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PubMed1997

Thoracic sequelae after surgical closure of the patent ductus arteriosus in premature infants.

Thirty-six children (median chronological age 6 years 1 month) who had undergone surgical closure of a patent ductus arteriosus through a left posterolateral thoracotomy in the neonatal period (median gestational age 32 weeks) were investigated prospectively with respect to anatomical and functional changes of the chest. At follow-up examination, residual or recurrent patent ductus arteriosus was not observed. Three patients had chronic bronchial obstruction. Two patients showed pathological musculoskeletal thoracic sequelae that did not require any treatment at the time of follow-up; persistence of immediate postoperative left phrenic palsy (n = 1) and thoracic scoliosis (n = 1). Twenty of the 27 patients in whom chest X-ray was performed had minor radiological skeletal anomalies in the form of rib deformation or fusion related to the thoracotomy, lesions which have a potential to induce thoracic scoliosis. Left shoulder elevation at chest X-ray and isolated left arm dysfunction at clinical examination were not observed. Despite the low incidence of scoliosis and the absence of left arm dysfunction observed at mid-term follow-up in our series, the incidence of minor rib deformations with a potential to induce severe anomalies such as scoliosis should motivate late follow-up examination at adolescence to definitively assess the prevalence of thoracic sequelae after surgical closure of the patent ductus arteriosus in premature infants.

Bronchial Diseases↗

PubMed1992

Patents on random complementary DNA fragments?

The proposal by the National Institutes of Health (NIH) to patent products resulting merely from sequencing the human genome is a mistake: at worst, it is wrong in patent law; at best, it relies on deficiencies in law concerning what is "useful" as a requirement for patents. The proposal is symptomatic of a problem besieging biotechnology--attempts to control the raw material of scientific experimentation before research has determined the practical value of such material--that needs curing on many fronts. Corrective measures are proposed for adoption by the Executive branch, the Congress, and the courts.

Base Sequence↗

PubMed1987

Atrial natriuretic peptide and patent ductus arteriosus in preterm infants.

Preterm infants with symptomatic patent ductus arteriosus had considerably raised plasma concentrations of atrial natriuretic peptide. Surgical ligation of the patent ductus arteriosus was associated with an immediate fall in plasma atrial natriuretic peptide concentration. Thus left to right shunting and left atrial distension may cause atrial natriuretic peptide release in preterm infants with patent ductus arteriosus.

Atrial Natriuretic Factor↗

PubMed1996

Transcatheter occlusion of the patent ductus arteriosus with Cook detachable coils.

OBJECTIVE: To report initial experience with a new occlusion device for native and residual patent ductus arteriosus. DESIGN: Descriptive study of consecutive non-randomised patients undergoing a new method of patent ductus arteriosus closure with detachable coils. SETTING: Tertiary centres for paediatric cardiology. PATIENTS: 71 consecutive patients, aged 1.2-22 years, with a patent ductus arteriosus (PDA) underwent elective transcatheter closure. 45 had native PDAs (group A) with a minimum diameter of 1.0 mm-5.0 mm (median 2.0 mm). A further 26 had undergone one or more previous occlusion attempts (group B). INTERVENTIONS: A total of 133 detachable (Cook) spring coils were successfully implanted in 70 patients. The procedure was performed transvenously in 51 patients, retrograde arterially in 13, and by both routes in a further 6 patients. One 5 mm coil migrated but was successfully retrieved. MAIN OUTCOME MEASURES: In group A colour flow Doppler echocardiography showed that complete occlusion was achieved in 40/45 (89%) at 24 hours, 41/45 (91%) at 1 month, and 44/45 (98%) by 6 months post procedure. Occlusion rates in residual PDAs were 22/25 (88%) occluded at 24 hours, 23/25 (92%) at 1 month, and 24/25 (96%) at 6 months follow up. CONCLUSIONS: Transcatheter occlusion using detachable (Cook) spring coils is a safe and effective alternative to presently available devices. The delivery system allows full retrieval of the coil until a satisfactory position is obtained.

Adolescent↗

PubMed2002

Minimal effective dose of indomethacin for the treatment of patent ductus arteriosus in preterm infants.

The aim of this study was to determine if it was possible to decrease the number of boluses of indomethacin for the treatment of patent ductus arteriosus. This retrospective study included 46 preterm neonates (<34 weeks' GA) who had had an ultrasound diagnosis predictive of subsequent symptomatic patent ductus arteriosus. All patients had received a daily intravenous doses of indomethacin, 0.1 mg/kg. Mean age at initiation of treatment was 4.5 +/- 3.1 days. Patency of the ductus arteriosus was controlled echocardiographically each day and treatment was discontinued as soon as the ductus arteriosus was closed. The initial success rate was 84.7%, of which 6.5% reopened. The mean cumulative dose of indomethacin was 0.35 mg/kg. There was no correlation between gestational age or birth weight and total cumulative dose. Overall tolerance was satisfactory with only one case of transient acute renal failure. A weak correlation between the cumulative dose of indomethacin and natremia (r = -0.43) or weight gain (r = 0.35) was noted, and none with serum creatinine or blood urea nitrogen levels. We confirm that lower indomethacin treatment of patent ductus arteriosus in premature neonates are as effective as standard protocols.

Cardiovascular Agents↗

PubMed1978

Real-time cross-sectional echocardiographic imaging and measurement of the patent ductus arteriosus in infants and children.

While echocardiography has been used to noninvasively document indirect effects on the heart of left-to-right shunting through a patent ductus arteriosus, no noninvasive technique has been developed to image the duct itself. In this study, 35 sequential studies were performed on 28 patients with a mechanical sector scanner to image the distal pulmonary artery and its bifurcation by scanning along the axis of the right ventricular outflow tract. Cross-sectional imaging, just superior to the take-off of the right pulmonary artery, provided visualization of the patent ductus as a distal continuation of the pulmonary artery connecting to the descending aorta. Ductal visualization by cross-sectional echo was validated by saline echo contrast observations of right-to-left and left-to-right shunting through the duct in 14 patients, by surgical observations in 11, angiographic observations in 13 and autopsy observations in three. Angiographic size of the ductus arteriosus, whether constricted or widely patent, tortuous or straight, was predicted correctly and echo/angiographic correlations for smallest inner ductal dimension were excellent (r = 0.97). This study provides a method for and validates the direct imaging of the ductus arteriosus and suggests that cross-sectional echocardiography can accurately predict ductal contour and quantitative ductal cross-sectional size noninvasively.

Adolescent↗

PubMed1993

Transcatheter occlusion of patent ductus arteriosus with Gianturco coils.

BACKGROUND: Transcatheter occlusion with Gianturco coils has been attempted in a small number of patients with tiny (< or = 1.5-mm diameter) patent ductus arteriosus, and preliminary results have been encouraging. The present study extends this method to larger ductus sizes and makes recommendations for proper coil size selection. METHODS AND RESULTS: Coil occlusion was attempted in 24 consecutive patients with patent ductus arteriosus who did not require other cardiac surgery. Median patient age was 4.2 years (8 months to 30 years), and mean ductus diameter was 1.7 +/- 0.8 mm. Two instances of coil embolization occurred in the first 4 patients, with successful coil retrieval. Based on this experience, we proposed that the coil helical diameter should be twice or more the minimum ductus diameter, with coil length sufficient for three or more loops. With these recommendations, coils were successfully implanted in the subsequent 20 consecutive patients. Of the 22 patients with successful coil implantation, 15 (68%) had no residual shunting, and 7 had trace residual shunting by angiography. The continuous murmur was abolished in all 22 patients. No significant complications occurred, and all patients were discharged within 24 hours of successful coil implantation. No change in the systolic pressure gradient between main and left pulmonary artery or ascending and descending aorta was observed. CONCLUSIONS: Transcatheter occlusion of patent ductus arteriosus can be safely and effectively achieved in patients with ductus diameters up to 3.3 mm. Coil occlusion does not cause obstruction to flow in the left pulmonary artery or descending aorta. Coils should be selected to provide a helical diameter twice or more the minimum ductus diameter and a length sufficient for three or more loops.

Cardiac Catheterization↗

PubMed2004

Patenting inventions arising from biological research.

Patents are the most important way in which researchers can protect the income that might come from ideas or technologies they have developed. This article describes the steps involved and the considerations needed for successful granting of a patent. For instance, inventions must be novel and not obvious, adequately described, and useful, and they should not be disclosed publicly before a patent is applied for.

Biology↗

PubMed2000

Randomized double-blind controlled trial comparing the effects of ibuprofen with indomethacin on cerebral hemodynamics in preterm infants with patent ductus arteriosus.

A prospective randomized controlled trial was performed to compare the effects of ibuprofen with indomethacin on cerebral hemodynamics measured using near infrared spectroscopy in preterm infants during treatment for patent ductus arteriosus. Infants were randomly assigned to three intravenous doses of either indomethacin (0.20-0.25 mg/kg, 12 hourly) or ibuprofen (5-10 mg/kg, 24 hourly) and also received a dose of saline. The primary end points of the study were the effects of the first dose on cerebral blood flow (CBF) and cerebral blood volume. Fifteen infants received indomethacin and 18 received ibuprofen. The group mean (SD) values for CBF (mL x 100 g(-1) x min(-1)) before and after the first dose of indomethacin were 13.6 (4.1) and 8.3 (3.1), respectively, the change being significant (p<0.001). In contrast, no significant changes in CBF were observed with the first dose of ibuprofen, the respective before and after values being 13.3 (3.2) and 14.9 (4.7) mL x 100 g(-1) x min(-1). The median (interquartile range) value for change in cerebral blood volume (mL/100 g) after the first dose in the indomethacin group was -0.4 (-0.3 to -0.6) and in the ibuprofen group was 0.0 (0.1 to -0.1), the difference between the two groups being significant (p<0.001). Cerebral oxygen delivery changed significantly after the first dose in the indomethacin group but not in the ibuprofen group. Significant reductions in CBF, cerebral blood volume, and cerebral oxygen delivery also occurred after the 24-h dose of indomethacin, but there were no significant changes after the 48-h dose of saline in the indomethacin group or after the 24- and 48-h doses of ibuprofen. The patent ductus arteriosus closure rates after indomethacin and ibuprofen were 93 and 78%, respectively. We conclude that ibuprofen, unlike indomethacin, has no adverse effects on cerebral hemodynamics and appears to mediate patent ductus arteriosus closure.

Brain↗

PubMed2001

Is there a unique moral status of human DNA that prevents patenting?

The gene patenting debate, which proved to be a focal point for divergent moral concerns about recent developments in genome research and biotechnology, has revealed that the moral status of DNA is not clear. One of the arguments used to stop undesirable developments was that DNA possesses a unique status, which renders it unfit for patenting. This paper investigates the allegedly unique (moral) status of genetic material and the information it holds from different perspectives. Several properties of DNA prove to be unique. We examine the relevance of these for patentability of genes and conclude that only the unique symbolic meaning of DNA is a relevant factor, which should be taken into account but weighed against other interests involved.

DNA↗

PubMed1979

A rational approach to ligation of patent ductus arteriosus in the neonate.

During a 23-month period, 25 premature infants underwent ligation of a patent ductus arteriosus performed in the neonatal intensive care unit utilizing a limited posterolateral muscle-retracting incision. This approach afforded adequate exposure with minimal surgical time and trauma. All infants manifested severe respiratory distress and congestive heart failure. Both standard and contrast echocardiographic studies were used for noninvasive preoperative evaluation. Echocardiographic study proved to be a highly reliable and sensitive indicator of ductal patency. Eight infants (32 percent) died at 8 to 225 days of age. The primary cause of death was progressive pulmonary disease with subsequent failure of multiple organ systems. Seventeen (68 percent) of the 25 infants survived to leave the hospital. Advantages of ligation of a patent ductus arteriosus in the neonatal intensive care unit include the elimination of problems of transportation (thermoregulation, ventilation, and loss of lines) and continuity of ongoing care and monitoring. The standard facilities of the neonatal intensive care unit proved completely satisfactory for ligation of a patent ductus arteriosus. Ligation in the neonatal intensive care unit is suggested to minimize potential complications of care in the operating room and transport of these critically ill infants.

Ductus Arteriosus, Patent↗

PubMed1988

Patent ductus arteriosus in the elderly.

Patent ductus arteriosus presenting in an elderly patient is unusual. This report describes the oldest patient (72 years) to undergo successful surgical interruption of a patent ductus arteriosus with a unique clinical presentation of typical angina pectoris with normal coronary anatomy. A possible pathophysiologic mechanism for this previously unreported presenting symptom is proposed. The natural history of patent ductus arteriosus and the role of surgery in the elderly patient are discussed.

Aged↗

PubMed2006

Pulmonary hypertension following L-lysine ibuprofen therapy in a preterm infant with patent ductus arteriosus.

Patent ductus arteriosus is one of the most common congenital abnormalities found in premature infants. Ibuprofen, a nonsteroidal drug that is commonly used as an antipyretic, analgesic and anti-inflammatory agent, is also used to induce closure of symptomatic patent ductus arteriosus in preterm infants. Recently, we gave L-lysine ibuprofen to a preterm infant with respiratory distress to induce closure of a patent ductus arteriosus, and the infant experienced pulmonary hypertension. Only 3 cases of pulmonary hypertension following early administration of an ibuprofen solution buffered with tromethamine have previously been reported. However, this severe side effect has never been observed in multicentre, randomized, double-blind controlled trials, nor in recent reviews or meta-analyses of L-lysine ibuprofen use.

Anti-Inflammatory Agents, Non-Steroidal↗

PubMed2007

[Evolution of the international intellectual property rights system: patent protection for the pharmaceutical industry and access to medicines].

This article discusses the evolution of the international intellectual property rights system in three phases and the implications for public health, especially for the implementation of policies for access to medicines. During the first phase, characterized by the Paris and Berne Convention, signatory countries defined which technological fields should be protected (or not). Under the second phase, with the enforcement of the WTO TRIPS Agreement, countries are obliged to grant patent protection for all technological fields, including for the pharmaceutical industry. Within their national legislations, countries also have the opportunity to implement access to TRIPS flexibilities for medicines. With the third phase, characterized by the negotiation and signing of bilateral and regional free trade agreements, countries will have to implement TRIPS-plus provisions which may have negative implications for the TRIPS flexibilities as well as for policies for access to medicines. The authors conclude that the currently proposed international intellectual property rights system favors patent-holder rights and that a balance is needed between patent holders' and health rights.

Brazil↗

PubMed2001

Preductal aortic coarctation and patent ductus arteriosus in a Sumatran tiger (Panthera tigris sumatrae) cub.

Preductal aortic coarctation and patent ductus arteriosus are described in a neonatal Sumatran tiger, Panthera tigris sumatrae. Eight days postpartum, the cub appeared weak, and it was separated from the dam for hand rearing. On examination it was dehydrated and hypothermic. Despite treatment, the animal's condition worsened and the cub died 12 days postpartum. Gross postmortem and histologic examinations revealed a preductal aortic coarctation and patent ductus arteriosus with a patent foramen ovale and moderate dilatation of the right ventricle of the heart. Focal pneumonia and mild hepatitis were also present; however, diffuse pulmonary congestion and edema were considered to be the proximate cause of death.

Animals↗

PubMed1989

The pharmacological treatment of patent ductus arteriosus. A review of the evidence.

Modern heart surgery began with operative intervention for patent ductus arteriosus in 1938. Half a century later, ligation and division of patent ductus arteriosus in an infant or child remains a simple and safe surgical procedure for a lesion identified relatively easily. In the intervening years, paediatric cardiologists and surgeons have also directed their attention to the management of more complex congenital cardiac defects. Recently, however, there has been a significant reappraisal and re-emphasis of the role of patent ductus arteriosus in the context of neonatal cardiopulmonary disease. Interest has focused on: (a) surgical and pharmacological management of the premature infant with a large ductal left-to-right shunt in the context of respiratory distress syndrome; (b) preservation of patency in ductal-dependent congenital heart disease; and (c) ductal right-to-left shunting in persistence of the fetal circulation (PFC) syndrome or other diseases associated with increased pulmonary vascular resistance. This review examines the above conditions and reviews the progress and current status of drug therapy in the treatment of these disorders. Closure of the ductus arteriosus with cyclo-oxygenase inhibition as well as re-opening and maintaining patency of the ductus arteriosus with prostaglandin therapy is discussed.

Ductus Arteriosus, Patent↗

PubMed1994

The Canadian Patented Medicine Prices Review Board. New rules and new status.

The influence of the Patented Medicine Prices Review Board in restraining the prices of patented drugs has been established over the past 6 years. Recent legislative and policy changes now in place may result in the Board assuming a more influential, public, and activist posture. This article reviews the way in which the Board carries out its mandate to ensure that patented medicines sold in Canada are not 'excessive'. The Board represents one segment of Canada's ongoing effort to balance what often appear to be irreconcilable tasks-the promotion of an increased domestic research and development investment by the pharmaceutical industry, and the control of expenditures for pharmaceuticals in response to the escalating concerns of the provincial health authorities and consumers.

Canada↗

PubMed2003

Morphologic assessment of patent ductus arteriosus in adults using retrospectively ECG-gated multidetector CT.

OBJECTIVE: Noninvasive imaging of a persistently patent ductus arteriosus in adults remains a challenge. Bearing in mind the excellent spatial resolution provided by multidetector CT (MDCT), we postulated that MDCT might be used to evaluate this anatomic defect. We sought to show that MDCT can depict in detail patent ductus arteriosus in adults and allow determination of the size of the duct, degree of calcification, and morphologic classification. CONCLUSION: MDCT represents a novel method of noninvasively assessing patent ductus arteriosus in adults that provides detailed anatomic information. Comparison with invasive angiographic findings is needed to validate the technique of sizing of ducts using MDCT.

Adult↗