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Society for Surgery of the Alimentary Tract

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Andrea Costantini*2,1, Pietro Familiari2, Mario Costantini1, Renato Salvador1, Michele Valmasoni1, Giovanni Capovilla1, Rosario Landi2, Francesca Mangiola2, Luca Provenzano1, Stefano Merigliano1, Guido Costamagna2
1Dept. of Surgical, Oncological and Gastroenterological Sciences, University of Padua, Padova, Italy; 2Digestive Endoscopy Unit, Catholic University of Sacred Heart, Rome, Rome, Italy

Background. POEM has recently had a widespread diffusion, aiming at being the treatment of choice for esophageal achalasia. The results of ongoing RCTs against other therapies (myotomy or dilations) are not available, yet. We therefore designed this study with the aim of comparing POEM and laparoscopic Heller myotomy + Dor fundoplication (LHD) in a case-control study by matching with the propensity score (PS) 2 groups of consecutive patients treated in two high volume Centers, one with extensive experience with POEM and one with LHD.
Methods. Patients undergoing treatment for primary achalasia from Jan 2014 to Nov 2017 were selected in both centers. Patients with previous endoscopic treatment were included, whereas patients with previous LHD or POEM were excluded. The PS for the patients was calculated by using the variable listed in Table 1, and a caliper of 0.2 was used: 140 patients in both centers were thus matched. LHD and POEM were performed following established techniques. Patients were followed with clinical (Eckardt score), endoscopic and pH-manometry evaluations.
Results. The procedure was successfully completed in all patients. POEM required a shorter operation time (47 min [35-57]) and postoperative stay (2 days [2-2]) compared to LHD (95 min [85-105] and 3 days [3-3], respectively, p<0.001). No mortality was recorded in either group. Seven complications were recorded in the POEM group (5 mucosal perforations) and 3 in the LHD group (3 mucosal perforations)(p=0.33). The perforations were repaired with clips or suture during the same operation. Complications had no effect on the post-operative course nor on the final results. Two patients in the POEM group and 1 in the LHD were lost to follow up. One patient in both groups died during the follow-up for unrelated causes. At a median follow up of 24 mos. [15-30] for POEM and 31 mos [15-41] for LHD (p<0.05), the median Eckardt score did not differ: 1 [0-1] for POEM vs 1 [0-2] for LHD, p=0.45. Moreover, 99.3% of the POEM patients and 97.7% of the LHD patients showed an Eckardt score ≤ 3 (p <0.12). Four years after the treatment, the probability to be symptom free was > 90% for both groups (98.2% for POEM and 93.9% for LHD, p=0.2, Log-rank test). HR-Manometry showed a similar reduction in the LES pressure and 4sIRP; 24-h pH-monitoring showed however an abnormal exposure to acid in 38.4% of POEM patients, as compared to 17.1% of LHD patients (p<0.01) and esophagitis was found in 37.4% of the POEM and 15.2% of LHD patients (p<0.05). Finally, the need for PPI therapy was higher in the POEM group (38.8%) compared to the LHD group (15.1%), p<0.001.
In conclusion, in treating achalasia, POEM provides the same mid-term results as LHD. This "quasi-randomized"? study confirms, however, a higher incidence of post-operative GERD with the former, even if its real significance needs to be further evaluated.

Clinical and demographic characteristics of the two groups of patients
VariablePOEM (n=140)LHD (n=140)p value
* Sex (M:F)70:7073:671
* Age (years)47 (38-60)48 (38-59)0.90
Weight (Kg)66 (57-77)65 (55-73)0.20
Height (cm)169 (160.5-176)169 (162-176)0.79
BMI (kg/m2)23 (20.3-26.2)22 (19.4-21.7)0.43
* Duration of symptoms (months)24 (12-39)24 (12-60)0.49
* Eckardt score7.5 (5.75-9)8 (5.75-9)0.35
Esophageal diameter (cm)4.4 (3.25-5.35)4.5 (3.5-5.0)0.67
Previous endoscopic treatment (%)9.3 %10 %0.35
* Radiological stage I29 (20.7%)31 (22.1%)0.63
* Radiological stage II78 (55.7%)83 (59.3%)0.44
* Radiological stage III24 (17.2%)19 (13.6%)0.88
* Radiological stage IV9 (6.4%)7 (5.0%)0.64
* Manometric pattern 128 (20.0%)35 (25.0%)0.07
* Manometric pattern 294 (67.2%)89 (63.6%)0.83
* Manometric pattern 310 (7.1%)13 (9.1%)0.64
* Manometric pattern n/a8 (5.7%)3 (2.2%)0.12
LES resting pressure (mmHg)41 (29-52)42 (32-60)0.13
4sIRP (mmHg)26 (20-35)31 (23-43)0.91

Data are expressed as Median and IQR. * = parameters considered for the calculation of the propensity score. n/a = not available

Post-treatment findings in the two groups of patients
VariablePOEMLHDp value
Duration of the procedure (min)47 (33-57)95 (85-105)<0.001
Post-operative stay (days)2 (2-2)3 (3-3)<0.001
Complications (%)7 (5.0%)3 (2.1%)0.33
Median F/U (months)24 (15-30)31 (15-41)0.006
Median Eckardt score1 (0-1)1 (0-2)0.45
Pts. with Eckardt score ≤ 3 (%) *137 (99.3%)133 (95.7%)0.12
LES Resting pressure (mmHg)17.6 (11-25)18.4 (13-23.5)0.48
4sIRP (mmHg)8.2 (4.75-11.9)9 (7-12.6)0.63
% time pH < 43.5 (1.35-8.65)0.3 (0-2.1)< 0.001
De Meester score14.5 (5.35-30.15)1.7 (0.3-23.5)< 0.001
Pts. with abnormal pH 38.4 %17.7 %< 0.001
Esophagitis grade A-D 37.4 %15.2 %< 0.001
Pts. on PPI at last follow up39.8 %15.1 %< 0.001

Data are expressed as Median and IQR. * 2 pts lost to follow-up in the POEM group and 1 in the LHD group.

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