In this month’s “GI & Hepatology News,” Dr. Ben Gold and Dr. Jose Garza comment on antireflux surgery in infants (page 12) (related article on page 1 of same issue). Initial reference: JAMA Surg 2013 [doi: 10.1001/jamasurg.2013.2685]. See the following link. They comment on the lack of workup for many of these infants who undergo this major surgery and the frequent lack of involvement by pediatric gastroenterologists.
PDF: December issue – American Gastroenterological Association
As noted about a week ago in this blog, gastrostomy tube (gtube) placement in children is much different from gtube placement in adults.
A retrospective study from Boston Children’s followed 138 patients who had PEG tube placed between 1999-2000 (JPGN 2013; 57: 663-67). The median followup was approximately 5 years.
Results:
Bottomline: The need for gastrostomy tube placement is associated with frequent comorbidities. A significant number of patients undergoing gastrostomy tube placement experience major complications.
Also noted:
JPGN 2013; 57: 659-62. This prospective study of 69 patients showed that early reintroduction of feedings after gastrostomy placement, 4 hours postoperatively, was safe and compared favorably to those fed 12 hours postoperatively. Early feedings were associated with hospital duration, on average, of 6.7 hours. At this center, prophylactic antibiotics were not administered without apparent increase in infections.
JPGN 2013; 57: 668-72. This retrospective study of 77 children with feeding disorders showed that inpatient behavioral interventions are effective in transitioning children from gastrostomy tube feeding to oral feeding.
Related blog entries:
A recent study questions the value of fundoplication in children with neurologic impairment who undergo gastrostomy tube placement (JAMA Pediatr doi:10.1001/jamapediatrics.2013.334).
This paper’s findings are limited by the study’s design as a retrospective, observational cohort study. However, the study has several strengths as well. First of all, this was a large study which identified 4163 neurologically-impaired infants who underwent either tube placement with (n=1404) or without fundoplication (n=2759). This population was drawn from 42,796 infants admitted to neonatal intensive care units from 42 children’s hospitals. Thus, a second advantage of this study was looking at a broad range of children from the same NICU population.
Findings:
The authors note that two previous studies had shown a reduction in reflux-related hospitalizations for children who had admissions due to reflux-related conditions. However, they note that in their study, these patients had fundoplication performed prophylactically based on clinical judgement.
But, “clinical symptoms, including dysfunctional swallowing and intolerance of gastric feedings, likely influence the decision to perform a concomitant fundoplication; however, these were unavailable in the database.” As such, the authors propensity score model could have failed to account for factors that are essential in deciding whether a concomitant fundoplication is worthwhile.
Bottom-line: A fundoplication may not effectively prevent reflux-related hospitalizations in neurologically-impaired infants; its expected benefits may be overstated. The only way to definitively determine how useful (or how ineffective) a fundoplication is would be a prospective study.
Related blog posts:
A lot has changed in the field of pediatric gastroenterology since I completed my training 16 years ago. One technology that is used frequently now is the gastrojejunal (GJ) tube for feeding neurologically-impaired children. Previously, GJ tubes were used as a temporary solution. Part of the rational for short-term usage was that these tubes were often difficult to maintain; they could easily become dislodged or clogged.
A recent study documents the more frequent usage of GJ tubes and their indefinite usage to treat complex feeding issues (JPGN 2013; 56: 523-27).
This retrospective chart review encompassed a 10 year period (1999-2009) at a single academic center. In total 33 patients were treated with GJ tubes with 160 placements. The mean age at initial placement was 6 years and the mean weight 19.4 kg. 76% of the patients had cerebral palsy/neurologic disorder, 21% had congenital heart disease, and 9% had chronic lung disease.
Common indications for replacement: dislodgment, obstruction, coiling into stomach, and broken tubing.
Three techniques were used:
Most procedures (85%) did not require sedation.
Outcomes:
When reading the study, it is hard to ignore Figure 3 which shows more than 30 placements per year after 2007 whereas the number was about two per year before 2001. In the discussion, the authors do not focus on how this technology has been embraced so widely. It is mostly a discussion on the indications, methods, and complications. Indications included high aspiration risk, intractable vomiting, failed Nissen fundoplication, and gastroparesis. “Our study showed that long-term jejunal feeding via GJ tubes is possible and safe.”
My preference is generally to avoid GJ feedings as a primary intervention for long-term feeding problems. That is, when patients need gastrostomy tube feeds but are prone to vomiting, most often a fundoplication is worthwhile. When a patient has had a fundoplication that is no longer effective, a GJ tube should be considered.
Related blog links:
Trying to decide whether a child should undergo a fundoplication is often quite difficult. The best candidates with gastroesophageal reflux disease (GERD) don’t need surgery because medical treatment is usually effective. Typical patients who fail medical treatments may have numerous comorbidities that could cause a complicated postoperative course or failure of the procedure.
One aspect about the surgery that has been questioned has been whether surgery causes dysmotility of the esophagus. A recent article describes a study, which enrolled only ten children who had surgery; however, these patients underwent extensive preoperative and postoperative evaluations to try to provide more information about the motility effects of fundoplication (J Pediatr 2013; 162: 566-73).
Patients were considered for surgery if they had failed medical therapy. Four of the ten patients were neurologically-impaired. Testing included automated impedance manometry, 24-hour pH-impedance, gastric emptying breath test, and GERD questionnaires (though the authors note that GERD questionnaires are not validated in children aged 1-12 years). Median patient age was 6.4 years, with a range of 1-17 years.
Surgery: laparascopic anterior partial fundoplication
Results:
Related blog posts:
The Medical Pendulum and Gastroesophageal Reflux | gutsandgrowth
Gastroesophageal Reflux: I know it when I see it | gutsandgrowth
Related references:
In so many areas of pediatric gastroenterology, there is a gradual development of enthusiasm for a medical treatment. In the vast majority, the enthusiasm goes too far and closer scrutiny often determines a more limited role for this medical treatment or potential adverse effects that were not initially appreciated. The latest example of this may well be with the use of proton pump inhibitors (PPIs) for gastroesophageal reflux disease, particularly in infants and individuals with asthma. Although these medications may not have reached their apogee, more and more their effectiveness for so many ailments has been questioned. In this month’s issue of JPGN, this is highlighted (JPGN 2012; 54: 8-14). The article which emanates from the offices of the FDA discusses the fact that the usage of PPIs has increased 11-fold from 2002-2009 in infants <12months of age; 404,000 prescriptions were dispensed to 145,000 infants in the U.S. in 2009. At the same time, althougth there have been four randomized controlled trials of PPIs in infants, NO studies have demonstrated the effectiveness of these drugs in this population. As a consequence, the authors recommend that these drugs be restricted to infants with endoscopically-proven GERD/erosive esophagitis. No other tools are sufficient to identify infants who are likely to respond. Perhaps the reason why these agents work less well in infants is due to the fact that acid secretion is much less in infants than in children and adults. For example, at 4months of life, average acid secretion rate in infants is ~27-fold lower than in adults (Am J Dig Dis 1969; 14: 400-14). As a consequence, their symptoms may not be responsive to acid reduction treatments.
Other related references on GERD in infancy:
–JPGN 2010; 50: 609-18. Pantoprazole helped improve symptoms but there were no significant differences compared to placeblo in withdrawal rates due to lack of efficacy. n=128.
-NASPGHAN 2009, Abstract#21. Meds/Rx of NICU pts did not shorten hospital stay or promote wt gain, n=1149.
–JPGN 2009; 49: 498. NASPGHAN GERD guidelines. “In infants and toddlers, there is no symptom or symptom complex that is diagnositc of GERD or predicts response to therapy.” Identical response to placebo (vs prevacid) in largest double-blind randomized study (54% at 4 weeks) (J Pediatrics 2009; 154: 514-20.)-Reflux is “not a common cause of unexplained crying. irritability..in otherwise healthy infants.” “There is no evidence to support the empiric use of acid suppression for the treatment of irritable infants.”
GERD and respiratory/ENT issues:
–Gastroenterology 2010; 139: 1887. PPIs decreased postnasal drainage compared to placebo. n=75. (50% vs 5%) age discrepancy in patient populations.
–Clin Gastro & Hep 2010; 8: 741 (excellent editorial), 770 (article on rabeprazole improving heartburn Sx in pts with laryngitis), n=82. Editorial suggests 1-2month trial of BID PPI and if not effective, then little to offer. May change when studies looking at surgery (after impedance) outcomes.
–Gastroenterology 2010; 139: 754. 716 (editorial). Acoustic cough & reflux. Study recorded cough during pH measurement. n=71. ‘causality cannot be established until effective treatment’ available.
–Gastroenterology 2009; 137: 1844. Critical review of below NEJM article. ‘a subset of asthmatics will have objective detection of GERD without typical symptoms…work by Amer Lung Assn suggests that twice daily PPI will not be helpful’..however, ‘perhaps 3-6months of PPI may still be reasonable until we can accurately identify subgroups of pts who may respond.’ –Gary Falk, Cleveland Clinic
–NEJM 2009; 360: 1487, 1551. Use of PPIs (nexium 40mg bid) in poorly-controlled asthma with no symptoms of GER –did not help w asthma control & pH studies were not predictive of response. n=412 adults. 40% c abnl pH studies in each group (nexium vs. placebo).
–Clin Gastro & Hep 2007; 5: 1379. Review of ENT findings and reflux.
–Am J Gastro 2007; 102: 716. Poor specificity of ENT findings for diagnosis of laryngopharyngeal reflux.
–Aliment Pharm Ther 2007; 25: 385-92. meta-analysis. Rx c PPIs not more effective than placebo in resolving ENT symptoms presumed to be due to GER. Editorial suggests some patients may benefit, but better tools are needed to identify them.
GERD and surgery:
–Gastroenterology 2011; 141: 1938. LOTUS study in JAMA summarized in this review. (JAMA 2011; 305: 1969) Medical treatment outperformed surgery. 92% under control (remission) with long term medical Rx vs 85% with surgery & fewer side effects of medical treatment.
–Clin Gastro & Hepatology 2009; 7: 1292, 1264 (editorial). 12yr outcomes for surgery vs PPI. n=154 omeprazole, n=144 surgery. Similar long term outcome ~50% with long term remission.
–Pediatrics 2006; 118:1828. 48,665 antireflux surgeries done from 1996-2003 (~7000/yr) in US
–Clin Gastro & Hep 2006; 4: 299. Frequent complications post-op and frequent need for GERD meds. Dysphagia in 19%, dilatation in 6%, repeat surgery in 2%, mortality in 0.8% (n=3145). 50% required GERD meds.
–Clin Gastro & Hep 2004; 2: 978-984. Pediatric study. n=198. 63% required post-op treatment for recurrent GERD -retrospective review 1996-99.
Proton Pump Inhibitors and reported adverse effects:
-Risk of Hypomagnesemmia -2011. http://www.fda.gov/drugs/drugsafety/ucm245011.htm
–NEJM 2010; 363: 2114. large Denmark study. 5082 fetuses with PPI exposure (out of 840,968 live births). Risk of birth defects NOT increased with exposure during 1st trimester. Possible slight increase risk with preconception use except with omeprazole.
–Gastroenterology 2010; 139: 1115. Review of safety of PPIs.
–Gastroenterology 2010; 139: 93. n=167,000. PPIs associated with hip fracture risk, OR 1.3, in patients with other risk factors.
–Gastroenterology 2010; 138: 896-904. 5yrs of PPI -no increase risk in hip/spine fx.
–Arch Intern Med 2010; 170: 765-71, 747 (ed). PP not related to hip fx (n=161,806) women 50-79. INCREASE risk of spine fx, hazard risk 1.47
–Arch Intern Med 2010; 170: 772-8. PPIs increase risk of Clostridium difficile infection (hazard ratio 1.42 –42% increase in risk), n=1166.
–Arch Intern Med 2010; 170: 784-90. n=101,796. OR 1.74 for daily PPI, OR 2.36 if BID Rx; thus ~70% increase risk of nosocomial infection.
–Clin Gastro & Hep 2010; 8: 504. Increased bacterial overgrowth with PPI use.
-JAMA 2009; 301: 2120-2128. Use of PPIs associated with INCREASED hospital acquired pneumonia by ~30%. Could result in 180,000 HAP cases/yr with ~33,000 deaths. n+ 63,878 admissions, 52% on PPIs or H2RAs (83% PPIs, 17% H2RAs). H2RAs NOT associated with HAP cases.
–Gastroenterology 2009; 137: 80. PPIs induce acid-related symptoms in ~22% vs 7% of placebo in healthy volunteers.
–Ann Intern Med 2008; 149: 391-398. Risk for pneumonia associated with short-term PPI use, not long term
–Clin Gastro & Hep 2007; 5: 1418. Increases risk of bacterial gastroenteritis.
–JPGN 2007; 45: 395, 421. Increasing use of PPIs-4-fold from 2000-2003; 0.5% of all infants. No safety/efficacy data.
–J Pediatrics 2007; 150: 262. Long term use (up to 11yrs of usage) of PPIs in 166 children; minimal problems: 2 c nausea, 2 c skin rash, 1 c diarrhea, 1 c agitation.
–JAMA 2006; 296: 2947-53. Risk of bone fracture –odds ratio 1.44-2.65 with long-term PPI treatment (>1yr); UK study looked at 1.8million
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