Characteristics and Outcomes of OviTex Mesh in Laparoscopic Hiatal Hernia Repair with Fundoplication and Mesh

Abstract

Background:

Laparoscopic repair is the standard treatment for symptomatic paraesophageal and mixed hiatal hernias; however, recurrence rates remain high, particularly in large defects. Mesh reinforcement has been used to improve outcomes, but the optimal mesh type remains debated. OviTex 1S, a reinforced tissue matrix composed of ovine extracellular matrix and polypropylene, has demonstrated safety in abdominal wall reconstruction, though data for hiatal hernia repair are limited.

Methods:

We conducted a prospective, single-arm, single-institution study evaluating laparoscopic hiatal hernia repair with OviTex 1S mesh between January 2020 and February 2024. Adults with radiologic or endoscopic confirmation of hiatal hernia requiring mesh reinforcement were included. Primary endpoints were hernia recurrence and reflux symptom improvement. Secondary endpoints included quality of life, assessed using reflux severity scores and the Gastroesophageal Reflux Disease (GERD)-Health-Related Quality of Life (HRQL) survey. Patients were followed at 1, 3, 6, 12, and 24 months.

Results:

Of 443 patients undergoing paraesophageal hernia repair, 108 received OviTex 1S reinforcement. Mean age was 65.5 years, mean body mass index (BMI) 28.1 kg/m², and 82.2% were female. Three perioperative recurrences (2.8%) required reoperation. Overall recurrence occurred in 21 patients (19.4%), most beyond six months. GERD-HRQL scores improved by more than 50% at 12 months (20 ± 4.75 vs 4 ± 7; P = .02). Proton pump inhibitor use declined from 91.6% preoperatively to 9.4% postoperatively. No mesh-related erosions or strictures were observed.

Conclusions:

OviTex 1S mesh reinforcement during laparoscopic hiatal hernia repair is safe, improves reflux-related quality of life, and demonstrates low early recurrence. Long-term benefits remain limited, warranting larger multicenter studies.

INTRODUCTION

Surgical treatment of hiatal hernias has evolved over the past several decades as new insights into the pathophysiology of the disease continue to emerge. While laparoscopic hiatal hernia repair is now the standard of care for the management of symptomatic paraesophageal hernia and mixed hiatal hernias since its introduction in the early 1990s, there is still no consensus on use of crural reinforcement, mesh type, or mesh fixation, especially in the setting of large hiatal hernias.^1–6 Recurrences and reoperation in this patient population have been high, ranging anywhere from 25–55%.^7–10

To reduce recurrences and reoperation rates, both synthetic and biological meshes have been used to reinforce cruroplasty.¹⁰ Several systemic reviews and meta-analyses have shown significant improvement in short term recurrence rate (<6 months) but ultimately showed significant high long-term recurrence rate, although it was much improved compared to those who underwent primary repair.¹¹ Early meshes were synthetic nonabsorbable products, which were abandoned secondary to reports of strictures with or without erosion into the esophageal lumen, paving the way for different types of bioresorbable mesh solutions that have been introduced in recent years.^12–14 Several studies have looked at poly-4-hydroxybutyrate (P4HB), a bioabsorbable mesh that has been demonstrated to be safe in soft tissue repair and reconstruction of the abdominal wall.¹⁵ A recently published study in 2024 looked at the use of coated P4HB in hiatal hernia repair and found it to be safe and effective.¹⁵

Biosynthetic mesh has also started to increase in popularity for cruroplasty. TELA Bio (Malvern, PA) has developed an ovine polymer-reinforced tissue matrix (RTM) to be used for reinforcement of abdominal wall and hiatal herniorrhaphies. A retrospective review in 2018 looked at 25 patients who underwent laparoscopic or open hiatal hernia repair utilizing resorbable OviTex RTM for crural reinforcement.¹⁶ The study concluded that use of OviTex in hiatal hernia repair was associated with excellent early patient outcomes.¹⁶ However, the current role of biosynthetic meshes is still under debate since there is a dearth in literature regarding their efficacy, particularly in terms of recurrence rates, morbidity, need for revision, and quality of life (QoL).

The aim of this study was to assess safety, efficacy, and QoL improvement after laparoscopic repair of hiatal hernia reinforced with OviTtex 1S, the permanent version of RTM from our institutional experience.

METHODS

Study Design

This is an Institutional Review Board approved prospective, single-arm, single-institution clinical trial that evaluated OviTex 1S Permanent in patients undergoing laparoscopic hiatal hernia repair. Patients were continuously recruited from January of 2020 to February of 2024. Subjects were 18 years or older and were eligible for consent if they had been radiologically or endoscopically diagnosed with a hiatal hernia.

Exclusion Criteria

Exclusion criteria included subjects younger than 18 years old, hiatal hernia repair that did not require mesh reinforcement, recurrent hiatal hernias and allergy to ovine-derived products.

Surgical Technique in Brief

All cases were performed laparoscopically. A complete mediastinal dissection was performed, which included incising the phrenoesophageal membrane circumferentially and mobilizing the esophagus as high up the mediastinum to the discretion of the surgeon to create 2–3 centimeters of intraabdominal length.¹⁶ Prior to closure of the defect, the patient’s esophageal hiatus was measured by obtaining 2 measurements—length of the defect perpendicular to the left sling of the right crus and tangential to the esophagus (b) and length of left sling of the crus from the crux of the crura to the esophagus (h). These measurements were taken after complete dissection of the esophagus and complete release of the pneumoperitoneum. The surface area of the hiatus, corresponding to a right-angled triangle, was calculated using the formula Area = (1/2) Base × Height (see Figure 1). The hiatal defect was closed with sutures of 0 Ethibond in an interrupted fashion over a 56 French bougie dilator. If more than 3 sutures, separated by 10 mm, were used, the repair was buttressed using a 6 × 10 cm OviTex 1S Permanent mesh, trimmed down and fashioned into a U-shape. The mesh was secured to the diaphragm, after which a fundoplication was performed. Post operatively, patients were kept nil per os (NPO) and admitted to the floor for observation. An upper gastrointestinal (UGI) series was performed on postoperative day 1 and a liquid diet was started if no leak was observed on imaging and then discharged home later that day or on postoperative day 2.

Figure 1.

Intraoperative scheme of esophageal hiatus surface area defect measurement. b represents the length of the defect perpendicular to the left sling of the right crus and tangential to the esophagus. h represents the length of the left sling of the crus from the crux of the crura to the esophagus.

Follow-Up

Endpoints for 108 subjects were evaluated at 1, 3, 6, 12, and 24 months. At each follow-up visit, patients underwent a detailed history including specific questions pertaining to gastroesophageal reflux disease (GERD) symptoms and GERD Heartburn Related Quality of life (HRQL) questionnaire to assess for postoperative adverse events, surgical complications, or hernia recurrent symptoms.

Primary Endpoints

The primary endpoints were incidence of hernia recurrence and improvement of reflux symptoms.

Secondary Endpoints

The secondary endpoints were assessing QoL by administration of a subjective reflux severity score survey and the validated GERD-HRQL survey.

Statistical Analysis

Patients were recruited from January of 2020 to February of 2024 and stored using encrypted Research Electronic Data Capture (REDCap). Quantitative baseline characteristics that had normal distribution were reported as mean and standard deviation (SD). Quantitative baseline characteristics that had a non-normal distribution were reported as median and interquartile range (IQR). Qualitative variables were reported as frequency and percentage. Single sample t test was used to compare the outcomes of quantitative variables as appropriate. χ² Goodness of Fit was used to compare the outcomes of qualitative variables as appropriate. Kaplan-Meier analysis was used to assess recurrence free survival following a hiatal hernia repair with OviTex mesh. Statistical analysis was performed using R and all statistical significance tests relied on a 2-sided P < .05.

RESULTS

Baseline Demographics and Diagnosis Characteristics

A total of 443 patients underwent a paraesophageal hernia repair from January 2020 to February 2024. One hundred and eight patients had placement of TelaBio Ovitex mesh and were followed preoperatively and up to 24 months postoperatively. The mean age was 65.5 years (SD 12.4 years) and majority were female (82.2%) with a mean body mass index (BMI) of 28.1 kg/m² (4.7 kg/m²) (Table 1). Preoperatively, most patients had GERD symptoms (84.9%) and were taking a proton pump inhibitor (PPI) (91.6%). Eighty-five patients (81.7%) had heartburn, 73 patients (70.1%) complained of regurgitation, 79 patients (75.2%) complained of dysphagia, 64 patients (61.0%) reported they had chest discomfort, 35 patients (33.3%) complained of nausea, and 18 (17.3%) complained of vomiting (Table 2).

Table 1.

Demographics

	N = 108
Age	65.5 (12.4) (n = 108)
Gender
Male	19 (17.8%) (n = 108)
Female	88 (82.2%) (n = 108)
Weight	181.3 (121.8) (n = 108)
BMI	28.1 (4.7) (n = 108)
Comorbidities
Cardiac Hx: Yes	46 (43.0%) (n = 108)
COPD/asthma: Yes	6 (5.6%) (n = 108)
PVD: Yes	8 (7.7%) (n = 108)
Diabetes: Yes	4 (3.8 %) (n = 108)
PUD: Yes	4 (3.8%) (n = 108)
Gastroparesis: Yes	6 (5.7%) (n = 108)
GERD: Yes	90 (84.9%) (n = 108)
Hepatitis: Yes	1 (0.96 %) (n = 108)
ERSD: Yes	4 (3.8 %) (n = 108)
Alcohol use: Yes	23 (21.5%) (n = 108)
History of tobacco: Yes	15 (14.0%) (n = 108)
Current smoker: Yes	9 (60%) (n = 108)
Medication
PPI	98 (91.6%) (n = 108)
H2RA	6 (5.6%) (n = 108)
Promotility agent	1 (94%) (n = 108)

Abbreviations: BMI, body mass index; COPD, chronic obstructive pulmonary disease; PVD, peripheral vascular disease; PUD, peptic ulcer disease; GERD, gastroesophageal reflux disease; ESRD, end stage renal disease; PPI, proton pump inhibitor; H2RA, histamine 2 receptor antagonist.

Table 2.

Diagnosis Characteristics

	N = 108
Duration of symptoms
Symptoms
Dysphagia	79 (75.2 %) (n = 105)
Solids	2 (2.5 %) (n = 79)
Liquids	3 (3.8 % ((n = 79)
Both	61 (77.2%) (n = 79)
Weight change	31 (30.7 %) (n = 101)
Regurgitation	73 (70.1%) (n = 104)
Aspiration	0
Cough	20 (19.4%) (n = 103)
Hoarseness	20 (20%) (n = 100)
Throat pain	9 (8.7%) (n = 103)
Voice changes	0
Choking episodes	13 (12.6%) (n = 103)
Globus sensation	18 (17.5%) (n = 103)
Nausea	35 (33.3%) (n = 105)
Vomiting	18 (17.3%) (n = 104)
Belching	39 (37.9%) (n = 103)
Bloating	59 (56.7 %) (n = 104)
Wheezing	1 (0.99%) (n = 100)
SOA	12 (11.5%) (n = 104)
Pneumonia	0
Heartburn	85 (81.7%) (n = 104)
Chest discomfort	64 (61.0 %) (n = 105)
Dyspepsia	30 (30.0% (n = 100)

Abbreviation: SOA, shortness of air.

Different modalities were utilized to diagnose hiatal hernias, including endoscopy, computed tomography (CT) and esophagograms. Additional workup adjuncts, such as pH testing, high-resolution manometry (HRM), and gastric emptying studies were also completed on some patients. In patients with large hernias who complaints were not reflux, pH-metry was not performed. Esophagogastroduodenoscopy (EGD) confirmed a hiatal hernia in 84 of the 108 patients. Sixty-two patients underwent a barium swallow study. Thirty-eight patients had preoperative imaging in the form of preoperative CT scan or UGI. The mean coronal height of the hiatal hernia on imaging was 7.3 cm (SD 3.2 cm). The rest of the patients who did not have any diagnostic workup were sent as referrals and already diagnosed.

Patients who underwent additional workup adjuncts had the following results. Fourteen of the 108 patients who received mesh underwent pH testing and had a mean DeMeester score of 52.10 (16.5). Sixty patients underwent HRM and the median lower esophageal pressure was 15.4 mmHg (15.8 mmHg). Fifty-one patients (49.5%) underwent a gastric emptying study and 17 patients (36.3%) were found to have delayed gastric emptying. The median preoperative GERD-HQRL score was 20 (18.5) and median reflux severity score was 5.1 (2.9) (see Table 3).

Table 3.

Diagnostic Characteristics Based on Type of Hiatal Hernia

	N = 108
EGD	85 (82.5 %) (n = 104)
Hernia Hill grade score	2.2 (1.095) (n = 5)
Esophagitis	2 (1.9%) (n = 108)
Gastritis	3 (2.8 %) (n = 108)
Hiatal hernia	84 (77.8%) (n = 108)
pH testing	14 (15.1%)
pH testing type
# of reflux episodes	96.4 (55.1) (n = 14)
# of reflux episodes >5 minutes	14 (8.4) (n = 14)
Longest Reflux Episodes (minutes)	51.3 (39.4) (n = 14)
DeMeester pH	52.1 (16.5) (n = 14)
Preoperative imaging
Coronal height (cm)	7.3 (3.2) (n = 38)
High-resolution manometry	60 (58.3%) (n = 103)
LES pressure	15.4 (15.8) (n = 57)
LES residual minimal pressure	5.7 (10.9) (n = 56)
Distal contraction integral pressure	834.2 (1135.8) (n = 57)
UES pressure	59.8 (34.9) (n = 57)
UES mean residual pressure	11.6 (8.0) (n = 57)
Esophagogram	62 (57.4 %) (n = 108)
Paraesophageal hernia	47 (43.5 %) (n = 108)
Sliding hiatal hernia	15 (13.9%) (n = 108)
Reflux	9 (8.3%) (n = 108)
Other	2 (1.9%) (n = 108)
	Mild esophageal dysmotility Recurrent hiatal hernia
Gastric emptying study	51 (49.5%) (n = 103)
Delayed gastric emptying	17 (36.3%) (n = 51)
Preoperative HRQL score	20 (18.0) (n = 96)
Severity score	5.1 (2.9) (n = 100)

Abbreviations: EGD, esophagogastroduodenoscopy; LES, lower esophageal sphincter; UES, upper esophageal sphincter; HRQL, health-related quality of life.

Intraoperative Characteristics

All patients underwent a laparoscopic hiatal hernia repair with mesh reinforcement. Sixty-one patients (56.5%) underwent a Nissen fundoplication. Forty-three patients (39.8%) underwent a Dor (anterior partial) fundoplication. Four patients (3.7%) underwent a Toupet (posterior partial) fundoplication. The median length of operation was 154.5 minutes (26 minutes). The esophageal hiatal defect was measured using the area of a right triangle. The median length of left sling of right crus (h) was 3 cm (1 cm). The median length of the line perpendicular to the left sling of the right crus (b) was 4.5 cm (1.6 cm). The median esophageal hiatal defect surface area was 5.89 cm² (4.13 cm²) (Table 4).

Table 4.

Intraoperative Characteristics

	N = 108
Length of operation (minutes)	154.2 (25.9) (n = 108)
Hiatal hernia SA (cm2)	7.3 (4.9) (n = 106)
Type of therapy
Laparoscopic hernia repair	108 (100% (n = 108)
Type of fundoplication performed
Nissen	61 (56.5%) (n = 108)
Dor	43 (39.8%) (n = 108)
Toupet	4 (3.7%) (n = 108)

Patient Reported Outcome Assessments

The GERD-HRQL assessment showed significant improvement from baseline in patients who underwent surgery at initial follow-up, 3 months, and 6 months (Table 5). Patients showed significant improvements in their severity score assessments at initial follow-up, 3 months, 6 months, and 12 months. A similar trend was seen with the longitudinal reflux severity scores at each follow-up appointment (Table 6).

Table 5.

Longitudinal HQRL Scores

	N	Mean	SD	Median	Min	Max	P-Value
Preoperative HQRL	98	19.65	12.63	20	0	49
Initial FU HQRL	106	3.78	6.02	2	0	33	<.001
1–3 month HQL	66	4.25	6.27	2	0	31	<.001
3–6 month HQRL	23	5.65	6.09	4	0	26	<.001
6–12 month HQRL	31	8.23	10.15	4	0	34	.002
12–24 month HQRL	7	9.14	9.41	6	1	29	.125

Abbreviation: HRQL, health-related quality of life.

Table 6.

Longitudinal Reflux Severity Scores

	N	Mean	SD	Median	Min	Max	P-Value
Preoperative severity score	103	4.99	2.91	5	0	19
Initial FU severity score	106	3.78	6.02	2	0	33	.005
1–3 month severity score	64	1.31	1.70	1	0	8	<.001
3–6 month severity score	23	2.21	2.09	2	0	6	<.001
6–12 month severity score	32	2.50	2.46	2	0	7	.003
12–24 month severity score	8	2.13	1.36	1.5	1	4	.016

Safety Outcomes and Complications

Initial follow-up outcomes

One hundred and seven (107) patients out of the one hundred and eight (108) patients returned for initial follow-up (99.1%), which occurred less than 30 days after their operation. Of these patients, there were 3 perioperative hernia recurrences that required surgical intervention. Two of these patients complained of significant dysphagia, chest pain, belching, and cough. These recurrences were diagnosed on routine postoperative day 1 esophagogram that illustrated recurrence of hiatal hernia. No other complications were observed in this 30-day period. Patients experienced statistically significant reduction in symptoms of heartburn, dysphagia, chest pain, and regurgitation. Most patients were able to stop any antireflux medication as only 9.4% required use of a PPI compared to 91.6% of the patients preoperatively (Table 7).

Table 7.

Initial Follow-Up (<30 Days)

	N = 107
BMI	27.8 (4.8) (n = 102)
Requiring antireflux medication	10 (9.09%) (n = 107)
PPI	10 (9.4%) (n = 105)
H2RA	1 (0.95%) (n = 105)
Promotility agent	1 (0.95%) (n = 105)
Heart burn	19 (18.1%) (n = 105)
Acid reflux	13 (12.15%) (n = 107)
Dysphagia	28 (26.4%) (n = 106)
Chest pain	21 (19.8%) (n = 106)
Postoperative severity score	0 (2) (n = 103)
Difficulty swallowing	0 (n = 107)
Slipped wrap	0 (n = 107)
Hematoma	0 (n = 106)
Wound infection	0
Postoperative HRQL	2 (4.5) (n = 103)

Abbreviations: BMI, body mass index; PPI, proton pump inhibitor; H2RA, histamine 2 receptor agonist; HRQ, health-related quality of life.

90-day outcomes

Sixty-six of 108 patients returned for 90-day evaluation outcomes. Of these patients, 3 hernia recurrences occurred. Two of these recurrences required surgical intervention. Two were diagnosed with esophagogram which demonstrated reherniation. The other was diagnosed with EGD and demonstrated a loose wrap. Patients continued to experience reduction in symptoms of acid reflux and chest pain (Table 8).

Table 8.

Follow-Up—1–3 Months

	N = 66
BMI	28.3 (4.59) (n = 63)
Average time since operation (months)	2.56 (0.30) (n = 66)
Continuation of symptoms	28 (42.42%) (n = 66)
Recurrence of symptoms	12 (18.18%) (n = 65)
Requiring antireflux medications	7 (10.94%) (n = 64)
PPI	6 (23.08%) (n = 26)
H2RA	0 (0%)
Promotility agent	2 (3.03%) (n = 66)
Follow-up severity score	1 (2) (n = 64)
Heartburn	18 (27.27%) (n = 66)
Acid regurgitation	0 (0%)
Dysphagia	24 (36.36%) (n = 66)
Chest pain	13 (20%) (n = 65)
UGI	2 (3.08%) (n = 65)
UGI findings
LES obstruction/tight wrap	0
Loose wrap	0
Slipped wrap	0
Reherniation	1 (1.52%) (n = 66)
Delayed gastric emptying	0
Other findings	0
EGD	1 (1.54%) (n = 65)
EGD findings
LES obstruction/tight wrap	0
Loose wrap	1 (1.54%)
Slipped wrap	0
Reherniation	0
Delayed gastric emptying	0
Other findings	0
Required additional operative intervention/procedure	2 (3.08%) (n = 65)
Patient status at end of visit
Follow-up pending	27 (42.19%) (n = 64)
Follow-up requested but patient did not return	1 (1.56%) (n = 64)
Follow-up PRN only	32 (50%) (n = 64)
Consult to GI	1 (1.56%) (n = 64)
Other	3 (4.69%) (n = 64)
Long-term follow-up HRQL	2 (5) (n = 66)

Abbreviations: BMI, body mass index; PPI, proton pump inhibitor; H2RA, histamine 2 receptor agonist; UGI, upper gastrointestinal; EGD, esophagogastroduodenoscopy; PRN, pro re nata; HRQL, health-related quality of life.

180-day outcomes

Twenty-three²³ patients of the one hundred and eight (108) patients returned to be evaluated at 180 days. Of these patients, thirteen (56.5%) complained of continuation of symptoms (heartburn, acid regurgitation, dysphagia, and chest pain). Nine (39.13%) reported recurrence of symptoms. Four (17.39%) required an UGI for evaluation, which showed a loose wrap, reherniation, a small sliding hiatal hernia, and small paraoesophageal hiatal hernia, all of which did not require surgical intervention (Table 9).

Table 9.

Follow-Up—3–6 Months

	N = 23
BMI	26.36 (5.57) (n = 22)
Average time since operation (months)	4.09 (.83) (n = 23)
Continuation of symptoms	13 (56.52%) (n = 23)
Recurrence of symptoms	9 (39.13%) (n = 23)
Requiring antireflux medications	8 (38.1%) (n = 21)
PPI	7 (87.5%) (n = 8)
H2RA	1 (12.5%) (n = 8)
Promotility agent	1 (5%) (n = 20)
Follow-up severity score	2 (4) (n = 23)
Heartburn	11 (47.83%) (n = 23)
Acid regurgitation	5 (21.74%) (n = 23)
Dysphagia	11 (47.83%) (n = 23)
Chest pain	9 (39.13%) (n = 23)
UGI	4 (17.39%)
UGI findings
LES obstruction/tight wrap	0
Loose wrap	1 (4.35% (n = 23)
Slipped wrap	0
Reherniation	1 (4.35 %) (n = 23)
Delayed gastric emptying	0
Other findings	2 (8.7%) (n = 23)
	Very small sliding hiatal hernia Small recurrent paraoesophageal hiatal hernia
EGD	0 (0%)
Patient status at end of visit
Follow-up pending	14 (60.87%) (n = 23)
Follow-up PRN only	6 (26.09%) (n = 23)
Other	3 (13.04%) (n = 23)
Long-term follow-up HRQL	4 (7) (n = 23)

Abbreviations: BMI, body mass index; PPI, proton pump inhibitor; H2RA, histamine 2 receptor agonist; UGI, upper gastrointestinal; EGD, esophagogastroduodenoscopy; PRN, pro re nata; HRQL, health-related quality of life.

12-month outcomes

Thirty-three³³ patients of the one hundred and eight (108) patients returned to be evaluated within 12 months. The average BMI was 29.6 kg/m² and their mean length of appointment 8.9 months (1.35 months). Eighteen patients (56.25%) complained of continuation of symptoms. Twelve patients (36.36%) reported recurrence of symptoms. These symptoms included, heart, burn, acid regurgitations, dysphagia, and chest pain. Four patients required UGI for evaluations of their symptoms. Two demonstrated reherniation that did not require surgical intervention; one demonstrated delayed gastric empty, and the other showed sliding hiatal hernia (Table 10).

Table 10.

Follow-Up—6–12 Months

	N = 33
BMI	29.62 (5.14) (n = 32)
Average time since operation	8.9 (1.35) (n = 32)
Continuation of symptoms	18 (56.25%) (N = 32)
Recurrence of symptoms	12 (36.36%) (n = 32)
Requiring antireflux medications	10 (31.25%) (n = 32)
PPI	10 (31.25%) (n = 32)
H2RA	1 (11.11%) (n = 9)
Promotility agent	3 (9.38%) (n = 32)
Follow-up severity score	2 (4.25) (n = 32)
Heartburn	17 (53.12%) (n = 32)
Acid regurgitation	13 (40.62%) (n = 32)
Dysphagia	11 (34.38%) (n = 32)
Chest pain	8 (25%) (n = 32)
UGI	4 (12.5%) (n = 32)
UGI findings
LES obstruction/tight wrap	0
Loose wrap	0
Slipped wrap	0
Reherniation	2 (6.06 %) (n = 33)
Delayed gastric emptying	1 (3.03 %) (n = 33)
Other findings	1 (3.03%) (n = 33)
	Findings are consistent with stomach slippage above diaphragm similar to prior UGI on 6/10/21
EGD	0
Patient status at end of visit
Follow-up pending	19 (61.29%) (n = 31)
Follow-up PRN only	7 (22.58%) (n = 31)
Consult to GI placed	3 (9.68%) (n = 31)
Other	2 (6.45%) (n = 31)
Long-term follow-up HRQL	8.23 (10.15) (n = 33)

Abbreviations: BMI, body mass index; PPI, proton pump inhibitor; H2RA, histamine 2 receptor agonist; UGI, upper gastrointestinal; EGD, esophagogastroduodenoscopy; PRN, pro re nata; HRQL, health-related quality of life.

24-month outcomes

Eight patients⁸ of the 108 patients returned to be evaluated within 24 months. The average BMI was 29.9 kg/m² and the mean time since operation was about 16.5 months. Of these patients, 2 patients complained of continuation of symptoms and 3 reported recurrence of symptoms. Three patients had hernia recurrence with no operative intervention at this time (Table 11).

Table 11.

Follow-Up—12–24 Months

	N = 8
BMI	29.94 (6.12) (n = 8)
Average time since operation	16.52 (2.51) (n = 8)
Continuation of symptoms	2 (25%) (n = 8)
Recurrence of symptoms	3 (37.5%) (n = 8)
Requiring antireflux medications	1 (12.5%) (n = 8)
PPI	0
H2RA	0
Promotility agent	1 (12.5%) (n = 8)
Follow-up severity score	1.5 (2.25) (n = 8)
Heartburn	5 (62.5%) (n = 8)
Acid regurgitation	3 (37.5%) (n = 8)
Dysphagia	1 (12.5%) (n = 8)
Chest pain	4 (50%) (n = 8)
UGI	0 (0%) (n = 8)
EGD	0 (0%)
Patient status at end of visit
Follow-up pending	3 (37.5%) (n = 8)
Follow-up PRN only	4 (50%) (n = 8)
Other	1 (12.5%) (n = 8)
Long-term follow-up HRQL	6 (5) (n = 8)

Abbreviations: BMI, body mass index; PPI, proton pump inhibitor; H2RA, histamine 2 receptor agonist; UGI, upper gastrointestinal; EGD, esophagogastroduodenoscopy; PRN, pro re nata; HRQL, health-related quality of life.

Recurrences

Overall, 21 symptomatic recurrences were noted in all patients who received Ovitex mesh reinforcement during hiatal hernia repairs (19.4%). Six of these recurrences occurred within the first 90 days of follow-up period. Each of these required operative interventions. The rest of the recurrences occurred after 180 days in the follow-up period, with the majority occurring after 12 months (Table 12). Kaplan-Meier analysis of recurrence-free survival following hiatal hernia repair with OviTex mesh shows low short-term recurrence, as recurrence-free survival remains very high (0.987 and 0.973) for the first 2 months. The survival curve illustrates that recurrences occur later in follow-up, approximately after month 8. There is substantial decline in sample size which makes the late-stage estimates less precise. However, recurrence-free survival falls to less than 50% after 16 months. Dashed lines represent the 95% confidence intervals (CIs), which widen at later time points due to the decreasing number of patients remaining at risk. Censoring events are indicated by tick marks on the survival curve (Table 13, Figure 2).

Table 12.

Development of Recurrences during Follow-Up Period

	Initial FU Recurrence (<30 Days)	1–3 Month FU Recurrence	3–6 Month FU Recurrence	6–12 Month FU Recurrence	13–24 Month FU Recurrence	25 + Month FU Recurrence	Total # of Recurrences
# of recurrences	3	3	0	6	4	5	21

Table 13.

Kaplan-Meier Survival Estimates for Patients

Time (Months) tj	N at Risk Nj	Number of Recurrences Rj	Survival Estimates S(tj)	95% CI
0	105	0	1.000
1	79	1	0.987	0.963–1.000
2	68	1	0.973	0.936–1.000
8	22	1	0.929	0.841–1.000
10	9	1	0.825	0.642–1.000
13	6	1	0.688	0.444–1.000
16	5	1	0.550	0.296–1.000
19	2	1	0.275	0.060–1.000
20	1	1	—	—

Figure 2.

Kaplan-Meier curve demonstrating recurrence-free survival following hiatal hernia repair with OviTex Mesh. Survival probabilities decrease progressively over the follow-up period, with excellent early recurrence-free survival and most recurrences occurring after 8–10 months. Shaded/dashed lines represent the 95% confidence intervals. Censoring is indicated by tick marks on the survival curve.

DISCUSSION

Hernia recurrence after laparoscopic repair continues to be an ongoing problem. To reduce anatomical and clinical recurrences, different type of meshes have been used to bolster the esophageal hiatal repair. This study looked at the safety, efficacy and clinical outcomes of patients who underwent laparoscopic hiatal hernia repair and crural reinforcement with OviTex 1S, an RTM. The biologic component is ovine forestomach, reinforced with polypropylene suture. Use of OviTex in our study demonstrated that crural reinforcement is safe and durable overtime with comparable rates of mechanical mesh-related complications over the 2-year study period in relation to other mesh types that exist. This will be the second study that looks at outcomes of OviTex for hiatal hernia repair.

An essential step in the surgical treatment of a paraesophageal hernia, especially a larger hernia (>8 cm), is a tension-free hiatal closure. Historically, simple cruroplasty has been done but high recurrence rates (up to 42%) have led to reinforcement of the hiatal closure.^17,18 Several studies have demonstrated the use of mesh have significant lower recurrence rates in hiatal repair.^17,19,20 In 2013, the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) recommended the use of mesh for the repair of large hernias as it was shown to lead to decreased short term recurrence rate.²¹ Additionally, it shows many surgeons began to embrace the use of mesh to reinforce the cruroplasty. A study performed by Schlottmann et al., found that utilization rates of mesh for laparoscopic paraesophageal hernia repair remained stably high between the years of 2011 and 2014 in the United States.²² The authors stated that in patients with giant paraesophageal hernias, redo operations, or cases where the surgeon could not close the diaphragm would be the individuals who could benefit the most from mesh reinforcement.²²

Despite the rising consensus on benefits of mesh utilization for large hiatal hernia repairs, there is still much debate on type of mesh to use. The ideal mesh material should be able to decrease tension of the crural approximation without causing mesh-related complications, such as erosion or dysphagia, and provide long-term durability.²³ The decision is further made more complex because of the wide variety of materials and shapes of the prostheses. Outcomes related to different types of nonabsorbable (polypropylene or polytetrafluoroethylene) and resorbable meshes have been reported. A 2016 European meta-analysis reviewed nine studies and included 676 patients and no significant difference was found in incidence of complications between mesh and simple suture cruroplasty.²⁴ The authors also found that hernia recurrence was significantly lower using mesh and that synthetic mesh was more effective than biologic. Regardless, the occurrence of serious morbidity, in some patients, after nonabsorbable mesh placement, such as erosions into the stomach or the esophagus, has prevented the use of these products from becoming standard.^13,14,25,26 To maintain the theoretical benefit of reducing the recurrence rate without the associated morbidity of the nonabsorbable materials, resorbable mesh were introduced. Two types of absorbable meshes exist. The first type of synthetic absorbable meshes include Vicryl (Ethicon, Somerville, NJ) or Bio-A (Gore, Flagstaff, AZ), versus biological absorbable meshes including Surgisis (Cook Medical, Bloomington, IN), AlloDerm, or Strattice (Allergan, Madison, NJ).²³ Absorbable meshes seem to be safe with low short term and long-term morbidity rates, but they as associated with high cost and uncertainty still exists regarding their long-term efficacy. Additionally, there is a dearth of literature comparing outcomes between absorbable products. Zehetner et al., published in 2011 a retrospective evaluation comparing open versus laparoscopic paraesophageal hernia repair using different absorbable meshes. The authors reported a comparable recurrence rate between the open and laparoscopic and within the different types of used mesh.²⁷ Jones et al., reported on long-term follow-up of reinforced cruroplasty with the use of different types of absorbable mesh. No mesh-related complications were observed. At 5-year follow-up, radiologic recurrence was similar across groups with a significant improvement of patents symptoms.²⁸ A recent systematic review and meta-analysis reported a significant reduction of recurrence rate after prosthetic reinforcement cruroplasty when compared with cruroplasty alone however, there is not enough evidence to compare different absorbable mesh compositions (synthetic vs biological).²⁹ One of the few studies that looked at long-term outcomes of absorbable mesh in paraesophageal hernia repair is Oelschlager et al. The authors performed a multicenter prospective and randomized trial which compared suture alone vs reinforced cruroplasty with Surgisis for the treatment of paraesophageal hernias. Short term outcomes demonstrated a statistically significant difference in recurrence rate in favor of the Surgisis group (24% vs 9%) and the only factor associated with decreased risk of recurrence was placement of Surgisis.³⁰ Long-term outcomes, which were obtained after 5 years, revealed that any initial advantage for use of biologic reinforcement of cruroplasty was erased, as recurrence rates were 59% in the suture-alone group and 54% in the Surgisis group.¹¹ While there is much literature on the outcomes between absorbable and synthetic mesh use in the hiatus, there is scant amounts regarding when each type is used and still seems to be based on surgeon preference. This would be an area that would benefit from future research.

There is minimal literature on the use of a RTM mesh in hiatal hernia repair. A 2018 retrospective review showed favorable early patient outcomes, but it only had a study population of 25 patients.¹⁶

Our study results are consistent with previous literature results. Only 6 out of 107 patients who followed up in the first 3 months were found to have a symptomatic recurrence of a hiatal hernia that required operative intervention. Most symptomatic recurrences occurred after 6 months, with most being after 12 months. This is further highlighted with the results from the Kaplan-Meier curve and survival table (Table 13, Figure 2). Hiatal hernia repair with OviTex mesh demonstrates early durability, with recurrence-free survival remaining greater than 97% during the initial follow-up period. Majority of the recurrences occurred between months 8 and 16, during which recurrence-free survival declined from 93% to 55%. This suggests that the greatest risk of recurrences occurs several months to years postoperatively. Overall, since recurrence-free survival decreases progressively over time, it further highlights the long-term challenges in maintaining a durable hiatal hernia repair. This is also complicated by the fact that recurrences can also be asymptomatic, which makes capturing this cohort much harder unless routine radiologic workup is performed. Long-term attrition is unfortunately a characteristic of this surgical problem, making true long-term recurrences much harder to quantify. This corroborates the previous findings that the benefit of mesh reinforcement for hiatal hernia repairs is erased in relation to long-term outcomes.

Postoperative symptom control and QoL improvement have been used as crucial and central indicators of procedure success. QoL in patients with a large hiatus hernia may be severely disrupted because of the negative impact on mental health and activities of daily living.³¹

In our patient cohort with RTM, we noticed a greater than 50% improvement in GERD-HRQL score from baseline up to 12-month median follow-up (20 ± 4.75 vs 4 ± 7; P = 0.02). Patients reported a significant improvement of GERD-related heartburn, dysphagia, regurgitation and overall satisfaction. These results are comparable with previous studies. A 2009 retrospective cohort study looked at patients from 1992 to 2007 who underwent laparoscopic hiatal hernia repair with mesh and reported that over a long-term follow-up period of approximately 8 years, patients reported better reflux control and greater patient satisfaction for mesh reinforced cruroplasty compared to simple crural repair.³² Zhang et al., performed a meta-analysis that reported a superior disease-specific QoL improvement (GERD-HRQL) for biological mesh-reinforced cruroplasty versus primary suture repair (MD = 13.68; 95% CI = 2.51–24.85; P = 0.02).³³ Another multicenter prospective clinical trial investigating the use of a hepatic derived porcine mesh for crural augmentation showed significant quality-of-life improvement up to 24 months follow-up.³⁴ While these are studies using absorbable biologic mesh, the results are consistent with the 2018 retrospective chart review that showed excellent early patient outcomes in patients who underwent mesh cruroplasty with biosynthetic mesh.

Despite the homogeneous patient population, there are several limitations that affect this study. The first limitation is the absence of a control group. It is difficult to fully see the significance of OviTex mesh as our study did not compare it to other RTM or other types of mesh that can be placed in the hiatus. In the future, comparing this to other types of meshes or repairs without mesh would be beneficial. The decrease in follow-up also limits this study, as does the lack of standardized recurrence assessment. This decrease could possibly be due to symptom resolution and/or lack of symptoms after repair. There also could be external factors unrelated to the repair, such as new social barriers (i.e., transportation, financial barriers, relocation). The low number of recurrences did not allow a univariate/multivariate Cox regression analysis to assess potential risk factors for recurrence. The decrease in follow-up allowed for a substantial amount of missing data that could have had statistical impact, such as addition of selection bias. While all patients were given the quality-of-life surveys preoperatively and postoperatively, we were unable to perform a paired t test to compare them due to the loss of follow-up. In addition, this loss of follow-up could also influence the survival analysis completed, affecting the precision of results. Further research with prospective, multicenter studies and longer follow-up is warranted.

In conclusion, our findings indicate that laparoscopic crural augmentation with OviTex 1S mesh is comparable in safety to existing mesh options for hiatal hernia repair and demonstrates promising effectiveness in long-term follow-up. OviTex crural reinforcement resulted in a hernia recurrence rate with a sustained symptoms akin to existing options. It also resulted in comparable QoL improvement for patients. However, it is important to note that these results are preliminary, and additional studies should be done in a prospectively and in multiple centers in the future.