J. Filser

Comprehensive Analysis of Adverse Events Associated with per Oral Endoscopic Myotomy in 1826 Patients: An International Multicenter Study

Objectives:The safety of peroral endoscopic myotomy (POEM) is still debated since comprehensive analysis of adverse events (AEs) associated with the procedure in large multicenter cohort studies has not been performed. To study (1) the prevalence of AEs and (2) factors associated with occurrence of AEs in patients undergoing POEM.Methods:Patients who underwent POEM at 12 tertiary-care centers between 2009 and 2015 were included in this case–control study. Cases were defined by the occurrence of any AE related to the POEM procedure. Control patients were selected for each AE case by matching for age, gender, and disease classification (achalasia type I and II vs. type III/spastic esophageal disorders).Results:A total of 1,826 patients underwent POEM. Overall, 156 AEs occurred in 137 patients (7.5%). A total of 51 (2.8%) inadvertent mucosotomies occurred. Mild, moderate, and severe AEs had a frequency of 116 (6.4%), 31 (1.7%), and 9 (0.5%), respectively. Multivariate analysis demonstrated that sigmoid-type esophagus (odds ratio (OR) 2.28, P=0.05), endoscopist experience <20 cases (OR 1.98, P=0.04), use of a triangular tip knife (OR 3.22, P=0.05), and use of an electrosurgical current different than spray coagulation (OR 3.09, P=0.02) were significantly associated with the occurrence of AEs.Conclusions:This large study comprehensively assessed the safety of POEM and highly suggests POEM as a relatively safe procedure when performed by experts at tertiary centers with an overall 7.5% prevalence of AEs. Severe AEs are rare. Sigmoid-type esophagus, endoscopist experience, type of knife, and current used can be considered as predictive factors of AE occurrence.

Neu erkannte Nebenwirkungen von Protonenpumpeninhibitoren

ZusammenfassungProtonenpumpeninhibitoren (PPI) werden unter anderem zur medikamentösen Therapie der gastroösophagealen Refluxkrankheit (GERD) verwendet. PPI sind die meistverschriebenen und -verwendeten Medikament in der Gastroenterologie. PPI wurden bislang als sehr nebenwirkungsarm angesehen. In den letzten Jahren häufen sich allerdings Studienergebnisse zu neuen relevanten Nebenwirkungen. Wir liefern einen Überblick zur aktuellen Datenlage der PPI-Nebenwirkungen und diskutieren deren Relevanz für die Therapieverfahrenswahl bei GERD (medikamentöse Dauertherapie vs. Antirefluxchirurgie).PPI sind nach neuen Daten assoziiert mit: osteoporosebedingten Frakturen, Clostridium-difficile-assoziierter Diarrhö (CDAD), nosokomialen und extranosokomialen Pneumonien, pharmakologischer Interaktion mit Clopidogrel und Acetylsalicylsäure und konsekutiv vermehrten kardiovaskulären Ereignissen, therapierefraktärer Hypomagnesiämie, Rebound-Refluxsymptomen etc. Die Nutzen-Risiko-Relation bei den PPIs sollte zunehmend kritischer beurteilt werden, da – insbesondere bei Langzeiteinnahme – die Nebenwirkungen die positiven Effekte überwiegen können. Die schweren PPI-Nebenwirkungen können als starkes Argument zugunsten der laparoskopischen Fundoplicatio bei GERD gelten.AbstractAmong other indications proton pump inhibitors (PPIs) are used as medical treatment of gastroesophageal reflux disease (GERD) and are the most frequently prescribed and most frequently used drugs in gastroenterology. Until recently PPIs were regarded as very safe and associated with very few side-effects. However, during recent years study results have revealed many severe adverse events associated especially with long-term PPI use. We review the currently available evidence, regarding the side-effects of PPIs and discuss the potential impact on treatment strategies for GERD (conservative treatment vs. antireflux surgery).Currently available data suggest that PPIs are associated with osteoporosis-related fractures, Clostridium difficile associated diarrhea (CDAD), community and hospital-acquired pneumonia, pharmacologic interaction with clopidogrel and acetylsalicylic acid with subsequent increased rate of cardiovascular events, refractory hypomagnesemia and rebound reflux symptoms etc. The risk-benefit ratio of PPIs is increasingly recognized as being less favourable. This leads to a more critical viewpoint and raises the question whether the side-effects of PPIs may outweigh the benefits, especially with long-term use. The side-effects of PPIs seem to make a strong argument in favour of laparoscopic fundoplication in the treatment of GERD.Among other indications proton pump inhibitors (PPIs) are used as medical treatment of gastroesophageal reflux disease (GERD) and are the most frequently prescribed and most frequently used drugs in gastroenterology. Until recently PPIs were regarded as very safe and associated with very few side-effects. However, during recent years study results have revealed many severe adverse events associated especially with long-term PPI use. We review the currently available evidence, regarding the side-effects of PPIs and discuss the potential impact on treatment strategies for GERD (conservative treatment vs. antireflux surgery). Currently available data suggest that PPIs are associated with osteoporosis-related fractures, Clostridium difficile associated diarrhea (CDAD), community and hospital-acquired pneumonia, pharmacologic interaction with clopidogrel and acetylsalicylic acid with subsequent increased rate of cardiovascular events, refractory hypomagnesemia and rebound reflux symptoms etc. The risk-benefit ratio of PPIs is increasingly recognized as being less favourable. This leads to a more critical viewpoint and raises the question whether the side-effects of PPIs may outweigh the benefits, especially with long-term use. The side-effects of PPIs seem to make a strong argument in favour of laparoscopic fundoplication in the treatment of GERD.

Perorale endoskopische Myotomie zur Therapie der Achalasie

ZusammenfassungDie perorale endoskopische Myotomie (POEM) ist ein neues, rein endoskopisches Therapieverfahren zur Behandlung der Achalasie. Durch den Verzicht auf Inzisionen ist POEM als echte NOTES („natural orifice endoscopic surgery“) -Verfahren zu bezeichnen. Mit POEM wird eine zum bisherigen Standardverfahren – der laparoskopischen Heller-Myotomie (LHM) – weitestgehend analoge Myotomie angelegt. Als Vorteil kann unter anderem die nahezu freie Wählbarkeit von Länge und Lokalisation der Myotomie angesehen werden. Bei der Durchführung der POEM wird eine Mukosainzision („mucosal entry“) angelegt, ein submukosaler Tunnel bis über den ösophagogastralen Übergang präpariert, die schrittweise antegrade Myotomie vorgenommen und schließlich die Mukosainzision mit endoskopischen Clips wieder verschlossen. Seit der Erstbeschreibung der Anwendung am Menschen im Jahr 2010 durch den Pionier der Methode, Haruhiro Inoue, Yokohama, Japan, wird die Methode zunehmend mit vielversprechenden Ergebnissen an verschiedenen Zentren in Asien, U.S.A. und Europa erprobt. Obwohl technisch anspruchsvoll, ist die Prozedur gut und mit geringer Komplikationsrate durchführbar. Die Dysphagiekontrolle kann als sehr gut bezeichnet werden (95–100 %). Zur Häufigkeit von Reflux nach POEM, der mit Protonenpumpeninhibitoren gut kontrollierbar ist, liegen noch sehr unterschiedliche Daten vor. Wir präsentieren in diesem Beitrag einen Literaturüberblick zur aktuellen Datenlage und unsere eigenen initialen Ergebnisse von 14 mit POEM behandelten Patienten.AbstractPeroral endoscopic myotomy (POEM) is a new, purely endoscopic procedure for treatment of achalasia. Due to the lack of incisions POEM can be regarded as a true NOTES procedure. With POEM a myotomy is created in a similar fashion to the previous standard treatment, laparoscopic Heller myotomy (LHM). The relatively free choice of length and localization of the myotomy may be regarded as advantages of POEM. The procedure starts with a mucosal incision (mucosal entry) followed by preparation of a submucosal tunnel crossing the esophagogastric junction and creation of a myotomy in an antegrade direction before the mucosal access is closed with endoscopic clip placement. Since the first description of the application of POEM in humans in 2010 by the pioneer Haruhiro Inoue, Yokohama, Japan, it has been used increasingly and investigated in some centers in Asia, the U.S.A. and also Europe. The results are very promising. Although the procedure is technically demanding it can be performed safely with low complication rates. The POEM procedure achieves very good control of dysphagia and gastroesophageal reflux witch is only a rare side-effect witch is well-controllable with proton pump inhibitors (PPI). We review the currently available data from the literature and present our own initial series of  14 patients treated with POEM.Peroral endoscopic myotomy (POEM) is a new, purely endoscopic procedure for treatment of achalasia. Due to the lack of incisions POEM can be regarded as a true NOTES procedure. With POEM a myotomy is created in a similar fashion to the previous standard treatment, laparoscopic Heller myotomy (LHM). The relatively free choice of length and localization of the myotomy may be regarded as advantages of POEM. The procedure starts with a mucosal incision (mucosal entry) followed by preparation of a submucosal tunnel crossing the esophagogastric junction and creation of a myotomy in an antegrade direction before the mucosal access is closed with endoscopic clip placement. Since the first description of the application of POEM in humans in 2010 by the pioneer Haruhiro Inoue, Yokohama, Japan, it has been used increasingly and investigated in some centers in Asia, the U.S.A. and also Europe. The results are very promising. Although the procedure is technically demanding it can be performed safely with low complication rates. The POEM procedure achieves very good control of dysphagia and gastroesophageal reflux witch is only a rare side-effect witch is well-controllable with proton pump inhibitors (PPI). We review the currently available data from the literature and present our own initial series of  14 patients treated with POEM.

Diagnostik und Therapie der Achalasie

ZusammenfassungDie primär idiopathische Achalasie hat gerade wegen ihrer geringen Inzidenz (1:100.000) für Patienten und Behandler eine besondere Bedeutung: Patienten haben oft einen langen Leidensweg hinter sich, bevor die Diagnose gestellt wird und eine adäquate Therapie erfolgt. Chirurgen, die Antirefluxchirurgie betreiben, müssen sicherstellen, dass Achalasiepatienten in ihrem Patientenkollektiv detektiert werden, um die streng kontraindizierte alleinige Fundoplikation zu vermeiden. Goldstandard für die Diagnosestellung ist die Manometrie, da insbesondere Frühstadien nicht mit ausreichender Sensitivität anhand Symptomevaluation, Endoskopie und Breischluckuntersuchung zu diagnostizieren sind. Zunehmend wird die High-resolution-Manometrie verwendet, die eine Unterscheidung verschiedener Typen (Typ I klassische Form, Typ II panösophageale Kompression, Typ III spasmodische Form) und eine Abgrenzung von anderen Motilitätsstörungen (distaler Ösophagospasmus, Jackhammer-Ösophagus, Nussknacker-Ösophagus etc.) ermöglicht. Bei Patienten > 45 Jahre werden zusätzlich eine Endosonographie und eine CT zum Ausschluss einer Pseudoachalasie empfohlen. Zwar gibt es keine kurative Therapie, wohl aber sehr gute Verfahren zur symptomatischen Behandlung. Ziele sind Dysphagiekontrolle, Verbesserung der ösophagealen Clearance, Refluxprophylaxe, und Aufhebung der Brustschmerzen. Standard ist die vor 100 Jahren von Ernst Heller beschriebene Kardiomyotomie, die den endoskopischen Therapieverfahren (Botox-Injektion, Ballondilatation) überlegen ist. Diese wird heute standardmäßig als laparoskopische Heller-Myotomie (LHM) durchgeführt und mit einer partiellen Fundoplikation kombiniert. Alternativ wird aktuell die perorale endoskopische Myotomie (POEM) in Zentren klinisch erprobt, mit der die Heller-Myotomie auf rein endoskopischem Wege durchgeführt wird und vielversprechende Ergebnisse erzielt werden.AbstractThe low incidence (1:100,000) makes primary idiopathic achalasia a problem of special importance. Patients often have a long medical history of suffering before the diagnosis is established and adequate therapy provided. Surgeons who perform antireflux surgery must be certain of detecting achalasia patients within their collective of gastroesophageal reflux disease (GERD) patients to avoid contraindicated fundoplication. The current gold standard for establishing the diagnosis of achalasia is manometry. Especially in early stages, symptom evaluation, endoscopy and barium swallow lack adequate sensitivity. High-resolution manometry (HRM) is increasingly used and allows characterization of different achalasia types (i.e. type I classical achalasia, type II panesophageal pressurization and type III spasmodic achalasia) and differentiation from other motility disorders (e.g. distal esophageal spasm, jackhammer esophagus and nutcracker esophagus). For patients over 45 years of age additional endoscopic ultrasound and computed tomography are recommended to exclude pseudoachalasia. A curative treatment restoring normal esophageal function does not exist; however, there are good options for symptom control. Therapy aims are abolishment of dysphagia, improvement of esophageal clearance, prevention of reflux and abolishment of chest pain. The current standard treatment is cardiomyotomy, which was first described 100 years ago by the German surgeon Ernst Heller and has been shown to be clearly superior when compared to endoscopic treatment (e.g. botox injection and balloon dilatation). Heller’s myotomy procedure is preferentially performed via the laparoscopic route and combined with partial fundoplication. Currently, an alternative to performing Heller’s myotomy via the endoscopic route is under intensive investigation in several centers worldwide. The peroral endoscopic myotomy (POEM) procedure has shown very promising initial results and warrants further clinical evaluation.

Erratum zu: Operative Therapie bei Achalasie – endoskopisch oder laparoskopisch? Vorschlag für die maßgeschneiderte Verfahrenswahl

ES(2013)Comparisonofesophagogastric junction distensibility changes during POEM and Heller myotomy using intraoperative FLIP. Surg Endosc 27:4547–4555 29. Hungness ES, TeitelbaumEN, Santos BF, Arafat FO, PandolfinoJE,KahrilasPJ, SoperNJ (2013)Comparison of perioperative outcomes between peroral esophageal myotomy (POEM) and laparoscopic Hellermyotomy. JGastrointestSurg17:228–335 30. Marano L, Pallabazzer G, Solito B, Santi S, Pigazzi A, De Luca R, Biondo FG, Spaziani A, Longaroni M, Di Martino N, Boccardi V, Patriti A (2016) Surgery or peroral esophageal myotomy for achalasia: a systematic review andmeta-analysis. Medicine (Baltimore) 95:e3001. doi:10.1097/MD. 0000000000003001 31. Kilic A, Schuchert MJ, Pennathur A, Gilbert S, Landreneau RJ, Luketich JD (2009) Long-term outcomes of laparoscopic Heller myotomy for achalasia. Surgery 146:826–833. doi:10.1016/j. surg.2009.06.049 32. PortaleG,CostantiniM,RizzettoC,GuirroliE,Ceolin M, Salvador R, Ancona E, ZaninottoG (2005) Longterm outcome of laparoscopic Heller-Dor surgery foresophagealachalasia:possibledetrimental role of previous endoscopic treatment. J Gastrointest Surg9:1332–1339 33. Cowgill SM, Villadolid D, Boyle R, Al-Saadi S, Ross S, Rosemurgy AS 2nd (2009) Laparoscopic Heller myotomy for achalasia: results after 10 years. Surg Endosc 23(12):2644–2649. doi:10.1007/s00464009-0508-1 34. Jeansonne LO, White BC, Pilger KE, Shane MD, Zagorski S, Davis SS, Hunter JG, Lin E, Smith CD (2007) Ten-year follow-up of laparoscopic Heller myotomy for achalasia shows durability. Surg Endosc21:1498–1502 35. Frantzides CT, Moore RE, Carlson MA, Madan AK, Zografakis JG, Keshavarzian A, Smith C (2004) Minimally invasive surgery for achalasia: a 10-year experience. JGastrointestSurg8:18–23 36. InoueH,SatoH,IkedaH,OnimaruM,SatoC,Minami H, Yokomichi H, Kobayashi Y, Grimes KL, Kudo SE (2015) Per-oral endoscopic myotomy: a series of 500 patients. J Am Coll Surg 221:256–264. doi:10. 1016/j.jamcollsurg.2015.03.057 37. Werner YB, Costamagna G, Swanström LL, von Renteln D, Familiari P, Sharata AM, Noder T, Schachschal G, Kersten JF, Rösch T (2016) Clinical response to peroral endoscopic myotomy in patients with idiopathic achalasia at a minimum follow-up of 2years. Gut 65(6):899–906. doi:10. 1136/gutjnl-2014-308649 38. Ngamruengphong S, Inoue H, Chiu P, Yip HC, BapayeA,UjikiM, Patel L,Desai PN,HayeeB,Haji A, Wong V, Perretta S, Dorwat S, PiocheM, Roman S, Rivory J, Mion F, Ponchon T, Garros A, Nakamura J, Hata Y, Balassone V, OnimaruM, Hajiyeva G, Ismail A, Chen YI, Bukhari M, Haito-Chavez Y, Kumbhari V, Maselli R, Repici A, Khashab MA (2016) Longterm outcomes of per-oral endoscopic myotomy in achalasia patients with a minimum follow-up of 2 years: an international multicenter study. Gastrointest Endosc. doi:10.1016/j.gie.2016.09. 017 Chirurg 2017 · 88:210 DOI 10.1007/s00104-017-0403-6 Online publiziert: 22. Februar 2017

Tu1229 Endoluminal Functional Lumen Imaging Probe (EndoFLIP) During Peroral Endoscopic Myotomy (POEM) for Achalasia Predicts Postoperative Clinical Success: A Multicenter Case-Control Study

Background: Anorectal manometry is useful in evaluating and planning treatment in patients with fecal incontinence (FI) and other disorders of defecation. Traditional water perfusion techniques are limited to 4 to 8 radial measurements obtained via a pullback technique. Three-dimensional high resolution anorectal manometry (3D HRAM) employs solid state micro transducers and can obtain 257 data points during resting, squeeze, and bear down (simulated defecation) sequences. Data are then reconstructed into a 3D format showing functional anatomy. While differences are known to exist between patients with FI and obstruction, patients with mixed disorders (of FI and obstruction) are less well described Objective: To determine physiologic differences between groups of female patients with FI, obstructed defecation, and mixed disorders. In addition to known parameters of mean resting pressure and maximal squeeze pressure, relationships between rectoanal pressure differential and percent anal relaxation were sought among the groups. Methods Retrospective chart review of 50 female patients undergoing 3D HRAM between 1/1/ 13 and 6/1/14. Physiologic values including mean resting, and maximal squeeze pressures, percent anal relaxation, and rectoanal pressure differential were recorded. Analysis of variance test, and linear regression analysis was performed as appropriate. Results:Women with mixed defecatory disorders had sphincter pressure profiles that were significantly different from patients with pure FI or obstruction (table). While rectoanal pressure differential was not different among the groups, patients with mixed disorders had a significant linear relationship between rectoanal pressure differential and percent anal relaxation that was not seen among the pure FI or obstructed groups (figure). Conclusion: Mixed defecatory disorders are associated with a unique physiologic profile that can be characterized using 3D HRAM. The mixed defecatory group demonstrates relationships between physiologic parameters that are not seen the incontinent or obstructed groups. This data will be helpful in the planning treatment regimens.

Diagnostik und Therapie der Achalasie@@@Diagnostics and therapy of achalasia

ZusammenfassungDie primär idiopathische Achalasie hat gerade wegen ihrer geringen Inzidenz (1:100.000) für Patienten und Behandler eine besondere Bedeutung: Patienten haben oft einen langen Leidensweg hinter sich, bevor die Diagnose gestellt wird und eine adäquate Therapie erfolgt. Chirurgen, die Antirefluxchirurgie betreiben, müssen sicherstellen, dass Achalasiepatienten in ihrem Patientenkollektiv detektiert werden, um die streng kontraindizierte alleinige Fundoplikation zu vermeiden. Goldstandard für die Diagnosestellung ist die Manometrie, da insbesondere Frühstadien nicht mit ausreichender Sensitivität anhand Symptomevaluation, Endoskopie und Breischluckuntersuchung zu diagnostizieren sind. Zunehmend wird die High-resolution-Manometrie verwendet, die eine Unterscheidung verschiedener Typen (Typ I klassische Form, Typ II panösophageale Kompression, Typ III spasmodische Form) und eine Abgrenzung von anderen Motilitätsstörungen (distaler Ösophagospasmus, Jackhammer-Ösophagus, Nussknacker-Ösophagus etc.) ermöglicht. Bei Patienten > 45 Jahre werden zusätzlich eine Endosonographie und eine CT zum Ausschluss einer Pseudoachalasie empfohlen. Zwar gibt es keine kurative Therapie, wohl aber sehr gute Verfahren zur symptomatischen Behandlung. Ziele sind Dysphagiekontrolle, Verbesserung der ösophagealen Clearance, Refluxprophylaxe, und Aufhebung der Brustschmerzen. Standard ist die vor 100 Jahren von Ernst Heller beschriebene Kardiomyotomie, die den endoskopischen Therapieverfahren (Botox-Injektion, Ballondilatation) überlegen ist. Diese wird heute standardmäßig als laparoskopische Heller-Myotomie (LHM) durchgeführt und mit einer partiellen Fundoplikation kombiniert. Alternativ wird aktuell die perorale endoskopische Myotomie (POEM) in Zentren klinisch erprobt, mit der die Heller-Myotomie auf rein endoskopischem Wege durchgeführt wird und vielversprechende Ergebnisse erzielt werden.AbstractThe low incidence (1:100,000) makes primary idiopathic achalasia a problem of special importance. Patients often have a long medical history of suffering before the diagnosis is established and adequate therapy provided. Surgeons who perform antireflux surgery must be certain of detecting achalasia patients within their collective of gastroesophageal reflux disease (GERD) patients to avoid contraindicated fundoplication. The current gold standard for establishing the diagnosis of achalasia is manometry. Especially in early stages, symptom evaluation, endoscopy and barium swallow lack adequate sensitivity. High-resolution manometry (HRM) is increasingly used and allows characterization of different achalasia types (i.e. type I classical achalasia, type II panesophageal pressurization and type III spasmodic achalasia) and differentiation from other motility disorders (e.g. distal esophageal spasm, jackhammer esophagus and nutcracker esophagus). For patients over 45 years of age additional endoscopic ultrasound and computed tomography are recommended to exclude pseudoachalasia. A curative treatment restoring normal esophageal function does not exist; however, there are good options for symptom control. Therapy aims are abolishment of dysphagia, improvement of esophageal clearance, prevention of reflux and abolishment of chest pain. The current standard treatment is cardiomyotomy, which was first described 100 years ago by the German surgeon Ernst Heller and has been shown to be clearly superior when compared to endoscopic treatment (e.g. botox injection and balloon dilatation). Heller’s myotomy procedure is preferentially performed via the laparoscopic route and combined with partial fundoplication. Currently, an alternative to performing Heller’s myotomy via the endoscopic route is under intensive investigation in several centers worldwide. The peroral endoscopic myotomy (POEM) procedure has shown very promising initial results and warrants further clinical evaluation.

Perorale endoskopische Myotomie zur Therapie der Achalasie@@@Peroral endoscopic myotomy for treatment of achalasia: Literaturüberblick und eigene initiale Erfahrung@@@Literature review and own initial experience

ZusammenfassungDie perorale endoskopische Myotomie (POEM) ist ein neues, rein endoskopisches Therapieverfahren zur Behandlung der Achalasie. Durch den Verzicht auf Inzisionen ist POEM als echte NOTES („natural orifice endoscopic surgery“) -Verfahren zu bezeichnen. Mit POEM wird eine zum bisherigen Standardverfahren – der laparoskopischen Heller-Myotomie (LHM) – weitestgehend analoge Myotomie angelegt. Als Vorteil kann unter anderem die nahezu freie Wählbarkeit von Länge und Lokalisation der Myotomie angesehen werden. Bei der Durchführung der POEM wird eine Mukosainzision („mucosal entry“) angelegt, ein submukosaler Tunnel bis über den ösophagogastralen Übergang präpariert, die schrittweise antegrade Myotomie vorgenommen und schließlich die Mukosainzision mit endoskopischen Clips wieder verschlossen. Seit der Erstbeschreibung der Anwendung am Menschen im Jahr 2010 durch den Pionier der Methode, Haruhiro Inoue, Yokohama, Japan, wird die Methode zunehmend mit vielversprechenden Ergebnissen an verschiedenen Zentren in Asien, U.S.A. und Europa erprobt. Obwohl technisch anspruchsvoll, ist die Prozedur gut und mit geringer Komplikationsrate durchführbar. Die Dysphagiekontrolle kann als sehr gut bezeichnet werden (95–100 %). Zur Häufigkeit von Reflux nach POEM, der mit Protonenpumpeninhibitoren gut kontrollierbar ist, liegen noch sehr unterschiedliche Daten vor. Wir präsentieren in diesem Beitrag einen Literaturüberblick zur aktuellen Datenlage und unsere eigenen initialen Ergebnisse von 14 mit POEM behandelten Patienten.AbstractPeroral endoscopic myotomy (POEM) is a new, purely endoscopic procedure for treatment of achalasia. Due to the lack of incisions POEM can be regarded as a true NOTES procedure. With POEM a myotomy is created in a similar fashion to the previous standard treatment, laparoscopic Heller myotomy (LHM). The relatively free choice of length and localization of the myotomy may be regarded as advantages of POEM. The procedure starts with a mucosal incision (mucosal entry) followed by preparation of a submucosal tunnel crossing the esophagogastric junction and creation of a myotomy in an antegrade direction before the mucosal access is closed with endoscopic clip placement. Since the first description of the application of POEM in humans in 2010 by the pioneer Haruhiro Inoue, Yokohama, Japan, it has been used increasingly and investigated in some centers in Asia, the U.S.A. and also Europe. The results are very promising. Although the procedure is technically demanding it can be performed safely with low complication rates. The POEM procedure achieves very good control of dysphagia and gastroesophageal reflux witch is only a rare side-effect witch is well-controllable with proton pump inhibitors (PPI). We review the currently available data from the literature and present our own initial series of  14 patients treated with POEM.Peroral endoscopic myotomy (POEM) is a new, purely endoscopic procedure for treatment of achalasia. Due to the lack of incisions POEM can be regarded as a true NOTES procedure. With POEM a myotomy is created in a similar fashion to the previous standard treatment, laparoscopic Heller myotomy (LHM). The relatively free choice of length and localization of the myotomy may be regarded as advantages of POEM. The procedure starts with a mucosal incision (mucosal entry) followed by preparation of a submucosal tunnel crossing the esophagogastric junction and creation of a myotomy in an antegrade direction before the mucosal access is closed with endoscopic clip placement. Since the first description of the application of POEM in humans in 2010 by the pioneer Haruhiro Inoue, Yokohama, Japan, it has been used increasingly and investigated in some centers in Asia, the U.S.A. and also Europe. The results are very promising. Although the procedure is technically demanding it can be performed safely with low complication rates. The POEM procedure achieves very good control of dysphagia and gastroesophageal reflux witch is only a rare side-effect witch is well-controllable with proton pump inhibitors (PPI). We review the currently available data from the literature and present our own initial series of  14 patients treated with POEM.

Neu erkannte Nebenwirkungen von Protonenpumpeninhibitoren@@@Newly recognized side-effects of proton pump inhibitors: Argumente Pro Fundoplicatio bei GERD?@@@Arguments in favour of fundoplication for GERD?

ZusammenfassungProtonenpumpeninhibitoren (PPI) werden unter anderem zur medikamentösen Therapie der gastroösophagealen Refluxkrankheit (GERD) verwendet. PPI sind die meistverschriebenen und -verwendeten Medikament in der Gastroenterologie. PPI wurden bislang als sehr nebenwirkungsarm angesehen. In den letzten Jahren häufen sich allerdings Studienergebnisse zu neuen relevanten Nebenwirkungen. Wir liefern einen Überblick zur aktuellen Datenlage der PPI-Nebenwirkungen und diskutieren deren Relevanz für die Therapieverfahrenswahl bei GERD (medikamentöse Dauertherapie vs. Antirefluxchirurgie).PPI sind nach neuen Daten assoziiert mit: osteoporosebedingten Frakturen, Clostridium-difficile-assoziierter Diarrhö (CDAD), nosokomialen und extranosokomialen Pneumonien, pharmakologischer Interaktion mit Clopidogrel und Acetylsalicylsäure und konsekutiv vermehrten kardiovaskulären Ereignissen, therapierefraktärer Hypomagnesiämie, Rebound-Refluxsymptomen etc. Die Nutzen-Risiko-Relation bei den PPIs sollte zunehmend kritischer beurteilt werden, da – insbesondere bei Langzeiteinnahme – die Nebenwirkungen die positiven Effekte überwiegen können. Die schweren PPI-Nebenwirkungen können als starkes Argument zugunsten der laparoskopischen Fundoplicatio bei GERD gelten.AbstractAmong other indications proton pump inhibitors (PPIs) are used as medical treatment of gastroesophageal reflux disease (GERD) and are the most frequently prescribed and most frequently used drugs in gastroenterology. Until recently PPIs were regarded as very safe and associated with very few side-effects. However, during recent years study results have revealed many severe adverse events associated especially with long-term PPI use. We review the currently available evidence, regarding the side-effects of PPIs and discuss the potential impact on treatment strategies for GERD (conservative treatment vs. antireflux surgery).Currently available data suggest that PPIs are associated with osteoporosis-related fractures, Clostridium difficile associated diarrhea (CDAD), community and hospital-acquired pneumonia, pharmacologic interaction with clopidogrel and acetylsalicylic acid with subsequent increased rate of cardiovascular events, refractory hypomagnesemia and rebound reflux symptoms etc. The risk-benefit ratio of PPIs is increasingly recognized as being less favourable. This leads to a more critical viewpoint and raises the question whether the side-effects of PPIs may outweigh the benefits, especially with long-term use. The side-effects of PPIs seem to make a strong argument in favour of laparoscopic fundoplication in the treatment of GERD.Among other indications proton pump inhibitors (PPIs) are used as medical treatment of gastroesophageal reflux disease (GERD) and are the most frequently prescribed and most frequently used drugs in gastroenterology. Until recently PPIs were regarded as very safe and associated with very few side-effects. However, during recent years study results have revealed many severe adverse events associated especially with long-term PPI use. We review the currently available evidence, regarding the side-effects of PPIs and discuss the potential impact on treatment strategies for GERD (conservative treatment vs. antireflux surgery). Currently available data suggest that PPIs are associated with osteoporosis-related fractures, Clostridium difficile associated diarrhea (CDAD), community and hospital-acquired pneumonia, pharmacologic interaction with clopidogrel and acetylsalicylic acid with subsequent increased rate of cardiovascular events, refractory hypomagnesemia and rebound reflux symptoms etc. The risk-benefit ratio of PPIs is increasingly recognized as being less favourable. This leads to a more critical viewpoint and raises the question whether the side-effects of PPIs may outweigh the benefits, especially with long-term use. The side-effects of PPIs seem to make a strong argument in favour of laparoscopic fundoplication in the treatment of GERD.