Gastroenterology Research, ISSN 1918-2805 print, 1918-2813 online, Open Access
Article copyright, the authors; Journal compilation copyright, Gastroenterol Res and Elmer Press Inc
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Original Article

Volume 18, Number 1, February 2025, pages 1-11

Analysis of Adverse Events of Endoscopic Ultrasound-Guided Lumen-Apposing Metal Stent Placement: Insights Across Various Indications and Techniques

Tables

Table 1. Sociodemographic and Health Behavior Characteristics of Patients Who Had EUS-Guided LAMS Placement
 
Result (n = 243)
Data were shown as n (%) unless otherwise indicated. EUS: endoscopic ultrasound; LAMS: lumen-apposing metal stent; BMI: body mass index; COPD: chronic obstructive pulmonary disease; SD: standard deviation.
Age (years), mean ± SD53.7 ± 15.9
Sex
  Female110 (45.3)
  Male133 (54.7)
Race/ethnicity
  Arabic2 (0.8)
  Asian (from India)1 (0.4)
  Black44 (18.1)
  Hispanic3 (1.2)
  White159 (65.4)
  Other17 (7.0)
  Not specified17 (7.0)
BMI (kg/m2), mean ± SD30.0 ± 9.5
Weight range by BMI
  Underweight (< 18.5 kg/m2)11 (4.5)
  Normal weight (18.5 - 24.9 kg/m2)69 (28.4)
  Overweight (≥ 25.0 kg/m2)163 (67.1)
Health behaviors
  Alcohol use102 (42.0)
  Illicit substance use34 (14.0)
  Smoking108 (44.4)
Comorbidities
  Asthma or COPD30 (12.3)
  Cirrhosis13 (5.3)
  Coronary artery disease20 (8.2)
  Diabetes89 (36.6)
  Dyslipidemia74 (30.5)
  End-stage kidney disease3 (1.2)
  Hypertension117 (48.1)
  Myocardial infarction10 (4.1)
  Stroke5 (2.1)
  Ulcerative colitis1 (0.4)

 

Table 2. Procedural Features, Success Rates and Outcomes, and Clinical Consequences and Serious Outcomes of Patients Who Had EUS-Guided LAMS Placement
 
Result (n = 243)
Data were shown as n (%) unless otherwise indicated. ERCP: endoscopic retrograde cholangiopancreatography; EDGE: endoscopic ultrasound-directed transgastric ERCP; EUS: endoscopic ultrasound; LAMS: lumen-apposing metal stent; SD: standard deviation; ICU: intensive care unit; AE: adverse event.
Indication for stent placement
  Abscess drainage2 (0.8)
  Acute cholecystitis11 (4.5)
  Cholangitis2 (0.8)
  First step of EDGE procedure22 (9.1)
  Gastric outlet obstruction27 (11.1)
  Pancreatic and bile duct obstruction from neoplasia5 (2.1)
  Pancreatic fluid collection (necrosis/pseudocyst)170 (70.0)
  Other4 (1.6)
Biliary-gastrointestinal connection type
  Cholecystoduodenostomy16 (6.6)
  Cholecystogastrostomy2 (0.8)
  Choledochoduodenostomy1 (0.4)
  Colo-abscess1 (0.4)
  Cystduodenostomy10 (4.1)
  Cystgastrostomy159 (65.4)
  Duodenojejunostomy1 (0.4)
  Gastrogastrostomy22 (9.1)
  Gastrojejunostomy31 (12.8)
Plastic stent also used176 (72.4)
Stent size
  10 × 10 mm28 (11.5)
  10 × 15 mm86 (35.4)
  10 × 20 mm127 (52.3)
  22 × 90 mm2 (0.8)
LAMS dilated during procedure146 (60)
  Maximum LAMS dilation diameter (mm), mean ± SD13.2 ± 2.7
Procedure time (min), mean ± SD62.9 ± 31.5
Maximal cyst/fluid collection diameter prior to LAMS placement (mm), mean ± SD97.2 ± 40.2
Success rates and outcomes
  Technical success of LAMS placement237 (97.5)
  Clinical success with no needed intervention226 (93.0)
Clinical outcome success
  Cholecystitis resolved (n = 11)10/11 (90.9)
  Pancreatic necrosis/pancreatic cyst resolved (n = 170)170/170 (100)
  Successful ERCP after EDGE procedure (n = 22)22/22 (100)
  Successful bypass of gastric outlet obstruction with oral intake ability (n = 27)22/27 (81.4)
Clinical consequences
  No clinical consequences or need for further intervention219 (90.1)
Unplanned hospital admission and stay requirements
  ICU admission > 1 night9 (3.7)
  Unplanned hospital admission/prolonged hospital stay ≤ 3 nights7 (2.9)
  Unplanned hospital admission/prolong hospital stay 4 - 10 nights2 (0.8)
Need for clinical interventions
  Blood transfusion8 (3.3)
  Interventional radiology for AE2 (0.8)
  Repeat endoscopy for AE6 (2.5)
  Surgery for AE2 (0.8)
  Unplanned anesthesia/ventilation support1 (0.4)
Serious outcomes
  Death5 (2.1)
  Permanent disability2 (0.8)

 

Table 3. Procedural Success and Complication Rates by Anastomosis Procedural Approach for Patients Who Had EUS-Guided LAMS Placement
 
EUS-guided LAMS placement anastomosis procedure
Cholecystoduodenostomy (n = 16)Cystoduodenostomy (n = 10)Cystogastrostomy (n = 158)Gastrogastrostomy (n = 20)Gastrojejunostomy (n = 31)
Data were shown as n (%) unless otherwise indicated. EUS: endoscopic ultrasound; LAMS: lumen-apposing metal stent; AE: adverse event.
Technical success16 (100%)10 (100%)156 (99%)18 (90%)29 (94%)
Clinical success14 (88%)9 (90%)150 (95%)19 (95%)29 (94%)
Early AEs3 (19%)1 (10%)28 (18%)4 (20%)8 (26%)
Late AEs3 (19%)4 (40%)47 (30%)4 (20%)6 (19%)

 

Table 4. AEs Experienced by Patients Who Had EUS-Guided LAMS Placement
 
Post-procedural AEaResults (n = 243)
Data were shown as n (%) unless otherwise indicated. aSome patients experienced more than one AE in more than one time period. Each AE was considered an independent event, and overall AE rates were calculated per total study population. A total of 155 AEs were recorded. EUS: endoscopic ultrasound; LAMS: lumen-apposing metal stent; AE: adverse event.
Total patients with at least one AE96 (39.5)
Early AE (< 48 h from procedure) (n = 60 AE in 48 patients)
  Bleeding9 (3.7)
  Cardiac arrest2 (0.8)
  Deep vein thrombosis1 (0.4)
  Hypoxia (O2 < 85%)3 (1.2)
  Infection (fever > 38 °C)6 (2.5)
  Misdeployment1 (0.4)
  Pain (abdominal)28 (11.5)
  Pain (non-abdominal)1 (0.4)
  Pancreatitis1 (0.4)
  Perforation1 (0.4)
  Pulmonary embolus1 (0.4)
  Stent migration1 (0.4)
  Stent occlusion1 (0.4)
  Other4 (1.6)
Late AE (48 h to 30 days from procedure) (n = 95 AE in 70 patients)
  Bile leak1 (0.4)
  Bleeding10 (4.1)
  Deep vein thrombosis2 (0.8)
  Disconnected duct syndrome1 (0.4)
  Hypoxia (O2 < 85%)6 (2.5)
  Infection (fever > 38 °C)13 (5.3)
  Pain (abdominal)25 (10.3)
  Pancreatitis4 (1.6)
  Perforation2 (0.8)
  Pneumonia1 (0.4)
  Pulmonary embolus2 (0.8)
  Stent migration7 (2.9)
  Stent occlusion10 (4.1)
  Other11 (4.5)
AE severitya (at least one AE in n = 96 patients)
  Mild75/96 (78.1)
  Moderate16/96 (16.6)
  Severe5/96 (5.2)

 

Table 5. A Comparison of AE Rates in Patients Who Had EUS-Guided LAMS Placement With or Without Concomitant Plastic Stents, and in Patients Who Had EUS-Guided LAMS Placement With or Without Dilation
 
Stent combination (n = 243)P value
LAMS + plastic stent (n = 176)LAMS with no plastic stent (n = 67)
All AEs85 (48.3)20 (29.9)0.009*
Early AE (< 48 h)
  All36 (20.5)12 (17.9)0.656
  Bleeding6 (3.4)3 (4.5)0.693
  Cardiac arrest1 (0.6)1 (1.5)0.476
  Deep vein thrombosis1 (0.6)0 (0)0.536
  Hypoxia (O2 < 85%)2 (1.1)1 (1.5)0.822
  Infection (fever > 38 °C)5 (2.8)1 (1.5)0.545
  Misdeployment0 (0)1 (1.5)0.104
  Pain (abdominal)22 (12.5)6 (9.0)0.439
  Pain (non-abdominal)1 (0.6)0 (0)0.536
  Pancreatitis1 (0.6)0 (0)0.536
  Perforation0 (0)1 (1.5)0.104
  Pulmonary embolus1 (0.6)0 (0)0.536
  Stent migration0 (0)1 (1.5)0.104
  Stent occlusion1 (0.6)0 (0)0.536
  Other2 (1.1)2 (3.0)0.311
Late AE (48 h to 30 days)
  All58 (33.0)12 (17.9)0.021*
  Bile leak0 (0)1 (1.5)0.104
  Bleeding8 (4.5)2 (3.0)0.584
  Deep vein thrombosis1 (0.6)1 (1.5)0.476
  Disconnected duct syndrome1 (0.6)0 (0)0.536
  Hypoxia (O2 < 85%)4 (2.3)2 (3.0)0.749
  Infection (fever > 38 °C)10 (5.7)3 (4.5)0.709
  Pain (abdominal)22 (12.5)3 (4.5)0.066
  Pancreatitis3 (1.7)1 (1.5)0.908
  Perforation0 (0)2 (3.0)0.021*
  Pneumonia0 (0)1 (1.5)0.104
  Pulmonary embolus1 (0.6)1 (1.5)0.476
  Stent migration6 (3.4)1 (1.5)0.425
  Stent occlusion10 (5.7)0 (0)0.046*
  Other9 (5.1)2 (3.0)0.476
Use of LAMS dilation (n = 243)P value
LAMS dilation (n = 146)No LAMS dilation (n = 98)
Data were shown as n (%) unless otherwise indicated. *P value < 0.05. LAMS: lumen-apposing metal stent; AE: adverse event.
All AEs64 (43.8)41 (42.6)0.809
Early AE (< 48 h)
  All25 (17.1)23 (23.7)
  Bleeding6 (4.1)3 (3.1)0.207
  Cardiac arrest0 (0)2 (2.1)0.681
  Deep vein thrombosis1 (0.7)0 (0)0.081
  Hypoxia (O2 < 85%)1 (0.7)2 (2.1)0.414
  Infection (fever > 38 °C)4 (2.7)2 (2.1)0.341
  Misdeployment0 (0)1 (1.0)0.739
  Pain (abdominal)14 (9.6)14 (14.4)0.219
  Pain (non-abdominal)1 (0.7)0 (0)0.247
  Pancreatitis0 (0)1 (1.0)0.414
  Perforation0 (0)1 (1.0)0.219
  Pulmonary embolus0 (0)1 (1.0)0.219
  Stent migration1 (0.7)0 (0)0.219
  Stent occlusion1 (0.7)0 (0)0.414
  Other1 (0.7)3 (3.1)0.414
Late AE (48 h to 30 days)0.149
  All50 (34.2)20 (20.6)
  Bile leak0 (0)1 (1.0)0.022*
  Bleeding7 (4.8)3 (3.1)0.219
  Deep vein thrombosis1 (0.7)1 (1.0)0.513
  Disconnected duct syndrome0 (0)1 (1.0)0.770
  Hypoxia (O2 < 85%)5 (3.4)1 (1.0)0.219
  Infection (fever > 38 °C)9 (6.2)4 (4.1)0.239
  Pain (abdominal)18 (12.3)7 (7.2)0.489
  Pancreatitis2 (1.4)2 (2.1)0.199
  Perforation0 (0)2 (2.1)0.678
  Pneumonia1 (0.7)0 (0)0.081
  Pulmonary embolus2 (1.4)0 (0)0.414
  Stent migration6 (4.1)1 (1.0)0.247
  Stent occlusion9 (6.2)1 (1.0)0.160
  Other8 (5.5)3 (3.1)0.049*
0.381

 

Table 6. A Comparison of AE Rates in Patients Who Had EUS-Guided LAMS With Dilation, With or Without Concomitant Plastic Stent Placement
 
Underwent both operationsUnderwent LAMS dilation onlySignificance
N%N%χ2P value
LAMS: lumen-apposing metal stent; EUS: endoscopic ultrasound; AE: adverse event.
Overall complications
  No6954.81675
  Yes5645.15252.86710.090
Early AE2217.629.50.00100.975
  Hypoxia (O2 < 85%)10.800.00.09490.758
  Deep vein thrombosis10.800.00.09490.758
  Stent occlusion10.800.00.09490.758
  Bleeding5418.30.72730.394
  Infection (fever > 38 °C)43.200.00.43640.509
  Pain (abdominal)1310.418.30.06230.803
  Pain (non-abdominal)10.800.00.09490.758
  Other10.800.00.09490.758
Late AE4636.8419.00.01430.905
  Hypoxia (O2 < 85%)43.218.31.0870.297
  Pneumonia00.018.311.7340.001
  Deep vein thrombosis10.800.00.08870.766
  Pulmonary embolus10.818.34.9930.025
  Stent occlusion97.200.00.9540.329
  Bleeding64.818.30.43690.509
  Infection (fever > 38 °C)97.800.00.9540.329
  Pain (abdominal)1814.400.02.4450.118
  Pancreatitis21.600.00.18120.670
  Stent migration5418.30.6950.404
  Other86.418.30.14430.704