MEASUREMENT OF SEROSAL TEMPERATURES AND DEPTH OF THERMAL-INJURY GENERATED BY THERMAL BALLOON ENDOMETRIAL ABLATION IN EX-VIVO AND IN-VIVO MODELS

Objective: To evaluate the safety profile of endometrial ablation perf ormed with a thermal balloon as defined by serosal temperature elevati on and depth of injury. Design: Observational study with histopatholog ic correlation conducted in ex vivo and in vivo phases. Setting: Acade mic medical center. Patient(s): Twenty patients undergoing total abdom inal hysterectomy. Intervention(s): Endometrial ablation with a therma l balloon. Main Outcome Measure(s): Serosal temperature elevation and histologic depth of injury. Result(s): Ex vivo phase results revealed serosal temperatures remained within a safe physiologic range (<45 deg rees C). Greatest depth of myometrial injury in the premenopausal uter i was 5.8 mm over the anterior lower uterine segment. In postmenopausa l uterus, the greatest depth of myometrial injury was 3.8 mm in the an terior midline. In vivo phase results revealed mean (+/- SD) peak sero sal temperatures of 36.1 +/- 1.6 degrees C. As with the ex vivo phase, histologic examination revealed deep endometrial and superficial myom etrial damage to all areas. The greatest depth of myometrial injury oc curred in the midfundus at 3.4 mm. Conclusion(s): No patients experien ced complications or adverse events secondary to treatment. Results sh owed that transuterine thermal injury is a highly unlikely scenario. I n both phases of this study, histologic examination revealed that temp eratures exposed to the endometrial layer were sufficient to cause tis sue damage. (Fertil Steril(R) 1998;70:692-7. (C) 1998 by American Soci ety for Reproductive Medicine.).