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Biosynthetic long-term resorbable meshes augmentation for hiatus hernia repair is feasible and safe

Updated: Apr 5, 2023

Hiatus hernia (HH) repair with biosynthetic long-term resorbable meshes (BSM) augmentation is feasible and safe with low perioperative morbidity and acceptable postoperative failure rates at early to mid-term follow-up, according to researchers from the University Hospital Zurich, Zurich, Switzerland. The investigators sad that BSM could be a useful alternative to non-resorbable materials in HH surgery.

Phasix ST (BD, Allschwil, Switzerland)

Biomeshs rapidly revascularised and have a high resistance to bacterial contamination. However, high cost, negative long-term results in randomized trials and cultural and religious issues have prevented widespread use of these materials, the researchers explained. The research team stated that a new, biosynthetic long-term resorbable meshes (BSM) have recently been developed with their design avoiding the downsides of both non-resorbable synthetic and biological materials.

New-generation long-term absorbable biosynthetic meshes (BSM), such as the Phasix ST (BD, Allschwil, Switzerland), is made from poly-4-hydroxybutyrate (P4HB), a material that handles well laparoscopically, absorbs and remodels to native host tissue within 6–18 months. Their study sought to assess the outcomes after HH repair with this new generation of mesh at their centre in Zurich.


From their prospective database, they identified 97 patients (elective primary cases n=76, redo cases n=13, emergency cases n=8) underwent HH with BSM augmentation. Redo cases had a history of one or two previous HH repairs in 11% and 3%, respectively. For mesh augmentation, a circular (8cm diameter) monofilament P4HB patch with a hydrogel barrier on the abdominal surface (Phasix ST Mesh, BD) was used. Prior to implantation, the patch was modified with a 2.5–3 cm central recess for the oesophagus via a radial incision.


Outpatient follow-up visits were scheduled at six weeks, three months and then annually. Outcome measures included postoperative morbidity, intensive care unit (ICU) and hospital stay, hospital readmission and failure rates (clinical, radiological, and endoscopic). Postoperative complications were graded according to the Clavien–Dindo (CD) classification [20] and the Comprehensive Complication Index (CCI) at 30 and 90 days after surgery. Recurrence was defined as any size hernia identified on postoperative UGI radiography or endoscopy.


Outcomes

The median follow-up was 12 months, 93 patients (96%) were followed up regularly with four patients (4%) lost to follow up. The median ICU and hospital stay was 0 and 4 days, respectively with only emergency cases requiring ICU care. An outcome without postoperative complications in elective primary, redo and emergencies cases was achieved in 88%, 100%, and 25%, respectively. Mortality was 0% within 30 days after surgery, and overall (CD ≥ 2) and severe (CD ≥ 3b) morbidity was 15% and 3%, respectively. Peri-operative morbidity was significantly (p<0.05) higher in emergency cases with no incidences of intraoperative complications or intra- and post-operative mesh-related morbidity.

At follow-up, complete success (defined as being asymptomatic without evidence of anatomical HH recurrence) was achieved in 69 patients (74%), partial success (defined as symptom improvement with or without anatomical HH recurrence or asymptomatic anatomical HH recurrence) was achieved in 15 patients (16%) and nine patients (10%) reported clinical failure (defined as unchanged or worsened symptoms with or without anatomical recurrence).


Upper gastrointestinal endoscopy and/or contrast swallow studies were performed in 25 (27%) and 55 patients (59%) at follow-up, respectively. Anatomical HH recurrence was found in eight patients (9%). Two patients required surgical revision for symptomatic hernia recurrence after 23 and 34 months, respectively. At re-operation, complete absorption of the mesh with mild adhesions to adjacent organs was reported.


“This study confirms that reinforcement of crurorrhaphy with the Phasix ST P4HB patch is feasible and clinically effective in the short- and mid-term follow-up. Furthermore, our series provides additional evidence that the safety profile of long-term absorbable BSM is excellent with a very low rate of mesh-related complications even in a “keyhole” position encircling the abdominal oesophagus,” they concluded. “Nevertheless, the ideal technique for hiatus reconstruction has yet to be determined and m- particularly with regard to the rapidly rising incidence of large HH in Western societies - well-designed prospective and preferably randomised studies are needed to confirm long-term reliability of new-generation long-term absorbable BSM.”


The findings were reported in the paper, 'Hiatus hernia repair with a new-generation biosynthetic mesh: a 4-year single-center experience', published in Surgical Endoscopy. To access this paper, please click here

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