Guillain-Barre syndrome secondary to COVID-19 infection: A case report.

Guillain-Barre syndrome (GBS) is a rare autoimmune disease that often manifests as a post-viral complication. However, its association with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is unclear. We present a rare case of GBS secondary to COVID-19 infection complicated by rapidly progressive sensorimotor deterioration resistant to plasma exchange therapy.

Efficacy and Safety of Advanced Therapies for Moderately to Severely Active Ulcerative Colitis at Induction and Maintenance: An Indirect Treatment Comparison Using Bayesian Network Meta-analysis.

Background: Given rapid innovation in advanced therapies for moderately to severely active ulcerative colitis (UC), we investigated their comparative efficacy and safety during induction and maintenance through network meta-analysis. Methods: Using Bayesian methods, endpoints of clinical remission and clinical response per Full Mayo score, and endoscopic improvement were assessed in bio-naive and -exposed populations. Safety was assessed in overall populations by all adverse events (AEs), serious AEs, discontinuation due to AEs, and serious infections. Phase 3 randomized controlled trials were identified via systematic literature review, including the following advanced therapies: infliximab, adalimumab, vedolizumab, golimumab, tofacitinib, ustekinumab, filgotinib, ozanimod, and upadacitinib. Random effects models were used to address between-study heterogeneity. Intent-to-treat (ITT) efficacy rates were calculated by adjusting maintenance outcomes by likelihood of induction response. Results: Out of 48 trials identified, 23 were included. Across all outcomes and regardless of prior biologic exposure, ITT efficacy rates were highest for upadacitinib, owing to its highest ranking for all efficacy outcomes in induction and for all but clinical remission during maintenance among bio-naive induction responders. For all advanced therapies versus placebo, there were no significant differences in serious AEs or serious infections across therapies. For all AEs, golimumab had higher odds versus placebo during maintenance; for discontinuation due to AEs, upadacitinib had lower odds versus placebo during induction, while ustekinumab and vedolizumab had lower odds versus placebo during maintenance. Conclusions: Upadacitinib may be the most efficacious therapy for moderately to severely active UC based on ITT analyses, with similar safety across advanced therapies.

Non-small cell lung cancer with EGFR exon 20 insertion mutation: a systematic literature review and meta-analysis of patient outcomes.

INTRODUCTION: EGFR exon 20 insertion mutation-positive non-small cell lung cancer (NSCLC) is rare, has a poor prognosis, and outcomes are not fully established. We describe and evaluate outcomes from real-world and clinical evidence in these patients. METHODS: A systematic literature review (SLR) identified interventional and real-world evidence (RWE) studies reporting clinical outcomes for EGFR exon 20 insertion mutation-positive NSCLC. Meta-analyses were conducted by line of therapy to synthesize pooled survival and response outcomes across RWE. Published evidence from interventional studies was summarized individually. RESULTS: The SLR identified 23 RWE and 19 original interventional studies. In the meta-analysis of RWE, pooled response and survival outcomes were low for first-line EGFR-tyrosine kinase inhibitors (TKIs) and immuno-oncology (IO) agents. First-line chemotherapy resulted in a pooled ORR 25.7%, pooled PFS 5.6 months, and pooled OS 18.3 months. Pooled outcomes were further reduced in second or later lines (≥2 L): pooled ORR was 5.0%, 3.3%, and 13.9%; pooled PFS was 2.1 months, 2.3 months, and 4.4 months; and pooled OS was 14.1 months, 8.8 months, and 17.1 months (not a pooled result) for EGFR-TKIs, IO agents, and chemotherapy, respectively. Interventional studies reported outcomes for TKIs (mobocertinib, poziotinib, osimertinib, afatinib, CLN-081, DZD9008), a monoclonal antibody (amivantamab), and a heat shock protein 90 inhibitor (luminespib). While there is limited RWE for the recently approved agents mobocertinib and amivantamab, which specifically target exon 20 insertion mutations, interventional evidence supports their potential as effective treatment options. CONCLUSIONS: Conventional treatments used in patients with EGFR exon 20 insertion mutation-positive NSCLC have limited efficacy, though chemotherapy appeared to be associated with better response and survival outcomes than non-exon 20 targeting EGFR-TKIs and IO agents. This supports the need to identify EGFR exon 20 insertion mutations as the availability of new targeted treatments may offer additional therapeutic options to these patients.

Treatment Outcomes of High-Risk Non-Muscle Invasive Bladder Cancer (HR-NMIBC) in Real-World Evidence (RWE) Studies: Systematic Literature Review (SLR).

BACKGROUND: To date, there has been limited synthesis of RWE studies in high-risk non-muscle invasive bladder cancer (HR-NMIBC). The objective of this research was to conduct a systematic review of published real-world evidence to better understand the real-world burden and treatment patterns in HR-NMIBC. METHODS: An SLR was conducted following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines with the scope defined by the Population, Intervention Comparators, Outcomes, and Study design (PICOS) criteria. EMBASE, MEDLINE, and Cochrane databases (Jan 2015-Jul 2020) were searched, and relevant congress abstracts (Jan 2018-Jul 2020) identified. The final analysis only included studies that enrolled ≥100 patients with HR-NMIBC from the US, Europe, Canada, and Australia. RESULTS: The SLR identified 634 RWE publications in NMIBC, of which 160 studies reported data in HR-NMIBC. The average age of patients in the studies was 71 years, and 79% were males. The rates of BCG intravesical instillations ranged from 3% to 86% (29-95% for induction and 8-83% for maintenance treatment). Five-year outcomes were 17-89% recurrence-free survival (longest survival in patients completing BCG maintenance), 58-89% progression-free survival, 71-96% cancer-specific survival (lowest survival in BCG-unresponsive patients), and 28-90% overall survival (lowest survival in patients who did not receive BCG or instillation therapy). CONCLUSION: BCG treatment rates and survival outcomes in patients with HR-NMIBC vary in the real world, with better survival seen in patients completing maintenance BCG, responding to treatment, and not progressing to muscle-invasive disease. There is a need to better understand the factors associated with BCG use and discontinuation and for an effective treatment that improves outcomes in HR-NMIBC. Generalization of these results is limited by variations in data collection, reporting, and methodologies used across RWE studies.

A Systematic Literature Review of the Epidemiology, Health-Related Quality of Life Impact, and Economic Burden of Immunoglobulin A Nephropathy.

Introduction: This systematic literature review analyzed published evidence on IgA nephropathy (IgAN), focusing on US epidemiology, health-related quality of life (HRQoL), and economic burden of illness. Methods: Using Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines, Embase®, MEDLINE®, Cochrane, and Econlit (January 2010 to June 2020) were searched, along with relevant congresses (2017-2020). Results: Of 123 epidemiologic studies selected for data extraction, 24 reported IgAN diagnosis rates ranging from 6.3% to 29.7% among adult and pediatric patients undergoing renal biopsy, with all reported US rates <15%. No US studies reported IgAN prevalence. A meta-analysis of US studies calculated an annual incidence of 1.29/100 000 people, translating to an annual US incidence of 4236 adults and children. Relative to Europe, the United States had more patients diagnosed with IgAN in later chronic kidney disease stages. US rates of transition to end-stage renal disease (ESRD) ranged from 12.5% to 23% during 3-3.9 years of observation, rising to 53% during 19 years of observation. Across 8 studies reporting HRQoL, pain and fatigue were the most reported symptoms, and patients consistently ranked kidney function and mortality as the most important treatment outcomes. Patients with glomerulopathy reported worse mental health than healthy controls or hemodialysis patients; proteinuria was significantly associated with poorer HRQoL and depression. Conclusion: While economic evidence in IgAN remains sparse, management of ESRD is a major cost driver. IgAN is a rare disease where disease progression causes increasing patient burden, underscoring the need for therapies that prevent kidney function decline and HRQoL deterioration while reducing mortality.

Humanistic and Economic Burden of Non-Muscle Invasive Bladder Cancer: Results of Two Systematic Literature Reviews.

PURPOSE: Non-muscle invasive bladder cancer (NMIBC) is a malignancy restricted to the inner lining of the bladder. Intravesical Bacillus Calmette-Guerin (BCG) following transurethral resection of the bladder tumor is the mainstay first-line treatment for high-risk NMIBC patients. Two systematic literature reviews (SLRs) were conducted to further assess the current evidence on BCG use in NMIBC and the humanistic and economic burden of disease. METHODS: Using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, Embase® and MEDLINE® were searched using the Ovid platform to identify interventional or real-world evidence studies on the health-related quality of life (HRQoL) and economic burden in NMIBC. Limited evidence was found from initial economic SLR searches in NMIBC, so additional targeted searches for bladder cancer were conducted to expand findings. RESULTS: Fifty-nine publications were included in the HRQoL SLR, of which 23 reported HRQoL and symptoms in NMIBC. At diagnosis, HRQoL was comparable with population norms but worsened considerably 2 years following diagnosis. Maintenance therapy with intravesical BCG was associated with reduced HRQoL, and treatment-related adverse events (AEs) resembled typical NMIBC symptoms. Twenty-two studies reported decreasing BCG compliance over time. Common AEs with BCG were frequent urination, lower urinary tract symptoms, pain, and hematuria. Forty-two publications were included in the economic SLR, of which nine assessed healthcare costs and resource use in NMIBC or bladder cancer. High-risk disease and high-intensity treatment were associated with increased healthcare costs. CONCLUSION: NMIBC has a considerable symptomatic, HRQoL, and economic burden. Symptoms persisted and HRQoL worsened despite intravesical BCG treatment. NMIBC is a costly disease, with higher healthcare costs associated with increased risk of disease progression and recurrence. There is a high unmet need for safe and effective treatments that reduce the risk of disease progression and recurrence, provide symptomatic relief, and improve HRQoL for patients.

Epidemiology and Comorbidities of Excoriation Disorder: A Retrospective Case-Control Study.

Excoriation disorder is a psychocutaneous disorder characterized by repetitive skin-picking and associated with significant morbidity. Currently, epidemiological data in patients with excoriation disorder are lacking so we sought to characterize common patient demographics and comorbidities. We conducted a retrospective case-control study comparing 250 patients with excoriation disorder with 250 age-, race- and sex-matched controls identified between 2007 and 2019 at a single tertiary care center. We found that the majority of excoriation disorder patients were female (76%), Caucasian (82%) and unmarried (62%), with a mean age of 49 years. Compared to the matched controls, patients with excoriation disorder had increased odds of several psychiatric illnesses, including obsessive compulsive disorder (odds ratio (OR) 28.48, 95% confidence interval (CI): 1.68, 481.75), substance use disorder (OR 24.33, 95% CI: 5.81, 101.77), post-traumatic stress disorder (OR 8.23, 95% CI: 2.24, 129.40), depression (OR 8.19, 95% CI: 4.86, 13.80), bipolar disorder (OR 7.55, 95% CI: 2.22, 25.65), attention-deficit/hyperactivity disorder (OR 5.63, 95% CI: 1.62, 19.57), and anxiety (OR 5.01, 95% CI: 2.92, 8.62). Only a minority (42%) of patients were given psychiatry referrals and of those referred, a majority (64%) did not follow-up with psychiatry. The outcomes were also generally unfavorable as only 21% of patients experienced a resolution or improvement in their symptoms. This highlights the need for a multidisciplinary approach to manage patients with excoriation disorder, involving both dermatologists and psychiatrists.

Real-world evidence on clinical outcomes in immune thrombocytopenia treated with thrombopoietin receptor agonists.

Aim: Eltrombopag and romiplostim are US FDA approved for treatment of immune thrombocytopenia in patients with insufficient response to other treatments. Clinical or real-world data comparing outcomes of the two drugs are limited. Methods: This retrospective cross-sectional study sought information on bleeding-related episodes (BREs), adverse events (AEs) and other outcomes of eltrombopag or romiplostim treatment in immune thrombocytopenia. Results: Patients receiving eltrombopag experienced significantly reduced BREs, severe BREs, rescue medication use and platelet transfusions. Diarrhea and headache were significantly less frequent in patients receiving eltrombopag; other AEs occurred equally in both groups. Conclusion: There may be a potential advantage for the use of eltrombopag versus romiplostim in the practice settings studied, based on rates of BREs and AEs and rescue medication utilization.

Diagnostic Workup and Evaluation of Patients with Prurigo Nodularis.

Prurigo nodularis (PN) is a chronic inflammatory skin disease characterized oftentimes by symmetrically distributed, severely pruritic nodules. Currently, the pathophysiology of PN remains to be fully elucidated, but emerging evidence suggests that neuroimmune alterations play principal roles in the pathogenesis of PN. There are several associated etiologic factors thought to be associated with PN, including dermatoses, systemic, infectious, psychiatric, and neurologic conditions. We conducted a systematic literature review to evaluate the clinical presentation, diagnosis, and etiologic factors of PN. In this review, we discuss common differential diagnoses of PN and recommend an evidence-based, standardized diagnostic evaluation for those with suspected PN.

Interview date trends for dermatology residency from 2012-2017.

Data regarding dermatology residency interview patterns can better inform applicants regarding the application process as well as encourage further coordination among programs. Our objective was to describe dermatology residency interview date patterns over the past five applications cycles from 2012 to 2017. A retrospective review of dermatology online forums (the Dermatology Interest Group Association and Student Doctor Network) was performed from 2012 to 2017; these web-based public databases were reviewed for interview dates and interview offer dates. Data from 117 programs per year were obtained. The majority of interview offers arrived in early November (41.5%), followed by late November (40%). Interviews were conducted predominantly in December (25.7%) and January (66.3%). On average, programs scheduled 2.26 (range 1-13) interview dates. Most interviews were held on Thursday (23.9%) and Friday (28.7%). Our results suggest that there is an increasing trend of overlapping interview dates among programs. Being cognizant of dermatology residency interview date patterns can help prepare applicants for interview scheduling while avoiding scheduling conflicts.

Health-related quality of life in acute myeloid leukemia patients not eligible for intensive chemotherapy: results of a systematic literature review.

BACKGROUND: AML is a rapidly progressing bone marrow cancer, with poor survival rates compared to other types of leukemia. IC and NIC as well as BSC treatment options are available; however, there is scant published literature on the impact of disease and treatment on the HRQoL in patients receiving NIC. AIM: This study determined the HRQoL among NIC AML patients. MATERIALS AND METHODS: Embase, Medline, Cochrane database, and conference abstracts were searched using the prespecified PICOS criteria from January 2000 to November 2017 for studies reporting HRQoL and patient preference utilities in NIC AML. Studies on patients with RAEB-t MDS, randomized clinical trials (RCTs), prospective observational studies, and patient surveys were included, while systematic reviews and meta-analyses were used for bibliographic searching. RESULTS: Thirteen records from 12 original studies were identified. These included five records from four RCTs, three prospective studies, four patient survey studies, and one cost-effectiveness analysis. At baseline, NIC AML patients had poor HRQoL scores especially in fatigue (33) and GHS (50) on a 0-100 scale, with higher scores indicating better health. Low baseline HRQoL scores, especially PF and fatigue (<50) were shown to be significant independent predictors of poor survival. Clinical responders demonstrated meaningful improvements, especially in PF and fatigue, along with other health domains after being treated with NIC agents across several studies. CONCLUSION: HRQoL is poor for patients with NIC AML; measures such as fatigue and PF at baseline have been identified as independent prognostic factors for overall survival with several studies showing improvement in both domains with treatment. RCTs should incorporate evaluation of treatment impact on patients' PF and fatigue as important measures of effectiveness.

A decision framework for treating chronic immune thrombocytopenia with thrombopoietin receptor agonists.

Aim: Eltrombopag and romiplostim are comparable second-line therapies in chronic immune thrombocytopenia. Treatment decisions are made in different contexts. A framework was created to outline decision pathways for physicians and payers. Materials & methods: The costs of drugs, administration, routine care, bleeding, other adverse events and mortality were included in the year-long calculation of total costs from a US private payer perspective. Treatment parameters and outcome data were obtained from relevant clinical trials. Results: The total cost per year, per patient of eltrombopag was US$51,000 versus US$76,000 for romiplostim. Drug costs and costs associated with bleeding-related events were the main drivers of cost difference. Conclusion: This framework facilitates decision-making in the management of chronic immune thrombocytopenia with eltrombopag and romiplostim.

Cost-effectiveness analysis of metformin+dipeptidyl peptidase-4 inhibitors compared to metformin+sulfonylureas for treatment of type 2 diabetes.

BACKGROUND: Patients with type 2 diabetes (T2D) typically use several drug treatments during their lifetime. There is a debate about the best second-line therapy after metformin monotherapy failure due to the increasing number of available antidiabetic drugs and the lack of comparative clinical trials of secondary treatment regimens. While prior research compared the cost-effectiveness of two alternative drugs, the literature assessing T2D treatment pathways is scarce. The purpose of this study was to evaluate the long-term cost-effectiveness of dipeptidyl peptidase-4 inhibitors (DPP-4i) compared to sulfonylureas (SU) as second-line therapy in combination with metformin in patients with T2D. METHODS: A Markov model was developed with four health states, 1 year cycle, and a 25-year time horizon. Clinical and cost data were collected from previous studies and other readily available secondary data sources. The incremental cost-effectiveness ratio (ICER) was estimated from the US third party payer perspective. Both, costs and outcomes, were discounted at a 3% annual discount rate. One way and probabilistic sensitivity analyses were performed to evaluate the impact of uncertainty on the base-case results. RESULTS: The discounted incremental cost of metformin+DPP-4i compared to metformin+SU was $11,849 and the incremental life-years gained were 0.61, resulting in an ICER of $19,420 per life-year gained for patients in the metformin+DPP-4i treatment pathway. The ICER estimated in the probabilistic sensitivity analysis was $19,980 per life-year gained. Sensitivity analyses showed that the results of the study were not sensitive to changes in the parameters used in base-case. CONCLUSIONS: The metformin+DPP-4i treatment pathway was cost-effective compared to metformin+SU as a long-term second-line therapy in the treatment of T2D from the US health care payer perspective. Study findings have the potential to provide clinicians and third party payers valuable evidence for the prescription and utilization of cost-effective second-line therapy after metformin monotherapy failure in the treatment of T2D.

FDA safety actions for antidiabetic drugs marketed in the US, 1980-2015.

OBJECTIVES: Concerns about safety and complexity of diabetes treatments have increased overtime. We assessed secular trends in the FDA approvals, market discontinuations, and safety actions of all antidiabetic drugs marketed in the US in the period 1980-2015. METHODS: Regulatory and safety related information about FDA-approved pharmaceuticals for diabetes treatment was collected from the FDA databases, the Orange Book, and Drugs@FDA. Descriptive statistics were performed to describe trends in approvals, discontinuations, and safety actions. RESULTS: The number of insulins and analogue approvals declined after the 1980s; whereas, the approvals of non-insulin antidiabetic drugs increased after 1995. The number of antidiabetic drugs with FDA safety actions significantly increased overtime. Overall, 59.0% of insulins and analogues and 5.7% of non-insulin antidiabetic drugs were discontinued from the market. The FDA released at least one safety action for 7.7% of insulins and analogues and 88.7% of non-insulin antidiabetic drugs. CONCLUSION: Newly approved antidiabetic drugs have raised safety concerns and led to FDA safety regulatory actions including boxed warnings, risk evaluation and mitigation strategies, medication guides, and safety communications to health care providers. There is a need for systematic post-marketing studies assessing the long-term safety of antidiabetic drugs to improve patient safety and health outcomes.

Factors influencing the long-term success of periurethral collagen therapy in the office.

INTRODUCTION: Glutaraldehyde crosslinked bovine collagen has been used for periurethral bulking for the treatment of urodynamic stress incontinence since 1989 with variable success. A retrospective study was undertaken to evaluate the factors involved in the long-term success of glutaraldehyde crosslinked bovine collagen used for periurethral bulking in the office. METHODS: Patients were followed objectively with stress testing after receiving periurethral collagen injection in the office under local anesthesia. Repeat injections were done as necessary during their follow-up appointments. The "success" group was defined as those women who demonstrated negative stress tests for over 1 year following their first injection. RESULTS: Nineteen of 184 women (10.3%) demonstrated negative stress tests for over 1 year following only one initial injection of glutaraldehyde crosslinked collagen. Their success lasted a mean of 829 days up to the time of follow-up. CONCLUSION: Prior anti-incontinence surgery was the one factor analyzed that showed a trend toward this long lasting success. No other factors were predictive of negative stress tests for over 1 year. Prior anti-incontinence surgery seems to represent a factor involved in the long-term success of periurethral bulking in the office with glutaraldehyde crosslinked bovine collagen for the treatment of urodynamic stress incontinence.

TVT versus SPARC: comparison of outcomes for two midurethral tape procedures.

To compare the subjective and objective cure rates in women who underwent either the SPARC or the TVT midurethral sling for the treatment of stress urinary incontinence. This retrospective study included all 122 consecutive women undergoing a TVT or SPARC midurethral sling procedure for objective stress urinary incontinence between January 2000 and March 2003 at the Evanston Continence Center. Primary outcomes were subjective and objective stress incontinence cure rates. Subjects underwent multichannel urodynamics preoperatively and 14 weeks postoperatively, and stress testing at last follow-up. The two groups were compared using univariate and multivariate analyses. Seventy-three subjects underwent a TVT and 49 subjects had a SPARC procedure. There were no statistical differences in demographic factors between the two groups. Subjects undergoing SPARC were more likely to void by Valsalva effort. One hundred and seven women returned for objective postoperative evaluation after surgery. The TVT procedure was associated with higher subjective (86 vs. 60%, P = 0.001) and objective (95 vs. 70%, P < 0.001) stress incontinence cure rates. There was no difference between the TVT and SPARC groups in the resolution of subjective and objective urge urinary incontinence. TVT was associated with a higher stress urinary incontinence cure rate than SPARC in this retrospective study. As new midurethral sling products are introduced, prospective randomized controlled trials should be conducted to evaluate their relative efficacy and safety.

A prospective randomized trial using solvent dehydrated fascia lata for the prevention of recurrent anterior vaginal wall prolapse.

OBJECTIVE: This study was undertaken to compare outcomes after anterior colporrhaphy with and without a solvent dehydrated cadaveric fascia lata graft. STUDY DESIGN: A total of 162 women were enrolled in a prospective, randomized trial that evaluated the impact of a solvent dehydrated cadaveric fascia lata patch on recurrent anterior vaginal prolapse. Subjects were randomly assigned to standard colporrhaphy with or without a patch. Before and after surgery, subjects were evaluated by both the Baden-Walker and pelvic organ prolapse quantification systems. "Failure" was defined as stage II anterior wall prolapse or worse. RESULTS: Of 154 women randomly assigned (76 patch: 78 no patch), all underwent surgery and 153 (99%) returned for follow-up. Sixteen women (21%) in the patch group and 23 (29%) in the control group experienced recurrent anterior vaginal wall prolapse (P = .229). Only 26% of all recurrences were symptomatic. Concomitant transvaginal Cooper's ligament sling procedures were associated with a dramatic decrease in recurrent prolapse (odds ratio [OR] 0.105 , P < .0001). CONCLUSION: Solvent dehydrated fascia lata as a barrier does not decrease recurrent prolapse after anterior colporrhaphy. Transvaginal bladder neck slings were associated with a significant reduction in the risk of recurrent anterior wall prolapse.

Site-specific rectocele repair compared with standard posterior colporrhaphy.

OBJECTIVE: To compare the anatomic and functional outcomes of site-specific rectocele repair and standard posterior colporrhaphy. METHODS: We reviewed charts of all patients who underwent repair of advanced posterior vaginal prolapse in our institution between July 1998 and June 2002 with at least 1 year of follow-up. RESULTS: This study comprised 124 consecutive patients following site-specific rectocele repair and 183 consecutive patients following standard posterior colporrhaphy without levator ani plication. Baseline characteristics, including age, body mass index, parity, previous pelvic surgeries, and preoperative prolapse were not significantly different between the 2 study groups. Recurrence of rectocele beyond the midvaginal plane (33% versus 14%, P = .001) and beyond the hymenal ring (11% versus 4%, P = .02), recurrence of a symptomatic bulge (11% versus 4%, P = .02), and postoperative Bp point (-2.2 versus -2.7 cm, P = .001) were significantly higher after the site-specific rectocele repair. Rates of postoperative dyspareunia (16% versus 17%), constipation (37% versus 34%), and fecal incontinence (19% versus 18%) were not significantly different between the 2 study groups. CONCLUSION: Site-specific rectocele repair is associated with higher anatomic recurrence rates and similar rates of dyspareunia and bowel symptoms than standard posterior colporrhaphy. LEVEL OF EVIDENCE: II-3.

The tensile strength of Cooper's ligament suturing: comparison of abdominal and transvaginal techniques.

This study was designed to compare the strength and position of sutures anchored into Cooper's ligament utilizing a minimally invasive transvaginal suturing technique, versus the 'open' abdominal approach. In 12 fresh cadavers, Cooper's ligament was accessed via abdominal and vaginal incisions. After randomization, polytetrafluoroethylene (00) sutures were spaced along one ligament with the transvaginal device (n=36). Contralaterally, sutures were placed abdominally (n=36). Progressive load was applied until suture breakage or dislodgement, and tensile strength was measured using a digital tensiometer. Peak tension averaged 14.5 psi for abdominal and 12.96 psi for vaginal (p=0.28). Suture breakage rather than ligament 'pullout' was more likely for abdominal (95 vs. 56%, p=0.0001). Vaginal and abdominal sutures demonstrated nearly identical mean distances from mid-symphysis (4.62 vs. 4.24 cm, p=0.56). Peak tension was not correlated with suture location (r2=0.17, p=0.28). We conclude that transvaginal suturing, using the minimally invasive device, achieved similar tensile strength and position to the open technique. Transvaginal sutures were associated with greater likelihood of ligament 'pullout' before suture breakage under maximal load; however, the clinical implications of this finding are uncertain.