A randomized controlled trial of the efficacy, safety and cost of a single-use myocardial bioptome

A randomized single-blind study was performed comparing a reusable 8 French bioptome with a single-use 7 French bioptome in a consecutive series of 63 myocardial biopsy procedures performed during follow-up of cardiac transplant patients. Safety, efficacy and cost were compared between 30 procedures performed with the single-use bioptome (Group I) and 33 procedures performed with the reusable bioptome (Group II). The two instruments were found equally efficient in obtaining adequate biopsy samples (69% of attempts for both instruments). The average specimen weight was not significantly different (Group I 2.5+/-1.3 mg, Group II 2.7+/-1.1 mg) despite different nominal jaw sizes. There was no significant difference in the incidence of incompletely cut specimens (Group I 13%, Group II 7%) and there were no complications in either group. The cost of the two instruments was, as expected, markedly different with an estimated average per-use cost of $250.00 for the single-use bioptome and $35.89 for the reusable instrument. In this small study, a single-use 7 French myocardial bioptome was found to be an acceptable substitute for the larger, reusable instrument with no decrement in specimen size. The substantial cost differential is noteworthy, although the maintenance required by the reusable instrument can present a formidable challenge.