Pilot studies have indicated that peroral endoscopic myotomy (POEM) might be a safe and effective treatment for achalasia. We performed a prospective, international, multicenter study to determine ...the outcomes of 70 patients who underwent POEM at 5 centers in Europe and North America. Three months after POEM, 97% of patients were in symptom remission (95% confidence interval, 89%–99%); symptom scores were reduced from 7 to 1 ( P < .001) and lower esophageal sphincter pressures were reduced from 28 to 9 mm Hg ( P < .001). The percentage of patients in symptom remission at 6 and 12 months was 89% and 82%, respectively. POEM was found to be an effective treatment for achalasia after a mean follow-up period of 10 months. Clinical Trials Gov Registration number: NCT01405417.
Pneumatic dilation and laparoscopic Heller's myotomy (LHM) are established treatments for idiopathic achalasia. Peroral endoscopic myotomy (POEM) is a less invasive therapy with promising early study ...results.
In a multicenter, randomized trial, we compared POEM with LHM plus Dor's fundoplication in patients with symptomatic achalasia. The primary end point was clinical success, defined as an Eckardt symptom score of 3 or less (range, 0 to 12, with higher scores indicating more severe symptoms of achalasia) without the use of additional treatments, at the 2-year follow-up; a noninferiority margin of -12.5 percentage points was used in the primary analysis. Secondary end points included adverse events, esophageal function, Gastrointestinal Quality of Life Index score (range, 0 to 144, with higher scores indicating better function), and gastroesophageal reflux.
A total of 221 patients were randomly assigned to undergo either POEM (112 patients) or LHM plus Dor's fundoplication (109 patients). Clinical success at the 2-year follow-up was observed in 83.0% of patients in the POEM group and 81.7% of patients in the LHM group (difference, 1.4 percentage points; 95% confidence interval CI, -8.7 to 11.4; P = 0.007 for noninferiority). Serious adverse events occurred in 2.7% of patients in the POEM group and 7.3% of patients in the LHM group. Improvement in esophageal function from baseline to 24 months, as assessed by measurement of the integrated relaxation pressure of the lower esophageal sphincter, did not differ significantly between the treatment groups (difference, -0.75 mm Hg; 95% CI, -2.26 to 0.76), nor did improvement in the score on the Gastrointestinal Quality of Life Index (difference, 0.14 points; 95% CI, -4.01 to 4.28). At 3 months, 57% of patients in the POEM group and 20% of patients in the LHM group had reflux esophagitis, as assessed by endoscopy; at 24 months, the corresponding percentages were 44% and 29%.
In this randomized trial, POEM was noninferior to LHM plus Dor's fundoplication in controlling symptoms of achalasia at 2 years. Gastroesophageal reflux was more common among patients who underwent POEM than among those who underwent LHM. (Funded by the European Clinical Research Infrastructure Network and others; ClinicalTrials.gov number, NCT01601678.).
The recently developed technique for peroral endoscopic myotomy (POEM) has been shown to be effective in several short-term studies. Longer term outcome data are largely non-existent.
To ...systematically report clinical outcome with a minimum post-POEM follow-up of 2 years.
All patients treated consecutively by POEM for achalasia at three centres were retrospectively analysed, with a minimum follow-up of 2 years. The main outcome was the rate of POEM failures (Eckardt score >3) related to follow-up time.
Of 85 patients treated, five (5.9%) cases were excluded due to protocol violation or loss to follow-up; the remaining 80 patients (mean age 44.9 years, 54% men) were followed clinically for 29 months (range 24-41). Initial clinical response was observed in 77 cases (96.3%). Clinical recurrences (later failures) were seen in a further 14 cases (17.7%), accounting for a total failure rate of 21.5%. In a multivariate analysis, age and endoscopic reflux signs were independent predictors of treatment success. Of the 17 failures, eight were among the first 10 cases treated in the participating centres. Reflux-associated sequelae included one case of a severe reflux-associated stricture requiring dilatation, and two patients with minor transient Eckardt score elevations curable by proton pump inhibitor (PPI) treatment. Endoscopic signs of reflux oesophagitis, mostly Los Angeles grade A/B, were seen in 37.5% (37/72) at the 2-year control.
In this multicentre retrospective analysis, a high initial success rate of POEM is followed by a mid-term recurrence rate of 18%. Reflux oesophagitis, albeit mild, is frequent and should probably be treated by regular low-dose PPI therapy.
NCT 01405417 (UKE study).
Abstract Background & Aims The recently developed technique of per-oral endoscopic myotomy (POEM) has been shown to be effective for the therapy of esophageal motility disorders. Limited information ...is available about POEM adverse events (AE). Methods POEM was performed with the patients under general anesthesia in 241 patients (58% male, mean age 47.4 ± 16.4 years) during 61 months. Main outcome was the rate of intra- and post-procedural adverse events (AE). Post-procedural checks comprised clinical and laboratory examination, and endoscopy, with further follow-ups being performed at 3, 6 and 12 months, respectively. Results 238 out of 241 procedures (mean procedure time 100.2± 39.5 min) were successfully completed. Reasons for abortion were excessive submucosal fibrosis preventing submucosal tunneling. 3 patients had severe procedural-related adverse events (SAE rate 1.2%); one case of pneumothorax requiring intraprocedural drainage, and two patients with delayed SAE (one ischemic gastric cardia perforation and one hemothorax, both leading to surgery). The overall rate of minor AE was 31.1%, mainly prolonged intraprocedural bleeding (>15 minutes hemostasis) and defects of the mucosa overlying the tunnel; none of them led to clinically relevant signs or symptoms. Patients experiencing any AE had a significant prolonged hospital stay (p=0.037) and a trend toward prolonged procedure time (p=0.094). Neck/upper thoracic emphysema and free abdominal air were noted in 31.5% and 35.7% (95.3% drained), but without relevant sequelae. Conclusions POEM has a low rate of serious adverse events; minor adverse events are more frequent but lack a consistent definition. Therefore, based on our experience and literature analysis, we suggest a classification of AE for POEM.
Endoscopic resection is considered a curative treatment for early upper GI cancers under certain histologic (low-risk) criteria. In tumors not completely fulfilling these criteria but resected R0 ...endoscopically, esophagectomy is still advised because of an increased risk of lymph node (LN) metastases (LNM). However, the benefit-risk ratio, especially in elderly patients at higher risk for radical surgery, can be debated. We now present the outcome of our case series of laparoscopic LN sampling (LLS) in patients with T1 esophagogastric junction tumors, which had been completely resected by endoscopy but did not fulfill the low-risk criteria (G1/2, m, L0, V0).
Retrospective review was done of all patients with T1 cancer undergoing LLS with at least 1 high-risk parameter after endoscopic resection during an 8-year period. Repeated endoscopy with biopsy and abdominothoracic CT had been performed before. The patients were divided into 2 periods: before (n = 8) and after (n = 12) the introduction of an extended LLS protocol (additional resection of the left gastric artery). In cases of positive LN, patients underwent conventional oncologic surgery; if negative, follow-up was performed. The main outcome was the number of harvested LNs by means of LLS and the percentage of positive LNs found.
Twenty patients with cardia (n = 1) and distal esophageal/Barrett’s cancer (n = 19) were included. The LN rate with use of the extended LLS technique increased by 12% (period 1: median 12 range, 5-19; 95% CI, 3.4-15.4 vs period 2: median 17.5 range, 12-40; 95% CI, 12.8-22.2; P = .013). There were 2 adverse events: 1 inadvertent chest tube removal and 1 postoperative pneumonia. In 15% of cases, patients had positive LNs. and in 2 cases there was local recurrence at the endoscopic resection site, all necessitating surgery.
An extended technique of laparoscopic LN sampling appears to provide adequate LN numbers and is a safe approach with short hospital stay only. Only long-term follow-up of larger patient numbers will allow conclusions about miss rate as well as oncologic adequacy of this concept.
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Background
The newly developed technique of peroral endoscopic myotomy (POEM) has been shown to be effective in several short- and mid-term studies. Limited information is available about the ...adequacy of immediate post-POEM monitoring tests.
Methods
POEM was performed under general anesthesia in 228 patients (59.6% male, mean age 45.6 ± 15.5 years). Post-procedural checks comprised clinical and laboratory examination, and, during post-procedure days 1–5, endoscopy and—in the first 114 cases—radiologic examination using water-soluble contrast (1st group); the remaining patients underwent post-procedure controls without radiology (2nd group). Main outcome was value of endoscopic compared to radiologic control for recognition of early adverse events.
Results
In the first group, routine fluoroscopic contrast swallow suggested minor leakages at the mucosal entry site in two cases which was confirmed endoscopically in only one. Endoscopy revealed two minor entry site leakages and, in six additional cases, dislocated clips without leakage (overall 5.3%). All eight patients underwent reclipping and healed without clinical sequelae. In the 2nd group, endoscopy showed 5 clip dislocations (all reclipped) and one ischemic cardiac perforation in a patient with clinical deterioration on post-POEM day 1 who had to undergo surgery after confirmation of leakage by CT.
Conclusions
Radiologic monitoring (contrast swallow) after POEM is not useful and can be omitted. Even routine endoscopic monitoring for detection and closure of minor defects of the mucosal entry site yields limited information with regards to final outcome; major complications are very rare and probably associated with clinical deterioration.
Clinical Trials Gov Registration number of the main study: NCT01405417.
Purpose
Peroral endoscopic myotomy (POEM) is a novel technique for treating esophageal achalasia. During POEM, carbon dioxide (CO
2
) is insufflated to aid surgical dissection, but it may ...inadvertently track into surrounding tissues, causing systemic CO
2
uptake and tension capnoperitoneum. This in turn may affect cardiorespiratory function. This study quantified these cardiorespiratory effects and treatment by hyperventilation and percutaneous abdominal needle decompression (PND).
Methods
One hundred and seventy-three consecutive patients who underwent POEM were included in this four-year retrospective study. Procedure-related changes in peak inspiratory pressure (p
max
), end-tidal CO
2
levels (etCO
2
), minute ventilation (MV), mean arterial pressure (MAP), and heart rate (HR) were analyzed. We also quantified the impact of PND on these cardiorespiratory parameters.
Results
During the endoscopic procedure, cardiorespiratory parameters increased from baseline: p
max
15.1 (4.5)
vs
19.8 (4.7) cm H
2
O; etCO
2
4.5 (0.4)
vs
5.5 (0.9) kPa 34.0 (2.9)
vs
41.6 (6.9) mmHg; MAP 73.9 (9.7)
vs
99.3 (15.2) mmHg; HR 67.6 (12.4)
vs
85.3 (16.4) min
−1
(
P
< 0.001 for each). Hyperventilation MV 5.9 (1.2)
vs
9.0 (1.8) L·min
−1
,
P
< 0.001 was applied to counteract iatrogenic hypercapnia. Individuals with tension capnoperitoneum treated with PND (
n
= 55) had higher peak p
max
values 22.8 (5.7)
vs
18.4 (3.3) cm H
2
O,
P
< 0.001 than patients who did not require PND. After PND, p
max
22.8 (5.7)
vs
19.9 (4.3) cm H
2
O,
P
= 0.045 and MAP 98.2 (16.3)
vs
88.6 (11.8) mmHg,
P
= 0.013 decreased. Adverse events included pneumothorax (
n
= 1), transient myocardial ischemia (
n
= 1), and subcutaneous emphysema (
n
= 49). The latter precluded immediate extubation in eight cases. Postanesthesia care unit (PACU) stay was longer in individuals with subcutaneous emphysema than in those without 74.9 min (34.5)
vs
61.5 (26.8 min),
P
= 0.007.
Conclusion
Carbon dioxide insufflation during POEM produces systemic CO
2
uptake and increased intra-abdominal pressure. Changes in cardiorespiratory parameters include increased p
max
, etCO
2
, MAP, and HR. Hyperventilation and PND help mitigate some of these changes. Subcutaneous emphysema is common and may delay extubation and prolong PACU stay.
Abstract Introduction Long‐term outcome data are limited for non‐achalasia esophageal motility disorders treated by peroral endoscopy myotomy (POEM) as a separate group. We investigated a subset of ...symptomatic patients with hypercontractile esophagus (Jackhammer esophagus). Methods Forty two patients (mean age 60.9 years; 57% female, mean Eckardt score 6.2 ± 2.1) treated by primary peroral myotomy for symptomatic Jackhammer esophagus 2012–2018 in seven European centers were retrospectively analyzed; myotomy included the lower esophageal sphincter but did not extend more than 1 cm into the cardia in contrast to POEM for achalasia. Manometry data were re‐reviewed by an independent expert. The main outcome was the failure rate defined by retreatment or an Eckardt score >3 after at least two years following POEM. Results Despite 100% technical success (mean intervention time 107 ± 48.9 min, mean myotomy length 16.2 ± 3.7 cm), the 2‐year success rate was 64.3% in the entire group. In a subgroup analysis, POEM failure rates were significantly different between Jackhammer‐patients without ( n = 22), and with esophagogastric junction outflow obstruction (EGJOO, n = 20) (13.6% % vs. 60%, p = 0.003) at a follow‐up of 46.5 ± 19.0 months. Adverse events occurred in nine cases (21.4%). 14 (33.3%) patients were retreated, two with surgical fundoplication due to reflux. Including retreatments, an improvement in symptom severity was found in 33 (78.6%) at the end of follow‐up (Eckardt score ≤3, mean Eckardt change 4.34, p < 0.001). EGJOO ( p = 0.01) and frequency of hypercontractile swallows ( p = 0.02) were predictors of POEM failure. The development of a pseudodiverticulum was observed in four cases within the subgroup of EGJOO. Conclusions Patients with symptomatic Jackhammer without EGJOO benefit from POEM in long‐term follow‐up. Treatment of Jackhammer with EGJOO, however, remains challenging and probably requires full sphincter myotomy and future studies which should address the pathogenesis of this variant and alternative strategies.
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