Transoral Incisionless Fundoplication Does Not Significantly Increase Morbidity of Subsequent Laparoscopic Nissen Fundoplication

Introduction

Endoluminal reflux treatments have been used to provide a less invasive procedural approach to the management of gastroesophageal reflux disease (GERD). Transoral incisionless fundoplication (TIF) using the Esophyx device (Endogastric Solutions, Redmond, WA) has emerged as a promising endoluminal approach in select patients. Studies have shown significant improvement of GERD symptoms, with 68% of patients achieving durable cessation of proton pump inhibitor treatment and patient satisfaction rates of greater than 80% after 12 months in some series.^1–3

Although TIF is effective in select patients, significant proportions of patients undergoing TIF develop persistent or recurrent GERD symptoms and may be considered candidates for antireflux surgery. The manner and degree to which endoluminal fundoplication affects the technical performance of subsequent laparoscopic antireflux surgery are uncertain, but a recent study suggests that prior endoluminal fundoplication may cause significant hiatal scarring with increased risk of iatrogenic gastric perforation during laparoscopic Nissen fundoplication (LNF). ⁴

Given the relatively high treatment failure rate reported with TIF, the technical difficulty determination and clinical outcomes of LNF after TIF represent important considerations when counseling patients about the risks and benefits of TIF. The objective of this study was to examine our early experience with the technical performance of LNF in this patient population.

Patients and Methods

Between 2008 and 2010, 66 patients in two large referral centers underwent TIF for treatment of GERD using techniques as previously reported.^3,5 Patients who presented for evaluation of persistent or recurrent GERD symptoms and subsequently underwent LNF were identified from a prospective Institutional Review Board–approved database.

Patients underwent LNF in one of the participating institutions by an experienced surgeon. Each procedure included complete mobilization of the prior TIF fundoplication, esophageal mobilization with at least 3 cm of intra-abdominal esophagus, mobilization of the gastric fundus including division of the short gastric vessels, posterior cruroplasty, and a 360° fundoplication.

The study end points included operative time, operative blood loss, gastric or esophageal perforation, and length of hospital stay. All data are presented as median (range).

Results

Seven of 66 (10.6%) TIF patients presented with persistent or recurrent GERD and underwent subsequent LNF. Fifty-seven percent (n=4) of patients were female, with a median (range) age of 44 (22–66) years and body mass index of 30.8 (20.7–34.8) kg/m². Two patients had persistent reflux following TIF, whereas the remaining 5 patients developed recurrent GERD symptoms between 5 and 33 months post-TIF after initially reporting good symptom control. The median interval to reoperation was 7 months, with a range of 3–28 months. Upon exploratory laparoscopy, each patient was found to have a partially disrupted endoscopic plication with polypropylene H-fasteners dislodged from the esophagus visible on the gastric serosal surface. One patient was found to have a sliding hiatal hernia at the time of reoperation.

Any hiatal hernia was reduced, and the endoscopic gastric plication was completely dissected by sharply dividing adhesions and cutting the remaining intact fasteners to restore normal gastric anatomy. LNF was successfully completed in all cases with median (range) estimated blood loss of 10 (0–50) mL. Median (range) operative time was 97 (48–122) minutes. No iatrogenic esophageal or gastric perforations were created during these procedures. All patients were discharged from the hospital tolerating a full liquid diet on the first postoperative day, and there were no postoperative complications.

Discussion

The objective of this study was to evaluate the impact of previous failed endoluminal fundoplication on the technical performance of LNF. We discovered that in our patient population, recurrent reflux warranting laparoscopic fundoplication was associated with significant TIF wrap dehiscence rather than development of a hiatal hernia. Hiatal scarring from prior TIF did not result in prolonged operative times, significant operative blood loss, or iatrogenic esophageal or gastric perforations. All patients tolerated a full liquid diet and were discharged on the first postoperative day.

The reported short-term outcomes of TIF have been fairly consistent in both European and North American studies. Endoluminal fundoplication has proven capable of significantly improving GERD-specific symptom scores in the majority of patients.^1–3,5 However, 30%–50% of patients report proton pump inhibitor use at the 12-month follow-up even in carefully selected populations. Only one study to date has provided follow-up extended to 2 years; it showed high patient satisfaction, but complete symptom resolution was only achieved in 31% of patients. ² In this series, 10% of patients went on to have an LNF, which is consistent with other short-term follow-up studies that reported subsequent fundoplication rates of 10%–53%.^3,6,7 Given the high treatment failure rate associated with TIF, the impact of this procedure on the technical difficulty and outcomes of subsequent LNF is an important consideration when discussing the risks and benefits of TIF.

A recent study examined a series of 11 patients who underwent LNF following failed TIF for recurrent or persistent GERD symptoms and reported a 18% incidence of iatrogenic gastric perforation and need for conversion to or subsequent laparotomy in 2 patients. ⁴ The authors described the presence of dense adhesions between the endoluminal fundoplication and the diaphragm that made dissection of the previous fundoplication difficult. There was also 1 case of intra-abdominal abscess in this series thought to be related to microperforation at the site of the full-thickness T-fasteners.

In this series, each case of recurrent GERD following TIF was associated with complete or near-complete disruption of the previous endoluminal fundoplication. In each case, polypropylene fasteners were visible within the gastric wall that appeared to have pulled through the esophageal wall and led to disruption of the fundoplication. The endoluminal fundoplication did result in mild or moderate hiatal scarring, but this was not severe and did not result in prolongation of the operation or any incidences of iatrogenic perforation. In this series, LNF required 97 minutes to perform, which is identical to the time reported by our group for primary LNF in a previous study. ⁸ The dissection was completed laparoscopically without complication in all cases.

The mechanism of failure in this series appears to be related to wrap disruption, rather than development of a hiatal hernia. A significant hiatal hernia accompanied by near-complete wrap dehiscence was discovered in 1 patient at the time of LNF. This patient underwent LNF 5 months after TIF, and this likely represents a missed hiatal hernia that was present at the time of the initial TIF rather than TIF followed by subsequent development of a significant hiatal hernia. The predominance of disrupted fundoplications in this series is likely related to the relatively short period of follow-up after TIF, and longer-term follow-up studies are required to determine whether subsequent hiatal hernia development will be a significant mechanism of TIF failure.

This study is limited by its retrospective design and small number of patients. It does, however, suggest that LNF can be safely performed following failed TIF without dramatically increased operative difficulty or morbidity. Larger studies of LNF after failed endoluminal fundoplication are required to more accurately assess the operative morbidity of this procedure as well as the clinical outcomes compared with primary LNF in order to accurately educate patients about the risks and benefits of TIF.