Our study aimed to provide a comprehensive, in-depth analysis of long-term POEM outcomes from the largest prospective database of POEM procedures in the U.S. (currently at ~800 POEMs, with the longest and most complete follow-up of patients, maximum follow-up of 12 years, mean follow-up approaching 5 years, with only 5% of patients missing follow-up data).
Many of the published long-term follow-up studies have small numbers of patients (<100). Most of the few larger series with >100 patients are plagued by high rates of missing follow-up data (up to 50% of patients). Therefore, their long-term estimates for efficacy are rather unreliable. There is even more limited data in the literature on “objective GERD” (assessed by pH studies and endoscopy). Therefore, our study of 610 consecutive POEMs performed over a 10-year period (between Oct 2009 and Oct 2019) with only 2% of patients missing follow-up data and 71% having had objective assessment for GERD is an important addition to the POEM literature.
1. POEM efficacy is exceptional with >90% success even at 5-9 years.
2. POEM safety is also exceptional (no aborted/converted POEMs or adverse events requiring surgery or IR drains or resulting in disability, altered functional status, or death).
3. Objective GERD is present in ~50% of patients but these data do not reflect the major impact of our anti-reflux POEM technique introduced in mid 2018. These data, showing a ~40% decrease in objective GERD by pH measurements, will be presented in an upcoming publication.
4. PPIs are effective with less than 1% of patients having required anti-reflux procedures or having developed GERD sequelae (strictures, Barrett’s) on long-term follow-up.
In this publication we introduce 2 novel concepts with supporting data: 1) ischemic tunnel ulcers that may be misinterpreted as reflux esophagitis; 2) improvement of post-POEM GERD over time probably due to tightening of the EGJ as it heals and “remodels” which is supported by our massive EndoFLIP data analysis on ~500 patients.
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