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A prospective study for treatment of nasal valve collapse due to lateral wall insufficiency: Outcomes using a bioabsorbable implant.

ABSTRACT: OBJECTIVE:To examine 6-month outcomes for treatment of lateral nasal wall insufficiency with a bioabsorbable implant. STUDY DESIGN:Prospective, multicenter, nonrandomized, single-blinded study. METHODS:One hundred and one patients with severe-to-extreme class of Nasal Obstruction Symptom Evaluation (NOSE) scores were enrolled at 14 U.S. clinics (September 2016-March 2017). Patients were treated with a bioabsorbable implant designed to support lateral wall, with or without concurrent septoplasty and/or turbinate reduction procedure(s). NOSE scores and visual analog scale (VAS) were measured at baseline and month 1, 3, and 6 postoperatively. The Lateral Wall Insufficiency (LWI) score was determined by independent physicians observing the lateral wall motion video. RESULTS:Forty-three patients were treated with implant alone, whereas 58 had adjunctive procedures. Seventeen patients reported 19 adverse events, all of which resolved with no clinical sequelae. Patients showed significant reduction in NOSE scores at 1, 3, and 6 months postoperatively (79.5?±?13.5 preoperatively, 34.6?±?25.0 at 1 month, 32.0?±?28.4 at 3 months, and 30.6?±?25.8 at 6 months postoperatively; P?

SUBMITTER: Stolovitzky P

PROVIDER: S-EPMC6585764 | biostudies-literature | 2018 Nov

REPOSITORIES: biostudies-literature

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A prospective study for treatment of nasal valve collapse due to lateral wall insufficiency: Outcomes using a bioabsorbable implant.

Stolovitzky Pablo P Sidle Douglas M DM Ow Randall A RA Nachlas Nathan E NE Most Sam P SP

The Laryngoscope 20180514 11

<h4>Objective</h4>To examine 6-month outcomes for treatment of lateral nasal wall insufficiency with a bioabsorbable implant.<h4>Study design</h4>Prospective, multicenter, nonrandomized, single-blinded study.<h4>Methods</h4>One hundred and one patients with severe-to-extreme class of Nasal Obstruction Symptom Evaluation (NOSE) scores were enrolled at 14 U.S. clinics (September 2016-March 2017). Patients were treated with a bioabsorbable implant designed to support lateral wall, with or without c ...[more]

PMID: 29756407

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Project description:Importance:While functional rhinoplasty has been broadly studied, to our knowledge no systematic review and meta-analysis of lateral wall repair has been done previously. Objective:To evaluate the effectiveness of repair of the lateral nasal wall in adult patients with nasal airway obstruction. Data Sources:Medline, Embase, Cinahl, Central, Scopus, and Web of Science databases and reference lists were searched for clinical and observational studies. Study Selection:The selection criteria were defined according to the PICO (population, intervention, comparison, and outcome) framework. The relevant studies were selected by 2 independent reviewers based on the studies' abstracts and full texts. Data Extraction and Synthesis:Data were extracted using standardized lists chosen by the authors according to Cochrane Collaboration guidelines. The effect sizes were first calculated for each study and then pooled together using random effects synthesis. Heterogeneity was assessed using the I2 statistic, and publication bias was evaluated by the Egger test. Main Outcomes and Measures:The results were reported as pooled row mean differences in changes from preoperative to postoperative Nasal Obstruction Symptom Evaluation scores at different times of follow-up (≤3 months, >3 to 6 months, and >6 months). Results:Of 1522 initial records, 10 studies were considered relevant-all of them observational. The pooled study sample included 324 participants. When combining all the repeated measures together, the pooled effect size for functional rhinoplasty was -47.7 (95% CI, -53.4 to 42.1) points on the Nasal Obstruction Symptom Evaluation scale with high heterogeneity of 72%. The pooled effect size outcomes were similar in short- (-45.0 points [95% CI, -47.8 to -42.2 points]), mid- (-48.4 points [95% CI, -52.5 to -44.4 points]), and long-term (-49.0 points [95% CI, -62.1 to -35.8 points]) follow-ups. Conclusions and Relevance:The pooled effect size of 10 observational studies supported the effectiveness of functional rhinoplasty for the treatment of nasal airway obstruction caused by lateral nasal wall insufficiency. To improve the level of evidence, randomized clinical trials are needed. Level of Evidence:NA.

Project description:HypothesisInsertion forces can be reduced by magnetically guiding the tip of lateral-wall cochlear-implant electrode arrays during insertion via both cochleostomy and the round window.BackgroundSteerable electrode arrays have the potential to minimize intracochlear trauma by reducing the severity of contact between the electrode-array tip and the cochlear wall. However, steerable electrode arrays typically have increased stiffness associated with the steering mechanism. In addition, steerable electrode arrays are typically designed to curve in the direction of the basal turn, which is not ideal for round-window insertions, as the cochlear hook's curvature is in the opposite direction. Lateral-wall electrode arrays can be modified to include magnets at their tips, augmenting their superior flexibility with a steering mechanism. By applying magnetic torque to the tip, an electrode array can be navigated through the cochlear hook and the basal turn.MethodsAutomated insertions of candidate electrode arrays are conducted into a scala-tympani phantom with either a cochleostomy or round-window opening. The phantom is mounted on a multi-degree-of-freedom force sensor. An external magnet applies the necessary magnetic bending torque to the magnetic tip of a modified clinical electrode array, coordinated with the insertion, with the goal of directing the tip down the lumen. Steering of the electrode array is verified through a camera.ResultsStatistical t-test results indicate that magnetic guidance does reduce insertion forces by as much as 50% with certain electrode-array models. Direct tip contact with the medial wall through the cochlear hook and the lateral wall of the basal turn is completely eliminated. The magnetic field required to accomplish these insertions varied from 77 to 225 mT based on the volume of the magnet at the tip of the electrode array. Alteration of the tip to accommodate a tiny magnet is minimal and does not change the insertion characteristic of the electrode array unless the tip shape is altered.ConclusionMagnetic guidance can eliminate direct tip contact with the medial walls through the cochlear hook and the lateral walls of the basal turn. Insertion-force reduction will vary based on the electrode-array model, but is statistically significant for all models tested. Successful steering of lateral-wall electrode arrays is accomplished while maintaining its superior flexibility.

Project description:BACKGROUND:Scaphoid excision and four-corner arthrodesis is an acceptable salvage procedure for the treatment of scapholunate advanced collapse (SLAC) and scaphoid nonunion advanced collapse (SNAC) wrists, since first popularized in the 1980s. We investigated the potential application of novel bioabsorbable plates and screws made of un-sintered hydroxyapatite/poly-L-lactide composite for the treatment of metacarpal fractures. We used this material for the fixation of four-corner fusions for SLAC or SNAC wrists commencing from April 2009. The purpose of this study was to clarify the controversy in the literature regarding the use of these plates. METHODS:The surgical procedures and clinical outcomes of four-corner fusions using a bioabsorbable (poly-L-lactic acid and hydroxyapatite) plate were reported. Ten patients (mean age, 59.2?years) with SLAC or SNAC wrists underwent fusions between April 2009 and June 2016. The primary diseases were scapholunate ligament injury, Preiser disease, and scaphoid pseudarthrosis. The mean postoperative follow-up period was 45.9?months (range, 12-86). RESULTS:In all patients, bone union was achieved without dislocation or pain. The mean wrist flexion and extension arc improved from 78.5 degrees before surgery to 90.5 degrees after surgery. Mean grip strength improved from 51 to 69% after surgery, and the Quick Disabilities of the Arm, Shoulder, and Hand (QuickDASH) score improved from 53.5 to 14.3. No complications such as infection, avascular swelling, or tendon adhesion were observed. This implant requires no removal of internal fixation devices, produces stable outcomes, and is an effective fusion technique. CONCLUSIONS:We summarized the outcomes of four-corner arthrodesis using bioabsorbable plates. Satisfactory clinical results were shown, with no obvious complications. This novel plate also serves as a good alternative for patients who are allergic to metals. Furthermore, bioabsorbable plates are advantageous as they do not require removal.

Dataset Information

A prospective study for treatment of nasal valve collapse due to lateral wall insufficiency: Outcomes using a bioabsorbable implant.

Publications

A prospective study for treatment of nasal valve collapse due to lateral wall insufficiency: Outcomes using a bioabsorbable implant.

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