Transoral Incisionless Fundoplication with Laparoscopic Hiatal Hernia Repair Reinforced with Biologic Mesh: Outcomes And Clinical Experience

Craig G Chang, MD. General and Bariatric Surgery

OBJECTIVE: Our objective was to examine efficacy and safety outcomes for laparoscopic hiatal hernia repair (LHHR) with biologic mesh reinforcement [VERITAS Collagen Matrix, Baxter Healthcare], followed by transoral incisionless fundoplication (TIF) [EsophyX, EndoGastric Solutions] in patients with hiatal hernias > 2 cm.

DESCRIPTION/METHOD OF APPLICATION: Gastroesophageal reflux disease (GERD) is an increasingly prevalent and costly affliction. While some patients may experience temporary relief from medication, patients with large anatomic defects (e.g., hiatal hernias) may continue to have troublesome symptoms that adversely affect their quality of life. For these patients, antireflux surgery is a well-established therapeutic option.

Because TIF is the least invasive surgical approach for fundoplication, we were interested in offering this to our patients. Introduced in the United States in 2008, we believe it is the safest fundoplication strategy. However, the guidelines for TIF alone exclude patients with a hiatal hernia > 2 cm in axial height due to the inability of the TIF EsophyX device to completely reduce the defect. Therefore, for hiatal hernias > 2 cm, our preferred approach is an LHHR with biologic mesh reinforcement followed by a TIF. The LHHR is performed in indicated patients receiving an endoscopic fundoplication just as it would be if they were receiving a laparoscopic fundoplication.

To determine the efficacy and safety of the combined procedure, we reviewed the records of 40 patients who met the aforementioned inclusion criteria. The primary efficacy outcome measures were: 1) relief from GERD symptoms as measured using a validated survey instrument, the GERD–Health-Related Quality-of-Life Scale (GERD-HRQL)(scale of 0: no symptoms to 50: debilitating symptoms) and 2) hiatal hernia recurrence. A secondary outcome measure was overall safety of the combined procedure.

PRELIMINARY RESULTS: From July, 2009 to October, 2014, a total of 40 patients underwent LHHR with biologic mesh reinforcement followed by TIF, and presented with hiatal hernias with an average size of 2.7±1.2 cm. The majority of patients, 73.7%, (28/38), presented with type I hernias, while approximately 26.3% (10/38) presented with type III (two patients’ hernia types were unrecorded). The study cohort included 26 females (65%) and 14 males (35%). The average BMI was 31.2±4.7. Sixteen (40%) of the patients were not obese (BMI < 30), whereas 24 patients (60%) were considered obese with a BMI > 30. The average age was 53.6±12.6 years.

At baseline, out of a possible total score of 50 (debilitating GERD symptoms), the mean GERD-HRQL score was 25.3±12.2. At follow-up (> 3 months), the mean score showed a statistically significant decline to a mean of 3.9±5.9 (p < 0.0001). To date, no patient in the series has experienced a hiatal hernia recurrence, despite the larger mean size of their defects. Complications included dysphagia, intractable hiccoughs (in one patient) and vomiting. All these issues resolved in time without further intervention.

CONCLUSIONS: LHHR with biologic mesh followed by transoral TIF for hiatal hernias that measure > 2 cm is effective and safe in obese and non-obese patients. GERD symptoms improve significantly in spite of initially large hiatal hernia defects.

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