OSNA (one-step nucleic acid amplification) sentinel lymph node intraoperative molecular analysis in breast cancer: a cost-benefit analysis.

The aim of the study was to analyze the medical and economic interest of OSNA molecular technique, compared to conventional postoperative histopathologic evaluation for sentinel lymph node exploration in breast cancer patients. This retrospective cost-benefit study was conducted in the French Universitary Hospital of Saint Etienne on patients who received sentinel lymph node exploration between July 1, 2007 and December 31, 2009. Lymph nodes were analyzed by conventional postoperative histological evaluation in group 1 (82 patients) and OSNA in group 2 (86 patients). Costs were analyzed in three different ways: surgery cost, hospitalization cost and histopathologic cost. Average operating time was slightly shorter for group 1 (histology) [71.9 vs. 76.8 min for group 2 (OSNA)]. Time and operating costs were not significantly different (p = 0.293). The average cost of pathological examination was significantly higher in group 2 (35.04 euros per node in group 1 vs. 291.84 euros per node in group 2 p < 10(-3)). The average length of hospital stay was significantly longer in group 1 (5.4 days in group 1 vs. 4.2 days in group 2, p = 0.0065). The total costs were not significantly different between both groups (3,774.6 euros in group 1 vs. 3,393.9 euros in group 2 p = 0.055). The sentinel lymph node analysis with OSNA technique does not lead to higher expenses. It also avoids another surgery for 20% of patients. A prospective multicentric medico-economic study made with a larger effective would probably confirm these results.

Female urinary incontinence and intravaginal electrical stimulation: an observational prospective study.

OBJECTIVE: To assess the efficacy of intravaginal electrical stimulation in the management of female urinary incontinence. STUDY DESIGN: 359 Women with urinary incontinence (207 with stress incontinence [group A], 33 with urge incontinence [group B] and 119 with mixed urinary incontinence [group C]) were included in this multicenter prospective observational study. Patients were managed by home intravaginal electrical stimulation of the pelvic floor for 20-30 min per day, 5 days a week, for a period of 10 weeks. Identical clinical assessments were performed before and after pelvic floor rehabilitation, comprising a voiding diary and validated symptom and quality of life scores. RESULTS: Objective assessment demonstrated an overall cure rate of 63.5% (228/359): 65.7% (136/207) for group A, 57.6% (19/33) for group B, and 61.3% (73/119) for group C. The overall significant improvement rate was 15.6% (56/359): 14.6% (30/207) for group A, 24.2% (8/33) for group B and 15.1% (18/119) for group C. All domains of quality of life were significantly improved after pelvic floor muscle training (p<0.0001) with a patient satisfaction rate of 83.6%. Treatment was well tolerated with 1.4% (5/359) of patients describing pain at the highest stimulation intensities. No significant difference was observed between the various types of electrodes used (p<0.0001). CONCLUSION: The quantitative and qualitative efficacy in terms of social and psychological consequences and quality of life of home pelvic floor muscle training stimulators probably make this treatment modality one of the first-line treatments for female stress urinary incontinence.

Diagnostic performance of one-step nucleic acid amplification for intraoperative sentinel node metastasis detection in breast cancer patients.

The purpose of this prospective multicenter study was to assess one-step nucleic acid amplification (OSNA) for intraoperative sentinel lymph node (SLN) metastasis detection in breast cancer patients, using final histology as the reference standard. OSNA results were also compared to intraoperative histology SLN evaluation and to standard clinicopathological risk markers. For this study, fresh SLNs were cut in four blocks, and alternate blocks were used for OSNA and histology. CK19 mRNA copy number was categorized as strongly positive, positive or negative. Positive histology was defined as presence of macrometastasis or micrometastasis. When discrepancies occurred, the entire SLNs were subjected to histological studies and the node lysates to additional molecular studies. Five hundred three SLN samples from 233 patients were studied. Mean time to evaluate two SLNs was 40 min. Sensitivity per patient was 91.4% (95% CI, 76.9-98.2%), specificity 93.3% (95% CI, 88.6-96.6%), positive likelihood ratio 13.7 and negative likelihood ratio 0.1. Sensitivity was 63.6% for frozen sections and 47.1% for touch imprint cytology. Both methods were 100% specific. Positive histology and positive OSNA were significantly associated with highest clinical stage, N1 status and vascular invasion; and OSNA results correlated with HER2/neu status and benefited patients with negative histology. These findings show that OSNA assay can allow detection of SLN metastasis in breast cancer patients intraoperatively with a good sensitivity, thus minimizing the need for second surgeries for axillary lymph node detection.

[News on antithrombotic therapy and pregnancy]. / Mise au point sur les antithrombotiques et la grossesse.

OBJECTIVES: State of the art of antithrombotics and their use recommendations during pregnancy. METHODS: A review RESULTS: Aspirin and heparins remain the safest molecules during pregnancy, and oral anticoagulants are still used for mechanical valves. Heparinoids are the methods of choice in case of heparin-induced thrombopenia but other molecules could find their place: fondaparinux at first and possibly the direct thrombin inhibitors. Thrombolysis may be used in case of life-threatening incident. At present, the new oral forms can not be used during pregnancy CONCLUSIONS: During pregnancy, all antithrombotics, except the oral forms, can be used, but the low molecular weight heparins replacing the unfractionated ones in the treatment and prevention of venous thromboembolism remain the treatment of choice.

Implementation of molecular intra-operative assessment of sentinel lymph node in breast cancer.

BACKGROUND: Sentinel lymph node (SLN) biopsy is used as a staging procedure in early breast cancer, however, histology based intra-operative assessment of the SLN status has a low sensitivity. The one-step nucleic acid amplification (OSNA) method was developed to detect metastases by amplification of cytokeratin (CK) 19 mRNA. Experience with OSNA during a French multi-centric prospective study, as well as intra-operative clinical routine use, is reported. PATIENTS AND METHODS: For the clinical study 80 SLNs from 46 patients were assessed. During routine use, the central slice of the SLN from 197 patients was investigated by permanent histology and the remainder was assessed by OSNA. RESULTS: During the clinical study, OSNA detected 15/17 metastases, including all the macrometastases, reaching a 96.3% concordance rate, 88.2% sensitivity and 98.4% specificity. During routine use, both OSNA and histology detected 25 patients with metastasis. CONCLUSION: OSNA is an accurate tool for intra-operative assessment of SLN status and could reduce the need for second surgery.

Three-dimensional sonographic diagnosis of abdominal wall endometriosis: a useful tool?

OBJECTIVE: To report the usefulness of three-dimensional (3D) ultrasonography for the assessment of parietal endometriosis. DESIGN: Case report. SETTING: Academic research hospital. PATIENT(S): A 35-year-old woman with a noncyclic, painful abdominal nodule near a caesarean delivery scar. INTERVENTION(S): 3D ultrasonography and wide surgical resection with healthy margins. MAIN OUTCOME MEASURE(S): 3D ultrasonographic assessment of the endometriotic nodule. RESULT(S): We found that 3D ultrasonography offered a more specific description of parietal endometriosis with irregular and spiculated margins and depth infiltration as well as provided preoperative evaluation of volume measurements. CONCLUSION(S): Three-dimensional ultrasonography is a useful, noninvasive tool in extrapelvic endometriosis.

Neonatal outcomes and four-year follow-up after spontaneous or iatrogenic preterm prelabor rupture of membranes before 24 weeks.

OBJECTIVE: To assess the neonatal outcome and four-year follow-up of pregnancies complicated by preterm prelabor rupture of membranes (PPROM) before 24 weeks. DESIGN: Retrospective study. SETTING: University Hospital of Saint Etienne, tertiary level center, France. METHODS: Obstetric and neonatal records of 38 pregnancies and 44 fetuses born between 1999 and 2004 (six years) with PPROM between 14 and 23 + 6 weeks of gestation were studied. We analyzed spontaneous (group A) and iatrogenic PPROM (Group B) cases, including maternal, fetal, placental, and neonatal characteristics. Surviving infants were followed until the age of four. RESULTS: Median gestational age at PPROM was 21 weeks [range 15-23 + 6]. Of the 38 women with PPROM, 22 (A) had spontaneous PPROM and 16 (B) underwent an invasive procedure during pregnancy. Expectant management was applied to 25 women: 12 (13 fetuses) from group A and 13 (16 fetuses) from group B. Median latency from PPROM to delivery was 35 days [range 1-163 days]. The two groups showed significant differences. The overall survival rate was 59% (17 fetuses) and three babies from group A died in the hospital. Survival rate of infants discharged from hospital was 48% (14/29). Of 14 surviving infants, 71% had a normal neurological and developmental outcome at four years. Only two infants from group A survived without obvious sequelae. CONCLUSION: Pregnancy after iatrogenic PPROM had a better prognosis than after spontaneous PPROM. Intensive management with corticosteroids and antibiotics appeared to be helpful. Neonatal survival in spontaneous PPROM before 24 weeks remained very poor and discussing pregnancy termination in these cases seems legitimate.

Feasibility of an easy-to-use risk score in the prevention of venous thromboembolism and placental vascular complications in pregnant women: a prospective cohort of 2736 women.

INTRODUCTION: Management of pregnant women at increased risk of venous thromboembolism (VTE) remains complex in the absence of an easy-to-use tool allowing individualised, risk-adapted prophylaxis. Our objective was to assess whether treatment based on risk score is feasible in these women. MATERIALS AND METHODS: A scoring system for VTE risk in pregnant women was developed, each score being associated with a specific treatment. This system was implemented in a prospective cohort of 2736 consecutive women delivered in our teaching hospital from July 2002 to June 2003. Thromboembolic and obstetrical outcomes during pregnancy and the early post-partum period were recorded. RESULTS: Treatment based on risk score was implemented in 2685 of the 2736 women included (98.1%). The scoring system identified 2431 women with no risk factor and 305 women (11%) with at least one risk factor. Eight women not at risk (0.3%, [95% CI: 0.1-0.5]) and one at risk (0.4%, [95% CI: 0-1.1]) experienced a VTE. This low event rate precluded estimation of the discriminatory power of the score. However, the benefit of the scoring system was evaluated indirectly by assessing VTE incidence in the 46 women at risk in whom it was not used (15.2%, [95% CI: 4.8-25.6]). CONCLUSIONS: Our simple scoring system offers an easily implemented procedure for risk-based VTE prophylaxis of pregnant women and the proposed therapeutic strategy appears to be effective and safe in reducing VTE. The discriminatory power of the score is currently being evaluated in a randomized, controlled trial.

Acute urine retention in early pregnancy resulting from fibroid incarceration: proposition for management.

OBJECTIVE: To define a therapeutic strategy adapted to acute urine retention resulting from uterine incarceration in early pregnancy. DESIGN: Case report and review of the literature. SETTING: University hospital. PATIENT(S): Two cases of acute urine retention induced by severe fibroid incarceration in first trimester. INTERVENTION(S): After failure of preventive measures and maneuvers to reduce the incarceration, surgery was performed as a last resort. MAIN OUTCOME MEASURE(S): Pregnancy and birth after surgery. RESULT(S): One miscarriage 1 week after surgery and one normal pregnancy. CONCLUSION(S): Acute urine retention constitutes an emergency, and rapid measures are essential to avoid extremely serious maternal morbidity. We propose a therapeutic strategy for managing this condition. Simple measures may be sufficient to prevent incarceration. Otherwise, bladder catheterization should be performed rapidly, and reduction measures attempted. If this approach fails, the incarcerated uterus must be treated as a last resort by surgery.

Prenatal discovery of an omphalocele associated with an inner umbilical cord Meckel's diverticulum.

The antenatal discovery of Meckel's diverticulum is a rare occurrence; the localization of both Meckel's diverticulum and omphalocele in the umbilical cord has never been described. We present herein a prenatal case of an omphalocele associated with inner umbilical cord dilated Meckel's diverticulum. An umbilical cord cyst was suspected with the cystic image seen during the first trimester exam, and sonography was repeated every month. Several possible diagnoses were discussed including umbilical cord cyst, omphalocele and umbilical cord hernia due to the changing sonographic images during pregnancy. Childbirth had to be arranged at a specialized center. After birth, clamping of the umbilical cord away from the base prevented iatrogenic atresia of the ileum. Surgical treatment had to be arranged during the first days of life.

Place of embolization of the uterine arteries in the management of post-partum haemorrhage: a study of 12 cases.

OBJECTIVE: To assess the current place of embolization of the uterine arteries in the treatment of severe post-partum haemorrhages. MATERIALS AND METHODS: A retrospective study of 13,160 deliveries in a level III maternity unit between January 1996 and December 2001. Five hundred and forty-nine post-partum haemorrhages were diagnosed. Seventeen (0.13%) patients had a haemorrhage which did not respond to treatment using obstetric manoeuvres and uterotonic drugs. Twelve patients aged between 19 and 34 years old benefited from embolization of the uterine arteries. Nine patients had delivered by Caesarian section and three vaginally. The aetiologies found were uterine atony (n=8), placenta praevia (n=1), placenta accreta (n=1), abruptio placentae (n=1) and uterine myomas (n=1). RESULTS: The success rate of embolization was 91.6%. One failure, resulting from cardiovascular shock during the procedure, led to the patient being transferred as an emergency to the operating theatre for a haemostasis hysterectomy. It was due to placenta increta. No maternal deaths were reported. No complications because of the technique used were noted. One patient successfully delivered, following a normal pregnancy, one year after embolization. CONCLUSION: Embolization of the uterine arteries is indicated in severe post-partum haemorrhage, irrespective of the aetiology or the type of delivery. It should be offered as soon as primary management measures undertaken for haemorrhage are judged as ineffective. Its place in the treatment strategy, is in all cases before embarking on surgery, which is the final recourse in the case of failure. It is a fairly uninvasive procedure, which preserves the potential for future pregnancies.

[Complications and medium-term functional results of TVT in stress urinary incontinence]. / Complications et résultats fonctionnels à moyen terme du TVT dans l'incontinence urinaire d'effort.

INTRODUCTION: The TVT technique has transformed the surgical management of stress urinary incontinence. The published results are excellent and appear to be maintained in the long term. We decided to obtain the patients' opinion by postal questionnaire. MATERIAL AND METHODS: 235 women with stress urinary incontinence, 79 of whom were simultaneously operated for genital prolapse, were treated by suburethral TVT between November 1998 and December 2000. We studied the complications and sent a questionnaire based on the Ditrovie scale and the urinary disability scale to each patient. RESULTS: Thirty one operative complications were reported (13.2%) with 26 bladder perforations (11%), 4 haemorrhages (1.7%) not requiring transfusion and 1 gastrointestinal injury (0.4%). 89.8% of patients reported cure of their incontinence at the postoperative visit. 159 patients completed the questionnaire (67.6%). The answers showed that, with a mean follow-up of 18 months, only 75.4% of women were completely dry. Women with sphincter incompetence or simultaneously treated for genital prolapse obtained similar results (84.2% and 73.2%). Only patients with recurrence of SUI obtained poorer results (71.4%). De novo urgency appeared to be rare, while pre-existing urgency resolved after the operation in 50% of cases. More than 80% of women reported a good or excellent quality of life, but 30% experienced pain that impaired quality of life. CONCLUSION: TVT is an effective technique for the treatment of stress urinary incontinence. Answers to a postal questionnaire provide a more realistic view of the functional results, revealing incomplete results and pain for some women, which justify further studies based on validated questionnaires.