BACKGROUND: Peroral endoscopic myotomy (POEM) is nowadays a standard method for treatment of achalasia; nevertheless, it remains an invasive intervention with corresponding risk of adverse events (AEs). The classification and grading of AEs are still a matter of discussion. The aim of our retrospective study was to assess the occurrence of all "undesirable" events and "true" adverse events in patients undergoing POEM and to compare the outcomes when either Clavien-Dindo classification (CDC) or American Society of Gastrointestinal Endoscopy (ASGE) lexicon classification applied. METHODS: This was a retrospective analysis of prospectively managed database of all patients who had undergone POEM between December 2012 and August 2018. We assessed the pre-, peri-, and early-postoperative (up to patient's discharge) undesirable events (including those not fulfilling criteria for AEs) and "true" AEs according the definition in either of the classifications. RESULTS: A total of 231 patients have successfully undergone 244 POEM procedures (13 × re-POEM). Twenty-nine procedures (11.9%) passed uneventfully, while in 215 procedures (88.1%), a total of 440 undesirable events occurred. The CDC identified 27 AEs (17 minor, 10 major) occurring in 23/244 (9.4%) procedures. The ASGE lexicon identified identical 27 AEs (21 mild or moderate, 6 severe or fatal) resulting in the severity distribution of AEs being the only difference between the two classifications. Only the absence of previous treatment was found to be a risk factor [p = 0.047, OR with 95% CI: 4.55 (1.02; 20.25)] in the combined logistic regression model. CONCLUSION: Undesirable events are common in patients undergoing POEM but the incidence of true AEs is low according to both classifications. Severe adverse events are infrequent irrespective of the classification applied. CDC may be more appropriate than ASGE lexicon for classifying POEM-related AEs given a surgical nature of this procedure.

Department of Anesthesiology and Intensive Care Institute for Clinical and Experimental Medicine IKEM Videnska 1921 140 21 Prague Czech Republic

Department of Hepatogastroenterology Institute for Clinical and Experimental Medicine IKEM Videnska 1921 140 21 Prague 4 Czech Republic

Faculty of Medicine Ostrava University Ostrava Czech Republic

Institute of Physiology 1St Faculty of Medicine Charles University Prague Czech Republic

Nd Department of Internal Medicine PJ Safarik University and L Pasteur University Hospital Trieda SNP 1 040 11 Kosice Slovakia

Royal Lancaster Infirmary University Hospitals of Morecambe Bay NHS Foundation Trust Lancaster UK

Zobrazit více v PubMed

Inoue H, Minami H, Kobayashi Y, Sato Y, Kaga M, Suzuki M, Satodate H, Odaka N, Itoh H, Kudo S (2010) Peroral endoscopic myotomy (POEM) for esophageal achalasia. Endoscopy 42(4):265–271. https://doi.org/10.1055/s-0029-1244080 PubMed DOI

Werner YB, Hakanson B, Martinek J, Repici A, von Rahden BHA, Bredenoord AJ, Bisschops R, Messmann H, Vollberg MC, Noder T, Kersten JF, Mann O, Izbicki J, Pazdro A, Fumagalli U, Rosati R, Germer CT, Schijven MP, Emmermann A, von Renteln D, Fockens P, Boeckxstaens G, Rösch T (2019) Endoscopic or surgical myotomy in patients with idiopathic achalasia. N Engl J Med 381(23):2219–2229. https://doi.org/10.1056/NEJMoa1905380 PubMed DOI

Shiwaku H, Inoue H, Onimaru M, Minami H, Sato H, Sato C, Tanaka S, Ogawa R, Okushima N (2020) Multicenter collaborative retrospective evaluation of peroral endoscopic myotomy for esophageal achalasia: analysis of data from more than 1300 patients at eight facilities in Japan. Surg Endosc 34(1):464–468. https://doi.org/10.1007/s00464-019-06833-8 PubMed DOI

Shiwaku H, Inoue H, Sato H, Onimaru M, Minami H, Tanaka S, Sato C, Ogawa R, Okushima N, Yokomichi H (2020) Peroral endoscopic myotomy for achalasia: a prospective multicenter study in Japan. Gastrointest Endosc 91(5):1037-1044.e2. https://doi.org/10.1016/j.gie.2019.11.020 PubMed DOI

Hungness ES, Sternbach JM, Teitelbaum EN, Kahrilas PJ, Pandolfino JE, Soper NJ (2016) Per-oral endoscopic myotomy (POEM) after the learning curve: durable long-term results with a low complication rate. Ann Surg 264(3):508–517. https://doi.org/10.1097/SLA.0000000000001870 PubMed DOI

Ponds FA, Fockens P, Lei A, Neuhaus H, Beyna T, Kandler J, Frieling T, Chiu PWY, Wu JCY, Wong VWY, Costamagna G, Familiari P, Kahrilas PJ, Pandolfino JE, Smout AJPM, Bredenoord AJ (2019) Effect of peroral endoscopic myotomy vs pneumatic dilation on symptom severity and treatment outcomes among treatment-naive patients with achalasia: a randomized clinical trial. JAMA 322(2):134–144. https://doi.org/10.1001/jama.2019.8859 PubMed DOI PMC

Oude Nijhuis RAB, Zaninotto G, Roman S, Boeckxstaens GE, Fockens P, Langendam MW, Plumb AA, Smout A, Targarona EM, Trukhmanov AS, Weusten B, Bredenoord AJ (2020) European guidelines on achalasia: United European gastroenterology and European society of neurogastroenterology and motility recommendations. United Eur Gastroenterol J 8(1):13–33. https://doi.org/10.1177/2050640620903213 DOI

Weusten BLAM, Barret M, Bredenoord AJ, Familiari P, Gonzalez JM, van Hooft JE, Ishaq S, Lorenzo-Zúñiga V, Louis H, van Meer S, Neumann H, Pohl D, Prat F, von Renteln D, Savarino E, Sweis R, Tack J, Tutuian R, Martinek J (2020) Endoscopic management of gastrointestinal motility disorders—part 1: European society of gastrointestinal endoscopy (ESGE) guideline. Endoscopy 52(6):498–515. https://doi.org/10.1055/a-1160-5549 PubMed DOI

Patel K, Abbassi-Ghadi N, Markar S, Kumar S, Jethwa P, Zaninotto G (2016) Peroral endoscopic myotomy for the treatment of esophageal achalasia: systematic review and pooled analysis. Dis Esophagus 29(7):807–819. https://doi.org/10.1111/dote.12387 PubMed DOI

Nabi Z, Reddy DN, Ramchandani M (2018) Adverse events during and after per-oral endoscopic myotomy: prevention, diagnosis, and management. Gastrointest Endosc 87(1):4–17. https://doi.org/10.1016/j.gie.2017.09.029 PubMed DOI

Werner YB, von Renteln D, Noder T, Schachschal G, Denzer UW, Groth S, Nast JF, Kersten JF, Petzoldt M, Adam G, Mann O, Repici A, Hassan C, Rösch T (2017) Early adverse events of per-oral endoscopic myotomy. Gastrointest Endosc 85(4):708-718.e2. https://doi.org/10.1016/j.gie.2016.08.033 PubMed DOI

Chen YI, Inoue H, Ujiki M, Draganov PV, Colavita P, Mion F, Romanelli J, Chiu P, Balassone V, Patel L, Abbas A, Yang D, Dunst C, Pioche M, Roman S, Rivory J, Ponchon T, Desilets D, Maselli R, Onimaru M, Nakamura J, Hata Y, Hajiyeva G, Ismail A, Ngamruengphong S, Bukhari M, Chavez YH, Kumbhari V, Repici A, Khashab MA (2018) An international multicenter study evaluating the clinical efficacy and safety of per-oral endoscopic myotomy in octogenarians. Gastrointest Endosc 87(4):956–961. https://doi.org/10.1016/j.gie.2017.02.007 PubMed DOI

Zhang XC, Li QL, Xu MD, Chen SY, Zhong YS, Zhang YQ, Chen WF, Ma LL, Qin WZ, Hu JW, Cai MY, Yao LQ, Zhou PH (2016) Major perioperative adverse events of peroral endoscopic myotomy: a systematic 5-year analysis. Endoscopy 48(11):967–978. https://doi.org/10.1055/s-0042-110397 PubMed DOI

Cotton PB, Eisen GM, Aabakken L, Baron TH, Hutter MM, Jacobson BC, Mergener K, Nemcek A Jr, Petersen BT, Petrini JL, Pike IM, Rabeneck L, Romagnuolo J, Vargo JJ (2010) A lexicon for endoscopic adverse events: report of an ASGE workshop. Gastrointest Endosc 71(3):446–454. https://doi.org/10.1016/j.gie.2009.10.027 PubMed DOI

Chavan R, Nabi Z, Reddy DN (2020) Adverse events associated with third space endoscopy: diagnosis and management. Int J Gastrointest Interv 9:86–97. https://doi.org/10.18528/ijgii200010 DOI

Dindo D, Demartines N, Clavien PA (2004) Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg 240(2):205–213. https://doi.org/10.1097/01.sla.0000133083.54934.ae PubMed DOI PMC

NOSCAR POEM White Paper Committee, Stavropoulos SN, Desilets DJ, Fuchs KH, Gostout CJ, Haber G, Inoue H, Kochman ML, Modayil R, Savides T, Scott DJ, Swanstrom LL, Vassiliou MC. 2014 Per-oral endoscopic myotomy white paper summary. Gastrointest Endosc. 80(1):1–15. Doi: https://doi.org/10.1016/j.gie.2014.04.014 .

Haito-Chavez Y, Inoue H, Beard KW, Draganov PV, Ujiki M, Rahden BHA, Desai PN, Pioche M, Hayee B, Haji A, Saxena P, Reavis K, Onimaru M, Balassone V, Nakamura J, Hata Y, Yang D, Pannu D, Abbas A, Perbtani YB, Patel LY, Filser J, Roman S, Rivory J, Mion F, Ponchon T, Perretta S, Wong V, Maselli R, Ngamruengphong S, Chen YI, Bukhari M, Hajiyeva G, Ismail A, Pieratti R, Kumbhari V, Galdos-Cardenas G, Repici A, Khashab MA (2017) Comprehensive analysis of adverse events associated with per oral endoscopic myotomy in 1826 patients: an international multicenter study. Am J Gastroenterol 112(8):1267–1276. https://doi.org/10.1038/ajg.2017.139 PubMed DOI

Martinek J, Svecova H, Vackova Z, Dolezel R, Ngo O, Krajciova J, Kieslichova E, Janousek R, Pazdro A, Harustiak T, Zdrhova L, Loudova P, Stirand P, Spicak J (2018) Per-oral endoscopic myotomy (POEM): mid-term efficacy and safety. Surg Endosc 32(3):1293–1302. https://doi.org/10.1007/s00464-017-5807-3 PubMed DOI

Parsa N, Haito-Chavez Y, Gutierrez OIB et al (2018) Sa1907 Classification and grading of adverse events related to peroral endoscopic myotomy (poem): a comparison between the American society of gastrointestinal endoscopy lexicon and the Clavien-Dindo classification. Gastrointest Endosc. https://doi.org/10.1016/j.gie.2018.04.429 DOI

Hucl T, Uchytilova E, Markvartova J, Tomasek P, Kieslichova E, Spicak J, Martinek J (2020) Cardiac arrest as a fatal periprocedural complication of peroral endoscopic myotomy (POEM). Endoscopy 52(11):E411–E412. https://doi.org/10.1055/a-1149-1055 PubMed DOI

Ross SW, Oommen B, Wormer BA, Walters AL, Matthews BD, Heniford BT, Augenstein VA (2015) National outcomes of laparoscopic heller myotomy: operative complications and risk factors for adverse events. Surg Endosc 29(11):3097–3105. https://doi.org/10.1007/s00464-014-4054-0 PubMed DOI

Costantini A, Familiari P, Costantini M, Salvador R, Valmasoni M, Capovilla G, Landi R, Mangiola F, Provenzano L, Briscolini D, Merigliano S, Costamagna G (2020) Poem versus laparoscopic heller myotomy in the treatment of esophageal achalasia: a case-control study from two high volume centers using the propensity score. J Gastrointest Surg 24(3):505–515. https://doi.org/10.1007/s11605-019-04465-w PubMed DOI

Martins RK, Ribeiro IB, de Moura DTH, Hathorn KE, Bernardo WM, de Moura EGH (2020) Peroral (POEM) or surgical myotomy for the treatment of achalasia: a systematic review and meta-analysis. Arq Gastroenterol 57(1):79–86. https://doi.org/10.1590/S0004-2803.202000000-14 PubMed DOI

Benias PC, Korrapati P, Raphael KL, D’Souza LS, Inamdar S, Trindade AJ, Lee C, Kumbhari V, Sejpal DV, Okolo P, Khashab MA, Miller L, Carr-Locke D (2019) Safety and feasibility of performing peroral endoscopic myotomy as an outpatient procedure with same-day discharge. Gastrointest Endosc 90(4):570–578. https://doi.org/10.1016/j.gie.2019.04.247 PubMed DOI

Tan S, Zhong C, Ren Y, Luo X, Xu J, Fu X, Peng Y, Tang X (2021) Efficacy and safety of peroral endoscopic myotomy in achalasia patients with failed previous intervention: a systematic review and meta-analysis. Gut Liver 15(2):153–167. https://doi.org/10.5009/gnl19234 PubMed DOI

Huang Z, Cui Y, Li Y, Chen M, Xing X (2021) Peroral endoscopic myotomy for patients with achalasia with previous heller myotomy: a systematic review and meta-analysis. Gastrointest Endosc 93(1):47-56.e5. https://doi.org/10.1016/j.gie.2020.05.056 PubMed DOI

Crespin OM, Liu LWC, Parmar A, Jackson TD, Hamid J, Shlomovitz E, Okrainec A (2017) Safety and efficacy of POEM for treatment of achalasia: a systematic review of the literature. Surg Endosc 31(5):2187–2201. https://doi.org/10.1007/s00464-016-5217-y PubMed DOI

Talukdar R, Inoue H, Nageshwar RD (2015) Efficacy of peroral endoscopic myotomy (POEM) in the treatment of achalasia: a systematic review and meta-analysis. Surg Endosc 29(11):3030–3046. https://doi.org/10.1007/s00464-014-4040-6 PubMed DOI