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.

Updated Markov Model to Determine Optimal Management Strategy for Patients with Paraesophageal Hernia and Symptoms, Cameron Ulcer, or Comorbid Conditions.

BACKGROUND: The current paradigm of watchful waiting (WW) in people 65 years or older with an asymptomatic paraesophageal hernia (PEH) is based on a now 20-year-old Markov analysis. Recently, we have shown that elective laparoscopic hernia repair (ELHR) provides an increase in life-years (L-Ys) compared with WW in most healthy patients aged 40 to 90 years. However, elderly patients often have comorbid conditions and may have complications from their PEH such as Cameron lesions. The aim of this study was to determine the optimal strategy, ELHR or WW, in these patients. STUDY DESIGN: A Markov model with updated variables was used to compare L-Ys gained with ELHR vs WW in hypothetical people with any type of PEH and symptoms, Cameron lesions, and/or comorbid conditions. RESULTS: In men and women aged 40 to 90 years with PEH-related symptoms and/or Cameron lesions, ELHR led to an increase in L-Ys over WW. The presence of comorbid conditions impacted life expectancy overall, but ELHR remained the preferred approach in all but 90-year-old patients with symptoms but no Cameron lesions. CONCLUSIONS: Using a Markov model with updated values for key variables associated with management options for patients with a PEH, we showed that life expectancy was improved with ELHR in most men and women aged 40 to 90 years, particularly in the presence of symptoms and/or Cameron lesions. Comorbid conditions increase the risk for surgery, but ELHR remained the preferred strategy in the majority of symptomatic patients. This model can be used to provide individualized management guidance for patients with a PEH.

Elective Laparoscopic Paraesophageal Hernia Repair Leads to an Increase in Life Expectancy Over Watchful Waiting in Asymptomatic Patients: An Updated Markov Analysis.

OBJECTIVE: The aim of this study was to perform an updated Markov analysis to determine the optimal management strategy for patients with an asymptomatic paraesophageal hernia (PEH): elective laparoscopic hernia repair (ELHR) versus watchful waiting (WW). BACKGROUND: Currently, it is recommended that patients with an asymptomatic PEH not undergo repair based on a 20-year-old Markov analysis. The current recommendation might lead to preventable hospitalizations for acute PEH-related complications and compromised survival. METHODS: A Markov model with updated variables was used to compare life-years (L-Ys) gained with ELHR versus WW in patients with a PEH. One-way sensitivity analyses evaluated the robustness of the analysis to alternative data inputs, while probabilistic sensitivity analysis quantified the level of confidence in the results in relation to the uncertainty across all model inputs. RESULTS: At age 40 to 90, ELHR led to greater life expectancy than WW, particularly in women. The gain in L-Ys (2.6) was greatest in a 40-year-old woman and diminished with increasing age. Sensitivity analysis showed that alternative values resulted in modest changes in the difference in L-Ys, but ELHR remained the preferred strategy. Probabilistic analysis showed that ELHR was the preferred strategy in 100% of 10,000 simulations for age 65, 98% for age 80, 90% for age 85, and 59% of simulations in 90-year-old women. CONCLUSIONS: This updated analysis showed that ELHR leads to an increase in L-Ys over WW in healthy patients aged 40 to 90 years with an asymptomatic PEH. In this new paradigm, all patients with a PEH, regardless of symptoms, should be referred for the consideration of elective repair to maximize their life expectancy.

Missed Opportunities: the Timing and Frequency of Screening Colonoscopy in Patients That Develop Esophageal Adenocarcinoma.

INTRODUCTION: Screening colonoscopy (SC) is widely accepted and has been shown to decrease the rate of colorectal cancer death. Guidelines and acceptance of screening for Barrett's esophagus (BE) are less established despite the fact that esophageal adenocarcinoma (EA) remains the fastest increasing cancer in the USA. The aim of this study was to assess the timing and frequency of SC in patients ultimately found to have EA and to evaluate the presence of symptoms and risk factors that might have prompted an esophagogastroduodenoscopy (EGD) and potentially earlier diagnosis of the EA. METHODS: A retrospective chart review was performed to identify all patients who were referred to a single center with esophageal cancer between July 2016 and November 2022. Patients with any histology other than adenocarcinoma were excluded. RESULTS: There were 221 patients referred with EA. Of these, a SC had been done prior to the diagnosis of EA in 108 patients (49%): 96 men and 12 women. A total of 203 SC had been done (range 1-7 per patient), and 47% of patients had more than 1 SC. The median interval from the last SC to the diagnosis of EA was 2.9 years. At the time of SC, gastroesophageal reflux disease (GERD) symptoms or chronic acid suppression medication use was reported by 81% of patients, and 80% had an American Society of Gastrointestinal Endoscopy (ASGE) indication for a screening EGD. Only 19 patients (18%) that had a SC had an EGD at any time prior to the diagnosis of EA, and in these patients, 74% had erosive esophagitis or BE. The EA in most patients was stage III or IV and associated with lymph node metastases. CONCLUSIONS: Nearly one-half of patients ultimately diagnosed with EA had one or more SCs, and most of these patients had GERD symptoms, were using acid suppression medications or had an ASGE indication for a screening EGD. Despite this, only 18% had an EGD prior to the EA diagnosis. The addition of an EGD at the time of SC in these patients may have allowed the detection of BE or EA at an early, endoscopically curable stage and represents a missed opportunity to intervene in the natural history of this disease.

Tumor differentiation impacts response to neoadjuvant therapy and survival in patients with esophageal adenocarcinoma.

OBJECTIVE: The current staging system for esophageal adenocarcinoma only considers tumor grade in early tumors. The aim of this study was to evaluate the impact of tumor differentiation on response to neoadjuvant chemoradiotherapy and survival in patients with locally advanced esophageal adenocarcinoma. METHODS: This was a multi-institution retrospective review of all patients with esophageal cancer who underwent neoadjuvant chemoradiotherapy followed by esophagectomy from January 2010 to December 2017. Response to neoadjuvant therapy and survival was compared between patients with well- or moderately differentiated (G1/2) tumors versus poorly differentiated (G3) tumors. RESULTS: There were 550 patients, 485 men (88.2%) and 65 women. The median age was 61 years, and the tumor was G1/2 in 288 (52.4%) and G3 in 262 patients. Overall clinical stage before neoadjuvant therapy was similar between groups. Pathologic complete response (pCR) was found in 87 patients (15.8%). The frequency of pCR was similar between groups, but residual disease in the esophagus and lymph nodes was significantly more likely with G3 tumors. Median follow-up was 63 months and absolute survival, overall survival, and disease-free survival were all significantly worse in patients with G3 tumors. Further, even with pCR, patients with G3 tumors had significantly worse survival. CONCLUSIONS: This study showed that response to neoadjuvant therapy was not affected by tumor differentiation. However, poor differentiation was associated with worse survival compared with patients with G1/2 tumors, even among those with pCR. These results suggest that poor differentiation should be considered as an added risk factor for clinical staging in patients with locally advanced esophageal adenocarcinoma.

Diaphragmatic relaxing incisions for complex hiatal reconstruction: longer-term follow-up confirms safety, efficacy and rare complications.

BACKGROUND: Tension is an important factor in hernia repairs. Relaxing incisions to reduce tension are common with ventral hernia repairs, and techniques for relaxing incisions also exist for the hiatus. The aim of this study was to update our original experience with a diaphragm relaxing incision (DRI) in a larger group of patients with longer follow-up. METHODS: A retrospective chart review was performed to identify all patients who had a DRI between August 2016 and September 2021 during hiatal hernia repair. All DRI defects were repaired with permanent mesh remote from the esophagus. Objective follow-up was with chest x-ray, upper GI series (UGI) or both. RESULTS: Seventy-three patients had a total of 79 DRI (right in 63, left in 4, and bilateral in 6 patients), during a primary (n = 52) or redo (n = 21) hiatal hernia repair. Concomitant Collis gastroplasty was used in 38 patients (52%). A single intra-operative complication occurred where the right crus tore during a right DRI. At a median of 15 months, 78% of patients had objective follow-up. There was one hernia through a repaired right DRI (1.2%). No patient had evidence of diaphragm paralysis and there were no mesh infections. The 1-year hernia recurrence rate in these patients was 3.9%. CONCLUSIONS: A DRI can be done safely with minimal risk of intra- or post-operative complications. There was a low rate of herniation through the defect when repaired with permanent mesh. No patient developed a mesh infection despite concomitant Collis gastroplasty in 52% of patients, and there was no evidence of diaphragm paralysis on imaging studies. Further, the low rate of hiatal hernia recurrence suggests efficacy of a DRI to reduce crural closure tension. These excellent outcomes should encourage use of a DRI in patients with a difficult hiatus during hernia repair.

The Nissen-Hill Hybrid Repair: Experience With the First 500.

INTRODUCTION: A new repair for gastroesophageal reflux and hiatal hernia, the Nissen-Hill hybrid repair, was developed to combine the relative strengths of its component repairs with the aim of improved durability. In several small series, it has been shown to be safe, effective, and durable for paraesophageal hernia, Barrett esophagus, and gastroesophageal reflux disease. This study represents our experience with the first 500 consecutive repairs for all indications. METHODS: Retrospective study of prospectively collected data for the first 500 consecutive Nissen-Hill hybrid repairs from March 2006 to December 2016, including all indications for surgery. Three quality of life metrics, manometry, radiographic imaging, and pH testing were administered before and at defined intervals after repair. RESULTS: Five hundred patients were included, with a median follow-up of 6.1 years. Indications for surgery were gastroesophageal reflux disease in 231 (46.2%), paraesophageal hernia in 202 (40.4%), and reoperative repair in 67 (13.4%). The mean age was 59, with body mass index of 30 and 63% female. A minimally invasive approach was used in 492 (98%). Thirty-day operative mortality was 1 (0.2%), with a 4% major complication rate and a median length of stay of 2 days. Preoperative to postoperative pH testing was available for 390 patients at a median follow-up of 7.3 months, with the median DeMeester score improving from 45.9 to 2.7. At long-term follow-up (229 responses), all median quality of life scores improved: Quality Of Life in Reflux And Dyspepsia 4 to 6.9, Gastroesophageal Reflux Disease-Health Related Quality of Life 22 to 3, and Swallowing 37.5 to 45 and proton pump inhibitor use dropped from 460 (92%) to 50 (10%). Fourteen (2.8%) underwent reoperation for failure. CONCLUSION: The combined Nissen-Hill hybrid repair is safe and effective in achieving excellent symptomatic and objective outcomes and low recurrence rates beyond 5 years.

High Resolution Manometry in a Functioning Fundoplication - Establishing a Standard Profile: Retrospective Chart Review.

OBJECTIVE: The aim of this study was to provide a full HRM data set in patients with a normal functioning fundoplication. BACKGROUND: The Chicago classification was devised to correlate HRM values to the clinical status of patients with swallowing disorder. However, it is unclear whether those values are applicable after fundoplication as the literature is sparse. METHODS: We identified patients with pre- and postoperative HRM who had a normal functioning primary fundoplication as defined by (1) resolution of preoperative symptoms without significant postoperative side effects, (2) no dysphagia reported on a standardized questionnaire given on the day of the postoperative HRM and (3) normal acid exposure determined objectively by esophageal pH-testing. RESULTS: Fifty patients met inclusion criteria for the study. Thirty-three patients (66%) underwent complete fundoplication and 17 patients (34%) underwent posterior partial fundoplication. Postoperative HRM was performed at a median of 12 months after primary surgery. Lower esophageal sphincter (LES) values significantly increased with the addition of a fundoplication. Median integrated relaxation pressure (IRP) was 14 mm Hg ( P = 0.0001), median resting pressure 19.5 mm Hg ( P = 0.0263), and median total length LES was 3.95 cm ( P = 0.0098). The 95th percentile for IRP in a complete fundoplication was 29 versus 23 mm Hg in a partial fundoplication ( P = 0.3667). CONCLUSION: We offer a new standard manometric profile for a normally functioning fundoplication which provides a necessary benchmark for analyzing postoperative problems with a fundoplication. The previously acceptedupper limit defining esophageal outflow obstruction (IRP >20 mm Hg) is not clinically applicable after fundoplication as the majority of patients in this dysphagia-free cohort exceeded this value. Interestingly, there does not seem to be a significant difference in HRM LES values between complete and partial fundoplication.

POEM: clinical outcomes beyond 5 years.

BACKGROUND: The short-term success of peroral endoscopic myotomy (POEM) is well documented but the durability of the operation is questioned. The aim of this study was to evaluate the clinical outcomes of the POEM procedure for esophageal motility disorders in a large cohort in which all patients had at least 5 years of follow-up. METHODS: All patients from a single center who underwent a POEM between October 2010 and September 2014 were followed for long-term clinical outcomes. Postoperative Eckardt symptom scores of short term and ≥ 5 years were collected through phone interview. Clinical success was defined as an Eckardt score < 3. Overall success was defined as Eckardt score < 3 and freedom from additional interventions. RESULTS: Of 138 patients, 100 patients were available for follow-up (mean age 56, 52% male). The indication for operation was achalasia in 94. The mean follow-up duration was 75 months (range: 60-106 months). Dysphagia was improved in 91% of patients. Long-term overall success was achieved in 79% of patients (80% of achalasia patients, 67% of DES patients). Preoperative mean Eckardt score was 6. At 6 months, it was 1, and at 75 months, it was 2 (p = 0.204). Five-year freedom from intervention was 96%. Overall, 7 patients had additional treatments: 1 balloon dilation (35 mm), 4 laparoscopic Heller myotomy, and 2 redo POEM at a mean of 51 months post-POEM. Ninety-three percent expressed complete satisfaction with POEM. CONCLUSION: A multitude of studies has shown the early benefits of POEM. Here, we show that nearly 80% of patients report clinical success with no significant decrement in symptom scores between their short- and long-term follow-up. Clearly POEM is an effective option for achalasia with durable long-term treatment efficacy.

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.

Adequacy of EGD Reporting: a Review of 100 Reports from 100 Endoscopists.

INTRODUCTION: Esophagogastroduodenoscopy (EGD) is commonly performed in patients with gastroesophageal reflux disease (GERD). An EGD report should document pertinent findings such as esophagitis, a columnar-lined esophagus (CLE), the location of the squamo-columnar and gastroesophageal junctions, the size and type of a hiatal hernia and the number and location of any biopsies. The aim of this study was to evaluate how commonly these findings were noted in the EGD reports of patients referred for antireflux surgery. METHODS: A retrospective review was performed of patient charts from 2012 to 2015 to identify 100 consecutive EGD reports from different endoscopists in different patients. Each EGD report was reviewed for pertinent findings and the use of a classification system for esophagitis (Savory-Miller or Los Angeles) and for reporting a CLE (Prague). RESULTS: In 100 EGD reports, esophagitis was noted in 33 patients, but was graded in only 14 (42%). A CLE was noted in 28 patients, but the length was reported in only 16 (57%) and no report used the Prague classification system. A hiatal hernia was noted in 61 patients, measured in 31 (51%) and the type classified in 26%. A biopsy was taken in 93 patients and the location noted in 86 patients (93%). The number of biopsies was recorded in only 20 patients (22%). In 12 patients the EGD was for Barrett's surveillance, yet a Seattle biopsy protocol was reported to be used in only 3 patients. CONCLUSION: Endoscopy reports frequently do not include the use of a grading system for esophagitis or the Prague system for CLE. This hampers the assessment of change with therapy or over time. The size of a hiatal hernia was typically reported in a subjective fashion and only infrequently was the type specified. Lack of clarity about the presence of a paraesophageal hernia can impede evaluation of acute symptoms. In patients with Barrett's esophagus a standard biopsy protocol was infrequently reported to be used. These findings raise concern about the quality of upper endoscopy, both in the performance of the procedure and the documentation of findings. A consistent reporting system is recommended for routine use with upper endoscopy.

Laparoscopic Hernia Repair and Fundoplication for Gastroesophageal Reflux Disease.

Antireflux surgery is challenging, and has become even more challenging with the introduction of alternative endoscopic and laparoscopic options for patients with gastroesophageal reflux disease (GERD). The Nissen fundoplication remains the gold standard for the durable relief of GERD symptoms and esophagitis. All antireflux procedures have a failure rate, and it is important to minimize factors that are associated with failure. The selection of patients for antireflux surgery as well as the choice of the procedure requires a thorough understanding of esophageal physiology and the pros and cons of various options.

Clinical outcome after laparoscopic Nissen fundoplication in patients with GERD and PPI refractory heartburn.

Typical reflux symptoms that respond well to proton pump inhibitor (PPI) therapy are key factors predictive of an excellent outcome with antireflux surgery for gastroesophageal reflux disease (GERD). Our aim was to evaluate whether poor preoperative heartburn (HB) relief with PPIs was associated with a worse outcome after Nissen fundoplication. Patients with a main symptom of HB and a positive pH-test who had a laparoscopic Nissen fundoplication between January 2008 and December 2014 were included. Prior to surgery, patients graded how effectively their HB symptoms were relieved by PPIs. Three groups were defined: good response (76-100% relief), partial response (26-75% relief) and poor response (0-25% relief). Outcomes and satisfaction were assessed at a minimum of 1 year after fundoplication. There were 129 patients who met inclusion criteria and 75 agreed to participate. The median follow-up was 48 months. Prior to Nissen fundoplication 13 patients had a good HB response to PPI-therapy, 36 had a partial response and 26 had a poor response. All patients were satisfied with their HB relief after fundoplication (mean satisfaction score: 9.5/10) and there was no difference in satisfaction score or heartburn relief between groups. Heartburn symptoms that respond poorly to PPI therapy are reliably relieved with a Nissen fundoplication in patients with objectively confirmed GERD. Patient satisfaction after Nissen fundoplication was excellent and was similar in patients with poor versus excellent HB relief with preoperative PPI therapy. Therefore, antireflux surgery is an option for patients with HB and confirmed GERD regardless of the degree of relief of HB symptoms provided by PPI medications.

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.

How Many Nodes Need to be Removed to Make Esophagectomy an Adequate Cancer Operation, and Does the Number Change When a Patient has Chemoradiotherapy Before Surgery?

INTRODUCTION AND DESIGN: Node dissection during esophagectomy is an important aspect of esophageal cancer staging. Controversy remains as to how many nodes need to be resected in order to properly stage a patient and whether the removal of more nodes carries a stage-independent survival benefit. A review of the literature performed by a group of experts in the subject may help define a minimum accepted number of lymph nodes to be resected in both primary surgery and post-induction therapy scenarios. RESULTS AND CONCLUSIONS: The existing evidence generally supports the goal of obtaining a minimum of 15 lymph nodes for pathological examination in both primary surgery and post-induction therapy scenarios.