Ranibizumab reimbursement and treatment patterns for neovascular age-related macular degeneration in Taiwan - Results from the 12-month, observational RENOWNED study.

BACKGROUND: The RENOWNED study investigated the treatment patterns, real-world effectiveness and safety of ranibizumab in Taiwanese patients with neovascular age-related macular degeneration (nAMD) treated with ranibizumab 0.5 mg in accordance with the first reimbursement scheme effective from 2012 to 2014. METHODS: This study was a Phase IV, 12-month, open-label, prospective, observational study conducted in Taiwan. Patients with visual impairment due to nAMD initiating treatment with ranibizumab 0.5 mg were included. The primary endpoint was mean change in best-corrected visual acuity (BCVA) from Baseline at Month 3. RESULTS: Overall, 202 patients with nAMD were included. Mean (standard deviation [SD]) BCVA Early Treatment Diabetic Retinopathy Study letters improved from Baseline (49.6 [21.5] letters) at Month 3 (+4.9 [11.8], P < 0.0001), and at Month 12 (+3.5 [14.1], P = 0.0043). The proportion of patients with nAMD who lost ≥5 letters at Months 3 and 12 was 13.6% (n = 27) and 26.6% (n = 37), respectively. Mean (SD) central retinal thickness decreased from Baseline (320.1 [127.2] µm) with a mean reduction of 49.1 (107.3) µm at Month 3 (P < 0.0001), but was not significant at Month 12 with a mean reduction of 11.6 (115.6) µm (P = 0.2861). Mean (SD) number of ranibizumab injections over 12 months was 3.1 (1.0). A mean treatment interval of 109.5 days was observed between the third and fourth injections. After limited reimbursed ranibizumab injections, 43.8% patients received other treatments. The safety findings are consistent with previous studies. CONCLUSION: Ranibizumab 0.5 mg treatment for 12 months under real-world settings improved visual outcomes in Taiwanese patients with nAMD.

Vaginal birth after cesarean section: 10 years of experience in a tertiary medical center in Taiwan.

OBJECTIVE: Because of the increased risk of uterine rupture and other morbidities, instances of trial of labor after cesarean (TOLAC) have decreased in number each year. Nevertheless, under careful assessment and advanced medical care, TOLAC is still a safe option for delivery. The objective of this study is to find the factors that impact the success rate for TOLAC and to compare the results with Taiwan national registry data. MATERIALS AND METHODS: A longitudinal cohort study that includes a total of 254 cases of women receiving TOLAC in a tertiary medical center over a period of 10 years. RESULTS: A total of 254 participants who underwent TOLAC, which accounts for 1.67% of total labor instances (254/15,166), were enrolled for analysis. The success rate of TOLAC was found to be 80.70% (205/254), including 146 (57.5%) normal deliveries, 45 (17.7%) vacuum-assisted deliveries, and 14 (5.5%) forceps-assisted deliveries. The conversion rate to cesarean section was 19.3%. There were no uterine rupture cases in our study, and there were only two suspected cases, which turned out to have no actual rupture. When analyzing the factors affecting the results of TOLAC, we found that a successfully spontaneously delivered baby had a lower birth weight than the failed TOLAC cases that were converted to cesarean delivery (mean, 2989 g vs. 3379 g; p < 0.001). Among the patients who were converted to cesarean section, the most common reason was dysfunctional labor (79.6%), followed by fetal distress (14.3%). CONCLUSION: Under intensive care and observation, TOLAC section may still be a feasible choice. Nevertheless, the body weight of the baby has been shown to be a factor that can influence the success rate.

Measurement of fetal maxillary and mandibular angles for first-trimester prenatal screening among Taiwanese women.

BACKGROUND: Early fetal structure evaluation is crucial. Fetal abnormalities might indicate chromosomal anomalies or abnormal fetal growth. The aim of this study was to establish the appropriate reference range of maxillary and mandibular angles among the Taiwanese population at 11(+0)-13(+6) weeks of gestation in normal singleton pregnancy as reference values for prenatal ultrasonographic examinations. METHODS: Fetal ultrasonographic data on maxillary angles and mandibular angles at a gestational age ranging from 11(+0) weeks to 13(+6) weeks were recorded in this study. Maternal background and pregnancy outcome were obtained from hospital records. RESULTS: A total of 87 patients were included in this study. Maxillary and mandibular angles were successfully recorded in 87 (100%) and 84 (96.6%) patients, respectively. The mean maternal age was 31 (range, 19-41) years, with a corresponding gestational age of 12(+4) (range, 11(+0)-13(+6)) weeks. The maxillary and mandibular angles were 79.9° ± 15.6° and 71.0° ± 12.8°, respectively. First-degree correlation was not found to exist between gestational age and maxillary and mandibular angles. CONCLUSION: Normative data for ultrasonographic measurements of maxillary and mandibular angles among the Taiwanese population are presented. Our results may serve as reference values in congenital anomaly screening during prenatal examination.

Assessment of placental volume and vascularization at 11-14 weeks of gestation in a Taiwanese population using three-dimensional power Doppler ultrasound.

BACKGROUND: The placental volume and vascular indices are crucial in helping doctors to evaluate early fetal growth and development. Inadequate placental volume or vascularity might indicate poor fetal growth or gestational complications. This study aimed to evaluate the placental volume and vascular indices during the period of 11-14 weeks of gestation in a Taiwanese population. METHODS: From June 2006 to September 2009, three-dimensional power Doppler ultrasound was performed in 222 normal pregnancies from 11-14 weeks of gestation. Power Doppler ultrasound was applied to the placenta and the placental volume was obtained by a rotational technique (VOCAL). The three-dimensional power histogram was used to assess the placental vascular indices, including the mean gray value, the vascularization index, the flow index, and the vascularization flow index. The placental vascular indices were then plotted against gestational age (GA) and placental volume. RESULTS: Our results showed that the linear regression equation for placental volume using gestational week as the independent variable was placental volume = 18.852 × GA - 180.89 (r = 0.481, p < 0.05). All the placental vascular indices showed a constant distribution throughout the period 11-14 weeks of gestation. A tendency for a reduction in the placental mean gray value with gestational week was observed, but without statistical significance. CONCLUSION: All the placental vascular indices estimated by three-dimensional power Doppler ultrasonography showed a constant distribution throughout gestation.

Umbilical artery Doppler velocimetry in normal pregnancies from 11(+0) to 13(+6) gestational weeks: a Taiwanese study.

OBJECTIVE: The aim of this study is to investigate the relationship between umbilical artery flow and gestational age (GA) at 11-13(+6) weeks in normal pregnancy in the Taiwanese population. MATERIALS AND METHODS: Two hundred and fifty-three normal singleton pregnancies with GA ranging from 11 to 13(+6) weeks were included in this study. The velocity of systolic, diastolic, and pulsatility index (PI) of the umbilical artery, and the mean velocity of the umbilical vein were recorded. RESULTS: One hundred and eighty-seven participants fulfilling the inclusion and exclusion criteria were analyzed. The mean maternal age was 31 (range 19-45) years, with a corresponding GA of 12(+4) (range 11-13(+6)) weeks. The absence of end-diastolic velocity of the umbilical artery was observed in most of our cases (90.1%). No significant change was found in the vascular indices with GA for the mean velocity of the umbilical vein (mean velocity = 0.923 × GA - 1.594, r = 0.1497, p = 0.115). The systolic velocity of the umbilical artery and PI, however, behaved differently from the other variables. There was a significant increase in systolic velocity with GA [systolic wave (S wave) velocity = 0.237 × GA + 2.267; r = 0.149, p = 0.041]. By contrast, the PI showed a significant decrease in relation to the GA (PI = -0.016 × GA + 4.068; r = 0.196, p = 0.007). CONCLUSION: The S-wave velocity of the umbilical artery increased with GA. By contrast, the PI of the umbilical artery showed a decreasing trend with GA. This may ensure optimal placental perfusion, which is necessary to accommodate the increased blood flow to the developing fetus. Furthermore, an absence of end-diastolic velocity in the first trimester and early second trimester was usually seen.

Fetal maxillary and mandibular length in normal pregnancies from 11 weeks' to 13(+6) weeks' gestation: a Taiwanese study.

OBJECTIVES: This study aims to establish the normal range of maxillary and mandibular lengths within the Taiwanese population at 11(+0) weeks to 13(+6) weeks of gestation in normal singleton pregnancy as a reference value for prenatal ultrasonographic examinations. MATERIALS AND METHODS: We examined nuchal translucency in 269 normal singleton pregnancies, with the gestational age ranging from 11 weeks to 13(+6) weeks in this study. Fetal biometric measurements, with an emphasis on maxillary and mandibular lengths, were obtained from the patients during consecutive routine prenatal ultrasonographic examinations. RESULTS: Maxillary and mandibular lengths were recorded successfully in 191 patients and 179 patients, respectively. The mean maternal age was 31 years (range 19-45 years), with a corresponding gestational age of 12 + 4 weeks (range, 11(+0)-13(+6) weeks). A first-degree correlation was found to exist between the gestational age and maxillary length (r = 0.596; p < 0.0001; y = 1.491 × GA - 10.523) as well as mandibular length (r = 0.465; p < 0.0001; y = 1.050 × GA - 6.50). CONCLUSION: Normative data for ultrasonographic measurements of maxillary and mandibular lengths within the Taiwanese population were presented. Our data can serve as a reference value in congenital anomaly screening during prenatal examination.

Quantitative analysis of normal fetal brain volume and flow by three-dimensional power Doppler ultrasound.

BACKGROUND: Assessment of the fetal brain volume and blood flow is important in the evaluation of fetal growth. We used three-dimensional (3D) ultrasound and power Doppler to assess the fetal brain volume and the blood flow index during normal gestation. The relationships of these parameters were further analyzed. METHODS: We assessed the total volume and the blood flow index of the fetal brain in normal pregnancies using 3D ultrasound (Voluson 730). The bilateral parietal diameter (BPD) plane was measured by a 3D transabdominal probe to scan the fetal brain under the power Doppler mode. Then, we quantitatively assessed the total volume of the fetal brain, mean grey area (MG), vascularization index (VI), flow index (FI), and vascularization-flow index (VFI) by applying Kretz VOCAL software. RESULTS: The study included 126 fetuses, ranging from 15 to 38 weeks of gestation. The total volume of the fetal brain was highly positively correlated with the gestational age (GA) (correlation coefficient [r] = 0.976, p < 0.0001). The MG, VI, and VFI were negatively correlated with the GA (correlation coefficient [r] = -0.520, p < 0.0001; [r] = -0.421, p < 0.001; [r] = -0.319, p < 0.0001). The FI was positively correlated with the GA (correlation coefficient [r] = 0.483, p < 0.0001). CONCLUSION: 3D ultrasound can be used to assess the fetal brain volume and blood flow development quantitatively. Our study indicates that the fetal brain vascularization and blood flow correlates significantly with the advancement of GA. This information may serve as a reference point for further studies of the fetal brain volume and blood flow in abnormal conditions.

Ductus venosus Doppler velocimetry in normal pregnancies from 11 to 13 + 6 weeks' gestation - a Taiwanese study.

BACKGROUND: To investigate flow in the ductus venosus at 11-13 + 6 weeks of gestation in women with normal pregnancies in the Taiwanese population. METHODS: Two hundred and fifty-two normal singleton pregnancies with gestational ages ranging from 11 to 13 + 6 weeks were examined in this study. The pulsatility index for veins (PIV), resistance index (RI), peak velocity during ventricular systole (S-wave), and peak velocity during ventricular diastole (D-wave) were recorded from the ductus venosus. RESULTS: We analyzed 252 participants who all fulfilled the inclusion and exclusion criteria of our study. The mean maternal age was 31 (range 19-45 years), with a corresponding gestational age of 12 + 4 weeks (range 11-13 + 6). No significant change was found in the vascular indices as gestational age increased for the S-wave (S-wave = 1.4214 (GA) + 17.448, r = 0.09, P = 0.154), PIV (PIV = -0.0358 (GA) + 1.4143, r = -0.05, P = 0.378) and RI (RI = -0.035 (GA) + 1.1478, r = -0.064, P = 0.468). In contrast, the D-wave behaved differently from the other variables. There was a significant increase (r = 0.155, P = 0.013) in the D-wave with gestational age (D-wave = 1.4896 (GA) - 7.1547). CONCLUSION: D-wave velocity in the ductus venosus increased with gestational age. S-wave peak velocity showed an increasing trend and PIV showed a decreasing trend with gestational age, but they did not reach statistical significance.

Mean grey value is lower in endometriomas: differentiating a hypoechogenic adnexal cyst by 3-dimensional power Doppler ultrasound--a preliminary study.

BACKGROUND: To assess parameters of 3-dimensional power Doppler ultrasound in differentiating an endometrioma from other hypoechogenic adnexal cysts. METHODS: We collected 58 patients with classic-appearing endometriomas (homogeneous hypoechogenic adnexal cysts with round shapes) on a 2-dimensional conventional sonography. The serum level of CA-125, parameters of 3-dimensional pelvic ultrasound including the volume of the cyst, the mean grey value (MGV), and three vascular indices: vascularization index, flow index, and vascularization flow index, were measured and then, after surgical intervention, were compared between the group with histologically proven endometriomas and the group with other histological diagnoses. RESULTS: In the chocolate cyst group, the parity was significantly lower (0.68±0.17, p=0.012). The MGV and lesion volume of histologically proven endometriomas were significantly lower (14.78±0.7; 118.34±15.5) than those of other hypoechogenic benign adnexal cysts (17.17±0.74; 227.18±47.46), and the p values were 0.038 and 0.041, respectively. No differences in vascularization index (VI), flow index (FI), and vascularization flow index (VFI) were found between the two groups. No relationship between lesion volume and MGV in the two groups, either (p=0.127 and 0.353). We also found little correlation between CA-125 and the volume of a histologically proven endometrioma as well as between CA-125 and its MGV. CONCLUSION: MGV might be useful to differentiate an endometrioma from other homogeneous hypoechogenic adnexal cysts.