Assessment of bioabsorbable implant treatment for nasal valve collapse compared to a sham group: a randomized control trial

Lee

Int Forum Allergy Rhinol

et al. 2020

Background: Nasal obstruction is a common cause of breathing problems with lateral wall insufficiency (LWI) a key anatomic contributor. Recently, a bioabsorbable nasal implant was introduced to correct LWI and treat nasal obstruction. The goal of this study was to perform a systematic review with meta-analysis to determine the efficacy of the bioabsorbable nasal implant for treating nasal obstruction caused by LWI. Methods:Five databases (PubMed, SCOPUS, EMBASE, Web of Science, and the Cochrane Database) were independently reviewed by 2 researchers, starting at the earliest time point recorded in the database to September 2019. Studies that scored endoscopic lateral wall movement and nasal obstruction related to quality of life (QOL) postoperatively before and a er bioabsorbable nasal implants and those that compared the outcomes of nasal implants (treatment group) with outcomes of sham surgery (control group) were included in the analysis. Results:Five studies (396 patients) met the inclusion criteria. Bioabsorbable nasal implants significantly reduced endoscopic lateral wall motion compared to pretreatment values and also improved QOL at 12 months postopera-tively. Most adverse effects following the nasal implant, such as skin or mucosal reaction, infection, or implant retrieval, were reported with a 5% incidence rate. All adverse outcomes were resolved without significant sequelae. Compared with sham surgery, bioabsorbable nasal implants significantly improved disease-specific QOL. Conclusion:Bioabsorbable nasal implants may reduce nasal wall movement and subjective symptom scores compared to preoperative status. More randomized clinical trials must be conducted to further verify the effectiveness of bioabsorbable nasal implants. C 2020 ARS-AAOA, LLC.

Section: Discussionmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Effectiveness of using a bioabsorbable implant (Latera) to treat nasal valve collapse in patients with nasal obstruction: systemic review and meta‐analysis

Lee

Int Forum Allergy Rhinol

et al. 2020

“…Future work using CFD with patients following BNI insertion could further clarify the impact that BNI has on both objective measures (e.g., heat flux and nasal airflow resistance) as well as PROMs. 27,28 As previously demonstrated, the butterfly graft has more consistent reduction in nasal airway resistance than the spreader graft, and it is more effective in achieving equivalent airflow allocation between the right and left nasal airways. 5 This study confirms our prior findings, and demonstrates statistically significant improvement in nasal airway resistance following butterfly graft placement (Fig.…”

Section: Discussionmentioning

confidence: 87%

Nasal Airflow Changes With Bioabsorbable Implant, Butterfly, and Spreader Grafts

et al. 2020

Objectives/Hypothesis: Internal nasal valve compromise is a major cause of nasal obstruction, with a growing number of ways to treat this condition. In this study, we compared the effects of butterfly graft, spreader graft, and the bioabsorbable nasal implant on nasal airflow resistance. Study Design: Cadaver study. Methods: Computational fluid dynamics (CFD) simulations were completed from nine preoperative and postoperative cadaveric subjects. Each cadaveric head underwent placement of a bioabsorbable nasal implant (BNI) (Spirox Latera; Stryker ENT, Plymouth, MN), butterfly graft, or spreader graft. Pre-and postoperative computed tomography (CT) scans were used to generate three-dimensional models of the nasal airway used in steady-state CFD simulations of airflow and heat transfer during inspiration. Results: Butterfly graft placement resulted in a mean improvement in nasal airway resistance of 24.9% (AE7.3), whereas BNI placement resulted in a 6.7% (AE1.2) improvement, and spreader graft placement also resulted in a consistent improvement of 2.6% (AE13.5). Pressure within the main nasal cavity was consistently lower following butterfly graft placement versus a spreader graft or BNI. Butterfly and spreader graft placement also resulted in modest improvements in airflow allocation, whereas BNI demonstrated more variation (−1% to 12%). Heat flux was not significantly different; however, a small improvement in total heat flux was seen with all three interventions. Conclusions: The results of this study demonstrate reduction in nasal airway resistance in all three surgical interventions, with the butterfly graft demonstrating superiority to the other two techniques. However, these data only reflect a static environment and not dynamic changes in airflow seen during respiration.

Plastic and Reconstructive Surgery - Global Open

“… 8 – 11 Two studies with inclusion criteria of failed medical management of at least 4 weeks evaluated functional outcomes following NVC treatment with the Latera implant under local anaesthesia in clinic-based settings. Both of them demonstrated significant improvement of NOSE and VAS scores at 3 months 10 and at 12 months. 11 San Nicoló et al 8 , 9 published 1- and 2-year evaluations of NVC treatment with the Latera implant, reporting significant improvement of NAO symptoms and improvement of NOSE scores.…”

Section: Discussionmentioning

confidence: 87%

“…After Institutional Review Board approval at Beth Israel Deaconess Medical Center (Protocol: 2019P000651), data were collected on adult patients with a history of multiple nasal procedures who underwent revision functional rhinoplasty with an absorbable implant (Latera; Spirox Inc., Redwood City, Calif.) (Fig. 1 ), which consists of a 70:30 blend of poly l -lactide and poly d -lactide polymers, 10 from January to December 2018. Those with midvault soft tissue dynamic collapse of the nose upon inspiration were offered implant placement (Fig.…”

Section: Methodsmentioning

confidence: 99%

Treating Symptomatic Midvault Soft Tissue Collapse in Revision Rhinoplasty with a Nasal Wall Implant

Seyidova

Chen

Kazei

et al. 2020

Summary: Persistent nasal airway obstruction (NAO) due to midvault soft tissue collapse in patients following rhinoplasty or nasal surgery is a clinical challenge for surgeons. An absorbable lateral nasal wall implant is one option available to help treat midvault soft tissue collapse and to improve NAO symptoms. Previous studies have not investigated its use in complex revision functional rhinoplasty with respect to patient-reported outcomes. Data were collected on all patients with a history of previous nasal procedures who underwent Latera implant placement in conjunction with functional rhinoplasty from January to December 2018. The Nasal Obstructive Symptom Evaluation and Visual Analogue Scale were used to evaluate functional outcomes. Eight implants were placed in 6 revision functional rhinoplasty patients with midvault collapse. All patients responded to the survey. Mean follow-up was 16 ± 4 months. There were no implant-related adverse events. Mean Nasal Obstructive Symptom Evaluation score was 33 ± 33, and mean Visual Analogue Scale score was 20 ± 9. In total, 1 patient reported complete resolution of NAO, whereas 2 patients reported mild, 1 reported moderate, 1 reported severe, and 1 reported extreme symptoms. Four of the 6 patients reported nasal obstruction improvement, with all reporting improvement in midvault soft tissue collapse. Apart from being used in nasal valve collapse treatment, a lateral nasal wall implant is a potentially useful solution that may help surgeons improve patients’ NAO symptoms in complex functional rhinoplasty cases. However, in certain cases, a patient’s nasal obstructive symptoms may continue to be multifactorial.