Key result
The Björk-Shiley monostrut prosthesis produced significantly louder sound levels (55.4 dB(A)) than CarboMedics (46.0 dB(A)) and StJude Medical (44.1 dB(A)) prostheses (p<0.0005).
Why the study?
Does the type of mechanical heart valve prosthesis affect sound production and related patient complaints?
RCT (n=166)
Does the type of mechanical heart valve prosthesis affect sound production and related patient complaints?
p-value: p=<0.0005
The Björk-Shiley monostrut mechanical valve produces significantly more noise and results in more patient complaints compared to CarboMedics and StJude Medical valves.
Björk-Shiley monostrut valves warrant caution for noise-related complaints; confirms prosthesis type influences audibility in mechanical valve recipients.
In a randomised study, we investigated the sound production of mechanical heart valve prostheses and the complaints related to this sound. The CarboMedics, Björk-Shiley monostrut and StJude Medical prostheses were compared. A-weighted levels of the pulse-like sound produced by the prosthesis were measured in 25 patients after aortic valve replacement. Additionally, 141 patients, 117 after aortic valve replacement, 20 after mitral valve replacement and 4 after double valve replacement were interviewed. The average sound pulse pressure levels were 46.0 +/- 2.9 dB(A) in the Carbomedics group, 55.4 +/- 1.2 dB(A) in the Björk-Shiley monostrut group and 44.1 +/- 4.4 dB(A) in the StJude Medical group, measured at a distance of 1 cm from the chest. The Björk-Shiley monostrut was louder than the other two prostheses (p less than 0.0005). Twenty (14.2%) of all patients had complaints related to the valve sound such as sleeping disturbances, irritation, nervousness or fear. Significantly more patients with a Björk-Shiley monostrut could hear their valve or had complaints when compared to the other two prostheses. Younger patients and patients with a mitral valve prosthesis could hear their valve more often than older patients or patients after aortic valve replacement. We conclude that sound characteristics and related complaints differ considerably among heart valve prostheses.
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Laurens et al. (1992) conducted an RCT in Mechanical heart valve replacement (n=166). Björk-Shiley monostrut prosthesis vs. CarboMedics and StJude Medical prostheses was evaluated on Average sound pulse pressure levels (p=<0.0005). The Björk-Shiley monostrut prosthesis produced significantly louder sound levels (55.4 dB(A)) than CarboMedics (46.0 dB(A)) and StJude Medical (44.1 dB(A)) prostheses (p<0.0005).
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