Transoral incisionless fundoplication for recurrent symptoms after laparoscopic fundoplication.

BACKGROUND: Revision of a failed laparoscopic fundoplication carries higher risk of complication and lower chance of success compared to the original surgery. Transoral incisionless fundoplication (TIF) may be an endoscopic alternative for select GERD patients without need of a moderate/large hiatal hernia repair. The aim of this study was to assess feasibility, efficacy, and safety of TIF 2.0 after failed laparoscopic Nissen or Toupet fundoplication (TIFFF). METHODS: This is a multicenter retrospective cohort study of patients who underwent TIFFF between September 2017 and December 2020 using TIF 2.0 technique (EsophyX Z/Z+) performed by gastroenterologists and surgeons. Patients were included if they had (1) recurrent GERD symptoms, (2) pathologic reflux based upon pH testing or Grade C/D esophagitis or Barrett's esophagus, and (3) hiatal hernia ≤ 2 cm. The primary outcome was improvement in GERD Health-Related Quality of Life (GERD-HRQL) post-TIFFF. The TIFFF cohort was also compared to a similar surgical re-operative cohort using propensity score matching. RESULTS: Twenty patients underwent TIFFF (median 4.1 years after prior fundoplication) and mean GERD-HRQL score improved from 24.3 ± 22.9 to 14.75 ± 21.6 (p = 0.014); mean Reflux Severity Index (RSI) score improved from 14.1 ± 14.6 to 9.1 ± 8.0 (p = 0.046) with 8/10 (80%) of patients with normal RSI (< 13) post-TIF. Esophagitis healed in 78% of patients. PPI use decreased from 85 to 55% with 8/20 (45%) patients off of PPI. Importantly, mean acid exposure time decreased from 12% ± 17.8 to 0.8% ± 1.1 (p = 0.028) with 9/9 (100%) of patients with normalized pH post-TIF. There were no statistically significant differences in clinical efficacy outcomes between TIFFF and surgical revision, but TIFFF had significantly fewer late adverse events. CONCLUSION: Endoscopic rescue with TIF is a safe and efficacious alternative to redo laparoscopic surgery in symptomatic patients with appropriate anatomy and objective evidence of persistent or recurrent reflux.

A Cost-Effectiveness Analysis Of An Adenocarcinoma Risk Prediction Multi-Biomarker Assay For Patients With Barrett's Esophagus.

PURPOSE: This study evaluates the cost-effectiveness of a quantitative multi-biomarker assay (the Assay) that stratifies patients with Barrett's Esophagus (BE) by risk of progression to high-grade dysplasia (HGD) or esophageal adenocarcinoma (EAC) and can be used to guide clinical decisions, versus the current guidelines (standard of care [SOC]) for surveillance and treatment of BE. PATIENTS AND METHODS: Markov decision modeling and simulation were used to compare cost and quality-adjusted life-years (QALYs) from the perspective of a US health insurer with care delivered by an integrated health system. Model assumptions and disease progression probabilities were derived from the literature. Performance metrics for the Assay were from an independent clinical validation study. Cost of the Assay was based on reimbursement rates from multiple payers. Other costs were derived from Geisinger payment data. RESULTS: Base-case model results for a 5-year period comparing the Assay-directed care to the SOC estimated an incremental cost-effectiveness ratio (ICER) of $52,483/QALY in 2012 US dollars. Assay-directed care increased the use of endoscopic treatments by 58.4%, which reduced the progression to HGD, EAC and reduced EAC-related deaths by 51.7%, 47.1%, and 37.6%, respectively, over the 5-year period. Sensitivity analysis indicated that the probability of the Assay being cost-effective compared to the SOC was 57.3% at the $100,000/QALY acceptability threshold. CONCLUSION: Given the model assumptions, the new Assay would be cost-effective after 5 years and improves patient outcomes due to improvement in the effectiveness of surveillance and treatment protocols resulting in fewer patients progressing to HGD and EAC and fewer EAC-related deaths.

A Self-Report Measure of Clinicians' Orientation toward Integrative Medicine.

OBJECTIVE: Patients in the U.S. often turn to complementary and alternative medicine (CAM) and may use it concurrently with conventional medicine to treat illness and promote wellness. However, clinicians vary in their openness to the merging of treatment paradigms. Because integration of CAM with conventional medicine can have important implications for health care, we developed a survey instrument to assess clinicians' orientation toward integrative medicine. STUDY SETTING: A convenience sample of 294 acupuncturists, chiropractors, primary care physicians, and physician acupuncturists in academic and community settings in California. DATA COLLECTION METHODS: We used a qualitative analysis of structured interviews to develop a conceptual model of integrative medicine at the provider level. Based on this conceptual model, we developed a 30-item survey (IM-30) to assess five domains of clinicians' orientation toward integrative medicine: openness, readiness to refer, learning from alternate paradigms, patient-centered care, and safety of integration. PRINCIPAL FINDINGS: Two hundred and two clinicians (69 percent response rate) returned the survey. The internal consistency reliability for the 30-item total scale and the five subscales ranged from 0.71 to 0.90. Item-scale correlations for the five subscales were higher for the hypothesized subscale than other subscales 75 percent or more of the time. Construct validity was supported by the association of the IM-30 total scale score (0-100 possible range, with a higher score indicative of greater orientation toward integrative medicine) with hypothesized constructs: physician acupuncturists scored higher than physicians (71 versus 50, p<.001), dual-trained practitioners scored higher than single-trained practitioners (71 versus 62, p<.001), and practitioners' self-perceived "integrativeness" was significantly correlated (r=0.60, p<.001) with the IM-30 total score. CONCLUSION: This study provides support for the reliability and validity of the IM-30 as a measure of clinicians' orientation toward integrative medicine. The IM-30 survey, which we estimate as requiring 5 minutes to complete, can be administered to both conventional and CAM clinicians.