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

STUDY

OBJECTIVE

The purpose of this study was to present the feasibility and potential clinical advantages of Apyx (Escala Medical, Israel), 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 models, 2 porcine specimens, and 3 fresh unembalmed female human cadavers.

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

MEASUREMENTS AND MAIN

RESULTS

Forty-two anchors were inserted into the SSLs on ovine and porcine models and on cadaver SSLs. No abnormalities or malfunctions were noted in the functional performance of the anchors or the retrieval device. Mean pullout force for the ovine animal model was 38.64 ± 2.80 N. Pullout force in the porcine model was found to be in correlation with the values observed in the ovine model. None of the measured forces was below 20 N. Accuracy and safety tests showed good consistency when deploying the Apyx device to the SSL with no damage to surrounding organs in the ovine or the human cadaver model. Histology demonstrated biologic 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 SSLs. Its clinical safety, efficacy, and impact on patient symptoms and quality of life should be further studied.