BACKGROUND & AIMS:Gastric peroral endoscopic myotomy (G-POEM) is an emerging treatment for gastroparesis, but clinical outcomes can be inconsistent; hence, it is vital to enhance our management strategies for patients with clinical failure. METHODS:This was a multicenter retrospective review of patients who underwent G-POEM for refractory gastroparesis from September 2015 to November 2023. Clinical outcomes and management post-G-POEM were assessed and categorized into 4 types based on symptom improvement and gastric emptying metrics. RESULTS:Of the 482 patients, 221 (46%) underwent evaluations with pre- and post-G-POEM gastric emptying tests and were included in the study. Type 1 clinical response (clinical success with improved gastric emptying scintigraphy [GES]) was the most common outcome, occurring in 56%. This was followed by type 4 (clinical failure with no GES improvement) at 23%, type 2 (clinical failure with improved GES) at 15%, and type 3 (clinical success with no GES improvement) at 6.7%. Patients with primary clinical failure (types 2 and 4) showed significantly higher daily opioid use at 23%, compared with 7% in types 1 and 3 (P = .032). Clinical failure overall was observed in 60% during a median follow-up of 48 months, with 31% managed by pylorus-directed retreatment and 7% with gastric neurostimulator placement. In the type 1 response group, clinical success was re-established in 71% following pylorus-directed therapies, with repeat G-POEM being an independent predictor of clinical success post-re-treatment (odds ratio, 2.2; P = .02). CONCLUSIONS:Our study highlights the importance of post-G-POEM GES assessments for characterizing clinical responses. Type 1 responders are more likely to benefit from subsequent pylorus-directed re-treatments, particularly repeat G-POEM interventions. CLINICALTRIALS:gov, Number: NCT04434781.
Background and Aims The postoperative management of gastric peroral endoscopic myotomy (G-POEM) lacks standardization. This study aimed to evaluate adverse events, readmission rates, and feasibility of same-day discharge (SDD) after G-POEM. Methods A multicenter retrospective review of prospectively collected G-POEM data was conducted. The primary outcome was the 15-day readmission rates in SDD and admitted patients. Secondary outcomes included readmission risk factors, clinical success, and adverse events (AEs). Results We found a 4.1% 15-day readmission rate in 482 patients (95% CI, 3.2%-5.4%). SDD clinical success rates at 6 to 12 months were 54.1% versus 59.7% for the admitted group. The overall AE rate was 4.1%. SDD patients tended to have shorter procedure times and higher frequencies of double myotomy and endoscopic suturing for closure. Conclusions G-POEM is safe with low incidence of AEs and 15-day readmission rates. SDD appears safe in uncomplicated cases, suggesting that upper gastrointestinal studies after G-POEM may be unnecessary. ClinicalTrials.gov (NCT04434781).
The COVID‐19 disease induces long term heart health complications and may induce autonomic nervous system dysfunction. Heart Rate Variability (HRV) is a measure of sympathetic (SNS) and parasympathetic (PNS) control of heart function. Recently, studies have shown that HRV analysis may be used as a predictor of COVID‐19 symptoms and correlates with progression of the disease. We aimed to uncover the interplay between SNS and PNS in hospitalized COVID‐19 patients at the time of admission and compare it with similar measurements in healthy patients (no comorbidities) and patients with cardiovascular disease. We hypothesized that COVID‐19 would induce autonomic dysfunction similar to patients with cardiovascular disease (CVD). ECG telemetry recordings of 30‐60 minutes in duration were acquired from patients that were admitted to Indiana University Health system hospitals for either COVID‐19 complications or for complications associated with cardiovascular disease (CVD) states (arrhythmia, heart failure, coronary artery disease). In addition, 20‐minute ECG Lead I recordings were obtained from healthy volunteers with no associated comorbidities. HRV parameters were calculated during sinus rhythm in the time, frequency, and nonlinear domains from the ECG telemetry recordings. The patient population was composed of 50 COVID‐19 patients (average age 63, range 26‐94), 32 healthy (average age 32.7, range 17‐69) and 49 patients with cardiovascular disease (average age 65.4, range 30‐88) as control groups. The COVID‐19 group had a higher percentage of patients with BMI>30 (obese) than the control groups (55% vs 36%). Also, the COVID‐19 and CVD patients had significantly higher heart rate and time‐domain HRV parameters (including SDRR, RMSSD, SDSD) and SD1 in the non‐linear domain when compared to healthy patients (88.8±53.0 and 87.9±55.2 vs 49.5±31.3, p<0.01). In the frequency domain, the LF/HF ratio was significantly lower in the COVID and CVD groups compared to healthy controls (0.5±0.76 and 0.55±0.50 vs 1.05±0.96, p<0.01). COVID‐19 patients have significant HRV alterations which suggest increased vagal tone than in healthy volunteers but similar to patients with severe cardiovascular disease comorbidities. Even though the COVID patients had an increased heart rate, the results of the HRV analysis indicate increased vagal tone which would support autonomic nervous system dysfunction in these patients.
BACKGROUND:Real-time prediction of histologic features of small colorectal polyps may prevent resection and/or pathologic evaluation and therefore decrease colonoscopy costs. Previous studies showed that computer-aided diagnosis (CADx) was highly accurate, though it did not outperform expert endoscopists. OBJECTIVE:To assess the diagnostic performance of histologic predictions by general endoscopists before and after assistance from CADx in a real-life setting. DESIGN:Prospective, multicenter, single-group study. (ClinicalTrials.gov: NCT04437615). SETTING:6 centers across the United States. PARTICIPANTS:1252 consecutive patients undergoing colonoscopy and 49 general endoscopists with variable experience in real-time prediction of polyp histologic features. INTERVENTION:Real-time use of CADx during routine colonoscopy. MEASUREMENTS:The primary end points were the sensitivity and specificity of CADx-unassisted and CADx-assisted histologic predictions for adenomas measuring 5 mm or less. For clinical purposes, additional estimates according to location and confidence level were provided. RESULTS:The CADx device made a diagnosis for 2695 polyps measuring 5 mm or less (96%) in 1252 patients. There was no difference in sensitivity between the unassisted and assisted groups (90.7% vs. 90.8%; P = 0.52). Specificity was higher in the CADx-assisted group (59.5% vs. 64.7%; P < 0.001). Among all 2695 polyps measuring 5 mm or less, 88.2% and 86.1% (P < 0.001) in the CADx-assisted and unassisted groups, respectively, could be resected and discarded without pathologic evaluation. Among 743 rectosigmoid polyps measuring 5 mm or less, 49.5% and 47.9% (P < 0.001) in the CADx-assisted and unassisted groups, respectively, could be left in situ without resection. LIMITATION:Decision making based on CADx might differ outside a clinical trial. CONCLUSION:CADx assistance did not result in increased sensitivity of optical diagnosis. Despite a slight increase, the specificity of CADx-assisted diagnosis remained suboptimal. PRIMARY FUNDING SOURCE:Olympus America Corporation served as the clinical study sponsor.
Indiana University School of Medicine, USA; Stanford University School of Medicine, USA; The University of Texas Medical Branch at Galveston, USA; Vanderbilt University Medical Center, USA; The University of Kansas Medical Center, USA; NorthShore University HealthSystem, USA; The University of Mississippi Medical Center, USA; Thomas Jefferson University, USA; Institut klinicke a experimentalni mediciny, Czechia; University of Virginia School of Medicine, USA; Sharp Healthcare, USA.