Carbon Dioxide-Based versus Saline Tissue Expansion for Breast Reconstruction: Results of the XPAND Prospective, Randomized Clinical Trial.

BACKGROUND: AeroForm is a new type of remote-controlled, needle-free, carbon dioxide-based expander involving a potentially faster method of tissue expansion. Results are presented here from the AirXpanders Patient Activated Controlled Tissue Expander pivotal trial comparing AeroForm to saline tissue expanders. METHODS: Women undergoing two-stage breast reconstruction were randomized at 17 U.S. sites in this U.S. Food and Drug Administration-approved investigational device exemption trial. Expansion in the investigational arm was performed by the patient in 10-cc increments up to 30 cc/day of carbon dioxide and in the control arm by the physician with periodic bolus injections of saline. Safety endpoints, expansion and reconstruction times, pain, and satisfaction were assessed. RESULTS: One hundred fifty women were treated: 98 with carbon dioxide expanders (n = 168) and 52 with saline expanders (n = 88). The treatment success rate (all breasts exchanged successfully excluding non-device-related failures) was 96.1 percent for carbon dioxide and 98.8 percent for saline. Median time to full expansion and completion of the second-stage operation was 21.0 and 108.5 days (carbon dioxide) versus 46.0 and 136.5 days (saline), respectively, with a similar rate of overall complications. Ease of use for the carbon dioxide expander was rated high by patients (98 percent) and physicians (90 percent). CONCLUSIONS: The AirXpanders Patient Activated Controlled Tissue Expander trial results demonstrate that a carbon dioxide-based expander is an effective method of tissue expansion with a similar overall adverse event rate compared to saline expanders, and provides a more convenient and expedient expansion. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, I.

Maintaining quality assurance for sonographic nuchal translucency measurement: lessons from the FASTER Trial.

OBJECTIVE: To evaluate nuchal translucency measurement quality assurance techniques in a large-scale study. METHODS: From 1999 to 2001, unselected patients with singleton gestations between 10 + 3 weeks and 13 + 6 weeks were recruited from 15 centers. Sonographic nuchal translucency measurement was performed by trained technicians. Four levels of quality assurance were employed: (1) a standardized protocol utilized by each sonographer; (2) local-image review by a second sonographer; (3) central-image scoring by a single physician; and (4) epidemiological monitoring of all accepted nuchal translucency measurements cross-sectionally and over time. RESULTS: Detailed quality assessment was available for 37 018 patients. Nuchal translucency measurement was successful in 96.3% of women. Local reviewers rejected 0.8% of images, and the single central physician reviewer rejected a further 2.9%. Multivariate analysis indicated that higher body mass index, earlier gestational age and transvaginal probe use were predictors of failure of nuchal translucency measurement and central image rejection (P = 0.001). Epidemiological monitoring identified a drift in measurements over time. CONCLUSION: Despite initial training and continuous image review, changes in nuchal translucency measurements occur over time. To maintain screening accuracy, ongoing quality assessment is needed.

Chorionic villus sampling before multifetal pregnancy reduction.

OBJECTIVE: This study was undertaken to determine the technical feasibility and accuracy of chorionic villus sampling before multifetal pregnancy reduction and to determine whether sampling increases the pregnancy loss rate after the reduction procedure. STUDY DESIGN: Between January 22, 1986, and January 20, 2000, a total of 1183 patients underwent first-trimester multifetal pregnancy reduction at Mount Sinai Medical Center. Chorionic villus sampling was attempted in 86 patients before the reduction procedure. Information on the technical success and accuracy of chorionic villus sampling, as well as pregnancy outcome, was collected on all patients. Pregnancy loss rates before 24 weeks' gestation in patients undergoing chorionic villus sampling before multifetal pregnancy reduction were compared with rates in patients not undergoing sampling. RESULTS: Chorionic villus sampling was successfully completed in 85 (98.8%) of 86 patients in whom sampling was attempted. Of 166 fetuses, 165 (99.4%) were successfully sampled. Of 165 fetuses, 3 (1.8%) had karyotypic abnormalities. Sampling errors were probably made in 2 (1.2%) of 165 fetuses. Of the 73 patients who have been delivered or are beyond 24 weeks' gestation, only 1 patient (1.4%) had a pregnancy loss after the multifetal pregnancy reduction. CONCLUSIONS: Chorionic villus sampling before multifetal pregnancy reduction is technically feasible and accurate, with an acceptably low sampling error rate. Chorionic villus sampling before multifetal pregnancy reduction appears to be safe and does not increase the risk of loss after the reduction procedure.

First-trimester screening for aneuploidy: research or standard of care?

First-trimester screening for Down syndrome has been proposed as a significant improvement with respect to second-trimester serum screening programs, the current standard of care, because of apparently higher detection rates and an earlier gestational age at diagnosis. First-trimester nuchal translucency on ultrasonography forms the basis of this new form of screening, although studies of its efficacy have yielded widely conflicting results, with detection rates ranging from 29% to 91%. Studies of first-trimester serum screening with measurements of pregnancy-associated plasma protein A and free beta-human chorionic gonadotropin serum concentrations have been much more consistent, with Down syndrome detection rates of 55% to 63% at a 5% false-positive rate. The combination of first-trimester ultrasonographic and serum screening has the potential to yield a Down syndrome detection rate of 80% at a 5% false-positive rate, although this approach has not been adequately studied. There have been no studies performed to date to directly compare the performance of first-trimester and second-trimester methods of screening. Two major trials are underway that will address this issue, one in the United Kingdom and one in the United States. Until the results of these trials are available, the current standard of care with respect to Down syndrome screening should not be changed, and first-trimester screening should remain investigational.

Outcomes among 562 recipients of placental-blood transplants from unrelated donors.

BACKGROUND: A program for banking, characterizing, and distributing placental blood, also called umbilical-cord blood, for transplantation provided grafts for 562 patients between August 24, 1992, and January 30, 1998. We evaluated this experience. METHODS: Placental blood was stored under liquid nitrogen and selected for specific patients on the basis of HLA type and leukocyte content. Patients were prepared for the transplantation of allogeneic hematopoietic cells in the placental blood and received prophylaxis against graft-versus-host disease (GVHD) according to routine procedures at each center. RESULTS: Outcomes at 100 days after transplantation were known for all 562 patients, and outcomes at 1 year for 94 percent of eligible recipients. The cumulative rates of engraftment among the recipients, according to actuarial analysis, were 81 percent by day 42 for neutrophils (median time to engraftment, 28 days) and 85 percent by day 180 for platelets (median, day 90). The speed of myeloid engraftment was associated primarily with the leukocyte content of the graft, whereas transplantation-related events were associated with the patient's underlying disease and age, the number of leukocytes in the graft, the degree of HLA disparity, and the transplantation center. After engraftment, age, HLA disparity, and center were the primary predictors of outcome. Severe acute GVHD (grade III or IV) occurred in 23 percent of patients, and chronic GVHD occurred in 25 percent. The rate of relapse among recipients with leukemia was 9 percent within the first 100 days, 17 percent within 6 months, and 26 percent by 1 year. These rates were associated with the severity of GVHD, type of leukemia, and stage of the disease. CONCLUSIONS: Placental blood is a useful source of allogeneic hematopoietic stem cells for bone marrow reconstitution.

Increased interleukin-6 concentrations in cervical secretions are associated with preterm delivery.

OBJECTIVE: This study sought to determine whether elevated concentrations of interleukin-6 in the cervical and vaginal secretions of patients between 24 and 36 weeks' gestation predicted subsequent preterm delivery and/or identified those preterm deliveries associated with maternal infectious morbidity. STUDY DESIGN: A cohort study was undertaken with cervical and vaginal samples collected from 161 consenting patients seen at 3- to 4-week intervals between 24 and 36 weeks. Levels of interleukin-6 were measured by immunoassay. Demographic, obstetric, neonatal, and laboratory data were analyzed by Fisher's exact test, Student t test, or Wilcoxon rank sum test, linear and multiple logistic regression, and receiver-operator characteristic curve analysis. RESULTS: There were 4.2-fold and 3.4-fold increases in maximal cervical and vaginal interleukin-6 concentrations, respectively, among patients with preterm deliveries versus term deliveries. The receiver-operator characteristics curve analysis indicated that a single cervical interleukin-6 value > 250 pg/ml of sample buffer, present between 24 and 36 weeks' gestation, optimally identified patients with subsequent preterm deliveries versus term deliveries (sensitivity 50.0%, 95% confidence interval 33.2% to 66.8%; specificity 85.0%, 95% confidence interval 78.8% to 91.2%; positive predictive value 47.2%, 95% confidence interval 30.9% to 63.5%; negative predictive value 86.4%, 95% confidence interval 80.4% to 92.4%). The optimal vaginal interleukin-6 cutoff value (> 125 pg/ml) proved less sensitive (45.5%, 95% confidence interval 28.5% to 62.4%) but equally specific (86.6%, 95% confidence interval 80.7% to 92.5%). Multiple logistic regression indicated that a cervical interleukin-6 level > 250 pg/ml was an independent predictor of preterm delivery (adjusted odds ratio 4.8, 95% confidence interval 1.7 to 14.3). Cervical interleukin-6 levels did not correlate with cervical change or gestational age at sampling. Among patients delivered preterm there were no differences in the mean white blood cell count on admission or the prevalence of vaginal pathogens, alkaline vaginal pH, chorioamnionitis, or endometritis among patients with cervical interleukin-6 values > 150 or < or = 250 pg/ml. CONCLUSIONS: Cervical interleukin-6 is a relatively insensitive, although fairly specific discriminator of patients with subsequent preterm deliveries. Among patients delivered preterm, elevated cervical interleukin-6 values are not apparently associated with maternal infectious morbidity.

Unrelated placental blood for bone marrow reconstitution: organization of the placental blood program.

The usefulness of placental/umbilical cord blood as a source of stem cells for marrow reconstitution of HLA-matched siblings has now been extended to the unrelated-donor setting. The need for HLA-matched donor tissue makes it essential to have available a frozen inventory of ready-to-use placental blood units. The New York Blood Center's Placental Blood Project, designed to evaluate the practical feasibility of unrelated placental blood transplantation, consists of four basic modules: collection of placental blood, maternal samples and donor data, accession and testing for genetic and infectious disease markers, freezing placental blood units, and data organization and retrieval. Additional modules include a computerized HLA matching algorithm and organization of data about patients requiring transplantation, which may be best taken up by organ-sharing organizations in the future. In this report, we describe the organization and discuss the methods and overall experience after collecting the first 1,000 units and supplying the tissue for the first two unrelated-donor placental blood transplants.

Morbidity of failed labor in patients with prior cesarean section.

OBJECTIVE: The aim of our study was to determine whether the reported increased morbidity associated with failed attempted vaginal birth after cesarean section is attributable to the presence of a uterine scar alone or to labor preceding a cesarean section. STUDY DESIGN: Primiparous women (N = 237) who underwent repeat cesarean section after a failed trial of vaginal birth after cesarean section were retrospectively compared with 1582 nulliparous women who underwent a primary cesarean section after a failed trial of labor. RESULTS: There were no significant differences in maternal or neonatal morbidity between the two groups except for an increase in the prevalence of thin meconium in patients undergoing primary cesarean section. CONCLUSION: Our results suggest that the presence of a previous cesarean section scar does not increase the overall baseline morbidity associated with cesarean section after labor.

Prophylactic and emergent arterial catheterization for selective embolization in obstetric hemorrhage.

Treatment of obstetric hemorrhage by the selective embolization of damaged pelvic vessels under fluoroscopy holds promise as an alternative to surgical intervention. Unfortunately, the effectiveness of selective embolization is often compromised by its use in emergent settings following the failure of primary operative approaches. Therefore we compared the efficacy of prophylactic versus emergent catheter placement for selective embolization in nine patients with or at risk for obstetric hemorrhage. In four patients with acute obstetric hemorrhage catheterization and embolization was carried out following the failure of initial medical and surgical approaches. In five patients determined to be at risk for intrapartum hemorrhage based on sonographic findings, catheters were inserted into the hypogastric vessels prior to elective cesarean delivery. Three of these five patients subsequently required selective embolization. In comparison to patients undergoing selective embolization following prophylactic catheter placement, patients in the emergent group all had a coagulopathy at the time of embolization, sustained substantially greater blood loss, and had an increased rate of postpartum complications. Finally, there was a significant reduction in total embolization time and therefore in radiation exposure in patients undergoing prophylactic catheter placement prior to selective embolization. These data support the conclusion that in patients determined to be at risk for intrapartum or postpartum hemorrhage the prophylactic placement of catheters allows for selective embolization in a hemodynamically intact patient with stable coagulation indices, theoretically reducing the risk of maternal morbidity and possibly mortality.

Contemporary management of a potentially lethal fetal anomaly: a successful perinatal approach to epignathus.

Prenatal diagnosis of epignathus (a teratoma originating in the oropharynx) has been reported previously. However, in many of these cases the neonates succumbed to acute respiratory distress secondary to airway obstruction at the time of birth. We describe a case of antepartum diagnosis of epignathus using ultrasonography and magnetic resonance imaging as complementary techniques. The ability to accurately define the fetal anomaly permitted us to plan a unique strategy for peripartum management. After cesarean delivery of the infant from the uterus, the umbilical cord was not clamped and the fetoplacental circulation was left undisturbed. A tracheostomy was then performed, after which the umbilical cord was clamped and the infant was stabilized. Several hours later, a debulking procedure was performed in the operating room to remove the tumor from its attachment to the bony palate. Both mother and infant did well postoperatively. The ability to plan and perform a controlled tracheostomy while the infant remained oxygenated and ventilated proved to be lifesaving in this case.

Infection following breast reconstruction.

Of 33 patients who underwent 49 breast implantations for reconstructive surgery, 8 (24%) patients developed implant infections. All 8 of these patients were among a subgroup of 15 having immediate breast reconstructions with tissue expander implants after simple or modified radical mastectomy (a 53% infection rate). The infection rate increased substantially when bilateral procedures involving implants were performed as opposed to unilateral implants. Nine implants were removed (an overall implant loss rate of 18%). Patients who underwent other breast reconstruction techniques (i.e., including immediate reconstruction with permanent implants or delayed reconstruction with or without tissue expanders) did not develop infection unless they had had simultaneous immediate reconstruction with a tissue expander in the contralateral breast. The most frequently isolated organism was the coagulase-negative staphylococcus. The study concludes that neither the tissue expander nor immediate reconstruction is a risk factor, but the combination may lead to an unacceptable infection rate, especially in the face of bilateral breast procedures.

Selective second-trimester termination of the anomalous fetus in twin pregnancies.

Selective termination of the affected fetus was performed during the second trimester in 17 pregnancies in which one twin was diagnosed to be anomalous. The affected twin had a chromosomal aneuploidy in 14 cases, neural tube defect in two cases, and an inborn error of metabolism in one case. With increasing operator skill and improvement in technique, a striking improvement occurred in pregnancy outcome in the last 11 patients as compared with the first six. In four of the first six cases, the entire pregnancy was lost. Among the last 11 patients, on the other hand, no pregnancy was lost. All 11 women delivered healthy, viable infants; eight delivered at term and three delivered between 31-35 weeks. Of the various techniques used, we found intracardiac injection of potassium chloride to be the most effective, but it should not be used in monochorionic twin gestations.

Choroid plexus cysts in the fetus: a benign anatomic variant or pathologic entity? Report of 41 cases and review of the literature.

During a 22-month period, 6288 women undergoing prenatal sonographic studies in the second and third trimesters were evaluated prospectively to determine the incidence of choroid plexus cysts in the fetus, to follow the natural course of these cysts in intrauterine life, and to determine the association of chromosomal and anatomic anomalies in these fetuses. We diagnosed choroid plexus cysts in 41 fetuses, an incidence of 0.65%. Unilateral and bilateral cysts were equally frequent, and in most cases diagnosed by 21 weeks' gestation. On follow-up scans, the cysts had completely disappeared by 23-24 weeks in 80% of the cases, and by 28 weeks in another 10%. Once resolved, the cysts did not recur, and a normal sonogram in the late second trimester predicted normal scans in late pregnancy and in the neonate. One fetus had a chromosomal abnormality (trisomy 18). Associated anatomic anomalies were detected in three fetuses, including the one with trisomy 18. We believe that in the great majority of cases, fetal choroid plexus cysts are benign transient variants of normal intracranial anatomy. It is, however, important to conduct a careful sonographic search for associated anomalies. Chromosomal studies are strongly recommended whenever associated anatomic abnormalities are detected and when the choroid plexus cysts are large, bilateral, and persistent beyond 20-22 weeks' gestation.

Red cell size heterogeneity during ontogeny.

To determine the manner in which erythrocyte changes occur during ontogeny, several red cell parameters were analyzed in fetuses, newborn infants, children, and adults. Although mean cell volume (MCV) and hemoglobin F (HbF) levels decreased as expected during in utero development, the coefficient of variation of red cell size (%CV), or red cell distribution width (RDW), increased from fetuses to newborn infants. In normal adults, the %CV was 15 (RDW was 13). The %CV in fetuses at 18-24 weeks gestation was 18, and it was 21 at term birth. High values for %CV or RDW indicate significant anisocytosis. Erythropoiesis at the time of birth is not a steady-state condition. Erythrocytes of a wide variety of sizes are present, with the appearance of new small cells on a background of older, larger red cells. This increased anisocytosis suggests that these new erythrocytes do not appear to be due to a smooth, continuous evolution of red cell size, but rather to discrete, perhaps clonal, changes.

The nonpredictive value of fetal urinary electrolytes: preliminary report of outcomes and correlations with pathologic diagnosis.

Fetal urine was sampled 12 times in nine fetuses with sonographically diagnosed urinary tract obstruction to assess renal function. By previously proposed criteria, four fetuses were predicted to have poor renal function. Two of these fetuses were found to have renal dysplasia on autopsy after elective termination. The other two died in the neonatal period but only one of these had histologic evidence of renal dysplasia. Five fetuses were predicted to have good renal function. Three of these developed renal failure after birth, one was found to have renal dysplasia on autopsy after elective termination, and one is alive and well. We conclude that fetal urine electrolytes are not necessarily an accurate predictor of neonatal renal function.

Fetal giant hemangiolymphangioma: report of a case.

A hemangiolymphangioma is a malformation of both lymphatic and blood vessels. A case of giant hemangiolymphangioma with extensive fetal involvement is presented and considerations in the antenatal diagnosis of this anomaly are discussed.

Prenatal diagnosis of fetal brain tumors.

Two cases of congenital brain tumors were detected during routine antepartum sonography at the Mount Sinai Medical Center Perinatal Ultrasound Unit. In both cases, diagnosis was made during the third trimester at 31 and 33 weeks, respectively. In one of these patients, no intracranial abnormalities were noted on a sonogram performed in conjunction with genetic amniocentesis at 18 weeks gestation. The histologic diagnosis of both tumors was glioblastoma multiforme grade III. Previous reports describing the prenatal sonographic diagnosis of intracranial tumors have been in cases with fetal intracranial teratomas.