Further evidence of symptom control following Nissen fundoplication with ePTFE-mesh in hiatal hernia repair

Background: Hiatal herniae ≥3 cm carry a threefold risk for recurrence after fundoplication when corrected without mesh. We report the use of ePTFE (Goretex®) mesh in hernia repair with Nissen fundoplication for gastroesophageal reflux disease (GERD).

Patients and methods. 25 Patients with GERD and typical symptoms entered a pilot study. Inclusion criteria comprised endoscopic evidence of erosions and/or abnormal esophageal acid exposure, and hiatal hernia of ≥3 cm in length. Study endpoints were the time to recurrence of reflux symptoms and the postoperative incidence of dysphagia with ensuing intervention. A cohort of 45 patients who have undergone fundoplication without mesh for reflux with hiatal hernia from 1996 – 2007, who underwent careful audit served as controls. In the study population tension free repair of the hiatus was carried out with ePTFE mesh. The patients were contacted at 1,3, and 6 months postop, and 6 monthly therafter. Symptom recurrence was heartburn and/or regurgitation more frequently than once a week and/or the need for PPI to control reflux symptoms. Significant dysphagia were swallowing difficulites severe enough that the patient accepted an offered intervention: endoscopy and/or dilatation. The patient characteristics are shown in Table 1.

Results: No conversions, revisions, or reoperations were suffered in the study group. Following a mean follow-up of 19+/-12 months no symptom recurrences were encountered. Two patients reported dysphagia, in one resolved after endoscopy, the other requiring two dilatations. The Weibull parametric analysis of symptom free survival revealed a borderline significant (p = 0.07) association in favor of of mesh and the Kaplan-Meier recurrence rate estimates shown in Tables 2/3.

Comment: ePTFE mesh in hiatal hernia repair seemed safe and effective. The difference in recurrence rates as compared to controls with otherwise identical technique approaches statistical significance. If the promising results sustain, ePTFE inlay in hiatal hernia should be proficient to further improve the performance of fundoplication.

Patient characteristics
Variable	PTFE Mesh (n = 25)	Controls (n = 45)
Age	51(34 – 70)	57(27 – 74)
Gender (M: F ratio)	1.5	2.5
Hiatal hernia (cm)	5 (3 – 8)	5(3 – 10)

Outcome I
Variable	PTFE Mesh (n = 25)	Controls (n = 45)
Sympt recurrences	0/25	13/45 (29%)
Overall follow-up	16 mo (2 – 44)	115 mo (12 – 183)
Time to recurrence	..	32 mo (10 – 115)

Outcome II
Group	Kaplan-Meier Estimated	rate of	recurrence
	12 mo	36 mo	120 mo
No mesh	7%	18%	33%
ePTFE	0	..	..