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Starr-Edwards Aortic Heart Valve, Model 1000 (Edwards Laboratories)

Health Sciences · Temerty Faculty of Medicine

A small (~2.9 cm tall) artifact consisting of a circular ring-like base covered in a white fabric (knitted Teflon) sewing ring to which is attached a metal cage containing a yellow-white translucent silicone ball. This cage consists of three struts that join above the sphere, enclosing it.

Accession Number: 2020.med.12

Alternative Name:

Primary Materials:

Metal ( Stellite, a cobalt-chromium-molybdenum-nickel alloy) , Plastic (Dow Corning heat cured “Silastic” silicone), Textile (Teflon).

Markings:

Dimensions (cm): Height = 2.9, Max diameter = 2.9.

Function:

The Starr-Edwards heart valve was an early replacement heart valve introduced in 1960. Replacement heart valves are surgically implanted in place of damaged or diseased heart valves that cannot be repaired. The valve is sutured to the heart valve annulus using the fabric sewing ring.

The Starr-Edwards heart valve was a caged ball design, in which blood flow causes a captive ball to alternately descend to the ring, closing the valve, or ascend to the roof of the cage, opening it. The valve was produced in both aortic and mitral versions.

The Starr-Edwards design proved a successful technology that endured for many decades. This is an early aortic version of the valve (model 1000), identifiable by the three small “feet” that extend into the orifice.


A Starr-Edwards mitral heart valve is stitched into place using silk tread. Detail of a medical illustration by Clarice Ashworth Francone (1901-1981). (Starr and Edwards 1961, 732)

Condition:

The artifact is intact and complete. Both the fabric cover and the spherical ball are dirty and slightly discoloured, likely if from repeated handling

Associated Instruments:

2020.med.15 is a slightly later version of Starr-Edwards Aortic Valve. 2020.med.18 is a Starr-Edwards Mitral Heart Valve.

Manufacturer:

Edwards Laboratories Inc. Santa Ana, California, USA.

Date of Manufacture: c. 1960s

Provenance:

This artifact belongs to a small collection of items related to cardiac surgery that was collected by Dr. Wilfred Gordon “Bill” Bigelow (1913 – 2005). After his death, the collection was donated to the Cardiovascular Sciences Collaborative Program of the University of Toronto, where it is currently on display.

Additional Information and References:

Edward Shorter, Hugh E Scully, and Bernard S Goldman (2022). The Heartbeat of Innovation : A History of Cardiac Surgery at the Toronto General Hospital. University of Toronto Press.

Andrea De Martino, Aldo D Milano, Mila Della Barbera, Gaetano Thiene, and Uberto Bortolotti (2022). “The Caged-Ball Prosthesis 60 Years Later: A Historical Review of a Cardiac Surgery Milestone.Texas Heart Institute Journal (United States) 49(2).

Andrea De Martino, Aldo D Milano, Gaetano Thiene, and Uberto Bortolotti (2020). “Diamond Anniversary of Mechanical Cardiac Valve Prostheses: A Tale of Cages, Balls, and Discs. The Annals of Thoracic Surgery 110(4): 1427–33.

Elliot L. Chaikof (2007). “The Development of Prosthetic Heart Valves — Lessons in Form and Function.The New England Journal of Medicine 357(14): 1368–71.

Oliver L. Gödje, Teddy Fischlein, Klaus Adelhard, Georg Nollert, Werner Klinner, and Bruno Reichart (1997). “Thirty-Year Results of Starr-Edwards Prostheses in the Aortic and Mitral Position.” The Annals of Thoracic Surgery 63(3): 613–19.

Albert Starr and M. Lowell Edwards (1961). “Mitral Replacement: Clinical Experience with a Ball-Valve Prosthesis.Annals of Surgery 154(4): 726–40.

Historical Notes:

The Starr-Edwards artificial heart valve is named after its inventors, cardiovascular surgeon Dr. Albert Starr (1926 – 2024) and engineer Miles “Lowell” Edwards (1898 – 1982), both based in Oregon, USA. The valve was an early and highly successful valvular replacement that emerged following the introduction of cardiopulmonary bypass in 1953. (The first prosthetic heart valve, the Hufnagel valve introduced in 1952, supplemented the patient’s heart valve.)

After refining the design over a series of canine experiments, the first Starr-Edwards replacement mitral valve was first implanted by Albert Starr in August of 1960. This was the first mitral valve replacement, though the patient later died of an air embolism. (See Starr and Edwards 1961, 734)

Over subsequent decades, roughly 175,000 Starr-Edwards heart valves were implanted before production ended in the early 2000s (De Martino,et al 2022, 216). Both the aortic and mitral versions of the device were modified and improved over this period. Various material issues were resolved, but some limitations were inherent to the design. For instance, the ball valve design produced turbulent flow compared to the natural leaflet valve. The ring of the valve likewise introduced a restriction to the flow. Later valves, such as the Björk–Shiley tilting-dish design, produced a more natural flow in order to reduce the likelihood of thrombus formation (Chaikof 2007, 1369).

Use of the Starr-Edwards Valve at Toronto General

Under Dr. Wilfred Gordon Bigelow, Head of the Cardiovascular Surgery Division at Toronto General Hospital, Dr. Ronald Baird (1930 – 2017) installed the first Starr-Edwards aortic valves beginning in 1962. Bard was responsible for all such aortic valve replacements. These had a much higher success rate than the earlier replacement valve leaflets. The first mitral Starr-Edwards mitral valve was implanted in 1963. (See Shorter, Scully and Goldman 2022, 181-182 for a detailed account from Dr. Hugh E. Scully of the early Starr-Edwards valves and their limitations.)

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