A prospective study of the effects of oral contraceptives on sexuality and well-being and their relationship to discontinuation.

The purpose of the study was to explore predictors of discontinuation of oral contraceptives (OC) including pre-OC use characteristics and adverse physical, emotional, and sexual effects of OCs. Women aged 18+ years in committed, sexually active relationships were assessed before starting OC and reassessed at 3, 6, and 12 months or shortly after discontinuation. Assessment included pre-OC use attitudes and expectations about the pill; self-reported side effects and perimenstrual symptoms including premenstrual syndrome (PMS); physical and emotional well-being; and sexual interest, enjoyment, and frequency of sexual activity. Seventy-nine women completed the study, 38% continued OCs, 47% discontinued, and 14% switched to another OC. Emotional side effects, worsening of PMS, decreased frequency of sexual thoughts, and decreased psychosexual arousability correctly categorized 87% of cases by using logistic regression. Emotional and sexual side effects were the best predictors of discontinuation/switching, yet such OC effects have been largely ignored in the research literature.

Experimental evaluation of a modified Amplatzer duct occluder.

The purpose of this study was to evaluate a new device specifically designed for patent ductus arteriosus (PDA) occlusion based on PDA anatomy. Percutaneous closure of aortopulmonary shunts was attempted in 10 dogs. Shunts were surgically created in the location and orientation of PDA. The occlusion prosthesis consisted of a cylindrical frame filled with polyester and a 32 degree angled retention disk. The delivery system of the device included a 6 Fr thin-walled Teflon introducing sheath, an antirotating delivery catheter, and cable. Complete occlusion of the shunt was obtained in nine animals. One animal died before device placement. Temporary hemolysis occurred in one dog after device placement. The disk of device was completely covered by smooth glistening neoendothelium at 1-3 months postmortem examination. None of the devices protruded into the lumen of the aorta. The device is an improvement over the standard Amplatzer duct occluder. The angled retention disk lies flatly against the aortic wall, avoiding turbulence or an aortic pressure gradient.

Transcatheter closure of membranous ventricular septal defects with a new nitinol prosthesis in a natural swine model.

Transcatheter closure of a membranous ventricular septal defect (MVSD) is much more difficult than closure of other intracardiac defects because of the proximity to the aortic and tricuspid valves and their relatively large size in small children. In this report, transcatheter closure of naturally occurring membranous VSDs was attempted in 12 Yucatan minipigs. The prosthesis is constructed from fine Nitinol wires in the shape of two buttons and a connecting waist filled with polyester fiber. Two kinds of prosthesis were used in this study: concentric and eccentric left-sided retention disks. A 6 or 7 Fr delivery sheath was advanced across the membranous VSD over a wire from femoral vein. The prosthesis was inserted through the sheath by pushing the delivery cable to deploy a button into left ventricle and the second button was then deployed into right ventricle by withdrawing the sheath. Successful implantation of the device was achieved in all animals except one. Complete closure rate was 58.3% immediately after placement, 100% at 1 week, 90.9% at 1 month and 3 months, and 100% at 6 months. An associated aneurysm of the membranous septum increased significantly in size in two of three animals using the concentric device, and in none of the animals using the eccentric device. A trace to mild aortic regurgitation was present in two of the three animals using the concentric device, and only in one of the eight animals using the eccentric device. Five animals developed a trace to mild tricuspid regurgitation. Pathologic examination showed all devices to be covered by smooth neoendothelium at 3 months. This report presents the first experimental study where closure of membranous ventricular septal defects in a swine model was attempted by specially constructed devices. Procedural success and occlusion rates are very encouraging but overall results cannot equal surgery. Further experimentation is needed with devices that are redesigned according to the experience gained from this study.

New device for closure of muscular ventricular septal defects in a canine model.

BACKGROUND: Repair of muscular ventricular septal defects (MVSDs) has always been challenging to the surgeon. Long-term morbidity and mortality are significantly increased if the defects are closed via left ventriculotomy or if they are associated with other complex congenital anomalies. The purpose of this study was to close MVSDs with the Amplatz ventricular septal defect device. This device is constructed from 0.004-in nitinol wire mesh filled with polyester fibers. It is retrievable, repositionable, self-centering, and of low profile. METHODS AND RESULTS: MVSDs were created with the help of a sharp punch in 10 dogs. The location of the defects was anterior muscular (n=3), midmuscular (n=3), apical (n=3), and inlet muscular (n=1). The diameter of the defects ranged from 6 to 14 mm. All defects were closed in the catheterization laboratory. The device was placed with the help of transesophageal echocardiography and fluoroscopy. A 7F sheath was used to deploy the device from the right ventricular side in 8 and the left ventricular side in 2 dogs. Placement was successful in all animals. The complete closure rate was 30% (3/10) immediately after placement and 100% at 1-week follow-up. Pathological examination of the heart revealed complete endothelialization of the device in dogs killed after 3 months. CONCLUSIONS: The Amplatz ventricular septal defect device appears highly efficacious in closing MVSDs. The advantages include a small delivery sheath, complete retrievability before release, and the fact that it is self-centering and self-expanding, thereby making it an attractive option in smaller children.

New self-expanding patent foramen ovale occlusion device.

Our purpose was to evaluate a new self-expanding device for closure of the patent foramen ovale (PFO). A transeptal catheter passage through the flap of the fossa ovalis was performed with a transeptal needle inside a catheter, creating a PFO in two minipigs. In an additional five animals, a naturally occurring PFO was found. The device is made from 0.005 inch nitinol wire mesh with polyester fabric inside, similar in construction to the Amplatzer atrial septal occluder. However, the left atrial disc is smaller (18 mm) than the right atrial disc (26 mm). Both discs are connected by a very short flexible waist (3 mm) that allows free movement of both retention discs. Pulmonary and right atrial angiography were performed after placement, at 1 month, and at 3 months follow-up. Placement of the device was technically successful in six animals. One animal died from ventricular fibrillation during placement. Pulmonary angiography and echocardiography showed complete occlusion of the PFO in six animals. Two animals were sacrificed after 1 month and four animals after 3 months. In the animals sacrificed at 1 month, histopathological examination showed partial (n = 2) endothelialization, and in the 3 months follow-up group (n = 4) endothelialization was complete. The device appears to be highly effective for occlusion of PFOs. This procedure may be performed as an outpatient procedure due to the small 7 Fr delivery system sheath. Cathet. Cardiovasc. Intervent. 47:370-376, 1999.

Oxygen desaturation of selected term infants in car seats.

OBJECTIVES: Premature infants are known to be at risk for oxygen (O2) desaturation and/or apnea in car seats. Since 1990, the American Academy of Pediatrics has recommended a period of monitoring in car seats before hospital discharge for infants born at < 37 weeks gestation. The objective of this report is to determine if selected term infants are also at risk for O2 desaturation, apnea, or bradycardia while in an infant car seat. METHODS: MetroWest Medical Center is a community hospital with a level II neonatal unit. Term infants who in the judgment of their pediatrician were felt to be at risk for O2 desaturation or apnea were monitored for a 90-minute period in a car seat and observed for transcutaneous O2 desaturation, apnea, or bradycardia. In addition, several infants who were admitted to the pediatric inpatient unit after discharge from the nursery were monitored in a similar fashion. RESULTS: Eight of 28 monitored infants (28.6%) had a period of O2 desaturation < 90%. In addition, five of 28 monitored infants (17.8%) had borderline results (O2 saturation, 90 to 93%). All four infants monitored because of genetic syndromes had abnormal results. O2 desaturation was also observed in two term infants who had been observed to be apneic by a parent after discharge from the nursery. CONCLUSIONS: In selected circumstances (eg, genetic disorders or observed apnea) term infants may be at risk for O2 desaturation in an upright car seat and monitoring these infants in car seats before nursery discharge should be considered. Because not all infants at risk for O2 desaturation can be identified at birth, an alternative approach would be to recommend, unless medically contraindicated (eg, gastroesphogeal reflux when supine), that infants should routinely be transported in a supine position car seat in the early months of life.

Childhood injury prevention counseling in primary care settings: a critical review of the literature.

OBJECTIVES: The American Academy of Pediatrics (AAP) believes that health education, through office-based counseling, can contribute to childhood injury prevention. This report presents the results of a critical review of the scientific literature on the effectiveness of primary care-based counseling to prevent childhood unintentional injury. METHODS: A panel selected from the AAP Committee and the AAP Section on Injury and Poison Prevention searched the English-language scientific literature for all articles about childhood unintentional injury prevention counseling. A standardized format was developed to record data on each study. Two members of the panel independently reviewed each article. Articles that were original reports and in which unintentional injury prevention counseling took place in a primary care setting were included. Articles were encoded and analyzed by computer and then grouped by quality of evidence using the US Preventive Services Task Force (USPSTF) method of categorizing results of medical care evaluation. Articles were rated by strength of study design in order to compare studies within each USPSTF group. RESULTS: Twenty articles met the criteria for inclusion. Of these, 18 showed positive effects of injury prevention counseling including five randomized/controlled, 10 non-randomized/controlled, two multiple time series, and one descriptive study. In 15 of the positive studies, physicians performed the counseling. Positive outcomes as measured by increased knowledge, improved behavior, or decreased injury occurrence were reported for both motor vehicle and non-motor vehicle injuries. CONCLUSIONS: The literature review supports the recommendation of the AAP to include injury prevention counseling as part of routine health supervision. This recommendation has implications for health care reimbursement and care content.

Monitoring premature infants in car seats: implementing the American Academy of Pediatrics policy in a community hospital.

OBJECTIVES: In 1990, the American Academy of Pediatrics (AAP) Committee on Injury and Poison Prevention issued a policy statement which recommended that all infants born at less than 37 weeks gestational age be monitored in their car seat before discharge to identify infants at risk for apnea associated with car seat use. The objective of this report is to summarize the experience of a community hospital in implementing this recommendation, including: education of health professionals about the problem and its management, development of an effective hospital policy and procedure for testing at-risk infants, overcoming logistical difficulties for nursing staff who implement the policy, overcoming liability concerns, and summarizing the clinical results which we observed during a 15-month period. METHODS: MetroWest Medical Center, Framingham Union Campus is a community hospital with a Level II Neonatal Unit with approximately 2200 deliveries annually. Hospital procedures and policies were developed to implement the AAP policy for safe transportation of premature infants. Consequently, infants less than 37 weeks gestation at birth were monitored for a 90-minute observation period for oxygen saturation, apnea, or bradycardia in the car seat that they would be going home in from the nursery. RESULTS: Policies and procedures for car seat monitoring were instituted successfully during 15-month period. Sixteen of 87 (18.4%) monitored infants 26 to 36 weeks gestation had abnormal results. In addition, one 37-week gestational newborn who was monitored because of duskiness during feeds also became apneic and bradycardic in the car seat. CONCLUSIONS: A car seat monitoring program can be incorporated effectively into a Level II community hospital nursery discharge plan provided that appropriate medical staff policies, nursing procedures, and administrative support to deal with the logistics of the program is established. Our monitoring results are consistent with previous reports that premature infants are at risk of desaturation in a car seat. In addition, we have demonstrated that a full-term neonate may also be at risk if other evidence of desaturation (eg, duskiness during feedings) is observed.

Results of a right ventricular outflow patch for pulmonary atresia with intact ventricular septum.

BACKGROUND: Although overall outcome has improved, pulmonary atresia with intact septum remains a difficult surgical and clinical problem. To determine whether an early right ventricular outflow patch will result in biventricular repair for this lesion, we reviewed the long-term follow-up (5.8 +/- 0.8 years) of 19 newborns who underwent repair between 1979 and 1990. METHODS AND RESULTS: An early right ventricular outflow patch was placed in 15 of 19 newborns; in the remaining four, this was preceded by an aortopulmonary shunt. Prostaglandin E1 infusion postoperatively eliminated the need for shunt in 14 of 15. Coronary sinusoids were ligated in three newborns. Based on right ventricular morphology, the newborns were divided into two groups: group 1 (tripartite, n = 9) and group 2 (bipartite and monopartite, n = 10). Before surgery, group 1 had significantly larger right ventricular volumes (23.6 +/- 3.7 versus 5.2 +/- 1.1 ml/m2, p < 0.002). Five-year survival was 79% for the entire series. Four infants, all group 2, died within 12 months of their initial surgery. Fourteen of 15 survivors (nine group 1 and five group 2) currently are acyanotic and New York Heart Association functional class I. A biventricular repair was achieved in 12 of 15, and three other children are awaiting evaluation. All 15 survivors had significant right ventricular and tricuspid annulus growth. CONCLUSIONS: Our data suggest that early placement of a right ventricular outflow patch in infants with pulmonary atresia and intact ventricular septum, regardless of right ventricular anatomy, results in an excellent chance for biventricular repair.

Parasitology screening of Latin American children in a primary care clinic.

A screening program based in a Massachusetts community hospital primary care clinic, which included 124 children from 12 different Latin American countries, demonstrated that nearly 35% were carriers of pathogenic parasites. The large majority (83.7%) of these children were asymptomatic at the time of the examination. Although there may be considerable variation based on country of origin, the present results, as well as a review of the literature, suggest this is likely to be a common finding among children born in most regions of Latin America. Compliance with the screening process was significantly higher in groups with higher infection rates and the successive yield in those patients who submitted two or more stool samples revealed that most pathogens were identified in the first sample. School-age children were found to have the highest risk for both roundworm infections and multiple parasitic infections. For those children with identified pathogens, nearly 90% received treatment. Current trends in immigration, international adoptions, and special circumstances including day care, family shelters, and increasing numbers of human immunodeficiency virus-infected children have made an appreciation of the extent of parasitosis, and awareness of possible management approaches, an important consideration for primary care physicians in the United States.