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Chan, B.; Singh, Y. Basis for Treatment of  Patent Ductus Arteriosus. Encyclopedia. Available online: https://encyclopedia.pub/entry/53431 (accessed on 21 May 2024).
Chan B, Singh Y. Basis for Treatment of  Patent Ductus Arteriosus. Encyclopedia. Available at: https://encyclopedia.pub/entry/53431. Accessed May 21, 2024.
Chan, Belinda, Yogen Singh. "Basis for Treatment of  Patent Ductus Arteriosus" Encyclopedia, https://encyclopedia.pub/entry/53431 (accessed May 21, 2024).
Chan, B., & Singh, Y. (2024, January 04). Basis for Treatment of  Patent Ductus Arteriosus. In Encyclopedia. https://encyclopedia.pub/entry/53431
Chan, Belinda and Yogen Singh. "Basis for Treatment of  Patent Ductus Arteriosus." Encyclopedia. Web. 04 January, 2024.
Basis for Treatment of  Patent Ductus Arteriosus
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This entry is adapted from the peer-reviewed paper 10.3390/jcdd11010007

Ductus arteriosus (DA) serves a crucial role in utero by redirecting the oxygenated blood away from the fluid-filled fetal lungs, and towards the systemic circulation for optimal fetal development. Typically, in term infants, DA undergoes functional constriction and closure within 1–3 days after birth, followed by tissue remodeling to ensure permanent closure. However, the DA may remain persistently patent postnatally, especially in very preterm infants, and is commonly referred to as patent ductus arteriosus (PDA). Its prevalence is inversely proportional to gestational age; more than 60% of preterm infants under 28 weeks of gestational age (GA) continue to have PDA 7 days after birth or longer. 

patent ductus arteriosus (PDA) premature infant preterm infant medical treatment indomethacin

1. Natural History of Patent Ductus Arteriosus Spontaneous Closure

To identify the optimal timing for patent ductus arteriosus (PDA) treatment and identify the right patient for intervention, it is crucial to understand the natural history of PDA. The closure of PDA is influenced by multiple intrinsic and extrinsic factors, such as GA at birth, birth weight, chronological age (CA), prenatal conditions, PDA anatomy and morphology, blood flow across DA, signaling factors (e.g., prostaglandins), genetic predisposition, and other clinical characteristics of the infants. These factors were comprehensively summarized in the recent article by Harmick et al., shedding light on the interplay that contributes to the closure of PDA [1].
When predicting the spontaneous closure of PDA, GA and BW stand out as the most influential factors that can be assessed at the bedside and impact spontaneous closure [2]. In the most comprehensive meta-analysis comprising 99 studies and a total of 29,532 preterm infants, Klerk et al. reported that the overall closure rate was 47% by 3 days and 61% by 7 days after birth. The PDA closure rate is inversely proportional to GA (Table 1), and lower BW proportionally correlates with a reduced rate of spontaneous PDA closure in preterm infants [2].
Table 1. The prevalence rate and median days of life (DOL) for the spontaneous closure of PDA.
GA (weeks) <28 <30 <32 <37
DOL 3 [2] 34% 47% 48% 55%
DOL 7 [2] 41% 77% 63% 78%
GA (weeks) <26 <28 <30 >30
Median Day [3] 71 13 8 9
de Klerk et al., 2020 [2] (n = 29,532); Semberova et al., 2017 [3] (n = 280).
If the DA remains patent 7 days after birth, there remains uncertainty on how long it takes for the spontaneous closure to occur in these infants. Semberova et al. followed 280 preterm infants who had not received any active PDA closure treatment and they reported that median days for PDA closure had an inverse relationship with both GA and BW as shown in Table 1 [3]. Sung et al. demonstrated that in infants of 23–28 weeks GA (n = 167), 95% had spontaneous closure of PDA by the time of discharge from the hospital [4].
Semberova et al. studied 56 infants who had patent DA at time of discharge from hospital and reported that 42% of cases (n = 24) had a spontaneous closure of PDA before their first follow-up appointment, 2 infants required surgical ligation or device closure, and 30 cases (56%) remained asymptomatic from PDA perspective during their follow-up. Overall, the spontaneous closure rate of PDA was 95% by 1 year of age [3]. In another study involving follow-up of 83 infants with GA of 26–30 weeks, Nielsen et al. reported a spontaneous PDA closure rate of 66% within the first year, 72% by the second year, 80% from 2–5 years. In total, 85% of infants with a diagnosis of PDA at discharge from hospital had a spontaneous closure within 5 years [5]. The risk factors associated with failure of spontaneous closure of PDA included the large size of the PDA, left atrial (LA) enlargement, and the presence of pulmonary hypertension [5].

2. Different Approaches in Patent Ductus Arteriosus Management

The likelihood of spontaneous closure of PDA in the vast majority of cases has sparked considerable debate on the need for PDA treatment in preterm infants. Currently, two approaches for PDA management in preterm infants are being described: (1) The conservative approach is based upon the belief that pharmacological or procedural intervention of PDA causes more harm by interrupting the natural closure process, (2) The active approach is based upon the concerns that prolonged exposure to significant PDA shunt may lead to pathological conditions causing short- and long-term consequences. This research presents evidence supporting each of these two conflicting arguments for the management of PDA in preterm infants.

3. Evidence to Support Conservative Patent Ductus Arteriosus Treatment Approach

Historically, PDA was treated with pharmacological agents (traditionally by non-steroidal anti-inflammatory drugs (NSAIDs such as ibuprofen and indomethacin), or surgical ligation soon after diagnosis of PDA. The findings from the Trial of Indomethacin Prophylaxis in Preterms (TIPP) shifted towards conservative PDA treatment approach [6]. The results of the clinical trial, involving1200 preterm infants weighing less than 1000 g, showed that prophylactic pharmacological treatment of PDA did not yield any long-term neurodevelopmental benefits, despite effectively reducing the incidence of IVH and acute pulmonary hemorrhage as compared to the control group [6]. A recent meta-analysis, summarizing 138 RCTs involving 11,856 preterm infants, also found that prophylactic pharmacological treatments effectively reduce the incidence of severe IVH, but these treatments have not improved the composite outcome of death or moderate/severe neurodevelopmental disability [7]. Similarly, a recent Cochrane review showed that prophylactic PDA pharmacological treatment did not decrease the risk of IVH, CLD, NEC, and mortality [8]. The PDA-TOLERATE trial, which investigated early routine PDA treatment within 6–14 days after birth among <28 weeks GA infants with a moderate to large PDA, revealed no reduction in the incidence of PDA ligation or prevalence of PDA at discharge compared to the control group [9]. On the contrary, the treatment group had an increased risk of late-onset sepsis, delayed time to achieve establishment of full feeds, and higher mortality among ≥26 weeks GA infants [9]. Overall, a comprehensive analysis of multiple published RCTs and observational studies published up to 2020 concluded that prophylactic or early pharmacological treatment of PDA has failed to show a reduction in mortality, BPD, NEC, and other morbidities [10][11][12]. Several recently published large RCTs, such as the Baby-OSCAR trial, the BeNeDuctus trial, and the TRIOCAPI trial, have included assessment of the hemodynamic impact of PDA but still consistently showed no long-term benefits associated with prophylactic treatment [13][14][15][16][17]. The latest BeNeDuctus RCT trial published in 2023 showed that expectant management of PDA in <28 weeks GA infants (n = 136) was non-inferior to early (<72 h) ibuprofen treatment (n = 137) in terms of a composite outcome of NEC, BPD, or death at 36 weeks GA [15].
All PDA treatments have associated risks from the intervention. A non-selective prophylactic treatment exposes a large number of infants to potential adverse effects of medications unnecessarily as PDA may close spontaneously in some of these infants [8]. Pharmacological medical treatment may lead to kidney injury and gastrointestinal bleeding [8]. Surgical PDA ligation is associated with even more serious complications, including vocal cord paralysis, post-ligation syndrome, pneumothorax, infection, or bleeding [18].
The evolving evidence has prompted significant changes towards conservative PDA management. A study conducted at 19 children’s hospitals in the USA revealed an 11% decrease in treatment of PDA from 2005 to 2014. Similarly, an extensive database encompassing over 61,000 preterm infants from 280 NICUs demonstrated a decline in the incidence of PDA diagnosis from 51 to 38%, a reduction in pharmacological treatment for PDA from 32 to 18%, and a 5% decrease in the PDA ligation rate when findings were compared between the two periods of 2011–2015 and 2006–2010 [19]. These changes have been witnessed across various countries worldwide [20][21][22].

4. Evidence to Support Active Patent Ductus Arteriosus Treatment Approach

The clinical trials targeting PDA closure have failed to show significant long-term benefits. However, clinical observational studies consistently showed a strong association between PDA and neonatal morbidities; as more co-morbidities have been observed within the same institution when more infants have their PDA managed conservatively over time [6][23][24][25][26][27][28]. A few explanations for these contradicting data have been proposed.
Firstly, the infants in the active PDA closure trials were heterogenous, particularly in their GA range. About 60% of the enrolled infants were beyond 26 weeks of GA whose PDA were more likely to close even without active treatment. Only fewer infants <26 weeks GA were enrolled in these trials, who are more likely to be affected by a hsPDA and less responsive to pharmacological treatment [14]. They may exhibit lower tolerance to the hemodynamic stress imposed by PDA, and a higher incidence of death or BPD compared to other GA subgroups [29]. Active treatment in the lower GA group may show more long-term benefits.
Secondly, the PDA trials analysis was based on intention-to-treat or if pharmacological treatments were given rather than actual PDA closure. Currently, pharmacological treatments report a PDA closure efficacy rate of 50–70% [7][8][14][30][31][32], hence a portion of infants in the treatment group may still have open PDA. On the other hand, infants in the control group may have open or spontaneously closed PDA. A major criticism of the RCTs is the high proportion of open-label or cross-over cases in the control arm [15][33]. About 52% (38–71%) of control patients in the 32 RCTs received PDA treatment at the treating clinician’s discretion [15]. Hence, the actual difference between the treatment and control arm in exposure duration to symptomatic PDA might have been lower than expected. The PDA-TOLERATE trial also exhibited selection bias in the enrollment process. Thirteen percent of non-enrolled patients, who were younger in GA and required more respiratory support, underwent PDA treatment as early as 5 days after birth, 3 days earlier than the infants in the treatment arm [9]. These non-enrolled infants, who received PDA treatment, had a lower incidence of BPD compared to the study patients. This may support the case for an earlier closure of PDA [34].
Lastly, around 25% of the 67 PDA trials did not provide details on how PDA was diagnosed, and 10% used clinical criteria instead of echocardiography evidence of hemodynamically significant PDA. The lack of standardized PDA diagnosis criteria raises the question of whether all enrolled infants had a moderate or large PDA, or PDAs in some cases were small and insignificant. Inconsistent diagnostic approach undermines the reliability and credibility of the study results.
The heterogenicity of RCTs generated equivocal evidence to support the active PDA closure approach. However, increasing numbers of transcatheter PDA closures in very preterm infants have provided invasive hemodynamic measurements to evaluate the impact of the PDA shunt. Cardiac catheterization data showed that the longer the duration of PDA exposure, the higher was the pulmonary vascular resistance (PVR) developed over time [35]. Prolonged pulmonary over-circulation from the PDA shunt leads to pulmonary vascular remodeling and an increase in PVR. Recently, Sathanandam et al. compared the invasively measured systolic pulmonary and systemic blood pressure in preterm infants undergoing transcatheter PDA closure [36]. They reported that infants with lower systolic pulmonary pressure were younger in chronological age (27 vs. 72 days, p < 0.001) and thus had a shorter exposure duration to the PDA effect. The study suggests that systolic pulmonary pressure and PVR may increase over time in the presence of PDA shunt. Infants with lower PVR recovered from the device closure procedure faster and extubated sooner, even when they were younger in chronological age at the time of intervention [36][37]. In addition to catheterization data, MRI brain imaging has shed light on the negative impact of prolonged PDA duration on cerebellar growth, and the subsequent poor neurodevelopmental outcomes even at 2 years of corrected age [38]. Brain imaging and monitoring may improve our understanding of PDA shunt’s effect on brain development. Infants with a prolonged exposure to PDA shunt also had poorer weight gain which can impair somatic and brain growth [36]. These studies provide additional strong and convincing evidence to support active PDA treatment, especially in infants with hemodynamically significant ductal shunt.

5. Defining Hemodynamically Significant Patent Ductus Arteriosus

A comprehensive definition of hemodynamically significant PDA (hsPDA) can help in targeting treatment in preterm infants: when to intervene and who to treat based upon the hemodynamic impact of PDA shunt. The shunt across PDA is a dynamic that extends beyond a simple binary classification of open or closed ductus arteriosus. Factors such as PDA size, flow volume, cardiovascular load, and end-organ perfusion play crucial roles in determining the clinical effects of PDA. Many literature reviews have discussed using clinical features, echocardiographic features, and patient status to define hsPDA [39]. Various PDA scoring systems have been developed to combine these features for risk stratification and identifying infants at higher risk of co-morbidities [13][40][41][42][43]. There is an urgent need for developing a universally agreed criteria with validated sensitivity and specificity for defining hsPDA, and even more importantly, which can be used easily by both pediatric cardiologists and neonatologists in their routine clinical practice.

References

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