Publications by authors named "Daniel Altman"

131 Publications

Can preoperative radiographs predict hardware complication or fracture displacement after operative treatment of pelvic ring injuries?

Injury 2021 Feb 27. Epub 2021 Feb 27.

Department of Orthopedic Surgery, Allegheny Health Network, 307 Federal St, 2nd floor, Pittsburgh, PA, USA.

Introduction: Operative fixation of pelvic ring injuries is associated with a high risk of hardware failure and loss of reduction. The purpose of this study was to determine whether preoperative radiographs can predict failure after operative treatment of pelvic ring injuries and if the method of fixation effects their risk.

Patients And Methods: We conducted a retrospective cohort study of 143 patients with pelvic ring injuries treated with operative fixation at a level 1 trauma center. Preoperative radiographs were examined for the presence of the following characteristics: bilateral rami fractures, segmental or comminuted rami fractures, contralateral anterior and posterior injuries, complete sacral fracture, and displaced inferior ramus fractures. The method of fixation was classified based on the presence of anterior, posterior, or combined anterior and posterior fixation as well as whether or not posterior fixation was performed at a single or multiple sacral levels. Post-operative radiographs were examined for hardware failure or loss of reduction.

Results: Twenty-one patients (14.7%) demonstrated either hardware complication or fracture displacement within 6 months of surgery. Male sex was associated with a decreased risk of hardware complication (OR 0.11 [0.014, 0.86]; p=0.03). Posterior pelvic ring fixation at multiple sacral levels was associated with a decreased risk of fracture displacement (OR 0.21 [0.056, 0.83]; p=0.02). We were unable to demonstrate a significant association between preoperative radiographic characteristics and risk of hardware failure or fracture displacement.

Conclusion: Our study demonstrates that both gender and the method of posterior fixation are associated with hardware failure or displacement.
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http://dx.doi.org/10.1016/j.injury.2021.02.087DOI Listing
February 2021

Association between surgical volumes and real-world healthcare cost when using a mesh capturing device for pelvic organ prolapse: A 5-years comparison between single- versus multicenter use.

Int Urogynecol J 2021 Feb 26. Epub 2021 Feb 26.

Department of Women's and Children's Health, Uppsala University, Uppsala, Sweden.

Introduction And Hypothesis: The aim of this study was to evaluate whether high surgical volume at a single center was associated with lower healthcare costs compared to lower surgical volume in a multicenter setting.

Methods: All patients had symptomatic and anatomical apical prolapse (POP-Q ≥ stage II) with or without cystocele and were operated on by a standard surgical procedure using the Uphold mesh. Data on time of resource use in terms of surgery time, hospital stay and re-interventions across 5 years were compared between the single center (97 patients) and multicenter (173 patients, at 24 clinics). Unit costs for surgical time, inpatient and outpatient visits were extracted from the single-center hospital's operation analysis program and prime production cost. Total costs were estimated for primary surgery and during 5-year follow-up.

Results: Costs for primary surgery were comparable between the single and the multicenter ($13,561 ± 2688 and $13,867 ± 1177, P = 0.29). Follow-up costs 5 years after primary surgery were 2.8 times higher at the multicenter than single center ($3262 vs. $1149, P < 0.001). Mean cost per patient over 5 years was significantly lower at the single than multicenter [$14,710 (CI: 14,168-15,252) vs. $17,128 (CI: 16,952-17,305), P < 0.001)].

Conclusions: Using a mesh kit for apical pelvic organ prolapse in a high surgical volume center was associated with reduced healthcare costs compared with a lower volume multiple-site setting. The cost reduction at the high surgical volume center increased over time because of lower surgical and medical re-intervention rates for postoperative complications and recurrence.
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http://dx.doi.org/10.1007/s00192-021-04698-xDOI Listing
February 2021

Association between pelvic inflammatory disease and subsequent salpingectomy on the risk for ovarian cancer.

Eur J Cancer 2021 Mar 6;145:38-43. Epub 2021 Jan 6.

Department of Clinical Sciences, Karolinska Institutet, Danderyd Hospital, Stockholm, Sweden.

Aim: Salpingectomy is associated with a lower risk for ovarian cancer, suggesting that the fallopian tubes constitute the origin of the disease. It is unclear whether the observed effect is mediated by pelvic inflammatory disease (PID); a major indication for salpingectomy and implicated in the aetiology of ovarian cancer.

Methods: In this population-based cohort study, we used nationwide registry-based data on women exposed for PID with and without subsequent salpingectomy (n = 97,912) compared with the unexposed population (n = 5,429,174) between 1973 and 2010. The effect of hormone treatment was considered in a subanalysis.

Results: Of the exposed women, 9538 women underwent salpingectomy during the study period. There was a significant association between PID and ovarian cancer (hazard ratio [HR] 1.44, 95% confidence interval [CI] 1.31-1.59), whereas an inverse association was observed for exposed women with subsequent salpingectomy (HR 0.55, 95% CI 0.36-0.83). Salpingectomy performed on other indications (n = 24,895) was associated with a lower incidence of ovarian cancer (HR 0.72, 95% CI 0.56-0.93). No effect modification was observed for the use of oral contraceptives or hormonal replacement therapy.

Conclusion: Salpingectomy is associated with a lower incidence of ovarian cancer regardless of indication.
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http://dx.doi.org/10.1016/j.ejca.2020.11.046DOI Listing
March 2021

Exploring the usefulness of medical clowns in elevating satisfaction and reducing aggressive tendencies in pediatric and adult hospital wards.

BMC Health Serv Res 2021 Jan 6;21(1):15. Epub 2021 Jan 6.

Technion - Israel Institute of Technology, Haifa, Israel.

Background: Most existing research on medical clowns in health care services has investigated their usefulness mainly among child health consumers. In this research we examined multiple viewpoints of medical staff, clowns, and health consumers aiming to identify the optimal audience (adult or child health consumers) for which medical clowns are most useful. We focused on exploring their usefulness in enhancing health consumers' satisfaction and, in turn, reducing their aggressive tendencies.

Methods: We conducted three studies that examined the placement fit of medical clowns from different points of view: medical staff (Study 1, n = 88), medical clowns (Study 2, n = 20), and health consumers (Study 3, n = 397). The main analyses in Studies 1 and 2 included frequencies and t-tests comparing perceived adult and child satisfaction with clowns' performance. Study 3 used moderated-mediation PROCESS bootstrapping regression analysis to test the indirect effect of negative affectivity on aggressive tendencies via satisfaction. Exposure to the medical clown moderated this relationship differently for different ages.

Results: Studies 1 and 2 show that the majority of medical clowns and medical staff report that the current placement of the medical clowns is in pediatric wards; about half (44% of medical staff, 54% of medical clowns) thought that this placement policy should change. In Study 3, data from health consumers in seven different hospital wards showed that clowns are useful in mitigating the effect of negative affectivity on satisfaction, thereby reducing aggressive tendencies among health consumers under the age of 21.6 years. Surprisingly, medical clowns had the opposite effect on most adults: for health consumers who were exposed to the medical clown and were above the age of 21.6 negative affectivity was related to decreased satisfaction, and an increase in aggressive tendencies was observed.

Discussion: Medical clowns are most useful in elevating satisfaction and reducing aggressive tendencies of children. Older adults, on the other hand, exhibit lower satisfaction and higher aggressive tendencies following exposure to the performance of medical clowns.

Conclusion: Medical clowns should be placed primarily in children's wards.
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http://dx.doi.org/10.1186/s12913-020-05987-9DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7789247PMC
January 2021

Measurable Residual Disease-Guided Treatment to Prevent Relapse in Acute Myeloid Leukemia and Myelodysplastic Syndrome.

Front Oncol 2020 22;10:576924. Epub 2020 Oct 22.

Department of Medical Oncology, Thomas Jefferson University Hospital, Philadelphia, PA, United States.

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http://dx.doi.org/10.3389/fonc.2020.576924DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7642833PMC
October 2020

Long-term outcomes of pelvic organ prolapse repair using a mesh-capturing device when comparing single- versus multicenter use.

Arch Gynecol Obstet 2021 01 11;303(1):135-142. Epub 2020 Sep 11.

Department of Clinical Sciences, Danderyd Hospital, Karolinska Institutet, 171 77, Stockholm, Sweden.

Purpose: The aim of this study was to compare long-term effects of high-volume surgery at a single-center to multicenter use when using a mesh-capturing device for pelvic organ prolapse (POP) repair.

Methods: Five years after surgery 101 (88%) at the single center were compared with 164 (81.2%) in the multicenter trial. Outcome measurements included clinical examination, prolapse-specific symptom questionnaires [Pelvic Floor Distress Inventory 20 (PFDI-20), Pelvic Floor Impact Questionnaire-short form (PFIQ-7), Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12)] and pain estimation by VAS (0-10).

Results: Optimal apical segment outcome was 95% in the single- compared to 83.3% in the multicenter study (p < 0.001). POP recurrence in the anterior and posterior walls (POP-Q, Ba and Bp ≥ 0) was more common at the multicenter as compared to the single center [(19.8% vs 5.4%) and (26% vs 2.7%), (p < 0.001)]. Reoperations for POP and mesh-related complications were more frequent in the multicenter study [31/202 (15.3%) vs 7/116 (6.1%), p < 0.001]. Total PFDI-20, PFIQ-7 and PISQ-12 scores were comparable between the cohorts. There were no significant differences in overall pain scores in-between the cohorts during follow-up. At the single center, 1/81 patients (1.2%) had VAS 7/10, i.e. severe pain, as compared to 3/131 (2.3%) in the multicenter study (p = 0.277).

Conclusions: Despite the high objective and subjective long-term effectiveness of the procedure in both regular use, and at a high-volume center, centralizing the use of a standardized capturing-device guided transvaginal mesh for POP repair reduced secondary interventions by more than half.
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http://dx.doi.org/10.1007/s00404-020-05764-3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7854402PMC
January 2021

Contraceptive use at the time of and after an ectopic pregnancy: a retrospective cohort study.

Eur J Contracept Reprod Health Care 2020 Apr 2;25(2):147-150. Epub 2020 Mar 2.

Department of Clinical Sciences at Danderyd Hospital, Karolinska Institutet, Stockholm, Sweden.

Approximately, 1-2% of all pregnancies are ectopic; 25% of unintended pregnancies are conceived despite the use of contraception. The primary objective of our study was to explore the proportion of ectopic pregnancies (EPs) that were conceived during contraceptive use among women in Stockholm County. Secondary objectives were to establish the prevalence of contraceptive methods used at the time of EP and the intended contraceptive method after treatment completion. We performed a retrospective cohort study of 1180 women diagnosed with and treated for EP between 1 December 2013 and 30 April 2017 at all hospitals in Stockholm County. Demographic variables and contraceptive use before and after treatment were noted. Exclusion criteria were uncertainty about the diagnosis of EP in the patient records and planned treatment/follow-up outside Stockholm County. A total of 222/1180 (18.8%) EPs were conceived during known contraceptive use. A total of 112/222 (50.5%) women with known use of contraception at the time of conception discontinued contraceptive use and 81/857 (9.5%) women with no prior use of contraception initiated contraceptive use. Among the 857 women, 520 (60.7%) expressed a desire to conceive. Results were compared using the Mann-Whitney test or Fisher's exact test as appropriate. EP occurring during use of contraception is an unexplored problem. Contraceptive use decreased in women who were using contraception at the time of EP conception, leaving these women at risk of a subsequent unintended pregnancy. There should be more focus on contraceptive use after treatment for EP, in order to preserve fertility.
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http://dx.doi.org/10.1080/13625187.2020.1726887DOI Listing
April 2020

Risk-factors for continuous long-term use of prescription opioid drugs 3 years after hysterectomy: A nationwide cohort study.

Acta Obstet Gynecol Scand 2020 08 6;99(8):1057-1063. Epub 2020 Mar 6.

Department of Clinical Science and Education, Södersjukhuset University Hospital, Karolinska Institutet, Stockholm, Sweden.

Introduction: The widespread misuse of prescription pain medication, including opioids, has serious public health implications. Postoperative pain is a risk factor for persistent or chronic pain unless treated effectively. There are only a few studies that have assessed the use of opioid-containing drugs after gynecological surgery and most of these usually have a short follow-up period. The aim of this study was to identify risk-factors for long-term use of prescription opioid drugs following hysterectomy.

Material And Methods: We performed a nationwide cohort study based on prospectively collected data. Information from two population-based registers, the Swedish National Quality Register of Gynecological Surgery and the Swedish National Drug Register, was linked. The study population consisted of women with benign disease undergoing a total hysterectomy from 1 January 2012 until 31 December 2015. To identify long-term changes in prescription of opioids, individual data were collected from 1 year prior to to 3 years after surgery between 2011 and 2018. Data analysis was performed using multivariable logistic regression models.

Results: The population included 17 385 women having had hysterectomy for benign disease. Of these women, 4233 (24.4%) were prescribed analgesics continuously for 3 years postoperatively and 1225 (7.1%) used opioids long term. Perioperative predictors of opioid use 3 years after surgery included a diagnosis of adenomyosis (adjusted odds ratio [aOR] 1.8, 95% confidence interval [CI] 1.2-2.7) and preoperative use of opioids (aOR 29.6, 95% CI 19.7-44.4), psycho- (aOR 3.5, 95% CI 2.4-5.0) and neuroactive drugs (aOR 1.8, 95% CI 1.0-3.1). For women with no opioid prescription preoperatively (n = 260, 1.5%), mild (aOR 2.8, 95% CI 1.1-7.3) and severe (3.0% vs 6.2%: aOR 6.4, 95% CI 1.4-20.0) postoperative complications and preoperative prescription of psychoactive drugs (aOR 4.6, 95% CI 1.9-10.7) were associated with long-term use of drugs containing opioids.

Conclusions: Long-term use of prescription opioids after hysterectomy is common and is, among other risk factors, strongly associated with preoperative use of opioids, as well as psychoactive drugs and adenomyosis. To avoid opioid misuse disorders among women at risk for long-term opioid drug prescriptions after hysterectomy, further studies and strategies are needed.
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http://dx.doi.org/10.1111/aogs.13826DOI Listing
August 2020

Efficacy of mifepristone and misoprostol for medical treatment of missed miscarriage in clinical practice-A cohort study.

Acta Obstet Gynecol Scand 2020 04 22;99(4):488-493. Epub 2019 Dec 22.

Department of Clinical Sciences, Danderyd Hospital, Karolinska Institutet, Stockholm, Sweden.

Introduction: It has been estimated that one out of every four women experience first-trimester miscarriage. Missed miscarriage is a common form of early miscarriage where the products of conception are not expelled from the uterus. It is diagnosed by ultrasound. The primary objective of this study was to evaluate the success rate of a combination treatment with mifepristone and misoprostol for missed miscarriage in clinical practice. The secondary objective was to identify significant factors influencing the rate of success.

Material And Methods: A cohort of 941 consecutive women with an ICD-10 diagnosis of missed miscarriage who received treatment with 800 µg vaginal misoprostol and 2 repeat doses of 400 µg oral misoprostol after mifepristone pretreatment between 1 January 2012 and 31 December 2014 was analyzed. Women with a uterine size smaller than 12 weeks who were planned for medical treatment were included in the study. The exclusion criteria were primary surgical management or planned follow up outside the Stockholm County Council area.

Results: The success rate of medical treatment, defined as no need for surgical treatment, was 85.5% (805/941) in women with a uterine size of less than 12 weeks. However, for women with uterine size below 9 weeks the success rate was 88.9% (586/659). Indeed, uterine size of 9 gestational weeks or larger at time of treatment was identified as the only significant risk factor for surgical intervention.

Conclusions: The medical regimen for missed miscarriage offered in this study appears to be safe and with high rates of success. Conclusions about which women to exclude from medical treatment could not be made. Medical treatment may therefore benefit all women with missed miscarriage who wish to avoid primary surgery.
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http://dx.doi.org/10.1111/aogs.13780DOI Listing
April 2020

Evaluation of bacterial presence on lead X-ray aprons utilised in the operating room via IBIS and standard culture methods.

J Infect Prev 2019 Jul 15;20(4):191-196. Epub 2019 Apr 15.

Department of Orthopaedic Surgery, Allegheny General Hospital, Allegheny Health Network, Pittsburgh, PA, USA.

Background: Despite precautions, surgical procedures carry risk of infection. Radiation-protective lead aprons worn by operating personnel are a potential source of bacterial contamination and have not been fully evaluated.

Aim/objective: To evaluate lead aprons as a source of bacterial contamination, identify organisms most commonly found on this source, and devise a method with which to lower the risk of contamination.

Methods: In this basic science study, 20 randomly selected lead X-ray aprons were swabbed at three time points. The experimental treatment was with a hospital-grade disinfectant wipe. The samples were assessed for bacterial growth via traditional plating methods and mass spectrometry. Plates were graded on a scale of 0 to 4+ based on the number of quadrants with growth. Growth on one quadrant or more was considered contaminated.

Findings/results: Bacteria were initially detected via IBIS on a majority of the aprons (32/40), most commonly and . Virulent organisms cultured were Methicillin-resistant (MRSE), Neisseria, Streptococcus viridans and pseudomonas. MRSE were detected on 5/20 of the samples. Immediately after treatment, the majority of aprons showed less bacterial contamination (0/20 standard culture positive; 13/20 IBIS positive) with some recurrence at the 6-h time point (2/20 standard culture positive, 16/20 IBIS positive). All MRSE detected initially was eradicated.

Discussion: Lead X-ray aprons worn in the operating room harbour bacteria. Disinfecting before use may prevent the introduction of virulent organisms to patients. Our proposed method of sanitising with a disinfectant wipe is quick and effective.
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http://dx.doi.org/10.1177/1757177419833163DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6683606PMC
July 2019

Clinical Outcomes After Spine Surgery for Traumatic Injury in the Octogenarian Population.

World Neurosurg 2019 Sep 14;129:e97-e103. Epub 2019 May 14.

Department of Surgery, Allegheny Health Network, Pittsburgh, Pennsylvania, USA.

Objective: To review the surgical outcomes of the octogenarian population at a single institution after spinal traumatic injury.

Methods: Patients with both radiographic and clinical evidence of acute traumatic spine injury were reviewed using an institutional trauma survey to determine patient demographics and outcome data in a population of patients aged 80 years and older.

Results: Thirty-nine patients aged 80 years and older underwent surgical intervention for acute spinal trauma. There were 25 cases of cervical spine and 14 cases of thoracolumbar spine surgical intervention. Falls were the number one cause of acute spinal injury (31/39, 71%). Major respiratory disorders were the most common postoperative adverse event (12/39, 31%). Five patients experienced superficial wound dehiscence, fascial dehiscence, superficial infection, or delayed wound erosion. Patients were either discharged to home (10.5%), inpatient rehabilitation, (38.5%), skilled nursing facilities (17.9%), or long-term care facilities (17.9%). The postoperative mortality was 10.3%.

Conclusions: Although the octogenarian population has increased risk for postoperative events after acute spinal injuries, surgical intervention may be worthwhile in the elderly population. Although direct surgical complication rates are not higher, medical risks are significantly higher after surgery.
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http://dx.doi.org/10.1016/j.wneu.2019.05.048DOI Listing
September 2019

Delivery outcome after trial of labor in nulliparous women 40 years or older-A nationwide population-based study.

Acta Obstet Gynecol Scand 2019 09 19;98(9):1195-1203. Epub 2019 Apr 19.

Department of Clinical Sciences, Karolinska Institutet, Danderyd Hospital, Stockholm, Sweden.

Introduction: The number of women postponing childbirth until an advanced age is increasing. Our aim was to study the outcome of labor in nulliparous women ≥40 years, compared with women 25-29 years, after both spontaneous onset and induction of labor.

Material And Methods: The nationwide population-based Swedish Medical Birth Register was used to study the perinatal outcome in nulliparous women with a singleton, term (gestational weeks 37-44), live fetus in cephalic presentation and a planned vaginal delivery from 1992 to 2011. We included 7796 nulliparous women ≥40 years and 264 262 nulliparous women 25-29 years. Prevalence and risk of intrapartum cesarean section, operative vaginal delivery, obstetric anal sphincter injury and a 5-minute Apgar score <7 were calculated for women ≥40 years stratified for spontaneous onset and induction of labor, using women 25-29 years as the reference in both strata. Crude and adjusted odds ratios (aOR) were calculated by unconditional logistic regression and presented with 95% confidence intervals (CI).

Results: Overall, 79% of women ≥40 years with a trial of labor reached a vaginal delivery. After spontaneous onset, intrapartum cesarean section was performed in 15.4% of women ≥40 years compared with 5.4% of women 25-29 years (aOR 3.07, 95% CI 2.81-3.35). Operative vaginal delivery was performed in 22.3% of women ≥40 years compared with 14.2% of women 25-29 years (aOR 1.71, 95% CI 1.59-1.85). After induction of labor, an intrapartum cesarean section was performed in 37.2% women ≥40 years compared with 20.2% women 25-29 years (aOR 2.51, 95% CI 2.24-2.81). Operative vaginal delivery was performed in 22.6% of women ≥40 years compared with 18.4% women 25-29 years (aOR 1.45, 95% CI 1.28-1.65). The risk of obstetric anal sphincter injury or a 5-minute Apgar score <7 was not increased in women ≥40 years, regardless of onset of labor.

Conclusions: Trial of labor ended in vaginal delivery in 79% of nulliparous women ≥40 years. The risks of intrapartum cesarean section and operative vaginal delivery were higher in women ≥40 years compared with women 25-29 years, after both spontaneous onset and induction of labor. The risk of obstetric anal sphincter injury or a 5-minute Apgar score <7 was not increased.
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http://dx.doi.org/10.1111/aogs.13614DOI Listing
September 2019

Urodynamics as a Prognosticator of Mirabegron Treatment Outcomes.

Gynecol Obstet Invest 2019 21;84(5):472-476. Epub 2019 Mar 21.

Stockholm Urogynecological Clinic, Stockholm, Sweden,

Aims: To determine if findings at urodynamics prognosticate improvements in overactive bladder symptoms among women receiving mirabegron treatment.

Methods: Before treatment, women completed a urodynamic investigation, a micturition diary and the Urinary Distress Inventory (UDI) with the irritative subscale UDIOAB. After 6 months mirabegron treatment, patients were clinically evaluated and completed the UDI. Associations were tested using regression analyses and nonparametric statistics.

Results: Testing urodynamic variables for association with treatment effects in multiple linear regression analysis showed that lower volumes at first sensation to void significantly correlated with greater improvement in the UDIOAB after 6 months mirabegron treatment (B = 0.026, 95% CI 0.002-0.049, p = 0.034). Improvements in UDIOAB showed no correlation with presence of nocturia (p = 0.65), previous use of anticholinergics (p = 1), menopausal status (p = 1), any detrusor overactivity during filling (p = 1), phasic detrusor contractions during filling (p = 1), or detrusor overactivity during inhibition (p = 1).

Conclusions: We found limited support for clinically relevant associations between findings at urodynamics and subsequent treatment outcomes for mirabegron in routine clinical practice. Our findings do not support the role of these investigations as predictors of outcomes in patients with overactive bladder symptoms.
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http://dx.doi.org/10.1159/000496606DOI Listing
December 2019

Management of Sacroiliac Joint Pain.

J Am Acad Orthop Surg 2018 Sep;26(17):610-616

From Orthopaedic Institute, Allegheny Health Network, Pittsburgh, PA.

Sacroiliac joint (SIJ)-based pain can be difficult to diagnose definitively through physical examination and conventional radiography. A fluoroscopically guided injection into the SIJ can be both diagnostic and therapeutic. The initial phase of treatment involves nonsurgical modalities such as activity modification, use of a sacroiliac (SI) belt, NSAIDs, and physical therapy. Prolotherapy and radiofrequency ablation may offer a potential benefit as therapeutic modalities, although limited data support their use as a primary treatment modality. Surgical treatment is indicated for patients with a positive response to an SI injection with >75% relief, failure of nonsurgical treatment, and continued or recurrent SIJ pain. Percutaneous SI arthrodesis may be recommended as a first-line surgical treatment because of its improved safety profile compared with open arthrodesis; however, in the case of revision surgery, nonunion, and aberrant anatomy, open arthrodesis should be performed.
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http://dx.doi.org/10.5435/JAAOS-D-15-00063DOI Listing
September 2018

Inferior Vena Cava Filter Strut Penetration into the Vertebral Column: A Case of 10-Year Clinical Follow Up.

Curr Probl Diagn Radiol 2020 May - Jun;49(3):215-217. Epub 2018 Apr 18.

Department of Diagnostic Radiology, Allegheny General Hosptial, Allegheny Health Network, Pittsburgh, PA.

Background: The rate of vena cava (IVC) filter placement has increased over the past decade, especially in the orthopaedic trauma patient population. With the increasing use of IVC filters, radiologists and referring clinicians must be familiar with potential complications.

Clinical Case: This case report presents an 18-year-old polytraumatized patient who had an IVC filter placed and required T8-L2 posterior spinal fusion. At 4.5 years of follow-up, a computed tomography (CT) scan for painful spinal hardware incidentally found that the IVC filter had migrated into the L3 vertebral body. The patient eventually underwent removal of her spinal hardware, but the IVC filter migration was managed conservatively with routine surveillance. At 10 years follow-up, the patient continued to remain asymptomatic despite of filter penetration into the vertebral body.

Conclusion: This case demonstrates, long term follow-up for an asymptomatic patient with IVC migration and vertebral body penetration. This case may suggest that attempt at complex IR filter retrieval is not necessarily warranted in scenarios of strut penetration.
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http://dx.doi.org/10.1067/j.cpradiol.2018.04.006DOI Listing
February 2021

Evaluating Postoperative Complications and Outcomes of Orthopedic Fracture Repair in Nonagenarian Patients.

Geriatr Orthop Surg Rehabil 2018 22;9:2151459318758106. Epub 2018 Mar 22.

Allegheny Orthopedic Associates and Allegheny General Hospital, Pittsburgh, PA, USA.

Introduction: The United States and the world are currently experiencing a tremendous growth in the elderly population. Moreover, individuals surpassing the ages of 80 and 90 are also continuing to increase. As this unique division of society expands, it is critical that the medical community best understands how to assess, diagnose, and treat this population. The purpose of this study was to analyze morbidity, mortality, and overall outcome of patients aged 90 years and older after orthopedic surgical fracture repair. Such knowledge will guide patients and their families in making decisions when surgery is required among nonagenarians.

Methods: The trauma registry of our level I academic medical center was queried to identify potential study participants over the past decade. Two hundred and thirty-three surgical procedures among 227 patients were included and retrospectively assessed. Parameters of specific interest were injury type, mechanism of injury (including high energy vs low energy and height of falls), injury severity score, preoperative comorbidities, postoperative complications, length of hospital stay, discharge destination, and postoperative mortality rate.

Results: Overall, 4.3% of the cohort died in the hospital following surgery. Of the patients who survived, 89.7% were discharged to a professionally supervised setting. The nonagenarian population displayed a considerable follow-up rate, as 82.8% of individuals returned for their first postoperative office visit.

Discussion: Historically, surgical morbidity and mortality are highly associated with this age group. However, the number of nonagenarians in the United States is increasing, as are these surgical procedures. The epidemiologic and clinical findings of our study support this trend and add further insight into the matter.

Conclusion: This investigation demonstrates that orthopedic surgery is an appropriate treatment in this population with an acceptable complication rate. Furthermore, nonagenarians have the potential to demonstrate a substantial follow-up rate, but postoperative discharge to a professionally supervised setting may be necessary.
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http://dx.doi.org/10.1177/2151459318758106DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5871047PMC
March 2018

No Difference Between Bracing and No Bracing After Open Reduction and Internal Fixation of Tibial Plateau Fractures.

J Am Acad Orthop Surg 2018 Mar;26(6):e134-e141

From the Division of Orthopaedic Trauma, Department of Orthopaedic Surgery, Allegheny General Hospital, Pittsburgh, PA.

Introduction: The use of a postoperative brace may be beneficial after open reduction and internal fixation of tibial plateau fractures. However, bracing has potential drawbacks related to cost, fitting, wound complications, and compliance. We hypothesized that no difference will be found between patients with and without bracing after open reduction and internal fixation of tibial plateau fractures.

Methods: In this prospective, comparative trial, patients were randomized to 6 weeks of bracing or no bracing after open reduction and internal fixation of tibial plateau fractures. Functional, subjective, and radiographic outcomes were recorded. Patients with an open physis, unstable ligamentous injuries, extensor mechanism disruption, and/or <6 months of prospective outcome data were excluded.

Results: The 24 patients with bracing (average age, 50 ± 16 years; 14 women and 10 men) were compared with the 25 patients without bracing (average age, 51 ± 12 years [P = 0.74]; 9 women and 16 men). No statistically significant differences were found in most of the functional, subjective, and radiographic outcomes, including fracture characteristics, complications, postoperative range of motion, Medical Outcomes Study 36-Item Short Form scores, and union rates. In the nonbraced group, one patient had late joint collapse with valgus malalignment (>10°). Two wound complications occurred in the braced group and four wound complications occurred in the nonbraced group, but this difference was not statistically significant.

Discussion: Improvements in conventional and locking plate technology have allowed more reliable rigid internal fixation of tibial plateau fractures. However, the use of a brace for postoperative rehabilitation after open reduction and internal fixation of tibial plateau fractures continues to be debated.

Conclusion: Our prospective study showed no statistically significant difference between bracing and no bracing after open reduction and internal fixation of tibial plateau fractures in terms of functional, subjective, and radiographic outcomes.

Level Of Evidence: Therapeutic level II.
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http://dx.doi.org/10.5435/JAAOS-D-16-00021DOI Listing
March 2018

A generic health-related quality of life instrument for assessing pelvic organ prolapse surgery: correlation with condition-specific outcome measures.

Int Urogynecol J 2018 08 6;29(8):1093-1099. Epub 2018 Mar 6.

Division of Obstetrics and Gynecology, Department of Clinical Sciences, Karolinska Institutet Danderyd Hospital, S-182 88 Danderyd, Stockholm, Sweden.

Introduction And Hypothesis: The aim of this study was to investigate the use of a generic and globally accessible instrument for assessing health-related quality of life (HR-QoL) in pelvic organ prolapse (POP) surgery.

Methods: In a prospective multicenter setting, 207 women underwent surgery for apical prolapse [stage ≥2, Pelvic Organ Prolapse Quantificcation (POP-Q) system] with or without anterior wall defect. Demographic and surgical characteristics were collected before surgery. Results of the 15-dimensional (15D) instrument and condition-specific pelvic floor symptoms as assessed using the Pelvic Floor Distress Inventory questionnaire (PFDI-20), including its subscales Pelvic Organ Prolapse Distress Inventory-6 (POPDI-6), Colorectal-Anal Distress Inventory-8 (CRADI-8), and Urinary Distress Inventory-6 (UDI-6), were assessed preoperatively and 2 months and 1 year after surgery.

Results: HR-QoL as estimated by 15D was improved 1 year after surgery (p < 0.001). Prolapse-related 15D profile-index measures (excretion, discomfort, sexual activity, distress, and mobility) were significantly improved after surgery (p < 0.05-0.001). Significant inverse associations were detected between increased 15D scores and a decrease in PFDI-20 and subscale scores (p < 0.001), indicating improvements on both instruments.

Conclusions: Generic HR-QoL as estimated by 15D improved significantly after apical POP surgery and correlated with improvements of condition-specific outcome measures. These results suggest that a comprehensive evaluation of global HR-QoL is valid in assessing pelvic reconstructive surgery and may provide novel and important insights into previously understudied areas, such as cost-utility and cost-effectiveness analysis after urogynecological surgery.
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http://dx.doi.org/10.1007/s00192-018-3587-5DOI Listing
August 2018

Developmental differences in stress responding after repeated underwater trauma exposures in rats.

Stress 2018 05 16;21(3):267-273. Epub 2018 Feb 16.

a Center for Military Psychiatry and Neuroscience, Department of Behavioral Biology , Walter Reed Army Institute of Research , Silver Spring , MD , USA.

Adolescence is a distinct developmental period characterized by behavioral and physiological maturation. Rapid ongoing changes during neurodevelopment in particular present potential opportunities for stress to have lasting effects on longitudinal outcomes of behavioral and neuroendocrine function. While adult stress effects on outcomes during adulthood have been characterized, little is known about the lasting effects of adolescent repeated stressor exposure on outcomes during adolescence. We have previously reported different stress responses in adolescent rats relative to adult rats, including a blunted fear response outcome in adulthood in rats stressed during adolescence. The present study characterized the ontogeny of behavioral and neuroendocrine responses to eight underwater trauma (UWT) exposures in rats over a two week poststress time period during adolescence (P34) or adulthood (P83) relative to age-matched control groups that underwent eight swimming episodes without UWT. Repeated UWT exposures starting in adolescence, but not adulthood, resulted in adverse behavioral responses on the elevated plus maze 1 day post-stress. Corticosterone responses did not differ between UWT-exposed and controls for either age group at 1 day or at 7 days poststress, although there was an effect of age on corticosterone levels. We conclude that repeated UWT stress events have a lasting, negative behavioral effect on adolescent rats that is not observed in adult rats after the two-week exposure window. These results suggest that neurophysiological mechanisms underlying recovery from a repeated stressor are immature in adolescence relative to adulthood in rats.
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http://dx.doi.org/10.1080/10253890.2018.1439012DOI Listing
May 2018

Cancer Risk After Midurethral Sling Surgery Using Polypropylene Mesh.

Obstet Gynecol 2018 03;131(3):469-474

Stockholm Urogynecological Clinic and the Department of Clinical Sciences, Karolinska Institutet, Stockholm, Sweden; the Department of Statistics and Quantitative Methods, University of Milano-Bicocca, Milan, Italy; the Department of Women's Health, University of Texas Austin Dell Medical School, Austin, Texas; the Department of Medical Epidemiology and Biostatistics, Karolinska Institutet, Stockholm, Sweden; the Department of Obstetrics and Gynecology, Medical University of Graz, Graz, Austria; and the Department of Obstetrics and Gynecology, MedStar Washington Hospital Center/Georgetown University School of Medicine, Washington, DC.

Objective: To assess whether there is any association between the implantation of synthetic polypropylene mesh slings for the treatment of stress urinary incontinence (SUI) and risk of cancer.

Methods: We performed a nationwide cohort study based on the general female population in Sweden. All women entered the observational period as unexposed on January 1, 1997, and contributed person-time as unexposed unless they underwent a midurethral sling procedure for SUI, after which they contributed person-time as exposed until first occurrence of any cancer, death, emigration, or end of the observational period (December 31, 2009). Occurrence of primary cancer was ascertained from the Cancer Register. Hazard ratios (HRs) with 95% CIs were calculated by Cox proportional hazards regression.

Results: The final study population included 5,385,186 women, including 20,905 exposed, encompassing a total of 44,012,936 person-years at risk. Other than an inverse association with rectal cancer (HR 0.5, 95% CI 0.3-0.8), there were no significant differences in risk between exposed and unexposed women for pelvic organ cancers including ovarian (HR 0.8, 95% CI 0.5-1.2), endometrial (HR 1.1, 95% CI 0.8-1.4), cervical (HR 0.4, 95% CI 0.2-1.0), bladder, and urethra (HR 0.7, 95% CI 0.4-1.2). No significant association was observed between exposed women and primary cancer in any organ system when compared with unexposed women. The relative risk for cancer after exposure showed little variation over time except for an inverse overall correlation within the first 4 years of surgery (HR 0.7, 95% CI 0.7-0.8). The incidence rates per 100,000 person-years (95% CIs) for exposed vs unexposed women were 20.5 (14.3-29.5) vs 21.0 (20.6-21.5) for rectal cancer, 25.5 (18.4-35.3) vs 19.8 (19.4-20.2) for ovarian cancer, 65.0 (53.0-79.8) vs 33.1 (32.6-33.7) for endometrial cancer, 5.7 (2.8-11.3) vs 11.9 (11.6-12.2) for cervical cancer, and 19.1 (13.1-27.8) vs 13.3 (13.0-13.7) for bladder and urethra cancer.

Conclusion: Our results suggest that midurethral polypropylene sling surgery for SUI is not associated with an increased cancer risk later in life.
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http://dx.doi.org/10.1097/AOG.0000000000002496DOI Listing
March 2018

Association between tubal ligation and endometrial cancer risk: A Swedish population-based cohort study.

Int J Cancer 2018 07 13;143(1):16-21. Epub 2018 Feb 13.

Department of Clinical Sciences, Karolinska Institutet Danderyd Hospital, Karolinska Institutet, Stockholm, Sweden.

Tubal ligation results in less advanced stages and lower risk of metastatic spread at diagnosis of endometrial cancer (EC) but the primary preventive effect of the procedure is unclear. In a Swedish nationwide population-based cohort study, we crosslinked registry data for tubal ligation, EC, and death for Swedish women between 1973 and 2010. All women were followed until EC, emigration, hysterectomy for non-cancerous reasons, death, or end of follow-up. Primary outcome was incidence of EC and secondary outcome overall survival. We calculated adjusted incidence rates (IR) per 100,000 person-years and hazard ratios (HR) using Cox regression models. A total of 35,711 cases of EC were identified among 5,385,186 women. The IR of EC among exposed was 17.7 (95% CI 15.7-19.9) versus 29.0 (95% CI 28.7-29.3) among unexposed (per 100,000 women years). Exposed individuals had significantly reduced risk of EC (HR 0.73, 95% CI 0.65-0.83). The mortality rate among women with EC was 72% lower in exposed compared to unexposed (IR 1,441; 95% CI 1,089-1,907 and IR 5,136; 95% CI 5,065-5,209, respectively) which following adjustment corresponded to a HR of 0.71 (95% CI 0.49-1.03). Tubal ligation was associated with lower risk of EC as well as mortality rates in women with EC. Elective tubal ligation may be adopted in future cancer preventive strategies but must be balanced against the irreversibility of the procedure, which preclude further unassisted reproduction.
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http://dx.doi.org/10.1002/ijc.31287DOI Listing
July 2018

High Thoracic Disc Herniation Causing Horner Syndrome with the Intraoperative Finding of Conjoined Nerve Root Compression: A Case Report.

JBJS Case Connect 2017 Jan-Mar;7(1):e4

1Departments of Orthopaedic Surgery (A.K.B., M.J.S., and D.T.A.) and Neurosurgery (N.D.T.), Allegheny General Hospital, Pittsburgh, Pennsylvania2Drexel University College of Medicine, Philadelphia, Pennsylvania.

Case: A 29-year-old man presented with right medial arm pain with paresthesia, as well as right-sided ptosis, miosis, and anhidrosis. Magnetic resonance imaging revealed a right paracentral disc herniation at the T1-T2 level. The patient underwent a hemilaminectomy with a medial facetectomy through a posterolateral approach to the T1-T2 disc space, followed by a discectomy. Intraoperative findings were notable for a conjoined nerve root.

Conclusion: Although high thoracic disc herniation is rare, its diagnosis should be considered when patients present with radicular arm pain and Horner syndrome. A high index of suspicion should be maintained for nerve root anomalies to limit iatrogenic injury and to ensure successful decompression.
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http://dx.doi.org/10.2106/JBJS.CC.16.00106DOI Listing
July 2018

Pelvic Organ Prolapse Repair Using the Uphold Vaginal Support System: 5-Year Follow-Up.

Female Pelvic Med Reconstr Surg 2019 May/Jun;25(3):200-205

Department of Obstetrics and Gynecology, Danderyd Hospital, Stockholm, Sweden.

Objective: This study aimed to assess the long-term (5 years) outcomes of the Uphold Vaginal Support System for symptomatic vaginal apical prolapse with or without anterior colporraphy.

Methods: In total, 164 (81.2%) of 202 women operated on in 24 centers were reached for follow-up. Outcomes were assessed by using the Pelvic Organ Prolapse Quantification, the Pelvic Floor Distress Inventory 20, and the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire questionnaires. Pain on pelvic area was evaluated using a visual analog scale. Adverse events and secondary procedures were recorded.

Results: An optimal outcome at the apical compartment (Pelvic Organ Prolapse Quantification stage <2) was achieved in 83.3% of patients (94% at 1 year). Quality of life improved in 78.8% of the women, with a significant decrease of bother in all domains (pelvic organ prolapse, rectoanal, urinary) compared with that preoperatively. Overall sexual satisfaction improved after 1 year, but the number of sexually active women was low. In total, 19.7% of patients had undergone repeat pelvic surgery during follow-up, most common of these were midurethral sling (38.4%), followed by prolapse-related operations. Mesh removal due to pain was performed in 3 women. Number of women with any pain decreased overall from 1 to 5 years, but 3 women had persistent severe pain despite treatment efforts (visual analog scale ≥7).

Conclusions: Apical objective and subjective outcomes were sustained after 5 years in women operated on for apical compartment prolapse by the Uphold Vaginal Support System.
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http://dx.doi.org/10.1097/SPV.0000000000000530DOI Listing
December 2019

Comparison of single- versus multicenter outcomes for pelvic organ prolapse repair using a mesh-capturing device.

Int Urogynecol J 2018 Jan 25;29(1):91-97. Epub 2017 May 25.

Division of Obstetrics and Gynecology, Department of Clinical Sciences, Karolinska Institutet Danderyd University Hospital, 182 88 Danderyd, Stockholm, Sweden.

Introduction And Hypothesis: The aim of this study was to compare the results of pelvic organ prolapse repair using a capturing device-guided transvaginal mesh in a single- vs multicenter setting.

Methods: One hundred and twelve women operated by two surgeons at one center (2-year follow-up) were compared with 207 women operated on by 26 surgeons at 24 centers (1-year follow-up). Patients were screened at baseline for apical (uterine or vaginal vault) prolapse stage II with or without concomitant anterior vaginal wall prolapse ≥ stage 2 according to the pelvic organ prolapse quantification (POP-Q) system. Outcome measurements included POP-Q evaluations, prolapse-specific symptom questionnaires, and surgical data.

Results: At the end of follow-up 95 out of 98 (96.9%) had an optimal anatomical outcome at the apical segment (POP-Q stage 0-1) in the single center compared with 154 out of 164 (93.9%) in the multicenter study (P = 0.03). There were no serious complications in the single-center study compared with 9 out of 207 (4.3%) in the multicenter study. In patients undergoing surgery for recurrence, the risk ratio for complications overall was 4:1 in favor of the single-center study. There were no significant differences between the studies in any subjective symptom scale.

Conclusions: Compared with multicenter use, large volumes at a single site only resulted in minor improvements of anatomical outcomes and no significant differences with regard to patient-reported outcomes on pelvic organ function or related quality of life. Instead, the greatest benefit of single-center use was the significantly decreased complication rates.
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http://dx.doi.org/10.1007/s00192-017-3364-xDOI Listing
January 2018

Transurethral Polyacrylamide Hydrogel Injection Therapy in Women Not Eligible for Midurethral Sling Surgery.

Female Pelvic Med Reconstr Surg 2017 Sep/Oct;23(5):318-323

From the *Stockholm Urogynecological Clinic; †Department of Clinical Sciences, Karolinska Institutet Danderyd Hospital, Stockholm, Sweden; ‡Department of Statistics and Quantitative Methods, University of Milano-Bicocca, Milan, Italy; §Department of Medical Epidemiology and Biostatistics, Karolinska Institutet; ∥Ultragyn, Sophiahemmet and ¶Department of Women's and Children's Health, Karolinska Institutet, Stockholm, Sweden.

Objectives: This study aims to determine the effects of transurethral polyacrylamide hydrogel injection in patients considered ineligible for midurethral sling surgery.

Methods: In this prospective observational study, 81 patients received treatment with transurethral polyacrylamide hydrogel injection. Patients were considered ineligible for placement of a midurethral sling based on significant comorbidity (48%), 1 or more previously failed invasive treatments (16%), mixed urinary incontinence (27%), continuous incontinence (5%), or previous pelvic radiation therapy (4%). Longitudinal assessment of subjective treatment outcomes was performed using the validated Urinary Distress Inventory (UDI) and the Pelvic Floor Impact Questionnaire at baseline, 2, and 6 months. To deal with repeated measurements, mixed linear models were used to assess changes in the outcomes over time.

Results: There was a significant improvement in the overall UDI score from baseline to month 2 follow-up (FU) (P<0.001). No major differences between the month 2 and 6 FUs were observed. The largest difference in effect was observed for the irritative and stress subscales. Twenty-five patients (33%) requested a second injection at the month 2 FU visit. At month 6 FU, the UDI scores for patients having had only 1 injection were largely unchanged, whereas all UDI domains worsened further for patients having had a second injection at the month 2 visit. After the injection, there were 3 minor adverse events (3.7%) and no serious adverse events.

Conclusions: In patients considered ineligible for midurethral sling surgery, transurethral injection with polyacrylamide hydrogel may alleviate urinary incontinence symptoms. Repeat injections did not improve outcomes in this complicated group of patients.
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http://dx.doi.org/10.1097/SPV.0000000000000385DOI Listing
May 2018

Thyroid cancer after hysterectomy on benign indications: Findings from an observational cohort study in Sweden.

Int J Cancer 2017 04 3;140(8):1796-1801. Epub 2017 Feb 3.

The Department of Clinical Sciences, Danderyd Hospital, Karolinska Institutet, Stockholm, Sweden.

To investigate the association between hysterectomy and thyroid cancer subtypes based on histopathology. They did a nationwide, population-based, cohort study from 1973 to 2009 in Sweden. All women above 18 years of age during the period between January 1, 1973 and December 31, 2009 from the Register of Population (n = 5.704,202) were identified as the study population. Individual case ascertainment of primary thyroid cancer subtypes were restricted to 1993-2009 based on histological pathologic-anatomical-diagnosis from the Cancer Register. Thyroid cancer subtypes were categorized based on histological morphology as: papillary, follicular and others (including anaplastic and medullary thyroid carcinoma). Information on benign hysterectomy derived from the Swedish Inpatient Register. Women with a hysterectomy (exposed) were compared with women not having had a hysterectomy (unexposed) using Cox's proportional hazard ratios (HRs). The adjusted HR for papillary thyroid cancer was significantly increased in exposed as compared with unexposed women (HR 1.70, 95% CI 1.04-2.79). There was no significant association between hysterectomy and follicular carcinoma or other thyroid cancers. There was a clear shift in the occurrence of thyroid cancer toward a lower attained age at the time of diagnosis among the exposed but no significant difference in overall survival when comparing exposed and unexposed (HR 1.02, 95% CI 0.48-2.16) Hysterectomy was associated with an increased risk for subsequent papillary thyroid cancer and diagnosis at a younger age compared with women not having had a hysterectomy but there were no differences in survival.
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http://dx.doi.org/10.1002/ijc.30606DOI Listing
April 2017

Quality of life after Uphold™ Vaginal Support System surgery for apical pelvic organ prolapse-A prospective multicenter study.

Eur J Obstet Gynecol Reprod Biol 2017 Jan 14;208:86-90. Epub 2016 Nov 14.

University of Helsinki and Helsinki University Central Hospital, Department of Obstetrics and Gynecology, Finland; Folkhälsan Research Center, Helsinki, Finland.

Objective: To study the effects on quality of life in women operated for apical pelvic organ prolapse using the Vaginal Uphold™ System.

Study Design: In this prospective cohort study, women (n=207) with symptomatic apical prolapse, with or without cystocele, were operated using the Uphold™ Vaginal Support System. Follow-up for quality of life was performed at 12 months after surgery, and assessed by the PFDI-20, and PFIQ-7, and sexual function by the PISQ-12. We used odds ratios (ORs) with 95% confidence intervals (CIs) for outcome association analyses using logistic regression.

Results: At one-year follow-up majority of women experienced an overall postoperative improvement in quality of life (p<0.001). One year after surgery Uphold™ operation alone increased the risk for prolapse related bother as compared to Uphold™ combined with anterior colporraphy (POP-IQ-7; OR 2.1; 95% CI 1.01-4.3). The frequency of dyspareunia decreased postoperatively (p=0.004), however, after one-year, overall sexual function deteriorated significantly (p<0.001). The worsening in sexual function scores was mainly attributed to the partner related domain, whereas the behavioral-emotive and physical domains showed no significant changes.

Conclusion: Apical prolapse repair using Uphold™ improved quality of life among our patients but worsened overall sexual function postoperatively.
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http://dx.doi.org/10.1016/j.ejogrb.2016.11.011DOI Listing
January 2017

Polymerase Chain Reaction-Electrospray-Time-of-Flight Mass Spectrometry Versus Culture for Bacterial Detection in Septic Arthritis and Osteoarthritis.

Genet Test Mol Biomarkers 2016 Dec 17;20(12):721-731. Epub 2016 Oct 17.

5 Institute for Molecular Medicine and Infectious Disease, Center for Genomic Sciences, Drexel University College of Medicine , Philadelphia, Pennsylvania.

Background: Preliminary studies have identified known bacterial pathogens in the knees of patients with osteoarthritis (OA) before arthroplasty.

Aims: The current study was designed to determine the incidence and types of bacteria present in the synovial fluid of native knee joints from adult patients with diagnoses of septic arthritis and OA.

Patients And Methods: Patients were enrolled between October 2010 and January 2013. Synovial fluid samples from the affected knee were collected and evaluated with both traditional microbial culture and polymerase chain reaction-electrospray ionization-time-of-flight mass spectrometry (molecular diagnostics [MDx]) to prospectively characterize the microbial content. Patients were grouped by diagnosis into one of two cohorts, those with clinical suspicion of septic arthritis (n = 44) and those undergoing primary arthroplasty of the knee for OA (n = 21). In all cases where discrepant culture and MDx results were obtained, we performed species-specific 16S rRNA fluorescence in situ hybridization (FISH) as a confirmatory test.

Results: MDx testing identified bacteria in 50% of the suspected septic arthritis cases and 29% of the arthroplasty cases, whereas culture detected bacteria in only 16% of the former and 0% of the latter group. The overall difference in detection rates for culture and MDx was very highly significant, p-value = 2.384 × 10. All of the culture-positive cases were typed as Staphylococcus aureus. Two of the septic arthritis cases were polymicrobial as was one of the OA cases by MDx. FISH testing of the specimens with discordant results supported the MDx findings in 91% (19/21) of the cases, including one case where culture detected S. aureus and MDx detected Streptococcus agalactiae.

Conclusions: MDx were more sensitive than culture, as confirmed by FISH. FISH only identifies bacteria that are embedded or infiltrated within the tissue and is thus not susceptible to contamination. Not all suspected cases of septic arthritis contain bacteria, but a significant percent of patients with OA, and no signs of infection, have FISH-confirmed bacterial biofilms present in the knee.
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http://dx.doi.org/10.1089/gtmb.2016.0080DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5180073PMC
December 2016

Hormonal influence on the effect of mirabegron treatment for overactive bladder.

Menopause 2016 12;23(12):1303-1306

1Department of Women's and Children's Health, Karolinska Institutet, Solna, Sweden 2Department of Clinical Sciences, Karolinska Institutet, Danderyd Hospital, Danderyd, Sweden 3Stockholm Urogynecological Clinic, Stockholm, Sweden 4Aarhus Institute of Advanced Studies, Aarhus University, Aarhus, Denmark 5Department of Statistics and Quantitative Methods, University of Milano-Bicocca, Milano, Italy.

Objective: The aim of this study was to evaluate if levels of gonadotropic and sex steroidal hormones influence the efficacy of mirabegron in the treatment of overactive bladder.

Methods: We included 58 female participants who received treatment with mirabegron 50 mg once daily and provided a blood sample for hormone profiling before treatment was initiated. Serum hormone concentrations for estradiol, progesterone, testosterone, FSH, LH, TSH, and T4 were analyzed. Urinary Distress Inventory (UDI), (overactive bladder domain: UDIOAB), and the short form Pelvic Floor Impact Questionnaire (PFIQ-7) were used to assess subjective outcomes.

Results: There were significant overall improvements in UDI, UDIOAB, and the PFIQ from baseline to the 2 months of follow-up (P = 0.001, 0.001, and 0.008, respectively). The magnitude of the mean difference of improvements was similar between pre- and postmenopausal women. Estrogen levels were nonsignificantly lower in participants who experienced an improvement in UDI and UDIOAB at 2 months of follow-up as compared with those that did not (P = 0.7). There were no other clinically relevant differences in hormone levels in relation to improvements in UDI, UDIOAB, or PFIQ. In logistic regression analysis there were no associations between UDIOAB outcomes and age, previous use of anticholinergic drugs, parity, menopause, and local estrogen treatment.

Conclusions: Estradiol, gonadotropic hormones, thyroid hormones, and testosterone levels did not influence the clinical effects of mirabegron in women with overactive bladder. Menopause status should not be a determinant for mirabegron treatment.
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http://dx.doi.org/10.1097/GME.0000000000000708DOI Listing
December 2016

Safety and efficacy of mirabegron in daily clinical practice: a prospective observational study.

Eur J Obstet Gynecol Reprod Biol 2016 Aug 9;203:167-72. Epub 2016 Jun 9.

Department of Clinical Sciences, Karolinska Institutet, Danderyd Hospital, Solna, Stockholm, Sweden; Stockholm Urogynecological Clinic, Solna, Stockholm, Sweden; Department of Statistics and Quantitative Methods, University of Milano-Bicocca, Milano, Italy. Electronic address:

Objective: To determine risks associated with prescribing mirabegron, the first-in-class β3-adrenoreceptor agonist, to non-selected female patients with overactive bladder.

Study Design: Routine female patients seeking treatment for overactive bladder (n=221) in a urology/gynecology outpatient clinic. Data on adverse events, cardiovascular outcomes, condition specific symptoms and drug discontinuation was collected at two months follow-up (FU). Non-parametric statistics was used as appropriate. Odds ratios (ORs) with 95% confidence intervals (CIs) for outcome association analyses using logistic regression.

Results: 16 patients (7.2%) discontinued treatment because of side effects. There were no significant associations between cardiovascular adverse events and pre-existing cardiovascular disease (OR 0.3, 95% CI 0.3-2.6), or pre-existing ECG abnormalities (OR 2.3, 95% CI 0.3-16.3). At FU ECGs there were no de novo cases of tachyarrhythmias and no significant difference in mean QTc between baseline (403ms, SD 21.7) and the 2 months follow-up ECG (403ms, SD 20.3) (p=0.75). There was a significant decrease in the mean systolic blood pressure (p=0.03) but no significant change in mean diastolic pressure (p=0.8) or heart rates (p=0.2) from baseline to FU. Overactive bladder specific symptoms and quality of life improved significantly (p<0.001 respectively).

Conclusions: Mirabegron treatment is associated with a satisfactory cardiovascular safety profile, as well as, significant symptomatic improvement also in a heterogeneous population of non-selected women with overactive bladder presenting in everyday clinical practice.
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http://dx.doi.org/10.1016/j.ejogrb.2016.05.048DOI Listing
August 2016