A0418 - Use of Reloadable Clips During Per-Oral Endoscopic Myotomy (POEM) Is Safe, Effective, and Cost-Effective

Sunday, October 23, 2022

5:00 PM – 7:00 PM ET

Location: Crown Ballroom

Presenting Author(s)

Val Molloy

Loyola University Stritch School of Medicine
Maywood, IL

Krishna Patel, DO¹, Val Molloy, ², Amar S. Naik, MD¹, Nikhil Shastri, MD¹
¹Loyola University Medical Center, Maywood, IL; ²Loyola University Stritch School of Medicine, Maywood, IL

Introduction: Endoscopic clip closure is routinely used in Per-Oral Endoscopic Myotomy (POEM). Clip use can be costly and our large volume tertiary center has seen a rise in clip utilization overall. POEM is a safe and effective procedure for achalasia patients (pts) when the endoscopist is properly trained. Continued POEM evolution will lead to improved outcomes and increased cost-effectiveness. We investigated the performance and cost effectiveness of implementing the newly available (in USA) Reloadable Clips (RC) in addition to Standard, Single-use clips (SC) during tunnel closure in POEM.

Methods: A retrospective cohort study of consecutive pts undergoing POEM for achalasia (before/after introduction of RC) was undertaken. Pt demographics, disease/treatment characteristics were recorded. POEM was performed by a single-trained Advanced Interventional Endoscopist with standardized protocol. All pts were admitted to observation with barium esophagram within 12 hours of POEM. Treatment efficacy was measured by immediate technical success, absence of leak on esophagram, and symptom evaluation at follow-up. Treatment related adverse events recorded were dysphagia, bleeding requiring transfusion, leak on esophagram, ED visit, and emergency operation. Procedural details of incision length, anterior/posterior approach, type of incision, myotomy length, and number and type of clips (RC vs SC - (Figure 1)) used for zipper closure technique were noted. Cost of clips used per case was calculated. Statistical analysis with Fisher’s exact and two-tailed unpaired T test was performed.

Results: 24 achalasia pts (Table 1) were evaluated. 14/24 (58%) patients were in Group 1 (RC + SC) and 10/24 (42%) were in Group 2 (SC only). 24/24 patients had immediate technical success and no early treatment related adverse events. Mean total number of clips/case in Group 1 (6.4 + 1) and Group 2 (5.7 + 1.2) did not differ (p = 0.15). Mean myotomy length in Group 1 vs Group 2 was (8.7cm vs 7.3cm, p = 0.08). Cost for RC was $100.50 for 1^st clip, $39.50 for 2^nd clip, and $39.50 for each subsequent clip. The cost for each SC was $150. Mean total clip cost per case in Group 1 was $454 compared to $855 for Group 2 (p < 0.001).

Discussion: Use of RC in POEM was safe, technically successful, and highly cost effective. RC can be used alongside SC for zipper closure technique. Further prospective studies evaluating their use in EMR/ESD may lead to similar cost savings.

Figure: Title: Figure 1: Examples of Reloadable (RC) and Standard, Single-use Clips (SC)
Caption: Zipper closure technique (figure 1a); Reloadable Clip (RC) (yellow arrows, figure 1a); Standard, Single-use Clip (SC) (blue arrow, figure 1a); opening width of RC (figure 1b), 135-degree jaw of RC (top of figure 1c).

	Reloadable and Standard, Single-use Clips (RC + SC) Group 1 (n = 14)	Standard, Single-use Clips (SC) Only Group 2 (n = 10)	p value
Achalasia Type
1 2 3	4/14 (29%) 7/14 (50%) 3/14 (21%)	2/10 (20%) 7/10 (70%) 1/10 (10%)	p = 1* p = 0.42* p = 0.61*

Mean Incision Length
2 - 2.5cm 3.5cm	11/14 (79%) 3/14 (21%)	9/10 (90%) 1/10 (10%)	p = 0.61* p = 0.61*

Location of Incision
Anterior Posterior	3/14 (21%) 11/14 (79%)	3/10 (30%) 7/10 (70%)	p = 0.66* p = 0.67*

Type of Incision
Circular Full Thickness	9/14 (64%) 5/14 (36%)	8/10 (80%) 2/10 (20%)	p = 0.65* p = 0.65*

Mean Myotomy Length (cm)	8.7 + 2.3	7.3 + 1.2	p = 0.08^

Mean Number of Clips/Case
Total Reloadable Clips Standard, Single-Use Clips	6.4 + 1 3 + 2.7 1.3 + 0.5	5.7 + 1.2 0 5.7 + 1.2	p = 0.15^

Mean Total Clip Cost ($)	454	855	p = 0.0001^

Early Treatment Related Adverse Events
Leak on Esophagram	0/14 (0%)	0/10 (0%)	p = 1*

Delated Treatment Related Adverse Events
Dysphagia Pain Fever	0/14 (0%) 1/14 (7%) 0/14 (0%)	1/10 (10%) 1/10 (10%) 0/10 (0%)	p = 0.42* p = 1* p = 1*

Table: Title: Table 1: Comparison of Utilization of Reloadable and Standard Clips versus Standard Clips Only in Patients with Achalasia Undergoing POEM
Caption: *Fisher’s Exact test; ^Two-tailed, unpaired T test

Disclosures:

Krishna Patel indicated no relevant financial relationships.

Val Molloy indicated no relevant financial relationships.

Amar Naik: Abbvie – Speakers Bureau. Bristol Meyers Squibb – Speakers Bureau. Eli Lilly & Company – Consultant. Pfizer – Speakers Bureau. Takeda – Speakers Bureau.

Nikhil Shastri indicated no relevant financial relationships.

Krishna Patel, DO¹, Val Molloy, ², Amar S. Naik, MD¹, Nikhil Shastri, MD¹. A0418 - Use of Reloadable Clips During Per-Oral Endoscopic Myotomy (POEM) Is Safe, Effective, and Cost-Effective, ACG 2022 Annual Scientific Meeting Abstracts. Charlotte, NC: American College of Gastroenterology.