Background: The breakdown of a hiatal hernia repair can lead to clinical failure. The use of prosthetic material at the esophageal hiatus to strengthen the crural repair is relatively new and questions remain. This report examines the safety and efficacy of a tension-free crural repair with mesh. Patients & Methods: Since 1993, 135 consecutive patients (19-86) [9 re-do] completed laparoscopic tension-free hiatal hernia repair prior to Nissen wrap. Esophageal hiatus was patched with a PTFE mesh (first 112 patients) or a PTFE/ePTFE composite (23 patients) secured across the defect with staples to each crura. 130 patients completed a phone questionnaire 2003(mean f/u 64 mos). Results: There have been no short-term nor long-term infections related to the PTFE mesh. Symptoms were resolved or improved and resolved with meds in 122/130 (94%). Early re-herniation occurred in one patient after vigorous exercise. Conclusions: Mesh repair/patch of the esophageal hiatus can be done without infection, with results similar to standard crural repair and consistent with surgical principles of non-tension.

Key Words: Hiatal Hernia, Fundoplication, Recurrences, Tension-free, Laparoscopic, ePTFE

Introduction

Over the last decade, laparoscopic anti- reflux surgery has emerged as a safe and effective treatment for gastro-esophageal reflux disease. However, early clinical success rates of 85 to 90% for laparoscopic fundoplication have been reported to diminish over time [1,2]. Recurrence rates after initial hiatal hernia repair range between 3 and 42% with aggregate average recurrent rates of 10-15%. With increasing numbers of operations, attention has been turned to surgical failures and underlying reason for failure [3,4,5,6] as well as efforts made to improve the initial outcome and durability [7,8].

Traditionally, a hiatal hernia repair requires a suture closure of the crural musculature to recreate the esophageal hiatus. [9,10] This hernia repair, along with esophageal mobilization and the wrap, helps to keep the distal esophagus within the abdomen. Subsequent breakdown of the crural repair with recurrent hiatal hernia is one of the more common causes of symptomatic failure after laparoscopic anti-reflux surgery. Breakdown of the diaphragmatic crural repair occurs in roughly 6-22% of patients and leads to intrathoracic wrap migration or paraesophageal herniation and contributes to the slipped Nissen (Table 1).

In an effort to prevent this recurrence, a number of centers have reported the use of prosthetic material to reinforce the crural closure [11,12]. A handful of others have described the use of prosthetic material to patch the hiatal hernia defect without crural closure [13](Table 2). However, there is limited follow-up and questions remain about the use of prosthetics at the esophageal hiatus.

This study reports on the short- and long- term safety as well as efficacy of a prosthetic tension free repair of the esophageal hiatus during laparoscopic fundoplication. A PTFE mesh (first 112 patients) or an ePTFE/PTFE composite patch (23 patients) was used to close the posterior esophageal defect without crural approximation. Patients were followed for up to 10 years.

Patients And Methods

Between November 1993 and December 2003, 135 consecutive patients underwent laparoscopic Nissen fundoplication with non-tension crural patch and a short-floppy gastric wrap. Patients were referred for persistent or recurrent reflux symptoms or complications despite adequate medical therapy. Patients ranged in age from 19 to 86. Twelve (9%) had pain from paraesophageal hernias,Type II. Nine patients were referred with re-herniation two to 26 years after initial anti-reflux surgery and “re-do” crural patch repair was done laparoscopically with PTFE mesh (7) or ePTFE/PTFE composite (2) and gastric re-wrap (5) or repositioning (4). At surgery, 34 patients (25%) had a large (> 8 cm) hiatal hernia defect, Type II and III. All patients were evaluated preoperatively by a combination of studies including upper GI series, endoscopy, 24 hour pH monitoring, and esophageal manometry.

Patients have been followed for a minimum of six months and up to 10 years. Mean follow-up is 64 months (median 62 months). Patients with any dysphagia after 6 weeks underwent barium swallow. All patients were seen 6-12 months post-op. Any patient with upper GI symptoms any time during follow-up had further x-ray study and upper GI series was performed on 60 patients one day to 6 years post-op(mean 26 months).

Phone Questionnaire

130 out of 135 patients were contacted by phone by one of the authors (PVG) during 2003/2004. Two were known to have expired (ages 66 and 79) and three could not be found (ages 27, 44 and 61). Patients were asked about “recurrent reflux or heartburn” or dysphagia, “ pain with eating” and specifically about “difficulty swallowing”, “food getting stuck” and “diarrhea”. Medication use and frequency was surveyed ie PPIs, H2 blockers and antacids. Patients were asked about subsequent Xrays, endoscopy or surgery and/or infections in abdomen or pelvis.

Technique

The surgical approach to hiatal hernia defect included reduction of the stomach, complete mobilization of the GE junction and distal esophagus along with excision of the hernia sac. Posterior hiatal hernia repair was performed without crural closure. The esophageal hiatus was patched with a PTFE mesh (Davol, Cranston RI) in the first 112 patients and with ePTFE/PTFE composite (CruraSoft; Davol) in the next 23 patients. The tension-free patch was secured across the defect with staples or sutures to each crura and sized with a 54 F bougie in the esophagus.

In the first group, an equilateral triangle was cut from a sheet of PTFE mesh so that each side measures 2 cm greater than the widest dimension of the esophageal hiatus measured in vivo. The more recent patients were patched with the precut, “V” shaped mesh (small: 7cm wide by 6cm tall, large: 11cm wide by 8cm tall) with the ePTFE surface facing viscera. With the esophagus and stomach held anteriorly, the mesh is stapled to the left crus first. The bougie is then placed under direct vision and the mesh is stapled to the right crus creating a snug sling under the esophagus with bougie in place. Staples are generously applied to both crus extending the mesh beyond the crus itself onto the diaphragm. This tension free hiatal hernia patch repair thereby held the subsequent wrap below the diaphragm. A single preop dose of cephalosporin was used in all patients.

Results

Safety: Short Term

All cases were completed laparoscopically. There were no deaths. No transfusions were required. The average length of stay was 2.4 days. Eleven patients had concomitant cholecystectomy. In the immediate post-op period, nine patients developed atelectasis and one each had pneumonia, IV site cellulitis and umbilical port site infection, gastrotomy(during re-do repair) and UTI. There were no intra-abdominal or mediastinal infections.

There was no tearing of crural tissues with mesh/patch placement. Stapling the mesh to the left and right crus took only 4-6 minutes including sizing with the bougie. Silk sutures were used to secure the patch in six patients. There were no complications related to prostheses placement.

Safety: Long Term

During the follow-up period, eleven patients have had subsequent abdominal surgery: Cholecystectomy(6), hysterectomy, appendectomy, sigmoid resection, small bowel resection and gastrotomy during re-application of the mesh. Eight patients had limited intra-abdominal infectious events: acute cholecystitis(2), diverticulitis(4), appendicicitis and necrotic bowel in hernia. Two had full-term vaginal deliveries. UGI endoscopy was performed on 43 patients and 26 had colonoscopy. Following 135 patients for a minimum of 6 months and 130 patients up to 10 years (mean 64 months), there were no prostheses-related infections in this series.

Upper GI xrays on 60 patients showed no mesh impingement on the esophagus or stomach. UGI endoscopy on 43 patients (53 procedures), mean 32 months post-op, finds no mesh erosion nor any evidence of protheses from within the esophagus or stomach.

Dysphagia requiring one post-op dilation occurred in 21/135 patients (15.5%) within the first year of surgery. Six of these patients had required pre-op dilation for symptoms of dysphagia. Only 2/130 patients had dysphagia after one year. One was a chronic stricture patient who had three pre-op dilations and four post-op dilations over six years. A “re-do” patient where crural breakdown was patched and wrap redone was dilated at 2 years for mild symptoms.

Efficacy

During the follow-up period, clinical resolution of reflux or hernia symptoms has been maintained in 112 of 130 patients (86%). Ten of 130 patients (8%) report improvement of symptoms and are asymptomatic on medication once per day. None of these patients had re-herniation on barium swallow. In eight patients (6%), some symptoms persist despite medication but all are improved from preop status. There was no re-herniation on barium swallow in 7/8 patients. Ten of these 18 patients still taking medications regularly were treating symptoms “different from heartburn”. Thirty-two patients report improvement in respiratory status. None of the “re-do” hernia repairs have recurred.

Crural repair breakdown and re-herniation did occur in one patient (0.8%). The patient felt a tearing sensation five days postop during exertion. Hernia symptoms developed eight weeks post-op (two weeks after reintroduction of solid food). Laparoscopic reoperation at five months found the mesh detached from the left crus. The mesh was solidly adherent to the right crus with tissue ingrowth. The Nissen wrap was still within the abdomen with adhesions to the mesh remnant. Paraesophageal herniation of the floppy greater curve caused his postprandial symptoms. Presumably, the mesh detached in the early post op period with extreme valsalva despite the tension- free repair.

One patient, asymptomatic for four years post-op, developed progression of Barrett’s esophagus to severe dysplasia and underwent esophagectomy thereby providing us with another hands-on look at the hiatal patch /repair, its relationship to the wrap and histology (Figure 1).

The PTFE mesh was intimately and firmly adherent to the crus. Tissue ingrowth, not the staples, provided the strength of the mesh attachment to the crus. The gastric wrap could be peeled off of the mesh. During the esophagectomy, the central mesh was excised but pieces were left on the crus rather than tear the tissues. Histology finds no erosion of the mesh into the stomach wall but rather a desmoplastic reaction with foreign body giant cells and macrophages between the gastric serosa and mesh and crural muscle was seen to surround the PTFE mesh. Because of the posterior wrap, the esophagus was not touching the mesh.

The recent 23 patients have been patched with a composite of ePTFE/PTFE so that only the smooth ePTFE surface faces the stomach and the esophagus where little tissue ingrowth occurs. There have been no patients in this recent group with breakdown of the crural repair and only one has required restarting medications for UGI symptoms.

Discussion

Essential components of anti- reflux surgery include returning the GE junction to the abdominal cavity with closure of the esophageal hiatus and partial or complete gastric wrap creating a valve. For decades, debate evolved around the gastric wrap, its tightness, its length, its completeness (e.g. Hill vs. Troupe vs. Nissen) and yet closure of the esophageal hiatus, the hernia repair, was simply a snug suture closure of the crural musculature with permanent stitches.

The breakdown of the crural repair leading to Nissen wrap herniation has been reported in large series ranging from 5 to 14 % (Table 1). Filipi and collegues [3,4,7] have addressed some of the forces that lead to crural breakdown and re-herniation, identifying post operative vomiting and severe intra-abdominal pressure as with heavy lifting as causative in the breakdown of the crural repair.

The esophageal hiatus transits the diaphragm posterior to the central tendon and the defined muscular bundles of the crura become tendinous once again as they approach insertion near the arcuate ligament. However, the crural musculature on both sides of the esophagus are soft parallel muscle fibers with few or no tendinous fibers. This muscle easily tears if sutured under tension. As the hiatal hernia defect grows larger, the distance between left and right crus become greater and more tension is required to draw these muscular bundles together. Casaccia has demonstrated that the vectors of muscle contraction are redirected when sutured so that a primary crural closure will pull apart the repair during respiration [14].

A number of investigators have published controlled studies of prostheses to re-inforce the crural closure or patch the hiatal defect (Table 2). Kamolz [11] randomized two hundred patients to primary crural closure with and without polypropylene reinforcement and at 2 years found 14% breakdown of the primary crural repair versus none in the reinforced group. Frantzides [12] studied 72 patients with defects larger than 8 cms who underwent primary crural closure randomized to reinforcement with a circumfrential PTFE prostheses or simple crural closure and found 22% recurrence rate in the un-reinforced group with no recurrences where prostheses were used. In a sequential study, Basso [13] noted in his first 67 patients crural breakdown and a recurrence rate of 14.5% prompting a change in technique to polypropylene mesh patch of the esophageal hiatus without primary closure. This subsequent group of patients had no recurrences of the hiatal hernia at 22 mos. None of these studies reported infectious complications related to the prosthetics.

Early in our experience, we witnessed tearing of the crural muscle bundle as the left and right crus were drawn together under tension so our technique was modified to create a tension free patch/repair of the posterior hiatal defect. We were reluctant to use polypropylene mesh adjacent to the esophagus or stomach and a solid sheet of PTFE seemed too rigid.

The PTFE mesh and the ePTFE/PTFE mesh/patch when secured to both crus forms a snug sling under the esophagus with bougie in place. When the bougie is removed the esophagus no longer sits against the patch and once the fundoplication is completed, the gastric wrap sits against the smooth ePTFE surface superiorly and holds the esophagus anteriorly. The space between the posterior crural bundles is patched without tension. [Figure 2a,b.] This tension-free repair contributes to the low clinical recurrence rate (0.8%) seen in this series.

While some post operative dysphagia occurs in many patients up to six weeks, our experience is consistent with other reports of early post-op dysphagia after primary crural closure [11]. Fifteen patients (11%) had new dysphagia lasting more than six weeks after surgery. Only 2 patients out of 130 required dilation after a year post op. There was no impingement of the mesh on the esophagus in 60 esophagrams. There has been no long term dysphagia attributable to the mesh patch in our series.

Recurrent hiatal hernia surgery is particularly prone to subsequent failure as the breakdown of the crural repair leaves a rigid defect and the resultant suture closure has undo tension. Granderath [15] followed 24 patients for a minimum of one year after polypropylene hiatal closure/patch for recurrent hiatal hernia after primary failed antireflux surgery and found this to be a safe and effective method of repair with good to excellent functional outcome. The nine “re-do” patients including our own recurrence presented as wrap migration (6) and para-esophageal herniation (3). Each had their recurrent defects patched with the PTFE or ePTFE.PTFE composite. None have recurred and only one has required post op dilation (mean follow-up of 34 months).

Infections with the use of prosthetic material at the diaphragmatic hiatus was a primary concern. Short-term infectious complications related to the mesh did not occur. While it may seem redundant, meticulous attention was paid to sterile technique. Preop antibiotics were used and the mesh soaked in antibiotic solution prior to application. Our patient population had the usual assortment of post-op infections. Six patients with atelectasis had low grade fever requiring no antibiotics. One elderly patient was treated with intravenous then outpatient oral antibiotics for right lower lobe pneumonia. Forearm cellulitis from an IV insertion was aggressively treated with antibiotics and a significant umbilical port site infection was treated with incision and drainage. Eleven patients had elective cholecystectomy performed immediately after completion of the antireflux operation. Mesh was applied despite a gastrotomy during a re-operation after staple closure of the stomach and thorough irrigation of the field.

Long-term infectious complications after prosthetic crural patch were not seen. There have been no mesh erosions after up to 10 years with the PTFE mesh. The newer composite mesh puts the smooth ePTFE surface against the stomach and esophagus preventing firm adherence of prosthetic to viscera. The mesh surface is vigorously incorporated into the crura and diagphram and the ePTFE surface protects the viscera from tissue ingrowth and significant adhesions similar to ePTFE composite protheses on the abdominal wall [16]

Six patients in this series underwent cholecystectomy during the follow-up period; four electively and two for acute cholecystitis. One patient had appendicitis and four had an episode of diverticulitis treated as outpatients with oral antibiotics. Three patients have had other elective clean contaminated intra-abdominal procedures, 43 had UGI endoscopy and 26 had colonoscopy where the risk of bacteremia exists. These were all remote from the original hiatal hernia surgery and as with prostheses elsewhere on the abdominal wall, incorporation or reperitonealization of the foreign material seems to protect against seeding of bacteria [17].

The perfect reconstruction for the esophageal hiatus has not yet been determined. This series demonstrates that prosthetic material can be used safely and effectively to patch the posterior crural defect without infection, impingement or erosion into viscera over a ten year follow-up. The PTFE or ePTFE/PTFE patch repair of this hernia defect is consistant with the surgical principle of non-tension and may provide a more durable hiatal hernia repair.

Images

• Figure 1. PTFE mesh with crural muscle ingrowth. After 4 years in vivo the mesh is separated from gastric serosa by foreign body giant cells and macrophages.
• Figure 2a. PTFE mesh as nontension patch to posterior crual defect (first 112 pts).
• Figure 2b. Composite patch stapled across crural defect (23 patients). ePTFE surfaces faces stomach, esophagus and wrap.