POEM outcomes: How long is long enough?
2017; Elsevier BV; Volume: 85; Issue: 5 Linguagem: Inglês
10.1016/j.gie.2017.01.022
ISSN1097-6779
Autores Tópico(s)Dysphagia Assessment and Management
Resumo“How long shall I take counsel in my soul, having sorrow in my heart daily? How long shall mine enemy be exalted over me?”Psalm 13, King James Bible The group from Hopkins presents a multicenter retrospective analysis of the clinical outcomes of per-oral endoscopic myotomy (POEM) for achalasia. Ten centers contributed a total of 205 patients with an average follow-up time of 28 months. As with most outcomes reports of the POEM, the results were excellent, with 12-month and 24-month Eckhart scores of 3 or below seen in 98% and 91% of patients, respectively.1Ngamruengphong S. Inoue H. Chiu P.W. et al.Long-term outcomes of per-oral endoscopic myotomy in patients with achalasia with a minimum follow-up of 2 years: an international multicenter study.Gastrointest Endosc. 2017; 85: 927-933Abstract Full Text PDF PubMed Scopus (54) Google Scholar This corresponds well with the only other “long-term” outcomes report, which was also multicenter and also had a mean 2-year follow-up.2Werner Y.B. Costamagna G. Swanström L.L. et al.Clinical response to peroral endoscopic myotomy in patients with idiopathic achalasia at a minimum follow-up of 2 years.Gut. 2016; 65: 899-906Crossref PubMed Scopus (170) Google Scholar POEM was first performed clinically by Inoue and colleagues3Inoue H. Minami H. Kobayashi Y. et al.Peroral endoscopic myotomy (POEM) for esophageal achalasia.Endoscopy. 2010; 42: 265-271Crossref PubMed Scopus (1197) Google Scholar in 2008, nearly 9 years ago. It has enjoyed a wildfire adoption, and it is estimated that today more than 6000 clinical cases have been performed worldwide (personal communication, Olympus Endoscopy, November 2016). This is phenomenal traction for a rare “orphan” disease, which already has several good palliation options, and for an approach that is both novel and technically demanding. I believe that there are 2 basic reasons for this rapid uptake. The first is that the procedure intuitively makes sense: a surgical myotomy performed by flexible endoscopy, truly providing the best of both worlds and truly minimally invasive. This is the recipe that patients look for when considering their options, and ultimately they are the ones who decide care trends, at least for benign elective diseases. The second reason is that POEM’s initial introduction was rapidly followed by reports showing exceptional safety and efficacy even during the learning curve. Adverse event rates in most reports are less than 10% and are almost always minor, the sole exception being the high adverse event rates reported by the Shanghai group (>50%) resulting from their use of air insufflation rather than CO2.4Ren Z. Zhong Y. Zhou P. et al.Perioperative management and treatment for complications during and after peroral endoscopic myotomy (POEM) for esophageal achalasia (EA) (data from 119 cases).Surg Endosc. 2012; 26: 3267-3272Crossref PubMed Scopus (166) Google Scholar Even the incidence of iatrogenic postmyotomy GERD, an early concern, has not been a major clinical problem and has been shown to be about equal to GERD incidence after laparoscopic Heller procedures with partial fundoplication.5Bhayani N.H. Kurian A.A. Dunst C.M. et al.A comparative study on comprehensive, objective outcomes of laparoscopic Heller myotomy with per-oral endoscopic myotomy (POEM) for achalasia.Ann Surg. 2014; 259: 1098-1103Crossref PubMed Scopus (224) Google Scholar, 6Kumagai K. Tsai J.A. Thorell A. et al.Per-oral endoscopic myotomy for achalasia: Are results comparable to laparoscopic Heller myotomy?.Scand J Gastroenterol. 2015; 50: 505-512Crossref PubMed Scopus (41) Google Scholar All in all, the more than 300 publications listed on PubMed seem to fulfil the validation criteria proposed by the Preservation and Incorporation of Valuable Endoscopic Innovations document published by the American Society for Gastrointestinal Endoscopy in 2015, which specified that for POEM to be “validated,” it should meet a threshold of “major complication rates <6%” and “comparable palliation outcomes to balloon dilation and laparoscopic Heller.”7Chandrasekhara V. Desilets D. Falk G.W. et al.American Society for Gastrointestinal Endoscopy PIVI CommitteeThe American Society for Gastrointestinal Endoscopy PIVI (Preservation and Incorporation of Valuable Endoscopic Innovations) on peroral endoscopic myotomy.Gastrointest Endosc. 2015; 81: 1087-1100Abstract Full Text Full Text PDF PubMed Scopus (40) Google Scholar An interesting and frustrating phenomenon here in the United States is that many third-party payors, after covering POEM for several years, have decided recently that it is an “experimental” procedure and have begun to refuse coverage. I find this particularly amazing for a procedure with a 9-year history that has shown uniformly good outcomes in hundreds of peer-reviewed publications, and that is less costly than its laparoscopic counterpart! When challenged for denials, the insurance companies uniformly claim that they need “randomized prospective trials” to validate clinical efficacy. I have to point out, as has been well established, that POEM outcomes are within a few percentage points of all other options, the power calculation would indicate that a properly constructed randomized controlled trial would need many, many hundreds of patients in each arm to show a significant difference. For a rare disease like achalasia, this is practically impossible to accomplish, particularly considering the patient populations’ overwhelming preference for this less invasive treatment. This short-sighted interference in clinical decision making and the physician/patient discussion is infuriating and should be vehemently opposed. I suppose the sole remaining potential criticism against POEM would be whether these uniformly extraordinary early results will withstand the test of time. Could we see a tsunami of bad results at long-term follow-up? Certainly, at 2 years there is no indication of rapid degeneration of the results. Of course, there might be at 5, 10, or 20 years, and it is certainly a bit frustrating that 9 years into the POEM experience, the longest follow-up time in the literature is 2 years. In the defense of POEM practitioners, I must point out that despite the 25-year-plus history of both balloon dilation and laparoscopic Heller’s procedure, there are also only a handful of outcome publications with more than a year or 2 of follow-up. Finally, I would have to say that after my own 7-year experience with POEM, even if the 5-year results were to show progressive failure, I would still consider it a good option for many patients simply because it is so minimally invasive and noninterfering with other treatment options. The author disclosed no financial relationships relevant to this publication. RETRACTED: Long-term outcomes of per-oral endoscopic myotomy in patients with achalasia with a minimum follow-up of 2 years: an international multicenter studyGastrointestinal EndoscopyVol. 85Issue 5PreviewThis article has been retracted: please see Elsevier Policy on Article Withdrawal ( https://www.elsevier.com/about/our-business/policies/article-withdrawal ). This article has been retracted at the request of the Editor-in-Chief due to overlapping/duplicate material. Data from some patients from this study have previously been published in other journals without cross-referencing. Twenty patients overlap with a paper by Kumbhari et al.1 Thirty five patients overlap with the study by Ngamruengphong et al. Full-Text PDF
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