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Tailored Per-Oral Endoscopic Esophageal Myotomy

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Tailored Per-Oral Endoscopic Esophageal Myotomy SAGES Research Grant: Tailored Per-Oral Endoscopic Esophageal Myotomy Based on 5 years Esophageal Function Testing for Achalasia Results in Identifying Predictors of Post-operative GERD or Recurrent Achalasia. PI: Kristin Beard, MD2, Co-Investigators: Ahmed M. Sharata MD1, Paul D. Colavita MD2, Ezra Teitelbaum MD2, Christy M. Dunst MD 1,2,3; Kevin Reavis MD 1,2,3, Lee L. Swanström MD.1,2,3 1. Foundation for Surgical Innovation and Education 2. Oregon Clinic GMIS Division 3. Providence Portland Medical Center Contact: 4805 Northeast Glisan Street, Suite 6N50, Portland, OR, 97213 USA (503) 281-0561 Statement of Funding: There is no other pending or on hand funding for this project. Duration of Project: 12 months SUMMARY: Introduction: Achalasia is an acquired, progressive esophageal motility disorder of failed esophagogastric junction (EGJ) relaxation and failed peristalsis of the esophageal body that is surgically treatable with myotomy. Per oral endoscopic myotomy (POEM) is a minimally invasive technique first performed clinically in 2008 which allows a completely endoscopic myotomy that can be tailored specifically to each patient. This technique has now been utilized in hundreds of patients worldwide, and in over 100 patients at our center. However, long term outcomes data for patients treated with POEM are lacking given its recent development. Studies thus far have shown safety and efficacy of the procedure, but have also identified a considerable rate of postoperative GERD, which is not reliably symptomatic and may go undiagnosed without routine scheduled testing. We mandate periodic objective testing for postoperative POEM patients for this reason. Impedance planimetry measurement with a trans-orally inserted functional lumen-imaging probe (EndoFLIP) technology allows effective, on the spot distensibility measurement of the esophageal lumen during endoscopy. EndoFLIP is used to guide the length and extent of myotomy at our center before and after myotomy during POEM intra- operatively. EndoFLIP measurements have been shown to correlate with reflux. Our group’s experience with POEM is approaching the 5 year mark, with those patients due for follow up symptom evaluation and objective testing – longer objective follow up than has ever been reported for POEM thus far. We propose the addition of repeat EndoFLIP evaluation in 5 year postoperative patients during regular follow up endoscopy. We aim to examine changes in distensibility and cross-sectional surface area over time as compared to pre and post myotomy, as well as determine correlation between these current measures and symptoms, to determine if intra-operative distensibility results may be predictive of changes over time. The ultimate aim is to provide guidelines for tailored myotomy that provides reliable, durable relief of achalasia while minimizing the incidence of GERD. Methods: POEM patients at our center are tracked in a secure database with their permission by previous participation in IRB approved study. Follow up with exam, Eckhart symptom scoring, as well as pH, manometry, contrast swallow, and endoscopy are already clinically indicated and standard in our practice, including at 5 years post POEM. We will identify 45 achalasia patients treated with POEM 5 years ago using intraoperative pre and post myotomy EndoFLIP measurement to participate in this study as part of their routine follow up. All patients will be contacted to schedule these 5 year follow up studies and will be consented for EndoFLIP evaluation to be completed during the upper endoscopy. Endoscopy will be performed by one of the surgeon investigators of this study assisted by a surgical fellow or surgical resident. Procedures will be performed in a hospital endoscopy center or at an ambulatory surgery center with conscious sedation. Monitored recovery will be provided per usual standards BACKGROUND Achalasia is a primary esophageal motility disorder that manifests as failed peristalsis of the esophageal body and failed esophagogastric junction (EGJ) relaxation [1]. Symptoms of this progressive disease can include dysphagia, chest pain, and regurgitation. The disease puts patients at risk for aspiration, malnutrition, weight loss, complete esophageal failure requiring eventual esophagectomy, and increases risk of esophageal cancer [2]. The underlying etiology of achalasia is not completely understood and a definitive cure has not been established, so treatment is symptom directed. Symptomatic relief can be achieved by allowing relaxation of esophageal smooth muscle to relieve EGJ outlet obstruction. Pharmacologic therapy options are limited in efficacy and available drugs have some significant side effects [3, 4]. Endoscopic botulinum toxin therapy is more effective, but short-lived, often require multiple repeat treatments, and resulting fibrosis can make definitive surgical treatment more challenging. Pneumatic dilation has also effective but with 3-6% rate of perforation, so it is no longer widely performed in the United States [4, 5]. The standard surgical treatment is the laparoscopic Heller myotomy with or without partial fundoplication [6]. POEM was first established by Inoue in 2008 as a less invasive natural orifice transluminal endoscopic surgical (NOTES) technique which consists of endoscopic creation of a submucosal tunnel and circular muscle myotomy. This technique was instituted at our center in 2010, where more than 100 cases have since been performed [7, 8]. As an adjunct to preoperative endoscopy, barium swallow, and manometry findings, we use functional lumen-imaging planimetry (EndoFLIP®), intra-operatively immediately prior to and following creation of the esophageal myotomy to provide immediate measurable and visual data (Figure 1). This technique uses a trans oral probe with impedance planimetry with 16 electrodes to measure CSAs at 5-mm intervals inside a saline- filled bag (length= 80 mm). Intra-balloon pressure (PRS) is assessed, the relationship of CSA and pressure (distensibility) of the EGJ can be evaluated. Diameter (mm), CSA (mm2), and distensibility indices (DI, mm2/mmHg) are measured.) [9] This technology allows on-site calculation and topographic visualization of cross-section area (CSA) and combines this with pressure evaluations to determine distensibility of the EGJ to guide our plan for the extent of the myotomy, and to double check the adequacy of the myotomy prior to completion of the procedure. [10, 11] Esophageal distensibility has been shown to be an important predictor of gastroesophageal reflux. [12] POEM has been shown by our group and several others internationally to be safe and efficacious for the surgical treatment of achalasia. Outcomes data worldwide is limited thus far between 6 months-3 years, with much of this data based on subjective symptoms scores and limited, selective objective testing. [8, 13-15] In contrast to conventional Heller myotomy, division of only the inner circular esophageal muscle layer and sling fibers leaves longitudinal muscle and crural diaphragm components of the EGJ intact, theoretically avoiding reflux disease to some extent. However, our follow up for patients treated with POEM identified postoperative GERD still affects around 39% of patients by pH impedance testing, though only less than half of those patients experienced reflux symptoms [8, 15]. This compares to a rate between 21-32% or more in objective studies of Heller myotomy with partial fundoplication [16,17]. It is yet to be determined if further tailoring the length or extent of the myotomy has a reliable effect on postoperative GERD. Considering the high rate of silent GERD after POEM, we take care to ensure regular follow up of POEM patients with objective testing. This includes periodic esophageal manometry, pH impedance, endoscopy, and timed barium swallow to completely evaluate postoperative parameters of motility and reflux. Our center is now approaching the 5 year anniversary of its first POEM case. We propose a study to re-evaluate patients 5 years after POEM with objective follow up testing, such long-term objective follow up has not yet been reported by any center. In addition to the routine battery of esophageal tests previously mentioned we propose to include distensibility testing with EndoFLIP technology at 5 year follow up during routinely scheduled endoscopy. We propose that this information can help guide treatment for patients after POEM (as early as during the same endoscopy) and guide technical surgical decisions in future POEM cases by identifying predictors of GERD or recurrent achalasia. Our goal is to provide new improved guidelines for tailoring the myotomy intraoperatively with EndoFLIP as an adjunct to traditional studies, in order to provide durable symptom relief of achalasia while decreasing incidence of iatrogenic GERD. Figure 1[15] Hypothesis: Five years after POEM for achalasia, measurements of esophageal physiology collected by EndoFLIP may have changed compared to intra-operative measurements. Establishing the pattern of EndoFLIP measurements 5 years after POEM in correlation with symptom scores, HRM, pH, esophagram, and endoscopy may help to identify predictors of post-operative GERD or recurrent achalasia. These predictors could inform the surgeon’s strategy for tailoring length and extent of myotomy in future POEM cases. Specific Aims: 1) Establish patterns of distensibility and cross sectional area in correlation with clinical outcomes 5 years after POEM. 2) Compare patterns of distensibility and cross sectional
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