A new algorithm for improving fetal weight estimation from ultrasound data at term.

OBJECTIVE: The purpose of this retrospective study was to find a method of improving the accuracy of fetal birth weight estimation on the basis of traditional ultrasonographic measurements of the head, thorax, and femur at term. In this context, we analyzed a novel regression method comparing to existing algorithms. METHODS: The delivery records of two hospitals were searched for women who delivered macrosomic infants, and the patients' medical records were retrospectively reviewed in order to derive clinical and ultrasonographic data at term. A total of 223 patients with macrosomic infants (birth weight > 4,000 g) were identified. These patients were complemented by data for 212 women who had ultrasound fetal assessments of less than 4,000 g. We used the method of isotonic regression to construct a birth weight prediction function that increases monotonically with each of the input variables and which minimizes the empirical quadratic loss. RESULTS: A suspicion of macrosomia was based on a history of macrosomia, fundal height, and sonographic weight estimation >4,000 g. The mean period between ultrasound weight estimation and delivery was 7.2 days. The ability of the biometric algorithms developed to predict fetal weight at term ranged between a mean absolute error of 312 and 344 g, given a confidence interval of 95%. We demonstrate that predictions of birth weight on the basis of ultrasound data can be improved significantly, if an isotonic regression model is used instead of a linear regression model. CONCLUSIONS: This study demonstrates that ultrasound detection of macrosomia can be improved using the isotonic regression method.

Long-term outcome prediction by clinicopathological risk classification algorithms in node-negative breast cancer--comparison between Adjuvant!, St Gallen, and a novel risk algorithm used in the prospective randomized Node-Negative-Breast Cancer-3 (NNBC-3) trial.

BACKGROUND: Defining risk categories in breast cancer is of considerable clinical significance. We have developed a novel risk classification algorithm and compared its prognostic utility to the Web-based tool Adjuvant! and to the St Gallen risk classification. PATIENTS AND METHODS: After a median follow-up of 10 years, we retrospectively analyzed 410 consecutive node-negative breast cancer patients who had not received adjuvant systemic therapy. High risk was defined by any of the following criteria: (i) age <35 years, (ii) grade 3, (iii) human epithelial growth factor receptor-2 positivity, (iv) vascular invasion, (v) progesterone receptor negativity, (vi) grade 2 tumors >2 cm. All patients were also characterized using Adjuvant! and the St Gallen 2007 risk categories. We analyzed disease-free survival (DFS) and overall survival (OS). RESULTS: The Node-Negative-Breast Cancer-3 (NNBC-3) algorithm enlarged the low-risk group to 37% as compared with Adjuvant! (17%) and St Gallen (18%), respectively. In multivariate analysis, both Adjuvant! [P = 0.027, hazard ratio (HR) 3.81, 96% confidence interval (CI) 1.16-12.47] and the NNBC-3 risk classification (P = 0.049, HR 1.95, 95% CI 1.00-3.81) significantly predicted OS, but only the NNBC-3 algorithm retained its prognostic significance in multivariate analysis for DFS (P < 0.0005). CONCLUSION: The novel NNBC-3 risk algorithm is the only clinicopathological risk classification algorithm significantly predicting DFS as well as OS.

Quality of life and adjuvant tamoxifen treatment in breast cancer patients.

About two-thirds of all breast cancer patients are treated with adjuvant hormonal therapy. Side effects of tamoxifen and their effects on physical, emotional and social functioning have been shown to impair the quality of life. Aim of this paper was to evaluate the side effects and level of influence on the physical, emotional and social functioning caused by tamoxifen treatment. For assessment of quality of life an own questionnaire was designed. Between January 2001 and December 2003, 136 women with breast cancer and adjuvant tamoxifen therapy were included in this study. Data of side effects, physical and mental health and patients' self-evaluation identified detrimental effects on patients' quality of life. Prevalence and severity of symptoms were not influenced by length of tamoxifen treatment. Patients were damaged in their constitution in respect to previous chemotherapy and pre-existing diseases; no influence was found by age or histopathological tumour characteristics. Our survey determines that breast cancer patients experience significant influence on quality of life by the negative impact on the physical, emotional and social functioning caused by tamoxifen treatment. Explicit attention to changes in quality of life should be considered as part of the standard care for women receiving adjuvant tamoxifen treatment.

The influence of macrosomia on the duration of labor, the mode of delivery and intrapartum complications.

OBJECTIVE: This study assessed the perinatal outcome in a series of macrosomic fetuses with mothers from a general obstetric population in whom vaginal delivery was planned. METHODS: In all, 215 women with macrosomic infants were included from a total of 2,622 deliveries. The pattern of maternal weight gain in pregnancy, the influence of fetal macrosomia on the duration of labor and the delivery outcome were investigated in this group. The main issues studied were the impact of fetal weight on the mode of delivery, the duration of the two stages of delivery and the incidence of intrapartum complications in fetuses larger than 4,000 g in comparison with normal-weight fetuses. RESULTS: Complete data were obtained for 594 patients, including 215 macrosomic infants and 379 randomly assessed normal-weight infants. With regard to the mode of delivery, a direct correlation was observed between maternal weight gain and the incidence of secondary cesarean section (P<0.014) when vaginal delivery was initially planned. There was also a direct correlation between increasing birth weight and a higher incidence of secondary cesarean section and assisted vaginal delivery (P<0.002). In the first stage of labor, there was a statistically significant difference for obstructed labor between the two groups (P<0.03). The rate of perineal injuries and the incidence of postpartum hemorrhage were similar in the two groups. CONCLUSIONS: As some of the risk factors identified are known prior to delivery, every woman in whom there is a suspicion that the fetus may weigh up to 4,500 g should receive individual guidance regarding special intrapartum and perinatal conditions.

Analysis of local complications following explantation of silicone breast implants.

A study was undertaken to analyse local complications in patients with breast implants and the total number of implant-related interventions when silicone breast implants were explanted. We studied 53 patients who had received breast implants for cosmetic augmentation or breast reconstruction following surgery for breast cancer at the time of explantation. The clinical records of all these patients were analysed, and clinical information on reason for implantation, implant properties, number and kind of implant-related interventions and reason for explantation was elicited. A complication was defined as a surgical procedure performed for any of the following reasons: capsular contracture, loss of implant integrity, haematoma or seroma, infection of the implant site, extrusion or wound dehiscence, and dissatisfaction with the result. The mean numbers of implant-related operations were 3.1 in patients who had undergone breast reconstruction and 2.3 in patients who had cosmetic augmentation (P < 0.03). We found a total of 35 complications in 28 patients, 21 patients (75%) each had one complication, five patients (18%) had two and two patients (7%) had three complications. A significantly higher incidence of early complications in patients who had undergone breast reconstruction (P < 0.03) marks the difference from complications in the cosmetic group, most of which arose after a longer time (P < 0.02). A complication analysis is presented. At the time of explantation, 78% of the patients decided to have a new implant, while 12% requested permanent removal of the implant without replacement. In the present study we saw no patients with connective tissue or other autoimmune disorders. When breast reconstruction or augmentation with silicone devices is considered, patients must be informed of the possible complications and of the potential choices in later implant-related revision surgery.

In vitro analysis of modified surfaces of silicone breast implants.

BACKGROUND: Although silicone breast implants are well tolerated, local complications such as capsular contracture occur because of insufficient integration with surrounding tissues. In this study, cell behaviour on hydrophilized silicone breast implant foils was analysed qualitatively and quantitatively under in vitro conditions in order to provoke the desired responses in a defined environment. METHODS: Silicone breast implant foils with different surface modifications were tested after 24 hours, 5 days and 7 days. The following modifications of silicone implant foils were tested: Unmodified silicone, silicone after-graft polymerisation for polyacrylic acid (pAAc), silicone-pAAc-fibronectin adsorptive, silicone-pAAC-fibronectin covalent, positive and negative controls. Experiments were conducted using cell culture with murine mouse fibroblasts L-929. Cytotoxicity assays were carried out in direct and indirect contact with cells grown on the material. For the viability test and qualitative analysis of cell proliferation on different foils, both fluoresceine-diacetate and ethidiumbromide were used and in addition the morphologic description of hemalaun-stained cells were used. Quantitative cell analysis was carried out using XTT after resuspension. RESULTS: Toxic influence on cell cultures could be excluded for coated and uncoated surfaces in contact with dissolved biomaterials. Unmodified silicone surfaces showed poor cell growth in direct contact. We found a gradual improvement of cell morphology, with the spread and proliferation depending on the type of surface modification. Better results were achieved with covalently coupled fibronectin and GRGDS than with pAAc. CONCLUSION: Covalent immobilisation of hydrophobic silicone rubber can improve the initial cell-biomaterial interactions that are required to aid the successful development of tissue-like structures.

Comparison of Obstetric Efficacy and Safety of the Kiwi OmniCup with Conventional Vacuum Extraction.

Purpose: The aim of the present study was to compare the safety and efficacy of the Kiwi OmniCup system with conventional vacuum delivery. Methods: A retrospective study of operative vaginal deliveries was done for 4682 births. The procedures included 217 operative vaginal deliveries (4.6 %), 79 of which were done using conventional vacuum extraction (37 %) and 138 using the Kiwi system (63 %). Results: Use of the Kiwi system was associated with a significant reduction in episiotomies (61 vs. 76 % in the control group; p < 0.05). The rates of successful completion of birth were comparable for the two systems (94 % with the Kiwi system and 99 % with conventional vacuum delivery). Cup detachment occurred significantly more often in the Kiwi group (p < 0.005), requiring a change to a different method of birth significantly more often. It was necessary to change the procedure significantly more often from the mid-pelvis (p < 0.05). The incidence of maternal and foetal injuries was similar for the two systems. Conclusions: With regard to obstetric efficacy and safety and foetal and maternal injuries, the Kiwi system is an acceptable alternative to the conventional vacuum cup. The advantages of the Kiwi system are its significantly lower episiotomy rate and its ease and rapidity of use.

Skin-reducing Mastectomy with Primary Implant Reconstruction.

Background: We present a series of skin-sparing mastectomies (SSMs) with skin reduction and immediate breast reconstruction to treat large and ptotic breasts. The technique combines oncological mastectomy with immediate subpectoral implant placement as a single-step procedure. Methods: Data was collected from a prospective database from February 2009 to April 2011. A total of 24 patients with macromastia or pronounced ptosis fulfilled the criteria for skin-saving mastectomy. All operations were carried out as a single-step procedure with adaptation of the contralateral breast by reduction mastopexy. Results: A total of 27 SSMs were performed in 24 patients. The mean implant volume was 265 cm3. Immediate reconstruction of the nipple-areola complex was done in 22 patients. The cosmetic and functional results were assessed in all patients 6 months postoperatively; mean follow-up time was 13 months. Mean patient age was 49 years. The cosmetic result was assessed as "very good" or "good" by 22 patients; 2 patients graded the result as "unsatisfactory". There was one local recurrence. Conclusion: Our results support the use of this technique as a safe oncoplastic procedure which is well tolerated by patients.

[Massive adenomyosis in a patient with uterus septus completus]. / Massive Adenomyose bei einer Patientin mit Uterus septus completus.

Septate uterus is a malformation caused by the defective resorption of the Müllerian ducts. It may be incomplete, or -- less frequently -- complete. We present a case of a uterus septus completus with special emphasis on the endometrial changes. We describe a 46-year-old female patient (nullipara) with a known uterus septus suffering from hypermenorrhea. Sonography demonstrated a massively enlarged uterus with several nodes. Hysterectomy was performed and tissue specimens were routinely processed. Macroscopical examination revealed a 1 230 g-weight uterus septus completus. In particular, the myometrium was enlarged and exhibited a cystic cut surface with several nodes measuring up to 4.5 cm. Histologically, we found prominent adenomyosis with several leiomyomas. Patients with uterine malformations are known to suffer from endometrial dysfunction, most commonly due to endometriosis. However, massive adenomyosis in combination with leiomyomas, as presented in this case report, has not been described so far. These endometrial changes are important, since they significantly contribute to infertility.

A priori implantation potential does not differ in eutopic endometrium of patients with and without endometriosis.

BACKGROUND: In endometriosis, angiogenesis is a crucial step for implantation of the exfoliates. A priori potential to induce angiogenesis by vascular endothelial growth factor (VEGF) expression was compared in eutopic endometrium of patients with and without endometriosis to discriminate the pivotal pathogenic step that differs in endometriosis. METHODS: In an experimental prospective study, endometrium samples were obtained from endometriosis patients (n=10) and from healthy, ovulating women as controls (n=6) undergoing curettage and laparoscopy for benign gynaecological conditions at the Aachen University Hospital, Aachen, Germany. Endometrial fragments were transplanted to the chicken chorioallantoic membrane (CAM) and re-explanted after 0, 24, 48, 72 and 96 h of cultivation for analysis. The main outcome measure was VEGF mRNA expression and protein localisation in endometrial fragments as parameters of angiogenic induction that was quantified by the vessel index. RESULTS: VEGF mRNA expression increased significantly in endometrial fragments of endometriosis and control patients (p<0.05). Protein is expressed in the glands and endometrial stroma. The vessel index is significantly elevated compared with native CAM controls. Endometrial fragments of endometriosis and control patients showed no significant differences in VEGF expression or angiogenic induction. CONCLUSIONS: Eutopic endometrial fragments of patients with and without endometriosis do not differ in their VEGF expression or angiogenic activity in the CAM assay. Implantation is obviously decided by external regulating influences on the exfoliates.

2-[Fluorine-18]-fluoro-2-deoxy-d-glucose positron emission tomography in the diagnosis of recurrent ovarian cancer.

OBJECTIVE: The aim of the study was to investigate the role of 2-[fluorine-18]-fluoro-2-deoxy-d-glucose positron emission tomography (FDG PET) in the diagnosis of recurrent ovarian cancer. METHODS: One hundred six FDG PET scans performed in 54 patients in the follow-up after cytoreductive surgery and chemotherapy of ovarian cancer were reevaluated. Fifty-eight scans were performed in patients with suspected recurrence and 48 scans in patients who were clinically disease free. Thirty-seven PET scans were validated by histology and 66 studies by a median follow-up of 22 months in disease-free patients or 12 months in patients with recurrent disease. Three scans were validated by concordant positive findings of tumor marker CA125, computed tomography, and FDG PET. RESULTS: FDG PET correctly identified recurrent disease in 73/88 cases. PET ruled out recurrent disease in 15/18 cases. The sensitivity and specificity for PET were 83 and 83%, respectively. In patients with suspected disease, sensitivity was 94% compared to 65% in patients judged clinically disease free. The sensitivity of PET was 96% if suspicion of recurrence was based on a rise of CA125 alone. PET preceded the conventional diagnosis by a median of 6 months in patients judged clinically free of disease. The median relapse-free interval after a negative PET scan was 20 months. CONCLUSION: FDG PET provides the chance to detect recurrent ovarian cancer at an earlier stage during follow-up. Patients with a negative PET scan have a longer relapse-free interval than patients with a positive PET scan.