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.

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.

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.

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.

Pediatric problems in a suburban shelter for homeless families.

The experience of an affiliation between a hospital-based clinic and a family shelter is presented. The medical implications of family shelter residence include special issues related to the spread of infectious diseases, particularly to the neonate. Preentry medical evaluation revealed that a large proportion of children and their parents had one or more medical problems. Of 67 children screened before entrance, 13% [corrected] had Giardia lamblia detected in the stool. In addition to carriage of enteric pathogens, the range of pediatric problems encountered included a variety of acute and chronic medical conditions, unmet primary care needs, and developmental and school difficulties. Fifty-eight percent of shelter residents were found to be "medically homeless." Formal liaison between a hospital-based clinic and a family shelter was found to be an effective way to promote a healthy environment in the family shelter and to provide needed medical services to shelter families.

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.

Isolated cleft mitral valve: a variety of congenital mitral regurgitation identified by 2-dimensional echocardiography.

Nine children with isolated cleft mitral valve, aged 1 day to 12 years, were studied. The electrocardiogram showed a normal QRS axis in 5 subjects. Cardiac catheterization was performed in 4 patients and demonstrated severe mitral insufficiency in 3 but failed to clearly demonstrate a cleft mitral valve or gooseneck deformity. The mitral cleft was confirmed at operation in 2 patients. Two-dimensional echocardiography demonstrated a cleft dividing the anterior mitral leaflet into 2 portions in each patient. The mitral anulus was normally positioned and the atrioventricular septum present. Atrial and ventricular septa were intact. Features similar to anatomic studies such as accessory chordae and thickening of the edges of the cleft with increasing age were also seen. Two-dimensional echocardiography is the only method available to reliably diagnose isolated cleft of the mitral valve.

Echocardiographic screening to assess the severity of congenital aortic valve stenosis in children.

Recent reports suggest that peak left ventricular systolic pressure can be estimated from the echocardiogram. This study compares the accuracy of echocardiographic measurements with clinical estimates of severity of aortic stenosis derived from information of the Joint Natural History Study. Twenty-seven children with isolated aortic valve stensosis were evaluated clinically and with echocardiography and cardiac catheterization. From the echocardiograms, the ratio of systolic left ventricular wall thickness to internal dimension (Ws/Ds) showed a better correlation (r = 0.82) with peak left ventricular systolic pressure than did the diastolic ratio. However, there was significant variation so that a precise estimate of peak left ventricular systolic pressure could not be made from the echocardiogram. Eight of the 27 patients had a normal Ws/Ds ratio (0.55 or less), and their cardiac catheterization data revealed mild aortic stenosis not requiring operation. In contrast, clinical criteria based on the Natural History Study identified only three of the patients with mild aortic stenosis. Prospective studies are needed to confirm the usefulness of echocardiography in noninvasive evaluation of children with aortic valve stenosis.

Echocardiographic incidence of cardiac rhabdomyoma in tuberous sclerosis.

Cardiac rhabdomyoma occurs frequently in patients with tuberous sclerosis (TS). Although there have been case reports of detection of cardiac rhabdomyoma by 2-dimensional echocardiography, no study has examined the frequency of cardiac rhabdomyoma detected by cardiac ultrasound in patients with TS. Echocardiography was performed in 16 consecutive patients with TS. Physical examination revealed normal cardiac findings in each. Discrete areas of increased acoustic density were found in 8 of the 16 patients (50%). The maximum diameters ranged from 3 to 20 mm. Multiple areas were found in 3 of 8. The left ventricle was involved in 5 of the 8. Six masses were intracavitary and 8 were intramyocardial. No atrial masses were seen. Left ventricular size and function were normal. Although other tumors cannot be excluded, the diagnosis of cardiac rhabdomyoma is almost certain in these young patients with TS. The male predominance and the high incidence of intracavitary and left ventricular masses are similar to those in reported autopsy series, also supporting the diagnosis of cardiac rhabdomyoma. The prognosis and potential for growth of these masses are not known, but can be determined by longitudinal follow-up. Cardiac ultrasound should be considered for all patients with TS regardless of physical findings.

Balloon angioplasty--branch pulmonary artery stenosis: results from the Valvuloplasty and Angioplasty of Congenital Anomalies Registry.

Balloon angioplasty for branch pulmonary artery stenosis was reported from 27 institutions to the Valvuloplasty and Angioplasty of Congenital Anomalies Registry. One hundred eighty-two procedures were performed in 156 patients ranging in age from 0.2 to 46.2 years (mean 7.7). Short-term angiographic appearance, hemodynamic results and immediate complications were recorded. Vessel dimension at the site of stenosis increased from 4.5 +/- 2.0 (mean +/- standard deviation) to 6.8 +/- 3.0 mm (p less than 0.001) with greater increases in vessel dimension at the site of stenosis if the balloon diameter was greater than 3 X the original dimension of the stenosis. There was no significant benefit related to age or prior surgical intervention. The mean peak systolic pressure gradient was reduced from 49 +/- 25 to 37 +/- 26 mm Hg (p less than 0.001) and pressure proximal to the stenosis decreased from 69 +/- 25 to 63 +/- 24 mm Hg (p less than 0.001). Complications occurred in 21 patients and included vessel rupture and death in 2 patients, vessel perforation or rupture with survival in 3, cardiac arrest and death in 1, paradoxical embolism and death in 1 and low output and death in 1. Balloon angioplasty for branch pulmonary artery stenosis increases vessel dimension at the site of stenosis, reduces systolic pressure gradient and to a minor degree, reduces proximal pressure. Long-term outcome and potential complications are as yet uncertain.

Chronic percutaneous pericardial drainage with modified pigtail catheters in children.

To determine the safety and efficacy of chronic percutaneous pericardial drainage in children, pigtail catheters were inserted over curved guidewires under fluoroscopic control into the pericardial space in 7 consecutive children with pericardial effusion. Pericardiocentesis was therapeutic (for tamponade) in 1 child, diagnostic in 4 and both therapeutic and diagnostic in 2. The children were 0.5 to 16 years old and weighed 5 to 65 kg. Underlying diagnoses included cancer (3 children), congenital heart disease (2 children) and immunodeficiency and hemolytic uremic syndrome (1 each). When unmodified pigtail catheters, designed for angiography, were used (as in the first 3 children), either the catheters clotted within 36 hours, necessitating operative pericardial drainage, or repeated heparin infusions were required to keep the catheter patent. However, when 8Fr catheters were modified by placing 0.050-inch side holes along the distal shaft, the catheters remained patent and effectively drained the pericardial space for 3 to 7 days. Heparin infusion was not required, no child managed with the modified catheters required subsequent drainage and no complications occurred. In conclusion, percutaneous pericardial drainage is safe, even in small children, and can be effective chronically if catheters with large drainage holes are used.

Transcatheter closure of patent ductus arteriosus in piglets.

To better determine the risks of transcatheter closure of a patent ductus arteriosus (PDA), a model of PDA was made in newborn piglets by using 5- to 7-mm angioplasty catheters to dilate the probe PDA. This maneuver resulted in a permanent PDA in most piglets. Four to 6 weeks later PDA closure was attempted using the Rashkind PDA occluder. Twelve such procedures were attempted, using clean but nonsterile technique. Nine of 12 PDAs were successfully closed. Two failures were the result of inability to successfully traverse the PDA. This problem was solved by using a long sheath to position the device properly. Four complications occurred, all related to device release: left pulmonary artery embolization in 1 case, femoral artery embolization in 1, torn pulmonic valve cusp in 1 and lodgment of a prosthesis on a pulmonic valve cusp. Two successfully implanted devices were infected at necropsy. This study demonstrates the value of a piglet model in testing transcatheter PDA occlusion devices, the importance of sterile technique in such procedures, the hazards of device retrieval through the right heart and the feasibility of transcatheter PDA closure.

Echocardiographic versus cardiac catheterization diagnosis of infants with congenital heart disease requiring cardiac surgery.

The success of noninvasive preoperative evaluation of infants with congenital heart disease using cardiac ultrasound depends not only on diagnostic accuracy, but also on risk of morbidity and mortality as compared with infants who undergo cardiac catheterization. Fifty-six infants (age 10 weeks or younger) with coarctation of the aorta (n = 16), coarctation with ventricular septal defect (n = 12), valvar aortic stenosis (n = 10) or total anomalous pulmonary venous connection (n = 18) were examined. Thirty-one underwent noninvasive preoperative assessment and 25 underwent evaluation including cardiac catheterization. Age, level and duration of support, pH, renal function, mortality, complications of cardiac catheterization and errors of diagnosis were compared. Significant differences between the 2 groups were more frequent preoperative use of prostaglandin E1 and shorter hospital stay in the noninvasively evaluated coarctation group. Of the infants with coarctation and ventricular septal defect, 1 who had cardiac catheterization required renal transplantation and 1 evaluated noninvasively required surgery at age 3 months for mitral stenosis not discovered on preoperative evaluation. One noninvasively evaluated infant with total anomalous pulmonary venous connection had a stenotic communication between the pulmonary venous confluence and the left atrium not detected by ultrasound. Surgery was successful in the latter 2 infants. Noninvasive preoperative diagnosis of some infants with congenital heart disease can be performed without increasing the risk of operative morbidity and mortality. Eliminating cardiac catheterization reduces hospital costs, decreases total numbers of catheterizations performed and influences the structure of training programs.

Balloon angioplasty for congenital mitral stenosis.

We attempted balloon angioplasty in 9 children (ages 0.1 to 10 years) with congenital mitral stenosis. All were symptomatic with severe congestive heart failure and failure to thrive. Effective reduction in mitral gradient was initially achieved in 7 patients. For the entire group, mean valve gradient decreased from 14.8 +/- 5.0 to 8.1 +/- 6.7 mm (p = 0.0007) and mean valve area increased from 1.1 +/- 0.5 to 1.8 +/- 0.9 cm2/m2 (p = 0.003). More than mild mitral regurgitation developed in 2 patients but none required surgery for mitral regurgitation. Poor gradient relief followed dilation of valves with unbalanced chordal attachments, with restriction to the valve apparatus as in mitral arcade, and where the obstruction was not purely valvar as it is with a supramitral ring. No strokes, infection or deaths were due to the procedure. Based on these data, balloon angioplasty of congenital mitral stenosis should be considered before mitral valve replacement in younger patients and in those in whom mitral valve replacement would be problematic.

Clinical pharmacology of bupropion and imipramine in elderly depressives.

The clinical efficacy and adverse reaction profile of bupropion, an atypical antidepressant, was compared with the tricyclic imipramine in 63 elderly depressives. Patients were randomly assigned to treatment with 150 or 450 mg/day of bupropion, 150 mg/day of imipramine, or placebo for 35 days. Both doses of bupropion were equivalent to imipramine in antidepressant efficacy. The higher dose of bupropion had a more rapid onset of effect than the low dose and significantly greater anxiolytic activity than either imipramine or the lower dose. Both doses of bupropion had adverse reaction profiles strikingly similar to placebo and, in marked contrast to imipramine, did not produce sedation or anticholinergic side effects. Cognition improved equally in all groups. It was concluded that bupropion has therapeutic advantages over the tricyclics in the treatment of elderly depressives.

Management of intracardiac fungal masses in premature infants.

Intracardiac fungal masses can develop following episodes of candidemia in premature infants with indwelling right atrial lines. We report the first premortem diagnosis and successful surgical removal of Candida-containing intracardiac masses in three premature infants. All had central venous lines and had been on systemic antibiotics prior to the development of candidemia. By echocardiography, two were pedunculated, solitary masses within the right atrium. Amphotericin B and 5-flucytosine for 21 to 42 days controlled the Candida sepsis, but the masses became increasingly mobile and did not decrease in size. In the third infant, large, irregular masses extended from the right atrium to the main pulmonary artery, and surgical removal was recommended 4 days after the start of antifungal therapy. In all three patients, the masses were nearly the size of the main pulmonary artery and presumably contained viable organisms. Removal was accomplished with the aid of cardiopulmonary bypass for two and inflow stasis for one infant weighing only 1,300 gm. The masses were filled with viable Candida organisms. All patients tolerated the operation well and have been followed up for 1 to 3.6 years without evidence of recurrent Candida infection. The case of a fourth infant, weighing 1,320 gm, is also reported. This infant had a bacteria-containing intra-atrial mass, which was removed successfully with the aid of inflow occlusion. This report documents the following points: (1) Echocardiography provides a noninvasive method of diagnosing the development of intracardiac masses and should be performed in infants who have had candidemia and a central venous line. (2) Prolonged systemic antifungal therapy does not appear to either sterilize or promote regression of the masses. (3) The masses can be safely removed, even in the premature infant, with either inflow stasis or cardiopulmonary bypass. (4) Surgical removal is an effective component of the treatment of infection in these infants.

Management of congenital stenosis of a branch pulmonary artery with balloon dilation angioplasty. Report of 52 procedures.

Twenty-four children, aged 4 months to 16 years (nine patients 2 years old or younger), underwent balloon dilation angioplasty of hypoplastic or stenotic branch pulmonary arteries between July, 1981, and April, 1984. Most children had tetralogy of Fallot, with or without pulmonary atresia, or isolated peripheral pulmonary artery stenosis. Fifty-two dilations were attempted, 44 in the catheterization laboratory and eight in the operating room. Of these, 26 (50%) were judged successful; the average vessel diameter on angiogram increased from 4.1 +/- 0.3 to 7.2 +/- 0.3 mm (76%), the gradient across the narrowed segment fell from 60 +/- 10 to 36 +/- 5 mm (40%), pressure in the main pulmonary artery or right ventricle proximal to the obstruction decreased from 83 +/- 10 to 66 +/- 6 mm Hg (20%), and the radionuclide-determined fraction of cardiac output directed to the lung ipsilateral to the dilated pulmonary artery increased from 40 +/- 4 to 51 +/- 4 (28%). All changes were significant at the p less than 0.005 level. Reasons for failure included inadequate technique (balloon too small, inability to position balloon or wire) in 14 and the refractory nature of the lesion itself in 11. Technical failures were age independent. Nondilatable lesions were more common in children more than 2 years old (10/25 versus 1/10) or with isolated peripheral pulmonary artery stenosis (5/7). Five of seven stenoses near previous shunts were nondilatable. One child exsanguinated when the pulmonary artery ruptured during dilation, but other complications were few. Eight dilations, followed up for an average of 6 months after dilation, showed angiographic persistence of improvement; two of four lesions were successfully redilated to a larger size. Balloon dilation angioplasty appears beneficial, both short and long term, for some patients with hypoplastic or stenotic branch pulmonary arteries, especially if performed early in life.

Effects of dilating the canine pulmonary annulus with two balloons. Doppler ultrasound and postmortem findings.

Simultaneous inflation of two balloons may be necessary for balloon dilation valvuloplasty in patients with a large annulus. We examined the cardiovascular effects of dilating the pulmonary annulus with two balloons in 18 normal dogs using pulsed Doppler ultrasound and gross and microscopic examination. When the ratio of the cross-sectional area (CSA) during dilation to the CSA of the pulmonary annulus was between 1.04 and 1.28, there was valvar regurgitation in only one dog, in which catheter manipulation was complicated by heartworms, and damage was confined to intimal changes. (The dog was killed 24 hours after dilation.) With ratios between 1.67 and 1.76 (equal to the CSA of a single balloon with a diameter 33% greater than the annulus), there was trivial or mild tricuspid or pulmonary regurgitation, and anatomic changes were more prominent but still superficial. Two animals killed after nine days had resolution of valvar regurgitation and healing damage. With CSA ratios greater than 2.00 or with balloon rupture, myocardial damage and laceration of the pulmonary arteries resulted. Simultaneous inflation of two balloons within the right ventricular outflow tract with CSA ratios of up to 1.76 results in minimal cardiovascular trauma.

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.

Educating parents about injury prevention.

Pediatricians usually spend very little time counseling parents about childhood safety. The Framingham Safety Surveys (FSS) were developed for pediatricians to use in counseling on childhood injury prevention. The use of FSS and supplemental safety instruction are reviewed. This study found increased preventive behaviors in homes after safety counseling by pediatricians using FSS.