Mesh in the Hiatus: a Controversial Issue

REVIEW ARTICLE Mesh in the Hiatus A Controversial Issue

Eduardo M. Targarona, MD, PhD; Gali Bendahan, MD; Carmen Balague, MD, PhD; Jordi Garriga, MD; Manuel Trias, MD, PhD

Objective: To analyze the experience acquired to date cedure have been published to date. The information avail- on the use of prosthetic mesh to prevent recurrence af- able showed that the use of a mesh for hiatal repair was ter laparoscopic repair of paraesophageal hernia. safe and prevented recurrence. However, data on the long- term results were lacking, and infrequent but severe com- Data Sources: Current English-language literature re- plications may arise. view. Conclusions: The mesh should be used selectively, and Study Selection: Case reports, series, and opinion ar- the decision to proceed should be based on clinical ex- ticles on the use of mesh for paraesophageal hernia repair. perience. In light of the evidence available, however, it appears to be safe, and the fears expressed in the past have Data Extraction and Synthesis: Study type and re- not been confirmed. sults were analyzed. Most articles were short case series. Few comparative or randomized trials assessing the pro- Arch Surg. 2004;139:1286-1296

UCCESS IN THE DEVELOPMENT THE PROBLEM of laparoscopic fundoplication has made this procedure a valid alternative to medical Laparoscopic repair of PEH and mixed hi- therapy for the treatment of atal hernias is a feasible, safe, but complex gastroesophageal reflux. Thanks to the ex- procedure. The experience during the past S 15 years suggests that viscera reduction, perience acquired, the laparoscopic approach is now used to treat more complex sac excision, retrogastric crural closure, situations, such as paraesophageal hernia and fundoplication are the key technical 1-8 (PEH) or type III (mixed) hiatal hernia.1-8 factors. Fixation of the gastric plicature, The results of several series have shown that abdominal wall gastropexy, and gastros- laparoscopic repair is also feasible and safe, tomy are more controversial technical despite the increased technical difficulty, steps for maintaining the stomach in place and its immediate and short-term results in the abdomen. Although controlled are excellent 9-43 (Table 1). However, the comparative trials with the open approach incidence of recurrences may be high: as are lacking (Table 4), the immediate clini- much as 42% in one series (Table 2). cal outcome of laparoscopic PEH repair is highly satisfactory. However, the recur- See Invited Critique rence rate is higher than expected after midterm follow-up—as high as 42% when on page 1296 compared with the open approach 66-95 (Table 5)—and some authors have sug- One of the most demanding laparo- gested that the laparoscopic approach is scopic technical steps is crural closure, es- unsuitable.17 The main reason for the fail- pecially when the gap is wide and the clo- ure of the hiatal repair is tension. Recur- sure inevitably entails a tension repair. Some rence has been related to the mean diam- authors recommend the use of prosthetic eter of the hiatus (Ͼ10 cm in some cases). mesh to reinforce the hiatal closure 44-66 Another factor is the anatomy of the pil- (Table 3 and Table 4), but others argue lars. The hiatal crus is a fleshy structure Author Affiliations: Service of against it. This review analyzes the expe- without tendinous reinforcement. Stan- Surgery, Hospital de Sant Pau, rience accumulated so far on the use of dard sutures may cut the muscle, and Autonomous University of mesh to reinforce the hiatus to prevent re- when the hiatus is particularly wide and Barcelona, Barcelona, Spain. currence after laparoscopic repair of PEH. the pillars are approached, the lateral

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No. (%) No. (%) Mean Mean Good or Mesh Source N Conversion Morbidity MortalityStay, d Follow-up, mo Recurrence Fair Outcome Used Comment Huntington,9 1997 58 1 (2) 4 (7) 0 2.8 12 0 NA Occ SE + ACR + FP Perdikis et al,10 1997 65 2 (3) 9 (14) 0 2 18 20 (13) 60 (92) 0 PCR + FP Edye et al,11 1998 58 3 (5) 10 (17) 1 (2) NA 38 8 (14) NA 1 (2) SE + PCR + FP Gantert et al,12 1998 55 5 (9) 5 (9) 1 (2) 3 11 NA 50 (91) 0 SE + PCR + FP Watson et al,13 1999 86 20 (23) 11 (13) NA 3 24 1 (1) 80 (93) 0 SE + PCR + FP Wu et al,14 1999 38 1 (3) 6 (16) 2 (5) 3 3 9 (24) 30 (79) 5 (13) Several repairs Horgan et al,15 1999 41 2 (5) 1 (2) 1 (2) 4 36 5 (12) NA Occ SE + PCR + FP Swanstrom et al,16 1999 52 0 6 (12) 0 3 18 4 (8) NA NA SE + PCR + FP Hashemi et al,17 2000 26 2 (8) 3 (12) 0 3 17 NA 20 (77) 0 SE + PCR + FP Peet et al,18 2000 22 3 (14) 1 (5) 0 NA 24 5 (22) NA 3 (14) SE + PCR + FP + fixation Dahlberg et al,19 2001 37 2 (5) 5 (14) 2 (5) 4 15 5 (14) 32 (87) Occ SE + PCR + FP Wiechmann et al,20 2001 60 6 (10) 1 (2) NA NA 19 4 (7) NA 0 SE + PCR + FP Velanovich and 31 5 (16) 3 (10) 1 (3) NA 24 NA NA NA Several repairs Karmy-Jones,21 2001 Khaitan et al,22 2002 31 6 (19) 6 (19) 0 2.9 25 12 (40) NA NA SE + PCR + FP Pierre et al,23 2002 203 3 (1.5) 57 (28.1) 1 (0.5) 3 18 4 (2.0) 170 (83.7) 22 (10.8) SE + PCR + collis Mattar et al,24 2002 136 3 (2.2) 14 (10.3) 3 (2.2) 4 40 41 (30.1) NA 0 Several repairs Diaz et al,25 2003 116 3 (2.6) 20 (17.2) 2 (1.7) 2 30 37 (31.9) 9 (7.8) Occ SE + PCR + FP + fixation Targarona et al,26 2004 46 0 0 NA 4 30 NA NA NA None Leeder et al,27 2003 53 4 (8) 7 (13) 1 (2) 2 46 5 (9) 41 (77) 14 (26) Several repairs Ponsky et al,28 2003 28 0 3 (11) 0 2 21 0 1 (4) NA PCR + Toupet + fixation Jobe et al,29 2002 56 4 (7) 11 (20) 0 2.6 39 18 (32) 45 (80) 6 (11) Hill repair Keidar and Szold,30 2003 33 1 (3) 5 (15) 1 (3) 3 58 5 (15) 28 (84) 28 (30) SE + PCR + FP Range (0-23) (0-28) (0-5.4) 2-4 (0-40) (77-94) (0-30)

Abbreviations: ACR, anterior crural repair; FP, fundoplication; NA, not available; Occ, occasionally; PCR, posterior crural repair; PEH, paraesophageal hernia; SE, sac excision.

Table 2. Recurrence After Surgical Treatment of PEH in Series With Systematic Radiologic Control

No. (%) of Patients Recurrence, Symptoms, Source With Esophagogram No. (%) PEH Recurrence, No. Sliding, No. No. (%) Mesh Type Open Surgery Luostarinen et al,44 1998 19/22 (86) 8 (42) 4 4 7 (37) ±Pledget Laparoscopy Wu et al,14 1999 35/38 (92) 8 (23) 2 5 12 (34) NA Hashemi et al,17 2000 21/27 (78) 9 (43) NA NA 8 (38) Pledget Wiechmann et al,20 2001 44/60 (73) 3 (7) 3 0 44 (100) NA Khaitan et al,22 2002 15/25 (60) 6 (40) 1 5 8 (50) Pledget Jobe et al,29 2002 34/52 (65) 11 (32) 8 3 22 (65) Pledget Ͼ4cm Mattar et al,24 2002 32/125 (26) 11 (34) NA NA 14 (44) Pledget Keidar and Szold,30 2003 NA 21 (15) 0 5 13 (40) NA Diaz et al,25 2003 66/96 (69) 21 (32) 7 14 41 (62) NA Tagarona et al,26 2004 30/37 (81) 6 (20) 1 5 15 (50) NA

Abbreviations: NA, not available; PEH, paraesophageal hernia.

portions of the diaphragm near the crura become tense, cera. This means that any prosthetic mesh will be in con- with a potential risk of disruption. tact with the esophagus, and so there is a theoretical risk Currently, all hernia repairs are tension free (for ex- of esophageal erosion and complication. This fact—along ample, the Lichtenstein repair or ventral hernia repair). with evidence of mechanical complications after place- However, performing a tension-free repair in the hiatus is ment of mesh for repair of abdominal wall defects and com- technically very demanding, because of the oblique situa- plications with mechanical devices located in the cardia tion of the pillars and the difficulty of fixing the mesh. Fur- (such as the Angelchik device97-99 and with the bands used thermore, the hiatus is a complex anatomic structure in in treatment of morbid obesity100)—seems to argue against which the esophagus moves during respiratory excursion the placement of foreign bodies in the hiatus. However, some of the diaphragm,96 whereas in inguinal or ventral hernia surgeons report that the use of mesh in the hiatus is safe repair the mesh passively supports the intra-abdominal vis- and the outcome acceptable (Tables 3 and 4).

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No. (%) No. (%)

Mean Mean GI Tract Source N Morbidity Mortality Stay, d Follow-up, mo Symptoms Recurrence Comment Open Surgery Carlson et al,45 1998 44 20 (45) 1 (2) 12 52 4 (10) 0 Onlay (polypropylene) Laparoscopy Kuster and Gilroy,46 1993 6 1 (17) 0 4 8-22 0 1 (17) Reduction + mesh + fixation (no sac excision) Edelman,47 1995 5 2 (40) 1 (20) 4 NA NA 0 Mesh tension-free + FP + gastrostomy Pitcher et al,48 1995 2 0 0 2.5 8 NA 0 ACR, FP, PTFE Oddsdottir et al,49 1995 10 2 (20) 0 NA 9 1 (10) 0 Pledget, SE + PCR + FP Behrns and Schlinkert,50 1996 2 0 0 NA 6 NA 0 Replacement mesh Huntington,51 1997 8 1 (12) 0 NA 8 0 0 Right crus patch (polypropylene) Paul et al,52 1997 3 0 0 3 12 0 0 Anterior, tension-free, PTFE Frantzides and Carlson,53 1997 3 0 0 0 13 0 0 Onlay PTFE Willekes et al,54 1997 30 8 (27) 0 3 NA NA 0 Onlay PTFE, no CR ± FP Wu et al,14 1999 38 6 (16) 2 (5) 3 3 2 (5) 9 (24) Several repairs ± mesh Hawasli and Zonca,55 1998 27 1 (4) 0 3.8 1-56 8 (30) 0 SE + free tension onlay mesh + fixation (polypropylene) Basso et al,56 2000 67 3 (4) 0 3.5 22 6 (9) 0 Tension-free (polypropylene) Lambert and Huddart,57 2001 7 1 (14) 0 0 NA 1 (14) 0 Onlay (polypropylene) Meyer et al,58 2002 10 1 (10) 0 8 24 0 0 SE + CR + FP + mesh (polypropylene 50%, PTFE 50%) Casaccia et al,59 2002 8 1 (12) 0 4 8 0 0 SE + tension-free + FP (composite A-shaped mesh) Kamolz et al,60 2002 100 0 0 0 NA NA 0 None Ponsky et al,28 2003 1 NA 0 0 21 0 0 Tension-free + gastropexy Champion and Rock,61 2003 52 0 0 1 25 21 (40) 1 (2) SE + CR + FP + buttress mesh Oelschlager et al,62 2003 9 0 1 (11) NA 8 NA 1 (11) SE + PCR + FP (biomaterial mesh) Leeder et al,27 2003 14 NA NA 2 46 2 (14) 2 (14) Several techniques (U-shaped mesh) Keidar and Szold,30 2003 10 NA 0 3 58 NA 1 (10) SE + PCR + FP (PTFE + polypropylene) Granderath et al,63 2003 24 1 (4) 0 NA 12 0 0 SE + PCR + FP + onlay (polypropylene)

Abbreviations: ACR, anterior crural repair; CR, crural repair; FP, fundoplication; NA, not available; PCR, posterior crural repair; PEH, paraesophageal hernia; PTFE, polytef; SE, sac excision.

RECURRENCES SURGICAL TECHNIQUE

Analysis of recurrences shows different patterns for time The most controversial issue in the use of prostheses in the hia- of presentation and shape (Table 2). Immediate recur- tus is the surgical technique. Several models have been proposed. rent hernias are usually secondary to total disruption of the hiatal closure with a relapsing PEH. Long-term re- Tension-Free Techniques currences may adopt several patterns: complete recurrent PEH, fundoplication migration, or a small sliding One tension-free technique is anterior placement of a triangular hernia, without a clear recurrence of the paraesoph- piece of mesh, proposed by Paul et al52 (Figure 1). A triangu- ageal sac. In the latter subgroup, the incidence of symp- lar or semilunar polytef patch is placed to occlude the anterior toms is variable, and most are identified only by esopha- segment of the hiatus and fixed with staples or stitches. The stomach is fixed to the abdomen and a fundoplication is added. gogram. Recurrences of symptoms are treated surgically. For posterior placement of a triangular piece of mesh However, there is tacit agreement that nonsymptomatic (Figure 2), the aim is the same as in the technique for ante- recurrences, especially in cases of small sliding hernias, rior placement. Kuster and Gilroy46 proposed a posterior seg- do not require repair. Recurrent hernias of any type should mental occlusion, occluding the base of the pillar overture, and be considered as technical failures, although the long- placing the esophagus anteriorly, fixing the mesh with staples term outcome of asymptomatic recurrent hernias is un- or stitches. Fixation to the abdominal wall or a gastrostomy is known. also performed. A third technique involves onlay of a piece of mesh, with a hole facilitating the passage of the esophagus. The mesh cov- METHODS ers the whole of the hiatal defect, and no attempt is made to close the hiatus (Figure 3). There are several shapes of mesh A systematic PubMed search looking for all of the studies pub- designed to allow the passage of the esophagus and to facili- lished in English in relation to treatment of paraesophageal and tate fixation (eg, U shape,22,53 A shape59)(Figure 4). Basso et mixed hiatal hernias was performed. Particular attention was paid al101 also proposed covering the mesh with autologous flaps of to the use of meshes for reinforcement of the hiatal repair. peritoneal tissue obtained from the hernia sac. Casaccia et al59

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No. (%) No. (%) Source and Type Operative Mean Mean Good or of Repair N Time, min Conversion Morbidity MortalityStay, d Follow-up, mo Recurrence Fair Outcome Reoperation Comment Laparoscopy vs Laparoscopy + Mesh Basso et al,56 2000* Laparoscopy 65 78 6 (1) 5 (8) NA 3.6 48.3 9 (14) NA 6 (9) None Laparoscopy + mesh 67 70 0 3 (4) 0 3.5 22.5 0 NA 0 Tension-free (polypropylene) Hui et al,64 2001* Laparoscopy 12 226 1 (8) 3 (25) NA 6 37 0 12 (100) NA SE + PCR + FP (PTFE + polypropylene) Laparoscopy + mesh 12 202 NA 2 (17) NA 4.5 37 0 12 (100) NA SE + PCR + FP Kamolz et al,60 2002* Laparoscopy 100 70 0 0 0 0 12 9 (9) 95 (95) 6 (6) PCR + FP Laparoscopy + mesh 100 70 0 0 0 0 12 NA 95 (95) 1 (1) PCR + FP + mesh polypropylene Frantzides et al,65 2002† Laparoscopy 36 NA 0 1 (3) NA NA 40 8 (22) NA 4 (11) SE + PCR + FP Laparoscopy + mesh 36 NA 0 1 (3) NA NA 40 0 NA 1 (3) SE + PCR + FP + PTFE Open Surgery vs Laparoscopy Kuster and Gilroy,46 1993 Open 27 120 NA NA 0 7 96 NA NA 2 (7) ACR 16, PCR 11, FP 7 Laparoscopic 6 86 1 (17) 1 (17) 0 4 8-22 1 (17) NA 0 Reduction + mesh + fixation Schauer et al,66 1998 Open 25 208 NA 15 (60) NA 10 48 NA 21 (84) NA None Laparoscopic 70 264 3 (4) 20 (29) NA 5 13 NA 66 (94) NA PCR + FP ± mesh Hashemi et al,17 2000 Open 25 176 NA NA 1 (4) 9 34 4 (16) 22 (88) NA SE + PCR + FP Laparoscopic 26 184 2 (8) 3 (12) 0 3 17 11 (42) 20 (77) NA SE + PCR + FP (pledget)

Abbreviations: ACR, anterior crural repair; FP, fundoplication; NA, not available; PCR, posterior crural repair; PEH, paraesophageal hernia; PTFE, polytef; SE, sac excision. *Nonrandomized; included all types of hiatal hernias. †Prospective randomized trial.

recently proposed a composite polytef-polypropylene A- shaped mesh. This mesh was designed according to the strength lines of the hiatus and produced good results after 8 months of follow-up. A piece of mesh may be placed just covering the defect below the esophagus, overlapping both pillars laterally. This was described by Basso et al56 (Figure 5). In another technique, after a standard closure of the hiatus, a relaxing incision lateral to the right crura is placed, and a patch is fixed with stitches or staples covering the diaphragmatic defect (Figure 6). Described by Huntington in 1997,51 it has been also proposed by Horgan et al.15

Non–Tension-Free Techniques

Simple crural closure with either simple stitches (Figure 7) or a continuous suture (Figure 8) is the most common method for hiatal closure. In 1992, Cuschieri et al102 described the first specific method for hiatal closure, using a continuous suture. Other non–tension-free techniques are reinforcement of the crural closure, to avoid the cutting effect of the stitches; simple 18,29 Figure 9 Figure 1. Tension-free repair: anterior placement of a triangular piece of stitches with Teflon or Dacron pledgets ( ); a 39 polypropylene strip along the crura to hold the stitches mesh. (Figure 10); and a piece of polypropylene mesh covering both edges of the pillars. The stitches close the hiatus including the ries of 52 cases, with a recurrence rate of 2%, although esopha- mesh and tissue, as proposed by Kamolz et al60 (Figure 11). gography was performed in only 52% of cases. A buttress mesh technique has also been described. A long Placement of onlay mesh around the esophagus with a hole strip of mesh is placed below the esophagus, covering the pil- in the middle, once the defect has been closed, has been used lar closure (Figure 12). The advantage is that it avoids the (Figure 13). There are also preshaped meshes designed to adapt encircling of the esophagus, reducing the risk of dysphagia or anatomically to the characteristics of the anatomic area31,62 erosion. Champion and Rock61 reported good results in a se- (Figure 4).

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No. (%) No. (%) Mean Mean Good or Source N Morbidity MortalityStay, d Follow-up, mo Recurrence Fair Outcome Collis Reoperation Comment Skinner and Belsey,67 1967 8 1 (8-13)* 1 (1.2) NA 60 2 (7-21)* 7 (88) (Mark IV) NA NA Thor, Mark IV (60%) Hill and Tobias,68 1968 22 NA NA NA 120 0 NA NA NA Lap, SE + ACR Wichterman et al,69 1979 27 4 (17) 1 (4) NA 62 0 NA NA 2 (7) Lap, SE + CR + FP + fixation Pearson et al,70 1983 53 6 (11) 1 (2) NA 72 2 (4) 36 (68) (70) 2 (4) Thor, gastroplasty + Belsey Ellis et al,71 1986 51 12 (24) 1 (2) 9 54 5 (10) (88) NA 4 (8) Lap, ACR + fixation Treacy and Jamieson,721987 54 NA 1 (2) NA 24-60 NA 8 (81)†–6 (45)‡ NA 0 Lap, SE + PCR + FP Menguy,73 1988 30 0 0 NA NA NA NA NA NA Lap, SE + ACR + fixation Ackermann et al,74 1989 40 NA 1 (2) NA 144 20 (50) 34 (85) NA NA Lap, CR + fixation ± FP Haas et al,75 1990 29 5 (17) 5 (17) 11 9 NA 24 (83) 0 0 SE + PCR + FP Harriss et al,76 1992 25 (12) 2 (8) NA 48 NA 22 (88) 0 0 Thor, ES + CP + FP Allen et al,77 1993 119 (27) 0 11 (9) 42 NA 111 (93) 78 (66) 1 (1) Thor, Collis-Nissen Williamson et al,78 1993 119 NA NA NA 61 12 (10) 99 (83) NA NA Lap, fixation ± Nissen Myers et al,79 1995 37 14 (38) NA NA 67 1 (3) 31 (84) NA NA SE + ACR + fixation ± FP Altorki et al,80 1998 47 NA 1 (2) NA 45 4 (9) 42 (89) NA 0 Thor, Belsey Mark IV, Nissen Luostarinen et al,44 1998 22 5 (23) 0 NA 37 9 (41) 21 (95) NA NA Lap, PCR ± FP (some pledget) Carlson et al,45 1998 44 20 (45) 1 (2) 12 52 0 NA NA NA Lap, PCR + mesh + gastrostomy Maziak et al,81 1998 94 18 (19) 2 (2) NA 93 2 (2) 75 (80) 70 (74) 5 (5) Thor + Belsey Mark IV Geha et al,82 1900 100 6 (6) 2 (2) NA NA 0 96 (96) NA NA 80% Abd, reduction + fixation Rogers et al,83 2001 60 5 (8) 0 9 19 1 (2) 51 (85) NA NA Thor, CP ± FP Low and Simchuk,84 2002 45 7 (16) 0 5 19 NA NA NA NA Hill procedure Range (6-45) (0-19) 5-12 (1.6-50) (68-95)

Abbreviations: Abd, abdominal; ACR, anterior crural repair; FP, fundoplication; Lap, laparotomy; NA, not available; PCR, posterior crural repair; PEH, paraesophageal hernia; SE, sac excision; Thor, thoracotomy. *Range indicates simple closure vs Belsey Mark IV operation. †Indicates of those with fundoplication. ‡Indicates of those without fundoplication.

Figure 2. Tension-free repair: posterior placement of a triangular piece of Figure 3. Tension-free repair: onlay piece of mesh, with a hole facilitating the mesh.46 passage of the esophagus.

Other Maneuvers abdominal wall, and gastrostomy.103,104 Fundoplication itself may Additional maneuvers for fixing the stomach in the abdominal have some fixation effect. Some authors have proposed that the cavity include a range of techniques, such as fixation of the fun- Toupet technique may avoid recurrence because the posterior doplication to the diaphragm, fixation of the gastric body to the placement of the fundus covers the crural closure and fixes it to

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©2004 American Medical Association. All rights reserved. Downloaded From: https://jamanetwork.com/ on 09/28/2021 Figure 4. Shapes of mesh designed to allow passage of the esophagus and to facilitate fixation (U shape,22,53 A shape59).

Figure 6. Tension-free repair. After a standard closure of the hiatus, a relaxing incision lateral to the right crura is performed, and a patch is fixed with stitches or staples covering the diaphragmatic defect.15,51

Figure 5. Tension-free repair: piece of mesh just covering the defect below the esophagus, overlapping both pillars laterally.56

the diaphragm.1,3 However, there are no definitive data from randomized trials to support any of these measures.

REPAIR MATERIAL

The prostheses available for hiatal reinforcement are made of a range of materials. Most authors agree that the material used should be nonresorbable, because resorbable material (poly- glycolic acid) loses its mechanical properties as it is resorbed. Nonresorbable material may be made of polypropylene, poly- Figure 7. Non–tension-free repair: simple crural closure with simple stitches. tef, or composite (polytef plus polypropylene; C. R. Bard, Inc, Murray Hill, NJ). Recently, a nonresorbable material of bio- follow-up is often adequate (up to 5 years). No long-term logical origin has been used (Surgisis; Cook Biotech Incorpo- experience (up to 10 years) is available. Mesh has been used rated, West Lafayette, Ind).62 The crucial aspect of the material used to reinforce the hiatus is stiffness. The advantages of mostly in adults, although there is some experience in the polytef are its softness and its lower capacity to induce adhe- pediatricsettingaswell.OverallresultsareplottedinTable2; sions. The different surfaces prevent tight adhesions to the vis- tolerance is good and the recurrence rate and morbidity are ceral face of the mesh, and the texture of the free margin in both low. Three comparative studies have been published near contact with the esophagus is potentially less dangerous. (Table 3), but only 1 was a prospective randomized trial. However, the handling and sewing of the mesh may be more In addition, 2 of the comparative trials included patients difficult than when polypropylene is used. The main draw- with all types of hiatal hernias, and only 1 focused on PEH back of polypropylene is the stiffness of the margins and the hernia repair. Basso et al56 compared simple and tension- possibility that the esophagus will be eroded. Experience with free closures using an onlay piece of polypropylene, divid- mixed mesh or with material of biological origin is scarce. ing their personal series chronologically into 2 parts. Ka- molz et al60 compared simple closure with a reinforcement RESULTS procedure that put the stitches over a piece of polypropylene covering the hiatal closure. Neither study was random- Most of the clinical results of the use of mesh in the hiatus ized; they were merely comparisons of initial experiences come from short series of patients, although the midterm withoutmeshwithmorerecentexperienceswithmesh.They

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©2004 American Medical Association. All rights reserved. Downloaded From: https://jamanetwork.com/ on 09/28/2021 Figure 8. Non–tension-free repair: simple crural closure with continuous Figure 10. Non–tension-free repair with reinforcement of the crural closure, suture.102 using a polypropylene strip along the crura to hold the stitches.

Figure 9. Non–tension-free repair with reinforcement of the crural closure to Figure 11. Non–tension-free repair with reinforcement of the crural closure, avoid the cutting effect of the stitches, using simple stitches with Teflon or using a polypropylene piece of mesh covering both edges of the pillars.60 Dacron pledgets.18,29 Mesh placed in the hiatus may induce complications be- also counted hiatal repair of all types, including type I her- cause of the type of mesh or the device used for fixation. nias or pure gastroesophageal reflux disease without her- Some complications may be related to local fibrosis (dys- nia. Mesh placement was followed by reductions in the in- phagia) or to the erosion of the digestive lumen. Others may cidence of recurrences, without specific morbidity. be induced by the device applied to fix the mesh, especially Frantzides et al65 showed the results of a prospective when staples or tackers are used, and injury to the vital struc- randomized trial comparing simple closure with polytef tures surrounding the hiatus may occur. Teflon pledgets onlay reinforcement for PEH hernia repair, in cases with may also erode the fundus or induce fibrous retraction and hiatus wider than 8 cm. Recurrences were significantly re- dysphagia. Table 6 shows the incidence of complications duced after mesh placement (20% vs 0%; PϽ.001), with- of this type in reports published to date.105-108 Mesh has also out long-term sequel, after a 40-month follow-up period. beenusedinpediatriccases,withoutlong-termproblems.52,109 The main drawback with the use of mesh in the hiatus is the risk of local complications (fibrosis and adhesions, erosion, or perforation). Nonetheless, the inci- COMMENT dence of mesh-related complications in the hiatus is currently less than 2%, although no reports on long- Surgical treatment of PEH and type III mixed hernias has term outcome (Ͼ10 years) are available. been a challenging chapter in digestive surgery for the past

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©2004 American Medical Association. All rights reserved. Downloaded From: https://jamanetwork.com/ on 09/28/2021 30 years (Table 4). The treatment used to be offered to a subset of elderly patients, some of them particularly frail and, in some cases, associated with urgent situations such as gastric volvulus or gastric incarceration. However, the results from centers with wide experience showed low morbidity and good long-term outcome after standard open tran- sthoracic or transabdominal approaches, although in most series the results were merely assessed on the basis of the presence or absence of symptoms without any anatomic (radiologic) evaluation.110 The experience available shows the efficacy of the laparoscopic approach for treatment of PEH.111,112 Despite the increased intraoperative technical difficulty, and although there are no comparative randomized trials with the open approach to conclusively deter- mine their relative merits, the immediate outcome clearly endorses this minimally invasive approach in a popula- tion that is typically at higher risk than conventional patients with GERD or small type I hiatal hernia. The large number of series published in recent years (20 series related to the open approach in 33 years, compared with 46 Figure 12. Non–tension-free repair with reinforcement of the crural closure series in 12 years for the laparoscopic approach) bears wit- using buttress mesh. A long strip of mesh is placed below the esophagus, 61 ness to the success of, and the interest in, the application covering the pillar closure. of laparoscopic techniques in PEH repair. Most accepted technical rules for the surgical treatment of PEH include stomach reduction, sac excision, and clo- sureofthehiataldefect—onoccasionmorethan8cmwide— with or without the addition of some type of fixation. The controversy arises after the definitive observation of a variable recurrence rate (up to 42%) when a routine radiologic follow-up is done. Some authors have suggested that alternative approaches (open or thoracic) may be better for this disease. Arguments put forward to account for this unac- ceptably high recurrence rate include the learning curve due to the technical difficulty of the procedure, poor technical crural closure, or a short esophagus. The learning curve for a difficult laparoscopic procedure undoubtedly plays a role, and it has been observed in several large series that the recurrence rate falls as surgeons gain experience. The signifi- cance of a short esophagus continues to be a controversial issue. It has been considered as a potential cause of failure, but most patients with PEH do not have advanced gastroesophageal reflux disease with esophageal scarring. The need to perform a Collis gastroplasty to lengthen the esophagus Figure 13. Non–tension-free repair with reinforcement of the crural closure. Onlay mesh is placed around the esophagus once the defect has been varied from 0% to 70% in the series analyzed, and as yet there closed.31,62 isnoclearagreementonwhetherthistechnicalstepisneeded during PEH repair. Clearly, as with other abdominal wall defects, the aim the defect, because of either the size of the defect or the is to achieve adequate closure. In contrast to the ac- technical impossibility of proceeding otherwise. cepted standard concept for inguinal or ventral hernia, There are no clear reasons for the differences in out- which is tension free, the most widely supported ap- come after open or laparoscopic approach to PEH. Possi- proach is to close the hiatus under tension, with the ob- bly the final results of laparoscopic repair are not as good vious risk of disruption. The rationale for this judgment because the laparoscopic approach is more technically de- is that, unlike the abdomen or groin, in which the aim manding. However, systematic evaluation with radio- of repair is to achieve passive containment, the cardial logic esophagogram, including asymptomatic patients, has region including the hiatus and the gastroesophageal junc- shown a higher number of recurrences. Haas et al75 found tion is a highly dynamic anatomic area and so anatomic an anatomic recurrence rate of 42% after systematic ra- repair is justified. However, since PEH repair causes wide- diologic evaluation. This suggests that the problem may ranging anatomic distortion and the risk of disruption also have been evident in the open-procedure era, but has is high, reinforcement with mesh is a logical forward step. only become relevant today since the increase in laparo- Hiatal closure is occasionally difficult. Surgeons who are scopic procedures and the possibility of more detailed study. in general against the placement of mesh in the hiatus One of the main arguments against mesh placement has are sometimes obliged to use the procedure to correct been the emergence of complications due mainly to vis-

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©2004 American Medical Association. All rights reserved. Downloaded From: https://jamanetwork.com/ on 09/28/2021 Table 6. Complications in Relation to Prosthesis Placement for Surgical Repair of Hiatal Hernia

Source No. With Complication/Total No. (%) Complication Open Surgery Carlson et al,45 1998 1/44 (2.3) Esophageal erosion 29 mo after mesh placement Laparoscopy Edelman,47 1995 1/5 (20.0) Dysphagia and fibrosis after tension-free repair with mesh + FP + gastrostomy; reoperation for esophageal stenosis Trus et al,105 1997 1/76 (1.3) Dysphagia, mesh extraction Schauer et al,66 1998 1/70 (1.4) Late esophageal perforation (ischemia), mesh (PTFE) extraction Kemppainen and Kiviluoto,106 2000 NA Cardiac tamponade secondary to mesh fixation with “tacker” Peet et al,18 2000 1/22 (4.5) Dysphagia and adherences secondary to crural closure, reinforcement with Dacron strips Baladas et al,107 2000 1/734 (0.1) Gastroesophageal fistula secondary to FP reinforced by Teflon pledgets Arendt et al,108 2000 NA Dysphagia; transmural migration of Teflon pledgets into esophagus 9 y after FP

Abbreviations: FP, fundoplication; NA, data not available; PTFE, polytef.

ceral erosion, a risk that is intrinsically related to the ex- garding the controversial technical aspects (type of mesh, istence of a foreign body. On the basis of this rationale, location, selective vs routine, additional maneuvers [fixa- many surgeons consider routine placement contraindi- tion], Collis esophageal lengthening, etc). cated. However, there are clear differences between the At present, the information available shows that the use placement of mesh and insertion of an Angelchik device of a mesh for hiatal repair after laparoscopic repair of PEH or bands used for gastric banding in obese patients. The is safe and prevents hernia recurrence. However, infor- latter devices are placed directly over the cardia, main- mation on the long-term results is lacking; severe com- taining a sustained and continued tension and favoring po- plications may arise, albeit infrequently. A selective use tential erosion; in contrast, mesh in the hiatus for rein- based on clinical experience is recommended, as the tech- forcement of the diaphragmatic closure is placed outside nique appears to be safe, and the fears expressed at earlier the esophagus and direct contact is avoided. Although sev- stages of its development have not been confirmed. eral serious complications have been reported, the morbidity rate associated with mesh placement is low (Table 6). Accepted for Publication: January 19, 2004. No objective information is available to guide the Correspondence: Eduardo M. Targarona, MD, PhD, Ser- choice of material. Most authors prefer soft materials with vice of Surgery, Hospital de Sant Pau, Padre Claret 167, less intense fibrotic response such as polytef rather than 08025 Barcelona, Spain ([email protected]). polypropylene, but no comparative trials of the materi- Acknowledgment: Isabel Salgado drew the illustrations als have been performed. 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Invited Critique

his review article by Targarona et al is a meta-analysis of reports using mesh in complex paraesophageal and mixed T hiatal hernias, with recurrence being the end point. Therein lies my first concern with this article. This complex dis- order is more than recurrences and mesh erosion. A review article should cover all important parameters, which, in this case, include postoperative dysphagia (10%), gas bloating (8%), patient satisfaction, nausea, early satiety, and the recurrence of symptoms absent recurrent hernia, since half of these patients have resumed taking antireflux medications within 3 to 5 years after surgery. I am also troubled by 2 other observations: first, the authors do not present any data from their own experience, and second, none of the 4 coauthors is credited with a single publication in the 112 citations in the bibli- ography. I personally feel that credibility is an issue with review articles, because the reader infers some measure of expertise by the authors. The authors list 13 variations using mesh, which confirms the complexity of this anatomy and the need for creativity among even the most experienced laparoscopic surgeons. One should be wary of dogma in this setting. Their argument against using mesh is scientifically unfounded and, short of using autologous tissues, closure in many of these patients is impossible otherwise. They are correct in their observation that there are too few studies extending over a long enough period to make definitive statements about recurrence rates, which may lead to the real “take-home” message from this article: surgeons need to include all of the variables listed above in their follow-up to make the data meaningful for patients, clinicians, and health care planners, who may ultimately rule on reimbursement for this diagnosis because of the large number of patients affected.

Eddie L. Hoover, MD

Correspondence: Dr Hoover, Department of Surgery, Buffalo VA Medical Center, 3495 Bailey Ave, Buffalo, NY 14215 ([email protected]).

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