International multicenter comprehensive analysis of adverse events associated with lumen-apposing metal stent placement for pancreatic fluid collection drainage

Abstract Background and Aims High rates of technical and clinical success were reported of lumen-apposing metal stent (LAMS) placement for peripancreatic fluid collection (PFC) drainage. However, data on the adverse event (AE) rates are heterogeneous. The aim of this study was to evaluate the incidence, severity, management, and risk factors of AEs related to the use of LAMSs for drainage of PFCs in a large cohort of patients. Methods This is a multicenter, international, retrospective review from 15 centers of all patients who underwent placement of LAMSs for the management of PFCs. A nested case-control study was conducted in patients with (case) or without (control) AEs. Results A total of 333 procedures in 328 patients were performed (5 patients treated with 2 LAMS). Technical success was achieved in 321 (97.9%) patients. Three hundred four patients were finally included in the study (7 excluded for lost to follow-up information; 10 excluded for deaths unrelated to LAMSs). The rate of clinical success was 89.5%. Seventy-nine LAMS-related AEs occurred in 74 out of 304 patients (24.3%), after a mean time of 25.3 days (median, 18 days, IQR, 6-30 days) classified as 20 (25.3%) mild, 54 (68.4%) moderate, or 5 (6.3%) severe. On multivariable analysis, compared with controls, cases were more likely to have walled-off necrosis (WON) versus pancreatic pseudocysts (PP) (ORs, 2.18; 95% CI, 1.09-4.46; P=0.028), whereas cases were less likely to have undergone tract (balloon) dilation (yes vs no, OR, 0.47; 95% CI, 0.22-0.93; P=0.034). Conclusions Data from this large international retrospective study confirm that the use of LAMSs for management of PFC has excellent technical and good clinical success rates. The rate of AEs, however, is not negligible and should be carefully considered before using these stents for drainage of PFCs, and in particular for WON. Further prospective studies are needed to confirm these findings.