NICE guidelines for LINX 11/1/2023 updated

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Anti-Reflux Surgery (LINX)

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Definition- Non-anatomical altering, life style anti-reflux surgery with or without synchronous hiatus hernia (hiatus hernia <3 cm) with the use of prosthetic implant

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LINX is a valid alternative to fundoplication in patients with symptomatic reflux with equivalent outcomes and safety and maybe superior in some patients

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Anti-Reflux surgeons should be aware of LINX outcomes and limitations compared to fundoplication and advise patients if asked

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LINX providers should have received appropriate training and mentorship

Completion of 2-day industry In-Hospital Training program (Virtual) with expert LINX surgeons

• Criteria for course

  • Performing anti-reflux and foregut surgeries regularly.

  • Performing a minimum of 10 laparoscopic Nissen fundoplication procedures (over the last 12 months).

  • Access & experience in pre-operative diagnostic work-up including OGD, pH monitoring, Manometry & Barium contrast study.

  • Works in collaboration with GI physician and multi-disciplinary team

1. Observe procedure where possible (COVID compliant)

2. Offer of proctorship to support first 2 cases using virtual technology to remote support during pandemic where face to face is not possible.

 

LINX providers should be preforming >15 procedures per year

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LINX should be offered as an alternative option to fundoplication surgery in eligible patients

- patients in whom the primary symptom is volume reflux/regurgitation

- a confirmed diagnosis of acid reflux and adequate symptom control with medical therapy but do not wish to continue with long term therapy

- patient with breakthrough symptoms despite maximum medical therapy

- a confirmed diagnosis of acid reflux and symptoms that respond to medical therapy but who are intolerant of medication side effects

- atypical symptoms such as aspiration, cough or hoarse voice (these patients as a group have less successful outcomes than patients with typical symptoms)

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Pass patients through a hiatal MDT prior to surgery

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Enter data into a registry to audit outcomes

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Not recommended with hiatal hernia > 3 cm

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Surgery not recommended with BMI >35

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Surgery not recommended in age <21

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Surgery not recommended in active smoker

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Surgery not recommended with significant history of dysphagia

 

Laparoscopic conversion to open < 5%

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Less than 24 stay for > 90%

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Readmission rates after within 30 days <5%

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Re-operation rate within 30 days (acute complications) <2%

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Re-operation for device herniation (within 1 year) <10%

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Long term device erosion <1%

 

Morbidity <10%

Mortality < 0.1%

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Minimum investigation set

OGD

pH analysis

High Resolution Manometry-     Mean contractile amplitude of >30 mm Hg in 70% of swallows OR a average DCI of >450 mmHg/s/cm for more than 50% of swallows is recommended prior to magnetic sphincter augmentation.

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Other investigations to consider in patients with additional upper gastrointestinal symptoms such as bloating, nausea, vomiting, and early satiety: Contrast swallow/gastric emptying study

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Patients with a history of eating disorders are relatively contraindicated due to potential poor compliance with oesophageal physiotherapy diet after surgery leading to a higher risk of post operative problems.

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Atypical symptoms: ENT or respiratory opinion sort pre-operatively

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Please also see the European Foregut Society recommendations on sizing the LINX prosthesis.

https://euro-fs.org/wp-content/uploads/2022/09/Expert-ConsensusSizing.pdf