RESUMEN

Most Asians have a nose with a short columella and a low dorsum; augmentation rhinoplasty using implants is commonly performed in Asian countries to achieve a taller and more well-defined nasal dorsum. However, the current knowledge is insufficient to fully understand the various subjective desires of patients, reflect on them during surgery, or to objectively analyze the results after surgery. Advances in digital imaging technologies, such as 3D printing and 3D scanning, have transformed the medical system from hospital-centric to patient-centric throughout the medical field. In this study, we applied these techniques to rhinoplasty. First, we used virtual 3D plastic surgery software to enable surgical planning through objectified numerical calculations based on the visualized data of the patient's medical images rather than simple virtual plastic surgery. Second, the customized nasal implant was manufactured by reflecting the patient's anatomical shape and virtual 3D plastic surgery data. Taken together, we describe the surgical results of applying these rhinoplasty solutions in four patients. Our experience indicates that high fidelity and patient satisfaction can be achieved by applying these techniques.

RESUMEN

Bioabsorbable implants (eg, Latera) have recently been approved for addressing nasal valve collapse. The purpose of this study is to summarize adverse events and treatment sequelae associated with bioabsorbable nasal implants queried in the Manufacturer and User Facility Device Experience (MAUDE) database. Of the 26 device reports entered between March 2017 and April 2022, the most frequently reported complications included abscess (n = 13) and implant protrusion (n = 5). Other common symptoms reported greater than 1-year postimplantation included facial pain/discomfort (n = 3) and failure to absorb (n = 3). Management of adverse events included treatment with antibiotics (n = 9), steroid injections (n = 4), and explantation (n = 20). In 3 reports, adverse reactions required a biopsy of adjacent tissue for pathologic analysis. These findings suggest that further research is required to assess the potential long-term complications and optimize the management of bioabsorbable nasal implants. Furthermore, standardized reporting templates may improve the utility of the MAUDE database.

Asunto(s)

RESUMEN

BACKGROUND: This study was conducted to address the potential of combining porous biocompatible scaffolds with primary cells or autologous diced cartilage in cartilage tissue engineering in the animal model. The purpose of this study is an experimental evaluation of polycaprolactone (PCL) scaffold cell-based nasal implant using three-dimensional (3D) printing. METHODS: In this study, we applied hollow PCL cage scaffolds with 200 and 400 µm pore sizes. The scaffolds were divided into three groups (n = 4 for each group): (1) PCL cage scaffolds loaded with agarose gel and chondrocytes; (2) PCL cage scaffolds loaded with agarose gel and fibroblasts, and (3) PCL cages loaded with autologous diced cartilage. In each group, chondrocytes and fibroblasts were seeded into the agarose gel at the density of 5 × 106 cells/mL. RESULTS: All implants showed sufficient integration into the surrounding tissue. It was revealed that chondrocytes were proliferated and differentiated better in the "400 µm" scaffolds than in the "200 µm" group. However, a pore size of 200 µm was optimal for fibroblasts' proliferation. In addition, the results of our study showed that the use of PCL-based scaffolds can achieve the desirable stable augmentation effect with almost none of the changes of contour. CONCLUSION: In this study, both groups: (1) PCL cage scaffolds loaded with agarose gel and chondrocytes and (2) PCL cages loaded with autologous diced cartilage demonstrated chondrogenic potential with scaffolds with 400 µm pore size. The PCL cage scaffolds loaded with agarose gel and fibroblasts demonstrated potential in cartilage tissue formation within the pore size of 200 µm.

Asunto(s)

RESUMEN

BACKGROUND: Intranasal corticosteroid sprays (INCSs) used to treat chronic rhinosinusitis are suboptimal due to limited penetration into the middle meatus, rapid clearance, and poor patient compliance. A bioresorbable drug matrix, developed with the XTreoTM drug delivery platform, may overcome the limitations of INCS by providing continuous dosing over several months. OBJECTIVE: To evaluate the in vitro drug release and in vivo pharmacokinetics of novel mometasone furoate (MF) matrices in a rabbit dorsal maxillary osteotomy model. METHODS: XTreoTM matrices were formulated to consistently elute MF for up to 6 months. Matrices were surgically placed bilaterally into the maxillary sinuses of New Zealand White (NZW) rabbits. Tissue and plasma MF concentrations were measured to assess the in vivo drug delivery. The in vivo and in vitro drug release kinetics of the matrices were quantified and compared to those of rabbits receiving daily Nasonex® MF nasal sprays. RESULTS: XTreoTM matrices self-expanded upon deployment to conform to the irregular geometry of the maxillary sinus cavities in the NZW rabbits. Sustained release of MF was demonstrated in vitro and in vivo for 2 MF matrices of distinct release durations and an in vitro-in vivo correlation was established. Therapeutic levels of MF in local tissues were measured throughout the intended dosing durations. In contrast to the variable peaks and troughs of daily nasal sprays, sustained dosing via a single administration of MF matrices was confirmed by quantifiable plasma MF concentrations over the intended dosing duration. CONCLUSION: The XTreoTM MF matrices provided targeted and efficient dosing to local sinus tissues that was superior to INCS. Sustained drug release was confirmed both in vitro and in vivo. The novel XTreoTM technology may provide precisely tuned, long-lasting drug delivery to sinus tissues with a single treatment.

Asunto(s)

RESUMEN

PURPOSE: An absorbable nasal implant for the treatment lateral nasal wall collapse was approved for use in patients with nasal obstruction. It remains to be seen whether this treatment is equivalent to open techniques for the treatment of nasal valve incompetence from collapsibility. MATERIALS AND METHODS: Two groups were analyzed for the study. One group had surgery which included the implant, septoplasty, and inferior turbinate submucous reduction and the other group had a variety of functional rhinoplasty techniques for lateral wall insufficiency in addition to septoplasty and inferior turbinate submucous reduction. NOSE and SNOT-22 were used to demonstrate pre and post-operative changes. RESULTS: Ninety total patients were identified. Fifty patients underwent insertion of an absorbable nasal implant and 40 underwent a traditional open technique to stabilize the LNW. For the implant group the mean NOSE score was 63.4 (SD 24) and post-operative was 22.9 (SD 19.9), in addition, the SNOT-22 score was 38.8 (SD 19.8) and post-operative was 18.5 (SD 15.2). For the open rhinoplasty group, the mean NOSE score was 57.9 (SD 23.2) and post-operative was 17.6 (SD 16.4). The SNOT-22 score was 33.6 (SD 14.9) and post-operative score was 11.5 (SD 15.2) The delta between pre and post-operative NOSE and SNOT-22 test were not different at an average of 3.95 months post-operatively between the groups (NOSE, P = 0.94 and SNOT-22, p = 0.53). CONCLUSION: In patients with multiple structural causes of nasal obstruction, including lateral wall insufficiency, insertion of an absorbable nasal implant, to support the LNW, seems to be equally effective as functional rhinoplasty techniques over a 4 month timeframe.

Asunto(s)

RESUMEN

Chronic rhinosinusitis (CRS) is a common disease in the general population that is increasing in incidence and prevalence, severely affecting patients' quality of life. Medical treatment for CRS includes self-management techniques, topical and oral medical treatments, and functional endoscopic sinus surgery (FESS). FESS is a standard procedure to restore sinus ventilation and drainage by physically enlarging the inflamed sinus passageways. Nasal drug-releasing stents are implanted to keep the surgically expanded aperture to the sinus frontalis open. The outcome of such an intervention is highly variable. We defined the anatomical structures which should be removed, along with 'no-go areas' which need to be preserved during FESS. Based on these definitions, we used cone beam computed tomography (CBCT) images to measure the dimensions of the frontal neo-ostium in 22 patients. We demonstrate anatomical variability in the volume and diameter of the frontal sinus recess after surgery. This variability could be the cause of therapy failure of drug-eluting implants after FESS in some patients. Implants individually made to fit a given patient's postsurgical anatomy may improve the therapeutic outcome.

RESUMEN

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% (±7.3), whereas BNI placement resulted in a 6.7% (±1.2) improvement, and spreader graft placement also resulted in a consistent improvement of 2.6% (±13.5). 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. LEVEL OF EVIDENCE: NA Laryngoscope, 130:E817-E823, 2020.

Asunto(s)

RESUMEN

OBJECTIVES: To examine 12-month outcomes for in-office treatment of dynamic nasal valve collapse (NVC) with a bioabsorbable implant. STUDY DESIGN: Prospective, multicenter, nonrandomized study. METHODS: One hundred sixty-six patients with severe-to-extreme class of Nasal Obstruction Symptom Evaluation (NOSE) scores were enrolled at 16 U.S. clinics (November 2016-July 2017). Patients were treated with a bioabsorbable implant (Latera, Spirox Inc., Redwood City, CA) to support the lateral wall, with or without concurrent inferior turbinate reduction (ITR), in an office setting. NOSE scores and Visual Analog Scale (VAS) were measured at baseline and 1, 3, 6, and 12 months postoperatively. The Lateral Wall Insufficiency (LWI) score was determined by independent physicians observing the lateral wall motion video. RESULTS: One hundred five patients were treated with implant alone, whereas 61 had implant + ITR. Thirty-one patients reported 41 adverse events, all of which resolved with no clinical sequelae. Patients showed significant reduction in NOSE scores throughout 12 months postoperatively (77.4 ± 13.4 baseline vs. 36.2 ± 22.7 at 1 month postoperatively, 33.0 ± 23.4 at 3 months, 32.1 ± 24.6 at 6 months, and 30.3 ± 24.3 at 12 months; P < 0.001). They also showed significant reduction in VAS scores postoperatively (69.7 ± 18.1 baseline vs. 31.3 ± 27.1 at 12 months postoperatively, P < 0.001). These results were similar in patients treated with implant alone and those treated with the implant + ITR. Consistent with patient-reported outcomes, postoperative LWI scores were demonstrably lower (1.42 ± 0.09 and 0.93 ± 0.08 pre- and postoperatively, P < 0.001). CONCLUSION: In-office treatment of dynamic NVC with a bioabsorbable implant improves clinical evidence of LWI at 6 months and improves nasal obstructive symptoms in a majority of patients up to 12 months. LEVEL OF EVIDENCE: 2b Laryngoscope, 130:1132-1137, 2020.

Asunto(s)

RESUMEN

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.

Asunto(s)

RESUMEN

In nasal reconstruction applications, the response of cells to titanium (Ti) implants is largely determined by the surface characteristics of the implant. This study investigated an electrochemical anodization surface treatment intended to improve the response of primary human nasal epithelial cells (HNEpC) to Ti surfaces in nasal implant applications. We used a simple and fast electrochemical anodization treatment, i.e., applying anodic current, to produce a titanium dioxide (TiO2) nanonetwork layer on the Ti surface with average lateral pore size below 100 nm, depending on the current applied. The TiO2 nanonetwork layer exhibited enhanced hydrophilicity and protein adsorption ability compared with untreated Ti surfaces. In addition, the spreading morphology, cytoskeletal arrangement, and proliferation of HNEpC on the nanonetwork layer indicated excellent cell response characteristics. This research advances our understanding regarding the means by which a TiO2 nanonetwork layer can improve the response of HNEpC to Ti surfaces in nasal implant applications.

RESUMEN

The silicone rubber implants are widely used in plastic surgery because of various advantages; however, calcification in surface of implant(as a chemical resistance) may transform or destroy the high molecular biomaterial when it stays too long within the human body. The purpose of this study is to determine the relationship between calcification and the histological disparities of the tissues surrounding the area adjoining the silicone nasal implant by examining the regional characteristics of calcium deposits in the silicone nasal implant via elemental analyses using EDX(energy-dispersive X-ray analysis) and ultrastructural analyses using SEM(scanning electron microscopy). The subjects of the study were 19 silicone nasal implants removed by revision rhinoplasty, all displaying calcification. According to the tissue characters, the implant surface was divided into 4 zones with the rhinion as the basis. For each zone, elemental and ultrastructural analyses were performed. Elemental analysis revealed that the calcium deposits consisted of Ca and P only. There were no statistically significant disparities among the ratios between Ca and P according to the zones. Ultrastructural analysis showed acellular mineral-like deposits coalesced to create amorphous deposits in all zones; however, in zones 1 and 3(more pressurized zones by periosteum or nasal bone), additional flaky cylinder-shaped calcium deposits were detected. Thus, it seems that the histological disparities in the surrounding tissues do not affect the components and their proportions in the calcification process. However, it can be inferred that the physical environment due to the histological disparities in the surrounding tissues affects the ultrastructures of calcium deposits.

Asunto(s)