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Comparative Resection Efficiency of a Hysteroscopic Tissue Removal System: A Prospective Multicenter Bench Study
Jay M Berman1, Sergio Haimovich2, David J Levine3
1Division of General Obstetrics and Gynecology (Dr Berman), Department of Obstetrics and Gynecology, Wayne State University School of Medicine, Gynecology Services, Detroit Medical Center, Harper Hutzel Hospitals, Detroit, Michigan.
Study Objective:
To evaluate the resection efficiency of the Aveta hysteroscopic tissue removal system and compare its performance with three established hysteroscopic morcellation devices using a standardized synthetic fibroid model designed to simulate the mechanical resistance of dense leiomyoma tissue.
Study Design:
Prospective, multicenter comparative bench study with repeated measures in an incomplete blocks design.
Setting:
Simulated hysteroscopic fibroid resections under standardized conditions.
Participants:
Ninety-one Ob/Gyn practicing physicians routinely performing hysteroscopic myomectomy procedures participated in the study.
Interventions:
Simulated hysteroscopic resections using 4 commercially available hysteroscopic tissue removal systems (Aveta Flex, MyoSure Reach, MyoSure XL, and TruClear Dense Tissue Shaver Plus (DTSP)) were performed in a synthetic fibroid analog tissue model with rheologic properties calibrated to simulate the mechanical resistance of highly fibrotic or partially calcified leiomyomas. Resection efficiency was quantified by measuring the mass of fibroid analog removed in g/min.
Measurements And Results:
Ninety-one physicians participated and a total of 220 device observations were included: Aveta Flex (n = 91), MyoSure Reach (n = 56), MyoSure XL (n = 37), and TruClear DTSP (n = 36). Least squares mean resection rates were 0.506 g/min for Aveta Flex, 0.184 g/min for MyoSure Reach, 0.274 g/min for MyoSure XL, and 0.389 g/min for TruClear DTSP. Parametric and nonparametric analyses demonstrated significantly higher resection rates for Aveta Flex compared with MyoSure Reach, MyoSure XL, and TruClear DTSP (mixed-effects model p < .005; Skillings-Mack p < .0001).
Conclusion:
In this prospective, multicenter study using a standardized synthetic fibroid analog model, the Aveta Flex hysteroscopic tissue removal system demonstrated significantly higher resection efficiency compared with established hysteroscopic morcellation devices. Given the importance of procedural efficiency in operative hysteroscopy, particularly within the limitations imposed by fluid deficit thresholds, these findings may have implications for operative duration, likelihood of complete resection, and overall procedural workflow in hysteroscopic myomectomy.
