Elsevier

The Journal of Pediatrics

Volume 157, Issue 3, September 2010, Pages 381-387.e1
The Journal of Pediatrics

Original Article
Early Surgical Ligation Versus a Conservative Approach for Management of Patent Ductus Arteriosus That Fails to Close after Indomethacin Treatment

https://doi.org/10.1016/j.jpeds.2010.02.062Get rights and content

Objective

To examine whether a more conservative approach to treating patent ductus arteriosus (PDA) is associated with an increase or decrease in morbidity compared with an approach involving early PDA ligation.

Study design

In January 2005, we changed our approach to infants born at age ≤27 weeks gestation who failed indomethacin treatment. We changed from an early surgical approach, in which feedings were stopped and all PDAs were ligated (period 1: January 1999 to December 2004; n = 216) to a more conservative approach in which feedings continued and PDAs were ligated only if cardiopulmonary compromise developed (period 2: January 2005 to August 2009; n = 180). All infants in both periods received prophylactic indomethacin therapy.

Results

The 2 periods had similar rates of perinatal/neonatal risk factors and indomethacin failure (24%), as well as ventilator management and feeding advance protocols. The conservative approach (period 2) was associated with decreased rates of duct ligation (72% vs 100%; P <.05). Even though infants subjected to this approach were exposed to larger PDA shunts for longer durations, the rates of bronchopulmonry dysplasia, sepsis, retinopathy of prematurity, neurologic injury, and death were similar to those in period 1. The overall rate of necrotizing enterocolitis was significantly lower in period 2 compared with period 1.

Conclusions

These findings support the need for new controlled, randomized trials to reexamine the benefits and risks of different approaches to PDA treatment.

Section snippets

Methods

This project design was approved by the University of California San Francisco's Institutional Review Board. Between January 1999 and July 2009, all infants ≤276/7 weeks gestation admitted to the William H. Tooley Nursery at University of California San Francisco were treated with a course of prophylactic indomethacin starting within 15 hours of birth provided that there were no contraindications. A full description of this approach has been published elsewhere.19 An echocardiogram was

Results

Infants who died ≤4 days before the first echocardiographic evaluation were excluded from the analysis (Figure). There were no differences between period 1 and period 2 in the percentages of infants that were excluded from the study (11% due to early death) or did not experience permanent PDA closure after prophylactic indomethacin treatment, were retreated with indomethacin, failed indomethacin retreatment, or were considered to have failed indomethacin treatment (24%) (Figure). There also

Discussion

This study spanning 2 consecutive time periods found no significant differences in the rates of BPD, sepsis, ROP, neurologic injury, or mortality between infants treated with early PDA surgery and those treated more conservatively (with surgical ligation only if the PDA was hemodynamically significant after failure of indomethacin treatment). We found a decreased risk of NEC in the more conservatively treated infants. Although the more conservative approach still resulted in eventual surgical

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    Supported in part by grants from the US Public Health Service (Grants NHLBI HL46691 and NIH/NCRR UCSF-CTSI UL1 RR024131) and a gift from the Jamie and Bobby Gates Foundation. R.C. received a research grant from Ovation Pharmaceuticals, Inc. The other authors declare no conflicts of interest.

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