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BackgroundA retrospective study evaluated safety, symptom resolution, patient satisfaction, and medication use 1–2 years after transoral incisionless fundoplication (TIF) in patients with gastroesophageal reflux disease (GERD) and/or laryngopharyngeal reflux (LPR) symptoms.MethodsThirty-four patients with a confirmed diagnosis of GERD symptoms that were inadequately controlled by antisecretory medications, and who where either dissatisfied with their current therapy or not willing to continue taking medication, underwent TIF using EsophyX at our community-based hospital. Follow-up assessments were completed in 28 patients.ResultsMedian age of the study group was 57 (range = 23–77) years, BMI was 25.7 (18.3–36.4) kg/m2, and 50% were female. All patients had documented chronic GERD for a median 5 (1–20) years and refractory symptoms to proton pump inhibitors (PPIs). Hiatal hernia was present in 75% (21/28) of patients, and 21% (6/28) had erosive esophagitis (LA grade A or B). TIF was performed following a standardized TIF-2 protocol and resulted in reducing hiatal hernia and restoring the natural anatomy of the gastroesophageal (GE) junction (Hill grade I). There were no postoperative complications. At a median 14-months follow-up, 82% (23/28) of patients were off daily PPIs (64% completely off PPIs), and 68% (19/28) were satisfied with their current health condition compared to 4% before TIF. Median GERD Health-Related Quality of Life scores were significantly reduced to 4 (0–25) from 26 (0–45) before TIF (P < 0.001). Heartburn was eliminated in 65% (17/26) and improved by >50% in 86% (24/28) of patients. Regurgitation was eliminated in 80% (16/20) of patients. Atypical LPR symptoms such as hoarseness, coughing, and throat clearing were eliminated in 63% (17/27) of patients as measured by Reflux Symptom Index scores.ConclusionOur results in 28 patients confirm the safety and effectiveness of TIF, documenting symptomatic improvement of GERD and LPR symptoms and clinically significant discontinuation of daily PPIs in 82% of patients.

TIF provided a safe and effective therapeutic option for carefully selected patients with chronic GERD.

BackgroundA single non-invasive gene expression profiling (GEP) test (AlloMap®) is often used to discriminate if a heart transplant recipient is at a low risk of acute cellular rejection at time of testing. In a randomized trial, use of the test (a GEP score from 0–40) has been shown to be non-inferior to a routine endomyocardial biopsy for surveillance after heart transplantation in selected low-risk patients with respect to clinical outcomes. Recently, it was suggested that the within-patient variability of consecutive GEP scores may be used to independently predict future clinical events; however, future studies were recommended. Here we performed an analysis of an independent patient population to determine the prognostic utility of within-patient variability of GEP scores in predicting future clinical events.MethodsWe defined the GEP score variability as the standard deviation of four GEP scores collected ≥315 days post-transplantation. Of the 737 patients from the Cardiac Allograft Rejection Gene Expression Observational (CARGO) II trial, 36 were assigned to the composite event group (death, re-transplantation or graft failure ≥315 days post-transplantation and within 3 years of the final GEP test) and 55 were assigned to the control group (non-event patients). In this case-controlled study, the performance of GEP score variability to predict future events was evaluated by the area under the receiver operator characteristics curve (AUC ROC). The negative predictive values (NPV) and positive predictive values (PPV) including 95 % confidence intervals (CI) of GEP score variability were calculated.ResultsThe estimated prevalence of events was 17 %. Events occurred at a median of 391 (inter-quartile range 376) days after the final GEP test. The GEP variability AUC ROC for the prediction of a composite event was 0.72 (95 % CI 0.6-0.8). The NPV for GEP score variability of 0.6 was 97 % (95 % CI 91.4-100.0); the PPV for GEP score variability of 1.5 was 35.4 % (95 % CI 13.5-75.8).ConclusionIn heart transplant recipients, a GEP score variability may be used to predict the probability that a composite event will occur within 3 years after the last GEP score.Trial registrationClinicaltrials.gov identifier NCT00761787Electronic supplementary materialThe online version of this article (doi:10.1186/s12872-015-0106-1) contains supplementary material, which is available to authorized users.

Results: Four of the six HTG EdgeSeq and NanoString nCounter recalibrated panels had negative predictive value (NPV) of at least 99% when tested in the replication cohort. The positive predictive value (PPV) was between 4 and 5% for all panels. Combining 2 or 3 of the panels into an ensemble improved the PPV slightly to 7% while keeping the NPV at > 99%. Sensitivity for detection of true rejection positives was 100% for most panels. These performance characteristics apply to all timepoints post-transplant. Conclusion: Blood-based biomarkers to monitor for absence of acute cardiac rejection have been identified and replicated, then transferred to and tested on two clinically relevant platforms. The HTG assay is being deployed at the local clinical laboratory. The team is currently designing a North American clinical trial to assess the validity of the selected biomarkers in a clinical setting. Once clinically validated, the assay and instrument will be deployed to other transplant centres.