Between January 1, 1989, and December 31, 1994, we have treated 122 primary heart recipients with FK 506 (group I) and 121 with cyclosporine (group II). Fifty patients in the cyclosporine (CyA) group received no lympholytic induction (CyA alone) and 71 others received lympholytic induction with either rabbit antithymocyte globulin or OKT3 (CyA+LI). The mean follow-up was longer in the FK 506 group than in the CyA groups (3.2 +/- 1.3 vs 2.3 +/- 1.8 years; p< 0.01). Patient survival did not differ on the basis of the type of immunosuppression used. At 3 months after transplantation, the freedom from rejection in the FK 506 group was higher than that of the CyA-alone group (47% vs 22%, p < 0.01) but similar to that of the CyA+LI group (47% vs 53%). The linearized rejection rate (episodes/100 patient-days) of the FK 506 group (0.09 episodes) was lower (p < 0.05) than that of the CyA-alone group (0.26) and the CyA+LI group (0.13). The requirement for pulsed steroids to treat rejection was less in common in the FK 506 group than in either CyA group. Eighteen patients in the CyA group had refractory rejections; all resolved with FK 506 rescue. Two patients in the FK 506 group had refractory rejection that resolved with total lymphoid irradiation (n=1) and methotrexate therapy (n=1). Patients receiving FK 506 had a lower risk of hypertension and required a lower dose of steroids. Although the mean serum creatinine concentration at 1 year was higher in the FK 506 group, this difference disappeared after 2 years. No patients required discontinuation of FK 506 because of its side effects. Our intermediate-term results indicate that FK 506 compares favorably with CyA as a primary immunosuppressant in heart transplantation.
D uring the last few years, pediatric cardiologists have witnessed a dramatic change in the utilization of the cardiac catheterization laboratory.1-21 Improved noninvasive diagnostic techniques have narrowed indications for diagnostic cardiac catheterizations while the laboratory is now increasingly being used for therapeutic procedures. Recently, numerous catheter techniques, increased numbers of persons and centers using these techniques, and the increased number of lesion types thought to be amenable to catheter therapy have caused concern about the appropriateness of some applications of pediatric therapeutic cardiac catheterization.Compared with diagnostic cardiac catheterization, therapeutic catheter procedures require more time and resources, are costlier and riskier, and demand more technical training and expertise. High levels of skill and expertise are required of the operator who performs the various therapeutic catheterization techniques. These procedures should only be performed in institutions with appropriate facilities, personnel, and programs.22 These considerations, combined with the rapid increase in the number of laboratories and cardiologists performing therapeutic catheterization procedures, cause concerns about hospital and physician credentialing, hospital and physician peer review, and human subjects investigational review. These concerns have prompted this report on the current status of pediatric therapeutic cardiac catheterization and its important new techniques as well as the development of guidelines for specific credentialing and review.
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