Thermal Balloon Endometrial Ablation in Patients with Prior Low Transverse Cesarean Section: Safety Analysis and Protocol Description
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Objective: Th purpose of this study was to evaluate the safety of thermal balloon endometrial ablation in patients who had had prior low transverse cesarean section(s) (CS). Design: This is a subanalysis of our previously published prospective, single-arm cohort study on treatment outcomes following Thermachoice III ablations. Time endpoints were 2 weeks, and 3 and 6 months post-ablation. Setting: The study took place in an inner-city community-based group practice. Outcome measures: Outcome measures included incidence of uterine perforation, vesicouterine fistula, or other transmural thermal injury possibly related to defective lower uterine structure. Vesicouterine fistulas were screened for by patient questionnaire. Positive screens were to be confirmed by in-office cystoscopy. Methods: Patients were recruited between November 2006 and November 2007. Prior inclusion/exclusion criteria have been described previously in the literature. The entire cohort was 148 patients. All underwent concurrent office hysteroscopy, dilation and curettage, and Thermachoice III ablation under local paracervical block of dilute mepivacaine. Patients with low transverse CS histories all underwent CS scar measurements pre-ablation. Those with measurements under 10mm underwent thermal balloon catheter placement and insufflations under transabdominal sonographic guidance. The ablation cycle was performed without ultrasound guidance. Results: Forty-one patients had had a history of prior low transverse CS. Mean uterine scar thickness was 12.3mm for the entire CS cohort. Mean thickness decreased as the number of CS increased. No patient had had more than three CS. Three patients had a uterine scar thickness of less than10mm (2 had thickness of 8mm and 1 had thickness of 9mm, in the third CS cohort). No vesicouterine fistulas or uterine perforations were noted in the CS cohort, up to 6 months after the performance of the uterine ablation procedure. Serious adverse events did not differ between the CS cohort and the remainder. Conclusions: Thermal balloon ablation can be accomplished safely in patients with prior CS. No conclusion can be drawn in those with more than three prior CS. Measurement of the CS scar and balloon catheter placement under sonogram guidance may be considered in these patients as a conservative measure to aid in perforation or visceral injury prevention. © 2011, Mary Ann Liebert, Inc.
author list (cited authors)
Chapa, H. O., Sandate, J., Antonetti, A. G., & Bakker, K.