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PubMedDate not supplied

Decision and cost-utility analyses of surgical versus transcatheter closure of patent ductus arteriosus: should you let a smile be your umbrella?

Decision and cost-utility analyses considered the tradeoffs of treating patent ductus arteriosus (PDA) using conventional surgery versus transcatheter implantation of the Rashkind occluder. Physicians and informed lay parents assigned utility scores to procedure success/complications combinations seen in prognostically similar pediatric patients with isolated PDA treated from 1982 to 1987. Utility scores multiplied by outcome frequencies from a comparative study generated expected utility values for the two approaches. Cost-utility analyses combined these results with simulated provider cost estimates from 1989. On a 0-100 scale (worst to best observed outcome), the median expected utility for surgery was 99.96, versus 98.88 for the occluder. Results of most sensitivity analyses also slightly favored surgery. Expected utility differences based on 1987 data were minimal. With a mean overall simulated cost of $8,838 vs $12,466 for the occluder, surgery was favored in most cost-utility analyses. Use of the inherently less invasive but less successful, more risky, and more costly occluder approach conferred no apparent net advantage in this study. Analyses of comparable current data would be informative.

Angioplasty↗
PubMed2001

Facial swelling associated with impaction of the deciduous and permanent maxillary fourth premolars in a dog with patent ductus arteriosus.

A three-year-old Labrador retriever was referred for decreased appetite, a painful swelling in the region of the maxillary right fourth premolar, and a heart murmur indicative of patent ductus arteriosus (PDA) diagnosed 1.5-weeks prior to presentation. Oral examination and intraoral dental radiographs showed impaction of the maxillary right fourth premolar surrounded by reactive alveolar bone. Necrotic bone, remnants of the deciduous maxillary right fourth premolar, and the impacted permanent maxillary right fourth premolar were removed following surgical exploration of the area. The PDA was repaired without complication 2-weeks following oral surgery. The extraction site was healing appropriately, and the dog's inappetence and painful facial swelling had resolved.

Animals↗
PubMed1993

Drug disposition in neonates with patent ductus arteriosus.

OBJECTIVE: To review the literature on the physiologic changes created by neonatal patent ductus arteriosus (PDA) and the potential impact on drug disposition in these infants. DATA SOURCES: An Index Medicus and bibliographic search of the English-language literature pertaining to neonatal PDA and drug usage in newborns. DATA SYNTHESIS: PDA in premature infants is associated with a variety of physiologic changes that could alter drug disposition. Perfusion of drug-elimination organs (i.e., liver and kidney) may be diminished, resulting in decreased drug elimination. Further, the general fluid overload state associated with PDA may result in larger volumes of distribution (Vd), and dilutional effects for many drugs. Drug absorption, Vd, tissue penetration, and clearance may be affected by the physiologic changes incurred by a PDA. Although the pharmacokinetics of several categories of therapeutic agents may be affected by a PDA, disposition changes with the aminoglycosides and indomethacin have been the best documented. The most reliable pharmacokinetic change appears to be related to drug Vd. The interpretation of many of these studies is confounded by a potential drug interaction with the concurrent administration of indomethacin for PDA closure. CONCLUSIONS: Close therapeutic drug monitoring is indicated in newborns with PDAs as abrupt changes in drug disposition can occur with PDA closure. PDA-induced changes in specific pharmacokinetic parameters of agents such as the aminoglycosides, indomethacin, and perhaps vancomycin may prove to be a valuable diagnostic adjunct for the identification of babies with undiagnosed PDA. More research into this pharmacophysiologic aspect of pharmacokinetics is warranted.

Absorption↗
PubMed2026

Use of indocyanine green fluorescence versus patent blue V dye for sentinel lymph node biopsy in early breast cancer, a randomized controlled trial.

BACKGROUND: Sentinel lymph node biopsy (SLNB) is standard for axillary staging in early breast cancer. While the combination of radioisotope and blue dye (e.g., patent blue V, PBV) remains the standard, it has limitations including logistics, variable identification rate (IR), and allergic potential. Indocyanine green (ICG) fluorescence is a promising alternative, but high-quality comparative evidence is needed. METHODS: This was a single-center, prospective, randomized controlled trial. Forty patients with early-stage, node-negative breast cancer were allocated to SLNB using either ICG (n&#x2009;=&#x2009;20) or PBV (n&#x2009;=&#x2009;20). All patients subsequently underwent completion level I-II axillary lymph node dissection (ALND) as the pathological reference standard for diagnostic performance assessment. Primary outcome was sentinel lymph node (SLN) IR. Secondary outcomes included detection time, number of SLNs retrieved, false-negative rate (FNR), and safety. RESULTS: Baseline characteristics were comparable between groups. The SLN IR was significantly higher with ICG (100% [20/20]) than with PBV (75% [15/20], p&#x2009;=&#x2009;0.047). ICG was associated with a significantly shorter median detection time (14.5 vs. 24.0&#xa0;min, p&#x2009;<&#x2009;0.001) and retrieved more SLNs (mean: 3.6 vs. 2.4, p&#x2009;=&#x2009;0.002). Most critically, ICG demonstrated 100% sensitivity, specificity, negative predictive value (NPV), and overall diagnostic accuracy, with a 0% FNR. In contrast, PBV achieved a sensitivity of 75%, an overall diagnostic accuracy of 90%, and an FNR of 25%. No ICG-related adverse events occurred. PBV caused skin discoloration in 75% of patients and one (5%) allergic reaction. CONCLUSION: ICG fluorescence achieved a higher SLN IR, shorter detection time, higher sensitivity, lower FNR, and fewer tracer-related adverse events than PBV as a single tracer for SLNB in patients with early-stage breast cancer. These findings suggest that ICG is a promising standalone tracer when radioisotope mapping is unavailable. Larger multicenter studies are required before widespread adoption can be recommended.

Humans↗
PubMed1984

Urinary excretion rates of 6-keto-PGF1 alpha in preterm infants recovering from respiratory distress with and without patent ductus arteriosus.

Patency of the ductus arteriosus in preterm infants is mediated by vasodilating prostanoids; however, reliable methods to monitor prostanoid activity or production in preterm infants are lacking. We measured the excretion rates of major and characteristic urinary metabolites of prostacyclin (PGI2), PGE1, and PGE2, 6-keto-PGF1 alpha, and 7 alpha-hydroxy-5,11-diketotetranorprostane-1,16-dioic acid (PGE-M), respectively. Besides these parameters which reflect total body prostanoid turnover and production, the urinary levels of PGE2 and PGF2 alpha, the primary prostaglandins, were measured as an index of renal prostanoid synthesis. There were four study groups. One contained 11 thriving preterm infants; a second, six preterm infants with respiratory distress syndrome (RDS); a third, 30 preterm infants with RDS and patent ductus arteriosus (PDA); and a fourth, nine fullterm infants. All infants with RDS required artificial ventilation. There were no significant differences in PGE-M, PGE2, and PGF2 alpha excretion rates among the various groups; however, a significant increase of the 6-keto-PGF1 alpha excretion rates was observed in the groups of infants with RDS and with and without PDA (P less than 0.01 and P less than 0.02, respectively). Spontaneous (n = 2) or indomethacin-induced (n = 6) closure of PDA was associated with weaning from the respirator and a concomitant drop into the normal and subnormal range of the excretion rates of 6-keto-PGF1 alpha (P less than 0.01) and PGE-M (P less than 0.02).

6-Ketoprostaglandin F1 alpha↗
PubMed1989

Treatment of patent ductus arteriosus after exogenous surfactant in baboons with hyaline membrane disease.

The effect of early treatment of patent ductus arteriosus (PDA) on the acute course of hyaline membrane disease was tested in a primate model, after intratracheal administration of 100 mg/kg exogenous bovine surfactant phospholipids at mean ages between 2.3-2.4 h. Twenty-two premature baboons were divided into four groups: seven animals were controls (group A); five were treated with surfactant but PDA was not intervened (group B); in five surfactant treatment was followed by three doses of 0.2 mg/kg intravenous indomethacin beginning at a mean age of 5.5 h (group C); and in five surfactant treatment was followed by a surgical ligation of PDA between 5-5.5 h of age. After surfactant instillation in groups B, C, and D, a prompt and sustained improvement was noted in a/APO2, mean airway pressure, ventilator efficiency index and pulmonary compliance. However, no consistent differences were found in the respiratory variables within the surfactant treated groups during the 72-h experiment: the respiratory course in the animals treated for PDA (groups C and D) was generally similar to the animals in which PDA was not treated (group B). In animals treated with surfactant and indomethacin (group C) the mean aortic blood pressure was maintained more optimally as compared to the other three groups. These findings suggest that although a significant early ductal shunting does occur after exogenous surfactant therapy in this animal model, the expected pulmonary deterioration does not occur, and an early abrupt interruption of PDA does not seem to provide additional advantage to the immediate course of hyaline membrane disease.

Animals↗
PubMed1990

Stroke volume and left ventricular output in preterm infants with patent ductus arteriosus.

To assess the effect of patent ductus arteriosus (PDA) on left ventricular output (LVO) we studied stroke volume (SV), LVO, and heart rate (HR) in 21 very low birth wt preterm neonates with clinically symptomatic PDA before and after surgical ligation. Six additional infants were also studied before PDA with left-to-right shunt was detectable by the pulsed Doppler technique. Gestational age (median and range) was 28 (24-32) wk. SV was measured by duplex Doppler and M-mode echocardiography, and LVO was calculated as product of SV and HR. LVO was 419 (305-562) mL/min/kg during symptomatic PDA. It decreased to 246 (191-292) mL/min/kg after ligation (n = 21, p less than 0.001). SV was 2.69 (1.98-4.10) mL/kg during symptomatic PDA decreasing to 1.63 (1.22-1.98) mL/kg after ductal closure (n = 21, p less than 0.001). HR did not change after ductal closure. In the six infants with three examinations, LVO and SV were normal before detectable ductal left-to-right shunt and after ligation, but LVO was increased by 59.5 +/- 23% (mean +/- SD) (p less than 0.05), and SV by 60 +/- 32% (p less than 0.05) during symptomatic PDA. In conclusion, preterm neonates with RDS, requiring mechanical ventilation, increased LVO during symptomatic PDA by increasing their SV, and not by changing their HR.

Cardiac Output↗
PubMed1990

The effects of the patent ductus arteriosus on diaphragmatic blood flow and function.

Decreased diaphragmatic blood flow (Qdi) is associated with decreased contractility in adult animals. To see whether the decrease in Qdi associated with a patent ductus arteriosus was associated with a decrease in diaphragmatic contractility (Pdi), we prepared 11 near-term fetal lambs by infiltrating the ductus with formalin and placing a snare around it to regulate its patency. The lambs (with open chest) were delivered and mechanically ventilated, and the phrenic nerves and diaphragm were paced (using transvenous wires) at rates of 20/min, 60/min, and 100/min (Inspiratory time/total respiratory cycle time = 0.5) for 7-min contraction periods after 30-min recovery periods. Qdi was measured with radiolabeled microspheres at the end of each contraction period. Diaphragmatic performance was determined by comparing Pdi at the start (Pdi-start) and end (Pdi-end) of the contraction period. When the ductus was closed, Qdi increased 6.9-fold at 20/min and 9.8-fold at 100/min (compared with Qdi at rest). Pdi-end was less than Pdi-start at all contraction rates, but the reduction was significantly greater at 100/min (Pdi-end/Pdi-start: 0.80 +/- 0.10 at 20/min; 0.67 +/- 0.17 at 100/min). Pdi-start also decreased with increasing rates of contraction. When the ductus was open, the left-to-right shunt was 64 +/- 11% of left ventricular output. Qdi in the unpaced diaphragm was significantly reduced (open 4.0 +/- 3.8 versus closed, 7.4 +/- 2.4 mL/min/100 g).(ABSTRACT TRUNCATED AT 250 WORDS)

Animals↗
PubMed1991

Patent ductus arteriosus, indomethacin, and intestinal distension: effects on intestinal blood flow and oxygen consumption.

To determine the relative importance of patent ductus arteriosus, indomethacin, and intestinal distension as factors that promote terminal ileum ischemia, eight near-term fetal lambs were surgically prepared by in situ cannulation of the proximal and distal ends of a loop of terminal ileum, formalin infiltration of the ductus arteriosus, and placement of a snare around the ductus arteriosus to control its patency. The incisions were closed; the lambs were delivered and mechanically ventilated. Terminal ileum blood flow and oxygen consumption were measured after the loop of ileum had been distended with 0.9% NaCl to luminal pressures of 1-2, 7, and 18 mm Hg (0.13-0.26, 0.93, and 2.38 kPa) (pressures observed in the intestinal lumen after feeding and during pathologic conditions). The effect of these pressures on terminal ileum blood flow and oxygen consumption was examined: 1) with ductus closed, 2) with ductus open, and 3) 1 h after administration of indomethacin (0.3 mg/kg; 0.8 mumol/kg) with ductus closed. Both open ductus and indomethacin produced a significant decrease in intestinal blood flow. This occurred over the entire range of luminal pressures examined. In all three study conditions, terminal ileum blood flow fell commensurate with a fall in perfusion pressure. Despite this absence of pressure-flow autoregulation, oxygen consumption was maintained when the ductus was closed or open. In contrast, indomethacin inhibited the ability of the terminal ileum to autoregulate its oxygen consumption. These findings suggest that both open ductus and indomethacin present an increased risk of intestinal ischemia. We hypothesize that indomethacin's beneficial effect on ductus closure may be counterbalanced by its negative effect on intestinal perfusion and metabolism.

Animals↗
PubMed1995

Bisferiens peaks in the radial artery pressure wave in newborn infants: a sign of patent ductus arteriosus.

Previously, we found evidence that radial artery pressure wave forms in newborns represent central aortic wave forms, provided that pressure is measured with adequate accuracy. Therefore, we postulated that the neonatal radial artery wave form, like the adult aortic wave form, may contribute to cardiovascular diagnosis. We investigated whether radial artery wave forms in infants suffering from patent ductus arteriosus (PDA) are different from the wave forms as seen without the presence of PDA. We studied 34 newborn infants with a radial artery line and with the possible clinical diagnosis of PDA with left-to-right shunt. On the basis of echocardiographic examination to assess PDA, these infants were divided in two groups: infants with PDA (n = 24) and without PDA (n = 10). In 15 out of 24 infants with PDA, recordings were repeated after ductal closure. Blood pressure measurement was performed with a high fidelity cathetermanometer system using a tip-transducer (natural frequency 95 Hz, damping coefficient 0.15). Contour analysis was performed by describing morphology of the waves during PDA and without PDA. In 23 out of 24 infants with PDA, a pulsus bisferiens was present: two peaks separated by a deep cleft. The average pressure difference between the first pressure peak and the cleft [delta Ppeak1] was 0.35 +/- 0.19 kPa, and the average difference between the cleft and the second pressure peak [delta Ppeak2] was 0.44 +/- 0.23 kPa. the ratio of mean magnitude of delta Ppeak1 and delta Ppeak2 was 0.81 +/- 0.26. None of the 10 infants without PDA showed pulsus bisferiens.(ABSTRACT TRUNCATED AT 250 WORDS)

Blood Pressure↗
PubMed1995

Aspirin versus indomethacin treatment of patent ductus arteriosus in preterm infants with respiratory distress syndrome.

Indomethacin (Indo) is commonly used for treatment of patent ductus arteriosus (PDA) but has renal failure as a main side effect. Aspirin (ASA) is an alternative, but there are no controlled trials on its efficacy. We randomly assigned 75 premature infants suffering from respiratory distress syndrome (RDS) (mean gestational age: 29.6 +/- 2.5 wk, mean birth weight: 1295 +/- 464 g) (+/- SD) and on artificial ventilation at the start of the study (mean: 3.4 d of life), to either Indo (3 x 0.2 mg/kg/12 h) or ASA (4 x 15 mg/kg/6 h). PDA and degree of shunting were evaluated by echocardio-Doppler; side effects were carefully recorded. PDA closed in 35/38 patients from the Indo group (92%) and in 16/37 patients from the ASA group (43%) (p < 0.0001). Nineteen patients needed further treatment with Indo or surgery (17 in the ASA group and 2 in the Indo group). The only side effect observed was a decrease of uresis in the Indo group during 4 d post treatment (p < 0.01). Closing of PDA was positively correlated with gestational age, but not with time of starting Indo/ASA or grade of shunting. We conclude that ASA is not as effective in closing PDA as Indo, but has no adverse effect on uresis.

Aspirin↗
PubMed1996

Bisferiens peaks in the radial artery pressure wave during patent ductus arteriosus in newborn infants: relationship with ascending aortic flow.

Previously, we found evidence that bisferiens peaks in the radial artery pressure wave in the newborn infant may suggest the presence of a left-to-right shunt through a patent ductus arteriosus (PDA). The purpose of the present study was to analyze the origin of this pulsus bisferiens. Starting from the assumption that the radial artery pressure wave form is similar to the aortic pressure wave form, as described previously, we attempted to explain the bisferiens peaks on the basis of echocardiographically obtained ascending aortic flow. We studied 11 preterm mechanically ventilated infants with a left-to-right shunt through a PDA and 7 without. Aortic volume flow was established echocardiographically, and radial artery blood pressure measurement was performed with a high fidelity cathetermanometer system. Ascending aortic peak flow during PDA was significantly higher in the case of PDA, compared with the case without PDA. An augmented peak flow with an abrupt decline after the high peak in PDA, resulting in a sharp pressure peak with a steep decline after the peak, was thought to explain the first sharp peak of pulsus bisferiens. An abrupt decline of flow after peak flow is thought to be due to the fast runoff of blood through the ductus. According to the pulsatile pressure dynamics theories, which state that pressure wave forms consist of forward and backward wave forms, the second peak of the pulsus bisferiens can be explained by the return of the reflected (backward) wave form when the forward wave form has already considerably decreased. We conclude that the bisferiens peaks found in PDA result from a combination of large stroke volume (augmented first peak) and large runoff (quick decline of the forward wave) before the return of the reflected wave.

Aorta↗
PubMed2007

Unrecognized anomalous origin of the left coronary artery from the pulmonary artery as a cause of ventricular fibrillation after patent ductus arteriosus ligation in an infant.

We present a case of an infant who developed ventricular fibrillation after patent ductus arteriosus (PDA) ligation. The infant had unrecognized anomalous origin of the left coronary artery from the pulmonary artery before PDA ligation. Acute reduction in systemic pulmonary artery pressures after PDA ligation resulted in an abrupt reduction in left main coronary artery blood flow. After prompt resuscitation, cardiac catheterization confirmed the diagnosis of anomalous origin of the left coronary artery from the pulmonary artery. The infant subsequently underwent coronary artery translocation and recovered uneventfully.

Angiography↗
PubMed2005

Coil occlusion for patent ductus arteriosus larger than 3 mm.

BACKGROUND: Coil occlusion of patent ductus arteriosus (PDA) is now widely accepted as the first-line treatment, but there are few reports of age-dependent differences in the complications associated with this technique. METHODS AND RESULTS: Sixteen patients (11 adults, 5 children) with a PDA larger than 3 mm, who underwent coil occlusion at Sapporo Medical University Hospital between September 1995 and August 2004, were enrolled. Immediate and intermediate outcomes and complications were analyzed. Procedural success rate was 72.7% (8/11) in the children and 100% (5/5) in the adults. Coil migration occurred in 4 children and 1 adult, and 3 adult patients had hemolysis. CONCLUSION: Hemolysis was more frequent in adults than in children even though the residual shunt was trivial.

Aged↗
PubMed2006

Coil occlusion of patent ductus arteriosus.

BACKGROUND: Coils are the only devices available for transcatheter occlusion of patent ductus arteriosus (PDA) in Japan. Since April 1999, we have introduced a 0.052-inch Gianturco coil (0.052-inch coil) to close PDA >or=2.5 mm. METHODS AND RESULTS: A retrospective survey of the outcome of coil occlusions for PDA >or=2.5 mm before and after the 0.052-inch coil became available found that (1) the frequency of PDA >or=2.5 mm among all candidates for coil occlusion significantly increased after the availability of a 0.052-inch coil (p<0.01); (2) deployment complicated by migration (p<0.01), and prolonged procedure time (p<0.05) were significantly decreased after the introduction of the 0.052-inch coil. In a multivariate logistic regression model for uneventful deployment adjusted for age, pulmonary to systemic flow ratio, and use of a 0.052-inch coil, use of the 0.052-inch coil significantly decreased eventful deployment (p<0.05); and (3) successful deployment of a coil for PDA >or=4 mm significantly increased with the 0.052-inch coil (p<0.01). Complete occlusion was achieved once deployment was successful. CONCLUSION: Introduction of the 0.052-inch coil decreased complicated coil occlusion deployment for PDA >or=2.5 mm, and contributed to a better likelihood of coil occlusion for PDA >or=4 mm.

Balloon Occlusion↗
PubMed1985

Quantitative radiocardiography in patients with patent ductus arteriosus.

Analytical models of the analog computer simulation method of radiocardiogram (RCG) were revised to obtain quantitative hemodynamic evaluations in patent ductus arteriosus (PDA). The theoretical and technical aspects are herein outlined, and the effects of clinical application discussed. Twenty-six patients with a left-to-right PDA shunt were studied by the revised RCG models, and the results were compared with oxymetric or echocardiographic data. Between RCG and oxymetry, the systemic blood flow (SBF) findings agreed well (r = 0.91), but in oxymetry, the pulmonary blood flow (PBF) findings were generally seen greater than in RCG (r = 0.81), and the oxymetric shunts appeared larger than in RCG (r = 0.75). This is because oxymetry cannot avoid the direct effects of the uneven partition of shunt flow to the lungs, whereas RCG can, in addition, measure the mean PBFs and SBFs. RCG may thus be said to be superior to oxymetry in assessing PDA shunts. Furthermore, RCG can estimate the mean left and right heart volumes (LHV and RHV) at the same time; the RCG LHV was found to correspond to the echocardiographic left ventricular end-diastolic volume (LVEDV) (r = 0.89). Moreover, the obtained relation between the RHV/LHV (Y) and the shunt ratio (X) proved to be the same that calculated theoretically (Y = -X + 1.0) in uncomplicated patients. Patients not presenting this relation may be assumed to suffer some condition complicating the PDA. In effect, the analog computer simulation method of RCG is a unique non-invasive means of obtaining quantitative analyses in PDA and in other congenital shunt diseases as well.

Adolescent↗
PubMed1997

Coil occlusion for patent ductus arteriosus in Japan.

We surveyed Japanese experience of coil occlusion of patent ductus arteriosus up to 30 September 1996 by sending questionnaires to 175 hospitals. Thirty-four hospitals reported outcome data for 231 procedures in 218 patients. Successful implantation was achieved in 94% and acute complete closure of the ductus occurred in 71% of those in whom implantation of the coil was successful. Of the latter, 83% reported late complete closure. When those patients who underwent reocclusion for residual shunt are included, 89% attained complete closure. No life-threatening complications have occurred so far. Late reopening was reported in 3 cases. Although the angiographic type of ductus was significantly related to successful implantation (p < 0.01), there was no significant correlation with complete occlusion. Ductuses with a minimum diameter greater than 3 mm had a decreased chance of successful implantation, whereas those less than 2 mm had a greater incidence of complete closure.

Child↗