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- W2327367078 abstract "OBJECTIVES: To determine the efficacy and perioperative complications in the use of Pinnacle® Pelvic Floor Repair Kit (Boston Scientific, Natick, MA) in the correction of anterior and apical pelvic floor defects. MATERIALS AND METHODS: This is a single center, retrospective study of 43 patients who underwent the Pinnacle® Anterior/Apical procedure from February 2008 through June 2009. The procedure involved transvaginal placement of Type I, monofilament, polypropylene mesh. The four mesh arms were anchored in a tension-free fashion with a Capio® Suture Capture Device to the sacrospinous ligaments and the proximal white line on each side. Preoperative assessment included a history and physical, POP-Q staging and urodynamics. At 6 weeks, 6 months and 1 year postoperatively assessment included POP-Q staging and evaluation for complications. Data are reported as proportions, means (±SD), or medians and interquartile range (IQR), as appropriate. The paired t test was used to compare pre- and post-operative measurements. RESULTS: The mean follow-up was 7.2 (range: 1.0–18.5) months. The mean age and BMI were 65.3 (±10.2) years and 28.3 (±3.8) kg/m2, respectively, while the median parity was 3.0 (IQR: 2.0). All patients had stage II (51.2%) or stage III (48.8%) prolapse with mean points Aa, Ba and C of +1.1 (±1.5), +1.7 (±2.0) and −1.8 (±2.7), respectively. Sixteen (37.2%) patients had a prior hysterectomy and 9 (20.9%) had a history of surgical prolapse repair. Concomitant procedures included 35 (81.4%) suburethral slings (28 transobturator, 3 retropubic and 4 mini-slings), 2 (4.7%) hysterectomies, 25 (58.1%) perineorrhaphies and 5 (11.6%) posterior repairs. Mean operating time was 102.5 (±37.4) minutes and median length of stay was 1.0 (IQR: 0.0) day. At the last follow-up visit, points Aa, Ba and C were −2.4 (±0.8) −2.4 (±0.8) and −6.7 (±1.7), all of which improved significantly (P < 0.0001 for each). Intra-operative complications consisted of 5 (11.6%) patients with estimated blood loss greater than 500 cc (median blood loss was 100 (IQR: 150.0) cc), two of which required embolization and blood products. Mesh exposure was noted in 12 patients (27.9%): 5 (11.6%) resolved with topical estrogen, 6 (14.0%) needed minor surgical revision and 1 (2.3%) persisted but was asymptomatic. Other post-operative complications included hematoma formation in 6 (14.0%), granulation tissue in 5 (11.6%), de novo stress urinary incontinence in 3 (7.0%), de novo overactive bladder in 3 (7.0%), buttock pain in 2 (4.7%) and urinary retention in 3 (7.0%) patients. CONCLUSION: The Pinnacle® procedure is comparable to other mesh kits; however, no blind trocar passes are needed through the transobturator or ischiorectal spaces. Excellent apical support was demonstrated in this cohort and appears to be due to improved superior mesh attachment to the sacrospinous ligaments, whereas other anterior mesh kits utilize the proximal white line for apical support. The mesh exposure rate in our patients is concerning, although the characteristics of the mesh utilized in this kit are similar to other prolapse mesh kits. Longer-term follow up and corroborative studies are needed." @default.
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- W2327367078 date "2010-03-01" @default.
- W2327367078 modified "2023-09-25" @default.
- W2327367078 title "Oral Poster 9" @default.
- W2327367078 doi "https://doi.org/10.1097/01.spv.0000370790.34702.75" @default.
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