Single-use Duodenoscope: The Cleaner Standard.

Endoscopic retrograde cholangiopancreatography (ERCP) is the gold standard in the endoscopic management of biliary disease. An average of 700,000 ERCPs are performed every year, and most are performed using a reusable flexible duodenoscope. The innovation of disposable duodenoscopes has changed the dynamic in the advanced endoscopy field of study to primarily reduce or eliminate the risk of cross-contamination between patients. Many factors affect whether institutions can convert from standard reusable duodenoscopes to single-use duodenoscopes including the cost of the devices, reimbursement from insurance companies for the new devices, and the overall environmental impact. However, the reduction of cross-contamination leading to active infection in patients, environmental waste produced with high-level disinfection procedures, staff and equipment required for reprocessing, and the inability to frequently upgrade duodenoscopes for optimal performance are all factors that favor transitioning to single-use duodenoscopes. As these devices are new to the field of gastroenterology, the purpose of this review is to analyze the advantages and disadvantages of transitioning to single-use devices and a brief mention of alternative options for institutions unable to make this change.

Comparing the Safety and Efficacy of Two Commercially Available Single-Use Duodenoscopes: A Multicenter Study.

INTRODUCTION: Single-use disposable duodenoscopes (SDD) have been developed to mitigate infectious risks related to reusable duodenoscopes. The aim of this study is to compare the safety and efficacy of the two available SDDs in the United States. METHODS: We conducted a comparative study of 2 SDD in consecutive ERCP procedures performed by expert endoscopists from 9 academic centers. Performance ratings, procedure details, and adverse events were collected. RESULTS: A total of 201 patients were included: 129 patients underwent ERCP with Exalt (mean age 63, Males- 66 (51%), 72 with aScope Duodeno (mean age 65, males=30 (42%). A majority of endoscopists had performed >2000 ERCPs in both groups (71% Exalt, 93% aScope Duodeno). Technical success was 92% in both groups (n=119 Exalt-group, n=66 aScope-Duodeno-group). The procedural complexity for the ERCP cases performed were: Grade 1: 35 cases (18%), Grade 2: 83 cases (41%), Grade 3: 65 cases (32%), and Grade 4: 18 cases (9%). Thirteen patients (10%) from the Exalt group and 16 patients (22%) from the aScope Duodeno group required conversion to a reusable duodenoscope. On a scale of 1 to 5, Exalt and aScope Duodeno, respectively, were rated: 2.31 versus 2.60 for location and visualization quality, 1.38 versus 1.57 for maneuverability based on papillary orientation, 1.48 versus 1.15 for suction/air control, and 2.31 versus 2.34 for elevator efficiency. None of the adverse events were related to the SDDs. CONCLUSIONS: The 2 SDDs were comparable. Further ongoing enhancements to these devices will improve maneuverability and clinical effectiveness.

Novel Uses of Lumen-apposing Metal Stents: A Review of the Literature.

The field of therapeutic endoscopy has seen many recent advancements. One such emerging field is the use of lumen-apposing metal stents (LAMS). Although a few LAMS have been developed, the most commonly reviewed and the only Food and Drug Administration (FDA)-approved LAMS is the Axios stent by Boston Scientific. In 2013, LAMS were initially approved by the FDA for the management of pancreatic fluid collection drainage in the presence walled-off necrosis. Pancreatic fluid collections are traditionally drained with either a plastic stent or a covered biliary self-expanding metal stent. Plastic stents have a double pigtail feature which prevents stent migration. However, their narrow lumen poses limitations as it can lead to early stent occlusion. Fully covered metal stents have larger diameters, allowing improved drainage and decreased stent occlusion but their tubular shape is prone to migration. Consequently, this results in leakage, and frequent retrievals. Over the years, due to their versatility, LAMS now have many off label uses. This includes management of gastric outlet obstruction, superior mesenteric artery syndrome, strictures, gallbladder drainage, and postsurgical collection drainage. In this review, we will be discussing the FDA approved and the nonapproved uses of LAMS.

Hearing Outcomes of Treatment for Acute Noise-induced Hearing Loss: A Systematic Review and Meta-analysis.

OBJECTIVE: To determine the efficacy of various treatment modalities used for acute noise-induced hearing loss (aNIHL) from acute acoustic trauma (AAT) via a systematic review and meta-analysis. DATA SOURCES: PubMed, Cochrane, and Scopus databases. STUDY SELECTION: The scientific literature was searched up to October 2018 for articles evaluating hearing outcomes after treatment of aNIHL. DATA EXTRACTION: The following were extracted: Oxford level of evidence, number of patients, mean age, time to presentation, source of noise exposure, method of treatment/intervention, baseline hearing threshold, posttreatment hearing threshold, hearing gain, proportion of patients with no recovery, partial recovery, or complete recovery, and treatment complications. DATA SYNTHESIS: Sixteen studies with 932 patients met inclusion criteria for systematic review and four studies with 187 patients were included in the meta-analysis. CONCLUSIONS: Treatment modalities identified were steroids, vascular agents, nootropics, antioxidants, vitamins, cell apoptosis inhibitors, and hyperbaric oxygen therapy. Meta-analysis demonstrated significant improvement in mean hearing threshold for patients with high-frequency hearing loss, those treated within 48 hours, and those receiving treatment with a nootropic agent. Significant heterogeneity was present in experimental design among included studies and many were of lower levels of evidence. More prospective, large scale, randomized, double-blinded, placebo-controlled clinical trials are required to determine optimal treatment regimens for patients suffering from aNIHL caused by AAT.

Sinonasal quality-of-life outcomes after endoscopic endonasal skull base surgery.

BACKGROUND: There are substantial gaps in our understanding of the influence of the endoscopic endonasal approach (EEA) for endoscopic skull base surgery on sinonasal-specific quality of life (QOL) as well as the instruments available for assessment. Our primary objective in this study was to characterize postoperative changes in sinonasal QOL, specifically using the 22-item Sino-Nasal Outcome Test (SNOT-22), with a secondary objective of delineating weaknesses in our current understanding of patient symptomatology after EEA for skull base surgery. METHODS: A comprehensive literature review was conducted using PubMed, CINAHL, Cochrane Library, and SCOPUS for studies reporting SNOT-22 data pre- and postoperatively in patients who underwent EEA for skull base pathologies. Studies were limited to patients ≥18 years of age and excluded patients diagnosed with chronic rhinosinusitis (CRS). RESULTS: Nineteen unique studies with 27 separate data sets and a total of 1025 patients were used in this meta-analysis. Overall SNOT-22 scores statistically improved at the 6-month (p = 0.0009) and 1-year (p = 0.002) time-points. Patients with preoperative SNOT-22 scores ≥20 achieved postoperative improvements at 12-week (p < 0.00001), 6-month (p < 0.0001), 1-year (p < 0.00001), and long-term follow-up (p < 0.0001). Patients with preoperative SNOT-22 scores <20 remained stable and did not worsen postoperatively. CONCLUSION: Patients undergoing EEA for skull base pathologies who have impaired sinonasal QOL preoperatively demonstrated significant postoperative QOL improvements. Those patients with relatively normal preoperative sinonasal QOL remained asymptomatic postoperatively. This study supports the need for development of a contemporary disease- and approach-specific, validated QOL instrument for skull base pathologies.

General Health Quality of Life Instruments Underestimate the Impact of Bilateral Cochlear Implantation.

OBJECTIVE: To determine the extent to which bilateral cochlear implantation increases patient-reported benefit as compared with unilateral implantation and no implantation. DATA SOURCES: PubMed, Scopus, CINAHL, and Cochrane databases searches were performed using the keywords ("Cochlear Implant" or "Cochlear Implantation") and ("bilateral"). STUDY SELECTION: Studies assessing hearing/CI-specific (CI) and general-health-related (HR) quality of life (QOL) in adult patients after bilateral cochlear implantation were included. DATA EXTRACTION: Of the 31 articles meeting criteria, usable QOL data were available for 16 articles (n = 355 bilateral CI recipients). DATA SYNTHESIS: Standardized mean difference (Δ) for each measure and weighted effects were determined. Meta-analysis was performed for all QOL measures and also independently for hearing/CI-specific QOL and HRQOL. CONCLUSION: When measured using hearing/CI-specific QOL instruments, patients reported very large improvements in QOL comparing before cochlear implantation to bilateral CI (Δ=2.07 [1.76-2.38]) and medium improvements comparing unilateral CI to bilateral CI (Δ=0.51 [0.32- 0.71]). Utilization of parallel versus crossover study design did not impact QOL outcomes (χ = 0.512, p = 0.47). No detectable improvements were observed in either CI transition when using HRQOL instruments (no CI to bilateral CI: Δ=0.40 [-0.02 to 0.81]; unilateral CI to bilateral CI: Δ=0.22 [-0.02 to 0.46]).The universal nature of HRQOL instruments may render them insensitive to the medium to large QOL improvements reported by patients using hearing/CI-specific QOL instruments. Given that HRQOL instruments are used to determine the economic benefit of health interventions, these measurement differences suggest that the health economic value of bilateral cochlear implantation has been underestimated.