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J Minim Invasive Gynecol. 2019 Jul 10. pii: S1553-4650(19)30307-3. doi: 10.1016/j.jmig.2019.07.005. [Epub ahead of print]

A Novel Incision-free Device for Transvaginal Apical Pelvic Organ Prolapse Repair.

Author information

1
Bruce and Ruth Rappaport Faculty of Medicine, Technion-Israel Institute of Technology, Haifa, Israel.
2
Division of Urogynecology, NorthShore University Healthsystem, University of Chicago Pritzker School of Medicine, Skokie, IL USA.
3
Division of Female Pelvic Medicine and Reconstructive Surgery, Department of Obstetrics and Gynecology, Hadassah - Hebrew University Medical Center, Ein Kerem, Jerusalem, Israel.
4
Department of Urology, Weill Medical College of Cornell University, New York, NY USA.
5
Division of Female Pelvic Medicine and Reconstructive Surgery, Department of Obstetrics and Gynecology, Hadassah - Hebrew University Medical Center, Ein Kerem, Jerusalem, Israel. Electronic address: dshveiky@hadassah.org.il.

Abstract

STUDY OBJECTIVE:

The purpose of this study was to present the feasibility and potential clinical advantages of Apyx, a minimally invasive incision-free anchoring device, for apical prolapse repair.

DESIGN:

An experimental prospective animal and cadaver study.

SETTING:

Animal facility and a cadaver laboratory of a tertiary care teaching hospital.

PATIENTS:

Included in this study were 7 ovine, 2 porcine specimens and 3 fresh unembalmed female human cadavers.

INTERVENTIONS:

The Apyx device for sacrospinous ligament suspension was tested on ovine and porcine models. Pullout force needed to detach the Apyx anchor from the sacrospinous ligament was measured. Safety, reliability, and feasibility of this new incision free procedure were also tested on ovine model and on human cadavers. The precision in deployment of the Apyx device to the sacrospinous ligament was tested via palpation by the surgeon, tissue dissection, and X-ray imaging. The efficacy was tested both by pullout forces and histological analysis of the vaginal attachment to the sacrospinous ligament.

MEASUREMENTS AND MAIN RESULTS:

Forty-two anchors were inserted into the sacrospinous ligaments on ovine and porcine models as well as on cadaver sacrospinous ligaments. No abnormalities or malfunctions were noted in the functional performance of the anchors or the retrieval device. Mean pull-out force for the ovine animal model was 38.64N ±2.80. Pull-out force in the porcine model was found to be in correlation with the values observed in the ovine model. None of the measured forces were below 20 N. Accuracy and safety tests showed good consistency when deploying the Apyx device to the sacrospinous ligament with no damage to surrounding organs in the ovine as well as in the human cadaver model. Histology demonstrated biological adhesion characterized by a gross assessment of a newly formed, firm fibrotic tissue 12 weeks after anchor deployment.

CONCLUSION:

The Apyx anchoring system, a novel incision free minimally invasive prolapse repair device, demonstrated an anatomically feasible, easy-to-use procedure for suspending the vaginal apex to the sacrospinous ligaments. Its clinical safety, efficacy, and impact on patient symptoms and quality of life, should be further studied.

KEYWORDS:

Pelvic organ prolapse; minimally invasive; sacrospinous ligament; vaginal vault suspension

PMID:
31301468
DOI:
10.1016/j.jmig.2019.07.005

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