C0210 - Evaluation of ICARUS Guidelines and Recommendations Not Supported by Randomized Controlled Trials

Monday, October 24, 2022

3:00 PM – 5:00 PM ET

Location: Crown Ballroom

Presenting Author(s)

Cassandra Mohr, BS

McGovern Medical School
Houston, TX

Cassandra Mohr, BS¹, Hailie Ciomperlik, BS¹, Naila Dhanani, MD¹, Oscar Olavarria, MD¹, Craig Hannon, BS¹, William Hope, MD², Scott Roth, MD³, Mike Liang, MD⁴, Julie Holihan, MD¹
¹McGovern Medical School, Houston, TX; ²New Hanover Regional Medical Center, Wilmington, NC; ³University of Kentucky, Lexington, KY; ⁴HCA Healthcare Kingwood, University of Houston, Kingwood, TX

Introduction: The ICARUS guideline is a systematic review and Delphi process that provides recommendations in the treatment and management of patients with GERD. Many of the recommendations were supported by randomized trials; some were not. This study assesses guidelines with limited evidence and weak endorsement.

Methods: Four ICARUS guidelines were chosen: the role of fundoplication for patients with BMI >35, regurgitation, chest pain, and extra-esophageal symptoms. A multicenter database of patients undergoing fundoplication surgery for GERD between 2015-2020 was accessed. Outcomes assessed were anatomic failure and symptom recurrence. Multivariable regression was performed.

Results: Five institutions performed a fundoplication on 462 patients for GERD with a median of follow-up of 14.7 months (IQR 14.2). Most patients were white (51.1%) or Hispanic (24.7%), with a mean age of 54 ± 14.1 years. Most patients were overweight (BMI=29.7 ± 5.3). Most patients presented with symptoms of heartburn (98.9%) and regurgitation (51.7%), and many had a hiatal hernia on EGD/esophagram (85.1%).

Laparoscopic fundoplication was the most common surgical approach (84.2%), with partial posterior fundoplication (63.0%) and no mesh reinforcement (58.9%). On multivariate analysis, patients with BMI >35 did not have significantly higher rates of anatomic failure (OR 1.78, 95%CI 0.90-1.04). Patients with preoperative regurgitation had similar symptom recurrence rates to those without (OR 1.06, 95%CI 0.55-2.06). Patients with non-cardiac chest pain had comparable rates of symptom recurrence (OR 1.55, 95%CI 0.92-2.62). Patients with chronic cough attributable to reflux had similar symptom recurrence rates postoperatively to patients without (OR 0.79, 95%CI 0.42-1.49).

Discussion: Among the ICARUS guidelines and recommendations, a small proportion were lacking evidence at low risk for bias and strong endorsement by the Delphi committee. The results of this multicenter study evaluated outcomes of patients with various pre-operative conditions: BMI >35, regurgitation, chest pain attributable to reflux, and extra-esophageal symptoms attributable to reflux. Our findings endorse patients with these characteristics as promising candidates for antireflux surgery.

1. Hernia Recurrence, BMI >35
Variables	Odds Ratio	95% Confidence Interval	p-value
BMI, >35	1.779	0.90-1.04	0.099
Age	1.021	0.99-1.04	0.062
Ethnicity Hispanic Black White Asian Other	Ref 1.888 1.227 1.405 1.900	- 0.67-5.30 0.53-2.83 0.15-13.55 0.70-5.19	- 0.227 0.630 0.769 0.211
Gender, Male	2.045	1.17-3.56	0.012
Institution 1 2 3 4 5	Ref 3.54 3.13 2.68 3.03	- 0.41-30.67 0.38-25.91 0.33-21.55 0.16-58.72	- 0.251 0.290 0.355 0.463

2. Symptom Recurrence, Preoperative Regurgitation
Variables	Odds Ratio	95% Confidence Interval	p-value
Preoperative Regurgitation	1.060	0.55-2.06	0.864
Age	1.000	0.98-1.02	0.962
Race/Ethnicity Hispanic Black White Other	Ref 0.322 0.588 1.022	- 0.10-1.08 0.27-1.27 0.40-2.58	- 0.067 0.176 0.963
Gender, Male	0.861	0.50-1.48	0.588
Institution 1 2 3 4 5	Ref 0.978 1.88 1.12 5.36	- 0.17-5.53 0.36-9.83 0.23-5.35 0.61-47.1	- 0.980 0.453 0.889 0.130

3. Symptom Recurrence, Preoperative Chest Pain attributable to reflux
Variables	Odds Ratio	95% Confidence Interval	p-value
Preoperative chest pain	1.554	0.92-2.62	0.099
Age	1.000	0.98-1.02	0.922
Race/Ethnicity Hispanic Black White Other	Ref 0.366 0.649 1.157	- 0.11-1.23 0.30-1.41 0.45-2.96	- 0.105 0.276 0.760
Gender, Male	0.868	0.51-1.49	0.609
Institution 1 2 3 4 5	Ref 0.929 1.942 1.194 5.31	- 0.17-5.00 0.40-9.54 0.25-5.75 0.63-45.09	- 0.932 0.414 0.825 0.126
4. Symptom Recurrence, Preoperative Cough attributable to reflux
Variables	Odds Ratio	95% Confidence Interval	p-value
Preoperative cough	0.794	0.42-1.49	0.470
Age	1.000	0.98-1.02	0.921
Race/Ethnicity Hispanic Black White Other	Ref 0.335 0.601 1.052	- 0.10-1.12 0.28-1.30 0.42-2.65	- 0.076 0.194 0.915
Gender, Male	0.847	0.49-1.46	0.549
Institution 1 2 3 4 5	Ref 0.880 1.711 1.114 5.158	- 0.16-4.76 0.35-8.41 0.23-5.34 0.61-43.36	- 0.882 0.509 0.893 0.131

Table: Multivariate Regression Analysis

Disclosures:

Cassandra Mohr indicated no relevant financial relationships.

Hailie Ciomperlik indicated no relevant financial relationships.

Naila Dhanani indicated no relevant financial relationships.

Oscar Olavarria indicated no relevant financial relationships.

Craig Hannon indicated no relevant financial relationships.

William Hope indicated no relevant financial relationships.

Scott Roth indicated no relevant financial relationships.

Mike Liang indicated no relevant financial relationships.

Julie Holihan indicated no relevant financial relationships.

Cassandra Mohr, BS¹, Hailie Ciomperlik, BS¹, Naila Dhanani, MD¹, Oscar Olavarria, MD¹, Craig Hannon, BS¹, William Hope, MD², Scott Roth, MD³, Mike Liang, MD⁴, Julie Holihan, MD¹. C0210 - Evaluation of ICARUS Guidelines and Recommendations Not Supported by Randomized Controlled Trials, ACG 2022 Annual Scientific Meeting Abstracts. Charlotte, NC: American College of Gastroenterology.