Evaluation of Short-term Outcomes of Laparoscopic Heller Cardiomyotomy with Dor Fundoplication Versus Pneumatic Dilatation for Treatment of Achalasia

Background: Achalasia is a rare esophageal motility disorder of unknown cause. However, the best treatment modality for achalasia is controversial. Treatment consists of disruption of the lower esophageal sphincter, classically either by endoscopic pneumatic dilation or laparoscopic Heller’s myotomy combined with an anti-re ﬂ ux procedure. The study aim was to compare laparoscopic Heller cardiomyotomy plus Dor Fundoplication with pneumatic dilatation for treatment of achalasia. Methods: In this interventional study, we included 50 adult patients diagnosed as having achalasia by performing either a barium study or by the absence of peristalsis and impaired relaxation of the lower esophageal sphincter on esophageal manometry. The patients were randomly classied into two groups according to the intervention performed: pneumatic dilation or laparoscopic Heller’s cardiomyotomy with Dor’s fundoplication(LHCM). Follow-up evaluations were performed after 8 and 16 months. Results: In total, 50 patients with achalasia and an Eckardt symptom score > 3 were managed by two different interventions according to their groups.After 16 months of follow up the height of a barium-contrast column after 5 min was signicantly lower in the LHCM group than in the pneumatic dilation group. There were no other statistically signicant differences in the primary or secondary outcomes(Eckardt score, lower esophageal sphincter, and quality of life) between the two groups. Conclusion: After 16 months of follow-up, the rates of therapeutic success and number of complications were nearly similar between LHCM and pneumatic dilation. We conclude that either treatment is suitable as an initial treatment for achalasia. after 8 months of follow-up between the groups, which is consistent with the results of a study reported by Boeckxstaens et al. [16] that showed a signicant difference after 1 year of follow-up between the two groups, with a higher LES pressure in the PD than in the LHCM group.Another study reported by An Moonen et al. [6] showed a signicant difference in the LES pressure after 1 year of follow-up between the two groups, with a higher pressure in the PD group than in the LHCM group. In contrast to a study reported by Borges et al. [18] that showed no signicant difference in the decrease in the LES pressure < 50% after 3 months of follow-up between the two groups, with 60.7% for the PD group and 85.7% for the LHCM group.

Randomized controlled trials that compared PD with LHCM have shown that the treatments were equally effective with no signi cant difference in the risk of complications between groups [5,6]. Another study showed that LHCM was more effective clinically and monometrically for patients with early stage achalasia than PD, with no signi cant difference between the two procedures regarding complications [7]. A metaanalysis also suggested that laparoscopic Heller's myotomy may deliver greater response rates than those of PD ≤ 1 year after treatment [odds ratio (OR), 1.98 for 95% con dence interval] [9].Currently, the choice of treatment depends largely on the physician's knowledge. Moreover, the outcome measures and treatment protocols in previous studies are different, making a comparison among various studies of the success rates of the treatment options problematic [10]. The main aim of this study was to compare LHCM with PD for the treatment of achalasia.

Patients And Methods
This study included 50 patients who were newly diagnosed with achalasia from June 2016 to June 2018 in three hospitals in two Middle Eastern countries. Written informed consent from all volunteers and approval of each institutional ethics committee were procured. The 50 patients were between the ages of 18 and 70 years and were enrolled on the basis of their diagnosis with achalasia either by esophageal manometry (showing absence of peristalsis and impaired relaxation of the LES with a nadir pressure of ≥ 10 mm Hg) or by a barium study if their Eckardt symptom score was > 3. The Eckardt score is the sum of regurgitation, dysphagia, weight loss, and chest pain (Table 1) and is higher with patients experiencing more severe symptoms, with 12 being the highest score. Table 1 Eckardt score: The nal score is the sum of all 4 symptoms score, with rang from 0-12  The following data were obtained from each patient: Personal history: age, sex, weight, Body Mass Index (BMI), height, occupation, marital status, smoking, family history, and history of chronic diseases.
A physical examination and standard hematological and blood chemical work up were also performed for all patients.
Upper gastrointestinal endoscopy and esophageal manometry were performed along with barium swallow to evaluate the degree of esophageal stasis before treatment and during follow-up. Four patients out of 50 did not meet the exclusion criteria, including patients un t for surgery, patients previously treated for achalasia, mega-esophagus (diameter > 7 cm), and pseudo-achalasia. The patient selection ow chart is shown in Fig. 1.

Interventions:
Pneumatic dilation: At the esophagogastric junction, a Rigi ex balloon was set and dilated for 1 min at a pressure of 5 PSI, followed by a pressure of 8 PSI for 1 min. All patients underwent two dilations: the rst was performed with a 30-mm balloon, and the second was performed 1-3 weeks later with a 35-mm balloon. However, if the Eckardt score was > 3, a third dilation was performed weeks later with a 40-mm balloon. If the Eckardt score was persistently > 3, the treatment was considered to have failed.
In the course of the follow-up period, patients with reappearance of symptoms received further dilation with a 35-mm balloon and, if required (i.e., if the Eckardt score remained > 3), a 40-mm balloon. After the second series of dilations, a concluding series of dilations were permitted only if the symptoms reoccurred after 2 years. In addition, if the patient showed recurring symptoms within 2 years after the second dilation series, the treatment was considered to have failed.
Laparoscopic Heller cardiomyotomy with Dor fundoplication: The rst step of the procedure was to mobilize the distal esophagus by exposing the diaphragmatic crura and dividing the phrenoesophageal ligament. Myotomy involved the division of all layers of the lower 4-6 cm of the esophagus abovethe gastroesophageal junction down to the mucosa as well as division of at least 1-2 cm over the stomach. Then, anterior Dor fundoplication of 180° was performed. During the followup period, if the patients exhibited symptoms of Eckardt score > 3 after surgery, the treatment was considered to have failed.

Outcomes:
The principle end result of the study was to keep the Eckardt score ≤ 3 during the follow-up period, which stretched to ≥ 18 months for all participating subjects. Therefore, esophageal manometry to assess the lower esophageal pressure along with barium swallow was performed at every follow-up attempt.
To indicating better results of good health [11]. In contrast, the QLQ-OES24 investigates multiple parameters of esophageal function, with lower scores indicating better results [12].

Results
After exclusions, a total of 50 patients with achalasia and Eckardt symptoms scores > 3 underwent one of two different procedures.   Complications of achalasia treatment are outlined in Table 4. The mucosal tear rate was 4.0% in the LHCM group, and the number of esophageal perforation complications was 8.0% in the PD group. The recurrence rates were 24.0% in the LHCM group and 32% in the PD group. . Some physicians consider PD to be the rst-line management option because it can be performed on an outpatient basis with fewer complications, and LHCM is considered to be the second-line option after PD failure [14,15]. Hence, the main objective of this study was to use a randomized study design to evaluate the two state-of-the-art treatments, PD and LHCM.
We conducted this study in a sample of 50 patients diagnosed with achalasia and who had an Eckardt symptom score > 3. The patients were randomly assigned to group A, which was treated by LHCM, and group B, which was treated by endoscopic PD. The patients' age, sex, and BMI were comparable between the two groups with no statistically signi cant differences shown. The symptom durations in groups A and B were 46.12 ± 27.187 and 52.84 ± 30.449 months, respectively, and there were no signi cant differences in occupation, comorbidity, and smoking habits between the groups. Our results are consistent with those of Boeckxstaens et al., [16], who conducted a study in 201 patients with idiopathic achalasia.
The current study showed a signi cant difference in the height of the barium-contrast column after 5 min at 16 months between the two groups, with lower height among patients in the LHCM group. Vela et al.
demonstrated that the post-procedure reduction in the height of the barium column at 5 min is considered to be a predictor of success, especially in men, and lack of improvement carries a risk for repeating the surgical procedure [17] in contrast to a study by An Moonen et al. [6] that found no signi cant differences in the height of the barium-contrast column after 5 min at 1, 2, and 5 years between the LHCM group and PD group.
Another study reported by Boeckxstaens et al. [16] showed no signi cant differences in the height of the barium-contrast column after 5 min at 1 and 2 years between the two groups.
However, for the other parameters of the primary and secondary outcomes at 8 and 16 months of follow-up, our study has shown no signi cant difference in Eckardt scores between the studied groups. In contrast to our ndings, the study of Boeckxstaensa et al. [16] found that the success rates after 1 and 2 years of followup were 93% and 90%, respectively, for LHCM and were 90% and 86%, respectively, for PD, when the cutoff point in the study was a decrease in the Eckardt scale scores to ≤ 3 as the criterion for successful treatment.
Regarding quality of life, the current study showed no signi cant differences in the physical or mental component after 8 and 16 months of follow-up between the PD and LHM groups, which agrees with the ndings of a study reported by An Moonen et al. [6] that showed no signi cant difference in the quality of life after 1, 2, and 5 years of follow-up between the two groups. Another study reported by Boeckxstaens et al.
[16] using the same SF-36 survey showed no signi cant difference in quality of life after 1 and 2 years of follow-up between the two groups. A study reported by Jan Persson et al. [7] using the Psychological General Well-being (PGWB) questionnaire showed that the total PGWB score was signi cantly higher in the LHM group than in the PD group after 3 years. The difference was evident in all domains, particularly for anxiety and self-control, but after 5 years, the difference was diminished.
The present study showed a signi cant difference in the LES pressure of 10.20 ± 1.3 and 14.00 ± 1.6 in the LHCM and PD groups, respectively, after 8 months of follow-up between the groups, which is consistent with the results of a study reported by Boeckxstaens et al. [16] that showed a signi cant difference after 1 year of follow-up between the two groups, with a higher LES pressure in the PD than in the LHCM group.Another study reported by An Moonen et al. [6] showed a signi cant difference in the LES pressure after 1 year of follow-up between the two groups, with a higher pressure in the PD group than in the LHCM group. In contrast to a study reported by Borges et al. [18] that showed no signi cant difference in the decrease in the LES pressure < 50% after 3 months of follow-up between the two groups, with 60.7% for the PD group and 85.7% for the LHCM group.
Effectiveness, durability of response, and procedure-related complications affect the choice of treatment.
Among the entire surgical community, mucosal tears that immediately healed during surgery occur in 4% of patients. Esophageal perforation complications in PD were noted in 8% of patients, a rate that is comparable to that previously reported by Boeckxstaens et al. [16]. Esophageal perforation appeared in four (4%) of the 95 patients in the PD group, which is comparable to that reported by Emad Hamdy et al. [9]. Esophageal perforation occurred in two (8%) of the 50 patients, mucosal tears occurred in 12% in the LHCM group, and abnormal gastric acid toxicity occurred in 15% of the PD patients and 23% of the LHCM patients. On the other hand, symptom improvement for PD and LHCM patients who experienced gastroesophageal re ux events was higher but transient in the PD group than in the LHM group, which may be explained by the combination of the DOR fundoplication technique with Heller myotomy to minimize postoperative acid re ux in the LHCM group. Twenty-six percent of the patients included in the study by Vela MF et al. were on protonpump inhibitors at the last follow-up evaluation, and complicated GERD was rare (4%); however, an anti-re ux procedure was performed in only 33% of those patients [17]. In a study by Emad Hamdy et al., 16% and 28% of patients developed re ux symptoms after PD and laparoscopic Heller myotomy, respectively [9].
The current study showed no signi cant difference in recurrence of symptoms after 1 month between the two groups, which were 24% and 32% in the LHCM and PD groups, respectively. These ndings were comparable to those reported by Emad Hamdy et al. who found that the rates of recurrent symptoms after 1 year were 26.3% and 8.3% in the PD and LHCM groups, respectively [9].
The Kaplan-Meier curve analyses in the present study showed no signi cant difference in the treatment success rates between the two groups, although the numerical results were higher for the LHM group than for the PD group at 7, 10, and 15 months. Those ndings agree with those of a study reported by An Moonen et al. [6] that showed no signi cant differences in the success rates of 94% for LHM and 90% for PD after 1 year, 89% (LHCM) and 86% (PD) after 2 years, and 84% (LHM) and 82% (PD) after 5 years of follow-up between the two groups. In contrast, another study reported by Jan Persson et al. [7] showed signi cant differences in the success rates of 96%, 96%, 92% and 88% for LHCM and of 79%, 68%, 64%, and 61% for PD after 1, 3, 5, and 6.5 years of follow-up, respectively, between the groups.
There were some study limitations that should be considered when interpreting the results. We performed our study in a single center, and the results could have been affected by the degree of operator experience. Other limitations included the small sample sizes of the studied groups and the lack of post-procedure motility studies.

Conclusion
This study showed that the therapeutic success rates of LHCM at different follow-up time points were not superior to those of PD, indicating that graded dilation starting with a 30-mm balloon is an appropriate procedure for PD.

Funding
No funding was received.