Dataset Information

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 < 0.01 for all). They also showed significant reduction in VAS scores postoperatively (71.9 ± 18.8 preoperatively, 32.7 ± 27.1 at 1 month, 30.1 ± 28.3 at 3 months, and 30.7 ± 29.6 at 6 months postoperatively; P < 0.01 for all). These results were similar in patients treated with the implant alone compared to those treated with the implant and adjunctive procedures. Consistent with patient-reported outcomes, postoperative LWI scores were demonstrably lower (1.83 ± 0.10 and 1.30 ± 0.11 pre- and postoperatively; P < 0.01).

Conclusion

Stabilization of the lateral nasal wall with a bioabsorbable implant improves patients' nasal obstructive symptoms over 6 months.

Level of evidence

2b. Laryngoscope, 2483-2489, 2018.

SUBMITTER: Stolovitzky P

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

REPOSITORIES: biostudies-literature

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Publications

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: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.

Dataset Information

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

Objective

Study design

Methods

Results

Conclusion

Level of evidence

Publications

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

Similar Datasets

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