Review Article Page 1 of 8 Mesh placement for hiatal hernia repair: can we solve the controversy? Carmen Balagué, Sonia Fdez-Ananín, David Sacoto, Eduardo M. Targarona Department of General and Digestive Surgery, Hospital de la Santa Creu i Sant Pau, UAB, Barcelona, Spain Contributions: (I) Conception and design: C Balagué, EM Targarona; (II) Administrative support: S Fdez-Ananín, D Sacoto; (III) Provision of study materials or patients: S Fdez-Ananín, D Sacoto; (IV) Collection and assembly of data: C Balagué; (V) Data analysis and interpretation: C Balagué; (VI) Manuscript writing: All authors; (VII) Final approval of manuscript: All authors. Correspondence to: Dra. Carmen Balagué, PhD. Av Can Pallas nº 16, 3º 1ª, 08192, Sant Quirze del Valles, Barcelona, Spain. Email: cbalague@santpau.cat. Abstract: Hiatal hernia is a common disorder characterized by the protrusion of abdominal structures other than esophagus in thoracic cavity. Large hiatal hernias, also called paraesophageal hernia (PEH), contain a large part of the stomach, including other organs, into the mediastinum. The Guidelines of Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) recommends that patients’ age and comorbidities must be considered before to decide the routine elective repair of asymptomatic PEH. Nevertheless, truly asymptomatic PEH are rare and post-prandial chest fullness or shortness of breath are often the symptoms present instead of heartburn and reflux. The complete reduction of the mediastinal sac with a wide esophageal mobilization and a tension-free hiatal closure are necessary for a correct PEH repair. However, a tension-free cruroplasty is not easy, with a recurrence rate of up to 42%. The introduction of synthetic mesh (SM) reinforcement, could ameliorate the results and several studies have reported lower recurrence rates with its use. However, also severe complications have been reported and biological meshes (BMs) have been proposed as an alternative although with conflicting results regarding efficacy. On the other hand, several studies describe better clinical results on long term follow-up than expected even with a high radiological recurrence rate. Keywords: Hiatal hernia; biological mesh (BM); nonabsorbable mesh; polytetrafluoroethylene (PTFE); polypropylene (PP) Received: 29 April 2020; Accepted: 30 June 2020; Published: 25 January 2021. doi: 10.21037/ls-20-89 View this article at: http://dx.doi.org/10.21037/ls-20-89 Introduction the population. Over 90% of large hiatal hernias are type III hernias, with a large part of the stomach herniating into Guidelines for the Management of Hiatal Hernia the mediastinum (2). The S.A.G.E.S guidelines recommend published by the Society of American Gastrointestinal and that patients’ age and comorbidities be considered before Endoscopic Surgeons (SAGES) (1) describe hiatal hernia routine elective repair of asymptomatic PEH is decided. as a common disorder characterized by the protrusion Nevertheless, patients with truly asymptomatic PEH are of abdominal structures other than esophagus into the rare. Heartburn and reflux are common in less severe stages thoracic cavity. Anatomic criteria permit categorization while post-prandial chest fullness or shortness of breath are into four subtypes. Around 95% of all hiatal hernias are frequent in patients with larger hernias (2). type I. Although only type II is pure paraesophageal hernia Correct PEH repair involves complete reduction of the (PEH), types III and IV are also referred to as PEH and mediastinal sac with a wide esophageal mobilization and are becoming increasingly more common with the aging of a tension-free hiatal closure (3). However, a tension-free © Laparoscopic Surgery. All rights reserved. Laparosc Surg 2021;5:6 | http://dx.doi.org/10.21037/ls-20-89 Page 2 of 8 Laparoscopic Surgery, 2021 cruroplasty is not easy, and recurrence has been reported The role of the short esophagus in hernia recurrence in up to 42% of cases (4). In an effort to lower recurrence has been evaluated by several authors, such as Morino rates, Kuster and Gilroy introduced synthetic mesh (SM) et al. (19). In a series of 65 patients submitted to elective reinforcement in 1993 (5) and several studies have since laparoscopic repair of large hiatal hernia they found 14 reported a decrease in recurrence rates with its use (6,7). patients had primary closure, 37 received a mesh, and 14 Nevertheless, severe complications have also been reported underwent a Collis-Nissen gastroplasty. The recurrence (8-10) and biological mesh (BM) has been proposed as an rate was 35% in the mesh group, considerably lower than alternative. Results regarding the efficacy of mesh, however, the 77% in the primary closure group. No recurrences are conflicting (11). While long-term clinical results were observed in the Collis-Nissen group, even are good, several studies (12-14) have reported a high though a case of distal esophagus perforation requiring radiological recurrence rate. esophagectomy and posterior esophagocoloplasty was described in this group. The authors recommend intraoperative evaluation once the hernia dissection has Recurrence of PEH and influencing factors been performed because the correct preoperative diagnosis The immediate clinical outcome of laparoscopic PEH of a short esophagus is extremely difficult. They also repair is highly satisfactory (15). However, when compared recommend an intraoperative endoscopic evaluation of the with the open approach the recurrence rate is higher than esophagogastric junction to decide whether or not Collis- expected at midterm follow-up (4,15). In 2000, Hashemi Nissen gastroplasty is required (19). et al. (4) reported an objective recurrence rate (determined by videoesophagram) of 42% after laparoscopic repair When should a mesh be placed? of PEH compared with 15% after open repair. One decade later, with the introduction of absorbable mesh The management of paraesophageal hernias continues to reinforcement in 84% of patients and Collis gastroplasty spark controversy. In the last decade, at least 24 systematic in 40% of patients, they reported a reduction in the reviews and meta-analysis on PEH repair have been hernia recurrence rate similar to that seen with the open published but only four randomized clinical trials (RCTs) approach (16). Several authors have analysed the possible have compared PEH repair with and without mesh (see factors influencing the hernia recurrence rate after Table 1). One of these RCTs is the trial of Frantzides et al. (6), laparoscopic PEH repair. One reason for failure of the where the authors compared the laparoscopic repair of hiatal hiatal repair is tension in the lateral portions of the hernia >8 cm with and without polytetrafluoroethylene diaphragm near the crura after approaching the pillars of (PTFE) mesh reinforcement. They reported a recurrence a particularly wide hiatus (15). However, the size of the rate of 0/36 vs. 8/36 (22%), respectively, at a median follow- hernia is not the only factor. The structure of the pillars up of 2.5 years. The meta-analysis of Antoniou et al. (23), is also an important anatomical element for the genesis of that included RCTs of Frantzides (6), Granderath (20) and failure (17). The use of mesh may therefore provide better Oelschlager (24), also found a lower incidence of recurrence results because it reinforces hernia repair. with the use of mesh. These results appeared to provide a Another aspect influencing the failure of hiatal high level of evidence for the use of mesh in hiatal hernia repair is the length of the esophagus. Laparoscopic repair. Nevertheless, the follow-up of these studies did not pneumoperitoneum elevates the diaphragm and can allow conclusions to be drawn regarding the long-term give surgeons the impression of more intra-abdominal effect. In addition, after a follow-up of more than 4 years, esophagus than there really will be once the diaphragm the randomized study of Oelschlager (21) observed no returns to its normal position with deflation of the differences in recurrence rates between patients receiving pneumoperitoneum (16). In addition, it can be complex primary repair and those receiving mesh reinforcement. to precisely determine the gastroesophageal junction in However, we must take into account that while Oelschlager chronic herniation of proximal stomach (16). In 1957, (21,24) used BM, Frantzides (6) and Granderath (20) used Collis described the technique for lengthening the SM, and no long-term results have yet been published. A esophagus. Currently, the most popular adapted technique fourth randomized study by Watson et al. (22,25) compared creates the gastroplasty tube by excising a wedge of the the use of absorbable mesh, nonabsorbable mesh, and fundus (18). primary suture in 126 patients. After a follow-up of only © Laparoscopic Surgery. All rights reserved. Laparosc Surg 2021;5:6 | http://dx.doi.org/10.21037/ls-20-89 Laparoscopic Surgery, 2021 Page 3 of 8 Table 1 Randomized clinical trials comparing PEH repair with and without mesh Mesh Suture Mesh Mean follow-up Recurrence rate Reoperation rate Author/year group (N) group (N) type (months) Mesh Suture Mesh Suture Frantzides/2002, (6) 36 36 SM 40 0 22% 0 13.8% Granderath/2005, (20) 50 50 SM 12 8% 26% 8% NR Oelschlager/2011, (21) 57 51 BM 58 46% 41% 0 3.5% Watson/2019, (22) 39 33 SM/BM 60 42.9% 39.3% 13% (SM)/ 15% (SM)/35(BM) (SM)/56.7% (BM) 11% (BM) PEH, paraesophageal hernia; SM, synthetic mesh; BM, biological mesh; NR, not reported. Table 2 Systematic reviews and meta-analysis comparing mesh vs. suture Studies Type of Number patients Follow-up Recurrence Mesh related Author/year included studies Mesh No mesh (months) Mesh No mesh complications Antoniou/2012, (23) 3 3 RCT 131 136 6/12 5.8% 24.3% – Furnée/2013, (28) 26 3 RCT, 16 ChS, 924 340 25 14.6% 26.3% – 7 C-C Müller-Stich/2015, (29) 12 3 RCT, 9 OCS 328 310 34 12.1% 20.5% 1.9% Antoniou/2015, (30) 5 2 RCT, 1 P, 2 R 161 156 6/12 3.7% 16.7% – Hudy/2016, (27) 9 4 RCT, 2 P, 3 R 366 310 – 14.5% 24.5% – Tam/2016, (14) 13 3 RCT, 4 P, 673 521 – 13% 24% – 4 R, 2 O Memon/2016, (31) 4 4 RCT 226 180 ND 16.3% 27.5% – Zhang/2017, (32) 11 4 RCT, 4 P, 3 R 719 755 ND 9.4% 2.6% – Sathasivam/2019, (11) 9 4 RCT, 5 O 517 425 ND OR: 0.48 P<0.05 – – favoring mesh group OR, odds ratio; NOS, Ottawa Newcastle score; OCS, observational clinical studies; RCT, randomized clinical trial; P, prospective; R, retrospective; O, observational; ChS, cohort study; C-C, case-control; ND, not determined. 12 months, they observed that overall outcomes after evidence regarding the optimum technique if risks and sutured repair and mesh repair were similar. In another benefits were considered. Other meta-analyses offer similar study of note, Zaninotto et al. (26) performed a follow up conclusions regarding the recurrence rate comparing mesh of 64 months, evaluating patients who underwent mesh repair vs. suture (see Table 2). surgery by endoscopy every 2 years. They observed that all Due to the lack of convincing RCTs, expert opinion recurrences occurred within the first eight postoperative (33,34) was requested to answer questions concerning the months. use of mesh in PEH repair. Using a Delphi consensus In a meta-analysis in 2016, Huddy et al. (27) evaluated process, Bonrath and Grantcharov (33) attempted to the results obtained in patients following suture repair generate information on current practices and highlight key (SR), BM or SM repair. They also carried out a survey topics of disagreement based on the opinions from a panel of surgeons to establish a perspective of current practice. of European experts from high-volume centers regarding They concluded that both BM and SM reduce the rate of foregut surgery. Eighteen of the 27 initially identified recurrence compared to suture, but they found insufficient experts participated throughout the entire consensus © Laparoscopic Surgery. All rights reserved. Laparosc Surg 2021;5:6 | http://dx.doi.org/10.21037/ls-20-89 Page 4 of 8 Laparoscopic Surgery, 2021 process. Consensus was a majority of at least two-thirds radiological study revealed a recurrence rate of 6%. of the participants. However, no consensus was reached Watson et al.’s randomized study (25) comparing regarding the importance of mesh use for PEH repair. Only absorbable mesh, nonabsorbable mesh, and primary suture 7 panellists considered the role of mesh reinforcement of did not identify significant differences in the recurrence rate the hiatus “important” or “very important”. Nevertheless, between groups (23.1% after SR, 30.8% after absorbable the majority (n: 12) felt that mesh use was relevant under mesh, and 12.8% after nonabsorbable mesh). There is specific circumstances. The size of the hiatal defect and no consensus regarding the configuration of the mesh the quality of the crura were the factors influencing the employed (39) but the options seem to have narrowed down decision for mesh use for most individuals who used mesh somewhat. Furnée et al. (35) stated that at present, the most (10/14). In the same year, Furnée et al. (35) published the frequently used configuration is the rectangular or “U” results of a web-based questionnaire completed by 165 shape, positioned posteriorly to the esophagus. European upper gastrointestinal (GI) surgeons identified through the European Association for Endoscopic Surgery. What about complications with mesh implants? The majority of respondents (77.6%, 128 respondents) used mesh selectively, depending on the size of the hiatus, the In 2009, Stadlhuber et al. (40) published a series of 28 tension on the sutured cruroplasty, or both. patients with mesh-related complications after hiatal hernia repair. Most patients (23 cases) required mesh removal due to intraluminal erosion in 17 cases. Esophagectomy was Which type of mesh should I use? required in six patients, while another three patients had a The characteristics of the mesh used should be taken into partial or total gastrectomy. consideration. Many different materials and configurations For the time being, we cannot establish the exact of mesh are available, but consensus regarding the best rate of mesh-associated complications. Müller-Stich et option is lacking. The Delphi process of Bonrath and al. (29) analysed their incidence through a systematic Grantcharov (33) did not reach a consensus regarding review including 124 studies (19 case reports) with a total the type of mesh. Of the 165 surgeons who completed of 5,499 patients submitted to laparoscopic PEH repair the questionnaire of Furnée et al. (35), 154 reported with mesh cruroplasty. They reported 91 (1.9%) mesh- that they used some type of mesh in hiatal hernia repair associated complications. The main causes were erosions (routinely or selectively). The most frequently used of the esophagus, the stomach, or the aorta, followed by types were polypropylene (PP) by 52.6%, followed by stenoses and cardiac tamponades. Four fatal complications expanded PTFE (ePTFE) by 32% and biomesh by 27.9%. occurred, all originating from cardiac tamponades due to The option for the majority was thus an SM. This result the staples used for the fixation of the mesh to the hiatus. is quite different from the results of the survey among PP and PTFE were the most frequently used materials SAGES members (36). American surgeons preferred the (71.5% of patients), followed by BM. Complication rates absorbable type of mesh (67%). were 0.8% for PP mesh, 2.5% for PTFE mesh and 1.3% When analyzing the results of RCTs according to the for BM. These results are similar to those observed in two type of mesh favoured, Oelschlager (21) did not observe other consecutive patient series where the complication significantly lower recurrence rates after a long-term rates published were about 1% (41,42). This incidence follow-up with the use of BM reinforcement. In their review may seem low, but the implications are serious. We should of the literature, Panait et al. (37) reached the conclusion take into account that we do not know the real incidence that definitive evidence is still lacking to support the use of secondary complications due to migration and erosion of biologic or bioabsorbable materials to reinforce hiatal because most studies do not include long-term results. closure in the cure of PEH. However, data available to date seems that around 90% of Frantzides (6) and Granderath (20) used SM but mesh-related complications occur within two years after their long-term results have not yet been published. surgery (29,39,43). Granderath (38), however, published their long-term Müller-Stich et al. (29) described a similar incidence experience with circular PP mesh reinforcement in of mesh-related complications for BM and SM, but they a series of 33 patients who underwent laparoscopic did not specify the type of complications due to each type refundoplication, and after a follow-up of 60 months, the of mesh (BM vs. SM). Serious complications are more © Laparoscopic Surgery. All rights reserved. Laparosc Surg 2021;5:6 | http://dx.doi.org/10.21037/ls-20-89 Laparoscopic Surgery, 2021 Page 5 of 8 Table 3 Follow-up results: Rx recurrence vs. reoperation Author/year N Follow-up (months) Rx recurrence Symptoms Reoperation of recurrence Oelschlager et al. (47) 72 58 57% – 3% Aly et al. (48) 100 nr 23% NR 4% Jobe et al. (49) 52 39 32% 19% 4% Luketich et al. (50) 662 30 15.7% 11% 3% Dallemagne et al. (13) 85 118 66% 15.7% 2% Zaninotto et al. (26) 54 71 20% 22% 9% Targarona et al. (12) 77 108 46% 22% 3.9% NR, not reported; Rx, radiological. commonly associated with synthetic materials and BM support this concept. In their study with a mean follow-up is suggested as an alternative. A survey among SAGES of 11 years, White et al. (51) found 10 hernia recurrences members published by Frantzides et al. (44)—and including in 31 patients, but only 20% of them were true PEH a total of 5486 PEH repairs—observed that biomaterial recurrences and reoperation was necessary only for two tended to be associated with failure while SM tended to patients. Dallemagne (13), with a median follow-up of 118 be associated with stricture and erosion. PP mesh has the months, reported a 2% reoperation rate despite an objective propensity to erode the surrounding tissue over an uncertain recurrence rate of 66%. Their findings are comparable data period ranging from days to years. It is also known to to those of Targarona et al. (12) who reported a recurrence induce a significant fibrotic reaction, possibly reducing rate of 46.5% and a reoperation rate of 3.9%. recurrence rates but carrying the risk of complications All authors seem to agree that no surgery is required in related to fibrosis of the lower esophagus. PTFE, on the cases of recurrence if the patient is asymptomatic. In the other hand, may lead to high dysphagia rates (33,45). The European expert consensus published by Bonrath et al. (33) shape of the mesh must also be considered. Five years ago, symptomatic recurrence was the only diagnostic factor that the key-hole shape was still used by around 25% of European achieved agreement for revision surgery. Armijo et al. (52) surgeons (35) compared to 10% of US surgeons according analyzed a series of 322 patients submitted to PEH repair to a report by Frantzides et al. in 2010 (44). The risk of mesh in order to identify factors that can predict hiatal hernia contracting and causing stricture at the gastroesophageal recurrence. Hernia recurrence was defined as a maximal junction is a strong argument against circular positioning (31). vertical height of a hernia ≥2 cm above the diaphragm Chen et al. (46) initially used a keyhole-shaped mesh, but detected by an upper GI contrast study. With a mean within 16 months of the operation, three of nine patients follow-up of 20 months, 15.5% of patients had an objective required reoperation because the mesh migrated into the hiatal hernia recurrence, but only 6% of them had a large oesophagus. They thus switched to a “U”-shaped composite hiatal hernia (≥5 cm) and required a redo hiatal hernia mesh and reported no complications after a follow-up of repair. The overall rate of reoperation was 1%. more than 5 years. Interest also focuses on QOL. In their long-term follow- up series, Targarona et al. (12) reported a mean gastro- intestinal quality of life index (GIQLI) of 111 (range, Impact on quality of life (QOL) 59–137) for patients with hiatal recurrence, comparable Even if the recurrence rate is high, the incidence of to that obtained for non-recurrence groups. The results patients requiring surgery is low (see Table 3). Zehetner were comparable to those reported by Dallemagne (13). et al. (16) observed that no patients with a recurrent hernia Oelschlager et al. (21,47) analyzed long-term clinical had a serious or catastrophic complication related to the data from the group of patients enrolled in a previously recurrence, suggesting that the natural history of a small published RCT comparing laparoscopic PEH repair with recurrent hernia is different from that of the original or without using BM reinforcement. They observed that intrathoracic stomach. Findings from another author although radiologic recurrences were frequent, they did not © Laparoscopic Surgery. All rights reserved. Laparosc Surg 2021;5:6 | http://dx.doi.org/10.21037/ls-20-89 Page 6 of 8 Laparoscopic Surgery, 2021 appear to impact on QOL or cause clinical symptoms. They Conflicts of Interest: All authors have completed the ICMJE appeared to remain well-controlled, with the exception uniform disclosure form (available at http://dx.doi. of hiatal hernias ≥40 mm producing a modest increase in org/10.21037/ls-20-89). The series “Minimally Invasive heartburn. Patient satisfaction was high, and the need for Approach for the Treatment of Gastro-esophageal Reflux reoperation was low. PEH repair with or without BM did Disease” was commissioned by the editorial office without not seem to influence QOL. Koetje et al. (53) also analyzed any funding or sponsorship. The authors have no other QOL outcomes from their previous published RCT (25), conflicts of interest to declare. comparing sutures versus repair with BM versus SM. With a follow-up of two years in 72.2% of patients, they observed Ethical Statement: The authors are accountable for all a significant improvement in QOL, measured by SF-36, aspects of the work in ensuring that questions related with no significant differences between groups. to the accuracy or integrity of any part of the work are appropriately investigated and resolved. Conclusions Open Access Statement: This is an Open Access article Since the first data comparing primary suture vs. mesh distributed in accordance with the Creative Commons reinforcement in laparoscopic PEH repair were published Attribution-NonCommercial-NoDerivs 4.0 International around 20 years ago, we continue to ask the same questions: License (CC BY-NC-ND 4.0), which permits the non- whether to perform hiatoplasty with simple interrupted commercial replication and distribution of the article with sutures or with prosthetic material, and if we use a mesh, the strict proviso that no changes or edits are made and the what material and what shape are the most appropriate. original work is properly cited (including links to both the The heterogeneity of data hinders the interpretation of formal publication through the relevant DOI and the license). results. In a systematic review including 26 studies, Furnée See: https://creativecommons.org/licenses/by-nc-nd/4.0/. et al. (28) observed that only 50% of studies reported the definition of large hiatal herniation and only the 19% References of studies used the same definition. The wide variety of materials and shape of the mesh used adds even more 1. Kohn GP, Price RR, Demeester SR, et al. Guidelines for heterogeneity. the Management of Hiatal Hernia. Society of American In conclusion, consensus about the type of mesh Gastrointestinal and Endoscopic Surgeons, 2013. Available continues to be elusive and we clearly need a higher level online: https://www.sages.org/publications/guidelines/ of evidence to address the controversy. In the meantime, it guidelines-for-the-management-of-hiatal-hernia/ seems that mesh reinforcement can effectively reduce the 2. Dallemagne B, Quero G, Lapergola A, et al. Treatment of hernia recurrence rate. 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Teflon pledget reinforced fundoplication Hiatal Hernia Recurrence after Laparoscopic Anti-reflux causes symptomatic gastric and esophageal lumenal Surgery with hiatal hernia repair: a Prospective Database penetration. Am J Surg 2004;187:226-9. Analysis. J Gastrointest Surg 2019;23:696-701. 42. Müller-Stich BP, Koninger J, Muller-Stich BH, et al. 53. Koetje JH, Irvine T, Thompson SK, et al. Quality of Life Laparoscopic mesh-augmented hiatoplasty as a method following repair of Large Hiatal Hernia is Improved but to treat gastroesophageal reflux without fundoplication: not influenced by use of mesh: Results from a Randomized single-center experience with 306 consecutive patients. Am Controlled Trial. World J Surg 2015;39:1465-73. doi: 10.21037/ls-20-89 Cite this article as: Balagué C, Fdez-Ananín S, Sacoto D, Targarona EM. Mesh placement for hiatal hernia repair: can we solve the controversy? Laparosc Surg 2021;5:6. © Laparoscopic Surgery. All rights reserved. Laparosc Surg 2021;5:6 | http://dx.doi.org/10.21037/ls-20-89