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Catheter-based closure of the patent ductus arteriosus in preterm infants: considerations in the design of a randomized trial

Journal of Perinatology volume 39, pages 1437–1438 (2019)Cite this article

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Patent ductus arteriosus (PDA) is the most common cardiovascular abnormality during infancy, increases mortality risk eightfold, and is linked to chronic lung disease, pulmonary hypertension, and congestive heart failure [1]. Early pharmacological treatment is a commonly employed to close PDA in the first weeks of life, but 35–50% infants fail or have contraindications to drug therapy (failed early treatment). Considerable uncertainty exists regarding best treatment for the cohort of infants following failed early treatment who continue to have clinical and hemodynamic perturbations potentially attributable to the ductus [2]. Traditionally, surgery was used following failed early treatment, with some evidence, albeit limited, suggestive of lower mortality and improved outcomes following surgical closure [3]. Over the past decade, associations between surgical PDA ligation and adverse outcomes within large cohort studies led to a secular trend away from definitive ductal closure [4].

Currently, most health care providers have adopted an observational (nonintervention) approach to the PDA following failed early treatment. This approach avoids (or at least delays) procedure-related complications, but prolongs the duration of PDA exposure while the clinician watchfully waits for a spontaneous ductal closure. However, consensus on how long observation can be tried is lacking, with some evidence of greater risks following prolonged exposure [5]. The American Academy of Pediatrics notes the urgent need for clinical trials to identify the optimal treatment strategy for this subgroup of infants, but lack of equipoise between the surgical and watchful waiting approaches’ precluded the conduct of such trials [2]. In the absence of clear evidence, the fundamental question of whether closure versus nonclosure of the ductus following failed early treatment improves important longer term patient outcomes remains unanswered. But what if there were an alternative, minimally invasive approach to achieve definitive ductal closure? Might it lead to improved outcomes in infants deemed to be at high risk for PDA-attributable complications?

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Funding

CHB and JLS, Co-PIs (R01 HL145032-01).

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Authors and Affiliations

  1. Center for Perinatal Research, Nationwide Children’s Hospital, Columbus, OH, USA

    Carl H. Backes & Jonathan L. Slaughter

  2. The Heart Center at Nationwide Children’s Hospital, Columbus, OH, USA

    Carl H. Backes

  3. Department of Pediatrics, The Ohio State University Wexner Medical Center, Columbus, OH, USA

    Carl H. Backes & Jonathan L. Slaughter

  4. Division of Neonatology, Nationwide Children’s Hospital, Columbus, OH, USA

    Carl H. Backes & Jonathan L. Slaughter

  5. Population Health Sciences, University of Bristol, Canynge Hall, Whiteladies Road, Bristol, UK

    Jenny L. Donovan

  6. Division of Epidemiology, The Ohio State University College of Public Health, Columbus, OH, USA

    Jonathan L. Slaughter

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  1. Carl H. Backes
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  2. Jenny L. Donovan
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Correspondence to Carl H. Backes.

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CHB is a consultant for Abbott. Other authors declare that they have no conflict of interest.

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Backes, C.H., Donovan, J.L. & Slaughter, J.L. Catheter-based closure of the patent ductus arteriosus in preterm infants: considerations in the design of a randomized trial. J Perinatol 39, 1437–1438 (2019). https://doi.org/10.1038/s41372-019-0484-9

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