Passive surveillance of heart valve devices: Björk-Shiley outlet strut fracture rates.
The Björk-Shiley Convexo-Concave heart valve has a mechanical failure mode called outlet strut fracture (OSF). Previous analyses have found that the hazard function for OSF is constant over time. This article uses the valve manufacturers implant database to examine the shape of the hazard function over time, employing a previously developed model to impute patient survival times. Decisions about patient management (e.g., elective explant) are based on projecting this risk into the future. An analysis that incorporates the decrement of patients at risk due to death and explant provides estimates of the actual occurrences of OSF over calendar time.
Grunkemeier
G L
GL
Providence Health System, Albert Starr Academic Center for Cardiac Surgery, Portland, Oregon 97225, USA.
Anderson
W N
WN
D000328:Adult; D000367:Age Factors; D000368:Aged; D005260:Female; D006350:Heart Valve Prosthesis; D006801:Humans; D008297:Male; D008875:Middle Aged; D008943:Mitral Valve; D016016:Proportional Hazards Models; D011474:Prosthesis Design; D011475:Prosthesis Failure; D012307:Risk Factors; D015996:Survival Rate; D013997:Time Factors