Gastric myoelectrical activity based AI-derived threshold predicts resolution of gastroparesis post-pyloric balloon dilation.

BACKGROUND: A patient subset with gastroparesis (GP) has normal gastric myoelectrical activity (GMA) and pyloric dysfunction. AIMS: (1) To determine pyloric balloon dilation (BD) effect on symptoms and gastric emptying in GP patients with normal 3 cycles per minute (cpm) GMA. (2) To demonstrate GMA-based artificial intelligence (AI)-derived formulae predict BD success at 10-12-month follow-up. METHODS: Cohort subjects completed baseline electrogastrogram w/water load satiety test (WLST), solid-phase nuclear gastric emptying, Gastrointestinal Cardinal Symptom Index (ANMS GCSI-DD) and Leeds questionnaires. Subjects were divided into two groups based on response to the WLST. Group 1 (n = 26) with hypernormal/normal 3 cpm GMA and Group 2 (n = 4) hyponormal/normal range 3 cpm GMA, compared to healthy normals. All subjects underwent endoscopic pyloric BD. After 10-12 months, gastric emptying and dyspepsia questionnaires were repeated to evaluate outcomes. RESULTS: Group 1 ANMS GCSI-DD scores improved from 2 points at baseline (BL) to 0 at follow-up (f/u) (p < 0.001); Group 2 ANMS GSCI-DD scores were 2 at BL and 1.6 at f/u (p = 0.25). Leeds scores improved (p < 0.001) only for Group 1. Group 1 gastric emptying improved (54.5% retained at 2 h at BL vs. 12.2% at f/u, p < 0.001) in contrast to Group 2 patients (51.25% at BL vs. 56.25% at f/u, p = 0.252). Percentage 3 cpm GMA decreased (41.1% at BL vs. 24.9% at f/u, p ≤ 0.005) in Group 1 versus Group 2 (15.3% at BL vs. 23.4% at f/u, p = 0.114). AI-derived GMA threshold (GMAT) of 0.59 predicted positive pyloric BD outcomes at 10-12 months with sensitivity 96%, specificity 75%, and 93% correct classification. CONCLUSIONS: Pyloric BD improved symptoms and gastric emptying long term in patients with GP and hypernormal/normal 3 cpm GMA. AI-derived GMAT predicted pyloric BD success. GMA post-WLST and GMAT are objective measures for improved selection and outcomes for endoscopic pyloric BD.

Adjustable intragastric balloon for treatment of obesity: a multicentre, open-label, randomised clinical trial.

BACKGROUND: Intragastric balloons are anatomy-preserving, minimally invasive obesity therapies. Enhanced tolerance and durability could help broaden clinical adoption. We investigated the safety and efficacy of an adjustable intragastric balloon (aIGB) in adults with obesity. METHODS: In this prospective, multicentre, open-label, randomised clinical trial done at seven US sites, adults aged 22-65 years with obesity were randomly assigned (2:1) to aIGB with lifestyle intervention or lifestyle intervention alone (control) for 32 weeks. Balloon volume could be increased to facilitate weight loss or decreased for tolerability. Coprimary endpoints included mean percentage total bodyweight loss and responder rate (≥5% total bodyweight loss) at 32 weeks. We used a multiple imputed intention-to-treat population analysis. This study was registered with ClinicalTrials.gov, NCT02812160. FINDINGS: Between Aug 9, 2016, and Dec 7, 2018, we randomly assigned 288 patients to aIGB (n=187 [65%]) or control (n=101 [35%]) groups. Mean total bodyweight loss at 32 weeks was 15·0% (95% CI 13·9-16·1) in the aIGB group versus 3·3% (2·0-4·6) in the control group (p<0·0001). Clinical response was observed in 171 (92%) patients in the aIGB group. Adjustments to the aIGB occurred in 145 (80%) patients for weight loss plateau or intolerance. Upward volume adjustment facilitated an additional mean 5·2% (4·5-5·8) total bodyweight loss. Downward volume adjustment allowed 21 (75%) patients in the aIGB group to complete the full duration of therapy. Intolerance caused early removal of the device in 31 (17%) patients. No micronutrient deficiencies were observed in the aIGB cohort. Device-related serious adverse events were observed in seven (4%) patients, without any deaths. INTERPRETATION: When aIGB was combined with lifestyle modification, significant weight loss was achieved and maintained for 6 months following removal. Balloon volume adjustability permitted individualised therapy, maximising weight loss and tolerance. FUNDING: Spatz Medical.

Radiofrequency energy delivery to the lower esophageal sphincter improves gastroesophageal reflux patient-reported outcomes in failed laparoscopic Nissen fundoplication cohort.

BACKGROUND: Patients with uncontrollable gastroesophageal reflux disease (GERD) often undergo laparoscopic Nissen fundoplication (LNF); however, long-term there are often recurring symptoms and need for continuous medication use. Refractory LNF patients may receive radiofrequency energy delivery to the lower esophageal sphincter (Stretta) to ameliorate symptoms and medication requirements. The aim was to assess and compare long-term patient-reported outcomes of Stretta in refractory patients with and without previous LNF. METHODS: We prospectively assessed and compared patient-reported outcomes in 18 refractory LNF patients and 81 standard refractory GERD patients that all underwent Stretta during 10-year follow-up. Patient-reported outcomes measured were GERD-HRQL (health-related quality of life), patient satisfaction scores, and daily medication requirements. RESULTS: The refractory LNF subset demonstrated median improvements in GERD-HRQL, satisfaction, and medication use at all follow-up time points ≥6 months to 10 years, which was significant from a baseline of both on- and off-medications (p < 0.05). Specifically at 10 years, median GERD-HRQL decreased from 36 to 7 (p < 0.001), satisfaction increased from 1 to 4 (p < 0.001), and medication score decreased from 7 to 6 (p = 0.040). Nine patients decreased medication use by half at 10 years. No significant differences existed between refractory LNF and standard refractory GERD subsets at any follow-up time point ≥6 months to 10 years (p > 0.05) after Stretta. At 10 years, no significant differences were noted between refractory LNF and standard Stretta subsets regarding medication use (p = 0.088), patient satisfaction (p = 0.573), and GERD-HRQL (p = 0.075). Stretta procedures were completed without difficulty or significant intraoperative or long-term adverse events. CONCLUSION: Within a small cohort of refractory LNF patients, Stretta resulted in sustained improvement over 10 years with equivalent outcomes to non-LNF standard Stretta patients. Refractory LNF patients are a subpopulation that may be safely, effectively, and robustly aided by Stretta with fewer complications compared to redo of Nissen or chronic medication use.

Long-term maintenance effect of radiofrequency energy delivery for refractory GERD: a decade later.

BACKGROUND: Patients with gastroesophageal reflux disease (GERD) often seek alternative therapy for inadequate symptom control, with over 40% not responding to medical treatment. We evaluated the long-term safety, efficacy, and durability of response to radiofrequency treatment of the lower esophageal sphincter (Stretta). METHODS: Using an intent-to-treat analysis, we prospectively assessed 217 patients with medically refractory GERD before and after Stretta. There was no concurrent control group in the study. Primary outcome measure was normalization of GERD-health-related quality of life (GERD-HRQL) in 70% or greater of patients at 10 years. Secondary outcomes were 50% reduction or elimination of proton pump inhibitors (PPIs) and 60% or greater improvement in satisfaction at 10 years. Successful treatment was defined as achievement of secondary outcomes in a minimum of 50% of patients. Complications and effect on existing comorbidities were evaluated. The results of a 10-year study are reported. RESULTS: The primary outcome was achieved in 72% of patients (95% confidence interval 65-79). For secondary outcomes, a 50% or greater reduction in PPI use occurred in 64% of patients, (41% eliminating PPIs entirely), and a 60% or greater increase in satisfaction occurred in 54% of patients. Both secondary endpoints were achieved. The most common side effect was short-term chest pain (50%). Pre-existing Barrett's metaplasia regressed in 85% of biopsied patients. No cases of esophageal cancer occurred. CONCLUSIONS: In this single-group evaluation of 217 patients before and after Stretta, GERD-HRQL scores, satisfaction, and PPI use significantly improved and results were immediate and durable at 10 years.

Gastrointestinal Myoelectrical Activity (GIMA) Biomarker for Noninvasive Diagnosis of Endometriosis.

Background/Objectives: Endometriosis represents substantial direct and indirect healthcare costs impacted by an absence of uniformly accurate, non-invasive diagnostic tools. We endeavored to demonstrate gastrointestinal myoelectrical activity (GIMA) biomarkers, unique to endometriosis, will allow non-invasive, uniformly accurate diagnosis or exclusion of endometriosis. Methods: Prospective open-label comparative study of 154 patients, age ≥ 18, with or without diagnosed endometriosis. Population included 62 non-endometriosis controls (Cohort 1), 43 subjects with surgically/histologically confirmed endometriosis (Cohort 2), and 49 subjects with abdominal pain and negative imaging (Cohort 3). Non-invasive electroviscerography (EVG) recorded GIMA biomarkers from three abdominal electrodes before and 30 min post water load protocol. Cohort 2 had postoperative EVG and Cohort 3 had preoperative EVG. Calculated specificity, sensitivity, negative predictive value (NPV), positive predictive value (PPV), and predictive probability or C-statistic used univariate, multivariate, linear, and logistical regression analyses of the area under the curve (AUC) at all frequency and time points, including age and pain covariants. Results: The non-endometriosis cohort differed significantly from the endometriosis cohorts (p < 0.001) for median (IQR) and AUC percent frequency distribution of power at baseline, 10 min, 20 min, and 30 min post water load at all frequency ranges: 15-20 cpm, 30-40 cpm, and 40-50 cpm. The endometriosis cohorts were statistically similar (p > 0.05). GIMA biomarker threshold scoring demonstrated 95%/91% sensitivity and PPV, 96%/95% specificity and NPV, and a C-statistic of >99%/98%, respectively, for age subsets. GIMA biomarkers in Cohort 3 predicted 47/49 subjects positive and 2/49 negative for endometriosis, confirmed surgically. Hormonal therapy, surgical stage, nor pain score affected diagnostic accuracy. Conclusions: EVG with GIMA biomarker detection distinguished participants with and without endometriosis based upon endometriosis-specific GIMA biomarkers threshold scoring.

Gastroparesis associated with gastroesophageal reflux disease and corresponding reflux symptoms may be corrected by radiofrequency ablation of the cardia and esophagogastric junction.

BACKGROUND: Reflux is a common medical condition with symptoms ordinarily controlled using drug/medical therapy. However, 20% of patients experience unmanageable symptoms despite twice-daily (BID) proton pump inhibitor (PPI) therapy. Growing clinical evidence shows that delayed gastric emptying (gastroparesis) may be a factor associated with severe reflux, dyspepsia, or both. Gastroparesis, concomitant in 25% of patients with gastroesophageal reflux disease (GERD), has been shown to improve after Nissen fundoplication. Radiofrequency treatment for GERD potentially corrects GERD-associated gastroparesis and resultant PPI BID reflux failures. METHODS: From July 2000 until July 2004, 227 patients undergoing Stretta for GERD were screened for gastric anomalies. Patients with gastroparesis, documented on a standardized nuclear gastric emptying scans, and patients with heartburn and regurgitation uncontrolled by PPI BID medications underwent radiofrequency ablation of the cardia and esophagogastric junction via the Stretta procedure. The patients had esophagogastroduodenoscopy and/or pH studies, manometry, solid-phase gastric emptying, and electrogastrography and completed standardized heartburn and health-related quality-of-life surveys before treatment, then 6 months afterward. Patients with pyloric obstruction and those taking motility agents were excluded from the study. Gastric emptying scans were repeated 6 months after Stretta. The nuclear radiologist was blinded to the study design. RESULTS: At baseline, 31 patients were classified as abnormal. At 6 months after the procedure, emptying scores had improved significantly, with the percentage of solid food emptied at 90 min improved from 41% to 66% (p < 0.0001) and at 120 minutes from 55% to 84%. Significant improvements were seen at all intervals. Overall, 23 patients (74%) experienced normalization of gastric emptying, and 4 patients were improved but remained abnormal. Four patients showed no improvement on their gastric emptying scans, with one patient electing to undergo a Nissen procedure. All the patients had a 1-year symptom follow-up assessment, which showed significant improvements in GERD health-related quality of life, dyspepsia, and heartburn scores. CONCLUSIONS: Radiofrequency treatment has been demonstrated to correct gastroparesis. Patients' symptoms improved significantly. The mechanism of action is unknown but may be related to reduction in transient lower esophageal sphincter relaxations (TLESRs), increased esophagogastric junction barrier, decreased esophageal venting, alteration of the gastric pacemaker function in the region of radiofrequency therapy administration, removal of medications for symptoms, or a combination of all these.

Randomized sham-controlled trial of the 6-month swallowable gas-filled intragastric balloon system for weight loss.

BACKGROUND: Obesity is a significant health problem and additional therapies are needed to improve obesity treatment. OBJECTIVE: Determine the efficacy and safety of a 6-month swallowable gas-filled intragastric balloon system for weight loss. SETTING: Fifteen academic and private practice centers in the United States. METHODS: This was a double-blind, randomized sham-controlled trial of the swallowable gas-filled intragastric balloon system plus lifestyle therapy compared with lifestyle therapy alone for weight loss at 6 months in participants aged 22 to 60 years with body mass index 30 to 40 kg/m2, across 15 sites in the United States. The following endpoints were included: difference in percent total weight loss in treatment group versus control group was >2.1%, and a responder rate of >35% in the treatment group. RESULTS: Three hundred eighty-seven patients swallowed at least 1 capsule. Of participants, 93.3% completed all 24 weeks of blinded study testing. Nonserious adverse events occurred in 91.1% of patients, but only .4% were severe. One bleeding ulcer and 1 balloon deflation occurred. In analysis of patients who completed treatment, the treatment and control groups achieved 7.1 ± 5.0% and 3.6 ± 5.1% total weight loss, respectively, and a mean difference of 3.5% (P = .0085). Total weight loss in treatment and control groups were 7.1 ± 5.3 and 3.6 ± 5.1 kg (P < .0001), and body mass index change in the treatment and control groups were 2.5 ± 1.8 and 1.3 ± 1.8 kg/m2 (P < .0001), respectively. The responder rate in the treatment group was 66.7% (P < .0001). Weight loss maintenance in the treatment group was 88.5% at 48 weeks. CONCLUSIONS: Treatment with lifestyle therapy and the 6-month swallowable gas-filled intragastric balloon system was safe and resulted in twice as much weight loss compared with a sham control, with high weight loss maintenance at 48 weeks.

Sustained improvement in symptoms of GERD and antisecretory drug use: 4-year follow-up of the Stretta procedure.

BACKGROUND: Approximately 20% of patients with GERD do not respond to medical therapy. The Stretta radiofrequency antireflux procedure represents an alternative to failed drug therapy for GERD. OBJECTIVE: The aim of this study was to assess symptom and medication changes after the Stretta procedure during a 4-year follow-up period. DESIGN: Prospective case series on intent-to-treat basis. SETTING: Community practice. PATIENTS: Patients with GERD with persistent symptoms despite twice-daily proton pump inhibitor (PPI) medications. INTERVENTIONS: The Stretta procedure was performed in drug-refractory patients with GERD diagnosed by the presence of endoscopically evidenced esophagitis or abnormal esophageal pH testing. Symptom assessment was performed with a validated health-related quality-of-life questionnaire (with and without medication) at baseline and 6, 12, 24, 36, and 48 months after treatment. Complications of the procedure and medication usage were analyzed. MAIN OUTCOME MEASUREMENTS: Significant changes in symptom scores, GERD quality-of-life parameters, and medication usage on the basis of clinical outcomes. RESULTS: We report on a series of 109 consecutive patients treated with the Stretta procedure who have reached 4-year follow-up. Complete long-term follow-up assessment was available in matched data for 109 patients at 12 months, 108 patients at 24 months, 102 patients at 36 months, and 96 patients at 48 months. A second procedure was performed in 13 patients. Heartburn scores decreased from 3.6 to 1.18 (P < .001), total heartburn score (GERD health-related quality-of-life questionnaire) decreased from 27.8 to 7.1 (P < .001), and patient satisfaction improved from 1.4 to 3.8 (P < .001) (see ). Medication usage decreased significantly from 100% of patients on twice-daily PPI therapy at baseline to 75% of patients showing elimination of medications or only as-needed use of antacids/over-the-counter PPIs at 48 months (P < 0.005). There were no serious complications of the procedure. LIMITATIONS: This is an uncontrolled, nonrandomized case series in consecutive patients that does not include long-term pH or motility studies. CONCLUSIONS: This study in drug-refractory patients with GERD found the Stretta procedure to be a safe, effective, and durable treatment that produced significant improvements in heartburn and quality of life and decreased medication usage during a 4-year period of follow-up.