Academic journal article The Hastings Center Report

New Research on Bjork-Shiley C/C Artificial Heart Valves

Academic journal article The Hastings Center Report

New Research on Bjork-Shiley C/C Artificial Heart Valves

Article excerpt

A study of a small number of Bjork-Shiley valve implants indicates a significantly higher strut fracture rate than previously expected. This surprising and disturbing development was reported recently by Dutch researchers (B. de Mol et al., "Single Leg Strut Fractures in Explanted Bjork-Shiley Valves," Lancet 343 [1 Jan. 1994]: 9-12). Twenty-two patients elected to have their Bjork-Shiley valves explanted because epidemiological data (age, size of valve, opening angle, and position) indicated they were at risk for strut fracture. In some patients there were additional indications for reoperation, such as the presence of moderate cardiac impairment or other cardiac complaints unrelated to the valve. There was no diagnostic or clinical indication in any patient to suggest a valve defect. Because only the epidemiological data indicating higher risk were used to select patients, the authors claim that they have a small but unbiased sample.

The results of the study of these twenty-four valves is breathtaking. Seven of them (29%) had single-leg fractures: one leg of the outlet strut had already broken. Two others showed characteristics of incipient fatigue failure (one was already cracked; the other showed intrusions and extrusions). …

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