Prosthetic Heart Valves

Presentation by Brian
Meyer

Topics to Be Discussed:
Introduction:

How the Heart/Heart Valves

Work
Brief History of Artificial Heart Valves
Types of Artificial Valves
(Examples,Materials Used)
In-Depth Look Bjork-Shiley Valves (Why
Failed? And Lessons to be learned)

Heart/Heart Valves
Heart consists of:
Right Atrium and Ventricle
Atrium
Left Atrium and Ventricle
Two Types of Valves:
Atrioventricular Valve:
separates the atrium from
the ventricle
Semi-Lunar Valve: separates
the ventricles from the
outgoing blood vessels

Heart/Heart Valves
Right Atrioventricular Valve:
Tricuspid Valve
Left Atrioventricular Valve:
Bicuspid Valve
Right Semi-Lunar Valve:
Pulmonary Valve
Left Semi-Lunar Valve:
Aortic Valve
Purpose of Valves: Prevent
backflow, or flow of blood back
into chamber from which it came

Heart/Heart Valves
When Ventricle expands:
atrioventricular valve allows blood
to flow forward to the atrium into
the ventricle while the semilunar
valve prevents blood from flowing
back in heart
When Ventricle contracts:
atrioventricular valve closes to
prevent backflow while semilunar
valve allows blood to body or lungs
Prevention of backflow: ensures the
proper direction of flow and
reduces amount of work heart must
do to pump blood

When Heart Valves Stop Working

Heart Valve diseases fall into two categories:

stenosis- hardening of the valve
incompetence- permittence of backflow

3 causes of Heart Disease:

Rheumatic Fever: stiffens valve tissue, causing stenosis
Congenitally defective valves: do not form properly as the heart
develops, but often go unnoticed until childhood
Bacterial infection: causes inflammation of valves, tissue
scarring, and permanent degradation

Evolution of Prosthetic Heart Valves

The development of the
original ball-and-cage valve
design can be attributed to
the bottle stopper in 1858
In the early 1950s, it led to
the idea of a prosthetic
heart valve consisting of a
cage with a mobile spherical
poppet

Evolution of Prosthetic Heart Valves

This first heart valve was
made of a Plexiglass(methyl
methacylate)cage
surrounding a siliconecoated nylon poppet
First implanted in a human in a
closed procedure in
September of 1952
(descending thoracic aorta)

Evolution of Prosthetic Heart Valve

Significant advances were made soon after to help

the development of the heart valve:
In 1953, marked successful use of the heart and
lung machine, paving the way for the 1st open heart
operations
The idea of using blood from another patient to
oxygenate the blood of the patient was developed
New methods were came for evacuating air from
the heart
New materials (Plexiglass, Teflon, and Dacron)

Evolution of the Prosthetic Heart Valve

On July 22, 1955, at the City General Hospital in

Sheffield, England, Judson Chesterman implanted
the first successful heart valve
The patient lived 14 hours after the valve was
placed, but died when the poppet twisted out of
position
Valve was made of Perspex, an outer cage, a poppet,
and 2 buttons to fasten the valve to the outside of
the heart

Evolution of the Prosthetic Heart Valve

Starr-Edwards valve was

first successful long-term
valve created
It was implanted in its first
8 patients in 1961 (6 of 8
survived
Ball-and-Cage design
Devised important Nine
Commandments in
developing a prosthetic
heart valve

Evolution of Prosthetic Heart Valves

Nine Commandments:
Embolism Prevention
Durability
Ease and Security of Attachment
Preservation of Surrounding Tissue Function
Reduction of Turbulance
Reduction of Blood Trauma
Reduction of Noise
Use of Materials Compatible with Blood
Development of Methods of Storage and Sterilization

Evolution of the Prosthetic Heart Valve

Since this time, over 30

mechanical heart designs
have been marketed in the
U.S. and abroad
These valves have
progressed from the simple
caged ball valves, to strutand-leaflet valves and the
modern bileaflet valves, to
human and animal tissue

Artificial Heart Valve Types

Mechanical Valves:
Ball Valves
This design uses a spherical occluder, or blocking
device, held in place by a welded metal cage
Problem and Why failed: Natural heart valves allow
blood to flow straight through the center of the
valve (central flow)
Caged-ball valves completely blocked central flow and
collisions with the occluder ball caused damage to
blood cells
Finally, these valves stimulated thrombosis, or
formation of blood clots

Starr-Edwards Ball Valve

Model: Starr-Edwards
Type: Aortic Caged Ball
Materials: Silicone Rubber ball
with 2% barium sulfate,
cage-Stellite alloy No. 21,
sewing ring- knitted Teflon
and polypropelene cloth
1 of 4 Starr-Edwards models
developed are still used
today, and is the only ball
valve currently used in U.S.

Magovern-Cromie Ball Valve

Model: Magovern-Cromie
valve
Type:Aortic Caged Ball
Materials: Ball-Silicone
rubber with barium,
cage-titanium, sewing
ring-none, Cage open at
top

Smeloff-Suttor Ball Valve

Model: Smeloff-Suttor valve
Type: Aortic, Mitral, Tricuspid
caged ball
Materials: Ball-Silicone rubber,
cage-titanium,
sewing ring-Teflon
Problems: Ball Variance,
swelling of ball from lipid
absorbtion, can cause
sticking of ball in inflow
orifice

Mechanical Valves:
Single Leaflet Disc Valves

Uses a tilting occluder disk

to better mimic natural flow
patterns through the heart
tilting pattern allow more
central flow while still
preventing backflow
Some damage still occurs to
blood cells
Reduces thrombosis and
infection, but does not
eliminate either problem

Bjork-Shiley Standard Aortic Valve

Model: Bjork-Shiley
Standard
Type: Aortic Tilting Disc
Materials: Disk-Pyrolytic
Carbon, cage-Haynes
25, sewing ring-Teflon

Medtronic-Hall Valve
Model: Medtronic-Hall
A7700 (aortic), M7700
(mitral)
Type: Aortic and Mitral
Tilting Disk
Materials: Cage-titanium,
Disk-Pyrolytic carbon,
sewing ring-knitted
teflon

Other Single Leaflet Disc Valves

Another similar valve is

the caged disc valve

Examples are StarrEdward Model 6500

and the Kay-Shiley
Model

Mechanical Valves:
Bileaflet Disc Heart Valves

Consists of two semicircular

leaflets that pivot on hinges
integrated onto the flange
Carbon leaflets and flange
exhibit high strength and
excellent biocompatibility
Provide closest
approximation to central
flow
Allows small amount of
backflow as leaflets cannot
close completely

St. Jude Bileaflet Valve

Model: St. Jude Valve
Standard
Design :Mitral, Aortic,
Tricuspid Bileaflet
Valve
Materials-Cage and diskpyrolytic carbon,
sewing ring-double
velour knitted
polyester

Animal Tissue Valves

Heterograft or
Xenograft Vavles
Most commonly used
tissues are the porcine
(pig) valve tissue and
Bovine (cow) pericardial
tissue

Porcine (pig) Valves

Two major brands of porcine
available today, Hancock and
Carpentier-Edwards
Has good durability and and
good hemodynamics
Materials: Porcine valve tissue,
stents made of wire,
Elgiloy(cobalt-nickel alloy),
sewing ring-knitted Teflon

Pericardial (cow) Valves

Lasts as long as standard

porcine valves at 10 years
The pericardial valve has
excellent hemodynamics,
even in smaller sizes(19mm
to 21mm)and has gained a
large market share (about
40% of US tissue valves) in
this group of patients

Stentless Porcine Valve

Stentless valves are made

by removing the entire
aortic root and adjacent
aorta as a block from the
pig
Drawbacks: Valve is more
difficult to to implant and
requires special
measurements for
successful implantation

Homografts(Human to Human)
Homografts

are valves transplanted from

one human to another
After donation, valves are preserved in
liquid nitrogen(cyropreserved) until needed
Since the valve must be thawed overnight,
the patients size must be known beforehand
As with heart transplants, homograft
availability is limited by donor availability

Autografts (Ross Procedure)

Autografts are valves taken from the same patient in which

the valve is implanted
Used for patients with diseased aortic valves
Advantages: patient receives a living valve in the aortic
position
Better durability and hemodynamics
Disadvantages: difficult procedure for the surgeon and
involves considerable skill and time
most common problem is leakage of the valve (aortic
regurgitation)

Animal Tissue Valves vs. Mechanical Valves

With the animal tissue, patients do not need lifelong

anticoagulant therapy required with mechanical
valves
Animal tissue is also inexpensive and mass-produced
However, animal tissue has uncertain durability (515 years )that will inevitably require a risky reoperation
Mechanical valves can also fail suddenly and
catastrophically
Have serious problem with thromboembolism

Bjork-Shiley Prosthetic Heart Valve

In 1979, the Bjork-Shiley

valve was modified to open
from 60 to 70 degrees
(Convexo-Concave valve)
82,000 were implanted
between the time of its
invention and its removal
from the market in 1986
Between 1979 and 1990,
600 fractures occurred
with 2 out of 3 fractures
resulting in death

Bjork-Shiley Valve:
Initial Fracture Assessment

Investigators determined
that the floating disc opens
and slams shut at least 70
times per minute or 40
million times per year,
causing fatigue failure
Although changes were
made, fractures continued to
occur
Finally, in 1984, Shiley
discovered the source, known
as Bimodal Closure
Phenomenon

Bjork-Shiley Valve:
Role of the FDA

In 1979, the Bjork-Shiley valve was approved very

quickly, only six months after Shileys first request
The main criticism of the FDA was its delay in
removing the valve from the market despite
knowledge of the outlet struts susceptibility to
fracture
The Bjork-Shiley heart valve failure prompted the
FDA to make substantial changes in its policies

Impact of Bjork-Shiley ConvexoConcavo(BSCC) Heart Valves

The

deaths and sicknesses have greatly

effected Shiley Incorporated, the FDA, and
the medical industry
Overall, Shiley and its associate company,
Pfizer, have faced hundreds of lawsuits and
paid more in legal fees and lobbying costs
than if they had simply replaced the valves
According to the Federal Device
Amendments, the BSCC is a justified killer