Complications of Antireflux Surgery

Yadlapati, Rena; Hungness, Eric S.; Pandolfino, John E.

doi:10.1038/s41395-018-0115-7

Cited by 101 publications

(83 citation statements)

References 61 publications

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“…Similar to existing anti-reflux surgery, the procedure as such can have complications of importance that require special care: bleeding and infection [28]. Infection could be a serious issue when placing an implant, however, the consequences of an infection are reduced if the device is completely covered/invaginated in the stomach wall by stomach-to-stomach sutures, thereby avoiding that the infection is spread to the device.…”

Section: Discussionmentioning

confidence: 99%

Non-active implantable device treating acid reflux with a new dynamic treatment approach: 1-year results

et al. 2020

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Background: RefluxStop™ is an implantable, non-active, single use device used in the laparoscopic treatment of GERD. RefluxStop™ aims to block the movement of the LES up into the thorax and keep the angle of His in its original, anatomically correct position. This new device restores normal anatomy, leaving the food passageway unaffected. Methods: In a prospective, single arm, multicentric clinical investigation analyzing safety and effectiveness of the RefluxStop™ device to treat GERD, 50 subjects with chronic GERD were operated using a standardized surgical technique between December 2016 and September 2017. They were followed up for 1 year (CE-mark investigation 6months). Primary safety outcome was prevalence of serious adverse events related to the device, and primary effectiveness outcome reduction of GERD symptoms based on GERD-HRQL score. Secondary outcomes were prevalence of adverse events other than serious adverse events, reduction of total acid exposure time in 24-h pH monitoring, and reduction in average daily PPI usage and subject satisfaction. Results: There were no serious adverse events related to the device. Average GERD-HRQL total score at 1 year improved 86% from baseline (p < 0.001). 24-h pH monitoring compared to baseline showed a mean reduction percentage of overall time with pH < 4 from 16.35 to 0.80% at the 6-month visit (p < 0.001), with 98% of subjects showing normal 24-h pH. At 1 year: No new cases of dysphagia were recorded, present in 2 subjects, which existed already at baseline. Regular daily PPI usage occurred in all 50 subjects at baseline. At 1-year follow-up, only 1 subject took regular daily PPIs due to a too low placement of the device thereby prohibiting its function. None or minimal occasional episodes of regurgitation occurred in 97.8% of evaluable subjects. Gas bloating disappeared in 30 subjects and improved in 7 subjects.

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Section: Discussionmentioning

confidence: 99%

Non-active implantable device treating acid reflux with a new dynamic treatment approach: 1-year results

et al. 2020

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“…Dysphagia and gas-bloat syndrome can be side effects associated with GERD surgery. 41 The long-term use of PPI was associated with various diseases, such as osteoporosis, dementia, infections, and cardiovascular disease. 10 However, these issues could not be addressed in this study, because evidence of their impact on costs and clinical outcomes has been unknown.…”

Section: Discussionmentioning

confidence: 99%

Anti-reflux Surgery Versus Proton Pump Inhibitors for Severe Gastroesophageal Reflux Disease: A Cost-Effectiveness Study in Korea

Park

Ryu

et al. 2020

J Neurogastroenterol Motil

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Background/Aims The economic burden for gastroesophageal reflux disease (GERD) has recently increased in Asian countries. This study investigates the cost-effectiveness between anti-reflux surgery and medication, with proton pump inhibitors (PPIs) for GERD in Korea. Methods We used a decision tree and Markov model to obtain the costs and quality-adjusted life years (QALYs) of the surgical and medical strategies. Our target cohort was the severe GERD patients aged 50 years old who required a continuous double dose of PPIs. The time horizon was 10 years and all estimates were discounted at 5% per year. The incremental cost-effectiveness ratio of the anti-reflux surgery compared with medication with PPIs was calculated. Sensitivity analyses were performed on all relevant variables. Results The cost-utility analysis indicated anti-reflux surgery was more cost-effective than medication among severe GERD patients over a 10year period. The model predicted that the surgical strategy had a cost savings of $551 and the QALYs had a gain of 1.18 as compared with the medical strategy. The break-even point in costs of the anti-reflux surgery over the medication was estimated to be 9 years. Sensitivity analyses using the varying parameter assumptions demonstrated the robustness of the study results. Conclusions This study showed anti-reflux surgery was less expensive and more effective therapy over the PPI medication after 9 years of follow-up. This suggests the surgical strategy is a cost-effective alternative to PPI medication among patients who need long-term management for GERD in Korea.

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“…Similar to existing anti-re ux surgery, the procedure as such can have complications of importance that require special care: bleeding and infection [28]. Infection could be a serious issue when placing an implant, however, the consequences of an infection are reduced if the device is completely covered/invaginated in the stomach wall by stomach-to-stomach sutures, thereby avoiding that the infection is spread to the device.…”

Section: Summary Of the Main E Cacy Endpointmentioning

confidence: 99%

Non-active implantable device treating acid reflux with a new dynamic treatment approach: 1-year results

Bjelović

Harsányi

Altorjay

et al. 2020

Preprint

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BACKGROUND RefluxStop™ is an implantable, non-active, single use device to be used in the laparoscopic treatment of GERD. RefluxStop™ aims to block the movement of the LES up into the thorax and keep the angle of His in its original anatomically correct position. This new device restores normal anatomy, leaving the food passageway unaffected. METHODS In prospective, single arm, multicentric clinical investigation analyzing safety and effectiveness of the RefluxStop™ device to treat GERD, 50 subjects with chronic GERD had been included. They were operated using standardized surgical technique between December 2016 and September 2017 and followed up for one year (CE-mark investigation 6-months). Primary safety outcome was the prevalence of serious adverse events related to the device and primary effectiveness outcome reduction of GERD symptoms based on the GERD HRQL score. Secondary outcomes were the prevalence of the adverse events apart from serious, reduction of the total acid exposure time on 24-hour pH monitoring, reduction in average daily PPI dosage and subject satisfaction. RESULTS There were no serious adverse events related to the device. Average GERD-HRQL total score at 1 year improved 86% from baseline (p<0.001). 24-h pH monitoring compared to baseline showed a mean reduction percentage of overall time with pH<4 from 16.35% to 0.80% at the 6-month visit (p<0.001). At 1-year: No new cases of dysphagia were recorded, occurred in 2 subjects, both significantly reduced compared to baseline. Regular daily PPI use before surgery occurred in all 50 subjects. At the 1-year follow-up only 1 subject took regular daily PPIs due to too low placement of the device thereby prohibiting its function. None or minimal occasional episodes of regurgitation occurred in 97.8% of evaluable subjects. Gas bloating disappeared in 30 subjects and improved in 7 subjects. CONCLUSION The new principle of RefluxStop™ is safe and effective to treat GERD according to investigation results. At 1-year follow up visit, both the GERD-HRQL score and 24-h pH monitoring results indicate success for the new treatment principle. In addition, with the dynamic treatment for acid reflux, which avoids compressing the food passageway, prevalence of dysphagia and gas bloating are significantly reduced.

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Complications of Antireflux Surgery

Cited by 101 publications

References 61 publications

Non-active implantable device treating acid reflux with a new dynamic treatment approach: 1-year results

Non-active implantable device treating acid reflux with a new dynamic treatment approach: 1-year results

Anti-reflux Surgery Versus Proton Pump Inhibitors for Severe Gastroesophageal Reflux Disease: A Cost-Effectiveness Study in Korea

Non-active implantable device treating acid reflux with a new dynamic treatment approach: 1-year results

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