High-intensity focused ultrasound with visually directed power adjustment for focal treatment of localized prostate cancer: systematic review and meta-analysis.

PURPOSE: To characterize patient outcomes following visually directed high-intensity focused ultrasound (HIFU) for focal treatment of localized prostate cancer. METHODS: We performed a systematic review of cancer-control outcomes and complication rates among men with localized prostate cancer treated with visually directed focal HIFU. Study outcomes were calculated using a random-effects meta-analysis model. RESULTS: A total of 8 observational studies with 1,819 patients (median age 67 years; prostate-specific antigen 7.1 mg/ml; prostate volume 36 ml) followed over a median of 24 months were included. The mean prostate-specific antigen nadir following visually directed focal HIFU was 2.2 ng/ml (95% CI 0.9-3.5 ng/ml), achieved after a median of 6 months post-treatment. A clinically significant positive biopsy was identified in 19.8% (95% CI 12.4-28.3%) of cases. Salvage treatment rates were 16.2% (95% CI 9.7-23.8%) for focal- or whole-gland treatment, and 8.6% (95% CI 6.1-11.5%) for whole-gland treatment. Complication rates were 16.7% (95% CI 9.9-24.6%) for de novo erectile dysfunction, 6.2% (95% CI 0.0-19.0%) for urinary retention, 3.0% (95% CI 2.1-3.9%) for urinary tract infection, 1.9% (95% CI 0.1-5.3%) for urinary incontinence, and 0.1% (95% CI 0.0-1.4%) for bowel injury. CONCLUSION: Limited evidence from eight observational studies demonstrated that visually directed HIFU for focal treatment of localized prostate cancer was associated with a relatively low risk of complications and acceptable cancer control over medium-term follow-up. Comparative, long-term safety and effectiveness results with visually directed focal HIFU are lacking.

Analytical and preparative chiral supercritical fluid chromatography resolutions using crown ether-derived column.

In this study, crown ether-derived column Crownpak® CR-I (+) was evaluated under SFC conditions using 12 primary amines, and the chromatographic results were compared against eight immobilized polysaccharide-based columns. Crownpak® CR-I (+) achieved a significantly higher success rate. It was found that the addition of 5% water to the modifier dramatically improved the peak shape for chiral separation of primary amines on Crownpak® CR-I (+). The first reported preparative SFC separations on Crownpak® CR-I (+) are shown, offering a new approach for the preparative resolution of primary amines. The case studies demonstrate that Crownpak® CR-I (+) is a very useful column in the chiral separation of challenging compounds that contain a primary amine group in the pharmaceutical industry.

Ultrasound-on-chip platform for medical imaging, analysis, and collective intelligence.

Over the past half-century, ultrasound imaging has become a key technology for assessing an ever-widening range of medical conditions at all stages of life. Despite ultrasound's proven value, expensive systems that require domain expertise in image acquisition and interpretation have limited its broad adoption. The proliferation of portable and low-cost ultrasound imaging can improve global health and also enable broad clinical and academic studies with great impact on the fields of medicine. Here, we describe the design of a complete ultrasound-on-chip, the first to be cleared by the Food and Drug Administration for 13 indications, comprising a two-dimensional array of silicon-based microelectromechanical systems (MEMS) ultrasonic sensors directly integrated into complementary metal-oxide-semiconductor-based control and processing electronics to enable an inexpensive whole-body imaging probe. The fabrication and design of the transducer array with on-chip analog and digital circuits, having an operating power consumption of 3 W or less, are described, in which approximately 9,000 seven-level feedback-based pulsers are individually addressable to each MEMS element and more than 11,000 amplifiers, more than 1,100 analog-to-digital converters, and more than 1 trillion operations per second are implemented. We quantify the measured performance and the ability to image areas of the body that traditionally takes three separate probes. Additionally, two applications of this platform are described-augmented reality assistance that guides the user in the acquisition of diagnostic-quality images of the heart and algorithms that automate the measurement of cardiac ejection fraction, an indicator of heart health.

Effect of aerobic exercise on erectile function: systematic review and meta-analysis of randomized controlled trials.

BACKGROUND: The health benefits of regular aerobic exercise are well established, although there is limited high-quality evidence regarding its impact on erectile function. AIM: To determine the effect of aerobic exercise on erectile function in men and to identify factors that may influence this effect. METHODS: This systematic review and meta-analysis included randomized controlled trials that evaluated the effects of aerobic exercise on erectile function via the Erectile Function domain of the International Index of Erectile Function (IIEF-EF). The mean difference in IIEF-EF scores between the aerobic exercise and nonexercising control groups was estimated by a random-effects meta-analysis. Meta-regression was used to evaluate the association of moderator variables on meta-analysis results. OUTCOMES: The IIEF-EF score is reported on a 6-30 scale, with higher values indicating better erectile function. RESULTS: Among 11 randomized controlled trials included in the analysis, aerobic exercise resulted in statistically significant improvements in IIEF-EF scores as compared with controls, with a mean difference of 2.8 points (95% CI, 1.7-3.9; P < .001) and moderate heterogeneity among studies (I2 = 53%). The effect of aerobic exercise on erectile function was greater in men with lower baseline IIEF-EF scores, with improvements of 2.3, 3.3, and 4.9 points for mild, moderate, and severe erectile dysfunction, respectively (P = .02). The meta-analysis results were not influenced by publication bias or individual study effects. CLINICAL IMPLICATIONS: Health care providers should consider recommending regular aerobic exercise as a low-risk nonpharmacologic therapy for men experiencing erectile difficulties. STRENGTHS AND LIMITATIONS: The primary strength of this review was the generation of level 1 evidence on a topic of general interest regarding sexual health in men. However, the included studies evaluated diverse groups, which may complicate data interpretation for specific segments of the population. CONCLUSION: Regular aerobic exercise can improve the erectile function of men, particularly those with lower baseline IIEF-EF scores.

Gastric per-oral endoscopic myotomy (G-POEM) for refractory gastroparesis: results from an international prospective trial.

OBJECTIVE: Although gastric per-oral endoscopic myotomy (G-POEM) is considered a promising technique for the management of refractory gastroparesis, high-quality evidence is limited. We prospectively investigated the efficacy and safety of G-POEM in unselected patients with refractory gastroparesis. DESIGN: In five tertiary centres, patients with symptomatic gastroparesis refractory to standard medical therapy and confirmed by impaired gastric emptying were included. The primary endpoint was clinical success, defined as at least one score decrease in Gastroparesis Cardinal Symptom Index (GCSI) with ≥25% decrease in two subscales, at 12 months. GCSI Score and subscales, adverse events (AEs) and 36-Item Short Form questionnaire of quality of life were evaluated at baseline and 1, 3, 6 and 12 months after G-POEM. Gastric emptying study was performed before and 3 months after the procedure. RESULTS: Of 80 enrolled patients, 75 patients (94%) completed 12-month follow-up. Clinical success at 12 months was 56% (95% CI, 44.8 to 66.7). GCSI Score (including subscales) improved moderately after G-POEM (p<0.05). In a regression model, a baseline GCSI Score >2.6 (OR=3.23, p=0.04) and baseline gastric retention >20% at 4 hours (OR=3.65, p=0.03) were independent predictors of clinical success at 12 months, as was early response to G-POEM at 1 month after therapy (OR 8.75, p<0.001). Mild procedure-related AEs occurred in 5 (6%) patients. CONCLUSION: G-POEM is a safe procedure, but showed only modest overall effectiveness in the treatment of refractory gastroparesis. Further studies are required to identify the best candidates for G-POEM; unselective use of this procedure should be discouraged. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov Registry NCT02732821.

Challenges of developing and executing a multi-site registry for a novel device with evolving indications for use.

BACKGROUND: The introduction of new technologies in endoscopy has been met with uncertainty, skepticism, and lack of standardization or training parameters, particularly when disruptive devices or techniques are involved. The widespread availability of a novel endoscopic suturing device (OverStitch™) for tissue apposition has enabled the development of applications of endoscopic suturing. METHODS: The American Gastroenterological Association partnered with Apollo Endosurgery to develop a registry to capture in a pragmatic non-randomized study the safety, effectiveness, and durability of endoscopic suturing in approximating tissue in the setting of bariatric revision and fixation of endoprosthetic devices. RESULTS: We highlight the challenges of the adoption of novel techniques by examining the process of developing and executing this multicenter registry to assess real-world use of this endoscopic suturing device. We also present our preliminary data on the safety and effectiveness of the novel device as it is applied in the treatment of obesity. CONCLUSIONS: The Prospective Registry for Trans-Orifice Endoscopic Suturing Applications (ES Registry) was an effective Phase 4, postmarketing registry aimed at capturing pragmatic, real-world use of a novel device. These findings serve to solidify the role of endoscopic suturing in clinical practice.

Surgical Reintervention Rate after Prostatic Urethral Lift: Systematic Review and Meta-Analysis Involving over 2,000 Patients.

PURPOSE: The surgical reintervention rate after prostatic urethral lift is not well characterized but has been estimated at 2% to 3% per year. We performed a systematic review and meta-analysis to determine the surgical reintervention rate after prostatic urethral lift. MATERIALS AND METHODS: We systematically searched MEDLINE®, Embase® and the Cochrane Central Register of Controlled Trials for studies of men treated with prostatic urethral lift reporting at least 1 year of maximum followup data. We performed a random effects meta-analysis to estimate the annual rate of surgical reintervention after prostatic urethral lift, including those performed for lower urinary tract symptoms or involving device explant, additions or replacement. The robustness of the meta-analysis conclusions was evaluated in a one-study removed analysis and heterogeneity was investigated with a subgroup analysis. RESULTS: In 11 studies (2,016 patients) 153 surgical reinterventions were performed, among which transurethral resection of the prostate/laser (51.0%), repeat prostatic urethral lift (32.7%) and device explant (19.6%) were most common. The annual rate of surgical reintervention was 6.0% per year (95% CI 3.0-8.9). These results were not significantly influenced by any single study. The annual rate of surgical intervention was significantly influenced by the mean duration of patient followup. Surgical reintervention rates were 4.3% per year in studies with 1 year or less mean followup, 10.7% per year in studies with more than 1 year to 3 years mean followup and 5.8% per year in a single study with more than 3 years mean followup (p=0.04). CONCLUSIONS: The surgical reintervention rate with prostatic urethral lift is 6.0% per year and is higher in studies with longer followup durations.

Remote video auditing in the endoscopy unit for evaluation of duodenoscope reprocessing in a tertiary care center.

BACKGROUND : A significant proportion of duodenoscope-transmitted infections have resulted from errors related to reprocessing. Remote video auditing (RVA) is a tool that can monitor reprocessing compliance but it has not been previously evaluated in a tertiary care setting. The aims of this study were to evaluate: 1) RVA feasibility in a tertiary care setting (defined as the ability to audit every step of duodenoscope reprocessing without delaying the next procedure due to unavailability of duodenoscopes); and 2) the use of RVA as a compliance monitoring tool. METHODS : This was a prospective study at a tertiary care center. A video camera with offsite monitoring was installed in March 2018. Auditors delivered a compliance score after each procedure. The duodenoscope was not used until it passed the audit. Feasibility and compliance data were collected from April 2018 to August 2019 after a 1-month run-in phase. Both per-step compliance and overall 100 % compliance rates were measured. RESULTS : Of 743 duodenoscope reprocessing procedures, 32 666 individual steps were audited and 99.9 % of the steps were fully viewable. The mean time per audit was 38.3 minutes, the mean duodenoscope turnover time was 76.1 minutes, and there were no delays to the next procedure due to unavailability of duodenoscopes. The per-step compliance rate was 99.5 % but the overall 100 % compliance rate was 90.3 %. CONCLUSIONS : The use of RVA in duodenoscope reprocessing was feasible and promoted sustained high-level compliance in a tertiary care center.

Chiral separation of underivatized amino acids in supercritical fluid chromatography with chiral crown ether derived column.

The supercritical fluid chromatographic separation of underivatized amino acids was explored using immobilized chiral crown ether column CROWNPAK CR-I (+) and mass spectrometric detection. The type of modifier, acidic additives, and the role of water were investigated. Enantioseparation was achieved for all 18 amino acids investigated with short retention times (less than 3 minutes) and average resolution of greater than 5.0. Analysis of enantiomerically pure standards demonstrated the D enantiomer eluted first for all amino acids using a CROWNPAK CR-I (+) column.

Six-Month Results of Selective Bladder Denervation in Women with Refractory Overactive Bladder.

PURPOSE: We report 6-month efficacy and safety outcomes of selective bladder denervation in women with refractory overactive bladder. MATERIALS AND METHODS: Women with refractory overactive bladder and urgency urinary incontinence were enrolled in 2 prospective feasibility studies with the same entry criteria. They underwent selective bladder denervation of the subtrigonal region containing afferent sensory nerves. Patients were followed for 6 months and assessed for adverse events, overactive bladder symptoms and health related quality of life measures. RESULTS: In the 35 women with a mean age of 66 years who were enrolled in the study all selective bladder denervation procedures were completed successfully. During 6 months of followup the symptom improvement based on 3-day bladder diaries was 59% for urgency urinary incontinence (p <0.001), 59% for urinary incontinence (p <0.001), 39% for urgency (p <0.001), 9% for urinary frequency (p = 0.01) and 27% for the total urgency and frequency score (p <0.001). Most of this treatment benefit was realized in the first month. The rate of clinical success, defined as a 50% or greater reduction in urgency urinary incontinence, was 70%, treatment benefit was reported in 75% of patients and the dry/cure rate was 27%. Statistically significant improvements during 6 months were identified on the symptom bother and health related quality of life scales on the OAB-q (Overactive Bladder Questionnaire) and on all KHQ (King's Health Questionnaire) domains except general health perception. Device or procedure related adverse events were reported in 6 patients (17%). CONCLUSIONS: Pooled results of 2 prospective feasibility studies suggest that selective bladder denervation is a promising minimally invasive treatment option in women with refractory overactive bladder.

Safety and feasibility of performing peroral endoscopic myotomy as an outpatient procedure with same-day discharge.

BACKGROUND AND AIMS: Peroral endoscopic myotomy (POEM) has emerged as a promising treatment option for achalasia and other foregut dysmotility disorders. However, much of the current postprocedural care, such as mandatory admission and routine esophagrams, has been adapted from current surgical practices and may not in fact be necessary. Here, we describe our algorithm and outcomes for same-day discharge. METHODS: Outcomes of 103 consecutive patients who underwent POEM for achalasia and other foregut dysmotility disorders from January 2015 to December 2018 were analyzed. Patients were discharged on the same day without esophagrams following a predetermined algorithm based on procedural adverse events and postprocedural pain. Patients were closely monitored after discharge for adverse events at 24 and 48 hours and then routinely in the office setting. RESULTS: Of the 103 POEMs, 101 were completed successfully. A total of 62.4% of patients were discharged safely on the same day, 29.7% were admitted for mild pain, and 7.9% were admitted for observation for other reasons. Overall, there were no serious adverse events at any time point. Univariate analysis identified duration of disease greater than 3 years, longer length of procedure (50.9 vs 68.5 min, P < .0001), and longer length of myotomy (7.2 vs 8.5 cm, P < .0068) as significant factors associated with postprocedural pain requiring admission. CONCLUSIONS: Although same-day discharge and foregoing routine esophagram have been suggested by many, this routine has not been systematically implemented. This series suggests that an algorithm for same-day discharge based on postprocedure chest pain and procedural complexity is both safe and feasible.

Initial clinical experience with selective bladder denervation for refractory overactive bladder.

AIMS: To report the initial clinical experience with selective bladder denervation (SBD) of the trigone in women with refractory overactive bladder (OAB). METHODS: Females with refractory OAB underwent SBD of the bladder sub-trigone region. Patients were treated using a 10-s voltage-controlled radiofrequency (RF) algorithm (RF10) at study onset. The protocol was modified during the study after which point remaining patients received 60-s temperature-controlled RF (RF60). Patients were followed for 12 weeks and evaluated for adverse events and changes in OAB symptoms. Exploratory analyses on the influence of RF duration were performed. RESULTS: Among 63 patients, SBD resulted in statistically significant and clinically important improvements for most outcomes. Comparing RF10 (n = 34) to RF60 (n = 29), treatment benefit was greater with RF60 including mean reduction in urgency urinary incontinence (-2.5 vs -0.9; P < 0.01), urinary incontinence (-2.6 vs -0.8; P < 0.001), and total urgency and frequency score (-13 vs -7; P = 0.02); and improvements in symptom bother (-33 vs -18; P < 0.01) and quality of life (28 vs 16; P = 0.02) on the OAB questionnaire. The proportion of urgency urinary incontinence treatment responders (≥50% reduction in episodes) was 79% with RF60 and 31% with RF10. The frequency of device- or procedure-related adverse events was comparable in RF10 versus RF60 groups (14.7% vs 17.2%). CONCLUSIONS: This study demonstrated the feasibility of SBD in alleviating symptoms of refractory OAB. A 60-s RF algorithm using deeper ablations of the sub-trigonal tissues was more effective and comparably safe to a 10-s RF algorithm using more superficial ablations.

Two-year real-world results of lumbar discectomy with bone-anchored annular closure in patients at high risk of reherniation.

PURPOSE: To determine the safety and effectiveness of limited lumbar discectomy with additional implantation of an annular closure device (ACD) among patients at high risk of herniation recurrence treated in routine clinical practice. METHODS: This was a prospective, single-center study of lumbar discectomy for sciatica caused by intervertebral disc herniation with adjunctive ACD implantation to reduce herniation recurrence risk among high-risk patients with large annular defects. Patients returned for follow-up visits at 6 weeks, 12 weeks, 26 weeks, 1 year, and 2 years. Main outcomes included reoperation, herniation recurrence, back pain severity, leg pain severity, and Oswestry Disability Index (ODI). The minimum important difference was defined as ≥ 20 mm decrease relative to baseline for leg pain severity, ≥ 20 mm decrease for back pain severity, and ≥ 15-point decrease for ODI. RESULTS: Among 75 high-risk patients (mean age 45 years, 59% female), the cumulative event incidence through 2 years was 4.0% for reoperation and 1.4% for herniation recurrence. Mean leg pain severity decreased from 73 to 6 (p < 0.001), back pain severity decreased from 51 to 13 (p < 0.001), and ODI decreased from 49 to 7 (p < 0.001). The percentage of patients achieving the minimum important difference was 91% for leg pain, 65% for back pain, and 94% for ODI. CONCLUSION: In patients at high risk of herniation recurrence following limited lumbar discectomy in routine clinical practice, additional implantation of an ACD was safe and reherniation recurrence rates were low at 2-year follow-up, which is favorably compared to reported rates in high-risk patients.

Three-year results from a randomized trial of lumbar discectomy with annulus fibrosus occlusion in patients at high risk for reherniation.

BACKGROUND: A larger defect in the annulus fibrosus following lumbar discectomy is a well-known risk factor for reherniation. Procedures intended to prevent reherniation by sealing or occluding the annular defect warrant study in high-risk patients. This study sought to determine 3-year results of lumbar discectomy with a bone-anchored annular closure device (ACD) or lumbar discectomy only (controls) in patients at high risk for reherniation. METHODS: This multicenter randomized trial enrolled patients with sciatica due to lumbar intervertebral disc herniation who failed conservative treatment. Patients with large annular defects after lumbar limited microdiscectomy were intraoperatively randomly assigned to receive ACD or control. Clinical and imaging follow-up was performed at routine intervals over 3 years. Main outcomes included rate of reherniations, reoperations, and endplate changes; leg and back pain scores on a visual analogue scale; Oswestry Disability Index (ODI); Physical Component Summary (PCS) and Mental Component Summary (MCS) scores from the SF-36; and adverse events adjudicated by a data safety monitoring board. RESULTS: Among 554 randomized patients, the modified intent-to-treat population consisted of 272 patients in which ACD implantation was attempted and 278 receiving control; device implantation was not attempted in 4 patients assigned to ACD. Outcomes at 3 years favored ACD for symptomatic reherniation (14.8% vs. 29.5%; P < 0.001), reoperation (11.0% vs. 19.3%; P = 0.007), leg pain (21 vs. 30; P < 0.01), back pain (23 vs. 30; P = 0.01), ODI (18 vs. 23; P = 0.02), PCS (47 vs. 44; P < 0.01), and MCS (52 vs. 49; P < 0.01). The frequency of all-cause serious adverse events was comparable between groups (42.3% vs. 44.5%; P = 0.61). CONCLUSIONS: The addition of a bone-anchored ACD in patients with large annular defects following lumbar discectomy reduces the risk of reherniation and reoperation, and has a similar safety profile over 3-year follow-up compared with lumbar limited discectomy only. TRIAL REGISTRATION: ClinicalTrials.gov NCT01283438.

Cost Analysis of Dual-Mobility Versus Large Femoral Head Constructs in Revision Total Hip Arthroplasty.

BACKGROUND: The purpose of this study is to report healthcare payer costs of dual-mobility (DM) and large femoral head (LFH) constructs in revision total hip arthroplasties (THAs). METHODS: A Markov model was constructed to analyze costs of re-interventions incurred by Medicare and private payers over a 3-year time horizon in patients who underwent unilateral revision THA with DM (n = 126) or LFH (n = 176) implants. Model states and probabilities were derived from prospectively collected registry data. Medicare costs were estimated as the weighted-average national Medicare payment for revision THA. Private payer costs were estimated by using a multiplier of Medicare costs. RESULTS: Over a 3-year period following revision THA, re-interventions were performed in 11 (9%) DM patients and 34 (19%) LFH patients, costing $263-$1898 in DM THAs and $1285-$3946 in LFH THAs for Medicare. When compared to LFH implants, DM constructs were less costly to Medicare and private payers, resulting in cost differentials of $1536 and $2611, respectively. CONCLUSIONS: At mid-term follow-up, DM constructs utilized in revision THAs were associated with 11% lower absolute risk of re-intervention and payer savings of $1500-$2500 per case when compared to LFH constructs. LEVEL OF EVIDENCE: Economic and decision analysis, Level III.

Incremental yield of dysplasia detection in Barrett's esophagus using volumetric laser endomicroscopy with and without laser marking compared with a standardized random biopsy protocol.

BACKGROUND AND AIMS: Volumetric laser endomicroscopy (VLE) is a new wide-field advanced imaging technology for Barrett's esophagus (BE). No data exist on incremental yield of dysplasia detection. Our aim is to report the incremental yield of dysplasia detection in BE using VLE. METHODS: This is a retrospective study from a prospectively maintained database from 2011 to 2017 comparing the dysplasia yield of 4 different surveillance strategies in an academic BE tertiary care referral center. The groups were (1) random biopsies (RB), (2) Seattle protocol random biopsies (SP), (3) VLE without laser marking (VLE), and (4) VLE with laser marking (VLEL). RESULTS: A total of 448 consecutive patients (79 RB, 95 SP, 168 VLE, and 106 VLEL) met the inclusion criteria. After adjusting for visible lesions, the total dysplasia yield was 5.7%, 19.6%, 24.8%, and 33.7%, respectively. When compared with just the SP group, the VLEL group had statistically higher rates of overall dysplasia yield (19.6% vs 33.7%, P = .03; odds ratio, 2.1, P = .03). Both the VLEL and VLE groups had statistically significant differences in neoplasia (high-grade dysplasia and intramucosal cancer) detection compared with the SP group (14% vs 1%, P = .001 and 11% vs 1%, P = .003). CONCLUSION: A surveillance strategy involving VLEL led to a statistically significant higher yield of dysplasia and neoplasia detection compared with a standard random biopsy protocol. These results support the use of VLEL for surveillance in BE in academic centers.

A Food-Derived Dietary Supplement Containing a Low Dose of Iron Improved Markers of Iron Status Among Nonanemic Iron-Deficient Women.

OBJECTIVE: Iron deficiency is the most common nutrient deficiency in the world. While deficiency can often be resolved through dietary supplementation with iron, adverse events are common and frequently preclude compliance. The objective of this study was to determine whether a food-derived dietary supplement containing a low dose of iron and nutrients that increase iron absorption could resolve iron deficiency with fewer adverse events than reported at higher doses. METHODS: A pilot clinical trial (NCT02683369) was conducted among premenopausal women with nonanemic iron deficiency that was verified by blood screening. Participants consumed a dietary supplement (Blood Builder®/Iron Response®) once daily for 8 weeks containing 26 mg of iron, vitamin C, folate, and other food-derived nutrients. Primary outcomes were markers of iron status (serum ferritin, hemoglobin, soluble transferrin receptor, total body iron stores) and secondary outcomes were self-reported fatigue and energy. All outcomes were assessed at baseline and 8 weeks. Adverse events were monitored with questionnaires, daily diaries, and contact with a physician. Dependent samples t test and Wilcoxon signed-rank test were used to analyze outcomes. RESULTS: Twenty-three participants enrolled in the study. Iron deficiency was resolved in the sample (mean serum ferritin: baseline = 13.9 µg/L, 8 weeks = 21.1 µg/L, p < 0.001). All other markers of iron status, fatigue, and energy also improved during the study (p < 0.04). No adverse events were reported. CONCLUSIONS: While larger and controlled studies are needed to confirm these findings, a food-derived dietary supplement with a low dose of iron and absorption-enhancing nutrients resolved iron deficiency and improved all other markers of iron status without any adverse events.

Perioperative Outcomes From the Prospective Multicenter Least Invasive Fast-Track EVAR (LIFE) Registry.

PURPOSE: To determine the feasibility, perioperative resource utilization, and safety of a fast-track endovascular aneurysm repair (EVAR) protocol in well-selected patients. METHODS: Between October 2014 and May 2016, the LIFE (Least Invasive Fast-track EVAR) registry ( ClinicalTrials.gov identifier NCT02224794) enrolled 250 patients (mean age 73±8 years; 208 men) in a fast-track EVAR protocol comprised of bilateral percutaneous access using the 14-F Ovation stent-graft, no general anesthesia, no intensive care unit (ICU) admission, and next-day discharge. The primary endpoint was major adverse events (MAE) through 30 days. The target performance goal for the MAE endpoint was 10.4%. RESULTS: Vascular access, stent-graft delivery, and stent-graft deployment success were 100%. A total of 216 (86%) patients completed all elements of the fast-track EVAR protocol. Completion of individual elements was 98% for general anesthesia avoidance, 97% for bilateral percutaneous access, 96% for ICU avoidance, and 92% for next-day discharge. Perioperative outcomes included mean procedure time of 88 minutes, median blood loss of 50 mL, early oral nutrition (median 6 hours), early mobilization (median 8 hours), and short hospitalization (median 26 hours). Fast-track EVAR completers had shorter procedure time (p<0.001), less blood loss (p=0.04), faster return to oral nutrition (p<0.001) and ambulation (p<0.01), and shorter hospital stay (p<0.001). With 241 (96%) of the 250 patients returning for the 30-day follow-up, the MAE incidence was 0.4% (90% CI 0.1% to 1.8%), significantly less than the 10.4% performance goal (p<0.001). No aneurysm rupture, conversion to surgery, or aneurysm-related secondary procedure was reported. There were no type III endoleaks and 1 (0.4%) type I endoleak. Iliac limb occlusion was identified in 2 (0.8%) patients. The 30-day hospital readmission rate was 1.6% overall. CONCLUSION: A fast-track EVAR protocol was feasible in well-selected patients and resulted in efficient perioperative resource utilization with excellent safety and effectiveness.

Lumen Apposing Metal Stents (LAMSs) for Drainage of Pancreatic and Gallbladder Collections: A Meta-analysis.

BACKGROUND AND AIMS: Endoscopic ultrasound-guided transmural drainage using lumen apposing metal stents (LAMSs) is becoming a popular and promising therapeutic approach for drainage of intra-abdominal fluid collections. There has been an increasing number of studies evaluating LAMS for drainage of pancreatic pseudocysts (PP), walled-off pancreatic necrosis (WOPN), and gallbladder (GB) drainage. The aim of this meta-analysis is to analyze the literature to date regarding the clinical success, technical success, and adverse events of LAMS in treatment of pancreatic fluid collections and GB drainage. METHODS: A comprehensive search of multiple literature databases through November 2016 was performed. Human studies with at least 10 subjects that examined the clinical success, technical success, and adverse events of LAMS in treating PP, WOPN, and GB drainage were included. RESULTS: A total of 993 patients (608-WOPN; 204-PP; 181-GB drainage) underwent drainage from 20 trials. For drainage of WOPN, the pooled technical success was 98.9% [95% confidence interval (CI): 98.2% to 99.7%] and clinical success was 90% (95% CI: 87% to 93%) (τ=0.001). For drainage of PP, the pooled technical success was 97% (95% CI: 95% to 99%) and clinical success was 98% (95% CI: 96% to 100%), (τ=0.001). For GB drainage, the pooled technical success was 95% (95% CI: 91% to 99%) and clinical success was 93% (95% CI: 90% to 97%), (τ=0.001). Total adverse events occurred in 11% of patients with higher complication rates observed in GB drainage. There was no evidence of publication bias in this meta-analysis. CONCLUSIONS: Endoscopic ultrasound-guided transmural drainage using LAMS is becoming a widely accepted therapeutic approach for the treatment of PP, WOPN, and GB drainage with high clinical and technical success rates and acceptable adverse events. Further prospective randomized trials reporting long-term clinical efficacy and cost-effectiveness are needed to validate LAMS as a therapeutic modality for pancreatic and GB collections.

Early Outcomes with Fast-Track EVAR in Teaching and Nonteaching Hospitals.

BACKGROUND: The influence of hospital teaching status on fast-track endovascular aneurysm repair (EVAR) outcomes is unknown. This study explored the feasibility, safety, and effectiveness of a fast-track EVAR protocol at teaching and nonteaching hospitals. METHODS: Patients underwent a fast-track EVAR protocol composed of bilateral percutaneous access using a 14F stent graft, avoidance of general anesthesia and intensive care admission, and next-day discharge. Patients were followed up for 1 month post-treatment. Participating hospitals were categorized by teaching status (teaching versus nonteaching) and compared for perioperative and 30-day outcomes. RESULTS: Between October 2014 and May 2016, 250 patients were enrolled at 31 centers in the United States. The study included 186 patients treated among 21 teaching hospitals and 64 patients treated among 10 nonteaching hospitals. Fast-track EVAR protocol completion was higher at teaching hospitals (91% vs. 73%, P = 0.01). Intensive care admission was avoided in 99% of patients at teaching hospitals versus 84% at nonteaching hospitals (P < 0.001). The ability to complete all other fast-track EVAR elements was proportionally higher at teaching hospitals, but differences were not statistically different. In-hospital outcomes by teaching status were comparable overall. Median time to discharge was 25 and 26 hr, respectively. There were no reports of type III endoleak, abdominal aortic aneurysm rupture, or secondary intervention. Comparing teaching versus nonteaching hospitals, there were no differences in major adverse events (1% vs. 0%), type I endoleak (0% vs. 2%), limb occlusion (1% vs. 0%), all-cause mortality (1% vs. 0%), and 30-day readmissions (1% vs. 3%). CONCLUSIONS: A fast-track EVAR protocol can be implemented with high success in well-selected patients at teaching and nonteaching hospitals. Health care resource utilization, perioperative data, and 30-day outcomes were excellent overall, with higher frequency of intensive care admission at nonteaching hospitals.