Short-term Surgical Outcomes and of Sacrospinous Ligament Suspension Using APYX

Objectives: Apical suspension is a major component of any surgery addressing uterine or vaginal vault prolapse. Primary native tissue methods to suspend the vaginal apex include sacrospinous ligament (SSL) fixation and uterosacral ligament suspension. Sacrospinous ligament fixation is an extraperitoneal procedure during which dissection to the SSL is performed which may cause bleeding and pain. The Apyx™ device (Escala Medical, Israel) offers a novel anchoring system to the SSL which enables surgeons to deploy the anchor within the SSL without performing the standard dissection used in other anchoring systems or use it in a traditional fashion with incision and dissection to ligament. This study aims to evaluate the short-term feasibility and safety of apical prolapse repair utilizing the Apyx™ device, showcasing its role as a minimally invasive, incision-free anchoring solution.

Methods: This retrospective observational cohort study was conducted in the division of urogynecology of a tertiary, university affiliated hospital. The cohort included patients who underwent apical prolapse repair using the Apyx™ device from January 2023 to March 2024. Comprehensive patient data—encompassing demographics, pre-, intra-, and postoperative information—were retrieved from electronic medical records. The primary endpoint of the study was incidence of postoperative complications within the first 30 days following surgery. Continuous variables are presented using means and standard deviations, while categorical variables are described through counts and percentages.

Results: A total of 28 patients, with an average age of 69.9 ± 11.2 years, underwent apical prolapse repair utilizing the Apyx™ device. Of these, 21.4% (6 patients) had a prior hysterectomy, and 14.3% (4 patients) had previously undergone abdominal surgery. The majority, 85.7% (24 patients), received bilateral anchor placement, while the remaining 14.3% (4 patients) had a unilateral procedure. Thirteen patients (46.4%) underwent Incision-free apical suspension. During the procedure, suture breakage occurred in one patient. On average, 2.6 ± 0.9 anchors were utilized per patient, with a distribution of 1.5 ± 0.6 anchors on the right and 1.2 ± 0.6 anchors on the left SSL. Additionally, concomitant repairs were as follows: 96.4% (27 patients) underwent anterior repair and 75% (21 patients) had posterior repair. Postoperative urinary retention was reported in 33.3% (9 patients) of the cohort. One patient required reoperation due to pelvic pain, during which bilateral anchors were removed.

Conclusions: The initial findings of this observational study suggest that performing sacrospinous ligament suspension using the Apyx device is feasible and safe. Future studies focusing on clinical and anatomical outcomes following the procedure are already underway and will shed light on efficacy and clinical utility of this novel procedure.