Aims:
Endoscopic ultrasound (EUS)-guided lumen-apposing metal stents (LAMS) placement may
facilitate pancreatic fluid collections (PFC) drainages but data on related-adverse
events, particularly bleeding, are limited. Few data suggest that a co-axial plastic
double pig tail stent (DPS) might reduce bleeding risk. Primary aim was the feasibility,
efficacy and safety of Hot Axios(Boston Scientific) in a series of patients undergoing
PFC EUS-guided drainage. Second aim was to assess the efficacy of DPS placement into
the LAMS in order to decrease bleeding.
Methods:
A retrospective review of Hot Axios placement for PFC drainage in our Institute between
Oct2014 and Sept2018 was performed. Patients demographics, PFC etiology and characteristics,
technical success (TS), clinical success (CS) rate (< 50% PFC + symptoms resolution)
and adverse events (± 7 days: immediate/delayed) were registered.
Results:
49 pts were identified. TS rate was 98%, CS rate 93.9%. Total adverse events were
16.3%. Bleeding rate was 10.2%(5/49): 3 early (arterial pseudoaneurysms-1 death),
2 delayed (1 hepatic artery branch vessel bleeding, 1 fatal WON cavity hemorrhage).
1 immediate perforation and 2"buried stent syndrome" occurred. DPS was positioned
in 34.7%(17/49). Bleeding rate in patients with DPS was lower (1/17;5.9%) compared
to patients without (5/32;15.6%), but this difference was not statistically significant
(p = 0.65). “Other” complications rate also did not differ with or without DPS (p
= 0.23). At logistic regression analysis PFC size, necrosis, access, sex, age and
DPS presence were not significantly associated with complications/bleeding risk.
Conclusions:
Hot Axios PFC drainage is highly feasible and effective, with a relatively safe profile.
Bleeding is a serious and potentially fatal complication. Although bleeding rate seems
lower after DPS positioning (5.9% vs. 15.6%), if this difference is true, a power
calculation with a β= 0.20 and an α= 0.10 suggests that a RCT would reach statistical
significance with > 200 patients per arm. Further multicenter studies are needed to
assess the possible DPS protective role in this setting.