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Stretta as the initial antireflux procedure in children
Journal of Pediatric Surgery (2005) 40, 148 – 152
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Stretta as the initial antireflux procedure in children Donald C. Liua,*, Stig Sommea, Peter G. Mavrelisa, Daniel Hurwicha, Mindy B. Stattera, Daniel H. Teitelbaumb, Beth T. Zimmermanna, Carl-Christian A. Jacksona, Charles Dyea a
University of Chicago Comer Children’s Hospital, Chicago, IL 60637, USA CS Mott Children’s Hospital, University of Michigan, Ann Arbor, MI 48109, USA
b
Index words: Stretta; Radio frequency; Gastroesophageal reflux; Children
Abstract Background: The Stretta procedure is an endoluminal antireflux procedure using radio frequency to induce collagen tissue contraction, remodeling, and modulation of lower esophageal sphincter physiology in an effort to treat gastroesophageal reflux disease (GERD). Although Stretta has been widely reported in the adult GERD literature as a viable initial surgical option, similar use in children has not been reported. The authors present the first report of Stretta as the initial antireflux procedure in children with GERD, evaluating indications, safety, and efficacy. Method: The charts of 8 children (aged 11-16 years) who received Stretta between January 2003 and September 2003 were retrospectively reviewed under an Institutional Review Board protocol. All patients had documented GERD preoperatively. Three children required concomitant feeding tube placement (percutaneous gastrostomy tube, group A). Five children with isolated severe GERD refractory to aggressive medical therapy received Stretta only (group B). Results: Stretta was successfully completed in all 8 children. In group A, 1 child developed a postoperative aspiration, which was successfully treated. All 3 children had resolution of their GERD symptoms (ie, feeding intolerance, emesis) and were able to tolerate full enteral nutrition post-Stretta. In group B, 3 of 5 children are currently off medications and asymptomatic on short-term follow-up (6-15 months). Of the remaining 2, 1 experienced symptomatic relief immediately postprocedure, but symptoms recurred off medications. Stretta was deemed unsuccessful in the remaining patient, and Nissen fundoplication was subsequently performed without difficulty. Conclusions: Stretta can be safely and successfully used as the initial antireflux procedure for children with GERD. Concomitant Stretta with PEG is an attractive option in children with preexisting GERD who require long-term feeding access. Longer follow-up and a larger patient population are needed to better confirm the safety and efficacy of Stretta presented in this report. D 2005 Elsevier Inc. All rights reserved.
Presented at the 35th Annual Meeting of the American Pediatric Surgical Association, Ponte Vedra, Florida, May 27-30, 2004. * Corresponding author. Tel.: +1 773 702 6175; fax: +1 773 702 1192. E-mail address: [email protected] (D.C. Liu). 0022-3468/05/4001-0027$30.00/0 D 2005 Elsevier Inc. All rights reserved. doi:10.1016/j.jpedsurg.2004.09.032
Gastroesophageal reflux disease (GERD) is one of the most prevalent disorders in children [1,2]. In the majority of afflicted children, medical therapy ranges in complexity from simple thickening of fees to prescription of antisecretory medications (ie, proton pump inhibitors is safe and effective) [3]. When conservative management fails, how-
Stretta as the initial antireflux procedure in children ever, antireflux surgery becomes necessary and is very effective, but is associated with morbidities including bloating and dysphagia as well as a small mortality risk [4]. The Stretta procedure is a new, endoluminal antireflux procedure using radio frequency (RF) energy application to the lower esophageal sphincter (LES) function in an effort to treat GERD [5,6]. Its novelty precludes the analysis of long-term results, but short-term results were promising in a recent prospective study by Richards et al [7] in which two thirds of a large group of adults were off antisecretory medications at 3 years. Recently, Islam et al [8] described the use of Stretta in children as a means to treat recurrent GERD after fundoplication. In this study, Stretta was shown to be safe and successful at 6 months’ follow-up. Although the exact mechanism for the technique has not been determined, 2 models predominate [9,10]. The thermal injury models postulate that RF treatment of the LES induces collagen tissue contraction, progressive intramuscular scar buildup, and remodeling and modulation of LES pressure to bolster esophageal sphincter function. The neurogenic model suggests that RF ablates the vagal afferent nerves involved in modulating transient LES relaxations, resulting in fewer transient LES relaxations and thereby decreasing acid exposure of the distal esophagus. Despite widely reported Stretta experience in the adult GERD literature as a viable initial surgical option, similar use in children has not been reported. We present the first report in children using Stretta as the initial antireflux procedure to treat GERD evaluating indications, safety, and efficacy.
1. Materials and methods 1.1. Patients The charts of 8 children (aged 11-16 years) who received Stretta between January 2003 and September of 2003 were retrospectively reviewed, and demographic and clinical data were collected. Institutional Review Board approval from The University of Chicago was obtained before any data collection. The Stretta device is a fully approved FDA device for adult use; however, it is not approved for pediatric use. Therefore, each use of this catheter was discussed with and approved by the medical director of the manufacturing company (Curon Medical, Inc, Sunnyvale, Calif). All children in the study had documented GERD via upper GI series, pH probe, and/or esophageal manometry. Children with large hiatal hernias (N1 cm) were excluded, as were children younger than 10 years. Group A consisted of 3 children with preexisting neurological impairment and GERD who required concomitant feeding tube placement because of inadequate oral intake. Two of the 3 children in this group were on continuous nasojejunal feedings, whereas the third child had been orally fed, albeit with gross symptoms of aspiration thought primarily related to GERD. Group B consisted of 5 neurologically normal
149 children with severe GERD refractory to aggressive medical therapy who received Stretta only. All children underwent Stretta under general anesthesia. By our protocol, all patients were observed at least overnight after the procedure.
1.2. Equipment The RF energy delivery system was as described previously [8]. Briefly, when the needles are deployed, RF energy is delivered to each electrode to achieve a temperature of 858C, with the mucosal temperature kept below 508C by continuous intraluminal irrigation to create a thermal lesion yet minimizing injury to the mucosa and submucosa. The Stretta procedure was performed as described previously [8]. Briefly, the child undergoes general anesthesia in the operating room and is placed in the left lateral decubitus position. A 28-F pediatric endoscope is passed into the stomach and proximal duodenum for diagnostic evaluation. A 0.035- to 0.039-in guide wire is then passed through the gastroscope to the level of the duodenum. As the gastroscope is removed, leaving the guide wire in place, the Z line (gastroesophageal junction) is identified and measured in centimeters from the teeth. The Stretta catheter is passed over the guide wire into the stomach and withdrawn to 0.5 cm proximal to the Z line using the measurements on the catheter. The balloon is inflated to 2.5 psi and the Stretta needles exposed to engage the muscular layer. Radio frequency energy is then delivered for 90 seconds. The needles are retracted, the balloon deflated, the catheter retracted 3 cm, rotated 458, and then advanced to the original position. A second set of lesions is created, establishing the first anterograde ring of 8 lesions. Five more rings are created in this manner in the esophagus at 0.5-cm intervals below the first set. This creates a 3-cm area in the esophagus in which the RF energy is delivered. A 20-F neonatal endoscope is then inserted alongside the Stretta catheter to visualize the esophageal mucosa and help confirm proper positioning for the subsequent cardia treatment. Additional rings are created in the cardia of the stomach using a pullback technique. After advancing the catheter into the gastric lumen, the balloon is inflated to 25 mL, retracted firmly against the hiatus, and the electrodes deployed. After 3 applications at this level, a second treatment is applied to the cardia with the balloon inflated to 22 mL of air. Please refer to the diagram shown in Islam et al [8] for further clarification. In children requiring concomitant gastrostomy, percutaneous gastrostomy tube placement was performed post-Stretta [11].
2. Results The procedure was performed on all 8 children without difficulty. Follow-up data are based on patient and family interviews; postoperative esophageal studies were not performed. The follow-up period for both groups ranges from 6
150
D.C. Liu et al.
Table 1 Data summary of children receiving Stretta as primary antireflux procedure for GERD (n = 8) Group A (n = 3)a
Group B (n = 5)
Tolerating full enteral regimen (3) Complications (1)c
Weaned off antisecretory agentsb (3/5) Complications (0)
a
Group A indulges neurologically impaired children with GERD receiving Stretta and gastrostomy; Group B, neurologically normal children with GERD receiving Stretta only. b Antisecretory agents: proton pump inhibitors; follow-up period: 6-15 months. c Postoperative aspiration pneumonitis.
to 15 months. All were kept overnight on the surgical service for observation, with 1 patient requiring an extended hospital stay secondary to a postoperative aspiration pneumonitis. No perforations or other endoscopy-related complications were noted in this series. Mean operating time was 46 F 8 minutes. In group A, 1 child aspired immediately after Stretta application. This aspiration was suspected intraoperatively based on increased oxygen requirements. Endoscopy showed no evidence of perforation, which was confirmed by an immediate postoperative thin barium esophagogram. The child recovered uneventfully with nonoperative management including intravenous antibiotics and chest physiotherapy. The other 2 children in group A were able to tolerate full enteral nutrition via continuous drip feedings by postoperative day 2. All 3 children were eventually able to tolerate full enteral nutrition via bolus feeding regimen status post-Stretta (range, 2-14 days). In group B, 3 of 5 children are currently off medications and asymptomatic on follow-up. In the remaining 2, 1 experienced symptomatic relief immediately postprocedure, but symptoms recurred off medications. This patient is currently asymptomatic on a once-daily proton pump inhibitor. Stretta was considered unsuccessful in the remaining patient as symptoms did not improve even on medications and subsequently underwent successful laparoscopic Nissen fundoplication. Data are summarized in Table 1.
3. Discussion The Stretta procedure has been used as a primary treatment option for severe GERD in adults since 1999 and has excellent safety record with a current complication rate of less than 0.1% [12]. Although serious complications such as esophageal perforation or death because of aspiration are documented, these occurred in the first 6 months of FDAapproved Stretta use [8,13,14]. The published open-label trial reported a short-term (1-year) success rate with more than 60% reducing their need for antisecretory medication. Recently, Richards et al [7] published a prospective study of Stretta in a large group of adults showing that two thirds of the subjects were symptomatically improved and off medications at 3 years; although fundoplication was clearly more
effective with greater than 90% success rate using the same criteria during the same period. There are 2 purported mechanisms by which RF prevents reflux [8]. First, there is mechanical alteration of the gastroesophageal junction by thermal energy– induced intramuscular scarring with resultant tightening of the LES mechanism. Treatment of the cardia also physically creates an endoluminal gastric placation of the distal esophagus further accentuating a barrier to acid reflux. Second, thermal ablation of esophageal and gastric cardia neural tissue leads to fewer transient LES relaxations theoretically leading to decreased acid exposure of the distal esophagus. Interestingly, Corley et al [15] reported on significant improvement of GERD symptoms after Stretta treatment in a randomized, sham-controlled study where improvement in symptoms was not associated with decreased esophageal acid exposure or medication use. However, when they evaluated acid exposure times in responders vs nonresponders, there was a notable decrease in 24-hour acid exposure. Clearly, the mechanism for improved symptoms after Stretta needs to be further elucidated and may well be a combination of limiting acid exposure and decreased visceral sensitivity of the distal esophagus. This is the first report of the Stretta procedure being used as the initial antireflux procedure in children. Our early experience in normal children with severe GERD (group B) showed excellent short-term results in 3 of 5 children, who are off medications and asymptomatic at more than 6 months and up to 15 months postprocedure. Of the remaining 2, 1 became symptomatic when medications were withdrawn but is asymptomatic on a decreased dose of a proton pump inhibitor. The last child had no symptomatic relief post-Stretta and underwent successful fundoplication, during which there was no evidence of esophageal scarring or adhesions. Clearly, the efficacy and durability of Stretta still need to be determined with long-term follow-up. Our experience in neurologically impaired children with GERD requiring gastrostomy led us to the following observations: (1) effective feeding regimens including bolus feedings can be achieved after a Stretta procedure in neurologically impaired children with GERD; (2) endoluminal techniques, albeit technically less invasive, do not necessarily lessen the risk of postoperative complications (ie, aspiration pneumonia, in this at-risk patient population); and (3) a Stretta percutaneous gastrostomy tube procedure is a potentially useful, even attractive option in this group of children. The Stretta procedure provides a safe and effective initial surgical treatment of symptomatic GERD in carefully selected neurologically normal and neurologically impaired children. As experience accrues, the inclusion criteria can be further refined. Continued long-term follow-up is necessary to fully appreciate the durability of the procedure as well as its effect on the growing child.
Stretta as the initial antireflux procedure in children
References [1] Turnage RH, Oldham KT, Coran AG, et al. Late results of fundoplication for gastroesophageal reflux in infants and children. Surgery 1989;105:457 - 64. [2] Fonkalsrud EW, Ashcraft KW, Coran AG, et al. Surgical treatment of gastroesophageal reflux in children: a combined hospital study of 7467 patients. Pediatrics 1998;101:419 - 22. [3] Castell DO, Kahrilas PJ, Richter JE, et al. Esomeprazole (40 mg) compared with lansoprazole (30 mg) in the treatment of erosive esophagitis. Am J Gastroenterol 2002;97:575 - 83. [4] Spechler SJ, Lee E, Ahnen D, et al. Long-term outcome of medical and surgical therapies for gastroesophageal reflux disease: follow-up of a randomized controlled trial. JAMA 2001;285:2331 - 8. [5] Utley DS, Kim M, Vierra MA, et al. Augmentation of lower esophageal sphincter pressure and gastric yield pressure after radiofrequency energy delivery to the gastroesophageal junction: a porcine model. Gastrointest Endosc 2000;52:81 - 6. [6] DiBaise JK, Brand RE, Quigley EMM. Endoluminal delivery of radiofrequency energy to the gastroesophageal junction in uncomplicated GERD: efficacy and potential mechanism of action. Am J Gastroenterol 2002;97:833 - 42. [7] Richards WO, Houston HL, Torquati A, et al. Paradigm shift in the management of gastroesophageal reflux disease. Ann Surg 2003;237: 638 - 49. [8] Islam S, Geiger JD, Coran AG, et al. Use of radiofrequency ablation of the lower esophageal sphincter to treat recurrent gastroesophageal reflux disease. J Pediatr Surg 2004;39:282 - 6. [9] Tam WCE, Schoeman MN, Zhan Q, et al. Delivery of radiofrequency energy to the lower esophageal sphincter and gastric cardia inhibits transient LES relaxations and reflux in patients with reflux disease [abstract]. Gastroenterology 2001;120:A16. [10] Kahrilas PJ. Editorial: radiofrequency energy treatment of GERD. Gastroenterology 2003;125:970 - 2. [11] Gauderer M. Twenty years of percutaneous endoscopic gastrostomy: origin and evolution of a concept and its expanded applications. Gastrointest Endosc 1999;50(6):879 - 83. [12] Triadafilopoulos G. Stretta: an effective, minimally invasive treatment for gastroesophageal reflux disease. Am J Med 2003;115:192S - 200S. [13] Thiny ME, Shaheen NJ. Is Stretta ready for primetime? Gastroenterology 2002;123:643 - 5. [14] Richards WO, Scholz S, Khaitan L, et al. Initial experience with the Stretta procedure for the treatment of gastroesophageal reflux disease. J Laparoendosc Adv Surg Tech 2001;11:267 - 73. [15] Corley DA, Katz P, Wo JM, et al. Improvement of gastroesophageal reflux symptoms after radiofrequency energy: a randomized, shamcontrolled trial. Gastroenterology 2003;125:668 - 76.
Discussion T. Buchmiller-Crair (New York, NY): Do you alter the technique that is described in adults when you apply it to the pediatric population? Are there any modifications based on weight or patient size?
151 surgical colleagues talking about not letting these technologies get out of our hands and just being performed by gastroenterologists, but I guess with this technology I have a significant concern. I think it is one thing to create a thermal injury in a 60- or 70-year-old person with reflux that might help them get by without an operative procedure, but I have significant concerns about doing this in children who will then live with that thermal burn for the next 60 to 70 years with really unknown consequences of that. As best I can tell in talking to anybody, no one has really looked at that problem or issue, and I just wonder if you have any concerns about that in doing a procedure that is not as effective as what I think we have shown now is a very effective low-morbidity low-mortality procedure and creating a thermal burn that may affect these children later on in life. C.-C. Jackson (response): Well, that is definitely a concern. I think the initial data in the adults do show it to be safe and at longer term follow-up there have been no incidences of complications such as dysphagia or motility disorders. It is certainly something that bears observation. I do not think anyone would argue that the fundoplication does offer a more definitive result for treatment of GERD, but I think the ability to use Stretta, which is a less invasive procedure, bears further examination. In histologic studies, it has been shown that there is no significant architectural distortion of the mucosa or areas outside the muscular layer, which seems to support that this would be a useful procedure. C. Reyes (Pensacola, FL): In the adult literature, there is some interesting information that suggests that Stretta is particularly useful in patients with gastroesophageal reflux and gastric dysrhythmias, particularly tachygastria, in that the Stretta procedure would not only provide treatment for the gastroesophageal reflux but also ameliorates that tachygastric pattern and many of these patients end up having normal gastric patterns after the Stretta procedure. Do you have any thoughts about that in kids? C.-C. Jackson (response): As I recall, there was a study showing that after treatment with Stretta you create a normal gastric emptying pattern. We have not examined gastric emptying in our patients.
C.-C. Jackson (response): The only real modification that we performed was increasing the length of the zone of entry. In adults, it is traditionally a 2-cm length and we chose to do a 3-cm zone for the reason that we are not sure with the child’s growth if that will become a factor.
J. Bleacher (Atlanta, GA): Could you comment on any incidence of dysphagia in these children after the Stretta procedure? And I noticed that in the one that was still symptomatic you did a fundoplication. Is there any indication for repeat application of Stretta in those children?
S. Rothenberg (Denver, CO): I applaud you for taking this on. I think it is important as I constantly hear our adult
C.-C. Jackson (response): There is certainly an indication for a repeat Stretta and Dr Islam in his paper presented
152 last year did do that for one of the patients with recurrent symptoms and was treated successfully. There was no evidence of dysphagia in our children, at least the neurologically normal children that we were able to follow. As you saw, the fundoplication in the child with
D.C. Liu et al. the recurrence, this was a judgment call because we did it fairly early after the Stretta procedure before the traditional time that Stretta is thought to take full effect and this was because her symptoms were fairly severe and we did not want to wait any longer than necessary.
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Stretta as the initial antireflux procedure in children Donald C. Liua,*, Stig Sommea, Peter G. Mavrelisa, Daniel Hurwicha, Mindy B. Stattera, Daniel H. Teitelbaumb, Beth T. Zimmermanna, Carl-Christian A. Jacksona, Charles Dyea a
University of Chicago Comer Children’s Hospital, Chicago, IL 60637, USA CS Mott Children’s Hospital, University of Michigan, Ann Arbor, MI 48109, USA
b
Index words: Stretta; Radio frequency; Gastroesophageal reflux; Children
Abstract Background: The Stretta procedure is an endoluminal antireflux procedure using radio frequency to induce collagen tissue contraction, remodeling, and modulation of lower esophageal sphincter physiology in an effort to treat gastroesophageal reflux disease (GERD). Although Stretta has been widely reported in the adult GERD literature as a viable initial surgical option, similar use in children has not been reported. The authors present the first report of Stretta as the initial antireflux procedure in children with GERD, evaluating indications, safety, and efficacy. Method: The charts of 8 children (aged 11-16 years) who received Stretta between January 2003 and September 2003 were retrospectively reviewed under an Institutional Review Board protocol. All patients had documented GERD preoperatively. Three children required concomitant feeding tube placement (percutaneous gastrostomy tube, group A). Five children with isolated severe GERD refractory to aggressive medical therapy received Stretta only (group B). Results: Stretta was successfully completed in all 8 children. In group A, 1 child developed a postoperative aspiration, which was successfully treated. All 3 children had resolution of their GERD symptoms (ie, feeding intolerance, emesis) and were able to tolerate full enteral nutrition post-Stretta. In group B, 3 of 5 children are currently off medications and asymptomatic on short-term follow-up (6-15 months). Of the remaining 2, 1 experienced symptomatic relief immediately postprocedure, but symptoms recurred off medications. Stretta was deemed unsuccessful in the remaining patient, and Nissen fundoplication was subsequently performed without difficulty. Conclusions: Stretta can be safely and successfully used as the initial antireflux procedure for children with GERD. Concomitant Stretta with PEG is an attractive option in children with preexisting GERD who require long-term feeding access. Longer follow-up and a larger patient population are needed to better confirm the safety and efficacy of Stretta presented in this report. D 2005 Elsevier Inc. All rights reserved.
Presented at the 35th Annual Meeting of the American Pediatric Surgical Association, Ponte Vedra, Florida, May 27-30, 2004. * Corresponding author. Tel.: +1 773 702 6175; fax: +1 773 702 1192. E-mail address: [email protected] (D.C. Liu). 0022-3468/05/4001-0027$30.00/0 D 2005 Elsevier Inc. All rights reserved. doi:10.1016/j.jpedsurg.2004.09.032
Gastroesophageal reflux disease (GERD) is one of the most prevalent disorders in children [1,2]. In the majority of afflicted children, medical therapy ranges in complexity from simple thickening of fees to prescription of antisecretory medications (ie, proton pump inhibitors is safe and effective) [3]. When conservative management fails, how-
Stretta as the initial antireflux procedure in children ever, antireflux surgery becomes necessary and is very effective, but is associated with morbidities including bloating and dysphagia as well as a small mortality risk [4]. The Stretta procedure is a new, endoluminal antireflux procedure using radio frequency (RF) energy application to the lower esophageal sphincter (LES) function in an effort to treat GERD [5,6]. Its novelty precludes the analysis of long-term results, but short-term results were promising in a recent prospective study by Richards et al [7] in which two thirds of a large group of adults were off antisecretory medications at 3 years. Recently, Islam et al [8] described the use of Stretta in children as a means to treat recurrent GERD after fundoplication. In this study, Stretta was shown to be safe and successful at 6 months’ follow-up. Although the exact mechanism for the technique has not been determined, 2 models predominate [9,10]. The thermal injury models postulate that RF treatment of the LES induces collagen tissue contraction, progressive intramuscular scar buildup, and remodeling and modulation of LES pressure to bolster esophageal sphincter function. The neurogenic model suggests that RF ablates the vagal afferent nerves involved in modulating transient LES relaxations, resulting in fewer transient LES relaxations and thereby decreasing acid exposure of the distal esophagus. Despite widely reported Stretta experience in the adult GERD literature as a viable initial surgical option, similar use in children has not been reported. We present the first report in children using Stretta as the initial antireflux procedure to treat GERD evaluating indications, safety, and efficacy.
1. Materials and methods 1.1. Patients The charts of 8 children (aged 11-16 years) who received Stretta between January 2003 and September of 2003 were retrospectively reviewed, and demographic and clinical data were collected. Institutional Review Board approval from The University of Chicago was obtained before any data collection. The Stretta device is a fully approved FDA device for adult use; however, it is not approved for pediatric use. Therefore, each use of this catheter was discussed with and approved by the medical director of the manufacturing company (Curon Medical, Inc, Sunnyvale, Calif). All children in the study had documented GERD via upper GI series, pH probe, and/or esophageal manometry. Children with large hiatal hernias (N1 cm) were excluded, as were children younger than 10 years. Group A consisted of 3 children with preexisting neurological impairment and GERD who required concomitant feeding tube placement because of inadequate oral intake. Two of the 3 children in this group were on continuous nasojejunal feedings, whereas the third child had been orally fed, albeit with gross symptoms of aspiration thought primarily related to GERD. Group B consisted of 5 neurologically normal
149 children with severe GERD refractory to aggressive medical therapy who received Stretta only. All children underwent Stretta under general anesthesia. By our protocol, all patients were observed at least overnight after the procedure.
1.2. Equipment The RF energy delivery system was as described previously [8]. Briefly, when the needles are deployed, RF energy is delivered to each electrode to achieve a temperature of 858C, with the mucosal temperature kept below 508C by continuous intraluminal irrigation to create a thermal lesion yet minimizing injury to the mucosa and submucosa. The Stretta procedure was performed as described previously [8]. Briefly, the child undergoes general anesthesia in the operating room and is placed in the left lateral decubitus position. A 28-F pediatric endoscope is passed into the stomach and proximal duodenum for diagnostic evaluation. A 0.035- to 0.039-in guide wire is then passed through the gastroscope to the level of the duodenum. As the gastroscope is removed, leaving the guide wire in place, the Z line (gastroesophageal junction) is identified and measured in centimeters from the teeth. The Stretta catheter is passed over the guide wire into the stomach and withdrawn to 0.5 cm proximal to the Z line using the measurements on the catheter. The balloon is inflated to 2.5 psi and the Stretta needles exposed to engage the muscular layer. Radio frequency energy is then delivered for 90 seconds. The needles are retracted, the balloon deflated, the catheter retracted 3 cm, rotated 458, and then advanced to the original position. A second set of lesions is created, establishing the first anterograde ring of 8 lesions. Five more rings are created in this manner in the esophagus at 0.5-cm intervals below the first set. This creates a 3-cm area in the esophagus in which the RF energy is delivered. A 20-F neonatal endoscope is then inserted alongside the Stretta catheter to visualize the esophageal mucosa and help confirm proper positioning for the subsequent cardia treatment. Additional rings are created in the cardia of the stomach using a pullback technique. After advancing the catheter into the gastric lumen, the balloon is inflated to 25 mL, retracted firmly against the hiatus, and the electrodes deployed. After 3 applications at this level, a second treatment is applied to the cardia with the balloon inflated to 22 mL of air. Please refer to the diagram shown in Islam et al [8] for further clarification. In children requiring concomitant gastrostomy, percutaneous gastrostomy tube placement was performed post-Stretta [11].
2. Results The procedure was performed on all 8 children without difficulty. Follow-up data are based on patient and family interviews; postoperative esophageal studies were not performed. The follow-up period for both groups ranges from 6
150
D.C. Liu et al.
Table 1 Data summary of children receiving Stretta as primary antireflux procedure for GERD (n = 8) Group A (n = 3)a
Group B (n = 5)
Tolerating full enteral regimen (3) Complications (1)c
Weaned off antisecretory agentsb (3/5) Complications (0)
a
Group A indulges neurologically impaired children with GERD receiving Stretta and gastrostomy; Group B, neurologically normal children with GERD receiving Stretta only. b Antisecretory agents: proton pump inhibitors; follow-up period: 6-15 months. c Postoperative aspiration pneumonitis.
to 15 months. All were kept overnight on the surgical service for observation, with 1 patient requiring an extended hospital stay secondary to a postoperative aspiration pneumonitis. No perforations or other endoscopy-related complications were noted in this series. Mean operating time was 46 F 8 minutes. In group A, 1 child aspired immediately after Stretta application. This aspiration was suspected intraoperatively based on increased oxygen requirements. Endoscopy showed no evidence of perforation, which was confirmed by an immediate postoperative thin barium esophagogram. The child recovered uneventfully with nonoperative management including intravenous antibiotics and chest physiotherapy. The other 2 children in group A were able to tolerate full enteral nutrition via continuous drip feedings by postoperative day 2. All 3 children were eventually able to tolerate full enteral nutrition via bolus feeding regimen status post-Stretta (range, 2-14 days). In group B, 3 of 5 children are currently off medications and asymptomatic on follow-up. In the remaining 2, 1 experienced symptomatic relief immediately postprocedure, but symptoms recurred off medications. This patient is currently asymptomatic on a once-daily proton pump inhibitor. Stretta was considered unsuccessful in the remaining patient as symptoms did not improve even on medications and subsequently underwent successful laparoscopic Nissen fundoplication. Data are summarized in Table 1.
3. Discussion The Stretta procedure has been used as a primary treatment option for severe GERD in adults since 1999 and has excellent safety record with a current complication rate of less than 0.1% [12]. Although serious complications such as esophageal perforation or death because of aspiration are documented, these occurred in the first 6 months of FDAapproved Stretta use [8,13,14]. The published open-label trial reported a short-term (1-year) success rate with more than 60% reducing their need for antisecretory medication. Recently, Richards et al [7] published a prospective study of Stretta in a large group of adults showing that two thirds of the subjects were symptomatically improved and off medications at 3 years; although fundoplication was clearly more
effective with greater than 90% success rate using the same criteria during the same period. There are 2 purported mechanisms by which RF prevents reflux [8]. First, there is mechanical alteration of the gastroesophageal junction by thermal energy– induced intramuscular scarring with resultant tightening of the LES mechanism. Treatment of the cardia also physically creates an endoluminal gastric placation of the distal esophagus further accentuating a barrier to acid reflux. Second, thermal ablation of esophageal and gastric cardia neural tissue leads to fewer transient LES relaxations theoretically leading to decreased acid exposure of the distal esophagus. Interestingly, Corley et al [15] reported on significant improvement of GERD symptoms after Stretta treatment in a randomized, sham-controlled study where improvement in symptoms was not associated with decreased esophageal acid exposure or medication use. However, when they evaluated acid exposure times in responders vs nonresponders, there was a notable decrease in 24-hour acid exposure. Clearly, the mechanism for improved symptoms after Stretta needs to be further elucidated and may well be a combination of limiting acid exposure and decreased visceral sensitivity of the distal esophagus. This is the first report of the Stretta procedure being used as the initial antireflux procedure in children. Our early experience in normal children with severe GERD (group B) showed excellent short-term results in 3 of 5 children, who are off medications and asymptomatic at more than 6 months and up to 15 months postprocedure. Of the remaining 2, 1 became symptomatic when medications were withdrawn but is asymptomatic on a decreased dose of a proton pump inhibitor. The last child had no symptomatic relief post-Stretta and underwent successful fundoplication, during which there was no evidence of esophageal scarring or adhesions. Clearly, the efficacy and durability of Stretta still need to be determined with long-term follow-up. Our experience in neurologically impaired children with GERD requiring gastrostomy led us to the following observations: (1) effective feeding regimens including bolus feedings can be achieved after a Stretta procedure in neurologically impaired children with GERD; (2) endoluminal techniques, albeit technically less invasive, do not necessarily lessen the risk of postoperative complications (ie, aspiration pneumonia, in this at-risk patient population); and (3) a Stretta percutaneous gastrostomy tube procedure is a potentially useful, even attractive option in this group of children. The Stretta procedure provides a safe and effective initial surgical treatment of symptomatic GERD in carefully selected neurologically normal and neurologically impaired children. As experience accrues, the inclusion criteria can be further refined. Continued long-term follow-up is necessary to fully appreciate the durability of the procedure as well as its effect on the growing child.
Stretta as the initial antireflux procedure in children
References [1] Turnage RH, Oldham KT, Coran AG, et al. Late results of fundoplication for gastroesophageal reflux in infants and children. Surgery 1989;105:457 - 64. [2] Fonkalsrud EW, Ashcraft KW, Coran AG, et al. Surgical treatment of gastroesophageal reflux in children: a combined hospital study of 7467 patients. Pediatrics 1998;101:419 - 22. [3] Castell DO, Kahrilas PJ, Richter JE, et al. Esomeprazole (40 mg) compared with lansoprazole (30 mg) in the treatment of erosive esophagitis. Am J Gastroenterol 2002;97:575 - 83. [4] Spechler SJ, Lee E, Ahnen D, et al. Long-term outcome of medical and surgical therapies for gastroesophageal reflux disease: follow-up of a randomized controlled trial. JAMA 2001;285:2331 - 8. [5] Utley DS, Kim M, Vierra MA, et al. Augmentation of lower esophageal sphincter pressure and gastric yield pressure after radiofrequency energy delivery to the gastroesophageal junction: a porcine model. Gastrointest Endosc 2000;52:81 - 6. [6] DiBaise JK, Brand RE, Quigley EMM. Endoluminal delivery of radiofrequency energy to the gastroesophageal junction in uncomplicated GERD: efficacy and potential mechanism of action. Am J Gastroenterol 2002;97:833 - 42. [7] Richards WO, Houston HL, Torquati A, et al. Paradigm shift in the management of gastroesophageal reflux disease. Ann Surg 2003;237: 638 - 49. [8] Islam S, Geiger JD, Coran AG, et al. Use of radiofrequency ablation of the lower esophageal sphincter to treat recurrent gastroesophageal reflux disease. J Pediatr Surg 2004;39:282 - 6. [9] Tam WCE, Schoeman MN, Zhan Q, et al. Delivery of radiofrequency energy to the lower esophageal sphincter and gastric cardia inhibits transient LES relaxations and reflux in patients with reflux disease [abstract]. Gastroenterology 2001;120:A16. [10] Kahrilas PJ. Editorial: radiofrequency energy treatment of GERD. Gastroenterology 2003;125:970 - 2. [11] Gauderer M. Twenty years of percutaneous endoscopic gastrostomy: origin and evolution of a concept and its expanded applications. Gastrointest Endosc 1999;50(6):879 - 83. [12] Triadafilopoulos G. Stretta: an effective, minimally invasive treatment for gastroesophageal reflux disease. Am J Med 2003;115:192S - 200S. [13] Thiny ME, Shaheen NJ. Is Stretta ready for primetime? Gastroenterology 2002;123:643 - 5. [14] Richards WO, Scholz S, Khaitan L, et al. Initial experience with the Stretta procedure for the treatment of gastroesophageal reflux disease. J Laparoendosc Adv Surg Tech 2001;11:267 - 73. [15] Corley DA, Katz P, Wo JM, et al. Improvement of gastroesophageal reflux symptoms after radiofrequency energy: a randomized, shamcontrolled trial. Gastroenterology 2003;125:668 - 76.
Discussion T. Buchmiller-Crair (New York, NY): Do you alter the technique that is described in adults when you apply it to the pediatric population? Are there any modifications based on weight or patient size?
151 surgical colleagues talking about not letting these technologies get out of our hands and just being performed by gastroenterologists, but I guess with this technology I have a significant concern. I think it is one thing to create a thermal injury in a 60- or 70-year-old person with reflux that might help them get by without an operative procedure, but I have significant concerns about doing this in children who will then live with that thermal burn for the next 60 to 70 years with really unknown consequences of that. As best I can tell in talking to anybody, no one has really looked at that problem or issue, and I just wonder if you have any concerns about that in doing a procedure that is not as effective as what I think we have shown now is a very effective low-morbidity low-mortality procedure and creating a thermal burn that may affect these children later on in life. C.-C. Jackson (response): Well, that is definitely a concern. I think the initial data in the adults do show it to be safe and at longer term follow-up there have been no incidences of complications such as dysphagia or motility disorders. It is certainly something that bears observation. I do not think anyone would argue that the fundoplication does offer a more definitive result for treatment of GERD, but I think the ability to use Stretta, which is a less invasive procedure, bears further examination. In histologic studies, it has been shown that there is no significant architectural distortion of the mucosa or areas outside the muscular layer, which seems to support that this would be a useful procedure. C. Reyes (Pensacola, FL): In the adult literature, there is some interesting information that suggests that Stretta is particularly useful in patients with gastroesophageal reflux and gastric dysrhythmias, particularly tachygastria, in that the Stretta procedure would not only provide treatment for the gastroesophageal reflux but also ameliorates that tachygastric pattern and many of these patients end up having normal gastric patterns after the Stretta procedure. Do you have any thoughts about that in kids? C.-C. Jackson (response): As I recall, there was a study showing that after treatment with Stretta you create a normal gastric emptying pattern. We have not examined gastric emptying in our patients.
C.-C. Jackson (response): The only real modification that we performed was increasing the length of the zone of entry. In adults, it is traditionally a 2-cm length and we chose to do a 3-cm zone for the reason that we are not sure with the child’s growth if that will become a factor.
J. Bleacher (Atlanta, GA): Could you comment on any incidence of dysphagia in these children after the Stretta procedure? And I noticed that in the one that was still symptomatic you did a fundoplication. Is there any indication for repeat application of Stretta in those children?
S. Rothenberg (Denver, CO): I applaud you for taking this on. I think it is important as I constantly hear our adult
C.-C. Jackson (response): There is certainly an indication for a repeat Stretta and Dr Islam in his paper presented
152 last year did do that for one of the patients with recurrent symptoms and was treated successfully. There was no evidence of dysphagia in our children, at least the neurologically normal children that we were able to follow. As you saw, the fundoplication in the child with
D.C. Liu et al. the recurrence, this was a judgment call because we did it fairly early after the Stretta procedure before the traditional time that Stretta is thought to take full effect and this was because her symptoms were fairly severe and we did not want to wait any longer than necessary.