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At least 847 records · Page 47Linked to original sources
PubMed1983

Evaluation of the preterm infant for patent ductus arteriosus.

As a first step in a multicenter, collaborative project to study the role of indomethacin in the management of patent ductus arteriosus in premature infants, a diagnostic scheme was developed, on an a priori basis, by a consensus of the participating neonatologists and pediatric cardiologists. The scheme, which utilizes clinical and noninvasive findings, was designed to detect infants with a "hemodynamically significant" patent ductus arteriosus (PDA). Among 1,689 infants with birth weight less than 1,750 g who were monitored during the first year of the study, 342 (20.2%) met the criteria for PDA. Rates were higher for smaller infants (42% with birth weight less than 1,000 g) than for larger infants (7% with birth weight 1,500 to 1,750 g). Although study protocol did not require a direct procedure to confirm the diagnosis of PDA, a marked decrease in the presence of most criteria was noted following surgical ligation of the ductus. Although the echocardiographic criterion (ratio of left atrium to aorta [LA/Ao] greater than or equal to 1.15) proved to have a low specificity for PDA, the data suggest that the overall scheme led to a very low rate of false-positive diagnosis. Following the application of the scheme for 1 year at 13 clinical centers, it has been shown to be a highly acceptable means of detecting infants with PDA.

Clinical Trials as Topic↗
PubMed1983

[Problems related to the deposition of microorganisms in the patent procedure].

Some practical aspects concerning deposition of microbial strains in connection with patenting are discussed. In particular, situations requiring deposition of individual strains, mixed cultures or associants are analysed. Problems of patent legislation pertinent to deposition of microorganisms are discussed.

International Cooperation↗
PubMed1984

Liquid-chromatographic determination of indomethacin in blood from newborns with patent ductus arteriosus.

This rapid, accurate "high-performance" liquid-chromatographic procedure is intended for measuring indomethacin in serum from neonates who are receiving indomethacin for symptomatic patent ductus arteriosus. Indomethacin and an internal standard (flufenamic acid) are extracted from serum or plasma with chloroform or diethyl ether at pH 5.0. For the chromatography we used a Waters' Radial Compression Separation System (Radial-NOVA PAK C18 reversed-phase column) and a mobile phase of methanol/sodium acetate buffer (10 mmol/L, pH 3.6), 70/30 by vol. The column effluent is monitored at 254 nm. Both indomethacin and flufenamic acid are eluted within 7 min. Indomethacin can be detected in concentrations as low as 50 micrograms/L, in 100-microL samples. Response varies linearly with indomethacin concentration to at least 2 mg/L. Analytical recovery is 75%; relative recovery is 100%. Precision is excellent. Using this method, we were able to improve the success rate for pharmacological management of symptomatic patent ductus arteriosus, especially in neonates with fast clearance rates for the drug.

Chromatography, High Pressure Liquid↗
PubMed1983

Ligation of patent ductus arteriosus in premature infants: importance of accurate anatomic definition.

The aortic arch anatomy of the premature infant may not be as simple to determine as the anatomy of an older child. A case of a premature infant who had inadvertent ligation of the left pulmonary artery during attempted ligation of a patent ductus arteriosus is described. On the fourth day following the initial operation, the patient underwent successful surgery to remove the pulmonary artery ligature and to ligate the persistent patent ductus arteriosus. A lung scan on the seventh day following removal of the pulmonary artery ligature showed normal perfusion of both lungs. Six months later, the child's growth, development, and chest roentgenogram were normal.

Aorta, Thoracic↗
PubMed1982

Abnormal cerebral hemodynamics in preterm infants with patent ductus arteriosus.

Blood flow patterns in the anterior cerebral arteries were studied in eight preterm infants with patent ductus arteriosus and left-to-right shunts. A noninvasive Doppler technique was used to obtain the blood flow patterns and to calculate a pulsatility index. Advancing diastolic blood flow was decreased in all eight infants, and two demonstrated retrograde anterior cerebral artery flow during diastole. Following ductal closure, the diastolic flow in the anterior cerebral arteries increased significantly, reaching levels seen in normal infants. These observations demonstrate that infants with patent ductus arteriosus and left-to-right shunts may have abnormal cerebral hemodynamics which return to normal following ductal closure.

Blood Flow Velocity↗
PubMed1995

[Prevalence of residual shunt after closure of patent ductus arteriosus with Rashkind umbrellas].

PURPOSE: To determine the prevalence of residual left-to-right shunt in patients submitted to closure of patent ductus arteriosus with use of Rashkind double-disc ductal occluding device, analyzing predictive factors that determine short and long-term prevalence of residual shunt. METHODS: Thirteen patients were submitted to percutaneous closure of patent ductus arteriosus with use of Rashkind double-disc device. Ten patients were male with mean age of 5.7 years. A 12mm diameter device was used in 7 cases and a 17mm device in the remaining six patients. All patients had clinical, radiological and echocardiographic follow up, after 24h, 1 month, 6 months and one year after the procedure. Morphology and length of the ductus arteriosus and the presence of residual shunt after 15 min, 24h and one year after the procedure, were correlated. RESULTS: In one case, embolization of the device to the pulmonary artery determined the in success of the procedure. Residual shunt was present in 75% of the patients after 15 min of the procedure, in 33.3% after 24h, in 25% after 1 month and 6 months and in 16.6% after 1 year. The most important and isolated predictive factor leading to a high prevalence of residual shunt after 24h and after 1 year of the procedure was the presence of ductus arteriosus diameter > or = 4.5mm at the site of its insertion in the pulmonary artery. CONCLUSION: Prevalence of residual left-to-right shunt decreases over the time, with a low incidence after one year follow-up. A higher incidence of residual shunt at 24h and 1 year after the procedure occurred in the cases where the diameter of the ductus arteriosus was > or = 4.5mm, at the site of its insertion in the pulmonary artery.

Adolescent↗
PubMedDate not supplied

Surgical treatment of patent ductus arteriosus (PDA). Analysis of 145 cases operated on in Abidjan (Cote D'Ivoire).

This retrospective study aims to analyse our surgical procedures and our results after surgery of patent ductus arteriosus (P.D.A.) in children. Since 1978 to 1992 we have reported Abidjan Cardiology Institute 145 children operated cases. The average age was 4.7 years, the average weight 16 kg. There was female predominance with a sex ratio of 2.3/1. All patent ductus arteriosus had been confirmed by two dimensional echocardiography (2D echocardiography) and cardiac catheterization. Type 11a of NADAS' Classification was the most frequent (50%). Double or triple ligation supported on teflon felt was the most frequent technique used (86 times ie 59.3%). This technique gave good results in view of the absence of hospital mortality, only 4 cases of ductus "recanalization" supervened, a low rate of ductus arteriosus recurrence patency at long follow up of all patients from one to 10 years (mean 5 years). Double or triple ligation on teflon felt according to Wright procedure seems to be a securising technique alternative in our countries.

Adolescent↗
PubMed1994

[Percutaneous closure of patent ductus arteriosus with the Rashkind device].

PURPOSE: To assess the efficacy and safety of the percutaneous closure of the persistent ductus arteriosus with the Rashkind device. DESIGN: Clinical, angiographic and echocardiographic assessment of the patency of the ductus arteriosus at the time of the implantation of the first or second Rashkind device, followed by clinical and echocardiographic control at one, three and six months and yearly thereafter. PATIENTS: Thirty two patients with patent ductus arteriosus. Twenty seven were female and five male. Their ages ranged between 10 months and 33 years (6.8 +/- 7.7 years) and their weights between 7.3 and 52 (20.1 +/- 12.4) kg. Two patients were excluded due to a ductal diameter greater than 8 mm. Thirty patients had successful device implantation. METHODS: Implantation at cardiac catheterization of the Rashkind double umbrella occluder device in the narrowest portion of the patent ductus arteriosus. Twenty one patients had one device implanted and five had the implantation of a second device four to 12 months later, due to persistent patency of the ductus. RESULTS: Total closure was achieved in 26 out of 30 patients. In 21 patients the occlusion was obtained with a single device and in five patients with two devices. Among the remaining four patients, one is awaiting the implantation of a second device and the other three are under follow-up as their first devices were implanted recently. There were no complications. CONCLUSIONS: Percutaneous closure of the ductus arteriosus with the Rashkind device represents an efficient and safe alternative to surgery in most patients.

Adolescent↗
PubMed1994

Pulmonary hemorrhage risk in infants with a clinically diagnosed patent ductus arteriosus: a retrospective cohort study.

OBJECTIVE: To determine if an early, clinically detectable patent ductus arteriosus (PDA) was associated with pulmonary hemorrhage (PH) in infants who received rescue artificial surfactant therapy. METHODS: This retrospective cohort study of 233 low birth weight infants (< or = 1700 g) who received artificial surfactant therapy for respiratory distress syndrome compared antenatal and postnatal characteristics of infants with PH and without PH. Pulmonary hemorrhage was defined by an onset of bright red blood from the endotracheal tube in quantities that resulted in increased ventilatory support and a new infiltrate on a chest radiograph. RESULTS: Pulmonary hemorrhage occurred in 6% (15/233) of the infants. Thirty-three percent (5/15) of the infants with PH died within 14 days of the hemorrhage. Of the 15 PH, 73% occurred within 48 hours of the first surfactant dose. Pulmonary hemorrhage was more common in male infants and infants of mothers who received antibiotic therapy during labor (P < or = .04). Infants with PH received surfactant earlier than those without PH (P = .04). Nursery events or therapies occurring following surfactant therapy that were associated with PH included: little improvement in ventilatory efficiency index (P = .01), dopamine infusion (P = .04), and the presence of a clinically detectable PDA before, or at the time of, the PH [60% (9/15) vs 33% (71/217), P = .03]. After adjusting for severity of illness before surfactant therapy, risk of PH remained greater in infants who developed symptoms of a PDA. Dopamine support appeared to modify the association between PDA and PH. CONCLUSIONS: In this retrospective cohort study, pulmonary hemorrhage, was associated with the presence of a clinically detectable patent ductus arteriosus before, or at the time of, pulmonary hemorrhage.

Cohort Studies↗
PubMed1994

The surgical and health care innovator: patents and marketing guidelines.

Many physicians and health professionals have had ideas for new devices but are reluctant to pursue the idea to production. Some abandon a sound innovation because of unfamiliarity with the intricate processes from concept to final marketing. The subject of surgical or medical innovation is not taught in medical schools or in residency training and few articles have appeared in the medical literature. This presentation is meant to guide the potential inventor from the concept stage through protection measures and the patent process to the final manufacture of a new device. It is hoped that this article will provide the innovator with a sound footing and stimulate him to contribute to medical technology and medical progress. Other disciplines (scientific, academic, and industry) might also be interested in these guidelines on patents and marketing strategies.

Commerce↗
PubMed1994

[Patents and innovations. Definitions--modes of action].

The author presents the various methods available for the doctor to protect and exploit his inventions or technological discoveries. In the medical field, as in other fields, there are three titles of industrial property: patent, registered model and trademark. The modalities of each of these titles are explained. Based on the his own experience, the author presents advice concerning the use of patents, contracts and the choice of industrial partners.

Diffusion of Innovation↗
PubMed1993

[Medical innovation. Patents and confidentiality].

Enhanced knowledge of medicine and commercialization of an innovation (product, equipment, drug ...) are the classical aims of all medical research. Only the successful commercialization of the innovation allows the largest number of patients to benefit from the achievements of this research. Successful commercialization depends on the effective cooperation between the medical researcher who possess the potential for innovation and industry which provides the means necessary for its development. This cooperation is facilitated if the innovation is patented and if researcher ans industry work together under a contract of confidentiality. In order to improve the cooperation necessary between industry, research scientists, and clinicians, we review the current rules and regulations pertaining to patents and confidentiality. An annex is included with examples of a consultants contract and a secrecy agreement.

Confidentiality↗
PubMed1993

[A case of surgical treatment of patent ductus arteriosus using left heart bypass in an adult].

This paper describes a new operative method for patent ductus arteriosus using left heart bypass. A 57-year-old woman with patent ductus arteriosus associated with severe pulmonary hypertension was successfully operated upon. Because of aneurysmal dilatation and calcification of the aortic side of the ductus, PDA was divided under left heart bypass with centrifugal pump. Postoperative course was uneventful, and is now well.

Ductus Arteriosus, Patent↗
PubMed1993

[Closure of patent ductus arteriosus using interventional catheterization].

Percutaneous closure of patent ductus arteriosus can be performed with the Rashkind technique. This procedure has been performed in 16 patients in Geneva since 1989. The age of the patients varied from 2 to 44 years (4 boys, 7 girls, and 5 women). Pulmonary hypertension was present in only 1 child. A 12 mm Rashkind umbrella was used in 11 patients with ductus of < or = 4 mm inner diameter, while a 17 mm umbrella was used in 5 cases for larger ducts. Ductus closure was carried out through a transvenous femoral approach in 15 cases, while in 1 patient a transarterial approach was employed because of impossibility of passing the ductus from the pulmonary artery. There was neither mortality nor morbidity in this series. The aortography performed just after device placement showed total ductus occlusion in 8 patients and partial closure in 8 others. The follow-up by color Doppler showed disappearance of the residual shunt in 4 of these 8 patients. Prophylaxis of bacterial endocarditis is therefore no longer necessary in 13 patients with complete ductus closure. Our experience with this technique confirms its efficacy and the possibility it offers of avoiding thoracotomy in the vast majority of patients with a patent ductus arteriosus. Further miniaturization of the device and delivery system should make it applicable in the neonatal period.

Adolescent↗
PubMed1996

[A case of video-assisted thoracoscopic surgery for patent ductus arteriosus under transesophageal echocardiography].

A six-year-old boy with patent ductus arteriosus was successfully treated by thoracoscopic surgery under transesophageal echocardiography, by which interruption of the ductal flow was confirmed. Postoperative course was uneventful and the patient was discharged on the 3rd postoperative day. The transesophageal echocardiography was effective to confirm disappearance of the flow in the operating room real-time. Video-assisted endoscopic surgery have reduced operative trauma in adult thoracic and general surgery, and can be safely applied to pediatric patients with patent ductus arteriosus. This technique may be an effective addition to the staged management of more complex forms of congenital heart disease.

Child↗
PubMedDate not supplied

Operative closure of patent ductus arteriosus in the neonatal intensive care unit.

Preterm infants undergoing surgical closure of patent ductus arteriosus are usually critically ill and are suffering from many concomitant diseases. The high risk of increased morbidity in transferring them from the neonatal intensive care unit (NICU) to a distant operating room is generally recognized. For this reason we report our experience in 33 premature infants with patent ductus arteriosus who have been operated in the NICU over a six-year period. There were no operative or immediate postoperative deaths and the 30 days hospital mortality was 6%. Based upon these findings we can confirm that operative closure of PDA can be performed safely in the NICU.

Comorbidity↗
PubMed1997

Drug patent expirations and the speed of generic entry.

OBJECTIVE: Using recent data, to analyze the generic drug entry phenomenon to determine the factors that influence the speed and likelihood of generic drug entries. DATA SOURCES: Data for 81 drugs that have lost patent between 1987 and 1994. Patent and exclusive marketing rights expiration dates: Food and Drug Administration's (FDA) Approved Drug Products with Therapeutic Equivalent Evaluations (1986-1989). Generic entry dates: FDA Drug and Device Product Approvals (Jan. 1987-Dec. 1994). Numbers of pending generic applications: FDA Office of Generic Drugs Quantitative Report-ANDAs and AADAs (Nov. 1990-Jan. 1993). Sales revenue: Pharmaceutical Data Services, Walsh-America. STUDY DESIGN: This study appropriately recognizes generic entry as a survival problem, and uses a proportional hazard method for analysis. PRINCIPAL FINDINGS: (1) There is a negative relationship between an innovative drug's sales revenue and the time to generic entry. (2) Entries of generics tend to be slower for drugs that have either very few or a very large number of competing brands in the marketplace. (3) The time to generic entry increased overall between 1987 and 1994. (4) Drugs that primarily treat chronic symptoms tend to enter faster than the types of drugs that primarily treat acute illnesses. CONCLUSIONS: The analysis shows that the generic industry is targeting large-revenue products and chronic drug markets. Entry of a generic drug is influenced by the existing branded substitutes in the marketplace. Surprisingly, the generic drug entry process has slowed despite many changes that would facilitate entry.

Drug Industry↗