Management of patients after failed peroral endoscopic myotomy: a multicenter study.

BACKGROUND: Although peroral endoscopic myotomy (POEM) is highly effective for the management of achalasia, clinical failures may occur. The optimal management of patients who fail POEM is not well known. This study aimed to compare the outcomes of different management strategies in patients who had failed POEM. METHODS: This was an international multicenter retrospective study at 16 tertiary centers between January 2012 and November 2019. All patients who underwent POEM and experienced persistent or recurrent symptoms (Eckardt score > 3) were included. The primary outcome was to compare the rates of clinical success (Eckardt score ≤ 3) between different management strategies. RESULTS : 99 patients (50 men [50.5 %]; mean age 51.4 [standard deviation (SD) 16.2]) experienced clinical failure during the study period, with a mean (SD) Eckardt score of 5.4 (0.3). A total of 29 patients (32.2 %) were managed conservatively and 70 (71 %) underwent retreatment (repeat POEM 33 [33 %], pneumatic dilation 30 [30 %], and laparoscopic Heller myotomy (LHM) 7 [7.1 %]). During a median follow-up of 10 (interquartile range 3 - 20) months, clinical success was highest in patients who underwent repeat POEM (25 /33 [76 %]; mean [SD] Eckardt score 2.1 [2.1]), followed by pneumatic dilation (18/30 [60 %]; Eckardt score 2.8 [2.3]), and LHM (2/7 [29 %]; Eckardt score 4 [1.8]; P = 0.12). A total of 11 patients in the conservative group (37.9 %; mean Eckardt score 4 [1.8]) achieved clinical success. CONCLUSION : This study comprehensively assessed an international cohort of patients who underwent management of failed POEM. Repeat POEM and pneumatic dilation achieved acceptable clinical success, with excellent safety profiles.

EUS-guided 22-gauge fine needle biopsy versus single-incision with needle knife for the diagnosis of upper gastrointestinal subepithelial lesions: a randomized controlled trial.

Background and study aims EUS-FNA has suboptimal accuracy in diagnosing gastrointestinal subepithelial tumors (SETs). EUS-guided 22-gauge fine needle biopsy (EUS-FNB) and single-incision with needle knife (SINK) were proposed to increase accuracy of diagnosis. This study aimed to prospectively compare the diagnostic accuracy and safety of EUS-FNB with SINK in patients with upper gastrointestinal SETs. Patients and methods All adult patients referred for EUS evaluation of upper gastrointestinal SETs ≥ 15 mm in size were eligible for inclusion. Patients were randomized to undergo EUS-FNB or SINK. Lesions were sampled with a 22-gauge reverse beveled core needle in the EUS-FNB group and by a conventional needle-knife sphincterotome and biopsy forceps in the SINK group. Patients were blinded to the technique used. The primary outcome was diagnostic accuracy. Secondary outcomes included adverse events, histological yield and procedure duration. Study enrollment was terminated early due to poor recruitment. Results A total of 56 patients (31 male (55.37 %); mean age, 67.41 ±â€Š12.70 years) were randomized to either EUS-FNB (n = 26) or SINK (n = 30). Technical success was 96.15 % and 96.66 %, respectively. The majority of lesions were gastrointestinal stromal tumors (51.78 %). No significant difference was found between EUS-FNB and SINK in terms of diagnostic accuracy for a malignant or benign disease (76 % vs. 89.28 %, respectively; P  = 0.278). The rate of adverse events (none severe) was also comparable (7.69 % vs. 10 %, respectively; P =  1.0) including two abdominal pain episodes in the EUS-FNB group compared to two delayed bleeding (one requiring hospitalization and radiologic embolization) and 1 abdominal pain in the SINK group. Conclusion EUS-FNB and SINK are equally effective techniques for upper gastrointestinal SETs sampling. SINK can be associated with mild to moderate delayed bleeding.

Peroral endoscopic myotomy: anterior versus posterior approach: a randomized single-blinded clinical trial.

BACKGROUND AND AIMS: Peroral endoscopic myotomy (POEM) has become the mainstay for the treatment of achalasia at many institutions around the world since its inception in 2008. POEM can be performed using either the anterior or posterior approach. The primary aim of this study was to compare the efficacy of the anterior and posterior approaches at 1 year after POEM. METHODS: This is a single-blinded, randomized, noninferiority international clinical trial. Eligible participants were adult patients with a confirmed diagnosis of achalasia via high-resolution esophageal manometry. Patients were randomly allocated with a 1:1 ratio to receive POEM with anterior or posterior approach. The primary aim was to compare the rate of clinical success (Eckardt score <3) of anterior and posterior approaches at 1 year. RESULTS: One hundred fifty patients were randomized to receive either anterior (n = 73) or posterior (n = 77) POEM. One hundred forty-eight patients received the POEM treatment, and 138 patients completed the 1-year follow-up and were included in the primary efficacy analysis. Technical success was achieved in 71 patients (97.3%) in the anterior group versus 77 patients (100%) in the posterior group (P = .23). The median (interquartile range) length of hospital stay after the procedure was 2 (1-3) days for both groups. Adverse events occurred in 15 patients (10%), 8 patients (11%) in the anterior group and 7 patients (9%) in the posterior group (P = .703). Clinical success was achieved in 90% of patients in the anterior group and 89% of patients in the posterior group. Abnormal esophageal acid exposure was detected in 29 of 59 patients (49%) and 25 of 60 patients (42%) in the anterior and posterior groups, respectively (P = .67). GERD questionnaire scores were also not significantly different between the study groups. In both groups, quality of life improved after POEM for all 36-Item Short-Form Health Survey measures and was similar between both groups. CONCLUSIONS: Posterior myotomy during POEM was not inferior to anterior myotomy in terms of efficacy and safety in the treatment of patients with achalasia. (Clinical trial registration number: NCT02454335.).

Peroral endoscopic myotomy achieves similar clinical response but incurs lesser charges compared to robotic heller myotomy.

BACKGROUND/AIM: Several uncontrolled studies comparing peroral endoscopic myotomy (POEM) and Heller myotomy have demonstrated equivalent short-term efficacy and safety. However, no data exists rergarding the cost of POEM and how it compares to that of robotic Heller myotomy (RHM). The primary aim of this study was to compare the inpatient charges incurred in patients who underwent POEM or RHM for the treatment of achalasia. PATIENTS AND METHODS: A retrospective single center review was conducted among 52 consecutive POEM patients (2012-2014) and 52 consecutive RHM patients (2009-2014). All RHM procedures included a Toupet fundoplication and were performed via a transabdominal approach. All POEM procedures were performed by a gastroenterologist in the endoscopy unit. Clinical response was defined by improvement of symptoms and decrease in Eckardt stage to ≤I. All procedural and facility charges were obtained from review of the hospital finance records. RESULTS: There was no difference between POEM and RHM with regards to age, gender, symptom duration, achalasia subtype, manometry findings, or Eckardt symptom stage. There was no significant difference in the rate of adverse events (19.2% vs 9.6%, P = 0.26) or the length of stay (1.9 vs. 2.3, P = 0.18) between both groups. Clinical response rate of patients in the POEM groups was similar to that in the RHM group (94.3% vs. 88.5%, P = 0.48). POEM incurred significantly less total charges compared to LHM ($14481 vs. $17782, P = 0.02). CONCLUSIONS: POEM when performed in an endoscopy unit was similar in efficacy and safety to RHM. However, POEM was associated with significant cost savings ($3301/procedure).

Interventional EUS Using a Flexible 19-Gauge Needle: An International Multicenter Experience in 162 Patients.

BACKGROUND AND AIMS: To facilitate access for interventional EUS, flexible (nitinol) 19-G needles have been introduced to permit needle puncture even when the echoendoscope is in an angulated position, such as in the second part of the duodenum. The aims of the study were to evaluate the performance of a flexible 19-G needle during interventional EUS procedures and compare outcomes when the echoendoscope was in the straight versus angulated position. METHODS: A retrospective review was undertaken of 162 consecutive patients that underwent a variety of interventional EUS procedures with a flexible 19-G needle across five centers. Patients were subdivided into categories (straight or angulated) depending on the echoendoscope position used for obtaining access to the area of interest (Fig. 1). Fig. 1 Flexible 19-G needle design. a The needle is able to exit the sheath despite the rotated position. b The needle beveled needle tip RESULTS: In the entire cohort, needle-specific technical success was achieved in 93.2 %, procedural success in 85.2 %, and overall clinical success in 76.5 % of cases at a mean follow-up of 3.1 months. Needle-specific technical success was similar between the straight and angulated cohorts (94.0 vs. 91.2 %, p = 0.74). Procedural success (86.7 vs. 77.2 %, p = 0.05), and rate of clinical success was similar between the cohorts (83.3 vs. 86.4 %, p = 0.79), respectively. Overall adverse events were noted in 14.2 % of patients with no difference between the straight and angulated cohorts (p = 0.48). CONCLUSIONS: This study demonstrates equivalent technical success, clinical success and safety of using a flexible 19-G needle in straight and angulated endoscope positions for interventional EUS. Therefore, a flexible needle may be considered where an angulated echoendoscope position is encountered.

Prospective international multicenter study on endoscopic ultrasound-guided biliary drainage for patients with malignant distal biliary obstruction after failed endoscopic retrograde cholangiopancreatography.

BACKGROUND AND AIMS: Endoscopic ultrasound-guided biliary drainage (EUS-BD) has emerged as an alternative to traditional radiologic and surgical drainage procedures after failed endoscopic retrograde cholangiopancreatography (ERCP). However, prospective multicenter data are lacking. The aims of this study were to prospectively assess the short- and long-term efficacy and safety of EUS-BD in patients with malignant distal biliary obstruction. PATIENTS AND METHODS: Consecutive patients at 12 tertiary centers (5 US, 5 European, 1 Asian, 1 South American) with malignant distal biliary obstruction and failed ERCP underwent EUS-BD. Technical success was defined as successful stent placement in the desired position. Clinical success was defined as a reduction in bilirubin by 50 % at 2 weeks or to below 3 mg/dL at 4 weeks. Adverse events were prospectively tracked and graded according to the American Society for Gastrointestinal Endoscopy (ASGE) lexicon's severity grading system. Overall survival and duration of stent patency were calculated using Kaplan-Meier analysis. RESULTS: A total of 96 patients (mean age 66 years, female 45 %, pancreatic cancer 55 %) underwent EUS-BD. Stent placement (technical success) was achieved in 92 (95.8 %) patients (metallic stent 84, plastic stent 8). Mean procedure time was 40 minutes. Clinical success was achieved in 86 (89.5 %) patients. A total of 10 (10.5 %) adverse events occurred: pneumoperitoneum (n = 2), sheared wire (n = 1), bleeding (n = 1), bile leak (n = 3), cholangitis (n = 2), and unintentional perforation (n = 1); 4 graded as mild, 4 moderate, 1 severe, and 1 fatal (due to perforation). A total of 38 (44 %) patients died of disease progression during the study period. The median patient survival was 167 days (95 %CI 112 - 221) days. The 6-month stent patency rate was 95 % (95 %CI 94.94 - 95.06 %) and the 1-year stent patency was 86 % (95 %CI 85.74 - 86.26 %). CONCLUSION: This study on EUS-BD demonstrates excellent efficacy and safety of EUS-BD when performed by experts. STUDY REGISTRATION: NCT01889953.

Predictors of incomplete optical colonoscopy using computed tomographic colonography.

BACKGROUND/AIMS: Optical colonoscopy (OC) is the primary modality for investigation of colonic pathology. Although there is data on demographic factors for incomplete OC, paucity of data exists for anatomic variables that are associated with an incomplete OC. These anatomic variables can be visualized using computed tomographic colonography (CTC). We aim to retrospectively identify variables associated with incomplete OC using CTC and develop a scoring method to predict the outcome of OC. PATIENTS AND METHODS: In this case-control study, 70 cases ( with incomplete OC) and 70 controls (with complete OC) were identified. CTC images of cases and controls were independently reviewed by a single CTC radiologist. Demographic and anatomical parameters were recorded. Data was examined using descriptive linear statistics and multivariate logistic regression model. RESULTS: On analysis, female gender (80% vs 58.6% P = 0.007), prior abdominal/pelvic surgeries (51.4% vs 14.3% P < 0.001), colonic length (187.6 ± 30.0 cm vs 163.8 ± 27.2 cm P < 0.001), and number of flexures (11.4 ± 3.1 vs 8.4 ± 2.9 P < 0.001) increased the risk for incomplete OC. No significant association was observed for increasing age (P = 0.881) and history of severe diverticulosis (P = 0.867) with incomplete OC. A scoring system to predict the outcome of OC is proposed based on CTC findings. CONCLUSION: Female gender, prior surgery, and increasing colonic length and tortuosity were associated with incomplete OC, whereas increasing age and history of severe diverticulosis were not. These factors may be used in the future to predict those patients who are at risk of incomplete OC.

Impact of prior intracoronary stenting on late outcomes of coronary artery bypass surgery in diabetics with triple-vessel disease.

OBJECTIVE: Recent studies have indicated that coronary artery bypass grafting (CABG) outcomes in patients with prior stents are suboptimal. We aimed to study the impact of prior percutaneous coronary intervention (PCI) with stenting (PCI-S) on late CABG mortality in diabetic patients with triple-vessel disease. METHODS: We reviewed the primary nonemergency CABG experience from a single U.S. institution (n = 7005; 1996-2007, Toledo, Ohio). Diabetics with triple-vessel disease (n = 1583) were identified and divided into 2 groups: (1) prior PCI-S (n = 202); and (2) no prior PCI (No-PCI [n = 1381]). Hierarchic Cox proportional hazards models were used to assess the effect of prior PCI-S on 5-year mortality after CABG. A propensity score for PCI-S and No-PCI patients was derived using a nonparsimonious logistic regression and used to generate a 1:1 (PCI-S to No-PCI) matched cohort. RESULTS: In model 1, after adjusting for preoperative clinical characteristics, medications, off-pump surgery, and isolated CABG surgery status, prior PCI-S was associated with a 39% increased risk of mortality (hazard ratio [HR] = 1.39, with 95% confidence interval [CI; 1.02, 1.90]; P = .04). Further adjustment for date of surgery (model 2) (HR = 1.39, with 95% CI [1.02, 1.91]; P = .04) or operative parameters (model 3) (HR = 1.38, with 95% CI [1.01, 1.88]; P = .046) did not alter the association. The 1:1 matched-cohort analysis confirmed the increased risk associated with PCI-S (HR = 1.61, with 95% CI [1.03, 2.51]; P = .037). CONCLUSIONS: Patients who have both diabetes and triple-vessel disease, and have undergone prior PCI-S, have poorer long-term outcomes after CABG compared with those who have had no prior PCI-S.

International multicenter experience with peroral endoscopic myotomy for the treatment of spastic esophageal disorders refractory to medical therapy (with video).

BACKGROUND: Limited data exist on the use of peroral endoscopic myotomy (POEM) for therapy of spastic esophageal disorders (SEDs). OBJECTIVE: To study the efficacy and safety of POEM for the treatment of patients with diffuse esophageal spasm, jackhammer esophagus, or type III (spastic) achalasia. DESIGN: Retrospective study. SETTING: International, multicenter, academic institutions. PATIENTS: All patients who underwent POEM for treatment of SEDs refractory to medical therapy at 11 centers were included. INTERVENTIONS: POEM. MAIN OUTCOME MEASUREMENTS: Eckardt score and adverse events. RESULTS: A total of 73 patients underwent POEM for treatment of SEDs (diffuse esophageal spasm 9, jackhammer esophagus 10, spastic achalasia 54). POEM was successfully completed in all patients, with a mean procedural time of 118 minutes. The mean length of the submucosal tunnel was 19 cm, and the mean myotomy length was 16 cm. A total of 8 adverse events (11%) occurred, with 5 rated as mild, 3 moderate, and 0 severe. The mean length of hospital stay was 3.4 days. There was a significant decrease in Eckardt scores after POEM (6.71 vs 1.13; P = .0001). Overall, clinical response was observed in 93% of patients during a mean follow-up of 234 days. Chest pain significantly improved in 87% of patients who reported chest pain before POEM. Repeat manometry after POEM was available in 44 patients and showed resolution of initial manometric abnormalities in all cases. LIMITATIONS: Retrospective design and selection bias. CONCLUSION: POEM offers a logical therapeutic modality for patients with SEDs refractory to medical therapy. Results from this international study suggest POEM as an effective and safe platform for these patients.

Iatrogenic pharyngoesophageal perforations treated with fully covered self-expandable metallic stents (with video).

BACKGROUND: Iatrogenic pharyngoesophageal perforations are a rare but serious complication of endoscopy. Surgical and non-surgical approaches have been reported but result in a significant morbidity and extended hospital stay. Therefore, an unmet need exists for an alternative management technique. We demonstrate a new endoscopic approach for the management of iatrogenic pharyngoesophageal perforations through the use of esophageal fully covered self-expandable metallic stents (FCSEMS). PATIENTS AND METHODS: Two patients who underwent flexible endoscopy each suffered a large iatrogenic perforation detected intraprocedurally. After emergency intubation, an esophageal FCSEMS was deployed in the hypopharynx and the patient admitted to the intensive care unit. On day 3, the patients underwent an esophagogastroduodenoscopy with stent removal. RESULTS: There was complete closure of the perforations on day 3. The patients were extubated and subsequently tolerated a soft diet. The patients were discharged home on day 4. CONCLUSIONS: The placement of a removable FCSEMS in the setting of an acutely diagnosed perforation may be a suitable minimally invasive approach for the management of iatrogenic pharyngoesophageal perforations.