Five-Year Outcomes from a Prospective Study on the Safety and Efficacy of Phasix-ST Mesh Use at the Hiatus During Paraesophageal Hernia Repair.

INTRODUCTION: Laparoscopic paraesophageal hernia (PEH) repair has a high hernia recurrence rate. The aim of this study was to assess the 5-year hernia recurrence rate after PEH repair using a combination of bioresorbable mesh and advanced surgical techniques to address tension as needed in a prospective group of patients. METHODS: In 2016 a prospective database was established for 50 patients undergoing primary, elective PEH repair with a new bioresorbable mesh (Phasix-ST). Intra-operatively, tension was addressed with Collis gastroplasty and / or diaphragm relaxing incisions as needed. All 50 patients from the initial study were tracked and asked to return for objective follow-up. Recurrence was considered present for any hernia > 2 cm in size. RESULTS: Objective follow-up was obtained in 27 of the original 50 patients (54%) at a median of 5.25 years after their PEH repair. Prior to the 5-year follow-up, 5 patients had a known recurrent hernia. Objective evaluation at 5 years identified an additional 3 recurrences, for a total recurrence rate of 25% (8/32 patients). The hernia recurrence rate in patients with a Collis gastroplasty was significantly lower compared to those without a Collis (7% vs 54%, p=0.008). Two patients underwent re-operation for hernia recurrence. No patient had a mesh infection or mesh erosion. CONCLUSION: The combination of Phasix-ST mesh and tension reducing techniques during PEH repair led to a 25% hernia recurrence rate at 5 years. The addition of a Collis gastroplasty led to significantly fewer hernia recurrences and is indicative of the potential for esophageal shortening in many patients with a PEH. The long-term safety and efficacy of Phasix-ST mesh in combination with surgical technique for PEH repair is confirmed.

Abnormal response after multiple rapid swallow provocation is not predictive of post-operative dysphagia following a tailored fundoplication approach.

INTRODUCTION: The aim was to evaluate the clinical significance of multiple rapid swallows (MRS) during high-resolution manometry (HRM) prior to fundoplication. Despite pre-operative HRM, up to 38% of patients report post-fundoplication dysphagia. Suggestion that MRS improves prediction of dysphagia after fundoplication has not been investigated when using a tailored approach. We hypothesize response to MRS is predictive of dysphagia after tailored fundoplication. METHODS: A retrospective cohort study was performed on patients undergoing HRM with MRS provocation 5/2019-7/2021 at a single institution. Patients who underwent subsequent index laparoscopic fundoplication, without peptic stricture or achalasia, were included. After performing standard 10-swallow HRM, MRS provocation was performed. Patient-reported dysphagia frequency scores were collected at initial consultation and post-operative follow-up. At least weekly symptoms were considered clinically significant. Normal MRS response was defined as adequate deglutitive inhibition and MRS contractile response. Fundoplications were tailored based on standard HRM values. RESULTS: HRM was performed in 1201 patients, 220 met inclusion criteria. Clinically significant pre-operative dysphagia was reported by 85 (38.6%). Patients undergoing partial fundoplication (n = 123, 55.9%) had lower mean distal contractile integer, distal esophageal contraction amplitude, and percent peristalsis (p < 0.005). Post-operatively, 120 (54.5%) were without dysphagia, 59 (26.8%) had improved dysphagia, 26 (11.8%) had unchanged dysphagia, and 15 (6.8%) reported new dysphagia. There was no statistical difference in early or late dysphagia outcome between tailored fundoplication groups (p = 0.69). On univariate and multivariate analysis, neither MRS response, nor standard HRM metrics were significantly associated with post-operative dysphagia. Younger age (OR 0.96, 95% CI 0.94-0.986, p = 0.042) and the presence of pre-operative dysphagia (OR 2.54, 95% CI 1.17-5.65, p = 0.015) were significant predictors of post-operative dysphagia. CONCLUSION: The risk of clinically significant dysphagia post-fundoplication is low when using a tailored approach based on standard HRM metrics. Additional data provided by MRS does not add to surgical decision-making using the investigated approach.

The Development and Natural History of Hiatal Hernias: A Study Using Sequential Barium Upper Gastrointestinal Series.

OBJECTIVE: The aim of this study was to use barium upper gastrointestinal series (UGI) to evaluate the development and natural history of a hiatal hernia. SUMMARY OF BACKGROUND DATA: Hiatal hernias are common but the natural history of sliding and paraesophageal type hernias is poorly understood. METHODS: We reviewed UGI reports from 1987 to 2017 using a word scanning software program to identify individuals that had a hiatal hernia. Only those with at least 2 UGI studies 5 or more years apart were selected. The studies were then reviewed. RESULTS: There were 89 individuals that met inclusion criteria. Twenty-one people had no hiatal hernia on initial UGI and over a median of 99 months a sliding hiatal hernia (SHH) developed in 16 and a PEH developed in 5 people. A SHH was present on initial UGI in 55 people and at a median of 84 months subsequent UGI showed the SHH was stable in 11 (20%), increased in size in 30 (55%), and changed to a PEH in 14 people (25%). In 13 people a PEH was present on initial UGI and over a median of 97 months it was stable in 5 and increased in size in 8 people (62%). CONCLUSIONS: We showed that both SHH and PEH can develop over time and that the majority of both increased in size on follow-up UGI study. Further, 25% of SHH became a PEH over time. Recognizing an increase in size or change in type of a hiatal hernia may be clinically relevant to help understand changing or worsening symptoms in an individual.

Can We Identify Patients Appropriate for Same-Day Discharge After Laparoscopic Fundoplication?

Background: Patients, surgeons, and payers are interested in reducing hospital length of stay. Outpatient laparoscopic fundoplication (LF) can be done safely and cost effectively. There is low acceptance of this practice due to fear of readmission and patient dissatisfaction. Our aim was to identify factors predicting failure of same-day discharge after LF. Methods and Procedures: We simulated an outpatient setting for patients who underwent LF from 2017 to 2018 and collected the data prospectively. A perioperative pain and nausea protocol was utilized. Postoperatively, patients were given a liquid diet and oral medications, observed overnight, and then discharged after standard criteria were met. Failure was defined by the need for physician intervention after 3 hours or failure to discharge. Univariate and multivariable logistic regression analyses were performed assessing factors associated with failure. Two-sample t-test and chi-squared tests were used for significance. Results: Ninety-eight patients were included. Twenty patients failed, primarily due to the need for intravenous medications. Seven were discharged on postoperative day 1 but required physician intervention after 3 hours. Thirteen patients stayed >23 hours. Two patients were readmitted within 1 week of discharge. There was one acute recurrence, requiring reoperation, and one conversion to laparotomy. We found no statistically significant patient risk factor, comorbidity, or perioperative variable that could reliably predict failure of same-day discharge. Conclusion: This study suggests that same-day discharge after LF is safe and feasible. However, 20% of patients will unpredictably fail to meet discharge criteria.

Safety and efficacy of magnetic sphincter augmentation dilation.

BACKGROUND: The magnetic sphincter augmentation device (MSA) provides effective relief of gastroesophageal reflux symptoms. Dysphagia after MSA implantation sometimes prompts endoscopic dilation. The manufacturer's instructions are that it be performed 6 or more weeks after implantation under fluoroscopic guidance to not more than 15 mm keeping 3 or more beads closed. The purpose of this study was to assess adherence to these recommendations and explore the techniques used and outcomes after MSA dilation. METHODS AND PROCEDURES: We conducted a multicenter retrospective review of patients undergoing dilation for dysphagia after MSA placement from 2012 to 2018. RESULTS: A total of 144 patients underwent 245 dilations. The median size of MSA placed was 14 beads (range 12-17) and the median time to dilation was 175 days. A second dilation was performed in 67 patients, 22 patients had a third dilation and 7 patients underwent 4 or more dilations. In total, 17 devices (11.8%) were eventually explanted. The majority of dilations were performed with a balloon dilator (81%). The median dilator size was 18 mm and 73.4% were done with a dilator larger than 15 mm. There was no association between dilator size and need for subsequent dilation. Fluoroscopy was used in 28% of cases. There were no perforations or device erosions related to dilation. DISCUSSION: There is no clinical credence to the manufacturer's recommendation for the use of fluoroscopy and limitation to 15 mm when dilating a patient for dysphagia after MSA implantation. Use of a larger size dilator was not associated with perforation or device erosion, but also did not reduce the need for repeat dilation. Given this, we would recommend that the initial dilation for any size MSA device be done using a 15 mm through-the-scope balloon dilator. Dysphagia prompting dilation after MSA implantation is associated with nearly a 12% risk of device explantation.

Combination of Surgical Technique and Bioresorbable Mesh Reinforcement of the Crural Repair Leads to Low Early Hernia Recurrence Rates with Laparoscopic Paraesophageal Hernia Repair.

INTRODUCTION: Laparoscopic paraesophageal hernia (PEH) is associated with a low morbidity and mortality but an objective hernia recurrence rate in excess of 50% at 5 years. Biologic mesh has not been shown to reduce hernia recurrence rates. Recently, a new bioresorbable mesh made with poly-4-hydroxybutyrate with a Sepra-Technology coating on one side (Phasix-ST mesh) has become available. The aim of this study was to evaluate the feasibility, safety, and short-term efficacy of Phasix-ST mesh for reinforcement of the primary crural closure in patients undergoing elective, laparoscopic PEH repair. METHODS: A prospective database was initiated and maintained for all patients undergoing PEH repair with the use of Phasix-ST mesh. We retrospectively reviewed the records of consecutive patients who had an elective, first-time laparoscopic PEH repair with Phasix-ST mesh and who completed their 1-year objective follow-up study. Patients having a reoperation, non-laparoscopic repair, or who failed to comply with the objective follow-up were excluded. RESULTS: To achieve the desired 50 patients with 1-year objective follow-up, we reviewed the records of 90 consecutive PEH patients. In the final cohort of 50 patients, there were 32 females (64%) and 18 males. The median age of the patients at surgery was 67 years (range 44-84). The operation was PEH repair with fundoplication alone in 29 patients (58%) and PEH repair with Collis gastroplasty and fundoplication in 21 patients (42%). Phasix-ST mesh was used for crural reinforcement in all patients, and there were no intraoperative issues with the mesh or any difficulty placing or fixating the mesh at the hiatus. A diaphragm relaxing incision was performed in 2 patients (4%). The mean length of hospital stay was 2.8 days, and there was no major morbidity or mortality. On the 1-year objective follow-up study (median 12 months) a recurrent hernia was found in 4 patients (8%). No patient that had a Collis gastroplasty or a relaxing incision had a recurrent hernia. No patient had a reoperation. No patient had a mesh infection or mesh erosion. CONCLUSIONS: Phasix-ST mesh reinforcement of the crural closure during laparoscopic primary, elective PEH repair was associated with no adverse mesh-related events such as infection or erosion. Phasix-ST crural reinforcement in combination with tension-reduction techniques when necessary resulted in a very low (8%) objective hernia recurrence rate at a median follow-up of 1 year. These results demonstrate the safety of Phasix-ST mesh for use at the hiatus for crural reinforcement. This safety, along with the encouraging short-term efficacy for reducing hernia recurrence, should encourage further studies using the combination of resorbable biosynthetic mesh crural reinforcement and tension-reducing techniques during repair of paraesophageal hernias.