Two-Year Outcomes After Pediatric In-Office Tympanostomy Using Lidocaine/Epinephrine Iontophoresis and an Automated Tube Delivery System.

OBJECTIVE: Evaluate 2-year outcomes after lidocaine/epinephrine iontophoresis and tympanostomy using an automated tube delivery system for pediatric tube placement in-office. STUDY DESIGN: Prospective, single-arm. SETTING: Eighteen otolaryngology practices. METHODS: Children age 6 months to 12 years indicated for tympanostomy were enrolled between October 2017 and February 2019. Local anesthesia of the tympanic membrane was achieved via lidocaine/epinephrine iontophoresis and tympanostomy was completed using an automated tube delivery system (the Tula® System). An additional Lead-In cohort of patients underwent tube placement in the operating room (OR) under general anesthesia using only the tube delivery system. Patients were followed for 2 years or until tube extrusion, whichever occurred first. Otoscopy and tympanometry were performed at 3 weeks, and 6, 12, 18, and 24 months. Tube retention, patency, and safety were evaluated. RESULTS: Tubes were placed in-office for 269 patients (449 ears) and in the OR for 68 patients (131 ears) (mean age, 4.5 years). The median and mean times to tube extrusion for the combined OR and In-Office cohorts were 15.82 (95% confidence interval [CI]: 15.41-19.05) and 16.79 (95% CI: 16.16-17.42) months, respectively. Sequelae included ongoing perforation for 1.9% of ears (11/580) and medial tube displacement for 0.2% (1/580) observed at 18 months. Over a mean follow-up of 14.3 months, 30.3% (176/580) of ears had otorrhea and 14.3% (83/580) had occluded tubes. CONCLUSION: In-office pediatric tympanostomy using lidocaine/epinephrine iontophoresis and automated tube delivery results in tube retention within the ranges described for similar grommet-type tubes and complication rates consistent with traditional tube placement in the OR.

Synthesis of a B-Antigen Hexasaccharide, a B-Lewis b Heptasaccharide and Glycoconjugates Thereof to Investigate Binding Properties of Helicobacter pylori.

Infecting the stomach of almost 50 % of people, Helicobacter pylori is a causative agent of gastritis, peptic ulcers and stomach cancers. Interactions between bacterial membrane-bound lectin, Blood group Antigen Binding Adhesin (BabA), and human blood group antigens are key in the initiation of infection. Herein, the synthesis of a B-antigen hexasaccharide (B6) and a B-Lewis b heptasaccharide (BLeb7) and Bovine Serum Albumin glycoconjugates thereof is reported to assess the binding properties and preferences of BabA from different strains. From a previously reported trisaccharide acceptor a versatile key Lacto-N-tetraose tetrasaccharide intermediate was synthesized, which allowed us to explore various routes to the final targets, either via initial introduction of fucosyl residues followed by introduction of the B-determinant or vice versa. The first approach proved unsuccessful, whereas the second afforded the target structures in good yields. Protein conjugation using isothiocyanate methodology allowed us to reach high glycan loadings (up to 23 per protein) to mimic multivalent displays encountered in Nature. Protein glycoconjugate inhibition binding studies were performed with H. pylori strains displaying high or low affinity for Lewis b hexasaccharide structures showing that the binding to the high affinity strain was reduced due to the presence of the B-determinant in the Bleb7-conjugates and further reduced by the absence of the Lewis fucose residue in the B6-conjugate.

Risk Factors for Nonunion After First Metatarsophalangeal Joint Arthrodesis With a Dorsal Locking Plate and Compression Screw Construct: Correction of Hallux Valgus Is Key.

First metatarsophalangeal joint (MTPJ) arthrodesis is currently the gold standard technique for advanced hallux rigidus. This retrospective study aimed to identify the risk factors for nonunion after first MTPJ arthrodesis with a dorsal locking plate and compression screw construct. Between April 2014 and April 2019, 165 consecutive patients (28 men and 137 women; mean age, 60 (range, 28-84) years) who underwent 178 primary first MTPJ arthrodeses were retrospectively reviewed. All arthrodeses were performed using either a dorsal locking plate with an integrated compression screw (Anchorage CP plate, Stryker, n = 97) or a dorsal locking plate (Anchorage V2 plate, Stryker, n = 81) with a separate compression screw (4 mm cannulated ACE screw). Union was defined as bone bridging across the fusion site on at least 2 of the 3 standard foot radiographs (anteroposterior, lateral, oblique) and no MTPJ movement or pain during clinical examination. Potential risk factors for nonunion were analyzed with the use of univariate and multivariate analyses. The overall nonunion rate was 6.2% (11 of 178 cases). The risk factors identified in the univariate analysis included preoperative hallux valgus deformity, postoperative residual hallux valgus deformity, and diabetes (p < .05). Multivariate analysis confirmed that postoperative residual hallux valgus deformity (odds ratio 6.5; p= .015) and diabetes (odds ratio 7.4; p = .019) are independent risk factors for nonunion after first MTPJ arthrodesis. Diabetes is the most important independent risk factor for nonunion after first MTPJ arthrodesis with a dorsal locking plate and compression screw construct. A residual postoperative hallux valgus deformity is associated with a significantly increased risk for nonunion. It is therefore crucial to correct the hallux valgus deformity to a hallux valgus angle of less than 20°.

Pes Planus Deformity and Its Association With Hallux Valgus Recurrence Following Scarf Osteotomy.

BACKGROUND: Hallux valgus recurrence is an unsatisfactory complication, with many causes postulated. This study investigated the effect of pes planus on recurrence after scarf osteotomy. METHODS: A total of 183 feet were retrospectively reviewed. All patients were treated with a scarf osteotomy and if required Akin osteotomy. We measured preoperative lateral talus first metatarsal angle (T1MA) to study pes planus; an angle of under -4 degrees was considered pes planus. We measured pre and postoperative hallux valgus angle (HVA), intermetatarsal angle (IMA), and sesamoid location. In total 164 feet were suitable for inclusion, with follow-up of at least 6 months (10 males and 154 females, mean age: 52 years). RESULTS: Recurrence frequency (HVA greater than 15 degrees) was 27 feet (16%). Hallux valgus recurrence was not influenced by gender (P value = .66) or preoperative IMA (P value = .48). Preoperative HVA greater than 35 degrees was associated with increased frequency of recurrence (P value = .004). Those with T1MA less than -10 degrees demonstrated progression in HVA and deterioration in sesamoid location up to 6 months postoperatively (P value = .038). HVA did not progress beyond 6 months. The prevalence of recurrent hallux valgus with normal T1MA was 1%, in T1MA -4 to -10 degrees it was 29% and in T1MA less than -10 degrees it was 47% (P value <.001). Breaks in T1MA less than -4 degrees were found at the naviculocuneiform joint in 68% of feet in this series. CONCLUSION: The prevalence of hallux valgus recurrence correlated with the severity of pes planus. LEVEL OF EVIDENCE: Level III, retrospective cohort study.

In-Office Tympanostomy Tube Placement in Children Using Iontophoresis and Automated Tube Delivery.

OBJECTIVES/HYPOTHESIS: Evaluate technical success, tolerability, and safety of lidocaine iontophoresis and tympanostomy tube placement for children in an office setting. STUDY DESIGN: Prospective individual cohort study. METHODS: This prospective multicenter study evaluated in-office tube placement in children ages 6 months through 12 years of age. Anesthesia was achieved via lidocaine/epinephrine iontophoresis. Tube placement was conducted using an integrated and automated myringotomy and tube delivery system. Anxiolytics, sedation, and papoose board were not used. Technical success and safety were evaluated. Patients 5 to 12 years old self-reported tube placement pain using the Faces Pain Scale-Revised (FPS-R) instrument, which ranges from 0 (no pain) to 10 (very much pain). RESULTS: Children were enrolled into three cohorts with 68, 47, and 222 children in the Operating Room (OR) Lead-In, Office Lead-In, and Pivotal cohorts, respectively. In the Pivotal cohort, there were 120 and 102 children in the <5 and 5- to 12-year-old age groups, respectively, with a mean age of 2.3 and 7.6 years, respectively. Bilateral tube placement was indicated for 94.2% of children <5 and 88.2% of children 5 to 12 years old. Tubes were successfully placed in all indicated ears in 85.8% (103/120) of children <5 and 89.2% (91/102) of children 5 to 12 years old. Mean FPS-R score was 3.30 (standard deviation [SD] = 3.39) for tube placement and 1.69 (SD = 2.43) at 5 minutes postprocedure. There were no serious adverse events. Nonserious adverse events occurred at rates similar to standard tympanostomy procedures. CONCLUSIONS: In-office tube placement in selected patients can be successfully achieved without requiring sedatives, anxiolytics, or papoose restraints via lidocaine iontophoresis local anesthesia and an automated myringotomy and tube delivery system. LEVEL OF EVIDENCE: 2b Laryngoscope, 130:S1-S9, 2020.

Recommendations for Potassium-Titanyl-Phosphate Laser in the Treatment of Cholesteatoma.

Potassium-titanyl-phosphage (KTP) lasers possess many characteristics suitable for otologic surgery. The objective of this report is to provide recommendations on the use of KTP laser for cholesteatoma surgery based on a narrative review of currently available evidence. PubMed and the Cochrane Review of randomized control trials were searched for relevant publications on efficacy and adverse effects and relevant articles appraised by the authors using Oxford Centre for Evidence-based Medicine criteria for recommendations. The potential benefits of KTP laser in cholesteatoma surgery include reduced rates of residual cholesteatoma and improved hearing outcomes. Cholesteatoma may be more effectively removed using KTP laser than using mechanical dissection alone. Reduced rates of residual cholesteatoma have been reported with KTP laser with level 2 evidence. In addition, KTP laser may facilitate the removal of cholesteatoma without the risk of mechanical trauma. This potentially allows for improved postoperative hearing outcomes through a) minimizing cochlear trauma and reducing sensorineural hearing loss and b) reducing the need for disruption of an intact ossicular chain. Currently, level 4 evidence exists to support improved postoperative hearing outcomes with the use of KTP laser. KTP laser use appears to be safe in otologic surgery if appropriate guidelines are followed. Current evidence is sufficient to strongly recommend KTP laser use for the prevention of residual cholesteatoma (Grade B recommendation) and an option for KTP laser use for optimizing hearing outcomes (Grade C recommendation).

Predictors for Readmission up to 1 Year Following Hip Fracture.

BACKGROUND: At Altnagelvin, a district general hospital in Northern Ireland, we have observed that a significant number of hip fracture admissions are later readmitted for treatment of other medical conditions. These readmissions place increasing stress on the already significant burden that orthopedic trauma poses on national health services. OBJECTIVES: The aim of this study was to review a series of consecutive patients managed at our unit at least 1 year prior to the onset of the study. Also, we aimed to identify predictors for raised admission rates following treatment for hip fracture. PATIENTS AND METHODS: We reviewed a prospective fracture database and online patient note system for patient details, past medical history, discharge destination and routine blood tests for any factors that may influence readmission rates up to 1 year. Data were analyzed using SPSS software. RESULTS: Over 2 years, 451 patients were reviewed and 23 were managed conservatively. There was a 1-year readmission rate of 21%. Most readmission diagnoses were medical including bronchopneumonia, falls, urosepsis, cardiac exacerbations and stroke. Prolonged length of stay and discharge to a residential, fold or nursing home were found to increase readmission rate. Readmission diagnoses closely reflected the perioperative diagnoses that prolonged length of stay. Increased odds radio and risk of readmission were also found with female gender, surgery with a cephalomedullary nail, hip hemiarthroplasty or total hip replacement, time to surgery < 36 hours, alcohol consumption, smoking status, Hb drop > 2 g/dL and also if a blood transfusion was received. CONCLUSIONS: Our results indicate that hip fracture treatment begins at acute fracture clerk in, with consideration of comorbid status and ultimate discharge planning remaining significant predictors for morbidity and subsequent readmission.

The safety and immunogenicity of an adenovirus type 35-vectored TB vaccine in HIV-infected, BCG-vaccinated adults with CD4(+) T cell counts >350 cells/mm(3).

BACKGROUND: The safety and immunogenicity of a replication deficient adenovirus serotype 35 tuberculosis (TB) vaccine containing gene inserts for Antigens (Ag) 85A, Ag85B and TB10.4 (AERAS-402/AD35.TB-S) was evaluated in previously BCG vaccinated, HIV-infected South African adults with baseline CD4 counts >350 cells/mm(3). METHODS: Subjects were randomized (1:1) to receive two doses of either intramuscular AERAS-402/AD35.TB-S or placebo at month 0 and at month 1. Participants were monitored for adverse events 28 days after each vaccination and for serious adverse events over 12 months. CD4(+) and CD8(+) T-cell and antibody responses to vaccine antigens were evaluated post first and second vaccination. RESULTS: 26 subjects were randomly assigned to receive AERAS-402/AD35.TB-S (N=13) or placebo (N=13). The mean age was 29.0 years, all were Black-African, 88.5% were female, 46.2% were QuantiFERON Test (QFT) positive at baseline, and the median CD4 count was 559.5 cells/mm(3), all similar by treatment group. All subjects received their first vaccination and 24 subjects received their second vaccination. Injection site reactions and some systemic reactions were reported more commonly in the AERAS-402/AD35.TB-S versus placebo recipients. AERAS-402/AD35.TB-S did not appear to influence CD4 counts and HIV-1 viral load over the course of study follow-up. AERAS-402/AD35.TB-S induced a mixed CD4(+) T-cell and CD8(+) T-cell responses to Ag85B. The CD4(+) T-cell responses peaked to Ag85A and Ag85B 14 days after the second vaccination and had declined by Day 182. AERAS-402/AD35.TB-S predominantly induced CD4(+) T-cells expressing three (IFN-γ, TNF, IL-2) or two (IL-2 and TNF) cytokines, two weeks after the last vaccination, which did not differ by baseline Quantiferon test status. AERAS-402/AD35.TB-S induced strong Ag85A and Ag85B specific antibody responses, particularly after the second vaccination. CONCLUSION: AERAS-402/AD35.TB-S was well tolerated, safe and induced predominantly polyfunctional CD4(+) and CD8(+) T-cell responses to vaccine.

Tonsillectomy does not improve bedwetting: results of a prospective controlled trial.

PURPOSE: Sleep disordered breathing caused by tonsillar hypertrophy has been implicated as a cause of primary and secondary nocturnal enuresis in children. We prospectively studied the preoperative and postoperative rates of nocturnal and daytime incontinence in a group of children with tonsillar hypertrophy undergoing tonsillectomy compared to a matched control group undergoing surgery unrelated to the airway or urinary tract. MATERIALS AND METHODS: A total of 326 toilet trained children 3 to 15 years old were included, with 257 in the tonsillectomy group and 69 in the control group. Severity of tonsillar hypertrophy was graded preoperatively on a scale of 1 to 4. A voiding questionnaire regarding number of bedwetting and daytime incontinence episodes per week, voids per day, bowel movements per week, secondary or primary enuresis and family history was completed by parents preoperatively, and at 3 and 6 months postoperatively. RESULTS: Preoperatively the respective rates of nocturnal enuresis and daytime incontinence were 33% and 17% in the tonsillectomy group (p=0.89), and 35% and 14% in the control group (p=0.3). The respective cure rates for bedwetting at 3 and 6 months postoperatively were 40% and 50% in the tonsillectomy group (p=0.60), and 35% and 48% in the control group (p=0.61). Similarly no difference was seen in improvement or cure of daytime incontinence at 3 and 6 months postoperatively. CONCLUSIONS: We found no association between tonsillar hypertrophy and urinary incontinence before or after tonsillectomy.