North American Expert Consensus on the Post-procedural Care of Patients After Per-oral Endoscopic Myotomy Using a Delphi Process.

BACKGROUND & AIMS: There is significant variability in the immediate post-operative and long-term management of patients undergoing per-oral endoscopic myotomy (POEM), largely stemming from the lack of high-quality evidence. We aimed to establish a consensus on several important questions on the after care of post-POEM patients through a modified Delphi process. METHODS: A steering committee developed an initial questionnaire consisting of 5 domains (33 statements): post-POEM admission/discharge, indication for immediate post-POEM esophagram, peri-procedural medications and diet resumption, clinic follow-up recommendations, and post-POEM reflux surveillance and management. A total of 34 experts participated in the 2 rounds of the Delphi process, with quantitative and qualitative data analyzed for each round to achieve consensus. RESULTS: A total of 23 statements achieved a high degree of consensus. Overall, the expert panel agreed on the following: (1) same-day discharge after POEM can be considered in select patients; (2) a single dose of prophylactic antibiotics may be as effective as a short course; (3) a modified diet can be advanced as tolerated; and (4) all patients should be followed in clinic and undergo objective testing for surveillance and management of reflux. Consensus could not be achieved on the indication of post-POEM esophagram to evaluate for leak. CONCLUSIONS: The results of this Delphi process established expert agreement on several important issues and provides practical guidance on key aspects in the care of patients following POEM.

The Efficacy of Peroral Endoscopic Myotomy vs Pneumatic Dilation as Treatment for Patients With Achalasia Suffering From Persistent or Recurrent Symptoms After Laparoscopic Heller Myotomy: A Randomized Clinical Trial.

BACKGROUND & AIMS: For patients with achalasia experiencing persistent or recurrent symptoms after laparoscopic Heller myotomy (LHM), pneumatic dilation (PD) is the most frequently used treatment. Per-oral endoscopic myotomy (POEM) is increasingly being investigated as rescue therapy. This study aimed to determine the efficacy of POEM vs PD for patients with persistent or recurrent symptoms after LHM. METHODS: This randomized multicenter controlled trial included patients after LHM with an Eckardt score >3 and substantial stasis (≥2 cm) on timed barium esophagogram and randomized to POEM or PD. The primary outcome was treatment success, defined as an Eckardt score of ≤3 and without unscheduled re-treatment. Secondary outcomes included the presence of reflux esophagitis, high-resolution manometry, and timed barium esophagogram findings. Follow-up duration was 1 year after initial treatment. RESULTS: Ninety patients were included. POEM had a higher success rate (28 of 45 patients [62.2%]) than PD (12 of 45 patients [26.7%]; absolute difference, 35.6%; 95% CI, 16.4%-54.7%; P = .001; odds ratio, 0.22; 95% CI, 0.09-0.54; relative risk for success, 2.33; 95% CI, 1.37-3.99). Reflux esophagitis was not significantly different between POEM (12 of 35 [34.3%]) and PD (6 of 40 [15%]). Basal lower esophageal sphincter pressure and integrated relaxation pressure (IRP-4) were significantly lower in the POEM group (P = .034; P = .002). Barium column height after 2 and 5 minutes was significantly less in patients treated with POEM (P = .005; P = .015). CONCLUSIONS: Among patients with achalasia experiencing persistent or recurrent symptoms after LHM, POEM resulted in a significantly higher success rate than PD, with a numerically higher incidence of grade A-B reflux esophagitis. NETHERLANDS TRIAL REGISTRY: NL4361 (NTR4501), https://trialsearch.who.int/Trial2.aspx?TrialID = NTR4501.

Impedance planimetry during per-oral endoscopic myotomy is associated with decreased inadvertent capnoperitoneum.

BACKGROUND: Per-oral endoscopic myotomy (POEM) has become an accepted minimally invasive alternative to Heller myotomy for the treatment of achalasia and other disorders of esophageal dysmotility. One associated adverse event is the inadvertent creation of capnoperitoneum. A proposed mechanism is that extension of the submucosal tunnel below the esophageal hiatus and onto the gastric wall leads to transmural perforation. We hypothesized that the use of impedance planimetry with the endoscopic functional luminal imaging probe (EndoFLIP) more accurately identifies the esophagogastric junction and helps to better define the myotomy's ideal limits, thus lowering the incidence of inadvertent capnoperitoneum. METHODS: This is a single-center, retrospective review of consecutive POEM cases from 06/11/2011 to 08/08/2022, with EndoFLIP introduced in 2017. Patient and procedural characteristics, including the incidence of clinically significant capnoperitoneum and decompression, were analyzed using univariate and multivariable linear regression statistics. RESULTS: There were 140 POEM cases identified, 74 (52.9%) of which used EndoFLIP. Clinically significant capnoperitoneum was encountered in 26 (18.6%) cases, with no differences in patient characteristics between those who had capnoperitoneum and those who did not. There was a decreased incidence of capnoperitoneum in cases using EndoFLIP compared to those without (n = 6, 23% vs n = 20, 77%, p = 0.001), with zero instances in the final 56 cases. After adjusting for potentially confounding factors, EndoFLIP use was associated with a - 15.93% (95% confidence interval - 30.68%, - 1.18%) decrease in procedure duration. CONCLUSIONS: The routine use of EndoFLIP during POEM was associated with decreased incidence of clinically significant capnoperitoneum, potentially due to improved myotomy tailoring and decreased duration of insufflation with shorter procedure times.

The effect of per-oral endoscopic myotomy by achalasia subtype as measured by impedance planimetry.

BACKGROUND: Achalasia is an esophageal motility disorder with three subtypes based on manometry that can treated with per-oral endoscopic myotomy (POEM). With the advent of impedance planimetry (EndoFLIP®), we hypothesized the three achalasia subtypes would have different pre-POEM EndoFLIP® diameter and distensibility index (DI) measurements but would be similar after POEM. METHODS: A single-institution, retrospective review of consecutive POEM cases by a single surgeon-endoscopist team from 04/07/2017 to 08/28/2023. Patients with a diagnosis of achalasia were stratified into type 1, 2, or 3 based on pre-POEM manometry. Patient characteristics, Eckardt scores, and pre-and-post-POEM diameter and DI were compared by subtype with descriptive, univariate, and multivariable linear regression statistics. RESULTS: Sixty-four patients met inclusion criteria, of whom 9(14.1%) had Type 1, 36(56.3%) had Type 2, and 19(29.7%) had Type 3. There were no differences between Types with respect to median pre-POEM Eckardt scores (9[IQR:7-9) vs. 8[IQR:6-9] vs. 7[IQR:5-8], p = 0.148), median post-POEM Eckardt scores (0[IQR:0-1] vs. 0[IQR:0-0] vs. 0[IQR0-0.5], p = 0.112). EndoFLIP® data revealed variation in median pre-POEM diameter and DI between Subtypes (6.9[IQR:6-8.5] vs. 5.5[IQR:5-6.8] vs. 5[IQR:5-6.1], p = 0.025 and 1.8[IQR:1.3-3.2] vs. 0.9[IQR:0.6-1.6] vs. 0.6[IQR:0.5-0.8], p = 0.003, respectively), but not in the change in diameter or DI post-POEM (5.1[IQR:4.3-5.9] vs. 5.1[IQR:4.1-7.1] vs. 5.9[IQR:5-6.4], p = 0.217 and 3.9[IQR:2.5-4.7] vs. 3.4[IQR:2.4-4.7] vs. 2.7[IQR:2.3-3.7], p = 0.461, respectively). However, after adjusting for potentially confounding factors, pre- or post-POEM diameter and DI did not demonstrate statistically significant differences among subtypes. CONCLUSIONS: Achalasia subtypes did not demonstrate different pre-POEM diameters or DI as measured by EndoFLIP® nor are there differences after POEM completion. While achalasia subtypes may have slightly different pathophysiology based on manometry findings, similar pre- and post-POEM impedance planimetry findings, along with similar Eckardt scores, support the use of POEM in the treatment of any achalasia subtype.

Does preoperative symptom duration affect outcomes following per oral endoscopic myotomy (POEM)?

BACKGROUND: Per oral endoscopic myotomy (POEM) is a safe therapy for the treatment of achalasia. Long-term effects of untreated achalasia include worsening dysmotility and disruptions in esophageal anatomy, i.e., tortuosity and dilation. We hypothesize that long-standing achalasia prior to intervention will have worse outcomes following POEM than in patients with symptoms for shorter duration. METHODS: We retrospectively analyzed achalasia patients who underwent POEM at our institution from 2011 to 2023, categorizing them into symptom duration cohorts (< 1 year, 1-3 years, 4-10 years, > 10 years). Inclusion criteria comprised patients with documented achalasia diagnosis who received POEM treatment at our facility. Exclusion criteria encompassed individuals lacking data pertaining to achalasia diagnosis, the time frame before intervention, or those missing pre and postoperative Eckardt scores. POEM failure was defined as symptom recurrence, necessity for repeat intervention, or high postoperative Eckardt score. We compared demographic, preoperative, and postoperative outcomes across these cohorts, and employed multivariable logistic regression to explore the link between symptom duration and POEM response. RESULTS: During the study period, in our increased cohort 234 patients met inclusion criteria. 75 patients had symptoms for < 1 year, 78 patients had symptoms from 1 to 3 years, 47 patients had symptoms from 4 to 10 years, and 34 patients had symptoms > 10 years. Patient demographics such as age, sex, BMI, Charleson-Deyo-Comorbidity-Index, and diabetes did not differ amongst cohorts. High-resolution manometry data, including achalasia type, Median IRP, LES residual pressure, and Basal LES pressure did not differ between groups. Preoperative Eckardt scores ranged from 4 to 5 across groups (p 0.24). Patients endorsed an average of three total preoperative symptoms across groups (p 0.13). Patients with symptoms greater than 4 years had significantly more endoscopic interventions prior to POEM (37% vs, 68% p .001). There was no significant difference in post-procedure mean Eckardt scores between cohorts. All cohorts experienced the same number of post-POEM symptoms. Post-POEM manometric measurements remained consistent across cohorts. Similarly, there were no significant differences in terms of symptom recurrence, requirement for repeat interventions, or repeat POEM among the cohorts. Multivariable logistic regression analysis determined achalasia symptoms greater than a decade did not result in increased odds of having a higher postoperative Eckardt score, worse dysphagia, regurgitation, or weight loss. CONCLUSIONS: In this increased cohort, this data once again suggests that longer symptom duration is not associated with increased rates of POEM failure.

Esophageal impedance planimetry during per-oral endoscopic myotomy guides myotomy extent.

INTRODUCTION: Peroral endoscopic myotomy (POEM) is the standard treatment for achalasia. Functional luminal imaging probe (FLIP) technology enables objective measurement of lower esophageal sphincter (LES) geometry, with literature linking specific values to improved post-POEM outcomes. Our study assesses FLIP's intraoperative use in evaluating myotomy extent in real-time. METHODS: Retrospective data from all patients undergoing POEM with intraoperative FLIP measurements were extracted from June 2020 to January 2023. The primary endpoint was intraoperative FLIP measurements, management changes, and symptom improvement (Eckardt score). RESULTS: Fourteen patients (age 56 ± 14 years, BMI 28 ± 7 kg/m2) were identified. Most patients were female (64%). Predominantly, patients presented with type II achalasia (50%). FLIP measurements were taken before and after myotomy, demonstrating increases in mean distensibility index (DI) 1.6 ± 1. 4 to 5.4 ± 2.1 mm2/mmHg (p < 0.05) and mean diameter (Dmin) 6 ± 1.8 to 10.9 ± 2.3 mm (p < 0.05) at 50 ml balloon fill. Additional myotomy was performed in one patient when an inadequate increase in FLIP values were noted. Mean operative time was 98 ± 28 min, and there were no intraoperative complications. At the 30-day follow-up, median Eckardt score decreased from mean a preoperative score of 7 ± 2 to a post-operative mean of 2 ± 3, with 10 patients (78%) having a score ≤ 2. In total, four patients experienced symptom recurrence, with repeat FLIP values revealing a significant decrease in DI from 7 ± 2.2 post-POEM to 2.5 ± 1.5 at recurrence. FLIP technology identified LES pathology in 3 out of 4 (75%) patients, facilitating referral to LES-directed therapy. CONCLUSION: Our study adds to the literature supporting the use of FLIP technology during the POEM procedure, with most patients achieving ideal values after a standard-length myotomy. This suggests the potential benefits of shorter myotomies guided by FLIP to achieve comparable outcomes and reduce postoperative GERD risk. Collaborative standardization of study designs and outcome measures is crucial for facilitating prospective trials and cross-setting outcome comparisons.

Elevated preoperative lower esophageal sphincter pressure predicts improved clinical outcomes after per oral endoscopic myotomy (POEM).

BACKGROUND: Although per oral endoscopic myotomy (POEM) has shown to be beneficial for the treatment of achalasia, it can be difficult to predict who will have a robust and long-lasting response. Historically, it has been shown that higher lower esophageal sphincter pressures have been associated with poorer responses to alternative endoscopic therapies such as Botox therapy and pneumatic dilation. This study was designed to evaluate if modern preoperative manometric data could similarly predict response to therapy after POEM. METHODS: This was a retrospective study of 237 patients who underwent POEM at a single institution over a period of 13 years (2011-2023) and who had a high-resolution manometry performed preoperatively and an Eckardt symptom score performed both preoperative and postoperatively. The achalasia type and integrated relaxation pressures (IRP) were tested for potential correlation with the need for any further achalasia interventions postoperatively as well as the degree of Eckardt score reduction using a linear regression model. RESULTS: The Achalasia type on preoperative manometry was not predictive for further interventions or degree of Eckardt score reduction (p = 0.76 and 0.43, respectively). A higher IRP was not predictive of the need for further interventions, however, it was predictive of a greater reduction in postoperative Eckardt scores (p = 0.03) as shown by the non-zero regression slope. CONCLUSION: In this study, achalasia type was not a predictive factor in the need for further interventions or the degree of symptom relief. Although IRP was not predictive of the need for further interventions, a higher IRP did predict better symptomatic relief postoperatively. This result is opposite that of other endoscopic treatment modalities (Botox and pneumatic dilation). Therefore, patients with higher IRP on preoperative high-resolution manometry would likely benefit from POEM which provides significant symptomatic relief postoperatively.

Initial experience and outcomes of per oral pyloromyotomy for the treatment of refractory gastroparesis.

BACKGROUND: Gastroparesis can be a debilitating disease process for which durable treatment options are lacking. While dietary changes and pharmacotherapy have some efficacy, symptoms frequently recur and some patients progress to needing supplemental enteral feeding access. Per oral pyloromyotomy (POP) has been shown to be a durable minimally invasive treatment option for refractory gastroparesis with a low side effect profile, and therefore has been performed at this institution for the past 6 years. METHODS: This was a retrospective case series of all patients who underwent a POP at a single institution over a 6-year period (2018-2023). Patient demographics, preoperative symptomatology and subsequent workup, postoperative complications, and symptom recurrence were collected and analyzed. RESULTS: There were 56 patients included in the study. There was a 1.8:1 female:male ratio. The average patient age was 56 years old (range 23-85). The average duration of symptoms was 1-3 years. Thirty-eight percent of patients had undergone previous endoscopic therapy for gastroparesis (pyloric botox injection or pyloric dilation) and 16% of patients underwent multiple endoscopic therapies. Twenty-nine percent of patients were on a medication for gastroparesis. Past surgery was the most common gastroparesis etiology for POP (50% of patients). Diabetes (23%) and idiopathic (19%) were the other most common gastroparesis etiologies for POP. Nausea was the most common symptom at first follow-up (30%) but these patients continued to improve with 14% of patients continuing to endorse nausea at 6 months. Twenty-seven percent of patients developed symptom recurrence. Forty percent of patients with symptom recurrence underwent a repeat endoscopic or surgical therapy. CONCLUSIONS: In this present study, POP leads to durable results in approximately 75% of patients with minimal complications. Furthermore, the majority of patients who do develop symptom recurrence do not require additional gastroparesis interventions.

Peroral endoscopic myotomy and its use in non-achalasia disorders.

The aim of this review is to provide an overview of per-oral endoscopic myotomy (POEM) and its utilization in non-achalasia disorders of the esophagus. POEM, a relatively novel endoscopic technique, involves submucosal tunneling to access esophageal muscle layers, enabling selective myotomy and mitigating the consequences of motor disorders of the esophagus. POEM is an effective treatment modality for diffuse esophageal spasm providing resolution of chest pain and dysphagia in a majority of patients who have refractory symptoms despite medical therapy. The results of POEM are more equivocal compared to esophagogastric junction outflow obstruction (EGJOO). POEM in EGJOO has been shown to have a 93% clinical success rate in 6 months. POEM appears to be more effective in motor disorders that affect the lower esophageal sphincter, such as EGJOO and opioid-induced esophageal dysfunction. While the current data for POEM in other entities such as DES and HE are positive, more supportive data are required to make POEM a consistent recommendation for patients.

Efficacy and safety of per-oral endoscopic myotomy in non-achalasia esophageal motility disorders: a systematic review and meta-analysis.

Per­oral endoscopic myotomy (POEM) is the preferred endoscopic modality for managing achalasia cardia. However, there are no recommendations on the role of POEM in non­achalasia esophageal dysmotility disorders (NAEMD), including esophagogastric junction outflow obstruction (EGJOO), distal esophageal spasm (DES), and hypercontractile esophagus (HE). The present systematic review and meta-analysis aimed to assess the safety and efficacy of POEM in the treatment of NAEMD. MEDLINE, Embase, and Scopus were searched from inception to August 2023 for studies analyzing the outcome of POEM in NAEMD. Clinical success and adverse events were the main outcomes assessed. The event rates and their 95% confidence interval were calculated using a random effects model. A total of 11 studies with 271 patients were included in the final analysis. The pooled clinical success rate with POEM in NAEMD was 86.9% (82.9-90.9). On subgroup analysis, the pooled clinical success rates of POEM in DES and EGJOO were 97.8% (90.9-100.0) and 92.7% (86.3-95.1), which were significantly higher than in HE 81.2% (73.5-88.8). Data from limited studies showed that the pooled rate of improvement in dysphagia and chest pain was 88.5% (83.0-93.9) and 87.4% (80.5-94.4). The pooled incidence of overall AEs and serious AEs was 12.6% (5.7-19.5) and 0.3% (0.0-1.9), respectively. On follow-up, the pooled incidence of new-onset heartburn was 18.7% (11.1-26.2). POEM is a safe and efficacious treatment modality for the management of NAEMD with a lower clinical success in patients with HE. Further large-scale studies are required to validate the findings of the present analysis.

Per-oral endoscopic myotomy in cases with prior Heller's myotomy: Outcomes at a median follow-up of 5 years.

BACKGROUND AND AIM: Per-oral endoscopic myotomy (POEM) is an established treatment for achalasia cardia. However, data on the long-term efficacy of POEM in patients with failed Heller's myotomy (HM) are limited. The purpose of this study was to evaluate the long-term outcomes of POEM in patients with persistent or recurrent symptoms following HM. METHODS: Data of patients with recurrence of symptoms after HM who underwent POEM (September 2013 to December 2022) were analyzed, retrospectively. Primary outcome was clinical success [Eckardt score (ES) ≤ 3]. Secondary outcomes included improvement of manometry parameters, barium emptying at 5 min and gastroesophageal reflux (esophagitis and increased esophageal acid exposure) after POEM. RESULTS: Seventy-two cases (45.9 ± 13.4 years, 43 men) with history of HM were included in the study. The subtypes of achalasia were type 1 (40.3%), type 2 (37.5%), and unknown (19.4%). Prior treatment included HM in 48 (66.7%), HM plus pneumatic dilatation in 20 (27.8%), and HM plus pneumatic dilatation and Botox in 4 (5.5%). Technical success was achieved in all cases. Mean length of myotomy was 10.7 ± 3.3 cm, and mean procedure duration was 59.2 ± 25.9 min. There was significant improvement in ES (pre-POEM 6.5 ± 1.8 vs post-POEM 0.7 ± 0.7), lower esophageal sphincter pressure pressures (31.7 ± 12.5 vs 13.3 ± 5.7 mmHg) and barium emptying (14.2 ± 4.2 vs 2.4 ± 3.1 cm) after POEM. At a median follow-up of 63 months (IQR 40-95), clinical success (ES ≤ 3) was documented in 58 (80.6%) patients. Reflux esophagitis and increased esophageal acid exposure were recorded in 28 of 49 (57.1%) and 11 of 20 (55%) patients, respectively. CONCLUSION: POEM is a durable treatment modality in cases with relapse of symptoms after HM.

Efficacy and safety of gastric per-oral endoscopic myotomy (GPOEM) in lung transplant patients with refractory gastroparesis: a systematic review and meta-analysis.

BACKGROUND: Post-lung transplant gastroparesis is a frequent debilitating complication of lung transplant recipients, as it can increase the risk for gastro-esophageal reflux disease and subsequent graft dysfunction. We performed a systematic review and meta-analysis to evaluate the efficacy and safety of GPOEM in lung transplant patients with refractory gastroparesis. METHODS: The present systematic review and meta-analysis wer performed according to the Preferred Reporting Items for Systematic reviews and Meta-Analyses guidelines. We selected studies that analyzed the gastroparesis cardinal symptom index (GCSI) before and after the procedure to verify the efficacy of GPOEM. Random-effects model was used and the analysis was performed with STATA 17. RESULTS: Four observational studies (one conference abstract) with 104 patients were included in the meta-analysis. Prior treatments for gastroparesis included prokinetic agents and botulinum toxin in 78% (78/104) and 66.7% (66/99), respectively. Pooled estimate for clinical efficacy of GPOEM was 83% (95% CI 76%-90%). The pooled mean reduction in GCSI following the procedure was - 2.01 (- 2.35, - 1.65, p = 0.014). Three studies reported statistically significant improvement of gastro-esophageal retention or emptying in the post-GPOEM period. 30-day post-operative complications included minor or major bleeding (11.6%), severe reflux (1.2%), and pyloric stenosis (1.2%) requiring re-intervention. 90-day all-cause mortality was 2.6% with one patient dying from severe allograft rejection. CONCLUSION: Our study showed that GPOEM is an effective and safe strategy for lung transplant patients with refractory gastroparesis and should be considered as a therapeutic strategy in this population. Larger multicenter trials are needed in the future to further evaluate the effect of GPOEM on allograft function and rates of rejection.

Intraoperative distensibility measurement in POEM for achalasia: impact on patient outcome and associations with other outcome variables at 1-year follow-up.

BACKGROUND AND AIMS: The functional luminal imaging probe (FLIP) can provide measurements of lower esophageal sphincter (LES) distensibility. Studies report that use of intraoperative FLIP examination during peroral endoscopic myotomy (POEM) for achalasia is associated with treatment success, but evidence is limited and inconsistent. The main aim of the present study was to assess associations between intraoperative FLIP values and 1-year outcomes. Additionally, associations between 1-year FLIP measurements and other 1-year outcome variables were studied. METHODS: We performed a single-center prospective study of consecutive achalasia patients treated with POEM with a standardized 1-year follow-up. The inclusion period was from June 2017 to January 2020. We compared 1-year outcomes (FLIP measurement values, Eckardt score (ES), reflux esophagitis, timed barium esophagogram (TBE), and lower esophageal sphincter resting pressure (LES-rp)) in patients with and without intraoperative FLIP examination. We also assessed associations between intraoperative FLIP values, 1-year FLIP values, and other 1-year outcomes. Results are given as median (IQR), and non-parametrical statistical analyses were applied. RESULTS: Sixty-two patients (27 females) with median age 45 years (35-54) were included. Baseline characteristics were similar in patients with (n = 32) and without (n = 30) intraoperative FLIP examination. In patients with intraoperative FLIP, ES was 2 (1-3) and LES distensibility index (DI) 3.7 (2.6-5.4) after 1 year, compared with ES 2 (1-3) and DI 4.0 (3.1-6.8)) in patients without intraoperative FLIP (ns). Intraoperative DI was not correlated with 1-year ES or DI. One-year DI correlated significantly with 1-year ES (rs - 0.42), TBE (rs - 0.34), and LES-rp (rs - 0.29). CONCLUSIONS: Use of intraoperative FLIP measurements in POEM for achalasia is not associated with improved 1-year outcome, and the clinical value of intraoperative FLIP in POEM for achalasia is questioned. Follow-up FLIP measurements are moderately associated with symptomatic outcome, and may serve as an additional diagnostic modality in post-treatment evaluation.

Endoscopic findings do not predict per-oral pyloromyotomy (POP) response.

INTRODUCTION: Gastroparesis is a life-altering diagnosis caused by the stomach's inability to function in the absence of a mechanical obstruction. The primary causes are idiopathic, diabetic, and postoperative. Our first-line treatment for medical refractory gastroparesis is the endoscopic per-oral pyloromyotomy (POP) procedure. Predicting clinical response cost effectively remains elusive. METHODS: All patients who underwent a POP procedure at our institution by a single surgical endoscopist from January 1, 2019 to June 30, 2020 were retrospectively reviewed. All endoscopic data were prospectively collected. The patients were followed by a survey including the Gastroparesis Cardinal Symptom Index (GCSI) and other relevant postoperative measures. The primary endpoint was clinical response defined as ≥ 1.0 decrease in the GCSI from preoperative to the time of survey. Secondary outcome was normalization of the gastric emptying study (GES). RESULTS: Our patient population is 85% female and has an average age of 44.8 years. The diagnosis of gastroparesis is 71% iatrogenic, 19% postoperative, and 10% diabetic. On endoscopy, 30% had bile in the stomach and 65% had any degree of pylorospasm. The primary outcome measure of clinical response was 39% at an average of 697 ± 151 days post-POP, but 66% of patients attested to an improvement in their symptoms. Of 68 postoperative gastric emptying studies 50% normalized at an average of 145 ± 98 days. Following univariate and multivariate analyses of preoperative data and endoscopic findings, there were no significant predictors of clinical response. A preoperative GCSI ≥ 2.6 trends toward significance (OR 6.87, p = 0.058). CONCLUSION: Endoscopic findings at the time of POP do not correlate with clinical response. The GCSI model currently used to measure clinical response may not accurately capture the full clinical picture. The long-term durability of endoscopic myotomy to treat medical refractory gastroparesis needs to be studied further to improve patient selection.

Clinical and financial outcomes of per-oral endoscopic myotomy compared to laparoscopic heller myotomy for treatment of achalasia.

BACKGROUND: Previous studies analyzing short-term outcomes for per-oral endoscopic myotomy (POEM) have shown excellent clinical response rates and shorter operative times compared to laparoscopic Heller myotomy (LHM). Despite this, many payors have been slow to recognize POEM as a valid treatment option. Furthermore, comparative studies analyzing long-term outcomes are limited. This study compares perioperative and long-term outcomes, cost-effectiveness, and reimbursement for POEM and LHM at a single institution. METHODS: Adult patients who underwent POEM or LHM between 2014 and 2021 and had complete preoperative data with at least one complete follow up, were retrospectively analyzed. Demographic data, success rate, operative time, myotomy length, length of stay, pre- and postoperative symptom scores, anti-reflux medication use, cost and reimbursement were compared. RESULTS: 58 patients met inclusion with 25 undergoing LHM and 33 undergoing POEM. There were no significant differences in preoperative characteristics. Treatment success (Eckardt ≤ 3) for POEM and LHM was achieved by 88% and 76% of patients, respectively (p = 0.302). POEM patients had a shorter median operative time (106 min. vs. 145 min., p = 0.003) and longer median myotomy length (11 cm vs. 8 cm, p < 0.001). All LHM patients had a length of stay (LOS) ≥ 1 day vs. 51.5% for POEM patients (p < 0.001). Both groups showed improvements in dysphagia, heartburn, regurgitation, Eckardt score, GERD HRQL, RSI, and anti-reflux medication use. The improvement in dysphagia score was greater in patients undergoing POEM (2.30 vs 1.12, p = 0.003). Median hospital reimbursement was dramatically less for POEM ($3,658 vs. $14,152, p = 0.002), despite median hospital costs being significantly lower compared to LHM ($2,420 vs. $3,132, p = 0.029). RESULTS: POEM is associated with a shorter operative time and LOS, longer myotomy length, and greater resolution of dysphagia compared to LHM. POEM costs are significantly less than LHM but is poorly reimbursed.

Probability of additional intervention and long-term follow-up of esophagomyotomy.

INTRODUCTION: Two common surgical procedures used to treat esophageal motility disorders are laparoscopic Heller myotomy (LHM) with partial fundoplication and per-oral endoscopic myotomy (POEM). The difference in frequency of follow-up interventions following these procedures is unknown. This study was designed to report differences in post-surgical interventions as one of the major long-term follow-up expectations. METHODS: An IRB approved registry was used to identify all patients undergoing surgery with LHM or POEM. Following surgery, patients requiring additional interventions with esophageal non-pneumatic dilation, botox injection, or repeat myotomy, as well as persistent proton pump inhibitor (PPI) use were recorded. Multivariable logistic regression analysis was performed to estimate risk factors associated with return for additional post-operative intervention. RESULTS: A total of 203 patients were identified, 139 met inclusion criteria (33 LHM and 106 POEM). There was a higher rate of non-pneumatic EGD dilation (33% vs 15%, p = 0.04), repeat myotomy (18% vs 2%, p < 0.01), and higher rate of overall post-operative intervention in LHM than POEM. With POEM, there was a higher rate of post-operative PPI use (63 vs 29%, p < 0.01). There was no difference in time to post-operative intervention for either group, but if intervention were to occur the median time was within the first year. Patients with a change in pre- to post-operative Eckardt score of 4 or greater decreased their chance of having a post-operative intervention. CONCLUSION: Our results for both LHM and POEM emphasize the importance of long-term follow-up in patients with an esophageal motility disorder. We have found that patients undergoing LHM are more likely to have a post-operative intervention as well as a higher rate of repeat myotomy than POEM. With both interventions, a greater change in Eckardt score decreased the likelihood of reintervention.

Gastric per-oral endoscopic myotomy versus pyloric injection of botulinum toxin for the treatment of gastroparesis: our institutional experience and a systematic review of the literature.

INTRODUCTION: Gastric Per-Oral Endoscopic Myotomy (GPOEM) has been developed as an effective treatment option for patients with medically refractory gastroparesis. Other endoscopic options, such as pyloric injection of botulinum toxin (Botox), is often performed with limited efficacy. The purpose of this study was to evaluate GPOEM for the treatment of gastroparesis and compare its efficacy to Botox injection results reported in the literature. METHODS: A retrospective review was conducted to identify all patients who underwent a GPOEM for the treatment of gastroparesis between September 2018 and June 2022. Changes in Gastric Emptying Scintigraphy (GES) studies and Gastroparesis Cardinal Symptom (GCSI) scores from the preoperative to postoperative period were analyzed. In addition, a systematic review was conducted to identify all publications reporting the outcomes of Botox injections for the treatment of gastroparesis. RESULTS: A total of 65 patients (51 female, 14 male) underwent a GPOEM during the study period. Twenty-eight patients (22 female, 6 male) had both preoperative and postoperative GES studies in addition to GCSI scores. The etiologies of gastroparesis were diabetic (n = 4), idiopathic (n = 18), and postsurgical (n = 6). Fifty percent of these patients had undergone previous failed interventions including Botox injections (n = 6), gastric stimulator placement (n = 2), and endoscopic pyloric dilation (n = 6). Outcomes showed a significant decrease in GES percentages (mean difference = - 23.5%, p < 0.001) and GCSI scores (mean difference = - 9.6, p = 0.02) postoperatively. In the systematic review for Botox, transient mean improvements in postoperative GES percentages and GCSI scores were reported at 10.1% and 4.0, respectively. CONCLUSION: GPOEM leads to significant improvement in GES percentages and GCSI scores postoperatively and is superior to Botox injection results reported in the literature.

Symptom duration is not associated with per oral endoscopic myotomy (POEM) failure.

INTRODUCTION: Per oral endoscopic myotomy (POEM) is a relatively novel technique to address achalasia; however, little is known about the efficacy of POEM for patients with long-standing achalasia. We hypothesize that patients with long-standing achalasia prior to intervention will be more recalcitrant to POEM than patients with symptoms for a short duration. METHODS: We performed a retrospective analysis of patients with achalasia who received a POEM at a single institution from 2012 to 2022. Patients were grouped into cohorts based on the time of symptom duration: < 1 year, 1-3 years, 4-10 years, > 10 years. POEM failure was defined as need for repeat intervention, symptom recurrence, and a high postoperative Eckart score. Demographic and clinical data were compared between cohorts. Measures of failure multivariable logistic regression analyzed the association between symptom duration and response to POEM. RESULTS: During the study period, 132 patients met inclusion criteria. Patient age at surgery, sex, BMI, Charleston-Deyo Comorbidity Index, and patients with diabetes with and without end organ complications, connective tissue diseases, and patients with ulcer diseases did not differ among cohorts. Patients who have had symptoms for greater than 10 years had significantly more endoscopic interventions prior to their POEM (30% vs, 60% p = 0.002). Patients in all cohorts experienced the same number of symptoms post-POEM. Manometric measurements did not vary across cohorts after POEM. Symptom recurrence, need for repeat endoscopic intervention, repeat surgical intervention, or repeat POEM also did not vary across cohorts. Having symptoms of achalasia > 10 years did not increase the odds POEM failure on multivariable logistical regression. CONCLUSIONS: These data suggest that longer symptom duration is not associated with increased rates of POEM failure. This is promising as clinicians should not exclude patients for POEM eligibility based on duration of symptoms alone.

Preoperative manometric data can predict symptom improvement after per oral endoscopic myotomy for treatment of achalasia.

BACKGROUND: While per oral endoscopic myotomy (POEM) has been shown to be efficacious in the treatment of achalasia, it can be difficult to predict who will have a robust and durable response. Historically, high lower esophageal sphincter pressures have been shown to predict a worse response to endoscopic therapies such as botox therapy. This study was designed to evaluate if modern preoperative manometric data could predict a response to therapy after POEM. METHODS: This was a retrospective study of 144 patients who underwent a POEM at a single institution by a single surgeon over an 8-year period (2014-2022) who had high-resolution manometry performed preoperatively and had an Eckardt symptom score performed both preoperatively and postoperatively. The achalasia type and integrated relaxation pressures (IRP) were then tested for potential correlation with need for any further achalasia interventions postoperatively as well as the degree of Eckardt score reduction using univariate analysis. RESULTS: The achalasia type on preoperatively manometry was not predictive of need for further interventions or degree of Eckardt score reduction (p = 0.74 and 0.44, respectively). A higher IRP was not predictive of need for further interventions however it was predictive of a greater reduction in postoperative Eckardt scores (p = 0.03) as shown by a nonzero regression slope. CONCLUSION: In this study, achalasia type was not a predictive factor in need for further interventions or degree of symptom relief. While IRP was not predictive of need for further interventions, a higher IRP did predict better symptomatic relief postoperatively. This result is opposite that of other endoscopic treatment modalities. Therefore, patients with higher IRP on high-resolution manometry would likely benefit from myotomy which provides significant symptomatic relief postoperatively.

Preoperative patient factors and anatomy do not predict who will develop reflux after per oral endoscopic myotomy.

BACKGROUND: Per oral endoscopic myotomy (POEM) has been shown to be an efficacious and safe therapy for the treatment of achalasia. Compared to laparoscopic Heller myotomy however, no antireflux procedure is routinely combined with POEM and therefore the development of symptomatic or silent reflux is of concern. This study was designed to determine if various patient factors and anatomy would predict the development of gastroesophageal reflux disease post-operatively. METHODS: This was a retrospective cohort study of all patients who underwent a POEM at a single institution by a single surgeon over an eight-year period (2014-2022). It has been our practice to obtain a postoperative ambulatory pH test on all patients 6 months after POEM off all acid reducing medications. Patients without a postoperative ambulatory esophageal pH monitoring test were excluded. Age, sex, obesity (BMI > 30), achalasia type, presence of a hiatal hernia, history of prior endoscopic achalasia treatments or myotomy were analyzed using univariate analysis as predictive factors for the development of postoperative GERD (DeMeester score > 14.7 on ambulatory pH monitoring). RESULTS: There were 179 total patients included in the study with 42 patients (23.5%) having undergone postoperative ambulatory pH testing. The majority of patients (137 or 76.5%) were lost to follow up and did not undergo ambulatory pH testing. Twenty-three out of those 42 patients (55%) had evidence of GERD on ambulatory pH testing. Multiple preoperative patient characteristics including demographics, manometric results, EGD findings, and history of prior achalasia interventions did not correlate with the development of post-operative GERD. CONCLUSIONS: Despite the high rate of reflux after POEM, there does not appear to be any reliable preoperative indicators of which patients have a higher risk of developing post-operative GERD after POEM.