Dagmar Simkova1, Jan Mares1, Zuzana Vackova1, Tomas Hucl1, Petr Stirand1, Eva Kieslichova2, Ondrej Ryska3, Julius Spicak1, Sylvia Drazilova4, Eduard Veseliny4, Jan Martinek5,6,7. 1. Department of Hepatogastroenterology, Institute for Clinical and Experimental Medicine IKEM, Videnska 1921, 140 21, Prague 4, Czech Republic. 2. Department of Anesthesiology and Intensive Care, Institute for Clinical and Experimental Medicine IKEM, Videnska 1921, 140 21, Prague, Czech Republic. 3. Royal Lancaster Infirmary, University Hospitals of Morecambe Bay NHS Foundation Trust, Lancaster, UK. 4. 2Nd Department of Internal Medicine, PJ Safarik University and L. Pasteur University Hospital, Trieda SNP 1, 040 11, Kosice, Slovakia. 5. Department of Hepatogastroenterology, Institute for Clinical and Experimental Medicine IKEM, Videnska 1921, 140 21, Prague 4, Czech Republic. jan.martinek@volny.cz. 6. Institute of Physiology, 1St Faculty of Medicine, Charles University, Prague, Czech Republic. jan.martinek@volny.cz. 7. Faculty of Medicine, Ostrava University, Ostrava, Czech Republic. jan.martinek@volny.cz.
Abstract
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.
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.
Authors: H Inoue; H Minami; Y Kobayashi; Y Sato; M Kaga; M Suzuki; H Satodate; N Odaka; H Itoh; S Kudo Journal: Endoscopy Date: 2010-03-30 Impact factor: 10.093
Authors: Yuki B Werner; Daniel von Renteln; Tania Noder; Guido Schachschal; Ulrike W Denzer; Stefan Groth; Jan F Nast; Jan F Kersten; Martin Petzoldt; Gerhard Adam; Oliver Mann; Alessandro Repici; Cesare Hassan; Thomas Rösch Journal: Gastrointest Endosc Date: 2016-09-05 Impact factor: 9.427
Authors: Fraukje A Ponds; Paul Fockens; Aaltje Lei; Horst Neuhaus; Torsten Beyna; Jennis Kandler; Thomas Frieling; Philip W Y Chiu; Justin C Y Wu; Vivien W Y Wong; Guido Costamagna; Pietro Familiari; Peter J Kahrilas; John E Pandolfino; André J P M Smout; Albert J Bredenoord Journal: JAMA Date: 2019-07-09 Impact factor: 56.272
Authors: Yuki B Werner; Bengt Hakanson; Jan Martinek; Alessandro Repici; Burkhard H A von Rahden; Albert J Bredenoord; Raf Bisschops; Helmut Messmann; Marius C Vollberg; Tania Noder; Jan F Kersten; Oliver Mann; Jakob Izbicki; Alexander Pazdro; Uberto Fumagalli; Riccardo Rosati; Christoph-Thomas Germer; Marlies P Schijven; Alice Emmermann; Daniel von Renteln; Paul Fockens; Guy Boeckxstaens; Thomas Rösch Journal: N Engl J Med Date: 2019-12-05 Impact factor: 91.245
Authors: Eric S Hungness; Joel M Sternbach; Ezra N Teitelbaum; Peter J Kahrilas; John E Pandolfino; Nathaniel J Soper Journal: Ann Surg Date: 2016-09 Impact factor: 12.969
Authors: Bas L A M Weusten; Maximilien Barret; Albert J Bredenoord; Pietro Familiari; Jan-Michel Gonzalez; Jeanin E van Hooft; Sauid Ishaq; Vicente Lorenzo-Zúñiga; Hubert Louis; Suzanne van Meer; Helmut Neumann; Daniel Pohl; Frederic Prat; Daniel von Renteln; Edoardo Savarino; Rami Sweis; Jan Tack; Radu Tutuian; Jan Martinek Journal: Endoscopy Date: 2020-05-06 Impact factor: 10.093