- Email: [email protected]
Improvement in the Reflux Symptom Index Following Surgery for Cricopharyngeal Dysfunction
ARTICLE IN PRESS Improvement in the Reflux Symptom Index Following Surgery for Cricopharyngeal Dysfunction Nancy Jiang, C. Kwang Sung, and Edward J. Damrose, Stanford, California Summary: Objectives. Gastroesophageal reflux may contribute to the development of cricopharyngeal dysfunction and Zenker’s diverticulum. Common dictum suggests that if upper esophageal sphincter tone is reduced through cricopharyngeal myotomy, symptoms of laryngopharyngeal reflux may worsen. We hypothesized that patients who undergo myotomy should show decreased dysphagia symptoms with concurrent worsening of reflux symptomatology and that these changes would be greater in those patients undergoing complete versus partial myotomy. Methods. A retrospective chart review was performed for patients who underwent endoscopic or open cricopharyngeal myotomy, with or without Zenker’s diverticulectomy. Preoperative and postoperative reflux symptomatology was subjectively measured with the Reflux Symptom Index (RSI), and dysphagia symptomatology was measured with the Eating Assessment Tool 10 (EAT-10). Patients who underwent partial myotomy via endoscopic stapling of Zenker’s diverticulum were compared with patients who underwent complete myotomy (either endoscopic laser-assisted or via an open transcervical approach). The patients were further subdivided into three groups for data analysis: endoscopic staple diverticulotomy, laser cricopharyngeal myotomy, and open approach. Results. A total of 41 patient charts were reviewed. Of these 41 patients, 17 underwent endoscopic stapler-assisted diverticulotomy, 4 underwent endosopic laser-assisted cricopharyngeal myotomy, and 20 underwent open transcervical cricopharyngeal myotomy, with diverticulectomy as indicated. Mean pre- and postoperative RSIs were 21.8 and 8.9, respectively (P < 0.001). Mean pre- and postoperative EAT-10 scores were 19.1 and 5.0, respectively (P < 0.001). Conclusions. Patients’ reflux symptoms significantly improved after cricopharyngeal myotomy, with significant improvement in dysphagia symptoms. Concern for worsening of reflux symptoms following surgery does not appear to be clinically common. Key Words: Bronchoesophagology–Surgical outcomes–Cricopharyngeal dysfunction–Swallow/dysphagia– Laryngopharyngeal reflux.
INTRODUCTION Cricopharyngeal achalasia and Zenker’s diverticulum are physiologically related in etiology as both are due to a dysfunction of the cricopharyngeus muscle. In Zenker’s diverticulum, cricopharyngeal dysfunction leads to the formation of a pharyngeal pouch from dehiscence in Killian’s triangle. In both cases, treatment involves cricopharyngeal myotomy. Myotomy can be performed either via an open transcervical or an endoscopic stapler-assisted transoral approach. With an endoscopic approach, myotomy has been shown to be incomplete on postoperative barium swallow studies, whereas with an open approach, a complete myotomy is obtained.1–3 This has been cited as the main reason for the higher rate of recurrent disease with the endoscopic approach compared with the open approach,4 which affords a complete myotomy with lower rates of surgical revision.5 Gastroesophageal reflux disease has been hypothesized to contribute to the etiology of cricopharyngeal dysfunction. 6 Cricopharyngeal myotomy, which impacts upper esophageal sphincter tone and continence, could potentially allow for Accepted for publication February 8, 2016. Funding: There is no funding support. Conflict of interest: There are no conflicts of interest. From the Department of Otolaryngology—Head and Neck Surgery, Stanford University School of Medicine, Stanford, California. Address correspondence and reprint requests to Nancy Jiang, Department of Otolaryngology, Stanford University School of Medicine, 801 Welch Road, Stanford, CA 94305. E-mail: [email protected] Journal of Voice, Vol. ■■, No. ■■, pp. ■■-■■ 0892-1997 © 2016 The Voice Foundation. Published by Elsevier Inc. All rights reserved. http://dx.doi.org/10.1016/j.jvoice.2016.02.006
regurgitation of refluxate into the hypopharynx and larynx and worsen the symptoms of laryngopharyngeal reflux (LPR). Similarly, patients who undergo a partial myotomy would hypothetically have less reflux symptoms than patients who undergo a complete myotomy. In this study, we sought to evaluate the impact of cricopharyngeal myotomy on the Reflux Symptom Index (RSI). We hypothesized that following cricopharyngeal myotomy, symptoms of LPR worsen and that these symptoms are less severe when a limited myotomy is performed when compared with a complete myotomy. METHODS An Institutional Review Board (IRB) approved retrospective chart review was performed at a single tertiary care institution. All patients underwent a barium swallow (esophagogram) study to diagnose the presence of a cricopharyngeal bar or Zenker’s diverticulum. Inclusion criteria consisted of all patients who underwent endoscopic or open cricopharyngeal myotomy, with or without Zenker’s diverticulectomy between April 1, 2010 and May 1, 2015. Patients were excluded if they subsequently underwent revision surgery. Endoscopic techniques included CO2 laser myotomy for patients with cricopharyngeal achalasia alone and staple diverticulotomy for patients with a Zenker’s diverticulum. To determine pre- and postoperative symptoms of LPR, the RSI, a self-administered nine-item outcomes instrument for LPR, was used.7 Eating Assessment Tool scores (EAT-10) were also compared pre- and postoperatively. The postoperative scores were obtained from the patient’s most recent follow-up
ARTICLE IN PRESS 2
Journal of Voice, Vol. ■■, No. ■■, 2016
appointment. The patients were subdivided into two groups for data analysis: patients who underwent partial myotomy (endoscopic stapler-assisted transoral approach) and patients who underwent complete myotomy (either endoscopic laser-assisted or via an open transcervical approach). The patients were then further divided into three groups based on surgical technique for data analysis: (1) open cricopharyngeal myotomy with or without Zenker’s diverticulectomy (open group), (2) endoscopic laser cricopharyngeal myotomy (laser group), and (3) endoscopic staple diverticulotomy (staple group). The Wilcoxon signed rank test was used to compare data between groups. A significant difference was defined as a P value < 0.05. All statistical analysis of the data was performed using SPSS version 22.0 (SPSS, Inc., Chicago, IL). RESULTS A total of 41 patients were included in the study. Of these, 24 (59%) were male patients and 17 (41%) were female patients. The average age for all patients was 74 years old (range 49–93 years). The average age for the open, staple, and laser groups were 71 years, 80 years, and 71 years, respectively. There was no statistically significant difference in average age between the groups. The average follow-up time for all patients was 163 days (ranging from 6 days to 2.7 years). The average follow-up time for the open, staple, and laser groups were 229 days, 110 days, and 66 days, respectively. There was no statistically significant difference in follow-up times between the three groups. A total of 9 patients had cricopharyngeal achalasia alone, and 32 patients had cricopharyngeal achalasia and concurrent Zenker’s diverticulum. The overall average pre- and postoperative RSI were 21.8 and 8.9, respectively (P < 0.001). The overall average EAT10 scores pre- and postoperatively were 19.1 and 5.0, respectively (P < 0.001). These data are summarized in Figure 1.
Pre-op Versus Post-op Instrument Scores 25
Pre-op and Post-op RSI for Partial Myotomy vs. Complete Myotomy 30 25 20 15
*
*
10 5 0
PreRSI
PostRSI Partial Myotomy
PreRSI
PostRSI Complete Myotomy
FIGURE 2. The average preoperative and postoperative RSI scores for patients undergoing partial versus complete myotomy are shown. Significant difference between the preoperative and postoperative scores are noted with the asterisk (*) symbol, which is defined as a P value < 0.05. The error bars represent standard error. The data were then analyzed by dividing the patients into two groups: partial versus complete myotomy. There were 17 patients in the partial myotomy group and 24 patients in the complete myotomy group. The preoperative RSI score for the partial myotomy group and complete myotomy group were 18.9 and 23.8, respectively. The postoperative RSI scores were significantly different than the preoperative scores for both groups (P < 0.001), at 7.1 for the partial myotomy group and at 10.2 for the complete myotomy group. The preoperative EAT-10 score for the partial versus complete myotomy group were 17.7 and 20.0, respectively. The postoperative EAT-10 score was significantly different for both groups, at 3.8 for the partial myotomy group and at 6.0 for the complete myotomy group. These data are summarized in Figures 2 and 3. The average pre- and postoperative RSI were then compared between the following three surgical technique subgroups: staple group, laser group, and open group. In the staple group, the average pre- and postoperative RSI were 18.9 and 7.1
20
Pre-op and Post-op EAT-10 for Partial Myotomy vs. Complete Myotomy 25
15
20
*
15
10
* 5
0
10
* *
5
0
PreRSI
PostRSI
PreEAT
PostEAT
FIGURE 1. The average preoperative and postoperative RSI and EAT10 scores for all patients are shown. Significant difference between the preoperative and postoperative scores are noted with the asterisk (*) symbol, which is defined as a P value < 0.05. The error bars represent standard error.
PreEAT
PostEAT Partial Myotomy
PreEAT
PostEAT
Complete Myotomy
FIGURE 3. The average preoperative and postoperative EAT-10 scores for patients undergoing partial versus complete myotomy are shown. Significant difference between the preoperative and postoperative scores are noted with the asterisk (*) symbol, which is defined as a P value < 0.05. The error bars represent standard error.
ARTICLE IN PRESS Nancy Jiang et al
Reflux Symptom Index Following Surgery
Pre-op versus Post-op RSI Scores For Each Of The 3 Different Surgical Techniques 40 30 Staple
20
*
*
Open
10 0
Laser
PreRSI
PostRSI
FIGURE 4. The average preoperative and postoperative RSI for the three surgical subgroups: staple, laser, and open. Significant difference is noted with the asterisk (*) symbol, which is defined as a P value < 0.05. The error bars represent standard error. (P < 0.001). In the laser group, the average pre- and postoperative RSI were 31.5 and 16.8 (P = 0.068), which did not reach statistical significance. This is likely due to the small number of patients in this group. The average pre- and postoperative RSI for the open group were 22.2 and 8.9, respectively (P < 0.001). These data are summarized in Figure 4. There was only one patient who had a higher RSI score postoperatively than preoperatively. In this patient, an open cricopharyngeal myotomy was performed, and the RSI increased from 35 preoperatively to 36 postoperatively. All other patients had a decrease in their RSI score postoperatively. DISCUSSION It is speculated that cricopharyngeal myotomy can worsen symptoms of gastroesophageal and LPR because loss of upper esophageal sphincter tone will facilitate refluxate into the hypopharynx. Classic dictum suggests that severe reflux should be considered a possible contraindication to cricopharyngeal myotomy.8,9 However, evidence to support this hypothesis is lacking. Interestingly, our study showed that symptoms of LPR (as determined by the RSI score) significantly improved after cricopharyngeal myotomy. This significant change was seen regardless of whether a partial or complete myotomy was performed. The average RSI score was above 13 preoperatively, which, according to Belafsky et al,7 suggests that on average, these patients likely had LPR preoperatively. Postoperatively, the average RSI decreased to less than 13, suggesting resolution of LPR. The data were then further analyzed by dividing the patients into three different groups based on the surgical technique used. The endoscopic versus open myotomy groups had similar significant decreases in RSI postoperatively. The average RSI score also decreased postoperatively in the endoscopic laser cricopharyngeal myotomy group, but this was not statistically significant. The lack of statistical significance in this group and the higher average RSI score postoperatively (RSI score of 16.8 in this group versus an RSI score of 8.9 and 7.1 in the other two groups) may be due to the small sample size. There
3
were only four patients who were included in the endoscopic laser cricopharyngeal myotomy group, and one of these patients had a preoperative RSI of 44 and postoperative RSI of 39, which skewed the data toward a higher RSI postoperatively. Of note, among all the study patients, the RSI score increased postoperatively in only 1 patient, and in that case, the score increased from 35 to 36, suggesting minimal change of baseline symptoms. Using RSI as a surrogate for 24-hour esophageal pH and impedance testing is certainly a limitation of this study. The RSI lacks specificity because there is overlap of many symptoms queried in the survey with other conditions. Although all of the subjects had what would be considered positive RSI scores for reflux preoperatively, we cannot be certain that these patients actually had pathologic reflux disease without objective testing. Similarly, without postoperative pharyngeal pH and impedance testing, we cannot determine if the patients were having more reflux events afterward. However, it can be argued that LPR disease is largely managed based on symptoms and quality of life. If symptoms are improved postoperatively, as suggested by the normalization of RSI, then that is the most important criteria. There was also a significant improvement in EAT-10 scores postoperatively, a validated outcome instrument for dysphagia.10 This finding shows that the surgery was successful in treating these patients’ dysphagia. Similar findings were reported in a study conducted by Dale et al.11 In their study, RSI was measured before and after endoscopic laser cricopharyngeal myotomy. They found that the RSI improved in 88% of patients postoperatively. Williams et al12 used objective measures to determine if reflux was worse after cricopharyngeal myotomy, and their study found no difference in reflux postoperatively. In their study, dual pH monitoring was performed preoperatively and postoperatively after open cricopharyngeal myotomy. The basal upper esophageal sphincter pressure was significantly reduced postoperatively, but esophagopharyngeal reflux was a rare event, and there was no change in frequency of reflux postoperatively. Limitations of our study include the retrospective nature of the study design and the lack of objective data in determining pre- and postoperative reflux, such as impedance/pH-metry testing. Because the data were collected retrospectively and the average follow-up period was less than 1 year, it is unknown if the symptoms of LPR worsen over a prolonged period of time after surgery, such as 5 or 10 years postoperatively. Furthermore, because only summed RSI data were analyzed, conclusions cannot be drawn about whether specific, individual symptoms of LPR worsen, just overall symptoms. Also, RSI alone as a diagnostic indicator for objective reflux findings may not be as sensitive or specific as the study by Belafsky et al7 suggests. Studies comparing RSI to double probe pH monitoring results showed that the sensitivity of RSI ranged from 56% to 80% and the specificity ranged from only 19% to 47%.13–15 However, the RSI score does serve as a measure of the patient’s subjective symptoms, and our study does show that at least symptomatically, patients do not have worsening LPR after cricopharyngeal myotomy. Objectively, we could not determine with our study whether LPR worsened or improved. Based on our study results, a patient can be counseled whether their LPR symptoms are unlikely to worsen after surgery.
ARTICLE IN PRESS 4 CONCLUSION There is a significant improvement in RSI scores after cricopharyngeal myotomy, with or without Zenker’s diverticulectomy. This is seen in cases of both partial myotomy and complete myotomy. Therefore, incontinence of the upper esophageal sphincter after myotomy does not worsen overall symptoms of LPR reflected in the RSI. REFERENCES 1. Witterick IJ, Gullane PJ, Yeung E. Outcome analysis of Zenker’s diverticulectomy and cricopharyngeal myotomy. Head Neck. 1995;17:382– 388. 2. Jaramillo MJ, McLay KA, McAteer D. Long-term clinicoradiological assessment of endoscopic stapling of pharyngeal pouch: a series of cases. J Laryngol Otol. 2001;115:462–466. 3. Ong CC, Elton PG, Mitchell D. Pharyngeal pouch endoscopic stapling—are post-operative barium swallow radiographs of any value? J Laryngol Otol. 1999;113:233–236. 4. Verdonck J, Morton RP. Systematic review on treatment of Zenker’s diverticulum. Eur Arch Otorhinolaryngol. 2014;doi:10.1007/s00405-0143267-0. 5. Pollei TR, Hinni ML, Hayden RE, et al. Comparison of carbon dioxide laser-assisted versus stapler-assisted endoscopic cricopharyngeal myotomy. Ann Otol Rhinol Laryngol. 2013;122:568–574.
Journal of Voice, Vol. ■■, No. ■■, 2016 6. Veenker EA, Andersen PE, Cohen JI. Cricopharyngeal spasm and Zenker’s diverticulum. Head Neck. 2003;25:681–694. 7. Belafsky PC, Postma GN, Koufman JA. Validity and reliability of the Reflux Symptom Index (RSI). J Voice. 2002;16:274–277. 8. Peters JH, DeMeester TR. Surgery for esophageal motor disorders. In: Castell DO, ed. The Esophagus. Boston, MA: Raven Press; 1993:395–434. 9. Bokstein F, Korczyn AD. Gastrointestinal manifestations of muscle disease. In: Quigley EMM, Pfeiffer RF, eds. Neuro-Gastroenterology. Philadelphia, PA: Elsevier; 2004:125. 10. Belafsky PC, Mouadeb DA, Rees CJ, et al. Validity and reliability of the Eating Assessment Tool (EAT-10). Ann Otol Rhinol Laryngol. 2008;117:919–924. 11. Dale OT, Mackeith S, Burgess CA, et al. Functional outcomes following endoscopic laser cricopharyngeal myotomy with mucosal repair. Eur Arch Otorhinolaryngol. 2014;271:1631–1634. 12. Williams RBH, Ali GN, Hunt DR, et al. Cricopharyngeal myotomy does not increase the risk of esophagopharyngeal acid regurgitation. Am J Gastroenterol. 1999;94. 13. Park KH, Choi SM, Kwon SU, et al. Diagnosis of laryngopharyngeal reflux among globus patients. Otolaryngol Head Neck Surg. 2006;134:81–85. 14. Oyer SL, Anderson LC, Halum SL. Influence of anxiety and depression on the predictive value of the Reflux Symptom Index. Ann Otol Rhinol Laryngol. 2009;118:687–692. 15. Friedman M, Hamilton C, Samuelson CG, et al. The value of routine pH monitoring in the diagnosis and treatment of laryngopharyngeal reflux. Otolaryngol Head Neck Surg. 2012;146:952–958.
INTRODUCTION Cricopharyngeal achalasia and Zenker’s diverticulum are physiologically related in etiology as both are due to a dysfunction of the cricopharyngeus muscle. In Zenker’s diverticulum, cricopharyngeal dysfunction leads to the formation of a pharyngeal pouch from dehiscence in Killian’s triangle. In both cases, treatment involves cricopharyngeal myotomy. Myotomy can be performed either via an open transcervical or an endoscopic stapler-assisted transoral approach. With an endoscopic approach, myotomy has been shown to be incomplete on postoperative barium swallow studies, whereas with an open approach, a complete myotomy is obtained.1–3 This has been cited as the main reason for the higher rate of recurrent disease with the endoscopic approach compared with the open approach,4 which affords a complete myotomy with lower rates of surgical revision.5 Gastroesophageal reflux disease has been hypothesized to contribute to the etiology of cricopharyngeal dysfunction. 6 Cricopharyngeal myotomy, which impacts upper esophageal sphincter tone and continence, could potentially allow for Accepted for publication February 8, 2016. Funding: There is no funding support. Conflict of interest: There are no conflicts of interest. From the Department of Otolaryngology—Head and Neck Surgery, Stanford University School of Medicine, Stanford, California. Address correspondence and reprint requests to Nancy Jiang, Department of Otolaryngology, Stanford University School of Medicine, 801 Welch Road, Stanford, CA 94305. E-mail: [email protected] Journal of Voice, Vol. ■■, No. ■■, pp. ■■-■■ 0892-1997 © 2016 The Voice Foundation. Published by Elsevier Inc. All rights reserved. http://dx.doi.org/10.1016/j.jvoice.2016.02.006
regurgitation of refluxate into the hypopharynx and larynx and worsen the symptoms of laryngopharyngeal reflux (LPR). Similarly, patients who undergo a partial myotomy would hypothetically have less reflux symptoms than patients who undergo a complete myotomy. In this study, we sought to evaluate the impact of cricopharyngeal myotomy on the Reflux Symptom Index (RSI). We hypothesized that following cricopharyngeal myotomy, symptoms of LPR worsen and that these symptoms are less severe when a limited myotomy is performed when compared with a complete myotomy. METHODS An Institutional Review Board (IRB) approved retrospective chart review was performed at a single tertiary care institution. All patients underwent a barium swallow (esophagogram) study to diagnose the presence of a cricopharyngeal bar or Zenker’s diverticulum. Inclusion criteria consisted of all patients who underwent endoscopic or open cricopharyngeal myotomy, with or without Zenker’s diverticulectomy between April 1, 2010 and May 1, 2015. Patients were excluded if they subsequently underwent revision surgery. Endoscopic techniques included CO2 laser myotomy for patients with cricopharyngeal achalasia alone and staple diverticulotomy for patients with a Zenker’s diverticulum. To determine pre- and postoperative symptoms of LPR, the RSI, a self-administered nine-item outcomes instrument for LPR, was used.7 Eating Assessment Tool scores (EAT-10) were also compared pre- and postoperatively. The postoperative scores were obtained from the patient’s most recent follow-up
ARTICLE IN PRESS 2
Journal of Voice, Vol. ■■, No. ■■, 2016
appointment. The patients were subdivided into two groups for data analysis: patients who underwent partial myotomy (endoscopic stapler-assisted transoral approach) and patients who underwent complete myotomy (either endoscopic laser-assisted or via an open transcervical approach). The patients were then further divided into three groups based on surgical technique for data analysis: (1) open cricopharyngeal myotomy with or without Zenker’s diverticulectomy (open group), (2) endoscopic laser cricopharyngeal myotomy (laser group), and (3) endoscopic staple diverticulotomy (staple group). The Wilcoxon signed rank test was used to compare data between groups. A significant difference was defined as a P value < 0.05. All statistical analysis of the data was performed using SPSS version 22.0 (SPSS, Inc., Chicago, IL). RESULTS A total of 41 patients were included in the study. Of these, 24 (59%) were male patients and 17 (41%) were female patients. The average age for all patients was 74 years old (range 49–93 years). The average age for the open, staple, and laser groups were 71 years, 80 years, and 71 years, respectively. There was no statistically significant difference in average age between the groups. The average follow-up time for all patients was 163 days (ranging from 6 days to 2.7 years). The average follow-up time for the open, staple, and laser groups were 229 days, 110 days, and 66 days, respectively. There was no statistically significant difference in follow-up times between the three groups. A total of 9 patients had cricopharyngeal achalasia alone, and 32 patients had cricopharyngeal achalasia and concurrent Zenker’s diverticulum. The overall average pre- and postoperative RSI were 21.8 and 8.9, respectively (P < 0.001). The overall average EAT10 scores pre- and postoperatively were 19.1 and 5.0, respectively (P < 0.001). These data are summarized in Figure 1.
Pre-op Versus Post-op Instrument Scores 25
Pre-op and Post-op RSI for Partial Myotomy vs. Complete Myotomy 30 25 20 15
*
*
10 5 0
PreRSI
PostRSI Partial Myotomy
PreRSI
PostRSI Complete Myotomy
FIGURE 2. The average preoperative and postoperative RSI scores for patients undergoing partial versus complete myotomy are shown. Significant difference between the preoperative and postoperative scores are noted with the asterisk (*) symbol, which is defined as a P value < 0.05. The error bars represent standard error. The data were then analyzed by dividing the patients into two groups: partial versus complete myotomy. There were 17 patients in the partial myotomy group and 24 patients in the complete myotomy group. The preoperative RSI score for the partial myotomy group and complete myotomy group were 18.9 and 23.8, respectively. The postoperative RSI scores were significantly different than the preoperative scores for both groups (P < 0.001), at 7.1 for the partial myotomy group and at 10.2 for the complete myotomy group. The preoperative EAT-10 score for the partial versus complete myotomy group were 17.7 and 20.0, respectively. The postoperative EAT-10 score was significantly different for both groups, at 3.8 for the partial myotomy group and at 6.0 for the complete myotomy group. These data are summarized in Figures 2 and 3. The average pre- and postoperative RSI were then compared between the following three surgical technique subgroups: staple group, laser group, and open group. In the staple group, the average pre- and postoperative RSI were 18.9 and 7.1
20
Pre-op and Post-op EAT-10 for Partial Myotomy vs. Complete Myotomy 25
15
20
*
15
10
* 5
0
10
* *
5
0
PreRSI
PostRSI
PreEAT
PostEAT
FIGURE 1. The average preoperative and postoperative RSI and EAT10 scores for all patients are shown. Significant difference between the preoperative and postoperative scores are noted with the asterisk (*) symbol, which is defined as a P value < 0.05. The error bars represent standard error.
PreEAT
PostEAT Partial Myotomy
PreEAT
PostEAT
Complete Myotomy
FIGURE 3. The average preoperative and postoperative EAT-10 scores for patients undergoing partial versus complete myotomy are shown. Significant difference between the preoperative and postoperative scores are noted with the asterisk (*) symbol, which is defined as a P value < 0.05. The error bars represent standard error.
ARTICLE IN PRESS Nancy Jiang et al
Reflux Symptom Index Following Surgery
Pre-op versus Post-op RSI Scores For Each Of The 3 Different Surgical Techniques 40 30 Staple
20
*
*
Open
10 0
Laser
PreRSI
PostRSI
FIGURE 4. The average preoperative and postoperative RSI for the three surgical subgroups: staple, laser, and open. Significant difference is noted with the asterisk (*) symbol, which is defined as a P value < 0.05. The error bars represent standard error. (P < 0.001). In the laser group, the average pre- and postoperative RSI were 31.5 and 16.8 (P = 0.068), which did not reach statistical significance. This is likely due to the small number of patients in this group. The average pre- and postoperative RSI for the open group were 22.2 and 8.9, respectively (P < 0.001). These data are summarized in Figure 4. There was only one patient who had a higher RSI score postoperatively than preoperatively. In this patient, an open cricopharyngeal myotomy was performed, and the RSI increased from 35 preoperatively to 36 postoperatively. All other patients had a decrease in their RSI score postoperatively. DISCUSSION It is speculated that cricopharyngeal myotomy can worsen symptoms of gastroesophageal and LPR because loss of upper esophageal sphincter tone will facilitate refluxate into the hypopharynx. Classic dictum suggests that severe reflux should be considered a possible contraindication to cricopharyngeal myotomy.8,9 However, evidence to support this hypothesis is lacking. Interestingly, our study showed that symptoms of LPR (as determined by the RSI score) significantly improved after cricopharyngeal myotomy. This significant change was seen regardless of whether a partial or complete myotomy was performed. The average RSI score was above 13 preoperatively, which, according to Belafsky et al,7 suggests that on average, these patients likely had LPR preoperatively. Postoperatively, the average RSI decreased to less than 13, suggesting resolution of LPR. The data were then further analyzed by dividing the patients into three different groups based on the surgical technique used. The endoscopic versus open myotomy groups had similar significant decreases in RSI postoperatively. The average RSI score also decreased postoperatively in the endoscopic laser cricopharyngeal myotomy group, but this was not statistically significant. The lack of statistical significance in this group and the higher average RSI score postoperatively (RSI score of 16.8 in this group versus an RSI score of 8.9 and 7.1 in the other two groups) may be due to the small sample size. There
3
were only four patients who were included in the endoscopic laser cricopharyngeal myotomy group, and one of these patients had a preoperative RSI of 44 and postoperative RSI of 39, which skewed the data toward a higher RSI postoperatively. Of note, among all the study patients, the RSI score increased postoperatively in only 1 patient, and in that case, the score increased from 35 to 36, suggesting minimal change of baseline symptoms. Using RSI as a surrogate for 24-hour esophageal pH and impedance testing is certainly a limitation of this study. The RSI lacks specificity because there is overlap of many symptoms queried in the survey with other conditions. Although all of the subjects had what would be considered positive RSI scores for reflux preoperatively, we cannot be certain that these patients actually had pathologic reflux disease without objective testing. Similarly, without postoperative pharyngeal pH and impedance testing, we cannot determine if the patients were having more reflux events afterward. However, it can be argued that LPR disease is largely managed based on symptoms and quality of life. If symptoms are improved postoperatively, as suggested by the normalization of RSI, then that is the most important criteria. There was also a significant improvement in EAT-10 scores postoperatively, a validated outcome instrument for dysphagia.10 This finding shows that the surgery was successful in treating these patients’ dysphagia. Similar findings were reported in a study conducted by Dale et al.11 In their study, RSI was measured before and after endoscopic laser cricopharyngeal myotomy. They found that the RSI improved in 88% of patients postoperatively. Williams et al12 used objective measures to determine if reflux was worse after cricopharyngeal myotomy, and their study found no difference in reflux postoperatively. In their study, dual pH monitoring was performed preoperatively and postoperatively after open cricopharyngeal myotomy. The basal upper esophageal sphincter pressure was significantly reduced postoperatively, but esophagopharyngeal reflux was a rare event, and there was no change in frequency of reflux postoperatively. Limitations of our study include the retrospective nature of the study design and the lack of objective data in determining pre- and postoperative reflux, such as impedance/pH-metry testing. Because the data were collected retrospectively and the average follow-up period was less than 1 year, it is unknown if the symptoms of LPR worsen over a prolonged period of time after surgery, such as 5 or 10 years postoperatively. Furthermore, because only summed RSI data were analyzed, conclusions cannot be drawn about whether specific, individual symptoms of LPR worsen, just overall symptoms. Also, RSI alone as a diagnostic indicator for objective reflux findings may not be as sensitive or specific as the study by Belafsky et al7 suggests. Studies comparing RSI to double probe pH monitoring results showed that the sensitivity of RSI ranged from 56% to 80% and the specificity ranged from only 19% to 47%.13–15 However, the RSI score does serve as a measure of the patient’s subjective symptoms, and our study does show that at least symptomatically, patients do not have worsening LPR after cricopharyngeal myotomy. Objectively, we could not determine with our study whether LPR worsened or improved. Based on our study results, a patient can be counseled whether their LPR symptoms are unlikely to worsen after surgery.
ARTICLE IN PRESS 4 CONCLUSION There is a significant improvement in RSI scores after cricopharyngeal myotomy, with or without Zenker’s diverticulectomy. This is seen in cases of both partial myotomy and complete myotomy. Therefore, incontinence of the upper esophageal sphincter after myotomy does not worsen overall symptoms of LPR reflected in the RSI. REFERENCES 1. Witterick IJ, Gullane PJ, Yeung E. Outcome analysis of Zenker’s diverticulectomy and cricopharyngeal myotomy. Head Neck. 1995;17:382– 388. 2. Jaramillo MJ, McLay KA, McAteer D. Long-term clinicoradiological assessment of endoscopic stapling of pharyngeal pouch: a series of cases. J Laryngol Otol. 2001;115:462–466. 3. Ong CC, Elton PG, Mitchell D. Pharyngeal pouch endoscopic stapling—are post-operative barium swallow radiographs of any value? J Laryngol Otol. 1999;113:233–236. 4. Verdonck J, Morton RP. Systematic review on treatment of Zenker’s diverticulum. Eur Arch Otorhinolaryngol. 2014;doi:10.1007/s00405-0143267-0. 5. Pollei TR, Hinni ML, Hayden RE, et al. Comparison of carbon dioxide laser-assisted versus stapler-assisted endoscopic cricopharyngeal myotomy. Ann Otol Rhinol Laryngol. 2013;122:568–574.
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