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(Circulation. 2004;109:2092-2096.)
© 2004 American Heart Association, Inc.

Clinical Investigation and Reports

Decision Guidelines for Prophylactic Replacement of Björk-Shiley Convexo-Concave Heart Valves

Impact on Clinical Practice

From the Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, (M.J.v.G., Y.v.d.G.), and Center for Clinical Decision Sciences, Department of Public Health, Erasmus Medical Center, Rotterdam (E.W.S.), the Netherlands.

Correspondence to Y. van der Graaf, MD, PhD, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, PO Box 85500, Str. 6.131, 3508 GA Utrecht, The Netherlands. E-mail Y.vanderGraaf{at}jc.azu.nl

Received September 18, 2003; revision received January 22, 2004; accepted February 2, 2004.

Background— Because of risk of outlet strut fracture, prophylactic replacement should be considered for Björk-Shiley convexo-concave (BScc) valve recipients. We assessed the effects of epidemiological and decision-analytic guidelines on actual BScc valve replacement.

Methods and Results— We performed a retrospective cohort study including all 2263 Dutch BScc patients with a mean follow-up of 11.3 years (range, 0 to 23 years). Outcomes were outlet strut fracture, mortality, and BScc valve replacement. For the surviving patients in 1992 (n=1330), we calculated the expected differences in life expectancy (LE) with and without BScc valve replacement according to decision guidelines developed in 1992. Differences in LE were compared with actual replacements. During 8 years of follow-up, there were 494 deaths (40%), and 11 patients had suffered outlet strut fracture. Of 1330 patients, 96 (10%) had undergone BScc valve replacement, particularly in years after introduction of initial and updated guidelines. One hundred seventeen patients (9%) had an estimated gain in LE after BScc valve replacement. These patients were more likely to undergo replacement than patients with an estimated loss of LE (hazard ratio, 6.6; 95% CI, 4.4 to 10; P<0.0001). A loss in LE after reoperation was predicted for 8 of 11 patients who experienced outlet strut fracture after guidelines were available.

Conclusions— Valve replacement for BScc heart valve patients was largely in concordance with guidelines in the Netherlands. Individualized guidelines that are based on high-quality epidemiological data and are updated and implemented rigorously can influence clinical practice in complex decision problems.

Key Words: follow-up studies • prevention • prosthesis • surgery • valves

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