Cholesafe 1.0

Anti-Reflux Surgery (Magnetic Sphincter Augmentation/LINX) Recommendations

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Definition:

 

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Non-anatomical altering, life style anti-reflux surgery with or without synchronous hiatus hernia repair with the use of magnetic bead prosthetic implant

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Recommendations:

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• LINX is a valid alternative to fundoplication in selected patients with symptomatic reflux with equivalent outcomes and safety

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• Anti-Reflux surgeons should be aware of LINX outcomes and limitations compared to fundoplication and advise patients appropriately 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)

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• Criteria for surgeons training in LINX:

  • Performing anti-reflux and foregut surgeries regularly.

  • Performing a minimum of 10 laparoscopic 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

 

• LINX providers should be performing >10 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 and confirmed evidence of GORD (these patients as a group have less successful outcomes than patients with typical symptoms)

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• As a minimum, complex/equivocal patients should be discussed at a hiatal MDT* prior to surgery, best practice to discuss all patients 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 (unless provider high volume/experienced)

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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

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Investigations:

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As a minimum, patients being considered for LINX should undergo​

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• OGD

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• pH analysis

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• High Resolution Manometry-     Mean contractile amplitude of >30 mm Hg in 70% 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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• Atypical symptoms: ENT or respiratory opinion sort pre-operatively

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Key performance Indicators:

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• Laparoscopic conversion to open < 2%

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• Less than 24 stay for > 90%

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• Readmission rates 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%

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• >80% of patients should not require regular anti-acid medication at 5 years after surgery

 

• Morbidity <5%

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• Mortality < 0.1%

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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