A Collective Review of Gore Bio-A Absorbable Synthetic Mesh in Cruroplasty Reinforcement

Abstract

Background:

Laparoscopic repair of hiatal hernia (HH) is associated with a considerable failure rate. Compared to suture repair alone, mesh-reinforced cruroplasty may be associated with fewer short-term recurrences, yet its use remains controversial. The aim of this study was to analyze the current literature assessing the use of Bio-A absorbable synthetic mesh in the reinforcement of primary crural closure after laparoscopic HH repair.

Methods:

A systematic review of primary literature in the MEDLINE and PubMed databases was conducted. We searched for investigations reporting patient outcomes in laparoscopic HH repair with onlay Gore Bio-A tissue reinforcement (W. L. Gore & Associates, Inc.) published between January 2008 and December 2019. The primary outcome was anatomical recurrence rate. Secondary outcomes were complication rate, symptomatic outcomes, and mortality.

Results:

Eight studies met inclusion criteria. There were two prospective and six retrospective cohort studies. In the included studies, laparoscopic HH repair was performed with Bio-A absorbable synthetic mesh in 734 patients. The anatomical recurrence data were extracted across all studies, and an objective recurrence was identified in 21/280 (7.5%) patients. There was only 1 (0.17%) mesh-related complication in the included studies.

Conclusions:

The use of Bio-A absorbable synthetic mesh in the repair of HHs may be promising, as it offers low rates of anatomical recurrence and mesh-related complications, but more data are still necessary to validate these findings. This collective review of literature is a basis for future randomized controlled trials to identify the most effective and safe mesh in the long term.

Introduction

Laparoscopic fundoplication is the gold standard for definitive management of gastroesophageal reflux disease (GERD) with or without hiatal hernia (HH), with reports of excellent clinical and patient-centered outcomes.¹ Surgical techniques include crural repair after reduction of HH (if present). Despite exceptional outcomes after laparoscopic repair, HH recurrence is relatively common and may be due to repeated stress from differential pressures that eventually overcome the tensile strength of the hiatus.² The repair of large or paraesophageal hernias (PEHs) is particularly challenging, and recurrences may be due to the low quality of the crura and size of the hiatal defect.³ In an effort to reduce the recurrence rate, surgeons began performing mesh-reinforced cruroplasty with nonabsorbable synthetic meshes, such as polypropylene or polytetrafluoroethylene.⁴ However, the use of non-absorbable mesh has been associated with certain complications, including erosions in the stomach, esophagus, and other surrounding visceral organs. Reports of these complications have prevented the widespread acceptance of prosthesis with nonabsorbable mesh.^5–8

Absorbable meshes, composed of either biologic or synthetic materials, were introduced for the repair of inguinal and ventral hernias, and then later popularized for HH repair. Some presumed that absorbable mesh would maintain the theoretical benefit of reducing recurrence rates without the associated risk of nonabsorbable mesh-related morbidities.⁹ A seminal investigation comparing suture alone versus reinforced cruroplasty with biologic mesh (e.g., porcine small intestine submucosa) found a lower risk of recurrence associated with mesh placement in the short term,¹⁰ which was negated in long-term follow-up (5 years).¹¹ Randomized trials have since confirmed these findings.^12–14 There remains few studies compiling data on hernia recurrence rates with newer, absorbable synthetic mesh for crural reinforcement during HH repair.

Gore Bio-A (W. L. Gore & Associates, Inc.) tissue reinforcement is an absorbable mesh constructed from biocompatible synthetic fibers, the use of which has been described in the repair of inguinal hernias,¹⁵ anal fistulas,^16,17 and most recently, HHs.^18,19 Despite existing evidence supporting its feasibility and safety profile,^18,19 questions remain regarding its efficacy in preventing recurrence. In this systematic review, we collectively analyzed all available evidence of reinforced cruroplasty for laparoscopic HH repair using Bio-A absorbable synthetic mesh, particularly evaluating recurrence rate as a primary outcome. Complication rate, symptomatic outcomes, and mortality were secondarily assessed.

Materials and Methods

Review of literature

Two reviewers (M.T.O. and R.M.B.) independently conducted systematic reviews of the available literature through the MEDLINE and PubMed databases, searching for primary studies that reported the use of Gore Bio-A tissue reinforcement in laparoscopic HH repair. The Gore Bio-A tissue reinforcement was first introduced in 2008 by W.L. Gore & Associates, Inc., Therefore, primary studies from January 2008 to December 2019 were selected. This systematic review was exempt from ethical approval, as the authors collected and synthesized data from previous studies in which informed consent had already been obtained by the study investigators.

The search was performed using the following search terms: “Bio-A mesh,” “surgical mesh,” “absorbable synthetic,” “hiatal hernia,” “paraesophageal hernia,” “cruroplasty,” “mesh-reinforcement,” and logical combinations of these terms using the Boolean operators “AND” and “OR.” Initial selection of studies for review was based on the title and the abstract. Duplicate records were removed.

Selection criteria

Retrospective and prospective studies reporting outcomes of Bio-A mesh-based laparoscopic repair of HH were included. An article was selected for further review when the study concerned adult human study participants undergoing laparoscopic HH repair with Bio-A absorbable synthetic mesh for crural reinforcement. Reference lists of relevant publications were assessed for additional references. A study was excluded from evaluation if it was a guideline, did not involve adult human study participants, did not report the use of Bio-A absorbable synthetic mesh in laparoscopic HH repair, or was not written in English. Case reports were excluded. Figure 1 offers a flowchart depicting an overview of study selection.

FIG. 1.

Study selection flowchart.

Data analysis

Data regarding study design, number of patients who received mesh as part of their surgical procedure, the size and type of HH, the primary indication for the repair, configuration and fixation of the mesh, length of follow-up, objective and subjective recurrence rate, complications, and symptomatic outcomes were extracted and pooled. Values are expressed as median (range) or mean (standard deviation).

Quality assessment

The methodological quality of all retrospective and prospective studies was evaluated using the Newcastle-Ottawa assessment scale of quality of nonrandomized studies in meta-analysis. The minimal score used is zero (very poor statistical quality) and the maximum score is 9 (excellent statistical quality). In addition, a level of evidence was assigned to each article according to the Oxford Centre of Evidence Based Medicine Levels of Evidence (Table 1).²⁰ Cohort studies with a Newcastle-Ottawa Assessment score of <6 were graded Level (of evidence) IV, and a score of >5 were graded Level II-B.

Table 1.

Grades of Evidence According to the Oxford Centre for Evidence-Based Medicine Levels of Evidence

Grade	Description
I-a	Evidence obtained from systematic reviews with homogeneity of RCTs
I-b	Evidence obtained from individual RCTs with narrow confidence interval
II-a	Evidence obtained from systematic reviews with homogeneity of well-designed cohort studies
II-b	Evidence obtained from individual cohort studies (including low-quality RCT; e.g., <80% follow-up)
II-c	Evidence obtained from “outcomes” research; ecological studies
III-a	Evidence obtained from systematic reviews with homogeneity of case–control studies
III-b	Evidence obtained from individual case–control studies
IV	Evidence obtained from case series and poor-quality cohort and case–control studies
V	Expert opinion without explicit critical appraisal, or based on physiology, bench research of “first principles”

RCT, randomized controlled trial.

Results

Included studies

The aforementioned search strategy returned a total of 54 articles eligible for selection. Thirteen duplicate records were removed. All articles were selected on title and abstract, based on the inclusion and exclusion criteria. Twenty-three articles were excluded for not reporting outcomes of Bio-A mesh in laparoscopic HH repair. Eighteen articles underwent critical appraisal of the full text. Seven case reports and three review articles highlighting the use of Gore Bio-A mesh were excluded from this review. Currently, no comparative studies or randomized controlled trials (RCTs) assess Bio-A mesh-related outcomes after laparoscopic HH repair in the literature. Finally, eight articles were included in this collective review; two studies were prospective and six were retrospective in nature. Three studies had a level of evidence II-B, and the remaining studies had a level of evidence IV. An overview of the included studies using Bio-A for crural reinforcement is provided in Table 2.

Table 2.

Overview of Included Studies Using Gore Bio-A Mesh for Crural Reinforcement

Author (year)	Level of evidence	Total (n)	Indication for surgery	Size of hernia defect	Measures of objective assessment	HH recurrence definition	Measures of symptomatic assessment	Mesh-related complications (n, %)
Iossa (2019)²⁶	IV	28	Type I and III	≥4 cm²	BAS, CT, UGI endoscopy	HH ≥2 cm above diaphragm	GERD-HRQL, Rome III	0/28 (0)
Olson (2018)¹⁹	II-b	399	Type I–IV	All sizes	NR	NR	Standard symptom questionnaire	1/305 (0.33)
Asti (2017)¹⁸	II-b	100	Type I–IV	All sizes	BAS, UGI endoscopy	HH ≥2 cm above diaphragm	GERD-HRQL	0/97 (0)
Berselli (2015)²¹	IV	8	Type III–IV	≥5 cm	UGI radiograph	Any size HH visible	Y/N system	0/8 (0)
Priego Jiménez (2014)²²	IV	10	Type II	>5 cm	Videoesophagram, UGI endoscopy	HH ≥2 cm above diaphragm	Y/N system	0/10 (0)
Alicuben (2014)²⁵	II-b	114	Type I–IV	NR	UGI radiograph, CT scan	Any size HH visible	NR	0/99 (0)
Gebhart (2013)²⁴	IV	64	Type I–IV	>3 cm	UGI contrast study	HH ≥2 cm above diaphragm	NR	0/27 (0)
Massullo (2012)²³	IV	11	Type 1–III	>5 cm	NR	NR	Y/N system	0/11 (0)
Pooled numbers	3 II-b, 5 IV	734	N/A	N/A	N/A	N/A	N/A	1/585 (0.17)

BAS, barium swallow; CT, computed tomography; GERD-HRQL, gastroesophageal reflux disease health-related quality of life; HH, hiatal hernia; IQR, interquartile range; N/A, not available; NR, not reported; PEH, paraesophageal hernia; UGI, upper gastrointestinal; Y/N, yes/no.

Baseline characteristics

A total of 734 patients were included in the eight articles we examined. The mean age of patients across all studies ranged from 46.0 (23.0) years to 77.3 (9.1) years. Median clinical follow-up ranged from 12 (11.6–15.7) months to 47.5 (36–60) months. Two studies included all hernia sizes^18,19 and three studies included only large hernias defined by a defect measuring larger than 5 cm at the time of surgery.^21–23 One study included only HHs larger than 3 cm based on preoperative endoscopy or upper GI study.²⁴ One study did not report hernia size, but performed laparoscopic HH repair on HH types I–IV.²⁵ The study cohort in one investigation exclusively consisted of patients who received mesh reinforcement for hiatal defects ≥4 cm².²⁶

Mesh characteristics

The Bio-A absorbable synthetic mesh was routinely shaped in a “U” configuration with dimensions of 7 × 10 cm, modified before being placed in position. One study reported cutting the Bio-A mesh patch into a heart-shaped pattern.²⁵ The modified Bio-A mesh was inserted through a trocar, superimposed on the cruroplasty, and fixed with absorbable tacks (AbsorbaTack, Covidien),^21–23,26 fibrin glue (Tisseel Fibrin Sealant; Baxter International, Inc.),^21,22,25,26 or nonabsorbable tacks,^18,19,24 thus obtaining an onlay mesh placement. Either partial or complete fundoplication was performed in all patients across the included studies. Figure 2 illustrates this operative technique.

FIG. 2.

Operative technique. (A) Reduction of hernia and mobilization of esophagus. (B) Posterior crural repair with absorbable suture. (C) Placement and fixation of onlay absorbable biosynthetic mesh. (D) 270° Toupet fundoplication. Labels: D, diaphragm; E, esophagus; L, liver; S, stomach. Used with permission from Norton Thoracic Institute, Phoenix, Arizona.

Recurrence and reoperation rates

Data on objective recurrence, symptomatic recurrence, and reoperation rates are reported in Table 3. An accurate analysis of the recurrence rate was challenging, as there was no standardized definition of recurrence across studies. The differences in definition are described here: some studies did not perform routine objective testing in patients at designated follow-up durations, unless investigation was warranted by the return of GERD symptoms.^19,23 Others defined an anatomical HH at follow-up as a recurrence. In those studies that reported anatomical findings identified at follow-up, some defined objective recurrence as the maximum vertical height of the stomach being at least 2 cm above the diaphragmatic impression,^18,22,24,26 whereas others defined recurrence as any size hernia visible on endoscopy or barium swallow.^21,25 One study characterized objective recurrence as the proportion of patients who required reoperation for recurrent symptoms.¹⁹ The anatomical (i.e., objective) recurrence data were extracted across all studies according to the abovementioned definitions, and objective recurrence was identified in 21/280 (7.5%) patients. The pooled reoperation rate was 48/606 (7.9%).

Table 3.

Recurrence and Reoperation Rates in 8 Included Studies^a

Author (year)	Total (n)	Objective follow-up duration (months)^b	Available objective follow-up	Objective recurrence	Clinic follow-up duration (months)^b	Available symptom follow-up	Symptomatic recurrence	Reoperation
Iossa (2019)²⁶	28	12	28 (100)	2/28 (7.1)	41 (17–51)	28 (100)	11/28 (39.3)	2/28 (7.1)
Olson (2018)¹⁹	399	NR	NR	NR	47.5 (36–60)	305 (76.4)	49/305 (16.1)	44/305 (14.4)
Asti (2017)¹⁸	100	12	97 (97.0)	9/97 (9.3)	30 (22)	100 (100)	NR	0/100 (0)
Berselli (2015)²¹	8	12	8 (100)	2/8 (25.0)	23.5 (14–44)	8 (100)	0/8 (0)	NR
Priego Jiménez (2014)²²	10	20.3 (10–30)	10 (100)	1/10 (10.0)	20.3 (10–30)	10 (100)	1/10 (10.0)	1/10 (10.0)
Alicuben (2014)²⁵	114	12	99 (86.8)	1/99 (0.9)	NR	NR	NR	0/99 (0)
Gebhart (2013)²⁴	64	30 (12–51)^c	27 (42.2)	5/27 (18.5)	NR	NR	NR	1/64 (1.6) [30-day]
Massullo (2012)²³	11	12 (11.6–15.7)	11 (100)	1/11 (9.0)	12 (11.6–15.7)	11 (100)	1/11 (9.0)	NR
Pooled numbers	734	N/A	280	21/280 (7.5)	N/A	462	62/362 (17.1)	48/606 (7.9)

Values are expressed as n (%), unless otherwise stated.

Value reported as median (range) when available.

Value reported as mean (range).

IQR, interquartile range; NR, not reported.

Complications

Data on intraoperative, postoperative, and mesh-related complications are collectively reported in Table 4. The reported complication rates were assessed, regardless of the type of complication. The most frequently reported intraoperative and postoperative complications, respectively, were pneumothorax in 3 patients²² and gastric distension in 3 patients.¹⁸ The only reported mesh-related complication was esophageal stenosis, occurring in 1 patient.¹⁹ The cause of the stenosis was unclear, but the authors postulated that it may have been due to a technical aspect of the mesh placement. This patient was managed with a percutaneous endoscopic gastrostomy tube and underwent reintervention for recurrent symptoms 2 months postoperatively. At 44 months after the primary operation, the patient reported excellent satisfaction with tolerable symptoms of heartburn. Most complications appeared in the postoperative period, and overall, 1/585 patients (0.17%) had a mesh-related complication. The overall pooled complication rate for patients undergoing Bio-A mesh-reinforced HH repair was 4.6%.

Table 4.

Reported Complications in Included Studies

Complications	n	Study
Intraoperative
Esophageal leak	2	²⁵
Pleural tears	2	²⁴
Pneumothorax	3	²²
Postoperative
Acute urinary retention	1	¹⁸
Atelectasis	1	¹⁸
Atrial fibrillation	2	^18,24
Deep vein thrombosis	1	²⁴
Gas bloat syndrome	1	²³
Gastric distension	3	¹⁸
Hematoma at trocar site	1	¹⁸
Pleural effusion	1	²¹
Pneumothorax	2	¹⁸
Respiratory failure	2	^23,24
Small bowel obstruction	2	^24,25
Superficial wound infection	2	^23,25
Mesh-related complications
Esophageal stenosis	1	¹⁹

Symptomatic outcomes

Data on available symptomatic outcomes within the included studies are recorded in Table 5. Three studies^23–25 reported no symptomatic outcomes, either preoperatively or postoperatively. The remaining five studies that reported symptomatic outcomes recorded inconsistent preoperative and postoperative variables. Some studies reported symptomatic outcomes through the use of validated assessment tools, such as the GERD-Health Related Quality of Life Questionnaire (GERD-HRQL).^18,26 More commonly, studies reported symptoms using a yes/no scoring system.^21–23 It was difficult to ascertain the proportion of procedures deemed successful, as this criterion was not reported in the individual articles. Therefore, this finding could not be pooled collectively. Gastroesophageal reflux, heartburn, dysphagia, anemia, and epigastric pain were the most consistently reported symptoms in the preoperative and postoperative periods. Two studies^19,26 reported significant differences in the number of patients who required proton pump inhibitors preoperatively (62.1% and 100%) versus the long term (28.6% and 28.6%, respectively; P < .05).

Table 5.

Reported Symptomatic Outcomes in 5 Included Studies^a

	Iossa (2019)²⁶	Olson (2018)¹⁹	Asti (2017)¹⁸	Berselli (2015)²¹	Priego Jimenez (2014)²²
Preoperative		(n = 399)
Median GERD-HRQL	23^b	NR	14^b	NR	NR
PPI use	28 (100)^b	248 (62.1)^b	NR	NR	NR
GER or heartburn	28 (100)	253 (63.4)^b	NR	6 (75.0)	6 (60.0)
Dysphagia	NR	159 (39.8)^b	26 (26.0)	2 (25.0)	5 (50.0)
Anemia	NR	NR	26 (26.0)	5 (62.5)	4 (40.0)
Epigastric pain	NR	151 (37.8)^b	NR	NR	5 (50.0)
Postoperative		(n = 217)
Median GERD-HRQL	6^b	NR	3^b	NR	NR
PPI use	8 (28.6)^b	62 (28.6)^b	NR	NR	NR
GER or heartburn	11 (39.3)^b	7 (3.2)^b	NR	0 (0)	1 (10.0)
Dysphagia	3 (10.7)	11 (5.0)^b	NR	0 (0)	0 (0)
Anemia	NR	NR	NR	0 (0)	0 (0)
Epigastric pain	NR	19 (8.8)^b	NR	0 (0)	0 (0)
Median follow-up (months)	41 (17–51)	54.0 (13.1)^c	30 (IQR 22)	23.5 (14–44)	20.3 (10–30)

Values are expressed as n (%), unless otherwise stated.

Difference between preoperative and postoperative values deemed significant in study (P < .05).

Value reported as mean (SD).

GER, gastroesophageal reflux; GERD-HRQL, gastroesophageal reflux disease health-related quality of life; NR, not reported; PPI, proton pump inhibitor; SD, standard deviation.

Mortality

Mortality after laparoscopic HH repair is very low. No mesh-related mortality was reported in any of the included studies. All-cause mortality data were otherwise not evaluated in three studies.^19,23,26 No deaths were reported in several studies at varying time points, including intraoperatively,^18,21,22,25 and at 90 days postoperatively.²⁴

Discussion

The traditional approach to laparoscopic HH repair has been primary suture closure of the diaphragmatic defect, but this procedure has been associated with a high rate of objective recurrence in both clinical series and RCTs.²⁷ Prosthetic reinforcement was originally introduced as a means to protect the repaired hiatus from disruption, and in some studies, this technique has produced significantly lower recurrence rates compared to primary repair alone.^13,28,29 Early investigations using nonabsorbable synthetic mesh at the hiatus offered substantive evidence for its benefit, but subsequent trials suffered from small samples and short follow-up durations.³⁰ Despite the promising low rates of recurrence associated with synthetic meshes, these products have remained controversial, given the reports of complex reoperations after failed repairs, and potentially serious mesh-related complications, such as erosion and shrinkage, which can cause severe dysphagia.^6,12 Without an ideal mesh material, many esophageal surgeons would traditionally avoid using mesh at the hiatus, opting instead to repair the recurrence as needed. With bioabsorbable mesh, however, surgeons have reported fewer complications, while maintaining the benefit of an acceptable rate of recurrence.^12,28,31

The current practice of HH repair may involve nonabsorbable synthetic mesh, biologic mesh, and recently developed absorbable synthetic mesh, based on the surgeons' preferences. A survey was conducted at the beginning of the last decade by the Society of American Gastrointestinal Endoscopic Surgeons (SAGES) to assess surgeons' adoption of mesh for HH repair.³² Responses were compiled from more than 2500 members, of which the majority (69%) performed HH repair. Only 25% of surgeons used mesh for the majority of repairs, but when mesh was used, it was most commonly absorbable (67%), demonstrating the paradigm shift in mesh-reinforced cruroplasty. A recent RCT conducted by Watson et al.¹² compared suture repair versus mesh repair with biologic mesh (Surgisis, Cook Medical) and nonabsorbable synthetic mesh (TiMesh, Zimmer Biomet). The authors identified no significant differences for HH recurrence measured at 1 year when comparing suture repair with absorbable and nonabsorbable mesh. Patients with nonabsorbable synthetic mesh repair had the lowest rates of radiologic recurrence and better postoperative symptom profiles than patients who received repair with biologic mesh. However, the advantage of synthetic over biologic mesh was counterbalanced by the need for more surgical revisions for a tight repair in the nonabsorbable mesh group. The benefit of biologically derived material for reinforcement in HH repair is its absorbability and potential to improve the durability of the repair, while mitigating the risk of mesh-related complications.^31,33,34 Although the use of biologic meshes is not without complications, the associated complications of biologic meshes may be fewer and less severe, suggesting one reason why absorbable mesh may be preferred.^6,12

In 2008, Gore introduced Bio-A tissue reinforcement, an absorbable synthetic mesh that acts as a scaffold for cells to lay down new matrix material as the mesh is absorbed. During the absorption, cells associated with the inflammatory response migrate into the interstices of the mesh. Over a 6-month period, the mesh is completely absorbed and replaced with the patient's own connective tissue. The Bio-A mesh is most commonly used for posterior hiatal reinforcement, and fixation of the mesh with absorbable tacks means that the foreign material is completely gone after 1 year. This mesh was designed with the intention of maximizing the benefit of both synthetic and absorbable materials. Foreign body presence is minimalized after surgical repair, which reduces the potential for the aforementioned mesh-related complications, while the biosynthetic fibers theoretically provide respectable protection from anatomical recurrence. There was only 1 (0.17%) mesh-related complication found in the included studies, which was described by Olson et al.¹⁹ The pooled sample of patients across the eight included studies remains small, and thus there is a risk of underreporting complications due to publication bias. However, the available findings summarized in this collective review offer considerable evidence that the absorbable synthetic Bio-A mesh is associated with low morbidity rates, and it may help prevent mesh-related complications over the long term.

Although the Bio-A mesh is shown to be safe, with very low complication rates, the main question regarding its applicability is its long-term efficacy in attenuating anatomical recurrence and subsequent need for reoperation. Several authors reported an objective recurrence rate of ∼10% at short-term follow-up.^18,22,23 Iossa and Silecchia²⁶ reported a similar objective recurrence rate (7.1%) at a median of 41 months (range, 17–51), defined by herniation of at least 2 cm above the diaphragm on endoscopy. Olson et al.¹⁹ recorded the longest available follow-up, with 44/305 patients (14.4%) requiring reoperation at a median of 47.5 months (range, 36–60). Twenty patients required reoperation for fundoplication failure, whereas the remaining 24 necessitated surgical reintervention for recurrent HH. With only 2 studies describing long-term recurrence outcomes after Bio-A mesh-reinforced cruroplasty, it is difficult to draw strong conclusions regarding its efficacy at this time. RCTs and studies with a larger sample size and longer follow-up are necessary to determine whether this mesh truly helps prevent objective recurrence and surgical reintervention. However, the initial evidence regarding objective recurrence provided by these studies remains promising and warrants consideration by the surgical community.

Laparoscopic repair of a large PEH is perhaps one of the more challenging cases a minimally invasive surgeon may perform. The optimal technical approach for surgical management continues to evolve; however, emphasis is placed on intraoperative assessment of the functional anatomy, esophageal length, and crural closure tension.³⁵ HH recurrence constitutes one of the leading forms of failure after antireflux surgery and may be secondary to unrecognized tension on the crural repair or a shortened esophagus. The independent role of tension-reducing techniques and esophageal-lengthening procedures, such as Collis gastroplasty, on long-term HH recurrence rates remains undetermined. Yet, some studies have detailed excellent early results when these surgical adjuncts are used in combination with prosthetic mesh materials.^36,37 However, only one study detailed in this collective review routinely performed a wedge-fundectomy Collis gastroplasty, particularly when less than 3 cm of intra-abdominal esophagus was present after mediastinal mobilization.²⁵ Crural-relaxing incisions were also deemed necessary to achieve tension-free primary crural closure in 4% of patients in this investigation. Ultimately, long-term follow-up is necessary to define the impact and utility of these techniques for paraesophageal and HH repair.

As demonstrated in Table 5, symptomatic outcomes were available in five of the eight included studies. The most common method to measure the symptomatic outcome was by a yes/no scoring system; two studies reported symptomatic outcomes through the GERD-HRQL. The criteria for successful symptomatic outcome were not appropriately defined in the individual studies, and there is great heterogeneity in the symptomatic outcomes. Notably, symptomatic recurrence was available as an endpoint in five studies^{19,21–23,26} that included a total of 362 patients. Symptomatic recurrence data were reported in these five studies at a median follow-up range of 12 to 47.5 months after the primary operation. Overall, an adequate assessment of symptomatic outcomes with the use of Bio-A mesh requires more patients followed at longer intervals. The only conclusion that can be made reliably is that there is an increasing need for a standardized method to report symptomatic outcomes after HH repair.

Prosthetic mesh materials should ideally help reduce tension of the crural closure, without causing erosion or dysphagia, while supporting the long-term durability of the repair. A mesh material that can sufficiently provide all these benefits has not yet been produced, despite the many different types and configurations of mesh available. Absorbable meshes, both synthetic and biological, fall short in either sustaining the long-term durability of the repair or effectively reducing recurrence rates without associated morbidity. Most recent clinical guidelines have not had sufficient evidence to be able to conclude that one mesh is superior, even compared to suture repair alone.³⁸ The surgical community eagerly anticipates the results of ongoing trials seeking to provide evidence with longer follow-up addressing the issue of both safety and durability of different mesh types in the repair of paraesophageal and HH.

Laparoscopic HH repair with the use of Bio-A mesh remains a safe procedure with excellent patient satisfaction and very low morbidity rates. There were no reported deaths in the five studies that evaluated all-cause mortality during and after the operation. Nonetheless, this systematic review has certain limitations that need to be acknowledged. One, the qualitative synthesis is limited by the quantity and quality of available studies. Two, the review is weakened in its assessment of objective recurrence rates; the included studies evaluated the impact of Bio-A mesh on the recurrence of both sliding hernias and PEHs (of varying sizes). It remains difficult to generalize the cumulative recurrence rates presented herein, as anatomic and radiologic recurrence rates differ for sliding hernias and PEHs. Regardless, this systematic review compiles findings from all available studies reporting the use of Bio-A mesh in the crural reinforcement of laparoscopic HH repair, providing succinct evidence for surgeons currently employing such material in surgical practice.

In conclusion, this is the first collective review to offer an overview of studies performed between 2008 and 2019 that summarize relevant outcomes after laparoscopic HH repair with the use of Gore Bio-A tissue reinforcement. Initial evidence regarding the use of Bio-A absorbable synthetic mesh may be promising with respect to the short-term reduction of anatomical recurrences; however, additional study is warranted to strengthen the validity of these findings. There is considerable variability among existing studies, with few available studies reporting symptomatic outcomes. Future investigative efforts should also be directed toward reporting long-term symptomatic outcomes after Bio-A mesh-reinforced cruroplasty, as well as establishing a standardized method of reporting success of the procedure, both symptomatically and anatomically. This collective review of literature serves as an important basis for future RCTs to identify the most effective and safe mesh in the long term.

Footnotes

Acknowledgments

The authors would like to thank Dr. Saurabh Singhal, MBBS, MS, for his expert critique in revising the final contents of this article. The authors would like to thank Clare Sonntag, MA, for providing editorial expertise.

Authors' Contributions

Each individual listed as an author on this article contributed substantially and in accordance with the guidelines of the International Committee of Medical Journal Editors.

Disclosure Statement

M.T.O., S.K.M., and R.M.B. have no conflicts of interest or financial ties to disclose.

Funding Information

This research did not receive any specific grant from funding agencies in the public, commercial, or non-for-profit sectors.

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