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Miscellaneous
History

Development of Mechanical Heart Valves - An Inspiring Tale

P. Rajashekar
Department of Cardiothoracic Surgery, All India Institute of Medical Sciences, New Delhi, India

Abstract
The historical evolution of the prosthetic heart valves from the first attempts with the Hufnagel’s valve in the treatment of the aortic
insufficiency to the Starr‑Edwards’ ball valve and later the tilting disc valves (Bjork–Shiley etc.,) and finally the bileaflet valves (St. Jude)
are discussed. The Indian contribution with Chitra valve is also described.

Key words: Chitra valve, history, mechanical valves, prosthetic valves

Introduction the descending aorta of a 30‑year‑old woman to correct

Valve replacement surgery has a long, important, and inspiring
history.[1‑5] The attempts to surgically correct valvular heart
disease through valvuloplasty started in the 1920s, but the
results had been discouraging. C. Walton Lillehei, Henry
Bahnson, and many other surgeons tried to attach individual
polymer leaflets, but the results were poor because of the
subsequent rupture.
The development of prosthetic heart valves involved a search
for biologically compatible materials and hemodynamically
tolerant designs. Several demonstrations and analysis were
carried out by trial and error methods, but no satisfactory
mechanism was found to achieve a hemodynamically stable,
implantable, and durable heart valve. This review is an effort
to discuss the innovations and designing efforts involved
in the development of mechanical prosthetic heart valves.
The search of avoiding thromboembolic complications of
mechanical prosthetic valves and lifelong anticoagulation
and associated side effects lead to bioprosthetic tissue valves
which were developed later in the history but are not included
in the present discussion.
Necessity is the Mother of Invention
The first steps
The need of prosthetic heart valves was recognized long ago
but seemed like an impossible vision until 1952. Dr. Charles
Hufnagel implanted an acrylic ball valve prosthesis into
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aortic valve insufficiency in 1952 at Georgetown Medical
Center in Washington, DC, who could lead a normal life
after the surgery [Figure 1].[1,2] Hufnagel’s invention was a
methylcrylate chamber containing the methylcrylaye ball in
the middle, which was “implanted quickly into the descending
aorta using a nonsuture technique.” More than 200 implanted
Hufnagel valves functioned for as long as 30 years with no
significant wear. No anticoagulation was used. The drawback
to this model, besides the mortality and cumbersome insertion
during the brief cross‑clamp period, was that patients could
hear the plastic ball bouncing around inside them. At a later
stage, a hollow nylon ball coated with silicone rubber was used
for designing the valve instead of the methacrylate ball which
eventually reduced the valve noise.
Hufnagel valves and his experiments on biocompatible
materials successfully proved that synthetic materials could be
used to create heart valves. The major hitch of Hufnagel valves
was that it could only be positioned in descending aorta and
not inside the heart and, therefore, had poor hemodynamics.
Because of these reasons, it failed to resolve the diseased valve,
instead it alleviated the symptoms.
Address for correspondence: Dr. P. Rajashekar,
Department of Cardiothoracic Surgery, All India Institute of
Medical Sciences, New Delhi, India.
E‑Mail: praja@doctor.com
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DOI:
10.4103/2395-5414.177309 How to cite this article: Rajashekar P. Development of mechanical heart
valves - An inspiring tale. J Pract Cardiovasc Sci 2015;1:289-93.

© 2015 Journal of the Practice of Cardiovascular Sciences | Published by Wolters Kluwer - Medknow 289
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Rajashekhar: History of Prosthetic Valves
Coming of the Caged Ball Valve
Dr Harken working with Mr W. C. Birtwell from Davol Rubber
Company, Rhode Island, started the modern era of prosthetic
valve replacement by the insertion of his double cage‑ball
valve into the aortic orifice below the coronary Ostia following
excision of the diseased cusps. The valve was fabricated with
stainless steel. Dr. Harken was concerned that the ball could
intrude into the aortic wall. Thus, he designed his valve with
a second outer concentric cage. The valve was implanted in
17 patients initially, of which only two could survive. Both
the patients required successive valve replacement, one at
3 years for peri‑valvular leak and another at 22 years for
bacterial endocarditis. The ball valve removed after 22 years
had no deterioration. The Harken’s valve model did not have
the benefit of the “heat curing process.”[3,4]
In the mid‑1960s, another successful valve was introduced,
called as Starr–Edwards Ball Valve[5‑7] ‑ which was actually
an improved version of Hufnagel’s ball‑valve which could
be implanted in the heart after excision of the diseased valve.
A silastic ball with circular sewing wing was used in designing
of the valve was slightly smaller in size and was caged from
both the sides [Figure 1].
Albert Starr, a physician, and Lowell Edwards, an electrical
engineer, simplified the caged‑ball valve using a single
titanium cage, a silastic ball, and a sewing ring covered with
Teflon. The Starr–Edwards valve was first implanted in the
mitral position in 1960, and later in the aortic position. The
valve became commercially available in 1965. In comparison
to Hufnagel’s valve, with the caged‑ball valve, the ease of
implantability was more. It had a sewing ring which made the
process of suturing of valve easy for surgeons. The silastic
ball of the valve had a tendency to absorb liquid which
malformed it or at times resulted in jamming. Moreover,
the obstacle to the laminar blood flow used to cause high
pressure gradients, which was observed more in patients
with a small aortic root.
Figure 1: The beginnings of the Prosthetic valve.
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Further Developments
In the early 1960s, many of the surgeons recognized the
obstacles faced during implant, especially in the placement
of prosthetic valves in the heart. Dr. Magovern Senior Chief
of Cardiothoracic Surgery and Mr. Harry Cromie [Figure 2],
an engineer worked together at the University of Pittsburgh
Medical Center and developed a ball valve. [8] He was
concerned more about the time taken to suture or fix the
valve into the heart and this outlook made him approach
the development of prosthetic valve in a different way.
He designed the valve in a manner that it eradicated the
requirement of suturing for fixation of prosthetic valve. The
procedure was based on mechanical fixation which requires
only a few minutes. The essential feature of this fixation
was the use of multiple curved pins to hold the valve in the
aortic annulus. The valve was for the 1st time implanted in
1962 and was used for many years in both mitral as well as
aortic positions. The production of the valve was stopped in
1980 due to various reasons, although Magovern continued
to implant the valve for the next couple of years. A study by
Dr. Magovern, collected the data of 25 years, which showed
that the valve was used in approximately 4,798 cases. The
data analyzed by them showed that the Magovern‑Cromie
valve was safe, durable, and efficient. The valve‑related
morbidity observed was in the lower expected ranges for
prosthetic aortic valves: Ball variance, 0.3%/patient‑year;
paraprosthetic leak, 0.41%/patient‑year; valve endocarditis,
0.43%/patient‑year; valve thrombosis, 0.04%/patient‑year;
and embolic events, 3.95%/patient‑year. The incidence of
aortic valve reoperation was 0.76%/patient‑year. The 5‑year,
10‑year, and 20‑year probability of survival corrected for
normal mortality was 77%, 64%, and 52% for all discharged
patients.
In 2008, the longest functioning Magovern-Cromie Sutureless
prosthetic aortic valve was reported. The valve was explanted
42 years after implant.
Figure 2: Some of the early valves.
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Rajashekhar: History of Prosthetic Valves
In 1963, Smeloff along with a mechanical engineer at
California State University,[9] Sacramento designed a valve to
employ a “FULL‑FLOW” orifice concept. The valve design
comprised a double set of cages permitting the silicone
elastomer ball to rest on the smaller inflow cage during
valve closure. As the valve was one of its kind, therefore
commercial manufacturing of it was then transferred to
Cutter Laboratories, Berkley California in 1966. In 1989
at the World Congress on Valve replacement, San Diego,
Dr. Smeloff reported that 50,000 Smeloff valves had been
implanted worldwide, with no structural failure for 22 years
of use.
Braunwald[10] developed a flexible polyurethane‑dacron
fabric mitral valve prosthesis with attached Teflon‑tape
chordae tendoneae. The valve was implanted in March, 1960.
Dr. Braunwald observed that the fabric was infiltrated by fibrous
connective tissue and she speculated that applying fabric to the
metal cage of a ball valve might reduce thrombus formation.
Thereafter, she started working with cutter laboratories to
develop a cloth covered caged ball valve. They covered the
struts with a knit dacron tubing and the inflow ring with an
ultrathin polypropylene mesh fabric. The valve was used
clinically from 1968 onwards. Results obtained were good and
low incidence for valve‑related complications were observed.
Approximately 475 valves were implanted. However, after
several years of clinical use cases were reported of fabric
wear and silicone poppet abrasion in aortic valves leading
to poppet escape. Thus, production of the Braunwald‑Cutter
valve ceased in 1979.
Use of Pyrolytic Carbon for the Fabrication of
Prosthetic Heart Valves
Dr Michael DeBakey and Harry Cromie of Surgitool
introduced a ball valve in 1967. In 1969, Dr. Jack Bokros at
the General Atomic Company, LaJolla, California introduced
a new carbon material pyrolytic carbon poppet which replaced
the polyethylene poppet. The pyrolyte ball was intended to
limit ball variance; unfortunately, the relatively hard ball
and soft titanium cage led to strut wear and some instances
of strut fracture. The fabrication of a hollow ball of pyrolytic
carbon (pyrolyte) was a landmark research in mechanical
valve development. It was originally developed for the
encapsulation of nuclear fuel rods, and became over the
next decade, the principal biomaterial for virtually all new
mechanical valves.
Dr Bokros’[11] found that highly polished pyrolytic carbon will
not bond with heparin and in canine in vivo screening tests,
the Bokros material proved to be the most thrombo resistant,
nonheparinized material that they had evaluated. Encouraged
by their findings, Bokros subsequently developed the ball
poppet for the DeBakey–Surgitool valve and the discs and
leaflets for virtually all mechanical valves developed over the
next 30 years.
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Coming of the Nontilting Disc Valves
Kay‑Shiley disc valve
Dr Jerome Kay, Professor of Cardiac Surgery at the University
of Southern California Medical Center, and a valve engineer,
Mr Donald Shiley collaborated together and introduced
the Kay‑Shiley disc valve.[12] It was the first disc valve that
achieved worldwide use beginning in 1965. It was designed
with a low profile. It was a reliable mitral prosthesis that
utilized a stellite housing and a flat silicone elastomer disc.
Unfortunately, there were problems with wear of the silicone
elastomer disc and hence was replaced with a Delrin polymer
disc in 1975. Valve durability was markedly improved with the
Derlin disc. Approximately, 12,000 of these Kay‑Shiley valves
were implanted worldwide at mitral and tricuspid positions.
To prevent the disc impingement by the left ventricular wall,
Dr. Kay modified the standard Kay‑Shiley valve and added a
muscle‑guard onto it. It was used by Dr. Kay primarily, but
was not used worldwide by other surgeons.
Beall–Surgitool disc valve
Following the trend, Dr. Arthur Beall, Baylor college of
Medicine in Houston in collaboration with Mr. Howard
Cromie, Surgitool developed a Teflon disc valve in the mid
1960s.[13] Over a period of 10 years of clinical existence, the
valve was redesigned 5‑time. Post this changes in design of
the valve, almost 5,000 valves were implanted at the mitral
position. In 1985, the production was discontinued due to the
fabric wear on the annular opening.
The Tilting Disc Valve in the 1970s
In the mid‑1970s the tilting disc valve were introduced. These
included the Bjork–Shiley convexo‑concave (BSCC) tilting
disc valve, Lillehei‑Kaster tilting disc valve, Omniscience
tilting disc valve, Omnicarbon tilting disc valve and
Hall‑Kaster and Medtronic‑Hall tilting disc valves [Figure 2].
The very first tilting disc model, i.e.,  BSCC tilting disc was
implanted in 1975.[14‑17] The valve was designed in a manner so that
a large flow through the orifice on the backside of the open disc
could be obtained. Both the stellite housing and concave pyrolyte
disc were used. The inlet and outlet struts were modified such the
disc could make a slide forward and down movement of about
2 mm, thereby achieving the desired enlargement of the valve
orifice. However in a few years of its use, cases were reported
of an inordinate number of fractures at the weld site of the small
c‑shaped outflow strut. Bjork reported the hazard function and
mechanical failure among the series of BSCC heart valves. The
trend was observed for almost 7‑year follow‑up period. The 7‑year
actuarial incidence of mechanical failure among these valves was
found to be 12.5% and many of the patients with these valves was
considered for prophylactic replacement.
Hall‑Kaster and Medtronic‑Hall tilting disc valves
Dr.  Kari Victor Hall, Chairman, Department of Surgery,
Rikshospitalet, Oslo, Norway and Robert Kaster developed
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Rajashekhar: History of Prosthetic Valves

the Hall‑Kaster valve which was used in 1977 for the 1st time.
The design of the valve, comprised a unique tilting prolyte
disc with a small central perforation for a thin metal strut
that guides the disc during opening and closing of the valve.
It was widely used throughout the world. In 1987 minimal
mechanical engineering changes were done in the design of
the valve. The manufacturing and distribution of the valve
was taken over by Medtronic. More than 300,000 Hall‑Kaster
and Medtronic‑Hall valves have been used worldwide with no
reports of structural failure.[18‑22]
Bileaflet Valves
Just after the era of tilting disc models, the bileaflet heart valve
model was introduced in 1979. The valves usually consist of
two semicircular leaflets that rotate about struts attached to
the valve housing.[23‑25]
The bileaflet model had advantages over earlier models. The
design of the valve was such that it resulted in a greater effective
orifice area (2.4–3.2 cm2). They were the least thrombogenic
valves in comparison to other prosthetic valves. The types of
bileaflet valves developed were Gott‑Dagette bileaflet valve,
Kalke–Lillehei bileaflet valve, St. Jude Medical bileaflet valve
and Carbomedics bileaflet valve [Figure 3].
The Gott‑Daggett bileaflet valve was the very first model of
bileaflet design and was introduced in the late 1960s. It was
implanted in approximately 500 patients at both mitral and
aortic positions. The clinical outcome was relatively good.
Despite of bileaflet design, the valve had one disadvantage.
A relatively stagnant blood flow in the area of the superstrut
used to capture the flexible leaflets, was observed. This area
was occasionally the site of thrombus; however, no clinical
episodes of thromboembolism were reported. For this reason,
the valve was withdrawn from the market in 1966; the patients
who were implanted with this valve were followed for more
than 25 years. No deterioration of the flexible silicone‑coated
Teflon leaflets were reported during this period or even
later on.
St. Jude Medical Bileaflet Valve
The St. Jude Medical bileaflet valve was implanted in 1977
for the 1st time. Mr. Manny Villafana, founder of Cardiac
Pacemaker St. Jude Medical was the implementer for the
development of St. Jude Medical bilefalet valve. The valve was
primarily designed by an individual engineer Xinon (Chris)
Posis, and he took suggestions from the cardiovascular surgeon
Dr. Demetre Nicoloff, University of Minnesota. Furthermore,
both of them worked together and took suggestions from other
surgeons and fellow engineers. Working with Jack Bokros,
the engineers Posis and Hanson modified the initial pivot
mechanism and came up with the concept of a leaflet‑tab
rotating in a “butterfly recess” in the inner wall of the housing.
Doctor Nicoloff implanted the first St. Jude valve on October 3,
1977. The design of the valve remained unchanged for over a
period of 26 years. Following this, St. Jude Medical introduced
their Regent Valve in 1999 which incorporated a housing
design that significantly improved the orifice size of smaller
aortic prostheses. With more than 1.3 million St. Jude valves
implanted, it is the most widely used prosthetic valve in the
world.
Indian Prosthetic Valve
The TTK Chitra valve was developed in Sri Chitra
Institute [Figure  4] in Trivandrum and first implanted in
December 1990. M. S Valiathan was the surgeon who was the
main force behind the development of the Chitra valve and
the current valve is the 4th generation valve. More than 75000
have been implanted. It is a tilting disc valve.[26] The Chitra
tilting disc valve has an integrally machined cobalt‑based alloy
cage, an ultra‑high molecular‑weight polyethylene disc, and a
polyester suture ring.
Between December 1990 and January 1995, 306 patients
underwent isolated aortic valve replacement ([AVR],
n = 101) or mitral valve replacement ([MVR], n = 205) at
six institutions in India. The early mortality rate was 6.9%
(seven after AVR; 14 after MVR). A total of 285 survivors

Figure 3: The tilting disc valves. Figure 4: Indian prosthetic valve TTK Chitra valve.

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Rajashekhar: History of Prosthetic Valves
was followed up until September 1998; total follow‑up was
1212 patient‑years (pt‑yr) (AVR, 445 pt‑yr; MVR, 767 pt‑yr).
There were 52 late deaths. Thirty‑five deaths were valve‑related.
One AVR patient and 12 MVR patients developed valve
thrombosis, and embolic episodes occurred in 25 patients.
Bleeding events and infectious endocarditis occurred infrequently.
There was no incidence of paravalvular leak or structural
dysfunction of the valve. Actuarial survival rates at 7 years
were 82.4 ± 4.0% for AVR and 65.2 ± 5.0% for MVR. Freedom
from all valve‑related mortality and morbidity at 7 years was
81.5 ± 4.1% after AVR, and 64.2 ± 5.1% after MVR.[27]
Conclusion
Over the last 60 years, a remarkable progress has been achieved
in mechanical valves. There are a number of valve substitutes
available in the market, but none of them are completely
achieving the standards laid by Harken for an ideal valvular
substitute. Two of the six mechanical heart valves currently
available for implantation (the Starr–Edwards ball valve and
the St. Jude Medical bileaflet valve) are virtually unchanged
from the original models implanted. Four other mechanical
valves approved for implantation (Omniscience, Omnicarbon,
Medtronic‑Hall, and Carbomedics valves) have been in use
for more than a decade with essentially no mechanical failure.
Pyrolytic carbon, a compatible and virtually indestructible
biomaterial adapted from the nuclear fuel industry, has enabled
a lot of progress. There will always be room for improvement
in mechanical valves. Eventually, with the right valve design
and the right valve material, it is conceivable that we may
someday have a mechanical valve that does not require lifelong
anticoagulation therapy.
Acknowledgements
Ms Neha Sharma, Clinical Research Associate for collecting
historical material related to the article.
Financial support and sponsorship
Nil.
Conflicts of interest
There are no conflicts of interest.
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