The Björk-Shiley Convexo-Concave Heart Valve Experience from the Perspective of the Supervisory Panel

Harrison, Donald C.; Ibrahim, Michel A.; Weyman, Arthur E.; Kuller, Lewis H.; Blot, William J.; Miller, David E.

doi:10.1016/j.amjcard.2013.08.020

Cited by 13 publications

(11 citation statements)

References 22 publications

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“…Prime examples of failed devices are the Christiansen hip prosthesis8 and the Björk–Shiley heart valve,9 as well as, recently, silicone breast implants in France 10. The potential legal and financial implications of such failures constitute significant risk for investment.…”

Section: Randd and Materials Failuresmentioning

confidence: 99%

Barriers to medical device innovation

Bergsland

Elle

Fosse

2014

MDER

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The US Food and Drug Administration (FDA) has defined a medical device as a health care product that does not achieve it’s purpose by chemical action or by being metabolized. This means that a vast number of products are considered medical devices. Such devices play an essential role in the practice of medicine. The FDA classifies medical devices in three classes, depending on the risk of the device. Since Class I and II devices have relatively simple requirements for getting to the market, this review will focus on “implantable devices”, which, in general, belong to Class III. The European Union and Canada use a slightly different classification system. While early generations of medical devices were introduced without much testing, either technical or clinical, the process of introducing a Class III medical device from concept to clinical practice has become strongly regulated and requires extensive technological and clinical testing. The modern era of implantable medical devices may be considered to have started in the 1920s with development of artificial hips. The implantable pacemaker was another milestone and pacemakers and cardioverters/defibrillators have since saved millions of lives and created commercial giants in the medical device industry. This review will include some examples of cardiovascular devices. Similar considerations apply to the total implantable device market, although clinical and technological applications obviously vary considerably.

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Section: Randd and Materials Failuresmentioning

confidence: 99%

Barriers to medical device innovation

Bergsland

Elle

Fosse

2014

MDER

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“…These factors require and justify long and detailed recipient follow-up. Key historic examples of the problems encountered in cohorts of heart valves that were identified and understood only after marketing include the Braunwald-Cutter Cloth-Covered heart valve (23), the Bjork-Shiley 60–70° Convexo-Concave heart valve (24, 25), bioprosthetic heart valve calcification (26), the Medtronic Parallel heart valve (27), the Carbomedics Photo-Fix pericardial heart valve (28), and the St. Jude Silzone valve (29, 30). In each case, clinico-pathologic correlations established by careful analysis of clinical data coupled with implant retrieval and pathological specimen evaluation studies were critical in identifying, understanding, and managing the issue.…”

Section: To What Extent Can Preclinical Testing Ensure the Safety Of mentioning

confidence: 99%

Preclinical Assessment of Cardiac Valve Substitutes: Current Status and Considerations for Engineered Tissue Heart Valves

Zhang

Bianco

Schoen

2019

Front. Cardiovasc. Med.

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Tissue engineered heart valve (TEHV) technology may overcome deficiencies of existing available heart valve substitutes. The pathway by which TEHVs will undergo development and regulatory approval has several challenges. In this communication, we review: (1) the regulatory framework for regulation of medical devices in general and substitute heart valves in particular; (2) the special challenges of preclinical testing using animal models for TEHV, emphasizing the International Standards Organization (ISO) guidelines in document 5840; and (3) considerations that suggest a translational roadmap to move TEHV forward from pre-clinical to clinical studies and clinical implementation.

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“…Structural dysfunction in first-generation and initial mechanical valves, such as the Starr-Edwards ball and Björk-Shiley valves, have been reported, although the long-term clinical results of both valves have been excellent [ 26 – 32 ]. The main causes of Starr-Edwards ball valve dysfunction have been ball fracture and cloth wear and tear, leading to valve regurgitation [ 33 , 34 ].…”

Section: Structural Dysfunctionmentioning

confidence: 99%

“…Gunn et al [ 31 ] concluded that the Björk-Shiley valve conferred excellent 30-year survival, was associated with three strut fractures during long-term follow-up, with a freedom from reoperation rate of 91 % at 30 years. Harrison et al [ 32 ] discussed 663 catastrophic failures of the valve among approximately 86,000 patients, and we reported a case of extraction of a worn Björk-Shiley prosthetic valve after 39 years because of the potential risk of structural valve dysfunction [ 35 , 36 ]. The implanted valve was functioning well in our case, but we identified the worn disc during aortic surgery for an acute aortic dissection.…”

Section: Structural Dysfunctionmentioning

confidence: 99%

Valve-related complications after mechanical heart valve implantation

Misawa

2014

Surg Today

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The number of heart valve surgeries is increasing, and 19,164 patients underwent heart valve surgery in Japan in 2011. The early mortality rate has remained stable for more than 10 years. Many patients now survive for many years, with a reported 10-year survival rate of at least 60 %. However, unfavorable complications can occur after valve surgery. Valve-related complications include thromboembolisms, bleeding complications and prosthetic valve endocarditis, followed by structural and nonstructural prosthetic valve dysfunctions. Our review of studies published after 2000 revealed that the rate of all valve-related complications was 0.7–3.5 % per patient-year. Thromboembolisms occur at a rate of approximately 1 % per patient-year, and bleeding complications occur at almost 0.5 % per patient-year. Thromboembolic and hemorrhagic events related to anticoagulant therapy should be considered during life-long follow-up. The occurrence rate of endocarditis reaches 0.5 % per patient-year, with a poor postoperative survival. Structural dysfunctions have been largely overcome, and the nonstructural dysfunction rate is 0.4–1.2 % per patient-year. The nonstructural dysfunctions induced by paravalvular leaks and pannus ingrowth are also issues that need to be resolved.

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The Björk-Shiley Convexo-Concave Heart Valve Experience from the Perspective of the Supervisory Panel

Cited by 13 publications

References 22 publications

Barriers to medical device innovation

Barriers to medical device innovation

Preclinical Assessment of Cardiac Valve Substitutes: Current Status and Considerations for Engineered Tissue Heart Valves

Valve-related complications after mechanical heart valve implantation

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