Comprehensive analysis of adverse events associated with transmural use of LAMS in patients with liver cirrhosis: International multicenter study (2024)

Abstract

Background and study aims Endoscopic ultrasound (EUS)-guided transmural (TM) deployment of lumen-apposing metal stents (LAMS) is considered relatively safe in non-cirrhotic patients and is cautiously offered to cirrhotic patients.

Patients and methods This was a retrospective, multicenter, international matched case-control study to study the safety of EUS-guided TM deployment of LAMS in cirrhotic patients.

Results Forty-three cirrhotic patients with model for end-stage liver disease score 12.5 ± 5, with 23 having ascites and 16 with varices underwent EUS-guided TM LAMS deployment, including 19 for pancreatic fluid collection (PFC) drainage, 13 gallbladder drainage, six for endoscopic ultrasound-directed transgastric endoscopic retrograde cholangiopancreatography (ERCP), three for EDGI, one for endoscopic ultrasound-directed transenteric ERCP, and one postsurgical collection drainage. Technical failure occurred in one LAMS for PFC drainage. Clinical failure was encountered in another PFC. Nine adverse events (AEs) occurred. The most common AE was LAMS migration (3), followed by non-bleeding mucosal erosion (2), delayed bleeding (2), sepsis (1), and anesthesia-related complication (pulseless electrical activity) (1). Most AEs were graded as mild (6), followed by severe (2), and moderate (1); the majority were managed conservatively. On univariable comparison, risk of AE was higher when using a 20 × 10 mm LAMS and the absence of through-the-LAMS plastic stent(s). Conditional logistic regression of matched case-control patients did not show any association between potential predicting factors and occurrence of AEs.

Conclusions Our study demonstrated that mainly in patients with Child-Pugh scores A and B cirrhosis and despite the presence of mild-to-moderate ascites in over half of cases, the majority of AEs were mild and could be managed conservatively. Further studies are warranted to verify the safety of LAMS in cirrhotic patients.

Publication History

© 2024. The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial-License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/).

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• References

• 1 Sharma P, McCarty TR, Chhoda A. et al. Alternative uses of lumen apposing metal stents. World J Gastroenterol 2020; 26: 2715-2728 DOI: 10.3748/wjg.v26.i21.2715. (PMID: 32550749)

  Google Scholar

• 2 Stier MW, Waxman I. Lumen-apposing metal stents: Which one and why?. Gastrointest Endosc Clin N Am 2018; 28: 207-217 DOI: 10.1016/j.giec.2017.11.008. (PMID: 29519333)

  Google Scholar

• 3 Bhenswala P, Lakhana M, Gress FG. et al. Novel uses of lumen-apposing metal stents: a review of the literature. J Clin Gastroenterol 2021; 55: 641-651 DOI: 10.1097/MCG.0000000000001566. (PMID: 34049379)

  Google Scholar

• 4 Bang JY, Hasan M, Navaneethan U. et al. Lumen-apposing metal stents (LAMS) for pancreatic fluid collection (PFC) drainage: may not be business as usual. Gut 2017; 66: 2054-2056 DOI: 10.1136/gutjnl-2016-312812. (PMID: 27582509)

  Google Scholar

• 5 Mohan BP, Jayaraj M, Asokkumar R. et al. Lumen apposing metal stents in drainage of pancreatic walled-off necrosis, are they any better than plastic stents? A systematic review and meta-analysis of studies published since the revised Atlanta classification of pancreatic fluid collections. Endosc Ultrasound 2019; 8: 82-90

  Google Scholar

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  Immediate multivessel revascularization after myocardial infarction: change of strategy?
• 6 Jain D, Bhandari BS, Agrawal N. et al. Endoscopic ultrasound-guided gallbladder drainage using a lumen-apposing metal stent for acute cholecystitis: A systematic review. Clin Endosc 2018; 51: 450-462 DOI: 10.5946/ce.2018.024. (PMID: 29852730)

  Google Scholar

• 7 Tyberg A, Kedia P, Tawadros A. et al. EUS-directed transgastric endoscopic retrograde cholangiopancreatography (EDGE): The first learning curve. J Clin Gastroenterol 2020; 54: 569-572 DOI: 10.1097/MCG.0000000000001326. (PMID: 32149820)

  Google Scholar

• 8 Krafft MR, Hsueh W, James TW. et al. The EDGI new take on EDGE: EUS-directed transgastric intervention (EDGI), other than ERCP, for Roux-en-Y gastric bypass anatomy: a multicenter study. Endosc Int Open 2019; 7: E1231-E1240

  Google Scholar

• 9 Khashab MA. Endoscopic ultrasound-directed transenteric ERCP (EDEE) in patients with postsurgical anatomy – novel but challenging. Endoscopy 2019; 51: 1119-1120 DOI: 10.1055/a-0958-2323. (PMID: 31775166)

  Google Scholar

• 10 Itoi T, Baron TH, Khashab MA. et al. Technical review of endoscopic ultrasonography-guided gastroenterostomy in 2017. Dig Endosc 2017; 29: 495-502 DOI: 10.1111/den.12794. (PMID: 28032663)

  Google Scholar

• 11 Mangiavillano B, Moon JH, Crino SF. et al. Safety and efficacy of a novel electrocautery-enhanced lumen-apposing metal stent in interventional EUS procedures (with video). Gastrointest Endosc 2022; 95: 115-122

  Google Scholar

• 12 Shah RJ, Shah JN, Waxman I. et al. Safety and efficacy of endoscopic ultrasound-guided drainage of pancreatic fluid collections with lumen-apposing covered self-expanding metal stents. Clin Gastroenterol Hepatol 2015; 13: 747-752

  Google Scholar

• 13 Bazaga Pérez de Rozas S, Carbajo AY, Garcia-Alonso FJ. et al. A retrospective, multicenter analysis of incidents associated with Axios lumen-apposing stents. Rev Esp Enferm Dig 2019; 111: 419-424

  Google Scholar

• 14 Ghandour B, Bejjani M, Irani SS. et al. Classification, outcomes, and management of misdeployed stents during EUS-guided gastroenterostomy. Gastrointest Endosc 2022; 95: 80-89

  Google Scholar

• 15 Ichkhanian Y, Runge T, Jovani M. et al. Management of adverse events of EUS-directed transgastric ERCP procedure. VideoGIE 2020; 5: 260-263 DOI: 10.1016/j.vgie.2020.02.005. (PMID: 32529164)

  Google Scholar

• 16 Garcia-Pagan JC, Gracia-Sancho J, Bosch J. Functional aspects on the pathophysiology of portal hypertension in cirrhosis. J Hepatol 2012; 57: 458-461 DOI: 10.1016/j.jhep.2012.03.007. (PMID: 22504334)

  Google Scholar

• 17 Engelmann C, Claria J, Szabo G. et al. Pathophysiology of decompensated cirrhosis: Portal hypertension, circulatory dysfunction, inflammation, metabolism and mitochondrial dysfunction. J Hepatol 2021; 75: S49-S66 DOI: 10.1016/j.jhep.2021.01.002. (PMID: 34039492)

  Google Scholar

• 18 Wiest R, Lawson M, Geuking M. Pathological bacterial translocation in liver cirrhosis. J Hepatol 2014; 60: 197-209 DOI: 10.1016/j.jhep.2013.07.044. (PMID: 23993913)

  Google Scholar

• 19 Runyon BA, Squier S, Borzio M. Translocation of gut bacteria in rats with cirrhosis to mesenteric lymph nodes partially explains the pathogenesis of spontaneous bacterial peritonitis. J Hepatol 1994; 21: 792-796 DOI: 10.1016/s0168-8278(94)80241-6. (PMID: 7890896)

  Google Scholar

• 20 Laique S, Franco MC, Stevens T. et al. Clinical outcomes of endoscopic management of pancreatic fluid collections in cirrhotics vs non-cirrhotics: A comparative study. World J Gastrointest Endosc 2019; 11: 403-412 DOI: 10.4253/wjge.v11.i6.403. (PMID: 31236193)

  Google Scholar

• 21 James TW, Krafft M, Croglio M. et al. EUS-guided gallbladder drainage in patients with cirrhosis: results of a multicenter retrospective study. Endosc Int Open 2019; 7: E1099-E1104

  Google Scholar

• 22 Parsa N, Nieto JM, Powers P. et al. Endoscopic ultrasound-guided drainage of pancreatic walled-off necrosis using 20-mm versus 15-mm lumen-apposing metal stents: an international, multicenter, case-matched study. Endoscopy 2020; 52: 211-219 DOI: 10.1055/a-1096-3299. (PMID: 32000275)

  Google Scholar

• 23 Runge TM, Chiang AL, Kowalski TE. et al. Endoscopic ultrasound-directed transgastric ERCP (EDGE): a retrospective multicenter study. Endoscopy 2021; 53: 611-618 DOI: 10.1055/a-1254-3942. (PMID: 32882722)

  Google Scholar

• 24 Ichkhanian Y, Yang J, James TW. et al. EUS-directed transenteric ERCP in non–Roux-en-Y gastric bypass surgical anatomy patients (with video). Gastrointest Endosc 2020; 91: 1188-1194e2

  Google Scholar

• 25 Ghandour B, Shinn B, Dawod QM. et al. EUS-directed transgastric interventions in Roux-En-Y gastric bypass anatomy: a multicenter experience. Gastrointest Endosc 2022; 96: 630-638 DOI: 10.1016/j.gie.2022.05.008. (PMID: 35623383)

  Google Scholar

• 26 Walter D, Teoh AY, Itoi T. et al. EUS-guided gall bladder drainage with a lumen-apposing metal stent: a prospective long-term evaluation. Gut 2016; 65: 6-8

  Google Scholar

• 27 Priyanka P, Hsueh W, Nasr J. Use of lumen-apposing stents for the treatment of postsurgical fluid collections: A case series and a review of literature. Case Rep Gastrointest Med 2019; 2019: 7656950 DOI: 10.1155/2019/7656950. (PMID: 30809400)

  Google Scholar

• 28 Cotton PB, Eisen GM, Aabakken L. et al. A lexicon for endoscopic adverse events: report of an ASGE workshop. Gastrointest Endosc 2010; 71: 446-454 DOI: 10.1016/j.gie.2009.10.027. (PMID: 20189503)

  Google Scholar

• 29 Choi JH, Kozarek RA, Larsen MC. et al. Effectiveness and safety of lumen-apposing metal stents in endoscopic interventions for off-label indications. Dig Dis Sci 2022; 67: 2327-2336 DOI: 10.1007/s10620-021-07270-1. (PMID: 34718905)

  Google Scholar

• 30 Nass KJ, Zwager LW, van der Vlugt M. et al. Novel classification for adverse events in GI endoscopy: the AGREE classification. Gastrointest Endosc 2022; 95: 1078-1085e8

  Google Scholar

• 31 Newman KL, Johnson KM, Cornia PB. et al. Perioperative evaluation and management of patients with cirrhosis: risk assessment, surgical outcomes, and future directions. Clin Gastroenterol Hepatol 2020; 18: 2398-2414e3

  Google Scholar

• 32 Johnson KM, Newman KL, Green PK. et al. Incidence and risk factors of postoperative mortality and morbidity after elective versus emergent abdominal surgery in a national sample of 8193 patients with cirrhosis. Ann Surg 2021; 274: e345-e354

  Google Scholar

• 33 Simon K, Orlowska I, Pazgan-Simon M. The risk of complications of endoscopic procedures in patients with liver cirrhosis. Clin Exp Hepatol 2017; 3: 135-140 DOI: 10.5114/ceh.2017.70284. (PMID: 29062903)

  Google Scholar

• 34 Leal C, Prado V, Colan J. et al. Adverse events and acute chronic liver failure in patients with cirrhosis undergoing endoscopic retrograde cholangiopancreatography: a multicenter matched-cohort study. Am J Gastroenterol 2019; 114: 89-97

  Google Scholar

• 35 James TW, Krafft M, Croglio M. et al. EUS-guided gallbladder drainage in patients with cirrhosis: results of a multicenter retrospective study. Endosc Int Open 2019; 7: E1099-E1104

  Google Scholar