ORIGINAL ARTICLES
Four Hundred Laparoscopic Myotomies for Esophageal Achalasia A Single Centre Experience Giovanni Zaninotto, MD, FACS,* Mario Costantini, MD,† Christian Rizzetto, MD,‡ Lisa Zanatta, MD,† Emanuela Guirroli, MD,† Giuseppe Portale, MD,† Loredana Nicoletti,† Francesco Cavallin, PhD,‡ Giorgio Battaglia, MD,† Alberto Ruol, MD, FACS,† and Ermanno Ancona, MD, FACS†
Objective: Laparoscopic myotomy is the currently preferred treatment for achalasia. Our objectives were to assess the long-term outcome of this operation and preoperative factors influencing said outcome. Methods: Demographic and clinical characteristics and data on long-term outcome were prospectively collected on patients undergoing laparoscopic myotomy for achalasia at our institution from 1992 to 2007. Treatment failure was defined as a postoperative symptom score higher than the 10th percentile of the preoperative score (⬎9). Logistic regression analysis was used to identify independent preoperative factors associated with successful myotomy. Results: Four hundred seven consecutive patients (220 men, 187 women) underwent the laparoscopic Heller-Dor procedure during the study period; 89 (22%) of them had previously had endoscopic treatment(s). The mortality rate was 0; the conversion and morbidity rates were 1.5% and 1.9%, respectively. The operation failed in 10% of patients (39/407) and the 5-year actuarial probability of being asymptomatic was 87%. Most failures (25/39, 64%) occurred within 12 months of the operation and can be considered as technical failures (incomplete myotomy). Pneumatic dilation overcome the dysphagia in 75% of patients whose surgery was unsuccessful. Considering both the primary surgery and this ancillary treatment, the operation was effective in 97% of achalasia patients. The frequency of sigmoid esophagus, lower esophageal sphincter (LES) resting pressures, and chest pain scores differed statistically between patients with and without recurrences. At multivariate analysis, high preoperative LES pressures (⬎30 mm Hg) was an independent predictor of a good response. The presence of chest pain and
of sigmoid esophagus independently predicted the failure of the procedure. Conclusion: Laparoscopic myotomy can durably relieve dysphagia symptoms. High preoperative LES pressures represent the strongest predictor of a positive outcome, probably reflecting a less severely damaged esophageal muscle. (Ann Surg 2008;248: 986 –993)
A
From the *Department of General Surgery, S Giovanni e Paolo Hospital, Venice, Italy; †Department of Surgical and Gastroenterological Sciences, Clinica Chirurgica 3°, Padua General Hospital, Padova, Italy; and ‡School of Medicine, Istituto Oncologico Veneto IOV-IRCCS, University of Padova, Padova, Italy. Reprints: Giovanni Zaninotto, MD, Department of General Surgery, S.Giovanni e Paolo Hospital Venice, ULSS 12 Venezia, Department of Surgical and Gastroenterological Sciences, University of Padova School of Medicine, Via Giustiniani 2, 35128 Padova Italy. E-mail: giovanni.
[email protected]. Copyright © 2008 by Lippincott Williams & Wilkins ISSN: 0003-4932/08/24806-0986 DOI: 10.1097/SLA.0b013e3181907bdd
chalasia is a relatively rare esophageal motility disorder characterized by impaired lower esophageal sphincter (LES) relaxations and the absence of esophageal peristalsis. These 2 conditions make the bolus stop at the cardia and dysphagia is common in achalasia patients. Although the pathogenesis of achalasia is unknown (so no definitive therapy is available), nearly a hundred years ago, the medical community learnt how to palliate dysphagia in achalasia patients by reducing the LES pressure by cutting the muscular coat1 of the cardia or by disrupting its fibers with forceful endoscopic dilations2 or, more recently, by paralyzing the fibers using botulinum toxin.3 In the last 20 years of the 20th century, endoscopic dilation became the first choice for treating achalasia because it was perceived as less invasive and less expensive, whereas surgery was relegated to an ancillary role when the former treatment failed.4 Shimi et al reported the first laparoscopic Heller myotomy5 in 1991, however, and Pellegrini et al described a thoracoscopic approach to cardiomyotomy in 1992.6 Reports on achalasia patients treated by laparoscopic Heller myotomy blossomed in the years that followed, and prolonged palliation of dysphagia, minimal postoperative pain, short hospital stay, and patients’ satisfaction were generally acknowledged. Thus, after 20 years of endoscopic dominance, the balance was tilting in favor of surgery again7! Most of the reports of laparoscopic Heller myotomies were, however, based on relatively small numbers of patients with a short follow-up. Despite the undeniable success of this therapy, there are still some issues to consider in large series of patients with a long-term follow-up. The aim of the present
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study was therefore to analyze the early and late results of the procedure and to investigate any preoperative predictors of failure in a consecutive series of 400 patients operated at a single institution since 1992.
geal body motility and LES relaxations were assessed, recording the pressure changes elicited by 10 wet swallows with the side holes of the catheter positioned inside the LES and 5, 10, 15, and 20 cm higher up, according to the technique described elsewhere.10 The residual LES pressure was defined as the minimum pressure (nadir) recorded in the LES during swallowing.
MATERIALS AND METHODS All patients referred to our center with a diagnosis of esophageal achalasia from January 1992 to December 2007 entered the study. Patients who had already had surgical (open or laparoscopic) Heller myotomy were excluded. Two multicenter randomized trials were conducted during the study period (on laparoscopic Heller myotomy vs. botulinum toxin injection and on laparoscopic Heller myotomy vs. pneumatic dilation); the patients involved are included in the present study.
Preoperative Assessment In all patients, the diagnosis of achalasia was substantiated by esophageal manometry. Barium swallow was performed to evaluate esophageal diameter and cardia shape. Endoscopy was always performed to rule out any malignancies. Clinical data were prospectively collected on each patient using a questionnaire and the patient’s symptoms were scored according to their severity and frequency. The symptom scores for dysphagia, chest pain, and regurgitation were calculated by combining the severity of each symptom (0 ⫽ none, 2 ⫽ mild, 4 ⫽ moderate, 6 ⫽ severe) with its frequency (0 ⫽ never, 1 ⫽ occasionally, 2 ⫽ once a month, 3 ⫽ every week, 4 ⫽ twice a week, 5 ⫽ daily); the highest total score obtainable was 33. The maximum esophageal diameter was measured at the barium-air interface in the standard anteroposterior image obtained during a barium swallow. In the last 3 years, the so-called timed-barium esophagram was used8; patients were asked to drink 200 mL of liquid barium while standing in an upright position and pictures were taken at 0 seconds, 1, 2, and 5 minutes. The height and maximum diameter of the barium column were measured at each time interval. Patients were classified according to their maximum esophageal diameter and the shape of the esophagogastric passage at preoperative barium swallow, as follows: grade I, ⬍4 cm; grade II, 4 to 6 cm; grade III, ⬎6 cm; grade IV ⬎6 cm and/or a sigmoid-shaped esophagus.9 Stationary esophageal manometry was performed using a pneumohydraulic perfusion system. The LES pressure was calculated by averaging the pressures recorded by 4 side holes positioned on the same level, 90° apart, and withdrawing the catheter twice using a motorized pull-through technique at a constant speed of 1 mm/s, from the stomach to the esophageal body, passing through the high-pressure zone10 (the LES pressure was therefore the average of 8 pressure recordings). The LES pressure was calculated as the midexpiratory pressure at the respiratory inversion point. Abdominal and overall LES lengths were calculated as the average distance from the point where the pressure trace rises steadily to at least 2 to 3 mm Hg more than the intragastric baseline pressure, from the respiratory inversion point (abdominal part) and from the point where the pressure trace falls below the esophageal baseline pressure (overall length).11 Esopha© 2008 Lippincott Williams & Wilkins
Surgical Technique and Postoperative Course The surgical technique has been described in detail elsewhere.12 Briefly, only the anterior part of the esophagus was dissected and a 6- to 8-cm long myotomy was performed, extending 1.5 to 2 cm on the gastric side. A 30-mm Rigiflex balloon was positioned inside the esophageal lumen at cardia level during the myotomy, using an endoscopically positioned guide wire; during the myotomy, the balloon was gently inflated and deflated with 40 to 60 mL of air using a syringe. This maneuver exposed the circular fibers that were stretched and then easily cut or torn apart; the edges of the myotomy were separated and peeled away from the submucosal plane; minimal bleeding from submucosal vessels was easily controlled by inflating the balloon, thus reducing the use of the cautery. An anterior partial hemifundoplication according to Dor completed the operation. A nasogastric tube was placed at the end of the operation and removed after a Gastrografin (Bracco, Milan, Italy) enhanced swallow on the first postoperative day revealed no leakage from the myotomy. A liquid diet was allowed and, the next day (second postoperative), patients were given soft food. Patients were discharged depending on how far away from the hospital they lived; if they lived within half an hour’s drive, they were discharged on the second postoperative day.
Follow-up and Outcome Clinical assessment was based on the same questionnaire administered 1 and 6 months after the operation, then yearly. If the patient failed to return to the Outpatient Clinic, a telephone interview was conducted. The treatment was considered unsuccessful if patients had postoperative symptom scores higher than the 10th percentile of their preoperative scores (ie, ⬎9).13 Barium study was repeated 1 month and then 2 to 4 years after the operation and whenever patients had symptoms. Esophageal manometry was repeated 6 months after surgery and whenever patients had recurrent symptoms. Endoscopy was repeated 1 year after the operation and then every 2 years. Any esophagitis was classified according to the Los Angeles classification. Twenty-four-hour pH monitoring was done 6 months after the operation to assess any abnormal gastroesophageal reflux (GER), positioning a glass electrode 5 cm above the upper border of the LES, according to the standard procedure used at our laboratory and described elsewhere.11 Traces from patients with abnormal reflux on computer analysis were carefully reviewed to distinguish true episodes of GER from false reflux because stasis.14
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Statistical Analysis Data are expressed as medians and interquartile ranges (IQR) for continuous variables, and as counts or proportions (%) for categorical variables. Nonparametric tests were used to compare groups (Mann-Whitney and Wilcoxon, as appropriate). Fisher exact test was used to compare categorical data. Disease-free survival estimates were calculated by the Kaplan-Meier method and survival comparisons were performed using the log-rank test. The 10-year probability of being asymptomatic was calculated only for patients who had a follow-up of at least 60 months. All independent variables with associations of P ⬍ 0.1 at univariate analysis then underwent multivariate analysis: logistic regression models were used to identify independent predictors of recurrence and model parameters were estimated using the maximum likelihood method. Odds ratios with 95% confidence intervals were calculated from these estimates. Correlations were analyzed by univariate regression analysis (Pearson) and using Spearman correlation coefficients. A probability of ⬍5% was assumed to be statistically significant (P ⬍ 0.05).
FIGURE 2. Distribution of the operated patients according to the age.
RESULTS Demographic Data and Morbidity During the study period, 407 patients underwent laparoscopic Heller myotomy and Dor fundoplication; they included 220 men and 187 women, with a median age of 44 years (IQR 31–55). Figure 1 shows the distribution of the patients operated over the years and Figure 2 the distribution according to the patients’ ages. The median symptom score was 16 (IQR 13–21) and their duration 24 months (IQR 12– 48). Figure 3 shows the distribution of the patients according to the dilation and shape of their esophagus at preoperative barium swallow. Eighty-nine patients had already had endoscopic treatment(s) (45 men, 44 women; median age 47 years; IQR 34 –59), involving pneumatic dilation in 46 cases, botulinum toxin injection in 33, and dilation and botulinum toxin injection in 10. Table 1 provides details of these previous treat-
FIGURE 1. Distribution of the operated patients during the study period. The percentage of patients referred with initial stages of achalasia was no different at the beginning and at the end of our experience.
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FIGURE 3. Distribution of the operated patients according to the stage of disease. Data on the esophageal diameter were available in 350 patients (86%). TABLE 1. Details on Previous Endoscopic Treatments Pneumatic dilation 1 Dilation 2 Dilations 3 Dilations ⬎3 Dilations Botulinum toxin injection 1 Injection 2 Injections 3 Injections Pneumatic dilation ⫹ botilinum toxin injection 2 Combined treatments ⬎2 Combined treatments
46/89 (52%) 11 (23%) 20 (44%) 10 (22%) 5 (11%) 33/89 (37%) 10 (30%) 20 (61%) 3 (9%) 10/89 (11%) 3 (30%) 7 (70%)
ments. Patients who had previously been treated were 5 years older than those undergoing primary surgery, ie, 42 years (IQR 31–54), P ⬍ 0.03. The median hospital stay was 5 days (IQR 4 –7). Mucosal perforations occurred in 16 cases (3.9%). In 14 patients, the perforation was detected and sutured during the operation (1 patient was converted to open surgery). In sutured cases, patients were kept on parenteral nutrition for 5 © 2008 Lippincott Williams & Wilkins
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TABLE 2. Causes of Conversion and Postoperative Complications Causes of conversion Adhesions Mucosal perforation Spleen damage Abdominal mass Complications Spleen damage Trocar site bleeding Pneumothorax Transient vocal cord palsy External sciatic-popliteal nerve palsy Unexpected persistent fever Mucosal perforation
6/407 (1.5%)* 2 2 1 1 8/407 (1.9%) 1 1 1 1 1 1 2
*All occurred in the first 50 cases.
FIGURE 4. The 5-year control of symptoms in the study population.
to 6 days and the Gastrographin swallow was obtained in the 6th to 7th postoperative day. Two perforations were detected at Gastrografin (Bracco, Milan, Italy) swallow on the first postoperative day; both patients were treated conservatively and healed within 2 weeks. The site of all but one of the perforations was in the distal part of the myotomy. No correlation emerged between the occurrence of perforations and any previous endoscopic treatments or the surgeon’s experience. The procedure was converted to open surgery in 6 patients (1.5%), all among the first 50 cases. The reasons for conversion and the postoperative complications are summarized in Table 2.
Follow-up and Early and Late Results Six patients died during the study period, all of causes unrelated to their esophageal achalasia, and 7 were lost to follow-up, so clinical information was available for 394 patients (97%), with a median follow-up of 30 months (IRQ 10.8 –78.2); 177 patients (45%) had a follow-up longer than 60 months. The median symptom score decreased from 16 (IQR 13–21) to 2 (IQR 0 – 6) P ⬍ 0.001. The average LES pressure dropped from 25 (IQR 18 –36) to 10 mm Hg (IQR 8 –13) P ⬍ 0.001 and the median esophageal diameter narrowed from 40 (IQR 30 – 45) to 20 mm (IQR 20 –25) P ⬍ 0.01. Thirty-nine patients (9.6%) had a symptom score higher than 9 and were considered treatment failures. The probability of remaining dysphagia-free at 5 years was 87.3%. In the first 177 patients with a follow-up longer than 5 years, the probability of remaining asymptomatic at 10 years was 82% (Figs. 4 and 5). Most of the recurrences (25/39, 64%) occurred within 12 months of the operation. Two or more pneumatic dilations were used to treat patients with recurrences and were effective in 75% of them. Dysphagia persisted in 9 patients, who were treated with redo Heller myotomy (in 4 cases) and esophagectomy (in 2). Two patients refused any further treatment and 1 was lost to follow-up. Considering both the primary treat© 2008 Lippincott Williams & Wilkins
FIGURE 5. Kaplan-Meier curve for symptom control for the first 177 patients who had a follow-up longer than 5 years. At 10 years after operation, 82% of patients were still free of symptoms. TABLE 3. Postoperative Manometric Findings in Patients With and Without Recurrence
LES LES LES LES
resting pressure (mm Hg) nadir pressure (mm Hg) total length (mm) abdominal length (mm)
Good Outcome (n ⴝ 356)
Failure (n ⴝ 38)
P
10 (8–13) 3 (1–5) 40 (34–48) 29.5 (23–35)
11 (11–16.5) 4 (2–6) 44 (37–53.5) 33 (26–41.5)
n.s. n.s. n.s. 0.03
Data are expressed in median (IQR). LES indicates lower esophageal sphincter; n.s., not significant.
ment (laparoscopic Heller myotomy) and any ancillary dilations, symptoms improved in 97% of the achalasia patients. The postoperative physiological findings in patients with and without recurrence are compared in Table 3; neither resting nor nadir LES pressures could discriminate between the 2 groups. Patients with recurrences, however, had a
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longer LES abdominal length than those whose surgery had been successful. Twenty-four-hour esophageal pH monitoring (performed in 260 patients, 64.1%) revealed an abnormal acid exposure in 22/260. Revision of the pH trace confirmed true reflux in 17 cases (6%); 5 patients revealed mild acidification of the esophagus, with a pH fluctuating between 3.8 to 4.2, which was judged to be because of saliva and food debris stasis in the esophageal lumen. Esophagitis was seen at endoscopy in 9 of these 17 patients, and was grade A in 5 cases and grades B to C in 4. All these patients were successfully treated with proton pump inhibitors.
TABLE 5. Independent Variables With Association of P ⬍ 0.1 at Univariate Analysis P Chest pain score Previous treatment (both pneumatic dilation and botox) LES resting pressure (mm Hg) Esophageal diameter (mm) Distal esophageal waves amplitude Sigmoid esophagus (%)
⬍0.01 0.06* ⬍0.01 ⬍0.01 0.015† 0.002
*Based on survival curve of Figure 6. † Based on the positive correlation between LES and distal esophageal waves amplitude before esophageal myotomy (Figure 7).
Predictors of Outcome Previous endoscopic treatments did not correlate with failure of the surgical procedure (Fig. 6). The demographics and clinical characteristics of patients with and without recurrences are presented in Table 4. The influence of LES pressure on outcome was calculated, excluding cases who had previously had endoscopic treatments. Four parameters differed statistically in the patients who expe-
FIGURE 6. The 5-year control of symptoms in the patients who had primary surgery compared with the patients who received a combination of dilation(s) and Botulinum toxin injection(s). TABLE 4. Demographic and Clinical Data of the Study Population Good Outcome (n ⴝ 356) Sex (M/F) Age Duration of symptoms (mos) Dysphagia score Chest pain score Previous treatment (both pneumatic dilation and botox) LES resting pressure (mm Hg) LES nadir pressure (mm Hg) LES total length (mm) LES abdominal length (mm) Esophageal diameter (mm) Sigmoid esophagus (%) Perforation (n)
Failure (n ⴝ 38) 22/17 43 (33–53) 22 (12–36) 19.5 (16–20) 8 (0–10.5) 2
25 (19–37) 11 (7–19) 41 (34–50) 28 (22–36) 40 (31–45) 5 (1.3%) 14
19.5 (15.5–27.5) ⬍0.01 12 (5.5–19.5) n.s. 43 (38–48.5) n.s. 30 (23.5–35.5) n.s. 45 (36–60) ⬍0.01 8 (20.5%) 0.002 2 n.s.
Data are expressed in median (IQR) when necessary.
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P
198/170 44 (31–55) 24 (12–48) 18 (12–20) 5 (0–8) 8
n.s. n.s. n.s. n.s. ⬍0.01 n.s.
rienced a recurrence, ie, chest pain scores, LES pressures, the diameter of their esophagus, and the presence of a sigmoid-shaped mega-esophagus. Table 5 summarizes the independent variables with association of P ⬍ 0.1 at the univariate analysis that were entered in the multivariate analysis. At multivariate analysis, a high preoperative LES pressure (⬎30 mm Hg) was an independent predictor of a good response to the treatment. Chest pain scores ⬎8 and the presence of a decompensated sigmoid esophagus (class IV) were associated with a negative outcome (Table 6). The median amplitude of contractions in the distal part of the esophagus was higher in patients with a LES pressure ⬎30 mm Hg than in those with a lower pressure (P ⬍ 0.005), and a nonlinear correlation emerged between LES pressure and amplitude of contractions (P ⬍ 0.05, r ⫽ 0.2) (Fig. 7). No correlation was found between high LES pressures and patients’ age, duration of symptoms, dysphagia score, or esophageal diameter.
DISCUSSION This is the largest reported single-center series of patients treated with laparoscopic Heller myotomy. It confirms the safety of the operation (no mortality and a very low morbidity). The most relevant complication, esophageal perforation, is usually recognized and repaired intraoperatively in the majority of cases (88%), with no further consequences and no influence on outcome. In the few cases, when perforation is detected later on, it can be managed safely with antibiotics, parenteral nutrition, and retention of the nasogastric tube for 6 to 7 days; using the Dor anterior fundoplication probably prevents spillage into the peritoneal cavity by covering the small hole, thus favoring healing. The 5-day hospital stay for laparoscopic Heller myotomy is longer than the one reported in most North American series15,16; this reflects the different approach adopted by our health service and the fact that our patients came from all over the country. Our patients are generally admitted on the day before the operation and discharge depends on how far away from the hospital they live (2 days if they live within a half-hour’s drive by car to the hospital, up to 4 days if they live further away). Laparoscopic Heller myotomy and Dor fundoplication is effective in nearly 90% of patients and the good results © 2008 Lippincott Williams & Wilkins
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TABLE 6. Multivariate Analysis of Predictors of Failure in all Patients (A) and in Patients Who Underwent Surgery as Primary Treatment (B) Risk Factors
P
OR
CI (95%)
Difference Associated With Odds Ratio
LES resting pressure Chest pain score Sigmoid esophagus Previous endoscopic treatment Distal esophageal waves amplitude Esophageal diameter
0.0416 0.0019 ⬍0.0001 n.s. n.s. n.s.
0.346 3.476 18.871
0.124–0.960 1.584–7.628 5.252–67.809
ⱕ30 vs. ⬎30 mm Hg ⱕ8 vs. ⬎8 Yes vs. no Yes vs. no ⱕ40 vs. ⬎40 mm Hg ⱕ45 vs. ⬎45 mm
LES resting pressure Chest pain score Sigmoid esophagus Distal esophageal waves amplitude Esophageal diameter
0.0337 0.0029 0.0008 n.s. n.s.
0.258 3.687 11.695
0.074–0.901 1.564–8.692 2.790–49.026
ⱕ30 vs. ⬎30 mm Hg ⱕ8 vs. ⬎8 Yes vs. no ⱕ40 vs. ⬎40 mm Hg ⱕ45 vs. ⬎45 mm
A
B
FIGURE 7. LES pressure correlate positively with distal esophageal waves amplitude before esophageal myotomy. The line represents the linear regression fitting.
persist in the short (5 years) and long term (10 years); the actuarial probability of being cured is 87% at 5 years and 80% at 10 years, similar to those reported in 2 recently published series analyzing the very long-term outcome of open Heller myotomy.17,18 More than half of the recurrences occur within the first 12 months of the operation and can be considered as incomplete myotomies.13 Extending the myotomy downward on the gastric side of the cardia remains a crucial part of the procedure, as demonstrated by Mattioli et al,19 dividing the muscle on the gastric side of the cardia over a length of at least 1.5 cm is essential to deal thoroughly with the unrelaxing sphincter problem. This part of the operation is the most difficult; however, the plane between the submucosa and the muscle layer is less evident at gastric level, bleeding is more common, and mucosal perforation may occur (all but 1 of the perforations reported in the present series were located in the distal part of the myotomy). The © 2008 Lippincott Williams & Wilkins
assumption that an insufficient downward myotomy is responsible for most recurrences stems from the observation that the LES abdominal length remained longer in patients whose myotomy failed, suggesting that dividing the sling fibers well beyond the border between the esophagus and stomach is crucial to eliminate any obstacle to the progress of the bolus. Pellegrini et al have recently advocated extending the myotomy to 3 cm on the gastric side20; though we had no experience of taking the myotomy so far, we did tend over the years of the study to extend the myotomy at least 2 cm downward. As reported previously, most of our patients with recurrent symptoms were treated endoscopically. Pneumatic dilations are safe to perform after myotomy and are effective in disrupting the small sling fibers remaining uncut (or the postmyotomy fibrotic scar tissue). Heller myotomy plus ancillary dilations is effective in most of patients with class I to III achalasia and redo myotomy was only necessary in a handful of patients. In stage IV decompensated achalasia, even complementary pneumatic dilations may be insufficient and esophagectomy is the only definitive therapy. GER is recognized as a potential complication of Heller myotomy and most authors now complete the operation with an antireflux procedure. Which fundoplication is to be added (anterior, posterior, or 360° Nissen total fundoplication) remains a matter of debate. A recent trial clearly demonstrated that an anterior partial fundoplication substantially reduces GER, without adding to the risk of dysphagia recurrence.21 The Dor anterior fundoplication is probably less effective than the Nissen or Toupet as an antireflux procedure (judging from experience gained in antireflux surgery), but it does have some advantages; no dissection of the posterior esophagus is required and it protects the exposed esophageal mucosa if a small hole is made during the myotomy. Postoperative GER (as measured objectively by 24-hour pH monitoring) was detected in only 6% of our patients, and mucosal erosions in 20% of these GER patients (less than 2% of the total sample). All patients responded well to standard medical therapy with proton pump inhibitors and the overall impression was that postoperative GER is a marginal issue
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after the Heller-Dor laparoscopic procedure. This study confirms that previous endoscopic treatment(s) do not generally affect the chances of success of laparoscopic myotomy. At multivariate analysis, LES resting pressures ⬎30 mm Hg predicted a good outcome. The positive effect of a high LES resting pressure has already been reported by Arain et al22 and Torquati et al16; the cut-offs used in these 2 studies were 35 and 35.9 mm Hg, respectively, and not unlike the value used in our study (30 mm Hg), which was chosen because it was the highest resting pressure recorded in our group of healthy volunteers. Why are high LES resting pressures positively associated with the resolution of dysphagia after laparoscopic Heller myotomy? In our study group, patients with higher LES pressures also had greater amplitudes of contraction in their distal esophagus; these contractions may feasibly help to clear the bolus once the obstacle at cardia level has been substantially reduced. On the other hand, we can speculate that patients with a high LES pressure may have a shorter gastric component of their sphincter and are therefore less exposed to insufficient myotomy. The limitation of perfusion manometry, using either a standard 4-side hole or a sleeve catheter, prevents us from establishing these details. The use of high-resolution manometry would probably help us to gain a better understanding of the complexities of the LES in achalasia patients. The reason why pain is an indicator of a negative outcome after laparoscopic Heller-Dor myotomy for achalasia is hard to explain; nearly half of the patients with chest pain scores ⬎8 whose dysphagia recurred had chest pain as the main postoperative symptom, and 5 patients had pain but minimal dysphagia. Barium swallow showed the bolus passing slowly or impacting at cardia level in 2 patients, though they complained of only minimal dysphagia. All but 1 of these patients responded well to endoscopic dilations, suggesting that the passage at the cardia was still abnormal, although the patient was nearly asymptomatic for dysphagia. In 1 patient, chest pain persisted and a long myotomy of the esophageal body was performed; it may be that chest pain is the expression, in some patients at least, of a more complex spastic disorder of the whole esophagus. As expected, the presence of a sigmoid esophagus was associated with a higher rate of failure of the surgical procedure. Omura et al23 reported only a 50% success rate in patients with a decompensated and twisted cardia, much the same rate as the one recorded in our study. Should we avoid operating on these patients? Probably not, but patients should be informed of their scarce chances of success. On the other hand, because the alternative to laparoscopic Heller Dor is usually esophagectomy, the less invasive treatment might be attempted first.
2. Patients with the best chance of cure have LES resting pressures ⬎30 mm Hg; this condition probably reflects a less severely damaged esophageal muscle function. 3. Patients with achalasia should be operated early; if the esophagus becomes twisted and acquires a sigmoid shape, dysphagia can persist in more than 50% of cases even if myotomy completely eliminates the pressure at LES level. 4. Most of patients whose laparoscopic Heller myotomy and Dor fundoplication fails can be safely and effectively treated with endoscopic dilations. When this additional treatment (where necessary) is also taken into account, achalasia could be managed successfully in 97% of the patients referred to our institution.
CONCLUSION The present study prompts a few considerations. 1. An accurate surgical technique is fundamental to success; to be effective, laparoscopic myotomy must eliminate all the sling fibers at the esophagogastric junction.
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REFERENCES 1. Heller E. Extramukose cardioplastik beim chronischen cardiospasmus mit dilation des oesophagus. Mitteilungen aus den Grenzgebieten der Medizin und Chirurgie. 1913:141–149. 2. Plummer HS, Vinson PP. Cardiospasm: a report of 301 cases. Med Clin North Am. 1921;5:355–365. 3. Pasricha PJ, Ravich WJ, Kalloo A. Treatment of achalasia with intrasphincteric injection of botulinum toxin: a pilot trial. Ann Intern Med. 1994;121:590 –591. 4. Parkman HP, Reynolds JC, Ouyang A, et al. Pneumatic dilatation or esophagomyotomy for idiopathic achalasia: clinical outcomes and cost analysis. Dig Dis Sci. 1993;38:78 – 85. 5. Shimi S, Nathanson LK, Cuschieri A. Laparoscopic cardiomyotomy for achalasia. J R Coll Surg Edinb. 1991;36:152–154. 6. Pellegrini C, Wetter LA, Patti M, et al. Thoracoscopic esophagomyotomy: initial experience with a new approach for the treatment of achalasia. Ann Surg. 1992;216:291–296. 7. Spiess AE, Kahrilas PJ. Treating achalasia: from whalebone to laparoscope. JAMA. 1998;280:638 – 642. 8. DeOliveiro M, Birgisson S, Dainoff C, et al. Timed barium swallow: a simple technique for evaluating esophageal emptying in patients with achalasia. Am J Roentegenol. 1997;197:473– 479. 9. Henderson RD, Barichello AW, Pearson FG, et al. Diagnosis of achalasia. Can J Surg. 1972;15:190 –201. 10. Passaretti S, Zaninotto G, Di Martino N, et al. Standards for oesophageal manometry. A position statement from the Gruppo Italiano di Studio Motilita` Apparato Digerente (GISMAD). Dig Liv Dis. 2000;32:46 –55. 11. Zaninotto G, Demeester TR, Schwizer W, et al. The lower esophageal sphincter in health and disease. Am J Surg. 1988;155:104 –111. 12. Ancona E, Peracchia A, Zaninotto G, et al. Heller laparoscopic cardiomyotomy with antireflux anterior fundoplication (Dor) in the treatment of esophageal achalasia. Surg Endosc. 1993;7:459 – 461. 13. Zaninotto G, Costantini M, Portale G, et al. Etiology, diagnosis, and treatment of failures after laparoscopic Heller myotomy for achalasia. Ann Surg. 2002;235:186 –192. 14. Crookes PF, Corkill S, DeMeester TR. Gastroesophageal reflux in achalasia: when is reflux really a reflux. Dig Dis Sci. 1997;42:1354 – 1361. 15. Deb S, Deschamps C, Allen MS, et al. Laparoscopic esophageal myotomy for achalasia: factors affecting functional results. Ann Thorac Surg. 2005;80:1191–1195. 16. Torquati A, Richards WO, Holzman MD, et al. Laparoscopic myotomy for achalasia. Predictors of successful outcome after 200 cases. Ann Surg. 2006;243:587–593. 17. Csendes A, Braghetto I, Burdiles P, et al. Very late results of esophagomyotomy for patients with achalasia: clinical, endoscopic, histologic, manometric, and acid reflux studies in 67 patients for a mean follow-up of 190 months. Ann Surg. 2006;243:196 –203. 18. Ortiz A, de Haro LF, Parrilla P, et al. Very long-term objective evaluation of heller myotomy plus posterior partial fundoplication in patients with achalasia of the cardia. Ann Surg. 2008;247:258 –264. 19. Mattioli S, Pilotti V, Felice V, et al. Intraoperative study on the relationship between the lower esophageal sphnicter pressure and the
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Annals of Surgery • Volume 248, Number 6, December 2008
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muscular components of the gastro-esophageal junction in achalasia patients. Ann Surg. 1993;218:635– 639. Oelkschlager BK, Chang L, Pellegrini CA. Improved outcome after extended gastric myotomy for achalasia. Arch Surg. 2003;138:490 – 497. Richards WO, Torquati A, Holzmn MD, et al. Heller myotomy versus Heller myotomy with Dor fundoplication for achalasia: a prospective randomized double- blind clinical trial. Ann Surg. 2004;240:405– 412. Arain MA, Peters JH, Tmhankar AP, et al. Preoperative lower esophageal sphincter pressure affects outcome of laparoscopic esophageal myotomy for achalasia. J Gastrointest Surg. 2004;8:328 –334. Omura N, Kashiwagi H, Ishibashi Y, et al. Laparoscopic Heller myotomy and Dor fundoplication for the treatment of achalasia. Surg Endosc. 2006;20:210 –213.
G. ZANINOTTO: I will answer your last question first. We did the evaluation excluding those patients who had previous endoscopic treatment; LES pressure remained a good predictor for good outcome when higher than 30 mm. As for your first question: have the results improved in the last years because of better patient selection? Certainly, in the last years most patients were referred to us at an early stage of disease. We did not find any significant difference when comparing the first and the last period of our experience, however. Your third question asked if there is a relationship between incomplete myotomy and elevated LES pressure. I do not think so. High LES pressure is correlated with high amplitude contractions in the distal esophagus. It is possible that these patients’ esophagi are less damaged. That is the probable reason, in my opinion, for why these patients get better, but this is just speculation.
20. 21. 22. 23.
Discussions T. LERUT: My first question relates to the annual incidence of interventions that you perform, which you said is about 50 patients a year. Do you now operate on patients in whom the diagnosis is made in an earlier stage of the disease as they are, presumably, referred more directly to you? Is this possibly a different subgroup of patients with a different profile? The results, I would think, would be better in that subset of patients in comparison to your earlier patient group. My next question goes to your conclusion that incomplete myotomy may be the main factor responsible for your early postoperative failure. On the other hand, you say that an LES pressure of less than 30 mm and the sigmoid-shaped esophagus are independently related factors to early postoperative failures. Is there a relation between these 2 factors and a potentially higher risk of an incomplete myotomy? The last question goes to the methodology. Given the importance of LES pressure in determining the chances for success, you included a group of patients in your analysis that was treated with botox injection and pneumatic dilatation; so this group, in terms of LES pressure as a predictor, may be contaminating your findings on manometry and, thus, the conclusion that you have drawn. If you left out this group, would you still be able to draw the same conclusion?
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T. DEMEESTER : You stated that a sigmoid dilated esophagus is an indicator of a poor outcome. If so, would you consider these patients to have end stage achalasia or end stage disease and recommend resection? If not, when would you not do a myotomy and recommend a resection? Second, previous studies reported that the effectiveness of the myotomy drops to 80% or less after 15 years. It seems that this might be related to the slow development of delayed gastric emptying from the loss of the mesenteric plexus in the stomach. Have you seen this? G. ZANINOTTO: I am convinced that laparoscopic Heller myotomy has less probability of success in patients with a sigmoid-shaped esophagus but I still advise the patients to have the operation. If the operation does not work, I will perform an esophagectomy. However, I will not offer an esophagectomy to a nonoperated patient as the first option because of the high risk related to this operation.
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