Adverse events associated with transoral incisionless fundoplication (TIF) for chronic gastroesophageal reflux disease: a MAUDE database analysis

Ramai, Daryl; Shapiro, Alexandra; Barakat, Mohamed; Facciorusso, Antonio; Dull, A. M.; Chandan, Saurabh; Adler, Douglas G.

doi:10.1007/s00464-021-08851-x

Cited by 12 publications

(6 citation statements)

References 13 publications

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“…Upon searching the literature, we came across a single case report describing an Esophageo-pulmonary fistula following an EF. The patient presented with a lung abscess caused by an esophageal leak, which required surgical management by a thoracotomy approach [18][19][20].…”

Section: Discussionmentioning

confidence: 99%

A Newly Reported Late Complication of Endoscopic Fundoplication: A Case Report

Bukhari,

Aref,

Ghunaim

et al. 2024

Reports

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Endoscopic methods are emerging as a possible adjunct to surgery in the management of gastroesophageal reflux disease. Initially, endoscopic treatment has failed because of inefficient suturing devices, and although over many years it proved to be safe, it still can result in serious adverse events. In this article, the authors present a rare case of a male patient who experienced severe reflux years following endoscopic fundoplication. Moreover, in this report, we discovered an interesting finding with the patient who was diagnosed and managed laparoscopically. Although considered minimally invasive, endoscopic fundoplication can have significant deleterious consequences, and early recognition of these complications is vital to limit associated morbidities.

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Section: Discussionmentioning

confidence: 99%

A Newly Reported Late Complication of Endoscopic Fundoplication: A Case Report

Bukhari,

Aref,

Ghunaim

et al. 2024

Reports

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“…Nevertheless, about 80% of patients will eventually need a lower dosage compared to pre-endoscopy assessment [ 45 , 52 , 53 , 54 , 55 , 56 , 58 ]. The TIF procedure has also shown an overall good safety profile, with common mild and transient postoperative complications and few SAEs, mostly managed conservatively (around 2%) [ 50 , 51 , 52 ]. However, as it requires additional single-use equipment, TIF can be costly and presents a steep learning curve, even for experienced endoscopists.…”

Section: Discussionmentioning

confidence: 99%

“…Post-marketing surveillance data from the FDA Manufacturer and User Facility Device Experience (MAUDE) database reported 131 complications out of a total of approximately 22,000 procedures over a 10-year period, including 26 cases of perforation (19.8%), 12 cases of bleeding (9.2%), 12 cases of pleural effusion (9.2%), 2 cases of pneumothorax (1.5%), 1 case of pulmonary embolism (0.8%), and 1 case of pneumomediastinum (0.8%). Complications were mostly treated conservatively or endoscopically, but in nine cases, emergent open surgery was needed [ 51 ].…”

Section: Endoscopymentioning

confidence: 99%

New Perspectives in Endoscopic Treatment of Gastroesophageal Reflux Disease

et al. 2023

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Gastroesophageal reflux disease has a high incidence and prevalence in the general population. Clinical manifestations are heterogenous, and so is the response to medical treatment. Proton pump inhibitors are still the most common agents used to control reflux symptoms and for healing esophagitis, but they are not a one-size-fits-all solution for the disease. Patients with persistent troublesome symptoms despite medical therapy, those experiencing some adverse drug reaction, or those unwilling to take lifelong medications deserve valid alternatives. Anti-reflux Nissen fundoplication is an effective option, but the risk of adverse events has limited its spread. In recent years, advancements in therapeutic endoscopy have been made, and three major endoluminal alternatives are now available, including (1) the delivery of radiofrequency energy to the esophago–gastric junction, (2) transoral incisionless fundoplication (TIF), and (3) anti-reflux mucosal interventions (ARMI) based on mucosal resection (ARMS) and mucosal ablation (ARMA) techniques to remodel the cardia. Endoscopic techniques have shown interesting results, but their diffusion is still limited to expert endoscopists in tertiary centers. This review discusses the state of the art in the endoscopic approach to gastroesophageal reflux disease.

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Section: Discussionmentioning

confidence: 99%

“…Despite the absence of macroscopic signs of injury, mucosal impedance reflects the degree of permeability of the mucosa and is correlated with its integrity, with low values indicative of an alteration in the intercellular spaces and tight junctions found in GERD (136)(137)(138)(139)(140). There are several methods available for measuring esophageal mucosal impedance, including mean nocturnal baseline impedance (MNBI), high-resolution impedance manometry (HRIM)-derived measurements, and mucosal impedance probes (single-channel or balloon).…”

Section: Esophageal Electrical Impedance Technologiesmentioning

confidence: 99%

Trends in gastroesophageal reflux disease research: A bibliometric and visualized study

Zhang

Tian

et al. 2022

Front. Med.

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BackgroundGastroesophageal reflux disease (GERD), a disorder resulting from the retrograde flow of gastric contents into the esophagus, affects an estimated 10–30% of the Western population, which is characterized by multifactorial pathogenesis. Over the past few decades, there have been many aspects of uncertainty regarding GERD leading to an ongoing interest in the field as reflected by a large number of publications, whose heterogeneity and variable quality may present a challenge for researchers to measure their scientific impact, identify scientific collaborations, and to grasp actively researched themes in the GERD field. Accordingly, we aim to evaluate the knowledge structure, evolution of research themes, and emerging topics of GERD research between 2012 and 2022 with the help of bibliometric approaches.MethodsThe literature focusing on GERD from 2012 to 2022 was retrieved from the Science Citation Index Expanded of the Web of Science Core Collection. The overall publication performance, the most prolific countries or regions, authors, journals and resources-, knowledge- and intellectual-networking, as well as the co-citation analysis of references and keywords, were analyzed through Microsoft Office Excel 2019, CiteSpace, and VOSviewer.ResultsA total of 8,964 publications were included in the study. The USA published the most articles (3,204, 35.74%). Mayo Clin ranked first in the number of articles published (201, 2.24%). EDOARDO SAVARINO was the most productive author (86, 0.96%). The most productive journal in this field was SURGICAL ENDOSCOPY AND OTHER INTERVENTIONAL TECHNIQUES (304, 3.39%). AMERICAN JOURNAL OF GASTROENTEROLOGY had the most co-citations (4,953, 3.30%). Keywords with the ongoing strong citation bursts were transoral incision less fundoplication, eosinophilic esophagitis, baseline impedance, and functional heartburn.ConclusionFor the first time, we obtained deep insights into GERD research through bibliometric analysis. Findings in this study will be helpful for scholars seeking to understand essential information in this field and identify research frontiers.

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Adverse events associated with transoral incisionless fundoplication (TIF) for chronic gastroesophageal reflux disease: a MAUDE database analysis

Cited by 12 publications

References 13 publications

A Newly Reported Late Complication of Endoscopic Fundoplication: A Case Report

A Newly Reported Late Complication of Endoscopic Fundoplication: A Case Report

New Perspectives in Endoscopic Treatment of Gastroesophageal Reflux Disease

Trends in gastroesophageal reflux disease research: A bibliometric and visualized study

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