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 performed with a thermal balloon as defined by serosal temperature elevation and depth of injury.


METHODS
Observational study with histopathologic correlation conducted in ex vivo and in vivo phases.


METHODS
Academic medical center.


METHODS
Twenty patients undergoing total abdominal hysterectomy.


METHODS
Endometrial ablation with a thermal balloon.


METHODS
Serosal temperature elevation and histologic depth of injury.


RESULTS
Ex vivo phase results revealed serosal temperatures remained within a safe physiologic range (<45 degrees C). Greatest depth of myometrial injury in the premenopausal uteri was 5.8 mm over the anterior lower uterine segment. In postmenopausal uterus. the greatest depth of myometrial injury was 3.8 mm in the anterior midline. In vivo phase results revealed mean (+/- SD) peak serosal temperatures of 36.1 +/- 1.6 degrees C. As with the ex vivo phase. histologic examination revealed deep endometrial and superficial myometrial damage to all areas. The greatest depth of myometrial injury occurred in the midfundus at 3.4 mm.


CONCLUSIONS
No patients experienced complications or adverse events secondary to treatment. Results showed that transuterine thermal injury is a highly unlikely scenario. In both phases of this study, histologic examination revealed that temperatures exposed to the endometrial layer were sufficient to cause tissue damage.
Shah
A A
AA
Department of Obstetrics and Gynecology, Wesley Medical Center, University of Kansas School of Medicine, Wichita 67214, USA.
Stabinsky
S A
SA
Klusak
T
T
Bradley
K R
KR
Steege
J F
JF
Grainger
D A
DA
D000328:Adult; D001833:Body Temperature Regulation / Q000502:physiology; D016022:Case-Control Studies; D017115:Catheter Ablation / Q000009:adverse effects*; D002404:Catheterization / Q000009:adverse effects*; D004717:Endometrium; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D006979:Hyperthermia, Induced; D007044:Hysterectomy; D008595:Menorrhagia / Q000628:therapy*; D008875:Middle Aged; D008954:Models, Biological