title: Recommendations for prophylactic removal of heart valve prostheses.
abstract: Should elective, prophylactic reoperation for removal ("recall") of a well-functioning mechanical heart valve, such as a 60 degree or 70 degree Convexo-Concave Bjork-Shiley prosthesis, be recommended to healthy, active patients, to prevent rare catastrophic valve failure (strut fracture)? Making such a recommendation inherently is tough because the risk of strut fracture is low, a heart reoperation is required, and the new replacement device might have problems of its own. The recommendation is made tougher by the lack of multivariable analyses of survival with and without "recall," including patient and manufacturing variables, that would permit desirable selective "recall" on the basis of direct patient-specific predictions and comparisons. We present available informative substitute multivariable equations that are combined to predict patient-specific survival without "recall". We propose that a multivariable equation for first-time valve replacement is an appropriate substitute for predicting the risk of "recall." Using these equations, survival and length of life risks and benefits of "recall", and their degree of uncertainty, are presented for older and younger patients using both realistic, although worst-case, assumptions and ones maximally favorable to "recall." From these analyses we would not at this time, in general, advise "recall" of 60 degrees-70 degrees Convexo-Concave Bjork-Shiley valves. Recommendations for a specific patient would need to be guided by patient-specific comparisons.
authors.affiliation: Department of Surgery, University of Alabama, Birmingham School of Medicine and Medical Center.
authors.forename: E H
authors.initials: EH
authors.lastname: Blackstone
authors.forename: J W
authors.initials: JW
authors.lastname: Kirklin
mesh_terms: D000328:Adult; D000367:Age Factors; D000368:Aged; D005260:Female; D006350:Heart Valve Prosthesis / Q000401:mortality / Q000706:statistics & numerical data; D006801:Humans; D015999:Multivariate Analysis; D011358:Product Surveillance, Postmarketing; D016016:Proportional Hazards Models; D011474:Prosthesis Design; D011475:Prosthesis Failure; D012086:Reoperation; D012307:Risk Factors; D016019:Survival Analysis; D013997:Time Factors