Endoscopic ultrasound-guided gallbladder drainage with long-term lumen-apposing metal stent indwell: 1-year results from a prospective nationwide observational study.

BACKGROUND AND AIM: This study aimed to determine safety and risk factors for adverse events (AEs) of endoscopic ultrasound-guided gallbladder drainage (EUS-GBD) with long-term indwell of lumen-apposing metal stents (LAMS). METHODS: This study is a multicenter prospective observational study on consecutive high surgical-risk patients requiring gallbladder drainage who underwent EUS-GBD with LAMS over 12 months. Centralized telephone follow-up interviews were conducted every 3 months for 1 year. Patients were censored at LAMS removal, cholecystectomy, or death. AE-free survival was determined using log-rank tests. Cumulative risks were estimated using life-table analysis. RESULTS: Eighty-two patients were included (53.7% male, median [interquartile range] age of 84.6 [76.5-89.8] years, and 85.4% with acute cholecystitis). Technical success was achieved in 79 (96.3%), and clinical success in 73 (89%). No patient was lost to follow-up; 45 patients (54.9%) completed 1-year follow-up with in situ LAMS. Median (interquartile range) LAMS indwell time was 364 (47-367) days. Overall, 12 (14.6%) patients presented 14 AEs, including 5 (6.1%) recurrent biliary events (3 acute cholangitis, 1 mild acute pancreatitis, and 1 acute cholecystitis). Patients with pancreatobiliary malignancy had an increased risk of recurrent biliary events (33% vs 1.5%, P = 0.001). The overall 1-year cumulative risk of recurrent biliary events was 9.7% (4.1-21.8%). The 1-year risk of AEs and of severe AEs was 18.8% (11-31.2%) and 7.9% (3.3-18.2%), respectively. Pancreatobiliary malignancy was the single risk factor for recurrent biliary events; LAMS misdeployment was the strongest risk factor for AEs. CONCLUSIONS: Long-term LAMS indwell does not increase the risk of delayed AEs following EUS-GBD.

Endoscopic removal of lumen-apposing metal stents - risk factors for stent embedment, complex removals, and adverse events: analysis from a multicenter prospective case series.

BACKGROUND: Removing lumen-apposing metal stents (LAMSs) may be difficult and even harmful, but these features have seldom been analyzed. We aimed to generate a comprehensive assessment of the feasibility and safety of LAMS retrieval procedures. METHODS: A prospective multicenter case series including all technically successfully deployed LAMSs between January 2019 and January 2020 that underwent endoscopic stent removal. All retrieval-related data were prospectively recorded using standardized telephone questionnaires as part of centralized follow-up that ended after stent removal had been performed. Multivariable logistic regression models assessed the potential risk factors for complex removal. RESULTS: For the 407 LAMSs included, removal was attempted in 158 (38.8 %) after an indwell time of 46.5 days (interquartile range [IQR] 31-70). The median (IQR) removal time was 2 (1-4) minutes. Removal was labelled as complex in 13 procedures (8.2 %), although advanced endoscopic maneuvers were required in only two (1.3 %). Complex removal risk factors were stent embedment (relative risk [RR] 5.84, 95 %CI 2.14-15.89; P = 0.001), over-the-wire deployment (RR 4.66, 95 %CI 1.60-13.56; P = 0.01), and longer indwell times (RR 1.14, 95 %CI 1.03-1.27; P = 0.01). Partial and complete embedment were observed in 14 (8.9 %) and five cases (3.2 %), respectively. The embedment rate during the first 6 weeks was 3.1 % (2/65), reaching 15.9 % (10/63) during the following 6 weeks (P = 0.02). The adverse event rate was 5.1 %, including seven gastrointestinal bleeds (5 mild, 2 moderate). CONCLUSIONS: LAMS removal is a safe procedure, mostly requiring basic endoscopic techniques attainable in conventional endoscopy rooms. Referral to advanced endoscopy units should be considered for stents with known embedment or long indwell times, which may require more technically demanding procedures.

Análisis retrospectivo multicéntrico de las incidencias asociadas a las prótesis de aposición luminal tipo Axios(TM) / A retrospective, multicenter analysis of incidents associated with Axios(TM) lumen-apposing stents

Introducción: existe controversia respecto a los riesgos asociados a las prótesis de aposición luminal (PAL), con importantes variaciones entre los trabajos disponibles. Objetivos: describir el tipo y la proporción de complicaciones durante la permanencia y retirada de PAL tipo Axios(TM). Describir la relación entre tiempo de permeabilidad, diana terapéutica y presencia de complicaciones. Métodos: serie de casos retrospectiva y multicéntrica que incluyó todos los pacientes consecutivos a los que se les colocó una PAL para acceder a estructuras extraluminales durante el año 2017. Se registraron únicamente aquellos casos que alcanzaron éxito técnico. Resultados: se incluyeron 179 pacientes de siete centros (rango 4-68 casos/centro) con edad media de 64,3 años (DE: 15,8, rango 24,6-98,8 años), 122 (68,2%) de ellos varones. Las indicaciones más frecuentes fueron las necrosis encapsuladas (58, 32,4%), seguidas de pseudoquistes (31, 17,3%) y drenajes vesiculares (26, 14,5%). Durante la permanencia de la PAL se documentaron complicaciones en 19 pacientes (10,9%), siendo las más frecuentes las obstrucciones de la luz protésica o del marco gastroduodenal en ocho (4,5%) casos y las hemorragias en siete (3,9%) pacientes. Las PAL no se retiraron en 86 pacientes (48%) por los siguientes motivos: intención permanente de la PAL en 46 (53,5%), pérdida del seguimiento en 18 (20,9%), fallecimiento del paciente en 16 (18,6%) y migración en seis (7%). Durante la retirada se observaron cinco complicaciones (5,4%), tres casos de hemorragia y dos perforaciones. No observamos una asociación entre el tiempo de permanencia y las complicaciones (p = 0,67). Conclusión: la aparición de complicaciones secundarias a la inserción de PAL es poco frecuente, aunque pueden ser graves. En este estudio no se ha observado una asociación entre la aparición de complicaciones y el tiempo de permanencia de la prótesis

Introduction: there is controversy with regard to the risks associated with lumen-apposing metal stents (LAMSs), with significant variations between available reports. Objectives: to describe the types and proportions of complications that arise during the permanence time and removal of Axios(TM) LAMS. Furthermore, the relationship between patency time, therapeutic target and the presence of complications was also described. Methods: a retrospective, multicenter case series study was performed of all patients with an implanted LAMS to access extra-luminal structures during 2017. Only technically successful cases were recorded. Results: a total of 179 patients from seven sites (range, 4-68 cases/site) were included in the study, with a mean age of 64.3 years (SD: 15.8; range: 24.6-98.8 years) and 122 (68.2%) were male. Most common indications included encapsulated necrosis (58, 32.4%), pseudocysts (31, 17.3%) and gallbladder drains (26, 14.5%). Complications during LAMS stay were reported in 19 patients (10.9%); stent lumen or gastroduodenal obstruction (8, 4.5%) and bleeding (7, 3.9%) were the most common. LAMS were not removed in 86 (48%) patients due to the following reasons: a permanent stent was used (46, 53.5%), loss to follow-up (18, 20.9%), patient demise (16, 18.6%) and stent migration (6, 7%). Five (5.4%) complications were reported during stent removal, which were three bleeds and two perforations. No association was found between stent duration and complications (p = 0.67). Conclusion: complications secondary to LAMS insertion are uncommon but may be serious. This study found no association between complications and stent duration

A retrospective, multicenter analysis of incidents associated with Axios™ lumen-apposing stents.

INTRODUCTION: there is controversy with regard to the risks associated with lumen-apposing metal stents (LAMSs), with significant variations between available reports. OBJECTIVES: to describe the types and proportions of complications that arise during the permanence time and removal of Axios™ LAMS. Furthermore, the relationship between patency time, therapeutic target and the presence of complications was also described. METHODS: a retrospective, multicenter case series study was performed of all patients with an implanted LAMS to access extra-luminal structures during 2017. Only technically successful cases were recorded. RESULTS: a total of 179 patients from seven sites (range, 4-68 cases/site) were included in the study, with a mean age of 64.3 years (SD: 15.8; range: 24.6-98.8 years) and 122 (68.2%) were male. Most common indications included encapsulated necrosis (58, 32.4%), pseudocysts (31, 17.3%) and gallbladder drains (26, 14.5%). Complications during LAMS stay were reported in 19 patients (10.9%); stent lumen or gastroduodenal obstruction (8, 4.5%) and bleeding (7, 3.9%) were the most common. LAMS were not removed in 86 (48%) patients due to the following reasons: a permanent stent was used (46, 53.5%), loss to follow-up (18, 20.9%), patient demise (16, 18.6%) and stent migration (6, 7%). Five (5.4%) complications were reported during stent removal, which were three bleeds and two perforations. No association was found between stent duration and complications (p = 0.67). CONCLUSION: complications secondary to LAMS insertion are uncommon but may be serious. This study found no association between complications and stent duration.