Background
While gastric per-oral endoscopic myotomy (G-POEM) of the pylorus has shown promising results in enhancing the quality of life (QoL) for patients with gastroparesis (GP), evidence supporting its sustained benefits over time is limited. We aimed to investigate the impact of G-POEM on QoL in GP patients for up to 60-months.

Methods
This was a prospective study of patients with GP at a single institution between 2/2018 and 11/2023. G-POEMs were performed by 2 expert third space endoscopists. Evaluation was conducted at baseline and at 1, 3, 6, 12, 24, 36, 48, and 60 months post-G-POEM using validated tools (Gastroparesis Cardinal Symptom Index (GCSI), Patient Assessment of Gastrointestinal Disorders Symptom Severity Index (PAGI-SYM), and 36-Item Short Form Survey (SF-36)). The primary endpoints were to assess clinical success and impact of G-POEM on QoL. Clinical success was defined as an improvement of ≥1 point on GCSI. Post-hoc analyses were performed on the effect of pre-G-POEM Botox response on QoL and the impact of G-POEM on QoL in clinical failure cases.

Results
A total of 139 patients (89% female, mean age 49±13 years) underwent G-POEM for idiopathic (44.6%), diabetic (33.1%), and post-surgical (22.3%) GP, with a median disease duration of 48 months (IQR 24-78). Average GCSI scores improved significantly from a baseline of 3.4±1.0 to 2.5±1.4 at 48 months post G-POEM (p<0.001), along with various symptom subscores (Fig.1). The average total SF-36 score significantly increased to 50.4±16.3 at 48 months post G-POEM vs. 40.6±18.2 at baseline (p=0.04), with sustained improvements up to 48 months in several domains (Fig.1). At 6 months, 41/84 (48.8%) patients did not achieve clinical success; however, their average total SF-36 score improved significantly to 46.8±21.8 vs. 41.5 ± 19.7 at baseline (p=0.03). Role limitations due to physical health and pain subscores improved from a baseline of 22.5±37.8 to 31.1±41.0 (p=0.046), and 35.7±27.0 to 48.2±30.3 (p=0.002), respectively post G-POEM.
At 12 months, clinical success was observed in 31/57 (54.4%) patients and was significantly associated with QoL scores improvement (p<0.001). At 24, 36, 48, and 60 months, clinical success rates were 38.2%, 52.4%, 50%, and 50%. G-POEM was preceded by at least 1 intrapyloric Botox injection in 92 (66.2%) patients. We report sustained QoL improvements post G-POEM in Botox responders (n=68), with 31 (45.6%) showing improvement at 12 months (p=0.002) and 12 (17.6%) maintaining improvement up to 36 months, compared to lower QoL score in Botox non responders (p=0.002; Table 1).

Conclusion
G-POEM consistently showed a positive impact on both symptom severity and QoL up to 60 months, even in patients who did not achieve clinical success. Positive response to Botox injection pre-G-POEM appears to be predictive of sustained improvement in QoL post G-POEM for up to 3 years.

<b>Figure 1.</b> 36-Item Short Form Survey (SF-36) average subgroup scores and Patient Assessment of Gastrointestinal Disorders Symptom Severity Index (PAGI-SYM) average subgroup scores (statistically significant results compared to pre-G POEM baseline scores are annotated with an asterisk).<br /> <br /> <i>Abbreviations:</i> GCSI, Gastroparesis Cardinal Symptom Index; G-POEM, gastric per-oral endoscopic myotomy.

Figure 1. 36-Item Short Form Survey (SF-36) average subgroup scores and Patient Assessment of Gastrointestinal Disorders Symptom Severity Index (PAGI-SYM) average subgroup scores (statistically significant results compared to pre-G POEM baseline scores are annotated with an asterisk).

Abbreviations: GCSI, Gastroparesis Cardinal Symptom Index; G-POEM, gastric per-oral endoscopic myotomy.

*p < 0.05 as compared to baseline.<br /> **Range from 0 to 100; <sup>+</sup>Range from 0 to 5<br /> ***Positive Botox response was assessed when > 50% of symptomatic improvement (using validated symptom tools) was accomplished after intrapyloric injection.<br /> <br /> <sup>a</sup> Cannot calculate p-value due to sample size of 1.<br /> <sup>b</sup> No valid pairs.<br /> <br /> <b>Table 1.</b> Results of SF-36 QOL, PAGI-SYM, and GCSI (mean ± SD) before and after G-POEM in patients with GP and in Botox responders vs non-responders.<br /> <br /> <i>Abbreviations: </i>SF-36, 36-Item Short Form Survey; PAGI-SYM, Patient Assessment of Gastrointestinal Disorders Symptom Severity Index; GCSI, Gastroparesis Cardinal Symptom Index; G-POEM, gastric per-oral endoscopic myotomy.

*p < 0.05 as compared to baseline.
**Range from 0 to 100; ⁺Range from 0 to 5
***Positive Botox response was assessed when > 50% of symptomatic improvement (using validated symptom tools) was accomplished after intrapyloric injection.

^a Cannot calculate p-value due to sample size of 1.
^b No valid pairs.

Table 1. Results of SF-36 QOL, PAGI-SYM, and GCSI (mean ± SD) before and after G-POEM in patients with GP and in Botox responders vs non-responders.

Abbreviations: SF-36, 36-Item Short Form Survey; PAGI-SYM, Patient Assessment of Gastrointestinal Disorders Symptom Severity Index; GCSI, Gastroparesis Cardinal Symptom Index; G-POEM, gastric per-oral endoscopic myotomy.

Yervant Ichkhanian

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