POEM: clinical outcomes beyond 5 years.

BACKGROUND: The short-term success of peroral endoscopic myotomy (POEM) is well documented but the durability of the operation is questioned. The aim of this study was to evaluate the clinical outcomes of the POEM procedure for esophageal motility disorders in a large cohort in which all patients had at least 5 years of follow-up. METHODS: All patients from a single center who underwent a POEM between October 2010 and September 2014 were followed for long-term clinical outcomes. Postoperative Eckardt symptom scores of short term and ≥ 5 years were collected through phone interview. Clinical success was defined as an Eckardt score < 3. Overall success was defined as Eckardt score < 3 and freedom from additional interventions. RESULTS: Of 138 patients, 100 patients were available for follow-up (mean age 56, 52% male). The indication for operation was achalasia in 94. The mean follow-up duration was 75 months (range: 60-106 months). Dysphagia was improved in 91% of patients. Long-term overall success was achieved in 79% of patients (80% of achalasia patients, 67% of DES patients). Preoperative mean Eckardt score was 6. At 6 months, it was 1, and at 75 months, it was 2 (p = 0.204). Five-year freedom from intervention was 96%. Overall, 7 patients had additional treatments: 1 balloon dilation (35 mm), 4 laparoscopic Heller myotomy, and 2 redo POEM at a mean of 51 months post-POEM. Ninety-three percent expressed complete satisfaction with POEM. CONCLUSION: A multitude of studies has shown the early benefits of POEM. Here, we show that nearly 80% of patients report clinical success with no significant decrement in symptom scores between their short- and long-term follow-up. Clearly POEM is an effective option for achalasia with durable long-term treatment efficacy.

Safety and efficacy of magnetic sphincter augmentation dilation.

BACKGROUND: The magnetic sphincter augmentation device (MSA) provides effective relief of gastroesophageal reflux symptoms. Dysphagia after MSA implantation sometimes prompts endoscopic dilation. The manufacturer's instructions are that it be performed 6 or more weeks after implantation under fluoroscopic guidance to not more than 15 mm keeping 3 or more beads closed. The purpose of this study was to assess adherence to these recommendations and explore the techniques used and outcomes after MSA dilation. METHODS AND PROCEDURES: We conducted a multicenter retrospective review of patients undergoing dilation for dysphagia after MSA placement from 2012 to 2018. RESULTS: A total of 144 patients underwent 245 dilations. The median size of MSA placed was 14 beads (range 12-17) and the median time to dilation was 175 days. A second dilation was performed in 67 patients, 22 patients had a third dilation and 7 patients underwent 4 or more dilations. In total, 17 devices (11.8%) were eventually explanted. The majority of dilations were performed with a balloon dilator (81%). The median dilator size was 18 mm and 73.4% were done with a dilator larger than 15 mm. There was no association between dilator size and need for subsequent dilation. Fluoroscopy was used in 28% of cases. There were no perforations or device erosions related to dilation. DISCUSSION: There is no clinical credence to the manufacturer's recommendation for the use of fluoroscopy and limitation to 15 mm when dilating a patient for dysphagia after MSA implantation. Use of a larger size dilator was not associated with perforation or device erosion, but also did not reduce the need for repeat dilation. Given this, we would recommend that the initial dilation for any size MSA device be done using a 15 mm through-the-scope balloon dilator. Dysphagia prompting dilation after MSA implantation is associated with nearly a 12% risk of device explantation.

Endoscopic resection of giant fibrovascular esophageal polyps.

BACKGROUND: Giant fibrovascular esophageal polyps are rare benign intraluminal tumors that originate from the submucosa of the cervical esophagus [Owens et al. (JAMA 103: 838-842, 1994), Totten et al. (JAMA 25:606-622, 1953)]. Due to their indolent course, these tumors tend to reach enormous proportions before patients develop symptoms. Accurately diagnosing these tumors is difficult, as endoscopy may miss 25% of these lesions because these polyps exhibit normal intact esophageal mucosa [Levine et al. (JAMA 166: 781-787, 1996)]. METHODS: Surgical resection has been the treatment of choice. We present a video that illustrates the feasibility of an endoscopic approach. TECHNIQUE/CASE: A 62-year-old man presented to our clinic with a pedunculated esophageal mass. During this time, he developed progressive dysphagia to solid foods. A complete workup confirmed the presence of a giant polyp and endoscopic resection under general anesthesia was planned. Using an endoscopic snare-technique, a 16 cm × 3 cm polyp was amputated and retracted out of the oropharynx. Upon repeat endoscopy a second 7 cm × 3 cm polyp was discovered originating proximal to the larger polyp. Again, removal of this polyp was attempted using a snare-technique. Following amputation of the polyp, a broad-based component of the polyp remained. Given its proximal location in the esophagus, we were able to use a snare to pull the broad base of the remaining polyp into the oropharynx and remove it at its origin. Postoperative endoscopy and endoscopic ultrasound confirmed that the polyps were completely removed and the muscular resection bed was hemostatic. Clinically, the patient's symptoms resolved and he encountered no adverse sequela as a result of the operation. CONCLUSION: Giant fibrovascular esophageal polyps are rare benign intraluminal tumors that can lead to obstructive symptoms. Surgical resection is the treatment of choice, and may be possible with an endoscopic approach. An endoscopic snare technique can be used to resect these lesions while minimizing patient morbidity.

Clinical outcomes five years after POEM for treatment of primary esophageal motility disorders.

BACKGROUND: Peroral endoscopic myotomy (POEM) is a novel operation for the treatment of achalasia and other esophageal motility disorders. While POEM has shown excellent short-term safety and efficacy, the long-term symptomatic outcomes after the procedure are unknown. METHODS: Patients from a single center that underwent POEM for treatment of esophageal motility orders and were greater than 5 years removed from their operation were studied. Patients were contacted to assess current symptoms and encouraged to undergo repeat endoscopy for objective follow-up. RESULTS: Thirty-six patients underwent POEM from October, 2010 to February, 2012 and current symptom scores were obtained from 29 patients at median 65-month follow-up. In the 23 patients with achalasia, Eckardt scores were significantly improved from preoperative baseline (mean current 1.7 vs. preoperative 6.4, p < 0.001). Nineteen patients (83%) with achalasia had a symptomatic success (Eckardt ≤3) and none required retreatment for symptoms. Eckardt scores were dramatically improved at 6 months and maintained at 2 years; however, there was a small but significant worsening of symptoms between 2 and 5-years. Of the five patients with EGJ outflow obstruction, all had current Eckardt scores ≤3 but two needed reintervention for persistent or recurrent symptoms, one with a laparoscopic Heller myotomy and another with an endoscopic cricomyotomy and proximal esophageal myotomy extension. At 6-month follow-up, repeat manometry showed decreased EGJ relaxation pressures and esophagram demonstrated improved emptying. 24-h pH monitoring showed abnormal distal esophageal acid exposure in 38% of patients. Fifteen patients underwent endoscopy at 5-years, revealing erosive esophagitis in two (13%), new hiatal hernia in two, and new non-dysplastic Barrett's esophagus in one. The patient with Barrett's underwent a subsequent laparoscopic hiatal hernia repair and Toupet fundoplication. CONCLUSIONS: POEM resulted in a successful palliation of symptoms in the majority of patients after 5 years, though these results emphasize the importance of long-term follow-up in all patients.

Clinical response to peroral endoscopic myotomy in patients with idiopathic achalasia at a minimum follow-up of 2†years.

BACKGROUND: The recently developed technique for peroral endoscopic myotomy (POEM) has been shown to be effective in several short-term studies. Longer term outcome data are largely non-existent. OBJECTIVE: To systematically report clinical outcome with a minimum post-POEM follow-up of 2 years. DESIGN: All patients treated consecutively by POEM for achalasia at three centres were retrospectively analysed, with a minimum follow-up of 2 years. The main outcome was the rate of POEM failures (Eckardt score >3) related to follow-up time. RESULTS: Of 85 patients treated, five (5.9%) cases were excluded due to protocol violation or loss to follow-up; the remaining 80 patients (mean age 44.9 years, 54% men) were followed clinically for 29 months (range 24-41). Initial clinical response was observed in 77 cases (96.3%). Clinical recurrences (later failures) were seen in a further 14 cases (17.7%), accounting for a total failure rate of 21.5%. In a multivariate analysis, age and endoscopic reflux signs were independent predictors of treatment success. Of the 17 failures, eight were among the first 10 cases treated in the participating centres. Reflux-associated sequelae included one case of a severe reflux-associated stricture requiring dilatation, and two patients with minor transient Eckardt score elevations curable by proton pump inhibitor (PPI) treatment. Endoscopic signs of reflux oesophagitis, mostly Los Angeles grade A/B, were seen in 37.5% (37/72) at the 2-year control. CONCLUSIONS: In this multicentre retrospective analysis, a high initial success rate of POEM is followed by a mid-term recurrence rate of 18%. Reflux oesophagitis, albeit mild, is frequent and should probably be treated by regular low-dose PPI therapy. TRIAL REGISTRATION NUMBER: NCT 01405417 (UKE study).

Hill procedure for recurrent GERD post-Roux-en-Y gastric bypass.

BACKGROUND: Roux-en-Y gastric bypass (RYGB) is considered to be an optimal surgical treatment option for GERD in the morbidly obese patient. Nevertheless, a subgroup of patients suffer from recurrent or persistent GERD after their gastric bypass. Unfortunately, limited treatment options are available in these patients. Fundoplication via mobilization of the remnant stomach and radiofrequency treatment of the lower esophageal sphincter have been described with some success. Our objective is to illustrate a safe and durable surgical option in the treatment of patients with medically refractory GERD post-RYGB. METHODS: After placing five trocars in the usual position for a foregut laparoscopic surgery, a lysis of adhesions and standard dissection of the hiatus is performed. The anterior and posterior vagal nerves associated phrenoesophageal tissue bundles are identified. A primary crural repair with interrupted nonabsorbable sutures is performed. Four full-length nonabsorbable sutures are placed sequentially through the anterior and posterior phrenoesophageal bundle, posterior fundus and finally through the pre-aortic fascia. The repair is calibrated on a 44 French bougie. The sutures are tied from medial to lateral in the order of their placement under endoscopic guidance. RESULTS: No peri-procedural complications were encountered. Standard post-antireflux surgery clinical follow-up with the patient completing a validated GERD clinical questionnaire at 1 and 6 months after the surgery demonstrated excellent GERD symptom control without any dysphagia. A pH study and EGD performed at 6 months post-Hill procedure show the absence of pathological reflux with an intact Hill mechanism. CONCLUSION: The Hill procedure is a valid treatment for the post-bariatric surgical patient with GERD in which the gastric fundus is absent or inaccessible thus eliminating standard fundoplication as a reasonable option. This also represents a safe and durable treatment of GERD in this uniquely challenging patient population.

Endoscopic suturing versus endoscopic clip closure of the mucosotomy during a per-oral endoscopic myotomy (POEM): a case-control study.

INTRODUCTION: Obtaining an adequate mucosal closure is one of the crucial steps in per-oral endoscopic myotomy (POEM). Thus far, there have been no objective data comparing the various available closure techniques. This case-controlled study attempts to compare the application of endoscopic clips versus endoscopic suturing for mucosotomy closure during POEM cases. METHODS: A retrospective review of our prospective POEM database was performed. All cases in which endoscopic suturing was used to close the mucosotomy were matched to cases in which standard endoclips were used. Overall complication rate, closure time and mucosal closure costs between the two groups were compared. RESULTS: Both techniques offer good clinical results with good mucosal closure and the absence of postoperative leak. Closure time was significantly shorter (p = 0.044) with endoscopic clips (16 ± 12 min) when compared to endoscopic suturing (33 ± 11 min). Overall, the total closure cost analysis showed a trend toward lower cost with clips (1502 ± 849 USD) versus endoscopic suturing (2521 ± 575 USD) without reaching statistical significance (p = 0.073). CONCLUSION: The use of endoscopic suturing seems to be a safe method for mucosal closure in POEM cases. Closure time is longer with suturing than conventional closure with clips, and there is a trend toward higher overall cost. Endoscopic suturing is likely most cost-effective for difficult cases where conventional closure methods fail.

Trans-oral cricomyotomy using a flexible endoscope: technique and clinical outcomes.

INTRODUCTION: Zenker's diverticulum (ZD) is a rare upper esophageal pathology that is most prevalent in the sixth and seventh decade. Three different therapeutical options are available: (1) open trans-cervical approach, (2) rigid endoscopy and (3) flexible endoscopy. Our hypothesis is that a flexible endoscopic cricomyotomy represents a safe and effective treatment of ZD as well as cricopharyngeal spasm. METHODS: A retrospective analysis of all patients that underwent a flexible endoscopic cricomyotomy at our institution between October 2008 and May 2014 was performed. Preoperative and postoperative (1 month and long-term follow-up) symptom scores and clinical outcomes were collected. Briefly, the ZD is carefully identified endoscopically and the common wall is divided using needle knife cautery with the help of an endoscopic cap. Clips are used to close the mucosal defect starting with the apex. RESULTS: Twenty-six patients underwent a flexible endoscopic myotomy for a ZD. Of 26 patients, five (19.2 %) had a history of previous open or stapled trans-oral myotomy and four (15.4 %) underwent a concomitant foregut procedure. Mean length of stay was 1.5 days (range 1-11). Mean operative time was 68 min (range 28-149). One patient presented with a postoperative leak, and one patient presented with a retained clip. Both were treated endoscopically. Recurrent weekly dysphagia was present in 3/26 (11.5 %). One patient (3.8 %) underwent an endoscopic bougie dilatation postoperatively. With regard to clinical outcomes, there was a statistically significant improvement in both short-term (1 month) and long-term (median follow-up 21.8 months; range 1-68.2 months) dysphagia (p < 0.001; p < 0.001), regurgitation (p = 0.001; p = 0.017), cough (p = 0.006; p = 0.025) and aspiration (p = 0.013; p = 0.013). CONCLUSION: Flexible endoscopic cricomyotomy offers durable relief of dysphagia, regurgitation, cough and aspiration in ZD patients. It appears to have a good safety profile with symptomatic recurrence occurring in up to 11.5 % of cases.

Early human experience with per-oral endoscopic pyloromyotomy (POP).

INTRODUCTION: Gastroparesis is a condition characterized by delayed gastric emptying, and a constellation of symptoms, including nausea, vomiting, early satiety, and bloating. Although current surgical options such as pyloroplasty have been shown to be effective, an endoscopic submucosal myotomy technique may be applied to divide the pyloric sphincter without surgical access. Such endoscopic technique may provide the benefits of a natural orifice procedure, and improve gastric emptying in gastroparetic patients. METHODS AND PROCEDURES: Per-oral pyloromyotomy (POP) was performed in seven female patients aged 33-65 years (mean 51 years). All patients had a pre-operative work-up that included upper endoscopy, and a gastric emptying study. A pH study, and esophageal manometry were also performed when a concomitant fundoplication was considered. RESULTS: POP was technically successful in all seven cases. There were no immediate procedural complications. Perioperative, complications included: one patient with an upper GI bleed 2 weeks post-procedure, necessitating transfusions, and endoscopic clipping of a pyloric channel ulcer; one patient who experienced difficulty swallowing post operatively, delaying discharge by 1 day; and one patient who developed a hospital-acquired pneumonia, delaying discharge by several days. Six of the seven patients experienced significant symptomatic improvement following the procedure. Three month follow-up nuclear medicine solid-phase gastric emptying studies are currently available for 5 of the 7 patients. Normal gastric emptying at 4 h was noted in four of five patients (80 %). One patient did not respond to endoscopic management subsequently underwent an uneventful laparoscopic pyloroplasty, which also failed to significantly improve her symptoms. CONCLUSION: POP is a technically safe and feasible endoscopic procedure. Early follow-up suggests promising symptomatic improvement as well as objective improvement in gastric emptying. Additional clinical experience is required to establish the role of this technique in the management of gastroparesis.

A comparative study on comprehensive, objective outcomes of laparoscopic Heller myotomy with per-oral endoscopic myotomy (POEM) for achalasia.

OBJECTIVE: To compare symptomatic and objective outcomes between HM and POEM. BACKGROUND: The surgical gold standard for achalasia is laparoscopic Heller myotomy (HM) and partial fundoplication. Per-oral endoscopic myotomy (POEM) is a less invasive flexible endoscopic alternative. We compare their safety and efficacy. METHODS: Data on consecutive HMs and POEMs for achalasia from 2007 to 2012 were collected. PRIMARY OUTCOMES: swallowing function-1 and 6 months after surgery. SECONDARY OUTCOMES: operative time, complications, postoperative gastro-esophageal reflux disease (GERD). RESULTS: There were 101 patients: 64 HMs (42% Toupet and 58% Dor fundoplications) and 37 POEMs. Presenting symptoms were comparable. Median operative time (149 vs 120 min, P < 0.001) and mean hospitalization (2.2 vs 1.1 days, P < 0.0001) were significantly higher for HMs. Postoperative morbidity was comparable. One-month Eckardt scores were significantly better for POEMs (1.8 vs 0.8, P < 0.0001). At 6 months, both groups had sustained similar improvements in their Eckardt scores (1.7 vs 1.2, P = 0.1).Both groups had significant improvements in postmyotomy lower esophageal sphincter profiles. Postmyotomy resting pressures were higher for POEMs than for HMs (16 vs 7.1 mm Hg, P = 0.006). Postmyotomy relaxation pressures and distal esophageal contraction amplitudes were not significantly different between groups. Routine postoperative 24-hour pH testing was obtained in 48% Hellers and 76% POEMs. Postoperatively, 39% of POEMs and 32% of HM had abnormal acid exposure (P = 0.7). CONCLUSIONS: POEM is an endoscopic therapy for achalasia with a shorter hospitalization than HM. Patient symptoms and esophageal physiology are improved equally with both procedures. Postoperative esophageal acid exposure is the same for both. The POEM is comparable with laparoscopic HM for safe and effective treatment of achalasia.

Peroral endoscopic myotomy (POEM) for esophageal primary motility disorders: analysis of 100 consecutive patients.

INTRODUCTION: Peroral endoscopic myotomy (POEM) is a flexible endoscopic approach to the lower esophageal sphincter (LES) providing access for a myotomy to relieve dysphagia. The technique has been adopted worldwide due to reports of excellent short-term clinical outcomes. We report on a consecutive patient cohort with clinical and objective outcomes representing the establishment of a POEM program within a busy esophageal surgical practice. METHODS: Comprehensive data was collected prospectively on all patients undergoing POEM from October 2010 to November 2013 at a single institution. Patients were classified based on high-resolution manometry (HRM). Operative data and immediate outcomes were reviewed. Symptom scores, HRM, and timed barium swallow (TBS) were performed prior to the procedure. Patients were asked to undergo routine postoperative testing 6-12 months after surgery with the addition of standard 24-h pH to the preoperative protocol. Morbidity was defined as requiring additional procedures or prolonged hospital stay >2 days. RESULTS: One hundred POEM patients were included in the final analysis. The mean age was 58 years (18-83 years). Primary presenting symptoms included dysphagia 81, chest pain 10, and regurgitation 9. The mean follow-up was 16 months. HRM diagnoses were 75 achalasia (30 type I, 43 type II, 2 type III), 12 nutcracker esophagus, 5 diffuse esophageal spasm (DES), and 8 isolated hypertensive non-relaxing LES. The mean operative time was 128 min. The median hospital length of stay (LOS) was 1 day. The overall morbidity was 6%; all were treated endoscopically or with conservative management without further sequelae (three had intra-tunnel leak diagnosed on routine esophagram and one developed a postoperative intra-tunnel hemorrhage, one developed Ogilvie's, and one required prolonged intubation for CO2 retention). The average LES resting/residual pressure significantly decreased (44.3/22.2 to 19.6/11.7 in millimeters of mercury). Esophageal emptying improved from 40 to 90% on TBS with 93% patients demonstrating >90% emptying at 1 min. Of the achalasia patients, 36% (17/47) showed some return of normal peristalsis (≥70% peristalsis) on post-op HRM. Abnormal acid exposure was present on postoperative testing in 38% (26/68). Of these, 14 were asymptomatic. No reflux patient required additional antireflux procedure. Eckardt scores decreased from 6 to 1. Dysphagia was improved or eradicated in 97% with a complete resolution accomplished in 89%. Complete dysphagia relief was better for achalasia patients (46/47 patients; 97.8%) vs. non-achalasia patients (17/24; 70.8%). Of those with preoperative chest pain, 91.5% reported complete relief. Four patients have refractory dysphagia. Two non-achalasia patients underwent subsequent laparoscopic Heller myotomy and two are improved following serial endoscopic dilatations. CONCLUSION: This study represents the largest POEM series to date that includes objective data. Despite reflux in one/three of patients, POEM provides excellent relief of dysphagia (97%) and chest pain (91.5%) for patients with esophageal spastic disorders with acceptable procedural morbidity.

End of the road for a dysfunctional end organ: laparoscopic gastrectomy for refractory gastroparesis.

INTRODUCTION: Gastroparesis is a functional disorder resulting in debilitating nausea, esophageal reflux, and abdominal pain and is frequently refractory to medical treatment. Therapies such as pyloroplasty and neurostimulators can improve symptoms. When medical and surgical treatments fail, palliative gastrectomy is an option. We examined outcomes after gastrectomy for postoperative, diabetic, and idiopathic gastroparesis. METHODS: A prospective database was queried for gastrectomies performed for gastroparesis from 1999 to 2013. Primary outcomes were improvements in pre- versus postoperative symptoms at last follow-up, measured on a five-point scale. Secondary outcome was operative morbidity. RESULTS: Thirty-five patients underwent laparoscopic total or near-total gastrectomies for postoperative (43 %), diabetic (34 %), or idiopathic (23 %) gastroparesis. Antiemetics and prokinetics afforded minimal relief for one third of patients. There were no mortalities. Six patients suffered a leak, all treated with surgical reintervention. With a median follow-up of 6 months, nausea improved or resolved in 69 %. Chronic abdominal pain improved or resolved in 70 %. Belching and bloating resolved for 79 and 89 %, respectively (p < 0.01). CONCLUSIONS: Regardless of etiology, medically refractory gastroparesis can be a devastating disease. Near-total gastrectomy can ameliorate or relieve nausea, belching, and bloating. Chronic abdominal pain commonly resolved or improved with resection. Despite attendant morbidity, gastrectomy can effectively palliate symptoms of gastroparesis.