Study shows antireflux procedures are overused in infants

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Does it matter if anti-reflux surgery is done in 'normal' infants?

McAteer et al. report a retrospective study of a large population-based database in the United States to identify factors associated with antireflux surgery (i.e., Nissen fundoplication) in infants, children, and adolescents hospitalized with gastroesophageal reflux disease. Perhaps the most critical question this study raises is, should the surgery be done at all, and if so, in which patients? Published guidelines (J. Pediatr. Gastroenterol. Nutr. 2009;49:498-547) suggest that other disorders that could mimic GERD should be ruled out with as much objectivity as possible prior to surgery.

One of the striking findings was that the majority of children, particularly young infants, did not undergo evaluation with diagnostic testing. Of the little diagnostic testing performed prior to surgery, upper gastrointestinal contrast fluoroscopy (UGI) was the most frequent test used. UGI, reasonable for characterizing upper GI anatomy, has no diagnostic value for GERD.

Cases were identified using ICD-9 codes, and with documented variability between clinicians in the diagnosis of GERD (Am. J. Gastroenterol. 2009;104:1278-95; quiz 96), it is concerning that not only were a great number of hospitalized children undergoing fundoplication, but over half of the cohort was 6 months or less in age.

Even more disturbing was the apparent lack of input from a consultant pediatric gastroenterologist in the decision-making process that led 11,621 (8.2%) of the 141,190 patients to antireflux surgery. Why more than half of the study cohort (52.7%) undergoing surgery to "correct" reflux at these 41 premier U.S. children's hospitals was 6 months of age or less is critical for both clinical decision making and health care utilization implications.

Numerous studies show that more than 85% of infants less than 6 months of age with reflux outgrow their reflux with little to no intervention, and, outcome studies of antireflux surgery show complications from fundoplication ranging from 8% to 28%, including death (Aliment. Pharmacol. Ther. 2007;25:1365-72; Arch. Dis. Child. 2005;90:1047-52).

In the NASPGHAN-ESPGHAN pediatric GERD guidelines, the expert panels reported that in operated children, those with neurologic impairment have more than twice the complication rate, three times the morbidity, and four times the reoperation rate of children without neurologic impairment (Am. J. Gastroenterol. 2005;100:1844-52). These data are particularly relevant to McAteer's study cohort in which antireflux surgery was performed significantly more often in those children with comorbid diagnoses of failure to thrive, neurodevelopmental delay, cardiopulmonary anomalies, cerebral palsy, aspiration pneumonia, tracheoesophageal fistula, and diaphragmatic hernia.

Thus, McAteer et al. provide a unique opportunity to not only reevaluate current clinical practice guidelines, but also implement multicenter prospective studies, using pediatric subspecialists to establish evidence-based criteria for the selection of the appropriate pediatric cases with GERD who would benefit from undergoing antireflux surgery.

Dr. Jose Garza and Dr. Benjamin D. Gold, FACG, are both in the division of pediatric gastroenterology, hepatology, and nutrition at the Children's Center for Digestive Healthcare, Atlanta. They had no relevant financial conflicts of interest.



Clinicians appear to be too quick to perform antireflux procedures in infants, compared with older children, according to a report published online Nov. 6 in JAMA Surgery.

In a retrospective cohort study involving 141,190 pediatric and adolescent hospitalizations for gastroesophageal reflux disease (GERD) across the country over an 8-year period, the proportional hazard ratio of undergoing antireflux surgery was markedly decreased for those aged 7 months to 4 years (0.63) or 5-17 years (0.43), compared with those aged 0-2 months or 2-6 months.

The reasons for this strong difference are not yet known for certain, but the data showed a lack of objective diagnostic studies preceding the surgery in all pediatric age groups, and most strikingly in the youngest patients. It may well be that clinicians are confusing physiologic regurgitation – which is common, benign, and self-resolving in infancy – with a more pathologic process, said Dr. Jarod McAteer of the division of pediatric general and thoracic surgery, Seattle Children’s Hospital, and his associates.

At the very least, it appears that many infants aren’t given an adequate trial of medical management, since most cases of gastroesophageal reflux in infancy will resolve with that alone within 3-6 months, they noted.

"Referral for surgical treatment of GERD is generally presumed to be a last resort after failure of medical management, with optimal candidates having undergone specific preoperative evaluations," the authors wrote. Diagnostic and treatment guidelines are well delineated for adults, but not so for children.

For example, "upper GI fluoroscopy is frequently used in the preoperative workup among children with GERD," even though it has been clearly demonstrated to be a poor predictor of pathologic reflux, the investigators said.

In what they described as the first study to examine the influence of patient age on progression to antireflux procedures, Dr. McAteer and his colleagues analyzed data from the Pediatric Health Information System database, which includes demographic and clinical information from 41 children’s hospitals that cover 85% of major metropolitan areas in the U.S.

Out of 141,190 patients aged 0-7 years who were hospitalized with gastroesophageal reflux or GERD, 64% were younger than 1 year of age, and 53% were younger than 6 months. These numbers highlight how common the diagnosis is in babies, they said.

They also "suggest that physicians may be more likely to apply the diagnosis in this patient group because of diagnostic uncertainty or because other characteristics of these hospitalized infants make it more likely that any regurgitation is perceived as pathologic and indicative of GERD."

Examples of such "other characteristics" include comorbidities such as neurodevelopmental delay, cardiopulmonary disorders, seizures, asthma, and cerebral palsy.

A total of 11,621 of the study population underwent antireflux procedures, of which 52.7% were aged 6 months or younger. Only 14% of these patients had first undergone upper GI endoscopy, 0.2% esophageal manometry, 1.3% a 24-hour esophageal pH study, 65% upper GI fluoroscopy, and 17.1% a gastric emptying study, the investigators said (JAMA Surg. 2013 Nov. 6 [doi: 10.1001/jamasurg.2013.2685]).

The study findings show that the threshold for performing antireflux procedures is lower in infants than in older children. And "despite the fact that expert guidelines urge the use of objective studies in the diagnosis of GERD and despite evidence that supports the use of objective studies before performing antireflux procedures, such a standardized evaluation is not common practice.

"A greater effort is needed to develop and disseminate best-practice standards for the diagnosis and treatment of children, especially infants, with possible GERD. We must clarify the indications for antireflux procedures," Dr. McAteer and his associates said.

No financial conflicts of interest were reported.

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