The Impact of Ineffective Esophageal Motility on Patients Undergoing Magnetic Sphincter Augmentation.

OBJECTIVE: To evaluate and characterize outcomes of MSA in patients with IEM. SUMMARY BACKGROUND DATA: MSA improves patients with gastroesophageal reflux and normal motility. However, many patients have IEM, which could impact the outcomes of MSA and discourage use. METHODS: An international, multi-institutional case control study of IEM patients undergoing MSA matched to normal patients was performed. Primary outcomes were new onset dysphagia and need for postoperative interventions. RESULTS: A total of 105 IEM patients underwent MSA with matching controls. At 1 year after MSA: GERD-Health Related Quality of Life was similar; DeMeester scores in IEM patients improved to 15.7 and 8.5 in controls ( P = 0.021); and normalization of the DeMeester score for IEM = 61.7% and controls = 73.1% ( P = 0.079).In IEM patients, 10/12 (83%) with preop dysphagia had resolution; 11/66 (17%) had new onset dysphagia and 55/66 (83%) never had dysphagia. Comparatively, in non-IEM patients, 22/24 (92%) had dysphagia resolve; 2/24 (8%) had persistent dysphagia; 7/69 (10%) had new onset dysphagia, and 62/69 (90%) never had dysphagia.Overall, 19 (18%) IEM patients were dilated after MSA, whereas 12 (11%) non-IEM patients underwent dilation ( P = 0.151). Nine (9%) patients in both groups had their device explanted. CONCLUSIONS: Patients with IEM undergoing MSA demonstrate improved quality of life and reduction in acid exposure. Key differences in IEM patients include lower rates of objective GERD resolution, lower resolution of existing dysphagia, higher rates of new onset dysphagia and need for dilation. GERD patients with IEM should be counselled about these possibilities.

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.

Ineffective esophageal motility is not a contraindication to total fundoplication.

INTRODUCTION: Ineffective esophageal motility (IEM) is a physiologic diagnosis and is a component of the Chicago Classification. It has a strong association with gastroesophageal reflux and may be found during work-up for anti-reflux surgery. IEM implies a higher risk of post-op dysphagia if a total fundoplication is done. We hypothesized that IEM is not predictive of dysphagia following fundoplication and that it is safe to perform total fundoplication in appropriately selected patients. METHODS: Retrospective chart review of patients who underwent total fundoplication between September 2012 and December 2018 in a single foregut surgery center and who had IEM on preoperative manometry. We excluded patients who had partial fundoplication, previous foregut surgery, other causes of dysphagia or an esophageal lengthening procedure. Dysphagia was assessed using standardized Dakkak score ≤ 40 and GERD-HRQL question 7 ≥ 3. RESULTS: Two hundred patients were diagnosed with IEM and 31 met the inclusion criteria. Median follow-up: 706 days (IQR 278-1348 days). No preoperative factors, including subjective dysphagia, transit on barium swallow, or individual components of manometry showed statistical correlation with postoperative dysphagia. Of 9 patients with preoperative dysphagia, 2 (22%) had persistent postoperative dysphagia and 7 had resolution. Of 22 patients without preoperative dysphagia, 3 (14%) developed postoperative dysphagia; for a combined rate of 16%. No patient needed re-intervention beyond early recovery or required reoperation for dysphagia during the follow-up period. CONCLUSION: In appropriately selected patients, when total fundoplication is performed in the presence of preoperative IEM, the rate of long-term postoperative dysphagia is similar to the reported rate of dysphagia without IEM. With appropriate patient selection, total fundoplication may be performed in patients with IEM without a disproportionate increase in postoperative dysphagia. The presence of preoperative IEM should not be rigidly applied as a contraindication to a total fundoplication.

Use of a report card to evaluate outcomes of achalasia surgery: beyond the Eckardt score.

BACKGROUND: Achalasia outcome is primarily defined using the Eckardt score with failure recognized as > 3. However, patients experience many changes after myotomy including new onset GERD, swallowing difficulties, and potential need for additional treatment. We aim to devise a comprehensive assessment tool to demonstrate the extent of patient-reported outcomes, objective changes, and need for re-interventions following myotomy. METHODS: We performed a retrospective chart review of surgically treated primary achalasia patients. We identified 185 patients without prior foregut surgery who underwent either per oral endoscopic myotomy (POEM) or Heller myotomy from 2005 to 2017. Eight outcome measures in subjective, objective, and interventional categories formulated a global postoperative assessment tool. These outcomes included Eckardt score, Dakkak Dysphagia score, GERD-HRQL score, normalization of pH scores and IRP, esophagitis, timed barium clearance at 5 min, and the most invasive re-intervention performed. RESULTS: Of 185 patients, achalasia subtypes included Type I = 42 (23%), II = 109 (59%), and III = 34 (18%). Patients underwent minimally invasive myotomy in 114 (62%), POEM in 71 (38%). Median proximal myotomy length was 4 cm (IQR 4-5) and distal 2 cm (IQR 2-2.5). Based on postoperative Eckardt score, 135/145 (93%) had successful treatment of achalasia. But, only 47/104 (45%) reported normal swallowing, and 78/108 (72%) had GERD-HRQL score ≤ 10. Objectively, IRP was normalized in 48/60 (80%), whereas timed barium clearance occurred in 51/84 (61%). No evidence of esophagitis was documented in 82/115 (71%). Postoperative normal DeMeester scores occurred in 38/76 (50%). No additional treatments were required in 110/139 (79%) of patients. CONCLUSIONS: Use of the Eckardt score alone to assess outcomes after achalasia surgery shows outstanding results. Using patient-reported outcomes, objective measurements, re-intervention rates, organized into a report card provides a more comprehensive and informative view.

Large Cell Neuroendocrine Tumor Size >3 cm Negatively Impacts Long-Term Outcomes After R0 Resection.

BACKGROUND: Minimal knowledge exists regarding the outcome, prognosis and optimal treatment strategy for patients with pulmonary large cell neuroendocrine carcinomas (LCNEC) due to their rarity. We aimed to identify factors affecting survival and recurrence after resection to inform current treatment strategies. METHODS: We retrospectively reviewed 72 patients who had undergone a curative resection for LCNEC in 8 centers between 2000 and 2015. Univariable and multivariable analyses were performed to identify the factors influencing recurrence, disease-specific survival and overall survival. These included age, gender, previous malignancy, ECOG performance status, symptoms at diagnosis, extent of resection, extent of lymphadenectomy, additional chemo- and/or radiotherapy, tumor location, tumor size, pT, pleural invasion, pN and pStage. RESULTS: Median follow-up was 47 (95%CI 41-79) months; 5-year disease-specific and overall survival rates were 57.6% (95%CI 41.3-70.9) and 47.4% (95%CI 32.3-61.1). There were 22 systemic recurrences and 12 loco-regional recurrences. Tumor size was an independent prognostic factor for systemic recurrence [HR: 1.20 (95%CI 1.01-1.41); p = 0.03] with a threshold value of 3 cm (AUC = 0.71). For tumors ≤3 cm and >3 cm, 5-year freedom from systemic recurrence was 79.2% (95%CI 43.6-93.6) and 38.2% (95%CI 20.6-55.6) (p < 0.001) and 5-year disease-specific survival was 60.7% (95%CI 35.1-78.8) and 54.2% (95%CI 32.6-71.6) (p = 0.31), respectively. CONCLUSIONS: A large proportion of patients with surgically resected LCNEC will develop systemic recurrence after resection. Patients with tumors >3 cm have a significantly higher rate of systemic recurrence suggesting that adjuvant chemotherapy should be considered after complete resection of LCNEC >3 cm, even in the absence of nodal involvement.

Tunneled pleural catheter use for pleural palliation does not increase infection rate in patients with treatment-related immunosuppression.

PURPOSE: Concerns for infections resulting from antineoplastic therapy-associated immunosuppression may deter referral for symptom palliation with a tunneled pleural catheter (TPC) in patients with malignant/para-malignant pleural effusions (MPE/PMPE). While rates of TPC-related infections range from 1 to 21%, those in patients receiving antineoplastic therapy with correlation to immune status has not been established. We aimed to assess TPC-related infection rates in patients on antineoplastic therapy, determine relation to immune system competency, and assess impact on the patient. METHODS: Patients with a MPE/PMPE undergoing TPC management associated with antineoplastic therapy, from 2008 to 2016, were reviewed and categorized into those with an immunocompromised versus immunocompetent immune status. RESULTS: Of the 150 patients, a TPC-related infection developed in 13 (9%): pleural space in 11 (7%) and superficial in 2 (1%). Ninety-three percent (139/150) were identified to be immunocompromised during their antineoplastic therapy. No difference in TPC-related infections was seen in patients with an immunocompromised (9%, 12/139) versus immunocompetent status (9%, 1/11); p = 0.614. The presence of a catheter-related infection did not negatively impact overall survival over a median follow-up of 144 days (interquartile range 41-341); p = 0.740. CONCLUSIONS: These results suggest that antineoplastic therapy may not significantly increase the overall risk of TPC-related infections, as the rate remains low and comparable to rates in patients not undergoing antineoplastic therapy. Regardless of immune status, the presence of a catheter-related infection did not negatively impact overall survival. These results should reassure clinicians that the need to initiate antineoplastic therapy should not delay definitive pleural palliation with a TPC.

Factors influencing the outcome of magnetic sphincter augmentation for chronic gastroesophageal reflux disease.

OBJECTIVES: Magnetic sphincter augmentation (MSA) is a surgical treatment option for patients with gastroesophageal reflux disease (GERD). MSA consistently improves quality of life, maintains freedom from PPIs, and objectively controls GERD. However, up to 24% of patients did not achieve these outcomes. We sought to identify factors predicting outcomes after MSA placement with the aim of refining selection criteria. METHODS: We retrospectively analyzed clinical, endoscopic, manometric, pH data, and intraoperative factors from two databases: Pivotal Trial (N = 99) and our prospectively maintained esophageal database (N = 71). A priori outcomes were defined as excellent (GERD-HRQL <5, no PPI, no esophagitis), good (GERD-HRQL 6-15, no PPI, grade A esophagitis), fair (GERD-HRQL 16 to 25, PPI use, grade B esophagitis), and poor (GERD-HRQL >25, PPI use, grade C/D esophagitis). Univariable and multivariable logistic regression analyses were performed to determine predictors of achieving an excellent/good outcome. RESULTS: A total of 170 patients underwent MSA with a median age of 53 years, [43-60] and a median BMI of 27 (IQR = 24-30). At baseline, 93.5% of patients experienced typical symptoms and 69% atypical symptoms. Median DeMeester score was 37.9 (IQR 27.9-51.2) with a structurally intact sphincter in 47%. Esophagitis occurred in 43%. At 48 [19-60] months after MSA, excellent outcomes were achieved in 47%, good in 28%, fair in 22%, and poor in 3%. Median DeMeester score was 15.6 (IQR = 5.8-26.6), esophagitis in 17.6% and daily PPI use in 17%. At univariable analysis, excellent/good outcomes were negatively impacted by BMI, preoperative LES residual pressure, Hill grade, and hiatal hernia. At multivariable analysis, BMI >35 (OR = 0.05, 0.003-0.78, p = 0.03), structurally defective LES (OR = 0.37, 0.13-0.99, p = 0.05), and preoperative LES residual pressure (OR = 0.89, 0.80-0.98, p = 0.02) were independent negative predictors of excellent/good outcome. CONCLUSIONS: Magnetic sphincter augmentation results in excellent/good outcomes in most patients but a higher BMI, structurally defective sphincter, and elevated LES residual pressure may prevent this goal.

Manometric Changes to the Lower Esophageal Sphincter After Magnetic Sphincter Augmentation in Patients With Chronic Gastroesophageal Reflux Disease.

OBJECTIVE: To evaluate the manometric changes, function, and impact of magnetic sphincter augmentation (MSA) on the lower esophageal sphincter (LES). BACKGROUND: Implantation of a MSA around the gastroesophageal junction has been shown to be a safe and effective therapy for gastroesophageal reflux disease, but its effect on the LES has not been elucidated. METHODS: Retrospective case control study (n = 121) evaluating manometric changes after MSA. Inclusion criteria consisted of a confirmed diagnosis of gastroesophageal reflux disease by an abnormal esophageal pH study (body mass index <35 kg/m, hiatal hernia <3 cm, and absence of endoscopic Barrett disease). Manometric changes, pH testing, and proton pump inhibitor use were assessed preoperatively and 6 and 12 months after MSA. RESULTS: MSA was associated with an overall increase in the median LES resting pressure (18 pre-MSA vs 23 mm Hg post-MSA; P = 0.0003), residual pressure (4 vs 9 mm Hg; P < 0.0001), and distal esophageal contraction amplitude (80 vs 90 mm Hg; P = 0.02). The percent peristalsis remained unaltered (94% vs 87%; P = 0.71).Overall, patients with a manometrically defective LES were restored 67% of the time to a normal sphincter with MSA. Those with a structurally defective or severely defective LES improved to a normal LES in 77% and 56% of patients, respectively. Only 18% of patients with a normal preoperative manometric LES deteriorated to a lower category. CONCLUSION: MSA results in significant manometric improvement of the LES without apparent deleterious effects on the esophageal body. A manometrically defective LES can be restored to normal sphincter, whereas a normal LES remains stable.

A combined thoracoscopic and laparoscopic approach for high epiphrenic diverticula and the importance of complete myotomy.

BACKGROUND: The traditional approach to epiphrenic diverticula is thoracotomy and diverticulectomy, together with myotomy ± partial fundoplication to address underlying dysmotility. A laparoscopic approach has been advocated but access to more proximal diverticula is problematic. We propose the selective addition of a thoracoscopic approach to overcome these challenges and reviewed our results. METHODS: A retrospective review from 2004 to 2015 identified 17 patients with an epiphrenic diverticulum who underwent surgery. Patients were grouped according to height of the diverticular neck (HDN) above the GEJ: group A < 5 cm, group B > 5 cm. Preoperative evaluation and type of surgery performed were recorded. Postoperative complications, mortality, and clinical outcomes using quality of life metrics and objective testing were assessed. RESULTS: The mean size of the diverticulum was 3.3 cm (2-6 cm) with a mean height above the GEJ of 5.5 cm (0-12 cm). A motility disorder was identified in 15/17. Group A, 9 patients, underwent laparoscopic diverticulectomy, myotomy, and partial fundoplication. For group B, 8 patients, the intended procedure was thoracoscopic diverticulectomy followed by laparoscopic myotomy and partial fundoplication, but this was only completed in 5. In 3 the myotomy was aborted or incomplete with subsequent staple line leaks resulting in 1 death. At a mean follow-up of 21 months, improvement of median QOLRAD scores from 3.42 to 6.2 (p = 0.18); GERD-HRQL from 23 to 1 (p = 0.05), swallowing score from 17.5 to 30 (p = 0.22), and Eckardt scores from 5 to 0 (p < 0.05) were observed. CONCLUSIONS: A minimally invasive strategy for epiphrenic diverticula based HDN above the GEJ and selective thoracoscopy for higher diverticula is feasible and appropriate, and resulted in improved quality of life. Incomplete myotomy was associated with a substantially higher complication rate. Laparoscopic myotomy should precede diverticulectomy for all cases, especially for high diverticula.

Repair of symptomatic paraesophageal hernias in elderly (>70 years) patients results in sustained quality of life at 5 years and beyond.

BACKGROUND: Paraesophageal hernias (PEHs) involve herniation of stomach and/or other viscera into the mediastinum. These commonly occur in the elderly and can severely limit quality of life. Short term outcomes of repaired PEH demonstrated low morbidity and significant improvement in quality of life, but long-term data for all patients, especially the elderly, are lacking. METHODS: Retrospective chart review of a prospectively collected database of patients aged 70 or greater with a symptomatic PEH repaired 5+ years ago. Quality of life data were assessed preoperatively, at 12-24 months, and at 5+ years using QOLRAD, GERD-HRQL, and DSS. RESULTS: We identified 137 patients who met the age criteria, with 69 patients undergoing surgery 5+ years ago. With ten patients were lost to follow-up, 59 patients were analyzed, including 24 males and 35 females. Median age at repair was 77 years. There were two 90-day mortalities, with one occurring within 30 days of surgery. Patients alive at evaluation had a median age of 74 years and were followed a median 7.4 years. From baseline, QOLRAD improved from 4 to 6.5, GERD-HRQL improved from 11 to 5, and swallowing improved from 11 to 38. During follow-up, 21 patients died. Deceased patients lived a median of 4 years after repair, with a median age at repair of 80 years. At a median time follow-up of 2 years, this group's QOLRAD improved from 5.1 to 7, GERD-HRQL improved from 16 to 4, and swallowing improved from 14.5 to 35. CONCLUSIONS: In elderly patients with symptomatic PEH undergoing surgical repair more than 5 years ago, there was sustained improvement in quality of life. This justifies surgical repair of symptomatic PEH in elderly patients.

Feasibility, safety, and short-term efficacy of the laparoscopic Nissen-Hill hybrid repair.

BACKGROUND: A novel antireflux procedure combining laparoscopic Nissen fundoplication and Hill repair components was tested in 50 patients with paraesophageal hernia (PEH) and/or Barrett's esophagus (BE) because these two groups have been found to have a high rate of recurrence with conventional repairs. METHODS: Patients with symptomatic PEH and/or non-dysplastic BE underwent repair. Quality of life (QOL) metrics, manometry, EGD, and pH testing were administered pre- and postoperatively. RESULTS: Fifty patients underwent repair. There was no mortality and four major complications. At 13-month follow-up, there was one (2%) clinical recurrence, and two (4%) asymptomatic fundus herniations. Mean DeMeester scores improved from 57.2 to 7.7 (p < 0.0001). Control of preoperative symptoms was achieved in 90% with 6% resumption of antisecretory medication. All QOL metrics improved significantly. CONCLUSIONS: The hybrid Nissen-Hill repair for patients with PEH and BE appears safe and clinically effective at short-term follow-up. It is hoped that the combined structural components may reduce the rate of recurrence compared to existing repairs.

Multi-institutional outcomes using magnetic sphincter augmentation versus Nissen fundoplication for chronic gastroesophageal reflux disease.

BACKGROUND: Magnetic sphincter augmentation (MSA) has emerged as an alternative surgical treatment of gastroesophageal reflux disease (GERD). The safety and efficacy of MSA has been previously demonstrated, although adequate comparison to Nissen fundoplication (NF) is lacking, and required to validate the role of MSA in GERD management. METHODS: A multi-institutional retrospective cohort study of patients with GERD undergoing either MSA or NF. Comparisons were made at 1 year for the overall group and for a propensity-matched group. RESULTS: A total of 415 patients (201 MSA and 214 NF) underwent surgery. The groups were similar in age, gender, and GERD-HRQL scores but significantly different in preoperative obesity (32 vs. 40 %), dysphagia (27 vs. 39 %), DeMeester scores (34 vs. 39), presence of microscopic Barrett's (18 vs. 31 %) and hiatal hernia (55 vs. 69 %). At a minimum of 1-year follow-up, 354 patients (169 MSA and 185 NF) had significant improvement in GERD-HRQL scores (pre to post: 21-3 and 19-4). MSA patients had greater ability to belch (96 vs. 69 %) and vomit (95 vs. 43 %) with less gas bloat (47 vs. 59 %). Propensity-matched cases showed similar GERD-HRQL scores and the differences in ability to belch or vomit, and gas bloat persisted in favor of MSA. Mild dysphagia was higher for MSA (44 vs. 32 %). Resumption of daily PPIs was higher for MSA (24 vs. 12, p = 0.02) with similar patient-reported satisfaction rates. CONCLUSIONS: MSA for uncomplicated GERD achieves similar improvements in quality of life and symptomatic relief, with fewer side effects, but lower PPI elimination rates when compared to propensity-matched NF cases. In appropriate candidates, MSA is a valid alternative surgical treatment for GERD management.

Assessment and reduction of diaphragmatic tension during hiatal hernia repair.

BACKGROUND: During hiatal hernia repair there are two vectors of tension: axial and radial. An optimal repair minimizes the tension along these vectors. Radial tension is not easily recognized. There are no simple maneuvers like measuring length that facilitate assessment of radial tension. The aims of this project were to: (1) establish a simple intraoperative method to evaluate baseline tension of the diaphragmatic hiatal muscle closure; and, (2) assess if tension is reduced by relaxing maneuvers and if so, to what degree. METHODS: Diaphragmatic characteristics and tension were assessed during hiatal hernia repair with a tension gage. We compared tension measured after hiatal dissection and after relaxing maneuvers were performed. RESULTS: Sixty-four patients (29 M:35F) underwent laparoscopic hiatal hernia repair. Baseline hiatal width was 2.84 cm and tension 13.6 dag. There was a positive correlation between hiatal width and tension (r = 0.55) but the strength of association was low (r (2) = 0.31). Four different hiatal shapes (slit, teardrop, "D", and oval) were identified and appear to influence tension and the need for relaxing incision. Tension was reduced by 35.8 % after a left pleurotomy (12 patients); by 46.2 % after a right crural relaxing incision (15 patients); and by 56.1 % if both maneuvers were performed (6 patients). CONCLUSIONS: Tension on the diaphragmatic hiatus can be measured with a novel device. There was a limited correlation with width of the hiatal opening. Relaxing maneuvers such as a left pleurotomy or a right crural relaxing incision reduced tension. Longer term follow-up will determine whether outcomes are improved by quantifying and reducing radial tension.

Long-Term Outcomes of Magnetic Sphincter Augmentation: A Comparative Study to Nissen Fundoplication.

BACKGROUND: Magnetic sphincter augmentation (MSA) demonstrates improvement in gastroesophageal reflux disease (GERD) across multiple short-term studies. Long-term, single-arm studies show durable outcomes, but there is limited comparative data to Nissen fundoplication (NF). METHODS: We performed a retrospective propensity-matched cohort study of patients with GERD undergoing MSA or NF between 2012 and 2018. Patients were matched on age, sex, body mass index, size of hiatal hernia, length of Barrett esophagus, and motility in a 1:1 fashion. A total of 523 patients (177 MSA, 346 NF) underwent surgery and after matching 177 MSA and 177 NF cases were analyzed. RESULTS: At 1 year, GERD quality of life scores improved (22 to 5 MSA vs 24 to 5 NF, P = .593). Proton pump inhibitor use was 14% vs 5% (P = .010). pH testing demonstrated improved DeMeester scores (42 to 21 vs 46 to 7, P < .001). At 5 years, GERD quality of life scores were stable (5 to 5 vs 5 to 4, P = .208). Proton pump inhibitor use was 31% vs 26% (P = .474). The incidence of endoscopic dilation was similar between MSA and NF (7% vs 10%, P = .347). Reoperation rates were higher for MSA (10% vs 4%, P = .022) and recurrent hiatal hernias were found in 18% vs 7% (P = .007). Compared to NF, MSA undergoing complete dissection showed no difference in dilation (5% MSA vs 7% NF, P = .527), reoperation (8% MSA vs 6% NF, P = .684) or hernia recurrence (10% MSA vs 6% NF, P = .432). CONCLUSIONS: MSA achieves similar improvements in quality of life and freedom from medical therapy compared to NF, especially with complete hiatal repair.

The classification of hiatal shapes and their use as a marker for complexity, operative interventions, and recurrence.

BACKGROUND: Diaphragmatic reconstruction is a vital, but challenging component of hiatal hernia and antireflux surgery. Results are optimized by minimizing axial tension along the esophagus, assessed with intra-abdominal length, and radial tension across the hiatus, which has not been standardized. We categorized hiatal openings into 4 shapes, as a surrogate for radial tension, to correlate their association with operative interventions and recurrence. METHODS: We retrospectively reviewed all primary hiatal hernias (≥3 cm) repaired at a single center between 2010 and 2020. Patients with intraoperative hiatal photos with at least 1 year of follow-up were included. The hiatal openings were classified into 4 shapes: slit, inverted teardrop, "D," and oval, and ordered in this manner of hypothesized increased complexity and tension. RESULTS: A total of 239 patients were studied, with 113 (47%) having a recurrence. Age (P < .001), proportion of paraesophageal hernias (P < .001), hernia axial length (P < .001), and hiatal width (P < .001) all increased as shape progressed from slit to inverted teardrop to "D" to oval. Mesh (P = .003) and relaxing incisions (P < .001) were more commonly employed in more advanced shapes, "D" and ovals. However, recurrence (P = .88) did not correlate with hiatal shape. CONCLUSION: Four different hiatal shapes are commonly seen during hernia repair. These shapes represent a spectrum of hernia chronicity and complexity necessitating increased use of operative measures but not correlating with recurrence. Despite failing to be a direct marker for recurrence risk, hiatal shape may serve as an intraoperative tool to inform surgeons of the potential need for additional hiatal interventions.

Thirty- and 90-Day Morbidity and Mortality by Clavien-Dindo after Surgery for Antireflux and Hiatal Hernia.

BACKGROUND: The historic morbidity and mortality rates of antireflux and hiatal hernia operation are reported as 3% to 21% and 0.2% to 0.5%, respectively. These data come from either large national and population level or small institutional studies, with the former focusing on broad 30-day outcomes while lacking granular data on complications and their severity. Institutional studies tend to focus on long-term and quality-of-life outcomes. Our objective is to describe and evaluate the incidence of 30- and 90-day morbidity and mortality in a large, single-institution dataset. STUDY DESIGN: We retrospectively reviewed 2,342 cases of antireflux and hiatal hernia operation from 2003 to 2020 for intraoperative complications causing postoperative sequelae, as well as morbidity and mortality within 90 days. All complications were graded using the Clavien-Dindo (CD) grading system. The highest grade of complication was used per patient during 30- and 31- to 90-day intervals. RESULTS: Of 2,342 patients, the overall 30-day morbidity and mortality rates were 18.2% (427 of 2,342) and 0.2% (4 of 2,342), respectively. Most of the complications were CD less than 3a at 13.1% (306 of 2,342). In the 31- to 90-day postoperative period, morbidity and mortality rates decreased to 3.1% (78 of 2,338) and 0.09% (2 of 2,338). CD less than 3a complications accounted for 1.9% (42 of 2,338). CONCLUSIONS: Antireflux and hiatal hernia operations are safe with rare mortality and modest rates of morbidity. However, the majority of complications patients experience are minor (CD less than 3a) and are easily managed. A minority of patients will experience major complications (CD 3a or greater) that require additional procedures and management to secure a safe outcome. These data are helpful to inform patients of the risks of operation and guide physicians for optimal consent.

Laparoscopic revisional antireflux and hiatal hernia surgery results in a higher rate of complications and severity at 90 days than primary surgery.

OBJECTIVE: Data on graded complications and their frequency after laparoscopic revisional antireflux and hiatal hernia surgery compared with primary surgery are lacking. We describe 30- and 90-day morbidity using the Clavien-Dindo classification. METHODS: A total of 298 patients underwent revision surgery between 2003 and 2020 and were propensity matched to primary surgeries (1:2 ratio) based on age, sex, body mass index, American Society of Anesthesiology classification, Los Angeles grade esophagitis, presence of Barrett's, and indication for surgery. Complications were graded using the Clavien-Dindo classification, with the highest grade of complication reported per patient. RESULTS: After matching, both groups had a majority of female patients, with a median age of 60 years and a median body mass index of 29.5 kg/m2. Most were healthy, with nonerosive esophagitis and modest levels of Barrett's esophagus. A laparoscopic Nissen fundoplication was most common; however, a partial fundoplication was more common in revisions. Mesh, relaxing incisions, and Collis were more common in revisional surgery. At 30 days, total complications were similar (23.5% [70/298] vs 20.6% [123/596], P = .373) with 1 death in each group. Minor complications (less than Clavien-Dindo 3A) were comparable. Patients undergoing revisional surgery experienced Clavien-Dindo 3B complications (4.7% [14] vs 0.8% [5], P > .001) more frequently, with esophageal obstruction requiring revision and esophageal/gastric leak being most common. Grade Clavien-Dindo 4 A/B complications were comparable in both groups. At 90 days, patients undergoing revisional surgery experienced overall complications (7.1% [21] vs 2.0% [12], P = .003), and Clavien-Dindo 3B complications (1.0% [3] vs 0, P = .037) more frequently, with intra-abdominal abscess washout being the most common Clavien-Dindo 3B complication. CONCLUSIONS: Revisional surgery results in similar total complications at 30 days, but additional complications can occur out to 90 days.

Morbidity and mortality after antireflux and hiatal hernia surgery across a spectrum of ages.

BACKGROUND: Antireflux surgery (ARS) and hiatal hernia repair (HHR) are common surgical procedures with modest morbidity. Increasing age is a risk factor for complications; however, details regarding acute morbidity are lacking. This study aimed to describe the incidence rates and types of morbidities across the spectrum of ages. METHODS: A total of 2342 consecutive cases were retrospectively reviewed from 2003 to 2020 for 30-day complications. All complications were assessed using the Clavien-Dindo (CD) grading system. Patients were divided into 5 age groups: ≤59, 60 to 69, 70 to 79, 80 to 89, and ≥90 years. RESULTS: The numbers per age group were 1100 patients aged ≤59 years, 684 patients aged 60 to 69 years, 458 patients aged 70 to 79 years, 458 patients aged 80 to 89 years, and 6 patients aged ≥90 years. A total of 427 complications (18.2%) occurred, including 2 mortalities, each in the 60- to 69-year age group and the 70- to 79-year age group, for a mortality rate of 0.2%. The complication rate increased from 13.5% (149) in patients aged ≤59 years to 35.0% (35) in patients aged ≥80 years (P = .006), with CD grades I and II accounting for >70% of complications, except in patients aged ≥80 years (57.1%). CD grades IIIa and IIIb were higher in patients aged ≥80 years (26.5% [P = .001] and 11.8% [P = .021], respectively). CD grade IVa and IVb complications were rare overall. CONCLUSION: There is a modest rate of morbidity that increases as patients age, regardless of hernia type, elective or primary surgery, with most being minor complications (CD grade≤II). Our data should help patients, referring physicians, and surgeons counsel patients regarding the effect of increasing age in ARS and HHR.

The laparoscopic Nissen-Hill hybrid: pilot study of a combined antireflux procedure.

BACKGROUND: Laparoscopic antireflux surgery is highly effective in patients with uncomplicated gastroesophageal reflux disease (GERD). However, long-term failure rates in paraesophageal hernia (PEH) and Barrett's metaplasia (BE) are higher and warrant a more durable repair. Outcomes for the laparoscopic Nissen fundoplication (LNF) and Hill repair (LHR) are equivalent, but their anatomic components are different and may complement each other (Aye R Ann Thorac Surg, 2012). We designed and tested the feasibility and safety of an operation that combines the essential components of each repair. METHODS: A prospective, phase II pilot study was performed on patients with symptomatic giant PEH hernias and/or GERD with nondysplastic Barrett's metaplasia. Pre- and postoperative esophagogastroduodenoscopy (EGD), upper gastrointestinal study (UGI), 48-hour pH testing, manometry, and three quality-of-life metrics were obtained. RESULTS: Twenty-four patients were enrolled in the study. Three patients did not complete the planned procedure, leaving 21 patients, including 12 with PEH, 7 with BE, and 2 with both. There were no 30-day or in-hospital mortalities. At a median follow-up of 13 (range 6.4-30.2) months, there were no reoperations or clinical recurrences. Two patients required postoperative dilation for dysphagia, with complete resolution. Mean DeMeester scores improved from 54.3 to 7.5 (p < 0.0036). Mean lower esophageal sphincter pressures (LESP) increased from 8.9 to 21.3 mmHg (p < 0.013). Mean short-term and long-term QOLRAD scores improved from 4.09 at baseline to 6.04 and 6.48 (p < 0.0001). Mean short-term and long-term GERD-HQRL scores improved from 22.9 to 7.5 and 6.9 (p < 0.03). Mean long-term Dysphagia Severity Score Index improved from 33.3 to 40.6 (p < 0.064). CONCLUSIONS: The combination of a Nissen plus Hill hybrid reconstruction of the gastroesophageal junction (GEJ) is technically feasible, safe, and not associated with increased side effects. Short-term clinical results in PEH and BE suggest that this may be an effective repair, supporting the value of further study.

Effect of Intrapleural Fibrinolytic Therapy vs Surgery for Complicated Pleural Infections: A Randomized Clinical Trial.

Importance: There is a paucity of high-quality prospective randomized clinical trials comparing intrapleural fibrinolytic therapy (IPFT) with surgical decortication in patients with complicated pleural infections. Objective: To assess the feasibility, safety, and efficacy of an algorithm comparing tissue plasminogen activator plus deoxyribonuclease therapy with surgical decortication in patients with complicated pleural infections. Design, Setting, and Participants: This parallel pilot randomized clinical trial was performed at a single urban community-based center from March 1, 2019, to December 31, 2021, with follow-up for 90 days. Seventy-four individuals were screened and 48 were excluded. Twenty-six patients 18 years or older with clinical pleural infection and positive findings of pleural fluid analysis were included. Of these, 20 patients underwent randomized selection (10 in each group), and 6 were observed. Interventions: Intrapleural tissue plasminogen activator plus deoxyribonuclease therapy vs surgical decortication. Main Outcomes and Measures: Primary outcomes were the percentage of patients enrolled to study completion and multidisciplinary adherence. Secondary outcomes included the number of patients with and the reason for inadequate screening, screening to enrollment failures, time to accrual of 20 patients or the number accrued at 1 year, and clinical data. Results: Twenty-six patients were enrolled, 10 were randomized to each group, and 6 were observed. There was 100% enrollment to study completion in each treatment group, no protocol deviations, 2 minor protocol amendments, and no screening to enrollment failures. It took 32 months to enroll 26 patients. The 20 randomized patients had a median age of 57 (IQR, 46-65) years, were predominantly men (15 [75%]), and had a median RAPID (Renal, Age, Purulence, Infection Source, and Dietary Factors) score of 2 (IQR, 1-3). Treatment failure occurred in 1 patient and 2 crossover treatments occurred, all of which were in the IPFT group. Intraprocedure and postprocedure complications were similar between the groups. There were no reoperations or in-hospital deaths. Median duration of chest tube use was comparable in the IPFT (5 [IQR, 4-8] days) and surgery (4 [IQR, 3-5] days) groups (P = .21). Median hospital stay tended to be longer in the IPFT (11 [IQR, 4-18] days) vs surgery (5 [IQR, 4-6] days) groups, although the difference as not significantly different (P = .08). There were no 30-day readmissions or 30- or 90-day deaths. Conclusions and Relevance: In this pilot randomized clinical trial, the study algorithm was feasible, safe, and efficacious. This provides evidence to move forward with a multicenter randomized clinical trial. Trial Registration: ClinicalTrials.gov Identifier: NCT03873766.