an adequate diastolic perfusion pressure.
The relationship between the mean systolic pressure and the energy requirements
of the left ventricle showed that the oxygen consumption of the left ventricle depends
largely on the total pressure generated per minute by that chamber during systole, or the
tension-time index.
Counter pulsation is accomplished by inserting a cannula into a major artery. The
cannula is attached to a bellows pump, which is activated through an electronic control
unit . This unit allows the pump to be triggered by either the R wave of the
electrocardiogram or the ascending limb of the systolic pressure pulse.
The pump aspirates blood during cardiac systole, thus lowering the systolic
pressure, and returns the blood to the arterial system during cardiac diastole, thus
elevating the diastolic perfusion pressure.
The metabolic and hemodynamic effects of counter pulsation have been
documented experimentally.
38
It deter mine the effects of short periods of counter pulsation on the myocardial
oxygen consumption, the tension—time index, left ventricular work, and coronary blood
flow. Fourteen experiments were conducted on healthy mongrel dogs.
Observations were made during a control period, after 15 min of counterpulsation,
and following a second control period. The experi mental results were divided into two
groups.
39
The coronary vascular resistance was reduced and the coronary flow rose by an
average of 50 percent. Myocardial oxygen consumption fell in each instance. The
average reduction in oxygen consumption was 22 percent. Cardiac output did not change;
thus left ventricular work decreased as a result of the reduction in systolic pressure.
42
Veno-Venous (VV):
This type of ECMO provides support for the lungs only. One or two cannulas are
placed in large vein(s) on the side of the neck or in the groin area at the top of the leg.
Your child’s heart will continue to work normally.
The ECMO machine will drain the blood from the vein through the cannula, oxygen
will be added to the blood, carbon dioxide will be removed, and then the blood is warmed
and returned back to the right side of the heart through the cannula.
The child’s heart pumps the oxygenated blood to the body, so that the lungs have
time to rest and recover.
Veno-Arterial (VA):
VA ECMO provides support for both the lungs and the heart. Two cannulas are
placed in large vessels on the side of the neck, directly into the chest (while the chest is
covered with a sterile protector) or into the groin vessels.
The ECMO machine will drain the blood from the vein, add the oxygen and remove
the carbon dioxide, warm the blood and then return the blood to the artery and “pump” the
blood through the body. This method allows the blood to “bypass” the heart and lungs,
allowing them to rest and get better.
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