Limited Hiatal Dissection Without Fundoplication Results in Comparable Symptomatic Outcomes to Laparoscopic Heller Myotomy with Anterior Fundoplication

Introduction

Laparoscopic Heller Myotomy with partial fundoplication remains the procedure of choice for the treatment of patients with achalasia.^1,2 Previous randomized controlled trials have demonstrated that partial fundoplication following Heller myotomy results in less pathologic acid exposure to the distal esophagus when compared to myotomy without fundoplication.^3,4 In these studies, a full hiatal dissection (FHD) was performed to facilitate the myotomy in each treatment arm, disrupting the natural anatomic reflux barrier (angle of His, phrenoesophageal ligament).

Several publications have questioned the necessity of a fundoplication, especially when a limited hiatal dissection (LHD) is performed and the angle of His is preserved.^5,6 In this study, we sought to determine the impact of selective fundoplication following Heller myotomy with FHD versus Heller myotomy with LHD. Patient-reported Gastroesophageal Reflux Disease (GERD)-related symptomatic outcomes, and side effects were compared between groups up to 2 years.

Materials and Methods

After IRB approval, a retrospective review of prospectively maintained data was undertaken of patients that underwent primary Heller myotomy for achalasia at the Medical College of Wisconsin between November 2011 and August 2014. The robotic approach was preferred and selected in all cases when possible. Patients underwent laparoscopic myotomy when access to the robot was limited due to scheduling conflicts. Patients were selected to receive Heller myotomy with FHD and Dor fundoplication or Heller myotomy with LHD based on clinical criteria. Exclusion criteria for LHD included the following: body mass index (BMI) >35 kg/m² (greater potential for postmyotomy GERD secondary to obesity), hiatal hernia, mucosal perforation during myotomy, and inability to perform an adequate myotomy due to limited approach to the hiatus.

In the FHD with the Dor fundoplication group, the entire phrenoesophageal ligament was divided exposing the anterior gastroesophageal junction (GEJ). A circumferential hiatal dissection with mediastinal mobilization of the esophagus was conducted. The goal of the circumferential dissection was to mobilize the GEJ well into the abdominal cavity to facilitate myotomy, reduce any hiatal hernia if present, and to ensure that the fundoplication covered the distal esophagus as well as the GEJ. The myotomy was performed by dividing the longitudinal and inner circular musculature of the distal 6–8 cm of the esophagus and extended 2 cm onto the proximal stomach using hook electrosurgery. The anterior fat pad was resected, and the anterior vagus nerve was identified, mobilized, and preserved. Intraoperative endoscopy was performed following myotomy to assess for mucosal integrity and myotomy completion. The posterior hiatus was reapproximated with 1–2 sutures, taking care not to compress what is often a dilated esophagus. A Dor anterior 180-degree partial fundoplication was performed in the standard manner.

In the LHD group, the anterior phrenoesophageal ligament was mobilized or incised to facilitate identification of the anterior surface of the esophageal muscle. All lateral and posterior phrenoesophageal ligaments and the angle of His were preserved. The anterior fat pad was then removed, allowing for identification of the anterior vagus nerve and GEJ. The myotomy was performed for 6–8 cm proximally, often rolling the esophagus into the operative field by retracting on the left and right myotomy edge. The vagus nerve was mobilized distally and elevated so that it could be preserved in all cases. The myotomy was carried onto the stomach for 2 cm. No hiatal sutures were placed, and no fundoplications were created in these patients. As in the FHD group, endoscopy was used to assess the myotomy.

Before surgery, all patients underwent high-resolution esophageal manometry to confirm the diagnosis of achalasia. Patients were subjected to the same long myotomy (6–8 cm or as long as possible), regardless of the Chicago classification subtype. Endoscopy and barium esophagram were part of the standard preoperative workup. Postoperatively, upper gastrointestinal endoscopy (EGD) or barium esophagram was not routinely performed unless clinically indicated. Patient symptomatic outcomes and quality of life were assessed using the validated Achalasia Severity Questionnaire (ASQ), Gastroesophageal Reflux Disease–Health-Related Quality of Life (GERD-HRQL), and Gastrointestinal Quality of Life Index (GIQLI).^7–9 Postoperative questionnaires were collected during follow-up visits or through mail at 2 weeks, 2 months, 6 months, 1 year, and 2 years postoperatively.

The ASQ is a 10-item disease-specific tool that assesses food tolerance, dysphagia-related behavior modification, pain, heartburn, lifestyle limitations, and satisfaction. Cumulative scores range from 0 to 100, with 100 being the worst possible score (most severe symptoms). ⁷

The GERD-HRQL questionnaire assesses the impact of GERD on quality of life and symptomatic outcomes. Items are scored from 0 to 5 (0 = no symptoms, 5 = symptoms are incapacitating, unable to do daily activities). The summation of all scores represents overall quality of life as it relates to GERD symptoms (0 = best score, 50 = worst score). ⁸

The GIQLI survey consists of 36 items related to gastrointestinal quality of life for a 2-week period before survey completion. Domains include gastrointestinal symptoms, physical, social, and emotional function. ⁹ Each item is scored from 0 to 4 (0 = least desirable option, 4 = most desirable). A summation of all scores assesses overall GI quality of life ranging from 0 being the worst possible quality of life to 144 being the best.

Statistical analysis was conducted using SPSS (Version 22.0; SPSS, Inc., Chicago, IL). Two-tailed Wilcoxon rank-sum tests were used for bivariate analysis, and Fisher's exact tests were used for categorical variables. A P value of <.05 was considered statistically significant.

Results

A total of 36 patients underwent Heller myotomy for achalasia during the study interval. Of these, 31 met inclusion criteria (4 excluded for undergoing other surgical procedures at time of myotomy, 1 excluded for redo Heller myotomy). Patient characteristics did not differ significantly between study groups (Table 1). Preoperative EGD revealed hiatal hernia more frequently in subjects to undergo a FHD, but endoscopic findings were similar in both study groups otherwise. The majority of patients (21, 68%) underwent robotic Heller myotomy. There was no difference in symptomatic or other evaluated outcome measures for robotic when compared to laparoscopic cases.

The majority of patients in both groups were classified as Chicago type II achalasia by high-resolution manometry. All 4 patients with Chicago type III achalasia underwent FHD. The Chicago classification subtype had no impact on symptomatic outcomes based on ASQ, GIQLI, or GERD-HRQL on univariate analysis. Operating time was significantly longer in the FHD compared to the LHD group. Length of stay was greater in the FHD group compared to the LHD group; however, this was not statistically significant. Preoperatively, 60% of patients in the LHD group were taking proton pump inhibitor medications (PPIs) or H2 blockers, while 62% of patients in the FHD group were taking one of these medications. No patients in the LHD required a PPI or H2 blocker at 1 year postoperation, while 6 (29%) of the patients in the FHD group required one at this time point (P = .20).

Baseline quality of life was poor, and symptom severity was significant in all patients before surgery and uniformly improved, regardless of the study group (Table 2). The mean ASQ score significantly improved following surgical intervention. Of note, the ASQ item dealing with disease-related health satisfaction (“I am satisfied with my health with regards to achalasia”) changed from 71% “strongly disagree” preoperatively to 71% “strongly agree” postoperatively, with no subject expressing dissatisfaction in any study group at 6 months and 1 year. There was no difference in response to this question based on the study group. The average GIQLI score for a “normal” person is 125. ⁹ The mean pretreatment GIQLI scores for our cohort (78 and 81) were significantly worse than that reported in chronic gallstone disease (87) or esophageal cancer (89). Post–treatment, GIQLI was significantly improved, but still slightly less than “normal.” Mean GERD-HRQL scores improved by >50%, a benchmark often used to indicate a successful therapeutic response. Mean follow-up for the entire study cohort was 11.2 ± 9.3 months. For patients who completed surveys at 1 year or more following surgery, the mean interval for completing the survey was 18 months postoperatively.

Intraoperative esophageal mucosal perforations occurred in the distal esophagus at the level of the GEJ during myotomy creation in 3 patients. In 2 of these patients, FHD was selected due to BMI >35 in one and a hiatal hernia in the other. In the 3rd patient, an attempt at limited dissection was aborted when the perforation occurred, and this patient is included in the full dissection cohort. All perforations were repaired intraoperatively using 2-0 or 3-0 interrupted Vicryl sutures with the anterior Dor fundoplication covering the entire sutured repair. Each of these patients to experience a mucosal perforation had preoperative esophageal instrumentation. Two patients had pneumatic balloon dilation, and 1 patient had undergone 10 prior Botox injection sessions. Two perforations occurred in patients undergoing laparoscopic and one in a patient undergoing robotic myotomy. There were no adverse postoperative events in patients with a mucosal perforation repaired intraoperatively. One 84-year-old patient developed a colonic pseudo-obstruction following surgery that responded to conservative management, leading to an overall morbidity rate of 3%.

Discussion

Since the technique of laparoscopic Heller myotomy was first described in 1991, it has grown in popularity to become the standard surgical treatment for achalasia. ¹⁰ Technical aspects of the procedure such as the length of the esophagomyotomy, the length of the cardiomyotomy, the necessity of fundoplication, and the type of fundoplication performed have received considerable attention in the literature.

We have demonstrated that in a small retrospective review of a clinical case series, selective fundoplication is a reasonable strategy in select patients. The longer operative times in the FHD group for our study are likely related to the more extensive dissection, the need to create a fundoplication, and the higher rate of mucosal perforations requiring operative repair in this group. Avoiding an extensive reconstruction and the need to create a fundoplication saves operative time and effort—an advantage to patient and surgeon alike. We feel that the LHD technique is simple and reproducible from surgeon to surgeon—provided that the surgeon in question has experience in Heller myotomy.

The rationale for a fundoplication following Heller myotomy is to prevent pathologic gastroesophageal reflux that occurs as a result of dividing the lower esophageal sphincter. GERD is the most common late complication following surgery for achalasia. ¹¹ Its true incidence is difficult to establish because of the many factors involved, such as the type of fundoplication, length of the myotomy, definition, and assessment method to document pathologic GER among others. In a review of 5000 cases collected from 75 articles, the mean incidence of GER following Heller myotomy was determined to be 8.6% (range 0%–29%). ¹²

Although some authors advocate for a complete Nissen fundoplication following Heller myotomy, ¹³ most do not recommend this approach. A randomized controlled trial comparing the long-term outcomes of Heller myotomy with Dor versus Nissen fundoplication revealed that Nissen fundoplication was associated with a significantly higher rate of dysphagia (2.8% versus 15% after mean follow-up 125 months; P < .001). ² Theoretical advantages to a posterior partial fundoplication such as a Toupet include the possibility that the fundoplication itself may act to hold the edges of the myotomy apart and prevent subsequent healing of the myotomy. Disadvantages to a Toupet include the possibility of a diverticula developing at the site of the myotomy and the need for more extensive dissection at the hiatus. Potential advantages to a Dor anterior partial fundoplication include the fact that less dissection is required when compared to a Nissen or a Toupet and that the fundoplication itself may help to prevent late mucosal perforation or to buttress the repair of a recognized intraoperative mucosal perforation—an event that occurs in ∼1%–15% cases. ¹⁴ A retrospective review of a clinical case series comparing outcomes of Heller myotomy with Dor versus Toupet partial fundoplication revealed equivalent outcomes with regard to satisfaction, heartburn, and dysphagia symptoms. ¹⁵

A recent meta-analysis comparing Dor partial fundoplication to “other” types of fundoplications and to no fundoplication at all revealed that Dor fundoplication was associated with a significantly higher rate of clinical regurgitation and pathologic acid reflux compared to the “other” fundoplication group. When compared to no fundoplication, there was no advantage to a Dor partial fundoplication. ¹⁶ A recent systematic review and meta-analysis determined that adding an antireflux procedure after laparoscopic myotomy dramatically decreased the incidence of GER symptoms from 31% down to 9% (OR 4.3; 95% CI 1.9–9.7; P = .001), without altering the resolution of dysphagia (90% versus 90%; OR 1.6; 95% CI 0.74–3.3; P = .23). ¹⁷ This same review determined that, based on pH, the incidence of GER after laparoscopic myotomy without fundoplication was 42% versus 15% after laparoscopic myotomy with fundoplication (OR 4.2; 95% CI 1.5–12.8; P = .01). The most common approach in clinical practice today is to perform a partial fundoplication of some type following surgical myotomy. ¹⁸

Most studies comparing outcomes of Heller myotomy with and without fundoplication involve a complete hiatal dissection in both study groups. In the presence of an FHD, the addition of a fundoplication has been demonstrated to lead to superior symptomatic outcomes when it comes to GERD. In a prospective, randomized double-blinded study of Heller with and without Dor fundoplication, the incidence of pathologic acid exposure to the distal esophagus was significantly higher on pH study 6 months postoperatively in patients without a fundoplication (48% without fundoplication versus 9% with fundoplication; P = .005). ³

The limited Heller myotomy technique was first described by Ellis and through the thoracic approach. ¹⁹ In a retrospective review of 126 patients to undergo Heller myotomy with LHD and no fundoplication over a 14-year period, preoperative and postoperative manometry and pH studies were attained in 60 patients. ²⁰ Of these 60 patients with postmyotomy pH studies, 68% had normal studies and the rest had abnormal esophageal acid exposure. Only 21% of the patients were symptomatic and all of these patients were well controlled with appropriate acid suppression. Based on these results, the authors conclude that LHD myotomy without fundoplication is an effective long-term treatment that does not cause symptomatic GERD in three quarters of patients. In a prospective randomized trial comparing complete hiatal dissection with a Heller myotomy and Dor fundoplication to LHD and Heller myotomy plus Dor fundoplication to LHD with Heller myotomy and no fundoplication, Simić et al. determined that LHD was associated with better reflux control in patients, regardless of fundoplication after 3 years follow-up. ²¹ These conclusions were based on the results of pH studies in these patients. Our results, while based on symptom control rather than pH studies, would support the author's conclusion that LHD avoids disruption of the intra-abdominal esophageal anatomic structures and diminishes the risk of postoperative GERD as a direct result.

There are several limitations of this study. This was a retrospective review of a single surgeon's case series. The two study groups are not equivalent, as the exclusion criteria for LHD, such as obesity and hiatal hernia, were present in only the complete hiatal dissection arm. The relatively small sample size and incomplete follow-up may also have an impact.

In summary, based on these results, we conclude that LHD with preservation of the angle of His and lateral as well as posterior attachments at the hiatus results in good symptom outcomes with regard to dysphagia with a low incidence of troublesome GERD symptoms on follow-up out to 2 years. This study lends support to a growing body of literature that suggests fundoplication may not be necessary in all patients undergoing Heller myotomy if the anatomy of the GEJ can be preserved. Further investigation is warranted.