This free floating artificial heart valve was the second type of prosthetic designed by pioneering heart surgeon Dr. Charles Hufnagel (1916-1989) and his team at Georgetown University. It was made of polypropylene. The disk initially received a coating of silicone rubber to ensure it did not make a loud noise. The valve could be implanted in the aortic and mitral and tricuspid valves. First clinically used in 1963, many of these early valves were still in use ten years later.
Hufnagel, invented and implanted the first successful artificial heart valve at Georgetown University Hospital in Washington, D.C. He experimented with various materials, but eventually settled on polymethylmethacrylate, a hard, clear plastic more popularly known by the trade name of Plexiglas or Lucite.
This free floating artificial heart valve was the second type of prosthetic designed by pionerring hear surgeon Dr. Charles Hufnagel (1916-1989), and his team at Georgetown University. It was made of polypropylene while the disk initially received a coating of silicone rubber to ensure it did not make a loud noise. The valve could be implanted in the aortic, mitral, and tricuspid valves. First clinically used in 1963, many of these early valves were still in use ten years later.
Hufnagel, invented and implanted the first successful artificial heart valve at Georgetown University Hospital in Washington, D.C. He experimented with various materials, but eventually settled on polymethylmethacrylate, a hard, clear plastic more popularly known by the trade name of Plexiglas or Lucite.
This valve, designed by doctors Gerald Lemole and Denton Cooley, is one of the rarest concept designs for a heart valve. It is not circular like other artificial heart valves, but rather, oval shaped like the mitral valve itself. This artificial valve has a Dacron fabric ring. It is the only valve the donor Manuel “Manny” Villafaña has seen that is not circular. But, for the valve to work well, it has to be big enough in size. The valve needs something to push the blood through, and this design would not work sufficiently. As a result, it was never implanted. The 'disc' has two prongs that have ball shapes at its ends.
Dr. Denton Cooley’s (b. 1920) career parallels the evolution of heart surgery beginning in the 1940s and 1950s. He was an intern for Dr. Alfred Blalock (1899-1964) and Dr. Helen Taussig (1898-1986), the first doctors to surgically correct malformations of the heart by reconstructing the valves (Blalock-Taussig Operation.) Dr. Cooley considered this breakthrough, "the dawn of heart surgery." He received training at Johns Hopkins University School of Medicine in 1944 and started a practice at Baylor College in Houston, TX. He led the team which implanted the first artificial heart in a human in 1969.
Dr. Gerald Lemole, MD (b. 1937) trained in Houston with Dr. Michael DeBakey and Dr. Denton Cooley. In 1968, he was on the team that carried out the first successful heart transplant in the United States. Lemole is also known to play rock music in the operating room. In 1991, he traveled to Beijing, China, to train surgeons in open-heart surgery and give lectures. He served as chief of cardiothoracic surgery at Temple University Hospital and chief of cardiovascular surgery at Medical Center of Delaware, Christiana Hospital.
The manufacturer, Surgitool Inc., was founded by Harry Cromie and Dr. George Magovern creators of the sutureless Magovern-Cromie Valve.
This trileaflet valve which looks similar to a natural human heart valve was developed by Charles Hufnagel, MD. It is coated in hepacone, silicone rubber impregnated with heparin, and is a size 5 with a diameter of 33mm. Hufnagel believed the trileaflet design would prove to be superior to the ball and cage heart valve because it provided better dynamics. The base of the valve was designed to fit the shape of the aorta when implanted. The leaflets or cusps were made of polypropylene and coated with silicone rubber at high pressure. A 1975 study of patients who had received this prostheses determined that the Hufnagel trileaflet valve was not durable enough to withstand constant blood flow. In a majority of cases, patients died due to prosthetic degeneration or thrombosis. Other problems included aortic regurgitation and stenosis. The Hufnagel tri-leaflet valve was distributed by Codman and Shurtleff, Inc. of Randolph, Massachusetts and manufactured by Heyer-Schulte Corporation.
This blue cardboard display of 3, Gerbode-Seager tri-leaflet valves has a yellow label with black print which reads "EARLY AORTIC PROSTHESES". Handwritten beneath it reads "HISTORY ON BACK". The valves are attached to the board with sewing string. From left to right: Silastic Cusps re-enforced with Dacron Mesh, Gold-coated cusps, and Silastic cusps. On the back is handwritten information about the valve and the doctor who used them.
"used by Dr. Frank Gerbode / in San Francisco / Dr. O'Brien (?) worked with Dr. Gerbode / at his --- in 1963 / on this valve. / Gold plated / thromboemboli occurred / + valve had to be / clinically ceased."
Another label reads, "Approx 20 used at Presbyterian Med. Center San Francisco. Most had trhombo-embolytic complications. There are two pin holes on either side of the display indicating at one time it hung for viewing.
Dr. Frank Gerbode (1907-1984) a native Californian took his undergraduate degree from Stanford University, and received his medical degree from Stanford Medical School. He founded the Medical Research Institute and Heart Research Institute at Presbyterian Hospital-Pacific Medical Center, San Francisco. He performed the first successful open heart surgery on the west coast in 1954 at what was then Presbyterian Hospital. He was the head of the Heart Research division at the Research Institute until his death in 1984. See also Gerbode's Modified Buford Rib Spreader accession 1994.0365.01.
This single heart leaflet or cusp was used to replace or supplement a compromised natural leaflet. One, two or three leaflets could be surgically implanted. The leaflets were made of polypropylene mesh and impregnated with silicone rubber. Charles A. Hufnagel, MD, the inventor believed polypropylene leaflets would be a better design solution than the ball and cage model because it provided better dynamics. He acknowledged that only a few of these leaflets worked well, "those leaflets were the only leaflets, I think, that really lasted for any significant length of time." The single leaflets were later used to develop a trileaflet valve which looked similar to a natural human valve.
Dr. Charles Hufnagel, (1916-1989) graduated in 1941 from Harvard Medical School. While a resident at Boston’ Children’s Hospital he worked with pioneer cardiac surgeon Dr. Robert Gross. In 1950 he left the Peter Bent Brigham Hospital in Boston to becoame the Director of Georgetown University Medical Research laboratory. In September 1952, he implanted the first artificial heart valve which consisted of a ball of plastic inside a chambered tube. Hufnagel also made significant contributions to the development of the modern heart-lung machine.
This 34.2mm Beall Surgitool Mitral Valve is a free floating titanium disk held in place by two struts. The titanium base is covered in Dacron velour. The Beall mitral valve was developed by Dr. Arthur C. Beall, Jr. (1929-2002) around 1960. Beall received his medical degree in 1953 from Emory University, and did his residency at Baylor from 1954-1959 under Dr. Michael DeBakey. Beall was inducted into the Michael E. DeBakey Legacy of Leadership honoree.
This is a Cross-Jones non-tilting disc mitral valve developed by Dr. Frederick Cross, MD. It is a size 90 with a lens weight of 2.6463 grams and serial number H-0021-9. Non-tilting valves fell into disuse because of issues such as frequent thromboembolic complications, and the destruction of blood cells known as hemolysis. The Cross-Jones valve was manufactured between 1967 and 1974. It has an open cage composed of three metal struts. The disc is radiolucent silicone rubber with a titanium ring to strengthen the disc and make it radiopaque. Other complications included cocking of the disc, retrograde dislodgement, and disc variance.
The valve was manufactured by Pemco Incorporated and designed by Dr. Frederick Cross of Saint Luke's Hospital in Cleveland, Ohio. In 1956 Cross collaborated with Dr. Earle Kay to build the Kay-Cross oxygenator rotating-disc heart-lung machine. He was director of department of surgery at St. Luke's Hospital in Cleveland, Ohio for more than twenty-six years, and head of thoracic and cardiovascular surgery for thirty-three. He retired in 1988.
Bjork-Shiley artificial heart valves are disc valves with a low profile, high orifice-to-tissue ratios, low embolic rates, and good hemodynamics. The minor orifice would often clog up because of its small opening. These earlier models have a disc made with Delrin polymer, which was later found to be an unsuitable material as it absorbs water and would break down easily. The Delrin was replaced with the more durable pyrolyte. The flat disc valve, when made with pyrolyte, was very successful. There were close to 300,000 implants of Bjork-Shiley valves between 1969 and 1986.
Dr. Viking Bjork (1918-2009), chairman of the Department of Surgery at Karaolinska Institute in Stockholm, Sweden, collaborated with Donald Shiley (1920-2010), a biomedical engineer in California, to develop this tilting disc valve. Shiley graduated from the University of Portland in 1951 and was involved in the design of the Starr-Edwards valve. He founded Shiley Laboratories, Inc., the company which manufactured this valve. Shiley Lab. was bought by Pfizer in 1979.
The Taber-Cutter non-tilting disc valve has a silastic disc and four titanium struts and cage. It is 37.6mm in diameter. It's serial number is 049M. The frame is made of titanium, a single piece to avoid weld marks, and takes an open strut design (to lower the incidence of thrombosis). The sewing ring is made of Teflon and Dacron. The valve remains sealed in a plastic bag. The valve design adopts principles of the Smeloff-Cutter prosthesis by using a full-orifice. The largest size valve that was compatible with the tissue would be used to minimize ventricular obstruction. The valve was tested in calves and dogs and results show that the valve may be advantageous for those with stenosis of the mitral valve. In 1970 the valve had been undergoing accelerated wear testing that equaled 2.5 years of clinical implantation. There was minimal wear and no evidence of cocking.
Dr. Rodman E. Taber completed medical school at the University of Iowa and afterwards served as a captain aboard a hospital ship in the Pacific during World War II. Following residency in thoracic and vascular surgery, he built a prototype heart lung machine, developed techniques used in freeze drying grafts used in vascular surgery and was instrumental in artificial heart valve design. He served as President of the Michigan Society of Thoracic Surgery.
The Gott-Daggett heart valve is a hinged bileaflet prosthesis developed by Dr. Vincent Gott, MD of Johns Hopkins University and Dr. Ronald Daggett, PhD. It has a central cross strut and prongs projecting inwards from base ring. Also called "butterfly valve," it was to be used for both mitral and aortic replacement. It has a very low profile and was first used in August 1964. It is made of polycarbonate plastic impregnated with colloidal graphite. The suture ring is made of Styrofoam, and the leaflet is heavy Teflon mesh impregnated with silicone rubber, or Dacron reinforced silicone rubber. The valve was manufactured by Daggett. Some problems included thromboembolism and hemolysis. Clotting did occur, but extended survival with this prosthesis has been reported.
Dr. Vincent Gott, MD (b. 1926) received his medical degree from Yale University. He then interned at the University of Minnesota Hospital in 1954 with Dr. C. Walton Lillehei.
While a research fellow in Lillehei’s laboratory (1956- 1957) he helped to develop the first practical pacemaker, and observed Lillehei's first cross-circulation case.
Gott trained with Christiaan Barnard of Cape Town and stopped operating at 67 years of age, after having been professor and surgeon at Johns Hopkins. Ronald Daggett (1916-2004) was a professor of Plastic Engineering at the University of Wisconsin, Madison.
In an interview donor Manuel “Manny” Villafaña said "he used principles that were totally against everything we knew about valves. He used plastic, not metal. He took the plastic and he painted it with a brush and paint, black paint made out of carbon. He painted every surface 'cause carbon is less thrombogenic than metal...everything you know about valves is contrary to this one. Then the most amazing thing is that they implanted 432 of these and some of them lasted 25 years."
This stainless steel case contains a set of Magovern-Cromie Sutureless valves. They range from 19 to 20 centimeters long. Each holds a different size valve and poppet (ball), and are numbered 2 through 7. The inserters are used to implant the valve. Once inserted into place the surgeon rotated the handle so that the pins attach themselves to the aorta. The device is then removed and the ball or poppet is placed into the cage.
The Magovern-Cromie valve utilizes an open cage and titanium struts. Later versions used a Dacron sewing ring and silicone rubber poppet with barium sulphate. It often took at least an hour for surgeons to sew a new valve into the heart, which raised the risk of irreparable heart damage and patient death. This inspired Magovern to design something that would save time and patient's lives. He and Cromie collaborated in the latter's suburban Pittsburgh basement to develop a valve that would clamp into place with small teeth. They developed a claw like fixation device that did not require any sewing. The ring has twenty-four upper and twenty-four lower sets of small, curved, pointed metal teeth or hooks. These hooks allowed for rapid fixation when time was critical. Production of these valves ceased in 1980. With sutureless valves, there was an increased risk of leaking and postoperative thromboembolism.
The Magovern-Cromie valve is an example of how several redesigns were needed to eliminate structural flaws and create a viable valve. The original Magovern-Cromie valves were all metal. Gradually over a period of years several changes were adapted. A silastic cuff was added to prevent blood regurgitation. Teflon and later Dacron was used, and the poppet was impregnated with barium sulfate.
Newspaper stories recorded an instance of a Magovern-Cromie Sutureless valve being replaced in a patient after twenty-four years of service.
Dr. George Magovern (1924-2013) was a cardiac surgeon at the University of Pittsburgh School of Medicine. Machinist/engineer Harry Cromie eventually founded Surgitool Incorporated around 1969. Surgitool became one of the leading manufacturers of heart valves in the United States.
Bjork-Shiley artificial heart valves are disc valves with a low profile, high orifice-to-tissue ratios, low embolic rates, and good hemodynamics. The minor orifice would often clog up because of its small opening. These earlier models have a disc made with Delrin polymer, which was later found to be an unsuitable material as it absorbs water and would break down easily. The Delrin was replaced with the more durable pyrolyte. The flat disc valve, when made with pyrolyte, was very successful. There were close to 300,000 implants of Bjork-Shiley valves between 1969 and 1986.
Dr. Viking Bjork (1918-2009), chairman of the Department of Surgery at Karaolinska Institute in Stockholm, Sweden, collaborated with Donald Shiley (1920-2010), a biomedical engineer in California, to develop this tilting disc valve. Shiley graduated from the University of Portland in 1951 and was involved in the design of the Starr-Edwards valve. He founded Shiley Laboratories, Inc., the company which manufactured this valve. Shiley Lab. was bought by Pfizer in 1979.
This interesting looking heart valve is sometimes called the toilet plunger valve with a tethered plunger prosthesis with a double cone-shaped poppet. It was designed by Christiaan Barnard of the University of Cape Town. It was available for implantation between 1961 and early 1970s. In 1967, Barnard led the surgical team that performed the first human-to-human heart transplant. After his residency at the University of Cape Town he came to the United States to receive training from Dr. Walter Lillehei (1918-1999) at the University of Minnesota.
Dr. Barnard (1922-2001) was inspired by the way in which the water tank in a toilets function, and he saw similarities with the human heart. Due to the tiny metal rings which held the 'plunger' in place, clotting occurred. In spite of that, this valve was implanted in humans. In the words of Manny Villafana, "you've gotta understand that there was no answer and everyone was looking for an answer." This is why the valve was used, in spite of thrombosis and thromboembolism. These issues led to its eventual discontinuation.
The Wada-Cutter cardiac valve prosthesis is a hingeless, tilting disc valve. There are two struts which project into the valve orifice, acting as hinges. The titanium inner ring and radiolucent solid Teflon (polyethylene) disc opens to an angle of 75 degrees. It is considered a low profile valve. Problems encountered included early disc wear, massive thrombosis, thromboembolism, paraprosthetic leaks, and poppet embolization. These complications led to valve the being discontinued.
In clinical trials the Wada-Cutter valve was implanted in 106 patients in whom 42 aortic valve replacements, 48 mitral valve replacements, 5 tricuspid valve replacements, and 11 multiple valve replacements were done. It was the first attempt at a tilting disc. A continuous knotless suture technique was invariably employed for fixation of the prosthesis regardless of the type of operation. Postoperatively there were eleven early and seventeen late deaths, a cumulative mortality of 26.4%. Thromboembolic complications occurred in nine patients following valve replacement. These consisted of thrombosed valve in six patients and embolization other than in the heart in three patients. In another study of 150 patients, there was an early mortality rate of 12% (1969). The Wada-Cutter valve was available between 1967 and 1972
The Wada-Cutter valve was developed by Dr. Juro Wada of Sapporo Medical College and Hospital of Sapporo, Japan in conjunction with Cutter Biomedical Corporation.
This is a closed cage, pyrolytic carbon ball valve designed by Dr. Michael DeBakey MD. The three bare titanium struts are coated in pyrolytic carbon. There is a plastic, polyethylene suture ring intended to prevent endothelial cover and avoid diastolic leakage. A major issue with this valve was strut wear. This is due to the hard pyrolytic carbon ball and soft titanium cage constantly hitting one another. It is also relatively noisy. The materials are thromboresistant and electronegative in blood. The perioperative mortality rate for 345 patients was 8.1%. and the five year survival rate was 81%. Dr. DeBakey gave this "original" aortic ball valve to the donor Manny Villafana in 2002.
Dr. Michael E. DeBakey (1908-2008) was chancellor of Baylor College of Medicine, Houston, Texas and director of The Methodist DeBakey Heart & Vascular Center. He earned his degrees from Tulane University and Charity Hospital, and completed a fellowship in France. Harry Cromie was an engineer of Surgitool Incorporated. DeBakey had worked in the past with Dr. Denton Cooley, until a controversy developed between the two of them. Surgitool was founded by Harry Cromie and Dr. George Magovern (the two creators of the sutureless Magovern-Cromie Valve).
Also called the toilet plunger valve because of its remarkable resemblance to the inner workings of a toilet, this valve was designed by Christiaan Barnard of the University of Cape Town, South Africa. This valve had been implanted and eventually explanted. Notice the worn and discolored cloth suture, and the wear of the silicone disc. The valve has a low profile and the principal causes of death with this valve were thromboembolism.
Dr. Barnard (1922-2001) was inspired by the way in which the water tank in a toilet functions, and he saw similarities with the human heart. Due to the tiny metal ring which held the 'plunger' in place, clotting occurred. In spite of that, this valve was implanted in humans. In an interview donor Manny Villafana explained, "you've gotta understand that there was no answer (a workable artificial heart valve) and everyone was looking for an answer." This is why the valve was used, in spite of thrombosis and thromboembolism. These issues led to its eventual discontinuation.
Barnard is best known for the dramatic headline grabbing first human-to-human heart transplant in 1967.
This valve was developed by Dr. Carl Goosen of the University of Cape Town, South Africa. One issue with this valve was its thick orifice. When the orifice is thick, the opening gets smaller. This means less blood will go through, creating more work for the heart. The ball at the top (added to prevent a piece from falling out) is not durable and runs the risk of wearing out and breaking. This valve was never implanted but was tested on animals. Dr. Goosen worked with colleague Dr. Christian Barnard (1922-2001) to design a new heart valve prosthesis.
This Muller-Littlefield Aortic Valve has a tri leaflet design and is 1-34 mm diameter. It is housed in a metal jar with a lid. It made of Teflon cloth with salvaged edges to keep the fabric from fraying. In a study of 23 patients (between 1961 and 1963), it was found that the valves stiffened and the fabeic would tear.
Joshua Bayley Littlefield was a manager and software engineer for the General Computer Company in Cambridge, Massachusetts. He graduated from Massachusetts Institute of Technology. Dr. William Muller Jr. (1920-2012) received his MD degree from Duke University, after which he completed a surgical residency and served as an Instructor of Surgery at The Johns Hopkins Hospital. He joined the faculty at The University of California at Los Angeles as one of its first faculty members to start the new medical school in 1940 and became associate professor of surgery in 1952. He developed the pulmonary artery banding procedure and applied it clinically. He was appointed Professor and Chairman of the Department of Surgery at the University of Virginia in 1954 and over the ensuing several years developed one of the first complete aortic valve prostheses.
Dr. Marshall Goldin of University Cardiovascular Surgeons at Rush University in Chicago gave the donor Manny Villafaña several heart valves including this Muller-Littlefield Aortic Valve in 2002.