Same-session endoscopic sleeve gastroplasty and transoral incisionless fundoplication: a possible solution to a growing problem.
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ABSTRACT:
SUBMITTER: Shah SL
PROVIDER: S-EPMC7570963 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:Background and study aims Transoral incisionless fundoplication (TIF) is a safe and effective minimally invasive endoscopic technique for treating gastroesophageal reflux disease (GERD). The learning curve for this technique has not been reported. We studied the learning curve for TIF when performed by a gastroenterologist by identifying the threshold number of procedures needed to achieve consistent technical success or proficiency (consistent creation of TIF valve ≥ 270 degrees in circumference, ≥ 2 cm long) and efficiency after didactic, hands-on and case observation experience. Patients and methods We analyzed prospectively collected data from patients who had TIF performed by a single therapeutic endoscopist within 17 months after basic training. We determined thresholds for procedural learning using cumulative sum of means (CUSUM) analysis to detect changes in achievement rates over time. We used breakpoint analysis to calculate procedure metrics related to proficiency and efficiency. Results A total of 69 patients had 72 TIFs. The most common indications were refractory GERD (44.7 %) and proton pump inhbitor intolerance (23.6 %). Proficiency was achieved at the 18 th to 20 th procedure. The maximum efficiency for performing a plication was achieved after the 26 th procedure, when mean time per plication decreased to 2.7 from 5.1 minutes (P < 0.0001). TIF procedures time varied until the 44 th procedure, after which it decreased significantly from 53.7 minutes to 39.4 minutes (P < 0.0001). Conclusions TIF can be safely, successfully, and efficiently performed in the endoscopy suite by a therapeutic endoscopist. The TIF learning curve is steep but proficiency can be achieved after a basic training experience and 18 to 20 independently performed procedures.
| S-EPMC8589558 | biostudies-literature
Project description:Background and study aims Gastroesophageal reflux disease (GERD) following peroral endoscopic myotomy (POEM) occurs in 40% to 60% of patients. There are limited data evaluating antireflux surgery or transoral incisionless fundoplication (TIF) for refractory post-POEM GERD. Patients and methods In a single-center prospective cohort study, consecutive patients with medically refractory post-POEM regurgitation and/or GERD treated with TIF or combined laparoscopic hernia repair and TIF (cTIF) were evaluated. Baseline evaluation: GERD-Health Related Quality of Life (GERD-HQRL) and Reflux Symptom Questionnaire 7-day recall (RESQ-7) questionnaires, EGD, high-resolution manometry (HRM), 48-hour pH test off proton pump inhibitors (PPIs) and impedance planimetry of the esophagogastric junction (EGJ) to calculate the diameter distensibility index (EGJ-DI). A PPI was taken twice daily for 2 weeks after TIF and restarted later if required. Patients returned 9 to 12 months after treatment when all preoperative studies were repeated. Quality of life, pH studies and EGJ metrics before and after antireflux surgery were compared. Results Seventeen patients underwent TIF (n=2, 12%) or cTIF (n=15, 88%) a mean 25±15 months after POEM. At follow-up a mean of 9±1 months after TIF/cTIF, patients required less frequent daily PPIs (n=0.001), were more satisfied (P=0.008), had improved GERD-HQRL (P=0.001), less intensity and frequency of GERD (P=0.001) and fewer reflux episodes (P=0.04) by pH testing. There was no change in EGJ-DI, EGJ diameter, integrated relaxation pressure, % total time pH <4, or DeMeester score. Conclusions TIF and cTIF for difficult-to-control post-POEM GERD appear safe, decrease PPI use and reflux episodes, and improve QOL without significant change in IRP, EGJ compliance, diameter or esophageal acid exposure time.
| S-EPMC10769579 | biostudies-literature
Project description:Background and study aims Given the sizable number of patients with symptomatic gastroesophageal reflux disease (GERD) despite proton pump inhibitor (PPI) therapy, non-pharmacologic treatment has become increasingly utilized. The aim of this study was to analyze the cost-effectiveness of medical, endoscopic, and surgical treatment of GERD. Patients and methods A deterministic Markov cohort model was constructed from the US healthcare payer's perspective to evaluate the cost-effectiveness of three competing strategies: 1) omeprazole 20 mg twice daily; 2) transoral incisionless fundoplication (TIF 2.0); and 3) laparoscopic Nissen fundoplication [LNF]. Cost was reported in US dollars with health outcomes recorded in quality-adjusted life years (QALYs). Ten-year and lifetime time horizons were utilized with 3 % discount rate and half-cycle corrections applied. The main outcome was incremental cost-effectiveness ratio (ICER) with a willingness-to-pay threshold of $ 100,000 per QALY. Probabilistic sensitivity analyses were also performed. Results In our base-case analysis, the average cost of TIF 2.0 was $ 13,978.63 versus $ 17,658.47 for LNF and $ 10,931.49 for PPI. Compared to the PPI strategy, TIF 2.0 was cost-effective with an incremental cost of $ 3,047 and incremental effectiveness of 0.29 QALYs, resulting in an ICER of $ 10,423.17 /QALY gained. LNF was strongly dominated by TIF 2.0. Over a lifetime horizon, TIF 2.0 remained the cost-effective strategy for patients with symptoms despite twice-daily 20-mg omeprazole. TIF 2.0 remained cost-effective after varying parameter inputs in deterministic and probabilistic sensitivity analyses and for scenario analyses in multiple age groups. Conclusions Based upon this study, TIF 2.0 was cost-effective for patients with symptomatic GERD despite low-dose, twice-daily PPI.
| S-EPMC9286770 | biostudies-literature
Project description:Video 1Video demonstration of endoscopic sleeve gastroplasty performed using a novel suture pattern termed the "cable" technique.
| S-EPMC8118129 | biostudies-literature
Project description: Not available
| S-EPMC7651751 | biostudies-literature
Project description:Obesity and its complications, such as type 2 diabetes, hypertension, hyperlipidemia, nonalcoholic fatty liver, are serious global public health problems. Endoscopic sleeve gastroplasty (ESG) can reduce the length and width of the stomach by simulating the anatomical structure of surgical sleeve gastrectomy to reduce the capacity of the stomach, and is safe and effective to reduce weight. ESG has the advantages of non- invasiveness, no gastrectomy, repeatability, simple operation, no incision scar, few complications, short hospital stay and quick postoperative recovery. As an intermediate means of medical treatment and surgery, ESG provides a new method for weight loss for obese patients who cannot tolerate or are unwilling to undergo surgery. Herein we trace the origin of ESG, analyze the unique advantages of ESG suture, explore the technical improvement in the development of ESG, and briefly describe the weight reduction effect of ESG and compare the curative effect of ESG with laparoscopic sleeve gastrectomy. ESG has undergone rapid development and maturity but also faces such challenges as the lack of established standard procedures, unclear weight reduction mechanism, and clarification of the indications for operation. Still, ESG is expected to become the mainstream technique for weight reduction.
| S-EPMC7321269 | biostudies-literature
Project description:ImportanceObesity is a disease with a large socioeconomic burden. Endoscopic sleeve gastroplasty (ESG) is a minimally invasive endoscopic bariatric procedure with wide global adoption. More recently, new weight-loss medications, such as glucagon-like peptide-1 receptor agonists (eg, semaglutide), have attracted increased attention due to their efficacy. However, their cost-effectiveness over an extended period compared with ESG is a critical gap that needs to be better explored for informed health care decision-making.ObjectiveTo assess the cost-effectiveness of semaglutide compared with ESG over 5 years for individuals with class II obesity.Design, setting, and participantsThis economic evaluation study, conducted from September 1, 2022, to May 31, 2023, used a Markov cohort model to compare ESG and semaglutide, with a no-treatment baseline strategy. The study comprised adult patients in the US health care system with class II obesity (body mass index [BMI] of 35-39.9). The base case was a 45-year-old patient with class II obesity (BMI of 37). Patients undergoing ESG were subjected to risks of perioperative mortality and adverse events with resultant costs and decrement in quality of life.InterventionsStrategies included treatment with semaglutide and ESG.Main outcomes and measuresCosts (2022 US dollars), quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratio (ICER) with a willingness-to-pay threshold of $100 000/QALY. A 5-year time horizon with a cycle length of 1 month with a 3% discount rate was used. Probabilities, costs, and quality-of-life estimates of the model were derived from published literature. One-way, 2-way, and probabilistic sensitivity analyses were also performed.ResultsThe model found that ESG was more cost-effective than semaglutide over a 5-year time horizon, with an ICER of -$595 532/QALY. Endoscopic sleeve gastroplasty added 0.06 QALYs and reduced total cost by $33 583 relative to semaglutide. The results remained robust on 1-way and probabilistic sensitivity analyses. Endoscopic sleeve gastroplasty sustained greater weight loss over 5 years vs semaglutide (BMI of 31.7 vs 33.0). To achieve nondominance, the annual price of semaglutide, currently $13 618, would need to be $3591.Conclusions and relevanceThis study suggests that ESG is cost saving compared with semaglutide in the treatment of class II obesity. On price threshold analyses, a 3-fold decrease in the price of semaglutide is needed to achieve nondominance.
| S-EPMC11015347 | biostudies-literature
Project description:BACKGROUND: A novel transoral incisionless fundoplication (TIF) procedure using the EsophyX system with SerosaFuse fasteners was designed to reconstruct a full-thickness valve at the gastroesophageal junction through tailored delivery of multiple fasteners during a single-device insertion. The safety and efficacy of TIF for treating gastroesophageal reflux disease (GERD) were evaluated in a prospective multicenter trial. METHODS: Patients (n = 86) with chronic GERD treated with proton pump inhibitors (PPIs) were enrolled. Exclusion criteria included an irreducible hiatal hernia > 2 cm. RESULTS: The TIF procedure (n = 84) reduced all hiatal hernias (n = 49) and constructed valves measuring 4 cm (2-6 cm) and 230 degrees (160 degrees -300 degrees ). Serious adverse events consisted of two esophageal perforations upon device insertion and one case of postoperative intraluminal bleeding. Other adverse events were mild and transient. At 12 months, aggregate (n = 79) and stratified Hill grade I tight (n = 21) results showed 73% and 86% of patients with >or=50% improvement in GERD health-related quality of life (HRQL) scores, 85% discontinuation of daily PPI use, and 81% complete cessation of PPIs; 37% and 48% normalization of esophageal acid exposure; 60% and 89% hiatal hernia reduction; and 62% and 80% esophagitis reduction, respectively. More than 50% of patients with Hill grade I tight valves had a normalized cardia circumference. Resting pressure of the lower esophageal sphincter (LES) was improved significantly (p < 0.001), by 53%. EsophyX-TIF cured GERD in 56% of patients based on their symptom reduction and PPI discontinuation. CONCLUSION: The 12-month results showed that EsophyX-TIF was safe and effective in improving quality of life and for reducing symptoms, PPI use, hiatal hernia, and esophagitis, as well as increasing the LES resting pressure and normalizing esophageal pH and cardia circumference in chronic GERD patients.
| S-EPMC2490723 | biostudies-other
Project description:Background and study aims Few reports exist about long-term outcomes of transoral incisionless fundoplication (TIF) for treating refractory gastro-esophageal reflux disease (GERD). Methods A literature search of four major scientific databases was performed up to May 2020 for studies reporting on more than 3-year outcomes of TIF. Data on atient satisfaction, proton pump inhibitor (PPI) daily consumption, PPI use reduction, GERD health-related quality-of-life (GERD-HRQL) score, and normalization of heartburn and regurgitation scores were pooled and summarized with forest plots. Publication bias and heterogeneity were explored. Results Overall, eight studies (418 patients, 232 men; 55.5 %) with a mean follow-up of 5.3 years (range: 3-10 years) were included. The pooled proportion of patient-reported satisfaction before and after TIF was 12.3 % (95 % CI:12.3-35.1 %, I 2 = 87.4 %) and 70.6 % (95 % CI:51.2-84.6, I 2 = 80 %), respectively, corresponding to an odds ratio of 21.4 (95 % CI:3.27-140.5). Pooled rates of patients completely off PPIs and on occasional PPIs were 53.8 % (95 %CI: 42.0 %-65.1 %) and 75.8 % (95 %CI: 67.6-82.6), respectively. The pooled estimated mean GERD-HRQL scores off PPI before and after TIF werey 26.1 (95 %CI: 21.5-30.7; range: 20.0-35.5) and 5.9, respectively (95 %CI:0.35.1-11.4; range: 5.3-9.8; P < 0.001). The overall pooled rates of heartburn and regurgitation scores normalization were 73.0 % (95 %CI: 0.62-0.82) and 86 %, respectively (95 %CI: 75.0-91.0 %). Conclusion Our study shows that TIF appears to offer a long-term safe therapeutic option for selected patients with GERD who refuse life-long medical therapy or surgery, are intolerant to PPIs, or are at increased surgical risk.
| S-EPMC7857958 | biostudies-literature
Project description:BackgroundBariatric endoscopic techniques are minimally invasive and induce gastric volume reduction to treat obesity. Aim : To evaluate endoscopic sleeve gastroplasty (Apollo method) using a suturing method directed at the greater curvature, as well as the perioperative care, two year safety and weight loss.MethodProspective single-center study over 154 patients (108 females) using the endoscopic sleeve gastroplasty procedure under general anesthesia with overnight inpatient observation. Of the154 initial patients, 143 were available for 1-month of follow-up, 133 for 6-month, 64 for 12-month and 28 completed the 24 month assessment. Follow-up was carried out by a multidisciplinary team (nutritionist and psychologist). Outcomes evaluated were: change in BMI; change in body weight (TBWL); % of loss of initial body weight (%TBWL); % of excess body weight loss (%EWL) (segregated in > or <25% and adverse effects. Voluntary oral contrasted radiological examinations were scheduled to assess the gastroplasty at different times post-procedure.ResultsMean age was 44.9 (23-69) years. At 24 months after the procedure baseline mean BMI change from 38.3 to 30.8 kg/m2. TBWL, %TBWL and %EWL were of 21.3 kg, 19.5% and 60.4% respectively. 85.7% of patients achieve the goal of >25% %EWL. There were no mayor adverse events intraprocedure or during the 24 months of follow-up .ConclusionEndoscopic sleeve gastroplasty with regular monitoring by a multidisciplinary team can be considered an effective, safe and well tolerated procedure for obesity treatment, at least for two years of follow-up.
| S-EPMC5424680 | biostudies-literature