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a Division of Thoracic Surgery, Department of Surgery, Faculty of Medicine, University of Toronto, Toronto, Canada
b Division of Thoracic Surgery, Department of Surgery, Faculty of Medicine, University of British Columbia and the Vancouver Hospital, Vancouver, British Columbia, Canada
Accepted for publication October 16, 2009.
* Address correspondence to Dr Christian Finley, Division of Thoracic Surgery, Department of Surgery, 200 Elizabeth St, EN9-946, Toronto, Ontario, M5G 2C4, Canada (Email: christianfinley{at}shaw.ca).
| Abstract |
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Methods: From 1994 to 2008, 261 patients undergoing laparoscopic esophageal myotomy were enrolled prospectively. The diagnosis of classic achalasia was made on clinical history, barium swallow, endoscopy, and manometry. A validated symptom questionnaire and history was taken for each patient at the preoperative visit and at each postoperative visit.
Results: In all, 261 patients had laparoscopic Heller myotomy during the study period. Preoperatively, 137 patients (62.3%) tried medications, 101 (38.7%) were treated with pneumatic dilation, and 29 (11.1%) were treated initially with at least one injection of botulinum toxin into the lower esophageal sphincter. In all, 134 patients (51.3%) received a Dor anterior fundoplication. On multivariate regression controlling for age and sex, preoperative dilation (p = 0.031), injection of botulinum toxin (p = 0.044), and a fundoplication (p = 0.005) were associated with significantly worse early postoperative dysphagia, with odds ratios of 2.11, 2.56, and 2.80, respectively; previous botulinum toxin injection was associated with worse late postoperative dysphagia (p = 0.001), regurgitation (p = 0.031), and heartburn (p = 0.049), with odds ratios of 5.24, 2.87, and 2.52, respectively. There was a trend for no fundoplication to be associated with late postoperative heartburn (p = 0.077) with an odds ratio of 1.80.
Conclusions: Many patients presenting for Heller myotomy have previously undergone a different form of treatment. Early postoperative dysphagia was affected by dilation, botulinum toxin injection, and fundoplication. Only botulinum toxin injection was associated with late symptoms.
| Introduction |
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Because the lower esophageal sphincter is the primary barrier to gastroesophageal reflux, disruption places the patient at risk for pathological gastroesophageal reflux. Treatment of patients with achalasia must strike a balance between the relief of dysphagia and the potential creation of pathological gastroesophageal reflux. The efficacy of antireflux procedures in protecting against reflux after esophageal Heller myotomy is controversial. Opponents believe that fundoplication causes a functional obstruction to an already aperistaltic esophagus. Total Nissen fundoplication after myotomy resulted in a 30% reoperation rate for dysphagia [6]. The proponents of an antireflux fundoplication procedure cite a relatively high rate of subsequent gastroesophageal reflux after myotomy alone [7, 8], as well as the protective effect against esophageal leaks. In a randomized controlled trial, Richards and colleagues [7] showed that Heller myotomy plus Dor anterior fundoplication was superior to Heller myotomy alone in reducing postoperative esophageal acid exposure.
Most studies suggest that Heller myotomy can be performed safely and effectively after botulinum toxin injection and dilation [9–12]. However, there is some debate whether preoperative treatment with dilation and botulinum toxin injection makes a Heller myotomy technically more challenging with inferior results. Some believe that pneumatic dilation does not appreciably affect these results [9, 12]. In one small series, however, mucosal perforation rate for Heller myotomy after dilation was 30% [13]. In a larger series, Patti and associates [3] found anatomic planes were affected by dilation, and even more so in patients who responded to botulinum toxin injection. That resulted in perforation rates of 5% and 50%, respectively, and worse symptomatic results with effective botulinum injection [9]. In another paper, anatomic planes were affected in 53% of cases after effective botulinum toxin injection, resulting in a 13.3% perforation rate [11].
To date, little information exists on the effect of preoperative therapies and their influence on the outcomes of heartburn, regurgitation, and dysphagia in the long term. Hence, the primary objective of this study is to examine the preoperative and operative factors influencing early and late postoperative heartburn, regurgitation, and dysphagia.
| Patients and Methods |
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Patients' symptom severity was ranked and subdivided into four classes as proposed by Van Trappen and Helman [8]: class 1, no symptoms; class 2, symptom occurring less than once a week; class 3, symptom occurring more than once weekly; and class 4, persistent symptom. The symptoms analyzed include dysphagia, heartburn, and regurgitation. To analyze the proportion of patients who were symptomatic, a Van Trappen score of 2 or more was considered significant and considered to be positive in analysis. In this study, early follow-up was defined as occurring within 1 year (or the closest available follow-up) of the procedure and late follow-up, more than 1 year.
This study was approved by the Ethics Review Board of Vancouver Hospital and Health Sciences Center and the University of British Columbia.
The techniques of laparoscopic Heller myotomy with and without fundoplication were described in a previous paper [14] and were consistent throughout the study. The surgeon used a Dor anterior fundoplication in the first half of the study and no fundoplication in the second half of the study, as a change in practice pattern.
Statistical Analysis
Means and standard deviations were calculated for demographic data. A
2 statistic was calculated for nonparametric data. Change in preoperative Van Trappen score to the early and late follow-up was performed using a paired Student t tests. Continuous variables were analyzed using a Student t test.
For exploratory purposes, univariate logistic regression was performed to evaluate the single variable effect of botulinum toxin injection, esophageal dilation, and anterior fundoplication on the primary outcomes of early and late dysphagia, heartburn, and regurgitation. These will be reported as odds ratios (OR). After univariate analysis, a backward multiple logistic regression was performed examining the effect of botulinum toxin injection, esophageal dilation, and anterior fundoplication on dysphagia, heartburn, and regurgitation in the early and later follow-up period, while controlling for age and sex. Statistical significance used, for all calculations, was p less than 0.05.
| Results |
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The mean length of stay was 2.4 ± 2.0 days. There were no major postoperative complications. Minor postoperative complications included wound infection 0.9%, pneumothorax 3.6%, pneumonia 0.9%, pleural effusion 0.9%, and atelectasis 3.2%.
Postoperatively, 261 patients were available for early follow-up (median months to follow-up, 1.4; range, 0 to 12.7). Of those, late follow-up was available on 165 patients (median months to follow-up, 36.4; range, 14.2 to 142.5). Eleven patients only had follow-up available for the early period as they had their procedure within 1 year of analysis. Table 2 displays the early and late symptom frequency and percentage of patients suffering from symptoms, by follow-up group.
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On multivariate regression controlling for age and sex, previous botulinum toxin injection was associated with significantly worse late postoperative dysphagia (p = 0.001), regurgitation (p = 0.031), and heartburn (p = 0.049), with ORs of 5.236, 2.874, and 2.519, respectively. There was a trend for no fundoplication to be associated with late postoperative heartburn (p = 0.077) with an OR of 1.798.
In the postoperative period, 3 patients required reoperation and takedown of their fundoplication for relief of dysphagia, and 2 patients required balloon dilation of the esophagogastric junction for dysphagia relief.
| Comment |
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In early follow-up, all three therapies of interest affected the early postoperative results. These findings are consistent with other papers that showed less symptomatic improvement in patients who received preoperative botulinum toxin injections or dilations [9, 11], in particular, that botulinum toxin has the most significant effect on early outcomes [3, 9]. Moreover, the early results are consistent with our own previous experience that anterior fundoplication does decrease esophageal clearance and increase dysphagia after Heller myotomy [14].
Most researchers have shown that botulinum toxin has a worse effect on the planes, resulting in fibrosis, which makes the operation technically more challenging [3, 9, 11, 13]. In our study, we have shown that it is the single most influential factor in long-term results, causing significantly worse dysphagia, heartburn, and regurgitation. The scope of this issue is emphasized by knowing that 50% of patients presented for surgery already have received some form of therapy affecting their long-term results. The low morbidity of the operation versus only temporary relief offered by botulinum toxin injection [2] and the increased risk of pneumatic dilation [1] suggests that the clinician should choose a laparoscopic Heller myotomy as the primary treatment for achalasia and that the other two modalities should only be used for patients who cannot tolerate an operation.
This study does have some limitations. Firstly, as only 165, or 59%, of patients were available in the late follow-up group, the results should be interpreted carefully. Were the patients missing to follow-up because of worse results? Or better? However, looking at Table 2, the results suggest that not only are the late follow-up patients proportionally representative in preoperative and intraoperative therapy, they are also similar in their preoperative and early postoperative symptoms. For this reason, we believe that the results are valid. Secondly, the questionnaires were given to the patients by the surgeon performing the operation. That could introduce some bias; however, it also ensures standardization of questions that are clinically relevant and contextualized. Overall, we are confident that this bias did not affect our results.
In conclusion, laparoscopic Heller myotomy remains a durable and well-tolerated operation for classic achalasia. Many patients presenting for Heller myotomy have previously undergone some other treatment. Early postoperative dysphagia was affected by dilation, botulinum toxin injection, and fundoplication. During the late period, botulinum toxin injection was associated with significantly more dysphagia, regurgitation, and heartburn.
| References |
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