SUCCESS IN THE DEVELOPMENT

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1 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 on the use of prosthetic mesh to prevent recurrence after laparoscopic repair of paraesophageal hernia. Data Sources: Current English-language literature review. Study Selection: Case reports, series, and opinion articles on the use of mesh for paraesophageal hernia repair. Data Extraction and Synthesis: Study type and results were analyzed. Most articles were short case series. Few comparative or randomized trials assessing the procedure have been published to date. The information available showed that the use of a mesh for hiatal repair was safe and prevented recurrence. However, data on the longterm results were lacking, and infrequent but severe complications may arise. Conclusions: The mesh should be used selectively, and the decision to proceed should be based on clinical experience. In light of the evidence available, however, it appears to be safe, and the fears expressed in the past have not been confirmed. Arch Surg. 2004;139: Author Affiliations: Service of Surgery, Hospital de Sant Pau, Autonomous University of Barcelona, Barcelona, Spain. SUCCESS IN THE DEVELOPMENT of laparoscopic fundoplication has made this procedure a valid alternative to medical therapy for the treatment of gastroesophageal reflux. Thanks to the experience acquired, the laparoscopic approach is now used to treat more complex situations, such as paraesophageal hernia (PEH) or type III (mixed) hiatal hernia. 1-8 The results of several series have shown that laparoscopic repair is also feasible and safe, despite the increased technical difficulty, and its immediate and short-term results are excellent 9-43 (Table 1). However, the incidence of recurrences may be high: as much as 42% in one series (Table 2). See Invited Critique on page 1296 One of the most demanding laparoscopic technical steps is crural closure, especially when the gap is wide and the closure inevitably entails a tension repair. Some authors recommend the use of prosthetic mesh to reinforce the hiatal closure (Table 3 and Table 4), but others argue against it. This review analyzes the experience accumulated so far on the use of mesh to reinforce the hiatus to prevent recurrence after laparoscopic repair of PEH. THE PROBLEM Laparoscopic repair of PEH and mixed hiatal hernias is a feasible, safe, but complex procedure. The experience during the past 15 years suggests that viscera reduction, sac excision, retrogastric crural closure, and fundoplication are the key technical factors. 1-8 Fixation of the gastric plicature, abdominal wall gastropexy, and gastrostomy are more controversial technical steps for maintaining the stomach in place in the abdomen. Although controlled comparative trials with the open approach are lacking (Table 4), the immediate clinical outcome of laparoscopic PEH repair is highly satisfactory. However, the recurrence rate is higher than expected after midterm follow-up as high as 42% when compared with the open approach (Table 5) and some authors have suggested that the laparoscopic approach is unsuitable. 17 The main reason for the failure of the hiatal repair is tension. Recurrence has been related to the mean diameter of the hiatus ( 10 cm in some cases). Another factor is the anatomy of the pillars. The hiatal crus is a fleshy structure without tendinous reinforcement. Standard sutures may cut the muscle, and when the hiatus is particularly wide and the pillars are approached, the lateral 1286

2 Table 1. Results of Laparoscopic Repair of PEH (Series With More Than 20 Cases) Source N Conversion Morbidity Mortality Mean Stay, d Mean Follow-up, mo Recurrence Good or Fair Outcome Comment Huntington, (2) 4 (7) NA Occ SE + ACR + FP Perdikis et al, (3) 9 (14) (13) 60 (92) 0 PCR + FP Edye et al, (5) 10 (17) 1 (2) NA 38 8 (14) NA 1 (2) SE + PCR + FP Gantert et al, (9) 5 (9) 1 (2) 3 11 NA 50 (91) 0 SE + PCR + FP Watson et al, (23) 11 (13) NA (1) 80 (93) 0 SE + PCR + FP Wu et al, (3) 6 (16) 2 (5) (24) 30 (79) 5 (13) Several repairs Horgan et al, (5) 1 (2) 1 (2) (12) NA Occ SE + PCR + FP Swanstrom et al, (12) (8) NA NA SE + PCR + FP Hashemi et al, (8) 3 (12) NA 20 (77) 0 SE + PCR + FP Peet et al, (14) 1 (5) 0 NA 24 5 (22) NA 3 (14) SE + PCR + FP + fixation Dahlberg et al, (5) 5 (14) 2 (5) (14) 32 (87) Occ SE + PCR + FP Wiechmann et al, (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, Khaitan et al, (19) 6 (19) (40) NA NA SE + PCR + FP Pierre et al, (1.5) 57 (28.1) 1 (0.5) (2.0) 170 (83.7) 22 (10.8) SE + PCR + collis Mattar et al, (2.2) 14 (10.3) 3 (2.2) (30.1) NA 0 Several repairs Diaz et al, (2.6) 20 (17.2) 2 (1.7) (31.9) 9 (7.8) Occ SE + PCR + FP + fixation Targarona et al, NA 4 30 NA NA NA None Leeder et al, (8) 7 (13) 1 (2) (9) 41 (77) 14 (26) Several repairs Ponsky et al, (11) (4) NA PCR + Toupet + fixation Jobe et al, (7) 11 (20) (32) 45 (80) 6 (11) Hill repair Keidar and Szold, (3) 5 (15) 1 (3) (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. Mesh Used Table 2. Recurrence After Surgical Treatment of PEH in Series With Systematic Radiologic Control Source of Patients With Esophagogram Recurrence, PEH Recurrence, No. Sliding, No. Symptoms, Mesh Type Open Surgery Luostarinen et al, /22 (86) 8 (42) (37) ±Pledget Laparoscopy Wu et al, /38 (92) 8 (23) (34) NA Hashemi et al, /27 (78) 9 (43) NA NA 8 (38) Pledget Wiechmann et al, /60 (73) 3 (7) (100) NA Khaitan et al, /25 (60) 6 (40) (50) Pledget Jobe et al, /52 (65) 11 (32) (65) Pledget 4cm Mattar et al, /125 (26) 11 (34) NA NA 14 (44) Pledget Keidar and Szold, NA 21 (15) (40) NA Diaz et al, /96 (69) 21 (32) (62) NA Tagarona et al, /37 (81) 6 (20) (50) NA Abbreviations: NA, not available; PEH, paraesophageal hernia. portions of the diaphragm near the crura become tense, with a potential risk of disruption. Currently, all hernia repairs are tension free (for example, the Lichtenstein repair or ventral hernia repair). However, performing a tension-free repair in the hiatus is technically very demanding, because of the oblique situation of the pillars and the difficulty of fixing the mesh. Furthermore, the hiatus is a complex anatomic structure in which the esophagus moves during respiratory excursion of the diaphragm, 96 whereas in inguinal or ventral hernia repair the mesh passively supports the intra-abdominal viscera. This means that any prosthetic mesh will be in contact with the esophagus, and so there is a theoretical risk of esophageal erosion and complication. This fact along with evidence of mechanical complications after placement of mesh for repair of abdominal wall defects and complications with mechanical devices located in the cardia (such as the Angelchik device and with the bands used in treatment of morbid obesity 100 ) seems to argue against the placement of foreign bodies in the hiatus. However, some surgeons report that the use of mesh in the hiatus is safe and the outcome acceptable (Tables 3 and 4). 1287

3 Table 3. Results of the Use of Mesh for PEH Repair Source N Morbidity Mortality Mean Stay, d Mean Follow-up, mo GI Tract Symptoms Recurrence Comment Open Surgery Carlson et al, (45) 1 (2) (10) 0 Onlay (polypropylene) Laparoscopy Kuster and Gilroy, (17) (17) Reduction + mesh + fixation (no sac excision) Edelman, (40) 1 (20) 4 NA NA 0 Mesh tension-free + FP + gastrostomy Pitcher et al, NA 0 ACR, FP, PTFE Oddsdottir et al, (20) 0 NA 9 1 (10) 0 Pledget, SE + PCR + FP Behrns and Schlinkert, NA 6 NA 0 Replacement mesh Huntington, (12) 0 NA Right crus patch (polypropylene) Paul et al, Anterior, tension-free, PTFE Frantzides and Carlson, Onlay PTFE Willekes et al, (27) 0 3 NA NA 0 Onlay PTFE, no CR ± FP Wu et al, (16) 2 (5) (5) 9 (24) Several repairs ± mesh Hawasli and Zonca, (4) (30) 0 SE + free tension onlay mesh + fixation (polypropylene) Basso et al, (4) (9) 0 Tension-free (polypropylene) Lambert and Huddart, (14) 0 0 NA 1 (14) 0 Onlay (polypropylene) Meyer et al, (10) SE + CR + FP + mesh (polypropylene 50%, PTFE 50%) Casaccia et al, (12) SE + tension-free + FP (composite A-shaped mesh) Kamolz et al, NA NA 0 None Ponsky et al, NA Tension-free + gastropexy Champion and Rock, (40) 1 (2) SE + CR + FP + buttress mesh Oelschlager et al, (11) NA 8 NA 1 (11) SE + PCR + FP (biomaterial mesh) Leeder et al, NA NA (14) 2 (14) Several techniques (U-shaped mesh) Keidar and Szold, NA NA 1 (10) SE + PCR + FP (PTFE + polypropylene) Granderath et al, (4) 0 NA 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 Analysis of recurrences shows different patterns for time of presentation and shape (Table 2). Immediate recurrent hernias are usually secondary to total disruption of the hiatal closure with a relapsing PEH. Long-term recurrences may adopt several patterns: complete recurrent PEH, fundoplication migration, or a small sliding hernia, without a clear recurrence of the paraesophageal sac. In the latter subgroup, the incidence of symptoms is variable, and most are identified only by esophagogram. Recurrences of symptoms are treated surgically. However, there is tacit agreement that nonsymptomatic recurrences, especially in cases of small sliding hernias, do not require repair. Recurrent hernias of any type should be considered as technical failures, although the longterm outcome of asymptomatic recurrent hernias is unknown. METHODS A systematic PubMed search looking for all of the studies published in English in relation to treatment of paraesophageal and mixed hiatal hernias was performed. Particular attention was paid to the use of meshes for reinforcement of the hiatal repair. SURGICAL TECHNIQUE The most controversial issue in the use of prostheses in the hiatus is the surgical technique. Several models have been proposed. Tension-Free Techniques One tension-free technique is anterior placement of a triangular piece of mesh, proposed by Paul et al 52 (Figure 1). A triangular or semilunar polytef patch is placed to occlude the anterior segment of the hiatus and fixed with staples or stitches. The stomach is fixed to the abdomen and a fundoplication is added. For posterior placement of a triangular piece of mesh (Figure 2), the aim is the same as in the technique for anterior placement. Kuster and Gilroy 46 proposed a posterior segmental occlusion, occluding the base of the pillar overture, and placing the esophagus anteriorly, fixing the mesh with staples or stitches. Fixation to the abdominal wall or a gastrostomy is also performed. A third technique involves onlay of a piece of mesh, with a hole facilitating the passage of the esophagus. The mesh covers the whole of the hiatal defect, and no attempt is made to close the hiatus (Figure 3). There are several shapes of mesh designed to allow the passage of the esophagus and to facilitate fixation (eg, U shape, 22,53 A shape 59 )(Figure 4). Basso et al 101 also proposed covering the mesh with autologous flaps of peritoneal tissue obtained from the hernia sac. Casaccia et al

4 Table 4. Results of Comparative Studies of PEH Repair Source and Type Operative Mean Mean Good or of Repair N Time, min Conversion Morbidity Mortality Stay, d Follow-up, mo Recurrence Fair Outcome Reoperation Comment Laparoscopy vs Laparoscopy + Mesh Basso et al, * Laparoscopy (1) 5 (8) NA (14) NA 6 (9) None Laparoscopy + mesh (4) NA 0 Tension-free (polypropylene) Hui et al, * Laparoscopy (8) 3 (25) NA (100) NA SE + PCR + FP (PTFE + polypropylene) Laparoscopy + mesh NA 2 (17) NA (100) NA SE + PCR + FP Kamolz et al, * Laparoscopy (9) 95 (95) 6 (6) PCR + FP Laparoscopy + mesh NA 95 (95) 1 (1) PCR + FP + mesh polypropylene Frantzides et al, 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, Open NA NA NA NA 2 (7) ACR 16, PCR 11, FP 7 Laparoscopic (17) 1 (17) (17) NA 0 Reduction + mesh + fixation Schauer et al, Open NA 15 (60) NA NA 21 (84) NA None Laparoscopic (4) 20 (29) NA 5 13 NA 66 (94) NA PCR + FP ± mesh Hashemi et al, Open NA NA 1 (4) (16) 22 (88) NA SE + PCR + FP Laparoscopic (8) 3 (12) (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 al 56 (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 Figure 1. Tension-free repair: anterior placement of a triangular piece of mesh. 39 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 al 102 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 stitches with Teflon or Dacron pledgets 18,29 (Figure 9); a polypropylene strip along the crura to hold the stitches (Figure 10); and a piece of polypropylene mesh covering both edges of the pillars. The stitches close the hiatus including the mesh and tissue, as proposed by Kamolz et al 60 (Figure 11). A buttress mesh technique has also been described. A long strip of mesh is placed below the esophagus, covering the pillar closure (Figure 12). The advantage is that it avoids the encircling of the esophagus, reducing the risk of dysphagia or erosion. Champion and Rock 61 reported good results in a series of 52 cases, with a recurrence rate of 2%, although esophagography was performed in only 52% of cases. Placement of onlay mesh around the esophagus with a hole in the middle, once the defect has been closed, has been used (Figure 13). There are also preshaped meshes designed to adapt anatomically to the characteristics of the anatomic area 31,62 (Figure 4). 1289

5 Table 5. Results of the Open Approach for PEH Repair Source N Mean Mean Morbidity Mortality Stay, d Follow-up, mo Recurrence Good or Fair Outcome Collis Reoperation Comment Skinner and Belsey, (8-13)* 1 (1.2) NA 60 2 (7-21)* 7 (88) (Mark IV) NA NA Thor, Mark IV (60%) Hill and Tobias, NA NA NA NA NA NA Lap, SE + ACR Wichterman et al, (17) 1 (4) NA 62 0 NA NA 2 (7) Lap, SE + CR + FP + fixation Pearson et al, (11) 1 (2) NA 72 2 (4) 36 (68) (70) 2 (4) Thor, gastroplasty + Belsey Ellis et al, (24) 1 (2) (10) (88) NA 4 (8) Lap, ACR + fixation Treacy and Jamieson, NA 1 (2) NA NA 8 (81) 6 (45) NA 0 Lap, SE + PCR + FP Menguy, NA NA NA NA NA NA Lap, SE + ACR + fixation Ackermann et al, NA 1 (2) NA (50) 34 (85) NA NA Lap, CR + fixation ± FP Haas et al, (17) 5 (17) 11 9 NA 24 (83) 0 0 SE + PCR + FP Harriss et al, (12) 2 (8) NA 48 NA 22 (88) 0 0 Thor, ES + CP + FP Allen et al, (27) 0 11 (9) 42 NA 111 (93) 78 (66) 1 (1) Thor, Collis-Nissen Williamson et al, NA NA NA (10) 99 (83) NA NA Lap, fixation ± Nissen Myers et al, (38) NA NA 67 1 (3) 31 (84) NA NA SE + ACR + fixation ± FP Altorki et al, NA 1 (2) NA 45 4 (9) 42 (89) NA 0 Thor, Belsey Mark IV, Nissen Luostarinen et al, (23) 0 NA 37 9 (41) 21 (95) NA NA Lap, PCR ± FP (some pledget) Carlson et al, (45) 1 (2) NA NA NA Lap, PCR + mesh + gastrostomy Maziak et al, (19) 2 (2) NA 93 2 (2) 75 (80) 70 (74) 5 (5) Thor + Belsey Mark IV Geha et al, (6) 2 (2) NA NA 0 96 (96) NA NA 80% Abd, reduction + fixation Rogers et al, (8) (2) 51 (85) NA NA Thor, CP ± FP Low and Simchuk, (16) 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 mesh. 46 Other Maneuvers Additional maneuvers for fixing the stomach in the abdominal cavity include a range of techniques, such as fixation of the fundoplication to the diaphragm, fixation of the gastric body to the Figure 3. Tension-free repair: onlay piece of mesh, with a hole facilitating the passage of the esophagus. abdominal wall, and gastrostomy. 103,104 Fundoplication itself may have some fixation effect. Some authors have proposed that the Toupet technique may avoid recurrence because the posterior placement of the fundus covers the crural closure and fixes it to 1290

6 Figure 4. Shapes of mesh designed to allow passage of the esophagus and to facilitate fixation (U shape, 22,53 A shape 59 ). 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 (polyglycolic acid) loses its mechanical properties as it is resorbed. Nonresorbable material may be made of polypropylene, polytef, or composite (polytef plus polypropylene; C. R. Bard, Inc, Murray Hill, NJ). Recently, a nonresorbable material of biological origin has been used (Surgisis; Cook Biotech Incorporated, West Lafayette, Ind). 62 The crucial aspect of the material used to reinforce the hiatus is stiffness. The advantages of polytef are its softness and its lower capacity to induce adhesions. The different surfaces prevent tight adhesions to the visceral face of the mesh, and the texture of the free margin in near contact with the esophagus is potentially less dangerous. However, the handling and sewing of the mesh may be more difficult than when polypropylene is used. The main drawback of polypropylene is the stiffness of the margins and the possibility that the esophagus will be eroded. Experience with mixed mesh or with material of biological origin is scarce. RESULTS Most of the clinical results of the use of mesh in the hiatus come from short series of patients, although the midterm Figure 7. Non tension-free repair: simple crural closure with simple stitches. follow-up is often adequate (up to 5 years). No long-term experience (up to 10 years) is available. Mesh has been used mostly in adults, although there is some experience in the pediatric setting as well. Overall results are plotted in Table 2; tolerance is good and the recurrence rate and morbidity are both low. Three comparative studies have been published (Table 3), but only 1 was a prospective randomized trial. In addition, 2 of the comparative trials included patients with all types of hiatal hernias, and only 1 focused on PEH hernia repair. Basso et al 56 compared simple and tensionfree closures using an onlay piece of polypropylene, dividing their personal series chronologically into 2 parts. Kamolz et al 60 compared simple closure with a reinforcement procedure that put the stitches over a piece of polypropylene covering the hiatal closure. Neither study was randomized; they were merely comparisons of initial experiences withoutmeshwithmorerecentexperienceswithmesh. They 1291

7 Figure 8. Non tension-free repair: simple crural closure with continuous suture. 102 Figure 10. Non tension-free repair with reinforcement of the crural closure, using a polypropylene strip along the crura to hold the stitches. Figure 9. Non tension-free repair with reinforcement of the crural closure to avoid the cutting effect of the stitches, using simple stitches with Teflon or Dacron pledgets. 18,29 also counted hiatal repair of all types, including type I hernias or pure gastroesophageal reflux disease without hernia. Mesh placement was followed by reductions in the incidence of recurrences, without specific morbidity. Frantzides et al 65 showed the results of a prospective randomized trial comparing simple closure with polytef onlay reinforcement for PEH hernia repair, in cases with hiatus wider than 8 cm. Recurrences were significantly reduced after mesh placement (20% vs 0%; P.001), without long-term sequel, after a 40-month follow-up period. 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 incidence of mesh-related complications in the hiatus is currently less than 2%, although no reports on longterm outcome ( 10 years) are available. Figure 11. Non tension-free repair with reinforcement of the crural closure, using a polypropylene piece of mesh covering both edges of the pillars. 60 Mesh placed in the hiatus may induce complications because of the type of mesh or the device used for fixation. Some complications may be related to local fibrosis (dysphagia) or to the erosion of the digestive lumen. Others may be induced by the device applied to fix the mesh, especially whenstaplesortackersareused,andinjurytothevitalstructures surrounding the hiatus may occur. Teflon pledgets may also erode the fundus or induce fibrous retraction and dysphagia. Table 6 shows the incidence of complications of this type in reports published to date Mesh has also beenusedinpediatriccases,withoutlong-termproblems. 52,109 COMMENT Surgical treatment of PEH and type III mixed hernias has been a challenging chapter in digestive surgery for the past 1292

8 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 transthoracic 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 determine their relative merits, the immediate outcome clearly endorses this minimally invasive approach in a population 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 series in 12 years for the laparoscopic approach) bears witness to the success of, and the interest in, the application of laparoscopic techniques in PEH repair. Most accepted technical rules for the surgical treatment of PEH include stomach reduction, sac excision, and closureofthehiataldefect 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 unacceptably 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 significance 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 variedfrom0%to70%intheseriesanalyzed,andasyetthere isnoclearagreementonwhetherthistechnicalstepisneeded during PEH repair. Clearly, as with other abdominal wall defects, the aim is to achieve adequate closure. In contrast to the accepted standard concept for inguinal or ventral hernia, which is tension free, the most widely supported approach is to close the hiatus under tension, with the obvious risk of disruption. The rationale for this judgment is that, unlike the abdomen or groin, in which the aim of repair is to achieve passive containment, the cardial region including the hiatus and the gastroesophageal junction is a highly dynamic anatomic area and so anatomic repair is justified. However, since PEH repair causes wideranging anatomic distortion and the risk of disruption is high, reinforcement with mesh is a logical forward step. Hiatal closure is occasionally difficult. Surgeons who are in general against the placement of mesh in the hiatus are sometimes obliged to use the procedure to correct Figure 12. Non tension-free repair with reinforcement of the crural closure using buttress mesh. A long strip of mesh is placed below the esophagus, covering the pillar closure. 61 Figure 13. Non tension-free repair with reinforcement of the crural closure. Onlay mesh is placed around the esophagus once the defect has been closed. 31,62 the defect, because of either the size of the defect or the technical impossibility of proceeding otherwise. There are no clear reasons for the differences in outcome after open or laparoscopic approach to PEH. Possibly the final results of laparoscopic repair are not as good because the laparoscopic approach is more technically demanding. However, systematic evaluation with radiologic esophagogram, including asymptomatic patients, has shown a higher number of recurrences. Haas et al 75 found an anatomic recurrence rate of 42% after systematic radiologic evaluation. This suggests that the problem may also have been evident in the open-procedure era, but has only become relevant today since the increase in laparoscopic procedures and the possibility of more detailed study. One of the main arguments against mesh placement has been the emergence of complications due mainly to vis- 1293

9 Table 6. Complications in Relation to Prosthesis Placement for Surgical Repair of Hiatal Hernia Source No. With Complication/Total Complication Open Surgery Carlson et al, /44 (2.3) Esophageal erosion 29 mo after mesh placement Laparoscopy Edelman, /5 (20.0) Dysphagia and fibrosis after tension-free repair with mesh + FP + gastrostomy; reoperation for esophageal stenosis Trus et al, /76 (1.3) Dysphagia, mesh extraction Schauer et al, /70 (1.4) Late esophageal perforation (ischemia), mesh (PTFE) extraction Kemppainen and Kiviluoto, NA Cardiac tamponade secondary to mesh fixation with tacker Peet et al, /22 (4.5) Dysphagia and adherences secondary to crural closure, reinforcement with Dacron strips Baladas et al, /734 (0.1) Gastroesophageal fistula secondary to FP reinforced by Teflon pledgets Arendt et al, 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 existence of a foreign body. On the basis of this rationale, many surgeons consider routine placement contraindicated. However, there are clear differences between the placement of mesh and insertion of an Angelchik device or bands used for gastric banding in obese patients. The latter devices are placed directly over the cardia, maintaining a sustained and continued tension and favoring potential erosion; in contrast, mesh in the hiatus for reinforcement of the diaphragmatic closure is placed outside the esophagus and direct contact is avoided. Although several serious complications have been reported, the morbidity rate associated with mesh placement is low (Table 6). No objective information is available to guide the choice of material. Most authors prefer soft materials with less intense fibrotic response such as polytef rather than polypropylene, but no comparative trials of the materials have been performed. Complications have been reported with the use of both types of mesh. No long-term follow-up data on this issue are available; experience with other types of material such as combined mesh types or biomaterials is limited, and the follow-up periods are short. Another controversial point is whether the use of mesh for hiatal repair in PEH should be routine or selective. The local conditions of the hiatus after sac excision may cause differences in the results, and sometimes, although the hernia sac is large, the pillars are of good quality and can be approached without difficulty. There are no studies investigating predictive factors for recurrence after laparoscopic repair of PEH, which may involve the anatomic features of the hiatus (such as the size of the gap, tension, or diaphragmatic weakness), the type of repair (single stitches, pledget, etc), additional fixation maneuvers (Toupet, fixation, gastrostomy, etc), and patient characteristics (heavy work, constipation, chronic cough, etc). Some authors recommend a tailored approach, placing a mesh in cases at major risk of recurrence, and its use seems more advisable in the case of reoperations. However, the decision clearly depends on the experience of the surgeon. The final answers to our questions should come from analysis of the long-term follow-up over 5 years of series of patients in whom mesh has been placed, and randomized trials of suitable design to provide answers regarding the controversial technical aspects (type of mesh, location, selective vs routine, additional maneuvers [fixation], Collis esophageal lengthening, etc). At present, the information available shows that the use of a mesh for hiatal repair after laparoscopic repair of PEH is safe and prevents hernia recurrence. However, information on the long-term results is lacking; severe complications may arise, albeit infrequently. A selective use based on clinical experience is recommended, as the technique appears to be safe, and the fears expressed at earlier stages of its development have not been confirmed. Accepted for Publication: January 19, Correspondence: Eduardo M. Targarona, MD, PhD, Service of Surgery, Hospital de Sant Pau, Padre Claret 167, Barcelona, Spain (etargarona@hsp.santpau.es). Acknowledgment: Isabel Salgado drew the illustrations for the figures in this article. REFERENCES 1. Cuesta MA, Peet DL, Klinkerberg-Knol EC. Laparoscopic treatment of large hiatal hernias. Semin Laparosc Surg. 1999;6: Floch N. Paraesophageal hernias: current concepts. J Clin Gastroenterol. 1999; 29: Hashemi M, Sillin LF, Peters JH. Current concepts in the management of paraesophageal hiatal hernia. J Clin Gastroenterol. 1999;29: Buenaventura PO, Schauer PR, Keena RJ, Luketich JD. Laparoscopic repair of giant paraesophageal hernia. Semin Thorac Cardiovasc Surg. 2000;12: Freeman ME, Hinder RA. 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11 tures of type III (mixed) paraesophageal hernias. Am J Gastroenterol. 1996; 91: Ellis FH. Controversies regarding the management of hiatus hernia. Am J Surg. 1980;139: Boerema I. Hiatus hernia: repair by right-sided, subhepatic, anterior gastropexy. Surgery. 1969;65: Carter R, Brewer LD, Hinshaw A. Acute gastric volvulus. Am J Surg. 1980;140: Hallissey MT, Ratliff DA, Temple JG. Paraoesophageal hiatus hernia: surgery for all ages. Ann R Coll Surg Engl. 1992;74: Hill LD. Incarcerated paraesophageal hernia: a surgical emergency. Am J Surg. 1973;126: Teague WJ, Ackroyd R, Watson DI, Devitt PG. Changing patterns in the management of gastric volvulus over 14 years. Br J Surg. 2000;87: Stylopoulos N, Gazelle GS, Rattner DW. Paraesophageal hernias: operation or observation? Ann Surg. 2002;236: Pros I, Targarona EM, Angás J, et al. Tratamiento quirúrgico del vólvulo gástrico. Cir Esp. 1992;51: Caskey CI, Zerhouni EA, Fishman EK, Rahmouni AD. Aging of the diaphragm: a CT study. 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Gastrointest Endosc. 2000;51: Simpson B, Ricketts RR, Parker PM. Prosthetic patch stabilization of crural repair in antireflux surgery in children. Am Surg. 1998;64: Ludemann R, Watson DI, Jamieson GG. Influence of follow-up methodology and completeness on apparent clinical outcome of funduplication. Am J Surg. 2003;186: Terry M, Smith CD, Branum GD, Galloway K, Waring JP, Hunter JG. Outcomes of laparoscopic fundoplication for gastroesophageal reflux disease and paraesophageal hernia. Surg Endosc. 2001;15: Trus TL, Laycock WS, Waring JP, Branum GD, Hunter JG. Improvement in quality of life measures after laparoscopic antireflux surgery. Ann Surg. 1999; 229: Invited Critique T his review article by Targarona et al is a meta-analysis of reports using mesh in complex paraesophageal and mixed hiatal hernias, with recurrence being the end point. Therein lies my first concern with this article. This complex disorder 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 bibliography. 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 (Eddie.Hoover@med.va.gov). 1296

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