How to select patients for antireflux surgery? The ICARUS guidelines (international consensus regarding preoperative examinations and clinical characteristics assessment to select adult patients for antireflux surgery)

24. Patients with GORD symptoms and a short oesophagus on barium swallow are poor candidates for antireflux surgery.

Statement not endorsed, overall agreement 17.6%: A+ 2.9%, A 14.7%, A? 23.5%, D? 41.2%, D 11.8%, D+ 5.9%; GRADE C.

In the absence of adequate comparative studies, the question of the short oesophagus remains controversial, and there is insufficient evidence to preclude patients with radiological suspicion of a short oesophagus from antireflux surgery. If patients progress to surgery, there is also insufficient evidence to define the best surgical procedure in this scenario. Well-designed case-control or randomised clinical trials are needed to provide an evidence base to address this question.

Oesophageal manometry

25. Oesophageal manometry is mandatory to select patients for antireflux surgery.

Statement endorsed, overall agreement 94.1%: A+ 82.4%, A 11.8%, A? 5.9%, D? 0.0%, D 0.0%, D+ 0.0%; GRADE D.

Oesophageal manometry should be performed prior to antireflux surgery to rule out a major motor disorder, such as achalasia, OGJ outflow obstruction or absent contractility.^177,178 There is no data to support that the manometric finding of distal oesophageal spasm (DOS), Jackhammer oesophagus or minor disorders of peristalsis, such as fragmented peristalsis predicts postoperative dysphagia. Incorporating HRM and impedance into pressure flow parameters might be helpful in predicting outcome since the dysphagia risk index appeared to be helpful in identifying patients at risk for post-fundoplication dysphagia.¹⁷⁹

26. Patients with GORD symptoms and a hypercontractile oesophagus (Jackhammer and the previously described Nutcracker) oesophagus on manometry are good candidates for antireflux surgery if symptoms can be attributed to reflux.

Statement not endorsed, overall agreement 64.7%: A+ 11.8%, A 52.9%, A? 29.4%, D? 2.9%, D 2.9%, D+ 0.0%; GRADE D.

Data on outcome of antireflux surgery of patients with a hypercontractile oesophagus is scarce: there are no randomised, controlled trials available in literature. However, retrospective data on outcome of patients with nutcracker oesophagus (although no longer defined in the Chicago classification V.3.0) undergoing antireflux surgery show no difference compared with patients with a normal oesophageal motility pattern.¹⁸⁰ Manometric abnormalities after a Nissen fundoplication were even improved in two patients with a Jackhammer oesophagus.¹⁸¹ Hypertensive oesophageal contraction patterns are not a contraindication for antireflux surgery; however, patients and clinicians should be aware of the risk of developing chest pain after the surgery.¹⁸²

27. Patients with GORD symptoms and distal oesophageal spasm on manometry are poor candidates for antireflux surgery.

Statement not endorsed, overall agreement 64.7%: A+ 26.5%, A 38.2%, A? 20.6%, D? 11.8%, D 0.0%, D+ 0.0%; GRADE D.

Patients with DOS are poor candidates for antireflux surgery, provided that the motor disorder has been well characterised, preferably using HRM. Therapeutic approaches indicated for patients with DOS include medicines such as sildenafil, as well as endoscopic injection of botulin toxin and surgical myotomy.^183-185 Although some patients may benefit from acid-suppressive therapy, antireflux surgery as the unique treatment should be avoided in patients with DOS.

28. In patients with GORD symptoms and hypocontractility of the oesophageal body on manometry, antireflux surgery should be tailored.

Statement not endorsed, overall agreement 47.1%: A+ 5.9%, A 41.2%, A? 41.2%, D? 0.0%, D 5.9%, D+ 5.9%; GRADE D.

There are no good data to suggest tailoring of antireflux surgery to oesophageal body hypomotility or hypocontractility.^186,187 Provocative manoeuvres during manometry could in the future identify patients where peristaltic performance following fundoplication can modify the risk for postoperative dysphagia. Multiple rapid swallows (MRS) are often added to the manometric protocol as a marker for esophageal body peristaltic reserve. It has been shown that MRS testing before laparoscopic antireflux surgery is able to help predict late postoperative dysphagia.^188,189

29. Patients with GORD symptoms and severe hypocontractility or failed peristalsis on manometry are poor candidates for antireflux surgery.

Statement not endorsed, overall agreement 64.7%: A+ 8.8%, A 55.9%, A? 23.5%, D? 2.9%, D 8.8%, D+ 0.0%; GRADE D.

Hypocontractility is not a contraindication for antireflux surgery, since surgery more often than not improved these manometric abnormalities.¹⁸⁶ Further research is warranted since very little data exists on outcome of patients with the most severe hypocontractility or aperistalsis. Similar as described above (statement 28) is the importance of adding MRS during a manometric protocol, which is a marker of contractile reserve of the oesophagus.^188,189 In addition, antireflux surgery can be tailored to each individual patient.

It has to be repeated that the main indication for manometry in patients with GORD considered for antireflux surgery is to identify patients with aperistalsis due to achalasia, who are candidates for fundoplication only when combined with myotomy of the LOS.

Reflux monitoring

30. Oesophageal pH (±impedance) monitoring off therapy is mandatory to select patients with NERD for antireflux surgery.

Statement endorsed, overall agreement 97.1%: A+ 91.2%, A 5.9%, A? 0.0%, D? 2.9%, D 0.0%, D+ 0.0%; GRADE B.

In the absence of oesophagitis (ie, presence of mucosal breaks), pathological GOR and/or positive reflux symptom association `off ' therapy should be documented before embarking to antireflux surgery.<sup>22,33,190-193</sup> In the preoperative setting, the added value of impedance in patients `off ' therapy remains to be determined.

Data on preoperative assessment `on' PPIs are scarce. Few uncontrolled and short studies suggest that good postoperative outcomes can be achieved in patients who are refractory to PPIs in whom pH-impedance monitoring demonstrated either an abnormal number of reflux episodes or positive symptom association analysis.^33,194

31. Oesophageal pH (±impedance) monitoring off therapy should be performed for selection for antireflux surgery of patients who have short Barrett's oesophagus in the absence of erosive oesophagitis.

Statement endorsed, overall agreement 88.2%: A+ 41.2%, A 47.1%, A? 5.9%, D? 0.0%, D 5.9%, D+ 0.0%; GRADE B.

Oesophageal (impedance-) pH-monitoring off therapy should be performed in patients with short segment Barrett's oesophagus as it provides an objective quantification of patient's GOR.¹⁹⁰ This evaluation of PPI therapy would provide a baseline comparator in assessing the efficacy of acid-suppressive therapy and/or reflux-reducing therapy.

32. Patients with GORD symptoms and normal reflux exposure on pH (±impedance) monitoring off PPI therapy are poor candidates for antireflux surgery.

Statement endorsed, overall agreement 82.4%: A+ 17.6%, A 64.7%, A? 17.6%, D? 0.0%, D 0.0%, D+ 0.0%; GRADE B.

There is very limited data examining the outcomes of surgery in patients with normal reflux monitoring. This is in large part due to the fact that most of the studies evaluating outcomes of antireflux surgery require abnormal reflux monitoring as a criteria to be eligible for surgery.⁵⁶ Based on the available evidence, it would appear that patients with normal reflux exposure on pH (±impedance) monitoring off therapy are indeed poor candidates for antireflux surgery.

33a. Patients with GORD symptoms, a normal reflux exposure on pH (±impedance) monitoring off therapy and a positive symptom association are good candidates for antireflux surgery.

Statement not endorsed, overall agreement 58.8%: A+ 14.7%, A 44.1%, A? 23.5%, D? 17.6%, D 0.0%, D+ 0.0%.

33b. Patients with GORD symptoms, a normal reflux exposure on pH (±impedance) monitoring off therapy and a positive reflux symptom association are good candidates for antireflux surgery, only if symptoms respond to PPI therapy.

Statement not endorsed, overall agreement 73.5%: A+ 11.8%, A 61.8%, A? 14.7%, D? 5.9%, D 5.9%, D+ 0.0%.

There is a very limited data examining the outcomes of surgery in patients with normal reflux monitoring. This is in large part due to the fact that most of the studies evaluating outcomes of antireflux surgery require abnormal reflux monitoring as a criteria to be eligible for surgery.⁵⁶ Some studies do suggest that reflux-hypersensitive patients with typical symptoms and an unsatisfactory response to PPIs may benefit from antireflux surgery with an outcome similar to the one of patients with pathological reflux.^31,195 However, as mentioned above (statement 3), a recent study by Patel et al showed that pure acid sensitivity was a negative predictor for symptom improvement with antireflux therapy, including surgical management.³⁵ Results should therefore be interpreted with caution.

34a. Patients with GORD symptoms and pathological reflux exposure on pH (±impedance) monitoring off therapy and a negative reflux symptom association are eligible for antireflux surgery.

Statement not endorsed, overall agreement 58.8%: A+ 5.9%, A 52.9%, A? 29.4%, D? 8.8%, D 2.9%, D+ 0.0%.

34b. Patients with GORD symptoms and pathological reflux exposure on pH (±impedance) monitoring off therapy and a negative reflux symptom association are eligible for antireflux surgery, only if symptoms respond to PPI therapy.

Statement not endorsed, overall agreement 66.7%: A+ 6.1%, A 60.6%, A? 9.1%, D? 6.1%, D 18.2%, D+ 0.0%.

The literature available suggests that patients with proven pathological acid exposure who do not experience symptoms during pH (±impedance) monitoring or presenting a negative symptom-reflux association may still obtain good results from anti-reflux surgery.^33,192 Moreover, there is a subgroup of patients that is truly refractory to PPIs, with ongoing acid secretion.¹⁹³

35. Patients with pathological reflux exposure on pH (±impedance) monitoring on PPI who respond to baclofen therapy are good candidates for antireflux surgery.

Statement not endorsed, overall agreement 20.6%: A+ 5.9%, A 14.7%, A? 61.8%, D? 2.9%, D 11.8%, D+ 2.9%.

Baclofen, a GABA B-agonist, is known to reduce the number of transient LOS relaxations and subsequently, it reduces all types of reflux, including weakly acidic reflux.¹⁹⁶ To date, there are no studies comparing baclofen with antireflux surgery, therefore it would be too speculative to say that patients responding to baclofen are good candidates for antireflux surgery. In the very recently published paediatric GOR clinical guidelines, the use of baclofen prior to antireflux surgery can be considered in children in whom other pharmacological treatments have failed (weak recommendation).¹⁹⁷

Gastric emptying

36. A gastric emptying test for solid food is necessary to select patients with GORD with concomitant dyspeptic symptoms for antireflux surgery.

Statement not endorsed, overall agreement 5.9%: A+ 2.9%, A 2.9%, A? 8.8%, D? 5.9%, D 67.6%, D+ 11.8%; GRADE C.

Studies performed to assess the role of a preoperative gastric emptying test in antireflux surgery have generated controversial results: some studies have shown that this evaluation is useful to select the best type of surgery and to avoid surgical failures, while others have denied the validity of such an approach.^198-200 However, so far no study has been performed to establish whether the assessment of gastric emptying is relevant or not to favour success of surgery in patients with GORD with concomitant dyspepsia symptoms.

37. If the gastric emptying test is abnormal for solid food, patients should not undergo an antireflux surgery.

Statement not endorsed, overall agreement 2.9%: A+ 0.0%, A 2.9%, A? 0.0%, D? 20.6%, D 67.6%, D+ 8.8%; GRADE C.

Literature shows that there is no evidence to suggest that preoperative slow gastric emptying for solids is associated with a poor outcome after surgery with regard to reflux parameters.^201,202 A study by Lundell et al suggests that a slow preoperative gastric emptying for solids is weakly associated with symptoms of bloating.²⁰² However, two other studies investigating the relationship between gastric emptying rates before and outcome after antireflux surgery could not confirm this.^198,199 There is insufficient evidence to support the statement.

Recommendations

Based on the statements that generated consensus, a number of recommendations can be made for selecting patients for antireflux surgery. These are summarised in table 4.

Table 4. Summary of the ICARUS guidelines
Recommendations	Based on state- ment(s)
Antireflux surgery can be considered for patients with typical symptoms of heartburn, with a good response to proton pump inhibitors (PPIs).;	1
Patients with functional heartburn and patients with eosinophilic oesophagitis are poor candidates for antireflux surgery.	4, 6
Patients with morbid obesity and patients with substance abuse are not excluded from antireflux surgery.	9, 11
Endoscopy (during the last year) is mandatory prior to referral for antireflux surgery. There is no need to wean the patient off PPI for endoscopy.	13, 14
Patients with GORD symptoms and a hiatal hernia, Barrett's oesophagus or erosive oesophagitis grade B or higher at endoscopy are good candidates for antireflux surgery.	15, 16b, 18
Patients without erosive oesophagitis are not excluded from antireflux surgery.	17
There is no need to obtain routine biopsies of the distal oesophagus in patients considered for antireflux surgery.	19
A barium X-ray should be obtained in patients with suspicion of a hiatal hernia or short oesophagus when considered for antireflux surgery.	20
Patients with GORD symptoms and a hiatal hernia on X-ray are good candidates for antireflux surgery.	21, 22
Patients with GORD symptoms and a para-oesophageal hernia on X-ray are good candidates for antireflux surgery in addition to para-oesophageal hernia repair.	23
A short oesophagus on barium X-ray does not exclude the patient from antireflux surgery.	24
Oesophageal manometry and oesophageal pH monitoring (±impedance) are mandatory prior to referral for antireflux surgery. The latter is preferentially done off PPI and in patients with NERD.	25, 30, 31
Patients with normal pH-monitoring off PPI are poor candidates for antireflux surgery.	32
Response to baclofen does not enhance patient eligibility for antireflux surgery.	35
There is no need to assess gastric emptying rate in patients considered for antireflux surgery.	36,37

The Delphi process also identified several areas of uncertainty, requiring further research. It is unclear whether patients with regurgitation as a main symptom, patients with NCCP, patients with extra-oesophageal manifestations of reflux and patients with dental erosions are good candidates for anti-reflux surgery (statements 2, 5 and 12). There is a lack of prospective controlled trials to support these statements. Patients with reflux hypersensitivity, patients with concomitant FD and IBS and patients with major psychiatric comorbidity are not considered good candidates for antireflux surgery (statements 3, 8 and 10). There is a need for additional markers of beneficial outcome of antireflux surgery in these patients, given the frequent overlap of GORD with FD and IBS symptoms. There is no consensus that patients with scleroderma are poor candidates for antireflux surgery (statement 7). It is unclear to which extent patients with Jackhammer (or Nutcracker) oesophagus or spasm on manometry are eligible for antireflux surgery (statements 26 and 27). The impact of oesophageal hypocontractility on the eligibility or type of antireflux surgery is unclear (statements 28 and 29). It is unclear whether patients with reflux hypersensitivity are eligible for antireflux surgery (statement 33). Finally, it is unclear whether patients with pathological reflux monitoring but negative symptom association are good candidates for antireflux surgery (statement 34).

It is important to stress that the decision of referring a patient for antireflux surgery has to take into account all positive as well as all negative support findings. Selecting patients suitable for antireflux surgery cannot be captured by one single statement and remains subject to guided clinical judgement and patient preference.



Conclusion

GORD, often accompanied by the typical reflux symptoms heartburn and regurgitation or by atypical reflux symptoms such as chronic cough and wheezing, is very common in the Western World.1 2 The first-line treatment for GORD is acid suppressive therapy, most often by PPI intake. PPIs have shown to be very effective in healing oesophagitis, however up to 40% of patients with GORD remain symptomatic while on an adequate dose of PPIs.5 6 Antireflux surgery is often recommended for patients with insufficient relief of symptoms during PPI intake, in case of intolerance to or anticipated long-term use of PPIs. However, to date, consensus guidelines defining clinical criteria and additional technical examinations that need to be performed for patient selection for antireflux surgery are lacking. Therefore, we aimed to develop the ICARUS guidelines using a Delphi process.

The Consensus Group defined several statements that may guide clinicians and surgeons in their decision to select patients for antireflux surgery. All patients require endoscopy, pH-monitoring off PPI and oesophageal manometry. The consensus process also identified areas of uncertainty and some patient groups in whom referral for surgery should be avoided, such as functional heartburn.

Acknowledgements. The ICARUS consensus was initiated under Jan Tack's presidency of the International Society for Diseases of the Esophagus (ISDE) and is endorsed by the European Society for Diseases of the Esophagus (ESDE), the European Society for Neurogastroenterology and Motility (ESNM) and the American Neurogastroenterology and Motility Society (ANMS) and the European Association for Gastroenterology, Endoscopy and Nutrition (EAGEN).

Contributors. AP, VB, TV, NR and PhR contributed to the reviewing list of publications. AP and VB drafted all the statements, tracked the voting process and wrote the manuscript. TV, NR, PhR and JT contributed to the revision of the statements and involved in the voting process. JT contributed to the study concept and design. All the other authors also contributed to the revision of the statements and involved in the voting process. All authors contributed to the critical revision of the manuscript for important intellectual content and approval of the final manuscript.

Funding. JT is supported by a Methusalem Grant from Leuven University. AP is funded by a personal grant from the Research Foundation Flanders (FWO). PhR is supported by Clinical Mandate from the Belgian Foundation against Cancer (Stichting tegen Kanker).

Competing interests. None declared.

Patient consent for publication. Not required.

Provenance and peer review. Not commissioned; externally peer reviewed.



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