101 results on '"Lipham JC"'
Search Results
2. The LINX® reflux management system: confirmed safety and efficacy now at 4 years.
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Lipham JC, Demeester TR, Ganz RA, Bonavina L, Saino G, Dunn DH, Fockens P, Bemelman W, Lipham, John C, DeMeester, Tom R, Ganz, Robert A, Bonavina, Luigi, Saino, Greta, Dunn, Daniel H, Fockens, Paul, and Bemelman, Willem
- Abstract
Background: Sphincter augmentation with the LINX® Reflux Management System is a surgical option for patients with chronic gastroesophageal disease (GERD) and an inadequate response to proton pump inhibitors (PPIs). Clinical experience with sphincter augmentation is now available out to 4 years.Methods: In a multicenter, prospective, single-arm study, 44 patients underwent a laparoscopic surgical procedure for placement of the LINX System around the gastroesophageal junction (GEJ). Each patient's baseline GERD status served as the control for evaluations post implant. Long-term efficacy measures included esophageal acid exposure, GERD quality-of-life measures, and use of PPIs. Adverse events and long-term complications were closely monitored.Results: For esophageal acid exposure, the mean total % time pH < 4 was reduced from 11.9 % at baseline to 3.8 % at 3 years (p < 0.001), with 80 % (18/20) of patients achieving pH normalization (≤ 5.3 %). At ≥ 4 years, 100 % (23/23) of the patients had improved quality-of-life measures for GERD, and 80 % (20/25) had complete cessation of the use of PPIs. There have been no reports of death or long-term device-related complications such as migration or erosion.Conclusions: Sphincter augmentation with the LINX Reflux Management System provided long-term clinical benefits with no safety issues, as demonstrated by reduced esophageal acid exposure, improved GERD-related quality of life, and cessation of dependence on PPIs, with minimal side effects and no safety issues. Patients with inadequate symptom control with acid suppression therapy may benefit from treatment with sphincter augmentation. [ABSTRACT FROM AUTHOR]- Published
- 2012
3. Cruroplasty as a standalone treatment for recurrent hiatal hernia repair.
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Tran A, Putnam LR, Harvey L, and Lipham JC
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- Humans, Male, Female, Retrospective Studies, Middle Aged, Aged, Laparoscopy, Gastroesophageal Reflux surgery, Quality of Life, Treatment Outcome, Hernia, Hiatal surgery, Recurrence, Reoperation statistics & numerical data, Herniorrhaphy methods, Fundoplication methods
- Abstract
Purpose: Following laparoscopic anti-reflux surgery (LARS), recurrence of hiatal hernia is common. Patients with symptomatic recurrence typically undergo revision of the fundoplication or conversion to magnetic sphincter augmentation (MSA) in addition to cruroplasty. However, patients with an intact fundoplication or MSA may only require repeat cruroplasty to repair their recurrent hiatal hernia. The purpose of this study is to compare outcomes following cruroplasty alone compared to full revision (i.e. redo fundoplication or MSA with cruroplasty) for the management of recurrent hiatal hernias., Methods: A retrospective review of patients undergoing surgical revision of a symptomatic recurrent hiatal hernia between February 2009 and October 2022 was performed. Preoperative characteristics, intraoperative details, and postoperative outcomes were compared between patients undergoing cruroplasty alone versus full revision., Results: A total of 141 patients were included in the analysis. 93 patients underwent full revision, and 48 patients underwent cruroplasty alone. The mean time between initial and revisional surgery was 8 ± 7.7 years. There was no significant difference in operative time or rates of intra-operative or post-operative complication between groups. Patients undergoing cruroplasty alone had a mean Gastroesophageal Reflux Disease Health Related Quality Life (GERD-HRQL) Questionnaire score of 9.6 ± 10.2 compared to a mean score of 8.9 ± 11.2 for full revision patients (p = 0.829). Recurrence rates following revision was 10.4% for cruroplasty alone patients and 11.8% in full revision patients (p > 0.999)., Conclusion: In patients with intact fundoplication or MSA, cruroplasty alone results in similar post-operative outcomes compared to full revision for recurrent hiatal hernia., (© 2024. The Author(s).)
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- 2024
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4. Utility of the mFI-5 as a predictor of post-operative outcomes following gastrectomy for gastric cancer: an ACS-NSQIP analysis.
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Tran A, Putnam LR, Lipham JC, and Shiraga S
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- Humans, Female, Male, Aged, Middle Aged, Retrospective Studies, Aged, 80 and over, Patient Readmission statistics & numerical data, Risk Assessment methods, Quality Improvement, Gastrectomy methods, Gastrectomy adverse effects, Stomach Neoplasms surgery, Postoperative Complications epidemiology, Postoperative Complications etiology, Frailty complications
- Abstract
Background: Gastric cancer is the 5th most common malignancy worldwide. Surgical treatment for the disease can often be highly morbid, especially in elderly patients. The modified 5-item frailty index (mFI-5), a recently developed tool for assessing patient frailty, has been shown to be an effective predictor of post-operative outcomes in various surgical fields. This study aims to assess the utility of the mFI-5 in predicting adverse postoperative outcomes following gastrectomy for gastric cancer., Methods: The National Surgical Quality Improvement Program (NSQIP) database was queried for patients who underwent partial or total gastrectomy for gastric cancer between 2011 and 2021. The mFI-5 score was calculated based on the presence of hypertension, congestive heart failure, diabetes mellitus, chronic obstructive pulmonary disease, and partially or fully dependent functional status. Patients were stratified into 3 groups according to mFI-5 score (mFI-5 = 0, mFI-5 = 1, mFI-5 ≥ 2). Univariate analysis and multivariate logistic regression were used to evaluate the association between mFI-5 score and post-operative outcomes., Results: 7438 patients were identified (mFI-5 = 0: 3032, mFI-5 = 1: 2805, mFI-5 ≥ 2: 1601). mFI-5 ≥ 2 was an independent predictor of overall complications (OR 1.43, p < 0.001), serious complications (OR 1.42, p < 0.001), pneumonia (OR 1.43, p = 0.010), MI (OR 2.91, p = 0.005), and readmission within 30 days (OR 1.33, p = 0.008). Patients with higher frailty were more likely to experience unplanned intubation (OR 2.06, p < 0.001; OR 2.47, p < 0.001), failure to wean from the ventilator (OR 1.68, p = 0.003; OR 2.00, p < 0.001), acute renal failure (OR 3.25, p = 0.003; OR 3.27, p = 0.005), 30-day mortality (OR 1.73, p = 0.009; OR 1.94, p = 0.004), and non-home discharge (OR 1.34, p = 0.001; OR 1.74, p < 0.001) relative to non-frail patients., Conclusion: Higher frailty, as indicated by an increased mFI-5 score, raises the risk of serious post-operative complications in patients with gastric cancer undergoing gastrectomy. The mFI-5 has the potential to help identify high-risk patients and enhance pre-operative discussions and optimization., (© 2024. The Author(s).)
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- 2024
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5. Tumor differentiation impacts response to neoadjuvant therapy and survival in patients with esophageal adenocarcinoma.
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McKay SC, Louie BE, Molena D, Andrews WG, Boerner T, Hofstetter WL, Yeung J, Darling GE, Sharata A, Peyre CG, Dunn C, Lipham JC, Marginean H, and DeMeester SR
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- Humans, Male, Middle Aged, Female, Retrospective Studies, Aged, Neoplasm Staging, Chemoradiotherapy, Adjuvant mortality, Neoplasm Grading, Cell Differentiation, Treatment Outcome, Adult, Disease-Free Survival, Risk Factors, Esophageal Neoplasms mortality, Esophageal Neoplasms therapy, Esophageal Neoplasms pathology, Adenocarcinoma mortality, Adenocarcinoma therapy, Adenocarcinoma pathology, Neoadjuvant Therapy mortality, Esophagectomy mortality, Esophagectomy adverse effects
- Abstract
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., Competing Interests: Conflict of Interest Statement The authors reported no conflicts of interest. The Journal policy requires editors and reviewers to disclose conflicts of interest and to decline handling or reviewing manuscripts for which they may have a conflict of interest. The editors and reviewers of this article have no conflicts of interest., (Copyright © 2023 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.)
- Published
- 2024
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6. Short term safety of magnetic sphincter augmentation vs minimally invasive fundoplication: an ACS-NSQIP analysis.
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Wisniowski P, Putnam LR, Gallagher S, Rawal R, Houghton C, and Lipham JC
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- Humans, Male, Fundoplication adverse effects, Fundoplication methods, Esophageal Sphincter, Lower surgery, Quality Improvement, Treatment Outcome, Postoperative Complications epidemiology, Postoperative Complications etiology, Postoperative Complications surgery, Magnetic Phenomena, Quality of Life, Retrospective Studies, Laparoscopy methods, Gastroplasty
- Abstract
Purpose: Magnetic Sphincter Augmentation (MSA) is an FDA-approved anti-reflux procedure with comparable outcomes to fundoplication. However, most data regarding its use are limited to single or small multicenter studies which may limit the generalizability of its efficacy. The purpose of this study is to evaluate the outcomes of patients undergoing MSA vs fundoplication in a national database., Materials and Methods: The 2017-2020 American College of Surgeons National Surgical Quality Improvement Program (ACS-NSQIP) Registry was utilized to evaluate patients undergoing MSA or fundoplication. Patients requiring Collis gastroplasty, paraesophageal hernia repair, and emergency cases, were excluded. Patient outcomes included overall complication rates, readmissions, reoperations, and mortality., Results: A total of 7,882 patients underwent MSA (n = 597) or fundoplication (n = 7285). MSA patients were younger (51 vs 57, p < 0.001), and more often male (49.6 vs 34.3%, p < 0.001). While patients undergoing MSA experienced similar rates of reoperation (1.0 vs 2.0%, p = 0.095), they experienced fewer readmissions (2.2 vs 4.7%, p = 0.005), complications (0.6 vs 4.0%, p < 0.001), shorter mean (SD) hospital length of stay(days) (0.4 ± 4.3 vs 1.8 ± 4.6, p < 0.001) and operative time(min) (80.8 ± 36.1 vs 118.7 ± 63.7, p < 0.001). Mortality was similar between groups (0 vs 0.3%, p = 0.175). On multivariable analysis, MSA was independently associated with reduced postoperative complications (OR 0.23, CI 0.08 to 0.61, p = 0.002), readmissions (OR 0.53, CI 0.30 to 0.94, p = 0.02), operative time (RC - 36.56, CI - 41.62 to - 31.49. p < 0.001) and length of stay (RC - 1.22, CI - 1.61 to - 0.84 p < 0.001)., Conclusion: In this national database study, compared to fundoplication MSA was associated with reduced postoperative complications, fewer readmissions, and shorter operative time and hospital length of stay. While randomized trials are lacking between MSA and fundoplication, both institutional and national database studies continue to support the use of MSA as a safe anti-reflux operation., (© 2024. The Author(s).)
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- 2024
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7. Is Endoscopic Surveillance Needed After Laparoscopic Sleeve Gastrectomy?
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Aiolfi A, Bona D, Lipham JC, and Bonavina L
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- Humans, Gastrectomy, Treatment Outcome, Laparoscopy, Obesity, Morbid surgery
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- 2024
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8. Magnetic sphincter augmentation: laparoscopic or robotic approach?
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Maharsi S, Lipham JC, and Houghton CC
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- Humans, Esophageal Sphincter, Lower surgery, Treatment Outcome, Magnets, Fundoplication adverse effects, Magnetic Phenomena, Robotic Surgical Procedures adverse effects, Gastroesophageal Reflux etiology, Gastroesophageal Reflux surgery, Gastroesophageal Reflux drug therapy, Laparoscopy
- Abstract
Gastroesophageal reflux disease (GERD)-the pathologic reflux of gastric contents into the distal esophagus-is the most common benign disorder of the esophagus. Its incidence is at 10-20% of the Western population and it yearly cost of treatment in the USA in 9.3 billion dollars. Although first line treatment for the disorder is medical therapy with proton pump inhibitors, an estimated 30-40% of patients will continue to experience medically refractory GERD. In this population anti-reflux surgery can be offered. Traditional anti-reflux surgery is done via the Nissen fundoplication, a technically difficult surgery with uncomfortable side effects of bloating and inability to belch. Magnetic sphincter augmentation (MSA) of the lower esophagus via the LINX device was introduced a less technically challenging alternative to the Nissen. The LINX provides fewer side effects of bloating and inability to belch and has been adapted widely to the practice of anti-reflux surgery. In this paper we discuss the progression of surgical practices with the LINX, including an analysis of the laparoscopic and robotic approaches to MSA device implantation., (© The Author(s) 2023. Published by Oxford University Press on behalf of International Society for Diseases of the Esophagus. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)
- Published
- 2023
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9. Lower Rates of Unplanned Conversion to Open in Robotic Approach to Esophagectomy for Cancer.
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Silva JP, Putnam LR, Wu J, Ding L, Samakar K, Abel S, Nguyen JD, Dobrowolsky AB, Bildzukewicz NA, and Lipham JC
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- Humans, Retrospective Studies, Carcinoma, Squamous Cell surgery, Minimally Invasive Surgical Procedures, Esophagectomy, Robotic Surgical Procedures, Esophageal Neoplasms
- Abstract
Background: Minimally invasive approaches to esophagectomy have gained popularity worldwide; however, unplanned conversion to an open approach is not uncommon. This study sought to investigate risk factors associated with converting to an open approach and to evaluate outcomes following conversion., Methods: Patients undergoing minimally invasive esophagectomy (MIE) for cancer were identified using the 2016-2019 Procedure Targeted NSQIP Database. Multivariable, stepwise logistic regression analysis was performed to investigate factors associated with unplanned conversion to open esophagectomy. Propensity-matched comparison of robotic (RAMIE) to traditional MIE was performed., Results: A total of 1347 patients were included; 140 patients (10%) underwent conversion to open. Morbid obesity, diabetes, hypertension, American Society of Anesthesiologists class, and squamous cell carcinoma were associated with a higher likelihood of conversion. A robotic approach was associated with a lower likelihood of conversion to open (OR .57, 95% CI 0.32-.99). On multivariable analysis, squamous cell carcinoma pathology was the only variable independently associated with higher odds of conversion (OR 2.66, 95% CI 1.02-6.98). Propensity-matched comparison of RAMIE vs MIE showed no significant difference in conversion rate (6.5% vs 9.1%, P = .298), morbidity, or mortality., Discussion: A robotic approach to esophagectomy was associated with a lower likelihood of unplanned conversion to open, and patients who were converted to open experienced worse outcomes. Future studies should aim to determine why a robotic esophagectomy approach may lead to fewer open conversions as it may be an underappreciated benefit of this newest operative approach.
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- 2023
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10. The Impact of Ineffective Esophageal Motility on Patients Undergoing Magnetic Sphincter Augmentation.
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Baison GN, Jackson AS, Wilshire CL, Bell RCW, Lazzari V, Bonavina L, Ayazi S, Jobe BA, Schoppmann SF, Dunn CP, Lipham JC, Dunst CM, Farivar AS, Bograd AJ, and Louie BE
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- Humans, Case-Control Studies, Esophageal Sphincter, Lower surgery, Magnetic Phenomena, Quality of Life, Retrospective Studies, Treatment Outcome, Deglutition Disorders etiology, Deglutition Disorders surgery, Gastroesophageal Reflux surgery, Laparoscopy
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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., (Copyright © 2022 Wolters Kluwer Health, Inc. All rights reserved.)
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- 2023
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11. Gastric electric stimulator versus gastrectomy for the treatment of medically refractory gastroparesis.
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Samaan JS, Toubat O, Alicuben ET, Dewberry S, Dobrowolski A, Sandhu K, Zehetner J, Lipham JC, and Samakar K
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- Gastrectomy adverse effects, Humans, Retrospective Studies, Treatment Outcome, Electric Stimulation Therapy, Gastroparesis etiology, Gastroparesis surgery
- Abstract
Background: Gastric electrical stimulation (GES) and laparoscopic gastrectomy (LG) are known therapeutic options for medically refractory gastroparesis (MRG) although there are limited data comparing their outcomes. We aim to compare clinical outcomes between patients undergoing GES vs upfront LG for the treatment of MRG while examining factors associated with GES failure and conversion to LG., Methods: We retrospectively analyzed 181 consecutive patients who underwent GES or LG for MRG at our institution from January 2003 to December 2017. Data collection consisted of chart review and follow-up telephone survey. Statistical analysis utilized Chi-squared, ANOVA, and multivariable logistic regression., Results: Overall, 130 (72%) patients underwent GES and 51 (28%) LG as primary intervention. GES patients were more likely to have diabetic gastroparesis (GES 67% vs LG 39%, p < 0.001), while primary LG patients were more likely to have post-surgical gastroparesis (GES 5% vs LG 43%, p < 0.001). Postoperatively, primary LG patients had higher rates of major in-hospital morbidity events (GES 5% vs LG 18%, p = 0.017) and longer hospital stays (GES 3 vs LG 9 days, p < 0.001). However, over a mean 35-month follow-up period, there were no differences in the rates of major morbidity, readmissions, or mortality. Multivariable regression analysis revealed patients undergoing GES as a primary intervention were less likely to report improvement in symptoms on follow-up compared to primary LG patients OR 0.160 (95% CI 0.048-0.532). Additionally, patients who converted to LG from GES were more likely to have post-surgical gastroparesis as the primary etiology., Conclusion: GES as a first-line surgical treatment of MRG was associated with worse outcomes compared to LG. Post-surgical etiology was associated with an increased likelihood of GES failure, and in such patients, upfront gastrectomy may be a superior alternative to GES. Further studies are needed to determine patient selection for operative treatment of MRG., (© 2022. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)
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- 2022
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12. Impact of Robotic Approach on Post-Anastomotic Leaks After Esophagectomy for Esophageal Cancer.
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Wu J, Putnam LR, Silva JP, Houghton C, Bildzukewicz N, and Lipham JC
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- Anastomosis, Surgical adverse effects, Anastomotic Leak epidemiology, Anastomotic Leak etiology, Anastomotic Leak surgery, Esophagectomy adverse effects, Humans, Retrospective Studies, Treatment Outcome, Esophageal Neoplasms etiology, Esophageal Neoplasms surgery, Robotic Surgical Procedures adverse effects
- Abstract
Introduction: Although mortality rates after esophagectomy have decreased over the last 30 years, anastomotic leaks still commonly persist and portend significant morbidity. Previous studies have analyzed patient and perio-perative risk factors for leaks, yet data describing the association of leaks and an open or minimally invasive approach are lacking. The purpose of this study was to evaluate the impact of operative approach on leak rates and subsequent management of the leaks., Methods: We queried the Procedure-Targeted National Surgical Quality Improvement Program Database for patients undergoing esophagectomy for cancer in the years from 2016 to 2019. Patient demographics, disease-related information, peri-operative data, and short-term outcomes were reviewed. Multivariable, stepwise logistic regression analysis was performed to investigate factors associated with post-operative anastomotic leaks., Results: Of the 2696 patients who underwent esophagectomy for cancer, anastomotic leaks occurred in 374 (14%). Based on approach, 13% of open, 14% of laparoscopic, and 18% of robotic cases were complicated by leak ( P = .123). Multivariable analysis identified the following significant risk factors for leak: diabetes (OR 1.32, P = .047), hypertension (OR 1.32, P = .022), and longer operative time (OR 1.61, P < .001). The percentage of leaks requiring endoscopic or operative intervention was 75% for open, 79% for laparoscopic, and 54% for robotic cases ( P = .004)., Conclusions: Anastomotic leaks after esophagectomy for cancer occur frequently regardless of surgical approach. Furthermore, these leaks are managed differently after an open, laparoscopic, or robotic approach. Robotic esophagectomies complicated by anastomotic leak required less invasive management.
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- 2022
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13. Loosening the belt on magnetic sphincter augmentation indications: does body mass index matter?
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James TJ, Burke JF, Putnam LR, Pan J, Bildzukewicz NA, Bell R, and Lipham JC
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- Body Mass Index, Esophageal Sphincter, Lower surgery, Female, Humans, Magnetic Phenomena, Obesity surgery, Overweight complications, Overweight surgery, Quality of Life, Retrospective Studies, Treatment Outcome, Gastroesophageal Reflux complications, Gastroesophageal Reflux surgery, Hernia, Hiatal surgery, Laparoscopy
- Abstract
Background: Magnetic sphincter augmentation (MSA) is an effective treatment for gastroesophageal reflux disease (GERD). However, the impact of obesity on MSA outcomes is unknown. The objective of this study was to evaluate the effectiveness of MSA in patients with GERD and obesity., Methods: A retrospective cohort study was performed of consecutive patients who underwent laparoscopic MSA at three high-volume centers from 2016 to 2019. Patients were grouped into four cohorts according to the World Health Organization body mass index (BMI) classification: BMI < 25 (normal weight), BMI 25-29.9 (overweight), BMI 30-34.9 (obese class I), and BMI > 35 (obese class II-III). Preoperative, operative, and postoperative data were compared between groups., Results: A total of 621 patients underwent laparoscopic MSA during the study period. Follow-up with endoscopy or video esophagram was available for 361 patients (58%) with a median follow-up of 15.4 months. Baseline characteristics of the groups were similar except the BMI > 35 group had more females and a higher preoperative median DeMeester score. There were no significant differences in outcomes between normal weight, overweight, and obese patient groups undergoing MSA. All groups experienced significant reductions in acid suppressive medication use, low GERD-HRQL scores, low DeMeester scores, few intraoperative and postoperative complications, and low rates of hiatal hernia recurrence after MSA., Conclusions: Magnetic sphincter augmentation is safe and effective in improving GERD symptoms, reducing esophageal acid exposure, and preventing hiatal hernia recurrence, irrespective of patient BMI. MSA should be considered an acceptable treatment option for obese patients with GERD., (© 2021. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)
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- 2022
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14. Response to the Comment on "Objective Evidence of Reflux Control After Magnetic Sphincter Augmentation: One Year Results From a Post Approval Study".
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Louie BE, Dunst C, and Lipham JC
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- Esophageal Sphincter, Lower surgery, Humans, Magnetic Phenomena, Gastroesophageal Reflux etiology, Gastroesophageal Reflux prevention & control, Gastroesophageal Reflux surgery
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- 2021
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15. Regression of Barrett's esophagus after magnetic sphincter augmentation: intermediate-term results.
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Dunn CP, Henning JC, Sterris JA, Won P, Houghton C, Bildzukewicz NA, and Lipham JC
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- Humans, Magnetic Phenomena, Male, Middle Aged, Retrospective Studies, Barrett Esophagus etiology, Barrett Esophagus surgery, Esophageal Neoplasms, Gastroesophageal Reflux
- Abstract
Background: Untreated gastroesophageal reflux disease (GERD) can lead to Barrett's esophagus and an increased risk for esophageal adenocarcinoma. Magnetic sphincter augmentation (MSA) is a safe and effective modality for the treatment of GERD. Preliminary research on short-term outcomes after MSA demonstrated significant regression of Barrett's. Further investigation is required to evaluate the long-term effect of this treatment., Methods: A retrospective review of patients was conducted with biopsy-proven Barrett's esophagus who underwent MSA between 2007 and 2019. As a part of their preoperative evaluation, patients underwent esophagogastroduodenoscopy (EGD) with biopsies of the distal esophagus and gastroesophageal junction including any abnormal-appearing segments, pH testing, and a videoesophagram. Patients were categorized according to the length of Barrett's identified (ultrashort < 1 cm, short 1-3 cm, long > 3 cm). Improvement was defined as a decrease in length (e.g. long to short)., Results: There were 87 patients identified for study inclusion. 55 patients were male. The median body mass index was 26.95. The median age was 61.81 (49.79-68.29). Mean follow-up time was 2.35 ± (1.57) years. 7 (8.0%) of these patients began with long segment Barrett's, 58 (66.7%) began with short segment disease, and 22 (25.3%) began with an ultrashort segment. Within this cohort, 74 (85.06%) had undergone postoperative biopsy. 7 out of 74 patients (9.46%) showed improvement in their intestinal metaplasia and 45/74 (60.81%) showed complete regression. Fisher's exact test showed a significant decrease in Barrett's length following MSA (p = 0.002). No patients progressed to dysplasia or neoplasia. There was a statistically significant decrease in the median Demeester score from 34.00 to 13.70 after surgery (p < .001)., Conclusion: MSA reduces esophageal acid exposure and can lead to reduction or resolution of Barrett's esophagus. MSA is also effective at preventing progression of metaplasia to dysplasia or neoplasia. This effect remains consistent even after 2 years of follow-up., (© 2020. Springer Science+Business Media, LLC, part of Springer Nature.)
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- 2021
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16. Magnetic sphincter augmentation with hiatal hernia repair: long term outcomes.
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Dunn CP, Zhao J, Wang JC, Patel TA, Putnam LR, Eka A, Houghton CC, Bildzukewicz NA, and Lipham JC
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- Aged, Esophageal Sphincter, Lower surgery, Female, Herniorrhaphy, Humans, Magnetic Phenomena, Male, Neoplasm Recurrence, Local, Quality of Life, Retrospective Studies, Treatment Outcome, Hernia, Hiatal surgery, Laparoscopy
- Abstract
Introduction: Magnetic sphincter augmentation (MSA) is a safe and effective treatment for patients with gastroesophageal reflux disease (GERD). MSA was initially indicated for patients with GERD and concomitant hiatal hernias < 3 cm. However, excellent short- and intermediate-term outcomes following MSA and hiatal hernia repair in patients with hiatal hernias ≥ 3 cm have been reported. The purpose of this study is to assess long-term outcomes for this patient population., Methods and Procedures: A retrospective review was performed of patients with GERD and hiatal hernias ≥ 3 cm who underwent MSA and hiatal hernia repair. Patients were treated at two tertiary medical centers between May 2009 and December 2016. Follow up included annual video esophagram, upper endoscopy, or both. Outcomes included pre- and post-operative GERD health-related quality of life (GERD-HRQL) scores, length and regression of Barrett's esophagus, resolution of esophagitis, need for endoscopic dilations or implant removal, and clinically significant hiatal hernia recurrence (> 2 cm) on videoesophagram or endoscopy., Results: Seventy-nine patients (53% female) with a median age of 65.56 (58.42-69.80) years were included. Median follow up was 2.98 (interquartile range 1.90-3.32) years. Median DeMeester scores decreased from 42.45 (29.12-60.73) to 9.10 (3.05-24.30) (p < 0.001). Severity of esophagitis (e.g. LA class C to class B) significantly improved (p < 0.01). Forty percent of patients with Barrett's esophagus experienced regression (p < 0.01). Median GERD-HRQL scores improved from 21 to 2. Five (6.3%) hiatal hernia recurrences occurred, and 1 required re-operation. Age, body mass index, size of the initial hiatal hernia, and sex had no significant effect on whether a patient developed a recurrence., Conclusions: Magnetic sphincter augmentation in conjunction with large hiatal hernia repairs for patients with GERD achieves excellent long-term radiographic and clinical results, and a low overall need for reoperation, without the need for mesh., (© 2020. Springer Science+Business Media, LLC, part of Springer Nature.)
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- 2021
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17. Less is more: cruroplasty alone is sufficient for revisional hiatal hernia surgery.
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Nguyen R, Dunn CP, Putnam L, Won P, Patel T, Brito S, Bildzukewicz NA, and Lipham JC
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- Fundoplication, Humans, Recurrence, Retrospective Studies, Treatment Outcome, Gastroesophageal Reflux surgery, Hernia, Hiatal surgery, Laparoscopy
- Abstract
Background: Recurrence of hiatal hernia after anti-reflux surgery is common, with past studies reporting recurrence rates of 10-15%. Most patients experience relief from GERD symptoms following initial repair; however, those suffering from recurrence can have symptoms severe enough to warrant another operation. Although the standard of care is to revise the fundoplication or convert to magnetic sphincter augmentation (MSA) in addition to redo cruroplasty, it stands to reason that with an intact fundoplication, a repeat cruroplasty is all that is necessary to alleviate the patients' symptoms. In other words, only fix that which is broken., Methods: A retrospective review of patients with symptomatic hiatal hernia recurrence who underwent reoperation between January 2011 and September 2018 was conducted. Patients who received revisional cruroplasty alone were compared with cruroplasty plus some other revision (fundoplication revision, or takedown and MSA placement). Demographics, operative details, and postoperative outcomes were collected., Results: There were 73 patients identified. Median time to recurrence after the first procedure was 3.7 (1.9-8.2) years. Thirty-two percent of the patients had GERD symptoms for more than 10 years. Twenty-six patients underwent cruroplasty only. Forty-seven patients underwent cruroplasty plus fundoplication revision. There were no significant differences in operative times (2.4 h cruroplasty alone, 2.8 h full revision, p = 0.75) or postoperative complications between the two groups. Patients had a mean follow-up time of 1.64 years. Of the 73 patients, 8 had subsequent hiatal hernia recurrence. The recurrence rate for patients with cruroplasty alone was 11%, and the recurrence rate for the full revision group was 12% (p = 1.00)., Conclusion: Leaving an intact fundoplication alone at the time of revisional surgery did not adversely affect surgical outcomes. This data suggests a role for hernia-only repair for recurrent hiatal hernias.
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- 2021
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18. Sleeve Gastrectomy as a Novel Procedure for Gastroparesis.
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Alicuben ET, Samaan JS, Houghton CC, Soffer E, Lipham JC, and Samakar K
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- Adult, Female, Gastric Emptying, Gastroparesis etiology, Gastroparesis physiopathology, Humans, Male, Middle Aged, Retrospective Studies, Treatment Outcome, Young Adult, Gastrectomy methods, Gastroparesis surgery, Laparoscopy methods
- Abstract
Background: Laparoscopic sleeve gastrectomy (LSG) has recently been considered for the surgical management of refractory gastroparesis. Our study aims to determine the efficacy of LSG as a new treatment modality for gastroparesis., Methods: A multi-surgeon single institution retrospective chart review of patients who underwent LSG for refractory gastroparesis from September 2016-December 2017. Pre- and postoperative Patient Assessment of Upper Gastrointestinal Disorders-Symptoms Severity Index and/or Gastroparesis Cardinal Symptom Index (GCSI) questionnaires were reviewed. A telephone survey was conducted. Statistical analysis consisted of two-sample t test and utilized SAS v9.4. A P -value <.05 was considered significant., Results: There were 10 patients included and 80% were women with an average age of 43 years (24-63). Mean Body Mass Index was 24.5 (16.8-39.6), and median gastric emptying at 4 hours was 50% (30-85). Etiology of gastroparesis was 50% idiopathic, 40% diabetic, and 10% postsurgical. 80% of patients had previously undergone gastric electrical stimulator implantation, 20% pyloric botox injections, and 1 patient jejunostomy tube placement. One patient required conversion from laparoscopic to open secondary to adhesions. Median length of stay was 5 days (2-13), and median follow-up was 13.3 months. 90% of patients were tolerating a regular diet at longest follow-up with significant improvement in self-reported symptoms. GCSI scores were 33.6 preoperatively and 14.9 postoperatively ( P = .01)., Discussion: Our study adds to the literature examining the role of LSG in the treatment of gastroparesis. LSG has favorable outcomes at short-term follow-up for patients with refractory gastroparesis.
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- 2021
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19. Safety and efficacy of robotic-assisted groin hernia repair.
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Maas MC, Alicuben ET, Houghton CC, Samakar K, Sandhu KK, Dobrowolsky A, Lipham JC, Katkhouda N, and Bildzukewicz NA
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- Adolescent, Adult, Aged, Aged, 80 and over, Groin, Herniorrhaphy adverse effects, Humans, Male, Middle Aged, Prospective Studies, Retrospective Studies, Surgical Mesh, Young Adult, Hernia, Inguinal surgery, Laparoscopy, Robotic Surgical Procedures methods
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Robotic surgical technology has grown in popularity and applicability, since its conception with emerging uses in general surgery. The robot's contribution of increased stability and dexterity may be beneficial in technically challenging surgeries, namely, inguinal hernia repair. The aim of this project is to contribute to the growing body of literature on robotic technology for inguinal hernia repair (RIHR) by sharing our experience with RIHR at a large, academic institution. We performed a retrospective chart review spanning from March 2015 to April 2018 on all patients who had undergone RIHR at our university hospital. Extracted data include preoperative demographics, operative features, and postoperative outcomes. Data were analyzed with particular focus on complications, including hernia recurrence. A total of 43 patients were included, 40 of which were male. Mean patient age was 56 (range 18-85 years) and mean patient BMI was 26.4 (range 17.5-42.3). Bilateral hernias were diagnosed in 13 patients. All of the patients received transabdominal approaches, and all but one received placement of synthetic polypropylene mesh. There was variety in mesh placement with 23 patients receiving suture fixation and 14 receiving tack fixation. Several patients received a combination of suture, tacks, and surgical glue. Mean patient in-room time was 4.0 h, mean operative time was 2.9 h, and mean robotic dock time was 2.0 h. Regarding intraoperative complications, there was one bladder injury, which was discovered intraoperatively and repaired primarily. Same-day discharges were achieved in 32 patients (74.4%) of patients. One patient was admitted overnight for management of urinary retention. Additional ten patients were admitted for observation. Post-operatively, none of the cases resulted in wound infections. Eleven patients developed seromas and one patient was diagnosed with a groin hematoma. Median follow-up was 37.5 days, and one recurrence was reported during this time. The recurrent hernia in this case was initially discovered during a separate case and was repaired with temporary mesh. The use of the robot is safe and effective and should be considered an acceptable approach to inguinal hernia repair. Future prospective studies will help define which patients will benefit most from this technology., (© 2020. Springer-Verlag London Ltd., part of Springer Nature.)
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- 2021
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20. Understanding the GERD Barrier.
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Dunn CP, Wu J, Gallagher SP, Putnam LR, Bildzukewicz NA, and Lipham JC
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- Esophageal Sphincter, Lower, Esophagogastric Junction, Humans, Esophagitis, Peptic, Gastroesophageal Reflux, Hernia, Hiatal
- Abstract
Gastroesophageal reflux disease (GERD) is steadily increasing in incidence and now affects 18% to 28% of the population in the United States. A thorough understanding of the pathophysiology underlying this disease is necessary to improve the current standard of care. Most GERD pathophysiology models focus on the lower esophageal sphincter (LES) as the key element which prevents esophageal reflux. More recent research has highlighted the crural diaphragm (CD) as an additional critical component of the GERD barrier. We now know that the CD actively relaxes when the distal esophagus is distended and contracts when the stomach is distended. Crural myotomy in animal models increases esophageal acid exposure, highlighting the CD's vital role. There are also multiple physiological studies in patients with symptomatic hiatal hernia that demonstrate CD dysfunction is associated with GERD. Finally, computer models integrating physiological data predict that the CD and the LES each contribute roughly 50% to the GERD barrier. This more robust understanding has implications for future procedural management of GERD. Specifically, effective GERD management mandates repair of the CD and reinforcement of the LES. Given the high rate of hiatal hernia recurrences, it seems that novel antireflux procedures should target this essential component of the GERD barrier. Future research should focus on methods to maintain crural integrity, decrease hiatal hernia recurrence, and improve long-term competency of the GERD barrier., (Copyright © 2021 Wolters Kluwer Health, Inc. All rights reserved.)
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- 2021
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21. Safety and efficacy of magnetic sphincter augmentation dilation.
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Fletcher R, Dunst CM, Abdelmoaty WF, Alicuben ET, Shemmeri E, Parker B, Müller D, Sharata AM, Reavis KM, Davila Bradley D, Bildzukewicz NA, Louie BE, Lipham JC, and DeMeester SR
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- Dilatation, Humans, Magnetic Phenomena, Retrospective Studies, Treatment Outcome, Esophageal Sphincter, Lower surgery, Gastroesophageal Reflux
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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.
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- 2021
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22. Magnetic sphincter augmentation versus fundoplication for gastroesophageal reflux disease: pros and cons.
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Sterris JA, Dunn CP, Bildzukewicz NA, and Lipham JC
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- Esophageal Sphincter, Lower surgery, Fundoplication, Humans, Magnetic Phenomena, Treatment Outcome, Gastroesophageal Reflux surgery, Laparoscopy
- Abstract
Purpose of Review: The purpose of this magnetic sphincter augmentation (MSA) year in review article is to provide a clear understanding for the current state of MSA literature in 2019, and contrast MSA outcomes with traditional fundoplication., Recent Findings: Continued work was performed in 2019 to expand patient populations eligible for MSA including those with hiatal hernia, post-bariatric patients, patients necessitating a thoracic approach, and patients with esophageal intestinal metaplasia. Additionally, a large systematic review reinforced earlier findings comparing laparoscopic fundoplication to MSA. This study demonstrated equivalency over many different operative outcomes, with MSA patients having less bloating while also retaining the ability to belch and vomit. Furthermore, independent research teams found a modest cost savings for MSA over laparoscopic fundoplication with budget analysis., Summary: MSA is a safe and efficacious procedure originally approved for patients with medically refractory, uncomplicated gastroesophageal reflux disease. The accumulating body of evidence suggests patients with intestinal metaplasia or hiatal hernias can safely and effectively undergo MSA, whereas further research will be required before MSA is widely used for post-bariatric patients or for patients requiring a transthoracic surgical approach. MSA is equivalent or superior to laparoscopic fundoplication in all surgical outcomes measured thus far.
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- 2020
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23. Surgical and endoscopic management options for patients with GERD based on proton pump inhibitor symptom response: recommendations from an expert U.S. panel.
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Gawron AJ, Bell R, Abu Dayyeh BK, Buckley FP, Chang K, Dunst CM, Edmundowicz SA, Jobe B, Lipham JC, Lister D, Canto MI, Smith MS, Starpoli AA, Triadafilopoulos G, Watson TJ, Wilson E, Pandolfino JE, Kaizer A, Van De Voorde Z, and Yadlapati R
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- Adult, Aged, Endoscopy, Endoscopy, Gastrointestinal, Female, Fundoplication, Humans, Los Angeles, Male, Middle Aged, Proton Pump Inhibitors therapeutic use, Treatment Outcome, Gastroesophageal Reflux drug therapy, Gastroesophageal Reflux surgery, Laparoscopy
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Background and Aims: The objective of this study was to examine expert opinion and agreement on the treatment of distinct GERD profiles from surgical and therapeutic endoscopy perspectives., Methods: We used the RAND/University of California, Los Angeles Appropriateness Method over 6 months (July 2018 to January 2019) to assess the appropriateness of antireflux interventions among foregut surgeons and therapeutic gastroenterologists. Patients with primary atypical or extraesophageal symptoms were not considered. Patient scenarios were grouped according to their symptom response to proton pump inhibitor (PPI) therapy. The primary outcome was appropriateness of an intervention., Results: Antireflux surgery with laparoscopic fundoplication (LF) and magnetic sphincter augmentation (MSA) were ranked as appropriate for all complete and partial PPI responder scenarios. Transoral incisionless fundoplication was ranked as appropriate in complete and partial PPI responders without a hiatal hernia. Radiofrequency energy was not ranked as appropriate for complete or partial responders. There was lack of agreement between surgery and interventional gastroenterology groups on the appropriateness of LF and MSA for PPI nonresponders. Rankings for PPI nonresponders were similar when results from impedance-pH testing on PPI therapy were available, except that LF and MSA were not ranked as appropriate for PPI nonresponders if the impedance-pH study was negative., Conclusions: This work highlights areas of agreement for invasive therapeutic approaches for GERD and provides impetus for further interdisciplinary collaboration and trials to compare and generate novel and effective treatment approaches and care pathways, including the role of impedance-pH testing in PPI nonresponders., (Copyright © 2020 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)
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- 2020
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24. Comment on: Systematic review of the introduction and evaluation of magnetic augmentation of the lower oesophageal sphincter for gastro-oesophageal reflux disease.
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Bonavina L, Boyle N, Dunn C, Horbach T, Knowles TB, Lipham JC, Louie BE, Markar S, Schppmann SF, and Zehetner J
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- Esophagogastric Junction, Humans, Magnetic Phenomena, Esophageal Sphincter, Lower surgery, Gastroesophageal Reflux
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- 2020
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25. Clinical outcome after laparoscopic Nissen fundoplication in patients with GERD and PPI refractory heartburn.
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Schwameis K, Oh D, Green KM, Lin B, Zehetner J, Lipham JC, Hagen JA, and DeMeester SR
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- Adult, Aged, Aged, 80 and over, Esophageal pH Monitoring, Female, Follow-Up Studies, Humans, Male, Middle Aged, Patient Satisfaction statistics & numerical data, Proton Pump Inhibitors therapeutic use, Retrospective Studies, Treatment Outcome, Young Adult, Esophagoscopy methods, Fundoplication methods, Gastroesophageal Reflux surgery, Heartburn surgery, Laparoscopy methods
- Abstract
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., (© The Author(s) 2020. Published by Oxford University Press on behalf of International Society for Diseases of the Esophagus. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)
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- 2020
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26. Clinical Significance of Esophageal Outflow Resistance Imposed by a Nissen Fundoplication.
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Ayazi S, DeMeester SR, Hagen JA, Zehetner J, Bremner RM, Lipham JC, Crookes PF, and DeMeester TR
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- Adult, Case-Control Studies, Deglutition Disorders epidemiology, Deglutition Disorders etiology, Esophagus surgery, Female, Follow-Up Studies, Humans, Male, Manometry, Middle Aged, Postoperative Complications epidemiology, Treatment Outcome, Deglutition Disorders prevention & control, Esophagus physiology, Fundoplication methods, Gastroesophageal Reflux surgery, Postoperative Complications prevention & control
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Background: Attention has been focused on the amplitude of esophageal body contraction to avoid persistent dysphagia after a Nissen fundoplication. The current recommended level is a contraction amplitude in the distal third of esophagus above the fifth percentile. We hypothesized that a more physiologic approach is to measure outflow resistance imposed by a fundoplication, which needs to be overcome by the esophageal contraction amplitude., Study Design: The esophageal outflow resistance, as reflected by the intra-bolus pressure (iBP) measured 5 cm above the lower esophageal sphincter (LES), was measured in 53 normal subjects and 37 reflux patients with normal esophageal contraction amplitude, before and after a standardized Nissen fundoplication. All were free of postoperative dysphagia. A test population of 100 patients who had a Nissen fundoplication was used to validate the threshold of outflow resistance to avoid persistent postoperative dysphagia., Results: The mean (SD) amplitude of the iBP in normal subjects was 6.8 (3.7) mmHg and in patients before fundoplication was 3.6 (7.0) mmHg (p = 0.003). After Nissen fundoplication, the mean (SD) amplitude of the iBP increased to 12.0 (3.2) mmHg (p < 0.0001 vs normal subjects or preoperative values). The 95th percentile value for iBP after a Nissen fundoplication was 20.0 mmHg and was exceeded by esophageal contraction in all patients in the validation population, and 97% of these patients were free of persistent postoperative dysphagia at a median 50-month follow-up., Conclusions: Nissen fundoplication increases the outflow resistance of the esophagus and should be constructed to avoid an iBP > 20 mmHg. Patients whose distal third esophageal contraction amplitude is >20 mmHg have a minimal risk of dysphagia after a tension-free Nissen fundoplication., (Copyright © 2019 American College of Surgeons. Published by Elsevier Inc. All rights reserved.)
- Published
- 2019
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27. Objective Evidence of Reflux Control After Magnetic Sphincter Augmentation: One Year Results From a Post Approval Study.
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Louie BE, Smith CD, Smith CC, Bell RCW, Gillian GK, Mandel JS, Perry KA, Birkenhagen WK, Taiganides PA, Dunst CM, McCollister HM, Lipham JC, Khaitan LK, Tsuda ST, Jobe BA, Kothari SN, and Gould JC
- Subjects
- Adult, Aged, Esophageal Sphincter, Lower physiopathology, Esophageal pH Monitoring, Female, Follow-Up Studies, Gastroesophageal Reflux metabolism, Gastroesophageal Reflux physiopathology, Humans, Male, Middle Aged, Prospective Studies, Prosthesis Design, Surveys and Questionnaires, Time Factors, Treatment Outcome, Young Adult, Deglutition physiology, Esophageal Sphincter, Lower surgery, Gastroesophageal Reflux surgery, Magnets
- Abstract
Objective: To report 1-year results from a 5-year mandated study., Summary Background Data: In 2012, the United States Food and Drug Administration approved magnetic sphincter augmentation (MSA) with the LINX Reflux Management System (Torax Medical, Shoreview, MN), a novel device for the surgical treatment of gastroesophageal reflux disease (GERD). Continued assessment of safety and effectiveness has been monitored in a Post Approval Study., Methods: Multicenter, prospective study of patients with pathologic acid reflux confirmed by esophageal pH testing undergoing MSA. Predefined clinical outcomes were assessed at the annual visit including a validated, disease-specific questionnaire, esophagogastricduodenoscopy and esophageal pH monitoring, and use of proton pump inhibitors., Results: A total of 200 patients (102 males, 98 females) with a mean age of 48.5 years (range 19.7-71.6) were treated with MSA between March 2013 and August 2015. At 1 year, the mean total acid exposure time decreased from 10.0% at baseline to 3.6%, and 74.4% of patients had normal esophageal acid exposure time (% time pH<4 ≤5.3%). GERD Health-Related Quality of Life scores improved from a median score of 26.0 at baseline to 4.0 at 1 year, with 84% of patients meeting the predefined success criteria of at least a 50% reduction in total GERD Health-Related Quality of Life score compared with baseline. The device removal rate at 1 year was 2.5%. One erosion and no serious adverse events were reported., Conclusions: Safety and effectiveness of magnetic sphincter augmentation has been demonstrated outside of an investigational setting to further confirm MSA as treatment for GERD.
- Published
- 2019
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28. Removing the magnetic sphincter augmentation device: operative management and outcomes.
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Tatum JM, Alicuben E, Bildzukewicz N, Samakar K, Houghton CC, and Lipham JC
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- Adult, Female, Follow-Up Studies, Humans, Male, Middle Aged, Outcome Assessment, Health Care, Perioperative Care methods, Retrospective Studies, Device Removal methods, Esophageal Sphincter, Lower surgery, Magnets, Prostheses and Implants, Prosthesis Failure
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Background: Recurrent or persistent symptoms of reflux, dysphagia, or device erosion can lead to removal of the magnetic sphincter augmentation (MSA aka Linx) device. Device removal has been previously reported, and outcomes of various surgical management strategies at the time of removal have not been well described., Methods: This is a retrospective review of patients undergoing MSA removal from March 2009 to September 2017 in a single institution. Reason for removal, operative management, and short-term outcomes are reported., Results: During the study, 435 MSA devices were implanted, 24 of which required removal (5.5%). Removal was due to refractory dysphagia in 1.8% (8/435), for recurrent or persistent GERD in 2.9% (13/435), and secondary to erosion in 0.5% (2/435). Mean time from implant to removal was 863 days (range 119-1762 days). The most common reasons for removal were recurrent GERD (54%), dysphagia (38%), or erosion (8%). Significant operative findings included recurrent or progressive hiatal hernia (38%), erosion (8%), and normal anatomy (46%). Hiatal hernia was found and repaired at the time of device removal in 38% of patients (9/24). The MSA device was removed through laparotomy (4%), laparoscopically (88%), or through a combination of endoscopy and laparoscopy (8%). After removal patients underwent repeat MSA (33%), fundoplication (21%), gastrectomy (4%), or no additional procedure (42%). Symptoms prompting removal of the MSA device had resolved in 52% of patients and improved in an additional 35% at last contact. Of the 10 patients having no anti-reflux procedure after removal, 9 were available for follow-up at a mean of 97 (106) days of whom 22.2% (2/9) had symptoms of GERD or required any anti-reflux medication. No major complications occurred after removal., Conclusion: MSA removal when necessary can be accomplished through minimally invasive means. Repeat Linx or fundoplication can be performed after removal, however may not be necessary in patients with removal for dysphagia.
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- 2019
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29. Routine esophageal manometry is not useful in patients with normal videoesophagram.
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Alicuben ET, Bildzukewicz N, Samakar K, Katkhouda N, Dobrowolsky A, Sandhu K, and Lipham JC
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- Adult, Esophageal Achalasia diagnostic imaging, Esophageal Motility Disorders physiopathology, Female, Humans, Male, Middle Aged, Video Recording, Esophageal Motility Disorders diagnostic imaging, Manometry methods
- Abstract
Background: Videoesophagram (VEG) and esophageal manometry (EM) are components of the preoperative evaluation for foregut surgery. EM is able to identify motility disorders and diminished contractility that may alter surgical planning. However, there are no clearly defined criteria to guide this. Reliable manometry is not always easily obtained, and therefore its necessity in routine preoperative evaluation is unclear. We hypothesized that if a patient has normal videoesophagram, manometry does not reveal clinically significant esophageal dysfunction., Methods: We reviewed patients who underwent protocolized videoesophagram and manometry at our institution. Measures of esophageal motility including the mean distal contractile integral (DCI), mean wave amplitude (MWA), and percent of peristaltic swallows (PPS) were analyzed. The Chicago Classification was used for diagnostic criteria of motility disorders. Normal VEG was defined as stasis of liquid barium on less than three of five swallows., Results: There were 418 patients included. 231 patients (55%) had a normal VEG, and 187 patients (45%) had an abnormal VEG. In the normal VEG group, only 2/231 (0.9%) patients had both abnormal DCI and PPS, 1/231 (0.4%) patients had both abnormal DCI and MWA and no patients had both abnormal MWA and PPS. There were no patients with achalasia or absent contractility and 1 patient with ineffective esophageal motility (IEM) in the normal VEG group. This was significantly different from the abnormal VEG group which included 4 patients with achalasia, 1 with absent contractility and 22 with IEM (p < 0.0001). The negative predictive value of VEG was 99.6% and the sensitivity was 96.4%., Conclusions: A normal videoesophagram reliably excluded the presence of clinically significant esophageal dysmotility that would alter surgical planning. Routine manometry is not warranted in patients with normal videoesophagram, and should be reserved for patients with abnormal VEG.
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- 2019
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30. Minimal versus obligatory dissection of the diaphragmatic hiatus during magnetic sphincter augmentation surgery.
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Tatum JM, Alicuben E, Bildzukewicz N, Samakar K, Houghton CC, and Lipham JC
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- Adult, Aged, Dissection methods, Female, Follow-Up Studies, Gastroesophageal Reflux complications, Hernia, Hiatal complications, Humans, Laparoscopy methods, Male, Middle Aged, Minimally Invasive Surgical Procedures instrumentation, Recurrence, Retrospective Studies, Treatment Outcome, Diaphragm surgery, Esophageal Sphincter, Lower surgery, Gastroesophageal Reflux surgery, Hernia, Hiatal surgery, Magnets, Minimally Invasive Surgical Procedures methods, Prostheses and Implants
- Abstract
Background: The magnetic sphincter augmentation (MSA) device was initially implanted with minimal hiatal dissection (MHD) at the diaphragmatic hiatus. Due to concern of possible MSA device dysfunction if herniated into an occult or small hiatal hernia, and increased understanding to the role of defective crura in reflux disease, the operative procedure was changed to planned obligatory dissection (OD) of the hiatus at the time of all implantations., Methods: Between December 2012 and September 2016, 182 patients underwent MSA implant at a single medical center and have complete records available for review through September 2017. The MHD dissection period extended from December 2012 to September 2015, from September 2015 to 2016 all patients underwent OD., Results: MHD occurred 53% (96/182) versus OD in 47% (86/182), mean follow-up time in days for MHD and OD was 554 (SD 427) versus 374 (298) days. Intraoperative measurement of hernia size for the MHD versus OD was 0.77 (1.1) versus 3.95 (2.4) cm, p < 0.001. At first visit follow-up, there was no difference in any dysphagia (p = 0.11). Recurrent GERD (defined as resumption of PPI after successful initial post-operative wean) was less frequent after OD than after MHD, 3.6 versus 16.3%, p = 0.006. Delayed onset dysphagia was 1.2% in the OD group versus 8.6% in the MHD group, p = 0.04. Recurrent hiatal hernia of 2 cm or greater occurred in 0.0% of the OD and 11.5% of the MHD, p = 0.03. Repeat surgery for hiatal hernia repair has occurred in 0% of the OD and 6.6% of the MHD, p = 0.02., Conclusion: OD of the hiatus with crural closure resulted in less recurrence of reflux symptoms and hiatal hernia, despite an increased proportion of patients with larger hiatal hernia and more complex anatomic disease at the time of operation.
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- 2019
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31. Regression of intestinal metaplasia following magnetic sphincter augmentation device placement.
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Alicuben ET, Tatum JM, Bildzukewicz N, Samakar K, Samaan JS, Silverstein EN, Sandhu K, Houghton CC, and Lipham JC
- Subjects
- Adolescent, Adult, Aged, Aged, 80 and over, Barrett Esophagus etiology, Barrett Esophagus pathology, Biopsy, Esophagus pathology, Female, Fundoplication, Gastroesophageal Reflux complications, Humans, Magnetic Phenomena, Male, Middle Aged, Prosthesis Implantation, Retrospective Studies, Young Adult, Barrett Esophagus surgery, Esophageal Sphincter, Lower surgery, Gastroesophageal Reflux surgery, Magnets
- Abstract
Background: Intestinal metaplasia represents an esophageal mucosal transformation due to uncontrolled gastroesophageal reflux disease. Fundoplication has been shown to lead to regression of disease. Magnetic sphincter augmentation is an alternative to fundoplication that effectively treats reflux disease. Initially, patients with intestinal metaplasia were not considered candidates for device placement, so outcomes in these patients are unknown., Methods: A retrospective review of all patients who underwent magnetic sphincter augmentation device placement between 2007 and 2017 was performed. All patients underwent pre-operative endoscopic evaluation and were categorized as having ultra-short segment (less than 1 cm), short-segment (1-3 cm), or long-segment (greater than or equal to 3 cm) disease. To be included in the study, pathologic examination demonstrating columnar mucosa with goblet cells was required., Results: There were 86 patients with biopsy-proven non-dysplastic intestinal metaplasia. 35 patients had ultra-short segment, 37 patients had short-segment, and 14 patients had long-segment disease. At a median follow-up of 1.2 years, 67/86 (78%) patients completed endoscopic follow-up. 48/67 (71.6%) patients had regression of intestinal metaplasia. There was no progression to dysplasia or carcinoma. Patients with abnormal post-operative DeMeester scores were less likely to have regression of disease. Regression was more likely in the ultra-short segment (82.8%) and short-segment (73.3%) groups compared to the long-segment group (25.0%)., Conclusions: Magnetic sphincter augmentation is effective in achieving regression of intestinal metaplasia. Longer-term follow-up is needed to assess durability of effect and make meaningful comparisons to fundoplication.
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- 2019
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32. Extraluminal Approaches to Gastroesophageal Reflux Disease.
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Tatum JM and Lipham JC
- Subjects
- Esophageal Sphincter, Lower surgery, Fundoplication, Gastric Bypass, Gastroesophageal Reflux diagnosis, Gastroesophageal Reflux therapy, Humans, Laparoscopy, Magnets, Prosthesis Implantation, Gastroesophageal Reflux surgery
- Abstract
Gastroesophageal reflux disease (GERD) is a common affliction in Western society. In patients in whom GERD is resistant to medical therapy or who desire nonpharmacological definitive therapy, several surgical interventions are available. The most common and traditional surgical therapy is partial or complete gastric fundoplication; however, new alternatives, including the magnetic augmentation system LINX and EndoStim device, are increasingly common and efficacious., (Copyright © 2018 Elsevier Inc. All rights reserved.)
- Published
- 2018
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33. Worldwide Experience with Erosion of the Magnetic Sphincter Augmentation Device.
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Alicuben ET, Bell RCW, Jobe BA, Buckley FP 3rd, Daniel Smith C, Graybeal CJ, and Lipham JC
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- Databases, Factual, Device Removal methods, Endoscopy, Gastrointestinal, Humans, Retrospective Studies, Deglutition Disorders etiology, Esophageal Sphincter, Lower surgery, Gastroesophageal Reflux surgery, Magnets adverse effects, Prostheses and Implants adverse effects
- Abstract
Background: The magnetic sphincter augmentation device continues to become a more common antireflux surgical option with low complication rates. Erosion into the esophagus is an important complication to recognize and is reported to occur at very low incidences (0.1-0.15%). Characterization of this complication remains limited. We aim to describe the worldwide experience with erosion of the magnetic sphincter augmentation device including presentation, techniques for removal, and possible risk factors., Materials and Methods: We reviewed data obtained from the device manufacturer Torax Medical, Inc., as well as the Manufacturer and User Facility Device Experience (MAUDE) database. The study period was from February 2007 through July 2017 and included all devices placed worldwide., Results: In total, 9453 devices were placed and there were 29 reported cases of erosions. The median time to presentation of an erosion was 26 months with most occurring between 1 and 4 years after placement. The risk of erosion was 0.3% at 4 years after device implantation. Most patients experienced new-onset dysphagia prompting evaluation. Devices were successfully removed in all patients most commonly via an endoscopic removal of the eroded portion followed by a delayed laparoscopic removal of the remaining beads. At a median follow-up of 58 days post-removal, there were no complications and 24 patients have returned to baseline. Four patients reported ongoing mild dysphagia., Conclusions: Erosion of the LINX device is an important but rare complication to recognize that has been safely managed via minimally invasive approaches without long-term consequences.
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- 2018
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34. Hiatal hernia recurrence following magnetic sphincter augmentation and posterior cruroplasty: intermediate-term outcomes.
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Rona KA, Tatum JM, Zehetner J, Schwameis K, Chow C, Samakar K, Dobrowolsky A, Houghton CC, Bildzukewicz N, and Lipham JC
- Subjects
- Adult, Aged, Deglutition Disorders etiology, Female, Humans, Male, Middle Aged, Proton Pump Inhibitors therapeutic use, Quality of Life, Recurrence, Retrospective Studies, Esophageal Sphincter, Lower surgery, Gastroesophageal Reflux surgery, Hernia, Hiatal surgery, Magnetic Field Therapy instrumentation
- Abstract
Background: We have previously reported short-term outcomes after hiatal hernia repair (HHR) at the time of magnetic sphincter augmentation (MSA) for gastroesophageal reflux disease (GERD). Here we report intermediate-term outcomes and hernia recurrence rate after concomitant MSA and HHR., Methods: This is a retrospective cohort study of patients who underwent repair of a hiatal hernia 3 cm or larger at the time of MSA implantation between May 2009 and December 2015. The primary endpoint was hiatal hernia recurrence identified by routine postoperative videoesophagography or endoscopy. Recurrence was defined by a 2 cm or greater upward displacement of the stomach through the diaphragmatic esophageal hiatus. Secondary endpoints included cessation of proton-pump inhibitor (PPI), persistent dysphagia requiring intervention, and GERD health-related quality-of-life (HRQL) scores 1 year from surgery., Results: During the study period, 47 of 53 (89%) patients underwent concomitant MSA with HHR and complied with surveillance. Hiatal hernias ranged from 3 to 7 cm (mean 4 ± 1). Mean clinical follow-up time was 19 months (range 1-39). GERD-HRQL score decreased from 20.3 to 3.1 (p < .001), 89% of patients remained off PPIs, and 97% of patients reported improvement or resolution of symptoms. Two recurrent hiatal hernias were identified on surveillance imaging for a recurrence rate of 4.3% at a mean 18 (± 10) months after initial operation. Persistent dysphagia occurred in 13% (6/47) over the first year, which resolved after a single balloon dilation in 67% (4/6). Two patients elected for device removal due to dilation-refractory dysphagia and persistent reflux symptoms., Conclusion: Concomitant magnetic sphincter augmentation and hiatal hernia repair in patients with gastroesophageal reflux disease and a moderate-sized hiatal hernia demonstrates durable subjective reflux control and an acceptable hiatal hernia recurrence rate at 1- to 2-year follow-up.
- Published
- 2018
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35. Videoesophagography versus Endoscopy for Prediction of Intraoperative Hiatal Hernia Size.
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Tatum JM, Samakar K, Bowdish ME, Mack WJ, Bildzukewicz N, and Lipham JC
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- Adult, Aged, Female, Hernia, Hiatal pathology, Hernia, Hiatal surgery, Humans, Magnetic Field Therapy, Male, Middle Aged, Predictive Value of Tests, Regression Analysis, Retrospective Studies, Esophageal Sphincter, Lower surgery, Gastroesophageal Reflux surgery, Hernia, Hiatal diagnosis, Laparoscopy methods, Video-Assisted Surgery methods
- Abstract
Magnetic sphincter augmentation is a novel surgical procedure for gastroesophageal reflux disease. Limited dissection at the hiatus is one of the benefits of the procedure, but makes precise and accurate preoperative assessment of even small hiatal hernia critical. Retrospective cohort study of 136 patients having undergone both endoscopy (EGD) and videoesophagography followed by operative assessment for hiatal hernia during magnetic sphincter augmentation. The objective of the study is to determine which preoperative modality more accurately predicts operative hiatal hernia size. Videoesophagography underestimated operative measurement by 0.37 ± 1.41 cm (P = 0.003) and was less accurate in predicting intraoperative hiatal hernia size than EGD on linear regression analysis (β -0.729, SE 0.057, P < 0.001). EGD was less accurate at predicting hiatal hernia size as patient age increased (β -0.018, SE 0.007, P = 0.014) and with larger hernias (β -0.615, standard error (SE) 0.067, P < 0.001); however, endoscopic measurements did not differ significantly from intraoperative measurements (0.93 ± 1.23 cm vs 1.12 ± 1.43 cm, P = 0.12). EGD better predicts the size of small hiatal hernia measured during subsequent laparoscopic surgery.
- Published
- 2018
36. Esophageal adenocarcinoma stage III: Survival based on pathological response to neoadjuvant treatment.
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Schwameis K, Zehetner J, Hagen JA, Oh DS, Worrell SG, Rona K, Cheng N, Samaan J, Green KM, and Lipham JC
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- Adenocarcinoma pathology, Adenocarcinoma therapy, Adult, Aged, Aged, 80 and over, Carcinoma, Squamous Cell pathology, Carcinoma, Squamous Cell therapy, Esophageal Neoplasms pathology, Esophageal Neoplasms therapy, Female, Follow-Up Studies, Humans, Middle Aged, Neoplasm Staging, Retrospective Studies, Survival Rate, Adenocarcinoma mortality, Carcinoma, Squamous Cell mortality, Chemoradiotherapy, Adjuvant mortality, Esophageal Neoplasms mortality, Neoadjuvant Therapy mortality
- Abstract
Background: Neoadjuvant chemoradiotherapy is the standard treatment for locally advanced esophageal adenocarcinomas (EAC). Pathological response is thought to be a major prognostic factor. Aims of this study were to determine the frequency of complete response and to compare the survival of complete and incomplete responders in stage III EAC., Methods: A retrospective review was performed of all stage III patients that underwent neoadjuvant therapy followed by esophagectomy between 1999 and 2015. Patients were classified into complete (pCR) versus incomplete responders (pIR)., Results: 110 patients were included. Neoadjuvant chemotherapy was applied in 25 (23%) and chemoradiotherapy in 85 (77%) patients. Pathologic response was complete in 25% (n = 27) and was more common after chemoradiotherapy. Mean F/U interval was 36 months (0.3-173). There was a significant difference in the overall survival between complete and incomplete responders (p = 0.036). Median survival in the pIR group was 24.4 months and the median survival was not reached during the observation time in pCR. The 3-year-survival-rate was 70% in pCR and 40% in pIR (p = 0.01). Positive lymph nodes (ypN+) were present in 56 patients (51%). The 3-year-survival-rate was 59% in pIR with ypN0 and 29% in pIR with ypN+ (p = 0.005)., Conclusions: Complete response to neoadjuvant therapy has a significantly better overall and 3-year-survival after esophagectomy than incomplete response. In incomplete responders, residual lymph node disease was associated with a significantly worse survival. These findings suggest that the degree of pathologic response and lymph node status are major prognostic factors for survival in EAC patients with stage III disease., (Copyright © 2017 Elsevier Ltd. All rights reserved.)
- Published
- 2017
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37. Lower Esophageal Sphincter Augmentation for Gastroesophageal Reflux Disease: The Safety of a Modern Implant.
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Smith CD, Ganz RA, Lipham JC, Bell RC, and Rattner DW
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- Adult, Databases, Factual, Device Removal statistics & numerical data, Female, Humans, Magnets, Male, Middle Aged, Postoperative Complications, Prostheses and Implants adverse effects, Treatment Outcome, United States, Esophageal Sphincter, Lower surgery, Gastroesophageal Reflux surgery
- Abstract
Introduction: Use of the magnetic sphincter augmentation device (MSAD) for gastroesophageal reflux disease (GERD) is increasing. As this innovative treatment for GERD gains widespread use and adoption, an assessment of its safety since U.S. market introduction is presented., Methods: Events were collected from the Manufacturer and User Facility Device Experience (MAUDE) database, which reports events submitted to the Food and Drug Administration (FDA) of suspected device-associated deaths, serious injuries, and malfunctions. The reporting period was from March 22, 2012 (FDA approval) through May 31, 2016, and included only events occurring in the United States. Additional information was provided by the manufacturer, allowing calculation of implant rates and durations., Results: An estimated 3283 patients underwent magnetic sphincter augmentation (165 surgeons at 191 institutions). The median implant duration was 1.4 years, with 1016 patients implanted for at least 2 years. No deaths, life-threatening events, or device malfunctions were reported. The overall rate of device removal was 2.7% (89/3283). The most common reasons for device removal were dysphagia (52/89) and persistent reflux symptoms (19/89). Removal for erosion and migration was 0.15% (5/3283) and 0% (0/3283), respectively. There were no perforations. Of the device removals, 57.3% (51/89) occurred <1 year after implant, 30.3% (27/89) between 1 and 2 years, and 12.4% (11/89) >2 years after implant. The rate of device removal and erosion with an implant duration >2 years were 1.1% (11/1016) and 0.1% (1/1016), respectively. All device removals and erosions were managed nonemergently, with no complications or long-term consequences., Conclusions: During a 4-year period in more than 3000 patients, no unanticipated MSAD complications have emerged, and there is no data to suggest a trend of increased events over time. The presentation and management of device-related issues have been less complicated than revisions for laparoscopic fundoplication or other interventions for GERD. MSAD is considered safe for the widespread treatment of GERD.
- Published
- 2017
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38. Efficacy of magnetic sphincter augmentation in patients with large hiatal hernias.
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Rona KA, Reynolds J, Schwameis K, Zehetner J, Samakar K, Oh P, Vong D, Sandhu K, Katkhouda N, Bildzukewicz N, and Lipham JC
- Subjects
- Adolescent, Adult, Aged, Aged, 80 and over, Female, Gastroesophageal Reflux etiology, Humans, Laparoscopy, Male, Middle Aged, Proton Pump Inhibitors therapeutic use, Quality of Life, Retrospective Studies, Young Adult, Esophageal Sphincter, Lower surgery, Gastroesophageal Reflux therapy, Hernia, Hiatal surgery, Magnetic Field Therapy instrumentation
- Abstract
Background: Magnetic sphincter augmentation (MSA) has demonstrated long-term safety and efficacy in the treatment of patients with gastroesophageal reflux (GERD), but its efficacy in patients with large hiatal hernias has yet to be proven. The aim of our study was to assess outcomes of MSA in patients with hiatal hernias ≥3 cm., Methods: We retrospectively reviewed all patients who underwent MSA at our institutions over a 6-year period. Information obtained consisted of patient demographics, symptoms of GERD, preoperative GERD Health-Related Quality-of-Life (HRQL) scores, perioperative details, and implantation of the MSA device. Primary endpoints included postoperative GERD-HRQL scores, proton-pump inhibitor (PPI) use, symptom change, and procedure-related complications. A large hiatal hernia was defined as a hernia measuring ≥3 cm by intraoperative measurement., Results: A total of 192 patients were reviewed. Median follow-up was 20 months (3-75 months). Mean GERD-HRQL scores in the overall population before and after MSA were 18.9 and 5.0, respectively (p < 0.001). In the majority of patients symptoms improved or resolved (N = 177, p < 0.001). Fifty-two patients (27.0 %) had a hiatal hernia ≥3 cm (range 3-7 cm). Their mean GERD-HRQL score decreased from 20.5 to 3.6 (p < 0.001) following MSA. When compared to patients with smaller hernias, patients with large hiatal hernias had decreased postoperative PPI requirement (9.6 vs. 26.6 %, p = 0.011) and lower mean postoperative GERD-HRQL scores (3.6 vs. 5.6, p = 0.027). The percent of patients requiring postoperative intervention for dysphagia was similar (13.5 vs. 17.9 %, p = 0.522), as was the incidence of symptom resolution or improvement (98.1 vs. 91.3 %, p = 0.118)., Conclusion: MSA in patients with large hiatal hernias demonstrates decreased postoperative PPI requirement and mean GERD-HRQL scores compared to patients with smaller hernias. The incidence of symptom resolution or improvement and the percentage of patients requiring intervention for dysphagia are similar. Short-term outcomes of MSA are encouraging in patients with gastroesophageal reflux disease and large hiatal hernias.
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- 2017
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39. Post-Nissen Dysphagia and Bloating Syndrome: Outcomes After Conversion to Toupet Fundoplication.
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Schwameis K, Zehetner J, Rona K, Crookes P, Bildzukewicz N, Oh DS, Ro G, Ross K, Sandhu K, Katkhouda N, Hagen JA, and Lipham JC
- Subjects
- Aged, Female, Flatulence etiology, Humans, Laparoscopy adverse effects, Male, Middle Aged, Operative Time, Postoperative Complications etiology, Quality of Life, Recurrence, Reoperation, Retrospective Studies, Syndrome, Deglutition Disorders etiology, Fundoplication adverse effects, Fundoplication methods, Gastroesophageal Reflux surgery
- Abstract
Introduction: Protracted dysphagia and bloating are potential troublesome side effects following Nissen fundoplication. The aim of this study was to evaluate the effects of conversion from Nissen to Toupet on dysphagia and bloating., Methods: The study used a retrospective chart review of all patients who had undergone conversion from Nissen to Toupet between 2001 and 2014. Endpoints were to determine the effect of conversion on dysphagia, bloating, and reflux control., Results: Twenty-five patients underwent conversion at a median of 3.7 years (1.4-10.5) after initial fundoplication. Indications were dysphagia in 19 (76%) and bloating syndrome in 6 (24%) patients. The median operative time was 104 min (86-146). There were no serious complications or mortality. Median follow-up was 27 months (0.8-130). Dysphagia was relieved in 16 (84%) and bloating in all 6 patients. Two patients developed reflux requiring a redo-Nissen. Two patients had persistent dysphagia and required endoscopic dilation. The GERD-HRQL post-conversion showed a median score of 5 (3-13)., Conclusions: Conversion relieved dysphagia in 84% and bloating in 100%. Significant recurrence of GERD was rare. Given the absence of serious complications, conversion should be considered in patients with severe bloating or dysphagia.
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- 2017
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40. Gastric cancer in the young: An advanced disease with poor prognostic features.
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Rona KA, Schwameis K, Zehetner J, Samakar K, Green K, Samaan J, Sandhu K, Bildzukewicz N, Katkhouda N, and Lipham JC
- Subjects
- Adenocarcinoma surgery, Adult, Aged, Aged, 80 and over, Female, Gastrectomy, Humans, Liver Neoplasms secondary, Los Angeles epidemiology, Male, Middle Aged, Peritoneal Neoplasms secondary, Prognosis, Retrospective Studies, Stomach Neoplasms surgery, Young Adult, Adenocarcinoma mortality, Adenocarcinoma pathology, Stomach Neoplasms mortality, Stomach Neoplasms pathology
- Abstract
Background and Objectives: Gastric cancer in young patients is rare. We analyzed the clinicopathological features and prognosis of early-onset gastric carcinoma., Methods: We retrospectively reviewed patients with gastric adenocarcinoma aged ≤45 years and >45 years at our institution over a 17-year period. Clinicopathological features were compared and survival analysis was performed using Kaplan-Meier curves., Results: A total of 121 patients with gastric carcinoma aged ≤45 years were identified. The young group (YG) had a higher incidence of stage III/IV disease (86.8% vs. 57.9%, P < 0.001), poorly-differentiated carcinoma (95.9% vs. 74.4%, P < 0.001), and signet-cell type tumor (88.4% vs. 32.2%, P < 0.001) relative to the older group (OG). The majority of tumors were in the middle third of the stomach in both groups (P = 0.108). Three-year survival in the YG was 87.1%, 32.2%, and 6.9% in stage I/II, III, and IV disease, respectively. Surgical intervention in young patients with advanced carcinoma was not associated with improved survival. Although median survival was shorter in the YG compared to the OG (11.7 vs. 41.0 months, P < 0.001), stage-specific survival was similar., Conclusion: Early-onset gastric cancer demonstrates advanced stage of disease, and a high incidence of poorly-differentiated and signet-cell type carcinoma. Overall survival is poor with no added benefit to surgical intervention in advanced disease., (© 2016 Wiley Periodicals, Inc.)
- Published
- 2017
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41. Intraoperative assessment of the effects of laparoscopic sleeve gastrectomy on the distensibility of the lower esophageal sphincter using impedance planimetry.
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Reynolds JL, Zehetner J, Shiraga S, Lipham JC, and Katkhouda N
- Subjects
- Adult, Aged, Bariatric Surgery, Female, Gastroesophageal Reflux physiopathology, Humans, Male, Middle Aged, Pneumoperitoneum, Artificial, Postoperative Complications physiopathology, Prospective Studies, Treatment Outcome, Electric Impedance, Esophageal Sphincter, Lower physiopathology, Gastrectomy methods, Gastroesophageal Reflux epidemiology, Intraoperative Care methods, Laparoscopy methods, Obesity, Morbid surgery, Postoperative Complications epidemiology
- Abstract
Background: Laparoscopic sleeve gastrectomy (LSG) has emerged as an effective weight-loss procedure for morbid obesity that is also effective for treating comorbidities such as diabetes. However, it has been associated with the development of GERD postoperatively. The pathophysiology of post-LSG GERD is unknown, and current studies have shown conflicting results. The aim of our study is to shed light on this issue by investigating the effect of LSG on the lower esophageal sphincter (LES) function and the relationship of LES function to GERD symptoms., Methods: A prospective study of patients undergoing LSG from 10/2013 to 8/2014 at a single academic tertiary referral center was carried out. Patients undergoing a concomitant procedure such as hiatal hernia repair or laparoscopic gastric band removal were excluded. Distensibility of the LES was measured after pneumoperitoneum and after LSG. Baseline GERD-HRQL was obtained with follow-up GERD-HRQL and weight at 3 and 6 months. The primary outcomes measured were LES distensibility and GERD-HRQL scores after LSG. Our secondary outcome was a correlation between LES distensibility and GERD-HRQL scores after LSG., Results: Fifteen subjects were enrolled (5M/10F). Mean age was 51 years (30-71 years), and mean BMI 45 kg/m
2 (30-58). We were able to obtain follow-up data for all patients at 3 months. Mean LES distensibility increased from 1.2 before LSG to 2.2 after LSG (p = 0.017). Median GERD-HRQL was 0 before LSG and remained essentially negative at 1 and 0 (3 and 6 months postoperatively, respectively). Three (27 %) of the patients had de novo GERD at 3 months following LSG. One (25 %) patient had remission of GERD. There was no correlation between LES distensibility and GERD symptoms., Conclusion: While LSG weakens the LES immediately, it does not predictably affect postoperative GERD symptoms; therefore, distensibility is not the only factor affecting development of postoperative GERD, confirming the multifactorial nature of post-LSG GERD.- Published
- 2016
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42. A Durable Laparoscopic Technique for the Repair of Large Paraesophageal Hernias.
- Author
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Reynolds JL, Zehetner J, Bildzukewicz N, Katkhouda N, and Lipham JC
- Subjects
- Adult, Chi-Square Distribution, Databases, Factual, Female, Follow-Up Studies, Gastroesophageal Reflux etiology, Hernia, Hiatal complications, Hernia, Hiatal diagnosis, Humans, Kaplan-Meier Estimate, Laparoscopy adverse effects, Male, Middle Aged, Postoperative Complications physiopathology, Postoperative Complications surgery, Recurrence, Retrospective Studies, Risk Assessment, Severity of Illness Index, Treatment Outcome, Fundoplication methods, Gastroesophageal Reflux surgery, Hernia, Hiatal surgery, Laparoscopy methods, Quality of Life, Surgical Mesh
- Abstract
Laparoscopic repair of large paraesophageal hernias has been challenging due to high recurrence rates with primary repair and complications associated with the use of nonabsorbable mesh to reinforce the hiatus. The aim of our study was to evaluate the recurrence rate over time and mesh-related complications using an absorbable polyglactin mesh secured with Bioglue to reinforce the hiatus after laparoscopic repair of large paraesophageal hernias. There were 190 patients who met inclusion criteria from June 2006 to June 2014. Follow-up was routinely performed at 1-year intervals, including endoscopy and/or video esophagram, and the gastroesophageal reflux disease health-related quality of life questionnaire. Mean follow-up was 21 months (3-88). There were no incidences of mesh erosion. Recurrence was detected in 17 patients (15.3%), with a median time to recurrence of 23 months (8-67). Recurrence rate was estimated with the Kaplan-Meier method to be 2.9 ± 1.6 per cent, 11.6 ± 3.7 per cent, 22.4 ± 5.6 per cent, 25.1 ± 6.0 per cent, and 29.5 ± 7.9 per cent at 12, 24, 36, 48, and 60 months, respectively. The mean gastroesophageal reflux disease health-related quality of life was 2 in patients both with and without recurrence. Laparoscopic intrathoracic stomach repair using absorbable polyglactin mesh and Bioglue for crural reinforcement is effective, safe, and durable. The rate of recurrence plateaus over time with the majority of recurrences being small to moderate asymptomatic hernias.
- Published
- 2016
43. Charges, outcomes, and complications: a comparison of magnetic sphincter augmentation versus laparoscopic Nissen fundoplication for the treatment of GERD.
- Author
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Reynolds JL, Zehetner J, Nieh A, Bildzukewicz N, Sandhu K, Katkhouda N, and Lipham JC
- Subjects
- Costs and Cost Analysis, Deglutition Disorders epidemiology, Digestive System Surgical Procedures economics, Female, Flatulence epidemiology, Gastroesophageal Reflux drug therapy, Humans, Length of Stay economics, Male, Middle Aged, Operative Time, Postoperative Complications epidemiology, Proton Pump Inhibitors therapeutic use, Retrospective Studies, Treatment Outcome, United States, Esophageal Sphincter, Lower surgery, Fundoplication economics, Gastroesophageal Reflux surgery, Hospital Charges, Laparoscopy economics, Magnets
- Abstract
Background: Magnetic sphincter augmentation (MSA) is approved for uncomplicated GERD. Multiple studies have shown MSA to compare favorably to laparoscopic Nissen fundoplication (LNF) in terms of symptom control with results out to 5 years. The MSA device itself, however, is an added cost to an anti-reflux surgery, and direct cost comparison studies have not been done between MSA and LNF. The aim of the study was to compare charges, complications, and outcome of MSA versus LNF at 1 year., Methods: This is a retrospective analysis of all patients who underwent MSA or LNF for the treatment of GERD between January 2010 and June 2013. Patient charges were collected for the surgical admission. We also collected data on 30-day complications and symptom control at 1 year assessed by GERD-HRQL score and PPI use., Results: There were 119 patients included in the study, 52 MSA and 67 LNF. There was no significant difference between the mean charges for MSA and LNF ($48,491 vs. $50,111, p = 0.506). There were significant differences in OR time (66 min MSA vs. 82 min LNF, p < 0.01) and LOS (17 h MSA vs. 38 h LNF, p < 0.01). At 1-year follow-up, mean GERD-HRQL was 4.3 for MSA versus 5.1 for LNF (p = 0.47) and 85 % of MSA patients versus 92 % of LNF patients were free from PPIs (p = 0.37). MSA patients reported less gas bloat symptoms (23 vs. 53 %, p ≤ 0.01) and inability to belch (10 vs. 36 %, p ≤ 0.01) and vomit (4 vs. 19 %, p ≤ 0.01)., Conclusion: The side effect profile of MSA is better than LNF as evidenced by less gas bloat and increase ability to belch and vomit. LNF and MSA are comparable in symptom control, safety, and overall hospital charges. The charge for the MSA device is offset by less charges in other categories as a result of the shorter operative time and LOS.
- Published
- 2016
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44. Multi-institutional outcomes using magnetic sphincter augmentation versus Nissen fundoplication for chronic gastroesophageal reflux disease.
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Warren HF, Reynolds JL, Lipham JC, Zehetner J, Bildzukewicz NA, Taiganides PA, Mickley J, Aye RW, Farivar AS, and Louie BE
- Subjects
- Adult, Case-Control Studies, Cohort Studies, Esophageal Sphincter, Lower surgery, Female, Humans, Laparoscopy, Length of Stay, Male, Middle Aged, Operative Time, Patient Satisfaction, Quality of Life, Retrospective Studies, Fundoplication, Gastroesophageal Reflux therapy, Magnetic Field Therapy
- Abstract
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.
- Published
- 2016
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45. Long-term Outcomes of Patients Receiving a Magnetic Sphincter Augmentation Device for Gastroesophageal Reflux.
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Ganz RA, Edmundowicz SA, Taiganides PA, Lipham JC, Smith CD, DeVault KR, Horgan S, Jacobsen G, Luketich JD, Smith CC, Schlack-Haerer SC, Kothari SN, Dunst CM, Watson TJ, Peters J, Oelschlager BK, Perry KA, Melvin S, Bemelman WA, Smout AJ, and Dunn D
- Subjects
- Adolescent, Adult, Aged, Female, Humans, Male, Middle Aged, Netherlands, Prospective Studies, Prosthesis Implantation adverse effects, Quality of Life, Surveys and Questionnaires, Treatment Outcome, United States, Young Adult, Esophageal Sphincter, Lower surgery, Gastroesophageal Reflux surgery, Magnets, Prosthesis Implantation methods
- Abstract
Background & Aims: Based on results from year 2 of a 5-year trial, in 2012 the US Food and Drug Administration approved the use of a magnetic device to augment lower esophageal sphincter function in patients with gastroesophageal reflux disease (GERD). We report the final results of 5 years of follow-up evaluation of patients who received this device., Methods: We performed a prospective study of the safety and efficacy of a magnetic device in 100 adults with GERD for 6 months or more, who were partially responsive to daily proton pump inhibitors (PPIs) and had evidence of pathologic esophageal acid exposure, at 14 centers in the United States and The Netherlands. The magnetic device was placed using standard laparoscopic tools and techniques. Eighty-five subjects were followed up for 5 years to evaluate quality of life, reflux control, use of PPIs, and side effects. The GERD-health-related quality of life (GERD-HRQL) questionnaire was administered at baseline to patients on and off PPIs, and after placement of the device; patients served as their own controls. A partial response to PPIs was defined as a GERD-HRQL score of 10 or less on PPIs and a score of 15 or higher off PPIs, or a 6-point or more improvement when scores on vs off PPI were compared., Results: Over the follow-up period, no device erosions, migrations, or malfunctions occurred. At baseline, the median GERD-HRQL scores were 27 in patients not taking PPIs and 11 in patients on PPIs; 5 years after device placement this score decreased to 4. All patients used PPIs at baseline; this value decreased to 15.3% at 5 years. Moderate or severe regurgitation occurred in 57% of subjects at baseline, but only 1.2% at 5 years. All patients reported the ability to belch and vomit if needed. Bothersome dysphagia was present in 5% at baseline and in 6% at 5 years. Bothersome gas-bloat was present in 52% at baseline and decreased to 8.3% at 5 years., Conclusions: Augmentation of the lower esophageal sphincter with a magnetic device provides significant and sustained control of reflux, with minimal side effects or complications. No new safety risks emerged over a 5-year follow-up period. These findings validate the long-term safety and efficacy of the magnetic sphincter augmentation device for patients with GERD. ClinicalTrials.gov no: NCT00776997., (Copyright © 2016 AGA Institute. Published by Elsevier Inc. All rights reserved.)
- Published
- 2016
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46. Magnetic Sphincter Augmentation for Gastroesophageal Reflux at 5 Years: Final Results of a Pilot Study Show Long-Term Acid Reduction and Symptom Improvement.
- Author
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Saino G, Bonavina L, Lipham JC, Dunn D, and Ganz RA
- Subjects
- Adult, Aged, Esophageal pH Monitoring, Female, Follow-Up Studies, Gastroesophageal Reflux complications, Gastroesophageal Reflux drug therapy, Humans, Laparoscopy adverse effects, Male, Middle Aged, Pilot Projects, Prospective Studies, Proton Pump Inhibitors therapeutic use, Surveys and Questionnaires, Symptom Assessment, Treatment Outcome, Esophageal Sphincter, Lower surgery, Gastroesophageal Reflux surgery, Magnets, Prostheses and Implants adverse effects, Quality of Life
- Abstract
Background: As previously reported, the magnetic sphincter augmentation device (MSAD) preserves gastric anatomy and results in less severe side effects than traditional antireflux surgery. The final 5-year results of a pilot study are reported here., Patients and Methods: A prospective, multicenter study evaluated safety and efficacy of the MSAD for 5 years. Prior to MSAD placement, patients had abnormal esophageal acid and symptoms poorly controlled by proton pump inhibitors (PPIs). Patients served as their own control, which allowed comparison between baseline and postoperative measurements to determine individual treatment effect. At 5 years, gastroesophageal reflux disease (GERD)-Health Related Quality of Life (HRQL) questionnaire score, esophageal pH, PPI use, and complications were evaluated., Results: Between February 2007 and October 2008, 44 patients (26 males) had an MSAD implanted by laparoscopy, and 33 patients were followed up at 5 years. Mean total percentage of time with pH <4 was 11.9% at baseline and 4.6% at 5 years (P < .001), with 85% of patients achieving pH normalization or at least a 50% reduction. Mean total GERD-HRQL score improved significantly from 25.7 to 2.9 (P < .001) when comparing baseline and 5 years, and 93.9% of patients had at least a 50% reduction in total score compared with baseline. Complete discontinuation of PPIs was achieved by 87.8% of patients. No complications occurred in the long term, including no device erosions or migrations at any point., Conclusions: Based on long-term reduction in esophageal acid, symptom improvement, and no late complications, this study shows the relative safety and efficacy of magnetic sphincter augmentation for GERD.
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- 2015
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47. Three-dimensional Laparoscopy: Does Improved Visualization Decrease the Learning Curve Among Trainees in Advanced Procedures?
- Author
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Cologne KG, Zehetner J, Liwanag L, Cash C, Senagore AJ, and Lipham JC
- Subjects
- Humans, Reproducibility of Results, Clinical Competence, Education, Medical, Continuing methods, Imaging, Three-Dimensional methods, Laparoscopy education, Laparoscopy methods, Learning Curve, Students, Medical
- Abstract
Purpose: Complex laparoscopy is difficult to master because it involves 3-dimensional (3D) interpretation on a 2-dimensional (2D) viewing screen. The use of 3D technology has an uncertain effect on training surgeons. We aim to evaluate the effectiveness of 3D on learning and performing laparoscopic tasks., Methods: Medical students without laparoscopic experience (novices) were evaluated doing inanimate object transfer and laparoscopic suturing. Tasks were repeated using 2D and 3D cameras with standard instruments. Time and error rates (missed attempts, dropped objects, and failure to complete the task) were recorded., Results: Twenty-nine novice medical students experienced a 45.5% decrease in the time to complete PEG transfer using 3D (mean 207 s with 2D vs. 113 s with 3D). Error rate was reduced to 50% (2D, 4 errors vs. 3D, 2 errors) and mean drop rate was reduced to 0. Similar decreases in suture time (46.5%) were seen (mean 403 s with 2D vs. 220 s with 3D)., Conclusions: Our results indicate that 3D significantly improved visualization and ability to perform complex tasks in the skills laboratory setting. This technology may be very effective in teaching advanced laparoscopic skills in the era of work-hour restrictions.
- Published
- 2015
- Full Text
- View/download PDF
48. Laparoscopic Magnetic Sphincter Augmentation vs Laparoscopic Nissen Fundoplication: A Matched-Pair Analysis of 100 Patients.
- Author
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Reynolds JL, Zehetner J, Wu P, Shah S, Bildzukewicz N, and Lipham JC
- Subjects
- Adult, Aged, Female, Follow-Up Studies, Gastroesophageal Reflux diagnosis, Humans, Laparoscopy instrumentation, Male, Matched-Pair Analysis, Middle Aged, Propensity Score, Retrospective Studies, Severity of Illness Index, Treatment Outcome, Esophageal Sphincter, Lower surgery, Fundoplication methods, Gastroesophageal Reflux surgery, Laparoscopy methods, Magnets
- Abstract
Background: The efficacy and safety of magnetic sphincter augmentation (MSA) with the LINX device (Torax Medical) has been reported in several short-and long-term studies, rivaling historic results of laparoscopic Nissen fundoplication (LNF), but with fewer side effects. However, there have been no studies comparing patients with similar disease to validate these results., Study Design: We conducted a retrospective analysis of 1-year outcomes of patients undergoing MSA and LNF from June 2010 to June 2013. Patients were matched using propensity scores incorporating multiple preoperative variables. Outcomes were measured by GERD Health Related Quality of Life scores, proton-pump inhibitor use, satisfaction, and complications., Results: One hundred and seventy-nine patients met inclusion criteria, 62 MSA and 117 LNF. Propensity score matching identified 50 patients in both groups using the "best-fit" model with a caliper of 0.5 SD. At 1 year after surgery, both groups had similar GERD Health Related Quality of Life scores (4.2 MSA and 4.3 LNF; p = 0.897) and proton-pump inhibitor use (17% of MSA and 8.5% of LNF; p = 0.355). Although there was no difference in the number of patients reporting mild gas and bloating (27.6% MSA and 27.6% LNF; p = 1.000), there were no patients with severe gas and bloating in the MSA group compared with 10.6% in the LNF group (p = 0.022). More LNF patients were unable to belch (8.5% of MSA and 25.5% of LNF; p = 0.028) or vomit (4.3% of MSA and 21.3% of LNF; p = 0.004). The incidence of postoperative dysphagia was similar between the groups (46.8% MSA and 44.7% LNF; p = 0.766)., Conclusions: Analogous GERD patients had similar control of reflux symptoms after both MSA and LNF. The inabilities to belch and vomit were significantly fewer with MSA, along with a significantly lower incidence of severe gas-bloat symptoms. These results support the use of MSA as first-line therapy in patients with mild to moderate GERD., (Copyright © 2015 American College of Surgeons. Published by Elsevier Inc. All rights reserved.)
- Published
- 2015
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49. Intraoperative Assessment of Perfusion of the Gastric Graft and Correlation With Anastomotic Leaks After Esophagectomy.
- Author
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Zehetner J, DeMeester SR, Alicuben ET, Oh DS, Lipham JC, Hagen JA, and DeMeester TR
- Subjects
- Aged, Anastomosis, Surgical adverse effects, Anastomotic Leak prevention & control, Esophagectomy methods, Female, Humans, Intraoperative Period, Lasers, Male, Middle Aged, Stomach transplantation, Anastomotic Leak etiology, Esophageal Diseases surgery, Esophagectomy adverse effects, Fluorescein Angiography, Stomach blood supply
- Abstract
Objective: The aim of the study was to evaluate laser-assisted fluorescent-dye angiography (LAA) to assess perfusion in the gastric graft and to correlate perfusion with subsequent anastomotic leak., Background: Anastomotic leaks are a major source of morbidity after esophagectomy with gastric pull-up (GPU). In large part, they occur as a consequence of poor perfusion in the gastric graft., Methods: Real-time intraoperative perfusion was assessed using LAA before bringing the graft up through the mediastinum. When there was a transition from rapid and bright to slow and less robust perfusion, this site was marked with a suture. The location of the anastomosis relative to the suture was noted and the outcome of the anastomosis ascertained by retrospective record review., Results: Intraoperative LAA was used to assess graft perfusion in 150 consecutive patients undergoing esophagectomy with planned GPU reconstruction. An esophagogastric anastomosis was performed in 144 patients. A leak was found in 24 patients (16.7%) and were significantly less likely when the anastomosis was placed in an area of good perfusion compared with when the anastomosis was placed in an area of less robust perfusion by LAA (2% vs 45%, P < 0.0001). By multivariate analysis perfusion at the site of the anastomosis was the only significant factor associated with a leak., Conclusions: Intraoperative real-time assessment of perfusion with LAA correlated with the likelihood of an anastomotic leak and confirmed the critical relationship between good perfusion and anastomotic healing. The use of LAA may contribute to reduced anastomotic morbidity.
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- 2015
- Full Text
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50. The Durability of Endoscopic Therapy for Treatment of Barrett's Metaplasia, Dysplasia, and Mucosal Cancer After Nissen Fundoplication.
- Author
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Johnson CS, Louie BE, Wille A, Dunst CM, Worrell SG, DeMeester SR, Reynolds J, Dixon J, Lipham JC, Lada M, Peters JH, Watson TJ, Farivar AS, and Aye RW
- Subjects
- Barrett Esophagus pathology, Disease Progression, Esophagus surgery, Female, Follow-Up Studies, Humans, Intestinal Mucosa surgery, Male, Metaplasia pathology, Middle Aged, Precancerous Conditions, Retrospective Studies, Treatment Outcome, Barrett Esophagus surgery, Catheter Ablation methods, Esophageal Neoplasms surgery, Esophagoscopy methods, Esophagus pathology, Fundoplication methods, Intestinal Mucosa pathology
- Abstract
Introduction: Radiofrequency ablation (RFA) ± endoscopic resection (EMR) is an established treatment strategy for neoplastic Barrett's and intramucosal cancer. Most patients are managed with proton pump inhibitors. The incidence of recurrent Barrett's metaplasia, dysplasia, or cancer after complete eradication is up to 43 % using this strategy. We hypothesize the addition of fundoplication should result in a lower recurrence rates after complete eradication., Methods: Multi-institutional retrospective review of patients undergoing endotherapy followed by Nissen fundoplication, Results: A total of 49 patients underwent RFA ± EMR followed by Nissen fundoplication. Complete remission of intestinal metaplasia (CR-IM) was achieved in 26 (53 %) patients, complete remission of dysplasia (CR-D) in 16 (33 %) patients, and 7 (14 %) had persistent neoplastic Barrett's. After fundoplication, 18/26 (70 %) remained in CR-IM. An additional 10/16 CR-D achieved CR-IM and 4/7 with persistent dysplasia achieved CR-IM. One patient progressed to LGD while no patient developed HGD or cancer., Conclusion: Endoscopic therapy for Barrett's dysplasia and/or intramucosal cancer followed by fundoplication results in similar durability of CR-IM to patients being managed with PPIs alone after endoscopic therapy. However, fundoplication may be superior in preventing further progression of disease and the development of cancer. Fundoplication is an important strategy to achieve and maintain CR-IM, and facilitate eradication of persistent dysplasia.
- Published
- 2015
- Full Text
- View/download PDF
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