Long-term mesh exposure after minimally invasive total hysterectomy and sacrocolpopexy.

INTRODUCTION AND HYPOTHESIS: The objective was to evaluate total and incident mesh exposure rates at least 2 years after minimally invasive total hysterectomy and sacrocolpopexy. Secondary aims were to evaluate surgical success and late adverse events. METHODS: This extension study included women previously enrolled in the multicenter randomized trial of permanent vs delayed-absorbable suture with lightweight mesh for > stage II uterovaginal prolapse. Owing to COVID-19, women were given the option of an in-person (questionnaires and examination) or telephone visit (questionnaires only). The primary outcome was total and incident suture or mesh exposure, or symptoms suggestive of mesh exposure in women without an examination. Secondary outcomes were surgical success, which was defined as no subjective bulge, no prolapse beyond the hymen, and no pelvic organ prolapse retreatment, and adverse events. RESULTS: A total of 182 out of 200 previously randomized participants were eligible for inclusion, of whom 106 (58%) women (78 in-person and 28 via questionnaire only) agreed to the extension study. At a mean of 3.9 years post-surgery, the rate of mesh or suture exposure was 7.7% (14 out of 182) of whom only 2 were incident cases reported after 1-year follow-up. None reported vaginal bleeding or discharge, dyspareunia, or penile dyspareunia. Surgical success was 93 out of 106 (87.7%): 13 out of 94 (13.8%) failed by bulge symptoms, 2 out of 78 (2.6%) by prolapse beyond the hymen, 1 out of 85 (1.2%) by retreatment with pessary, and 0 by retreatment with surgery. There were no serious adverse events. CONCLUSIONS: The rate of incident mesh exposure between 1 and 3.9 years post-surgery was low, success rates remained high, and there were no delayed serious adverse events.

E-PACT: EXTENSION TRIAL OF PERMANENT VERSUS DELAYED-ABSORBABLE MONOFILAMENT SUTURE FOR VAGINAL GRAFT ATTACHMENT DURING MINIMALLYINVASIVE TOTAL HYSTERECTOMYAND SACROCOLPOPEXY

Introduction: We previously reported a 6.1% rate of mesh/permanent suture exposure at 1 year after minimally-invasive total hysterectomy and sacrocolpopexy (TLH + SCP) with a light-weight polypropylene mesh. Vaginal mesh exposures may increase over time. Objective: The goal of this extension study was to evaluate total and incident mesh/permanent suture exposure rates at least 2 years after surgery. Our secondary aims were to evaluate surgical success and late adverse events. Methods: This extension study included women previously enrolled in the multicenter randomized trial of permanent (2-0 GoreTex) vs delayed-absorbable (2-0 PDS) suture with Upsylon™ mesh during TLH + SCP for > stage II prolapse (POP), for follow-up at least 24 months after surgery. Due to COVID-19, women were given the option of an in-person (symptoms + exam) or telephone visit (symptoms only). The primary outcome was total and incident permanent suture or mesh exposure, or symptoms suggestive of mesh exposure in women without a pelvic examination (vaginal bleeding, bothersome discharge, partner feeling mesh). Women who did not enter the extension trial but were confirmed to have mesh exposure at 1 year were carried forward as a mesh exposure. Secondary outcomes were: 1) Surgical success, which was defined as no subjective bulge on PFDI questionnaire, no prolapse beyond the hymen, and no POP retreatment and 2) Adverse events, which were classified according to Dindo grading scale. Results: 182/200 previously randomized participants were eligible for inclusion, of which 106 (58%) women (78 in-person and 28 via questionnaire only) agreed to the extension study. Demographic characteristics are presented in Table 1. At a mean of 3.9 years post-surgery, the rate of mesh/suture exposure was 7.7% (14/182): 5 in-person,1 in the questionnaire only group and 8 cases carried forward from 1-year follow-up. Only 2 were incident cases reported after 1-year follow-up. There were 2 cases of suture exposure in the original cohort at 1 year, and 0 suture exposures in the current group, for a carry forward rate of 1.1% (2/182). There was no significant difference in mean age or follow-up time for women with and without an exam. None reported vaginal bleeding/discharge, dyspareunia, or penile dyspareunia. Mesh/suture exposures were managed as follows: 4 (66.7%) vaginal estrogen, 2 (33.3%) office trimming and 1 (16.7%) vaginal mesh excision surgery. For women without a study visit, there was one reported mesh exposure which was treated with office removal. Surgical success was 93/ 106 (87.7%): 13/94 (13.8%) failed by bulge symptoms, 2/78 (2.6%) by prolapse beyond hymen, 1/85 (1.2%) by retreatment with pessary, and 0 retreatment with surgery. There were 34 (32%) subjects who reported an adverse event. The most common were vaginal atrophy (16), pelvic or vaginal pain (7), dyspareunia (5), UTI (3), vaginal bleeding (3), and vaginal discharge (3). There were no serious adverse events. Conclusions: The rate of incident mesh exposure between 1 and 3.9 years postsurgery was low, success rates remained high, and there were no delayed serious adverse events after TLH + SCP with lightweight polypropylene mesh (Table Presented).

COST ANALYSIS OF MINIMALLY-INVASIVE SACROCOLPOPEXY COMPARED TO NATIVE TISSUE VAGINAL REPAIR IN THE ERA OF ERAS

Introduction: Minimally invasive sacrocolpopexy (SCP) is the gold-standard treatment for patients with apical prolapse and is increasingly used as a primary intervention in women with uterovaginal prolapse. There is a lack of comparative data evaluating costs between SCP versus native tissue vaginal repair in the post-ERAS implementation era. Objective: The primary aim was to determine the cost difference between performing hysterectomy and minimally-invasive sacrocolpopexy as compared to vaginal hysterectomy with native tissue vaginal repair for uterovaginal prolapse. We hypothesized that minimally-invasive sacral colpopexy has a higher cost when compared to native tissue repair but when failure rates of native tissue repair approach 15%, costs equilibrate. Methods: This was a retrospective cohort study at a tertiary care center. The electronic medical record system was queried for women who underwent native tissue vaginal repair or minimally invasive SCP with concomitant hysterectomy for uterovaginal prolapse in calendar year 2021 (post-COVID enhanced recovery after surgery implementation). We excluded all patients who had concomitant colorectal procedures and where billing was not complete or re-imbursement was not received. Hospital charges, direct and indirect costs and operating margin (net revenue minus all costs) were obtained from Strata Jazz and were compared using R statistical program. Net revenue (reimbursement) was directly obtained from the record as the total payment received by the hospital from the payor. Results: A total of 81 women were included, (33 SCP (25 robotic and 8 laparoscopic) versus 48 native tissue). Payor mix included 27% Medicare, 5% medicaid, 61% employer-based and 7% private insurance. Demographic and surgical data is presented in Table 1. The mean total charge per case for services was higher in the SCP group compared to the vaginal repair group ($119,863 vs. $82,205, P < 0.01). Cost of supplies was more in the SCP group ($4429 vs. $2108, P < 0.01), but the cost of operating room time and staff was similar ($7926 vs. $7216, P = 0.06). Controlling for surgeon, age and BMI, the direct and indirect costs were also higher in the SCP group ($13,649 vs. $10,168, P < 0.01 and $5068 vs. $3685, P < 0.01, respectively). Net revenue was lower for the vaginal repair group compared to the SCP group ($14,614 vs. $31,618, P < 0.01). The operating margin was significantly higher in the SCP group ($11,770 vs. $ 517, P < 0.01). Additionally, there were no significant differences in the net revenue between different payors (P = 0.8997). Same-day discharge and EBL were similar among both groups with operative time being higher in the SCP group (204 vs. 161, P < 0.01). Using the means of the direct costs between groups, a re-operation rate of 25.5% would be needed for the native tissue repair costs to equilibrate to the SCP group. From a hospital perspective, due to the low operating margins experienced with native tissue vaginal repair, 227 native tissue vaginal repairs would need to be performed for the same net return as 10 minimally-invasive SCP's. Conclusions: Vaginal hysterectomy with native tissue repair had lower direct and indirect costs compared to minimally-invasive SCP. However, operating margins are significantly higher for SC P due to net revenue received. (Table Presented).

Prolapse surgery: What are the current trends in England?

Objective: Raising concerns regarding safety of synthetic meshes have led to changes in practice (Zacche et al, 2018). In July 2018, a “pause” for vaginal mesh surgery has been introduced by NHS England. Then, the unprecedented challenge of Covid hit the urogynaecology service. We aim to provide an up-to- date report on surgical trends for women with pelvic organ prolapse (POP). Design: We retrospectively analysed data from the public domain Hospital Episode Statistics (HES) database, which contains information from NHS hospitals in England. Method: Surgical interventions are coded using the Office of Population Censuses and Surveys Surgical Operations and Procedures, Fourth Edition (OPCS-4). A report covering a financial year (from April until March) is released every year. We considered numbers for “all procedures”, which have been published since 2013. Results: Overall, annual POP procedures declined from over 30000 (between 2013 and 2017) to a nadir of 8848 (in 2020-2021). Following the vaginal mesh “pause”, admissions for sacrocolpopexy and sacrohysteropexy more than halved, with respective numbers of 1275 and 585 procedures (in 2016-2017) versus 471 and 245 (in 2019-2020). Sacrospinous fixation of vagina reduced to a lesser extent, from approximately 3000 in the years preceding the “pause” to 2630 in 2019-2020. Concomitantly, suspension of the uterus without mesh increased 2-fold, with a peak of 105 in 2018-2019, while there were small numbers (less than 30 per year) for infracoccygeal hysteropexy throughout the study period. Up to 2019-2020, no significant shifts in practice were noted for Manchester repairs and obliterative procedures, with admissions in the order of 200s and 400s, respectively. Of note, we counted nearly 140 vaginal repairs with mesh-augmentation in 2018-2019 and 2019-2020, while there was a negative trend for native tissue repairs. In fact, numbers for anterior and posterior repairs dropped from 9621 and 6000 (in 2017-2018) to 7414 and 4596 (in 2019-2020), respectively. The report for 2020-2021 highlighted an obvious decrease in admissions for all procedures during the Covid pandemic. Compared to the previous year, reduction rates ranged from 49.2% (colpocleisis) to 69.8% (sacrocolpopexy). Conclusions: Despite a “pause” for vaginal mesh surgery, admissions for alternative options including native tissue repairs have dropped. Procedures involving abdominal mesh have markedly decreased in the last few years. Interestingly, surgeons are still offering vaginal repairs with mesh-augmentation. However, we are unable to further comment on whether this was synthetic or biological. These trends may have an impact on the training of future urogynaecologists.