The lateral nasal wall implant is an absorbable, biocompatible, copolymer composed of 70% poly (L-lactide) and 30% poly (D-lactide), which is indicated for supporting the upper and lower lateral cartilages in patients with dynamic nasal valve collapse with complaints of nasal airway obstruction. Once implanted, the copolymer degrades into water-soluble fragments, is metabolized, and eliminated. Prior studies have demonstrated decomposition within an average of 24 months and the formation of a fibrous capsule at about 3 months postimplantation. It is thought that the replacement of the implant with fibrocollagenous scar may provide additional support to the lateral wall and nasal valve region, thereby diminishing collapse and reducing NAO.

The implantation procedure may be performed in the operating room, but one of the benefits of the lateral nasal wall implant is that it can be performed in the clinic under local anesthesia.

Before the procedure, the nasal anatomy should be examined, and the point of maximal collapse should be marked. The forked tip of the implant should be overlying the bone of the maxilla, and the main portion of the implant should be positioned along the upper and lower lateral cartilages crossing the point of maximal collapse. The included template can then be used to plan the trajectory of implant deployment and the proximal and distal points are marked on the external nasal skin.

Once the planned trajectory has been established, the local anesthetics may then be applied. Topical anesthetics may be used in the nasal vestibule, followed by injection of local anesthesia along the planned trajectory of the implant. Additionally, supratrochlear and infraorbital nerve blocks may be performed to provide additional anesthesia.

After adequate anesthesia, a double-pronged skin hook is used to reflect the nasal ala. The entry point should approximate the mid portion of the nasal ala, along the nasal vestibular skin at the level of the nasal vibrissae. The cannula is inserted perpendicular to the septum until the tip reaches the caudal margin of the lower lateral cartilage. Caudal retraction with the skin is then applied, and the cannula is advanced lateral to the upper and lower lateral cartilages, until the preplanned location over the maxillary bone is reached. The orientation of the implant is then confirmed using the fork orientation features on the delivery device, and then the implant is delivered. Gentle pressure is applied over the deployed forks, and then the device is withdrawn. After retraction of the cannula, the insertion site should be inspected to confirm that there is no extrusion of the implant.

Numerous studies have investigated outcomes related to lateral nasal wall implantation ( Table 21.1 ). The first trial comparing NAO symptoms before and after implantation was a nonrandomized, single-arm trial enrolling 30 subjects by San Nicolo and colleagues. The authors reported an average within-subject reduction in NOSE score of 40.9 ± 31.2 points and noted a responder rate of 86.2%, 80%, and 75.9% at 3, 6, and 12 months postprocedure. A 2-year follow-up to this study showed consistent results at up to 24 months postimplant.

A 2019 multicenter, randomized controlled trial was then conducted with 71 subjects receiving the implant and 66 subjects receiving a sham intervention. The primary endpoint of the study, responder rates between arms at 3 months postintervention, was noted to be significantly higher in the implant arm than the sham control arm (82.5% vs. 54.7%, P = 0.001). NOSE scores were also compared between study groups, and a significantly greater reduction was noted in the implant group at 3 months postprocedure (–42.2 ± 23.4 vs.–22.7 ± 27.9; P < 0.0001). A follow-up 2020 study enrolled 166 subjects, 105 of whom were treated with lateral nasal wall implantation alone and 61 of whom had implant plus inferior turbinate reduction (ITR). At 12 months the authors noted significant reduction in NOSE scores compared to baseline (77.4 ± 13.4 vs. 30.3 ± 24.3, P < 0.001) and visual analog scale scores (69.7 ± 18.1 vs. 31.3 ± 27.1, P < 0.001). These improvements were similar between those with implant alone and implant plus ITR.

Kim et al. then conducted a systematic review and meta-analysis in 2020, including five studies with a total of 396 patients, and reported a consistent reduction of both NOSE scores and visual analog scale scores at all time points following implantation.

Finally, Clark et al. reported on their series of patients undergoing autologous cartilage grafting versus lateral nasal wall implantation plus concomitant procedures (including septoplasty and/or inferior turbinate reduction). The mean NOSE scores were reduced at each postoperative visit in both groups. However, the autologous cartilage grafting group experienced greater reduction in NOSE scores at each time point.

Lateral nasal wall implantation is considered a minimally invasive procedure for nasal valve collapse with an overall low risk profile. As the popularity of this procedure has increased, but there have been some reports of both short- and long-term complications. Short-term complications are generally related to local infection/inflammation and implant extrusion. In their series of 70 patients randomized to the treatment arm, Stolovitzky et al. reported 19 procedure-related adverse events (6 implant retrievals, 4 pain, 3 foreign body sensation, 2 localized swelling, 1 inflammation, 1 skin puncture, 2 vasovagal response). Sidle et al. reported adverse events in 31 of their subjects including 6 foreign body sensations, 1 skin irritation, 1 hematoma, 4 infections, 5 bumps, and 17 implant retrievals. The indications for implant retrieval included patient manipulation, patient request, bump felt, and the reason was unknown in 10 cases. Typically, there is no cosmetic change following implantation, but nine patients did report experiencing a cosmetic change that was worse than at baseline.

In January 2021, a unique CPT code (CPT 30468) was assigned for repair of nasal valve collapse with subcutaneous/submucosal lateral wall implant(s). CPT 30468 is used to report a bilateral procedure. A unilateral procedure should be reported with modifier 52 for reduced services. This code cannot be reported with CPT 30465 for repair of nasal vestibular stenosis with spreader grafting or lateral nasal wall construction. It is recommended that the ICD-10 diagnosis code should be reported as J34.89 for Unspecified disorder of the nose and nasal sinus. The work RVU assigned to this code is 2.80 and there is a 0-day global period.

It is important to note that assignment of a Category I CPT code does not guarantee coverage and/or payment. While Medicare and Tricare recognize the code, commercial insurers differ in the coverage, and many still consider this an investigative procedure. Obtaining a prior authorization is always recommended, even if one is not required. Additionally, individual coverage policies may need to be investigated to ensure payment.

Radiofrequency remodeling of the nasal valve is indicated in patients with nasal obstruction resulting from static or dynamic nasal valve collapse. Radiofrequency cartilage remodeling has been investigated since the early 2000s. Investigators demonstrated in an ex vivo model that cartilage treated with temperature-controlled radiofrequency retained the user-specified shape up to 14 days. The cartilaginous support of the lateral nasal wall makes it an area that can be targeted with radiofrequency remodeling. This method is postulated to produce mechanical deformation and shape change of the lateral nasal wall by inducing tissue retraction and volume reduction. A benefit of temperature-controlled radiofrequency is that it can also be used along the septum and inferior turbinates to reduce mucosal hypertrophy.

Radiofrequency treatments to the nasal valve are typically performed in the office and may be conducted either via direct visualization with a nasal speculum and headlight or by using a nasal endoscope.

First, the region of the upper lateral cartilage is anesthetized with topical 4% lidocaine and/or 4% tetracaine, followed by an injection of lidocaine 1% with epinephrine. Once adequate anesthesia has been achieved, the Vivaer stylus is inserted into the console, and the settings of 60°C and 4 W are automatically selected. The stylus is then inserted intranasally and placed overlying the caudal margin of the upper lateral cartilage, typically starting at the most medial aspect. The device is then activated with the foot pedal, which initiates an 18-second treatment pulse followed by a 12-second cooling time. It is important to provide gentle and continuous upward pressure with the stylus to aid in the remodeling. Two additional treatments are then applied to more lateral nonoverlapping zones of the upper lateral cartilage.

Following the procedure, patients are instructed to apply an antibiotic ointment to the treatment area twice daily. Additionally, patients should be informed that they may experience some crusting overlying the treatment area for about 1 week postprocedure.

The first study investigating radiofrequency of the lateral nasal wall was performed using a skin incision and a radiofrequency-induced thermotherapy turbinate probe. Patients were followed for 16 weeks, and the authors reported a reduction in visual analog scale scores from 8.2 to 3.4. The initial trial of the Vivaer device for treatment of the nasal valve was a prospective, open-label trial including 31 subjects. The results of this trial demonstrated a significant reduction of NOSE scores at 3 months postprocedure (median [IQR]: 65.00 [20.00] vs. 30.00 [25.00]). A similar, nonrandomized trial including 50 subjects reported a significant reduction of mean NOSE scores from baseline to 26 weeks postprocedure (79.9 vs. 24.7, P < 0.0001). A 2-year follow-up to this study showed maintained improvement in the NOSE scores at 12, 18, and 24 months postprocedure (27.5, 32.7, and 26.5, P < 0.0001). Finally, NOSE scores remained stable throughout an additional 2-year follow-up period (32.3 at 36 months and 25.7 at 48 months).

The first randomized controlled trial evaluating temperature-controlled radiofrequency treatment of the nasal valve was conducted by Silvers et al. and published in July 2021. Seventy-seven subjects were randomized to receive treatment, while 41 underwent a sham procedure. At 3 months postprocedure, the responder rate within the treatment arm was 88.3%, compared to 42.5% in sham group ( P < 0.001). Responder rate was defined as greater than 20% reduction in NOSE score or ≥1 reduction in clinical severity category. NOSE scores had a significantly greater decrease in the active treatment arm compared to the sham group (–42.3 vs.–16.8, P < 0.001). A 12-month follow-up, crossover study was then conducted using the same patient cohort. Within the combined active treatment group, the responder rates at 3, 6, and 12 months were 86.0%, 91.0%, and 89.8%, respectively. Correspondingly, the authors reported 53.6%, 56.6%, and 58.8% improvement in NOSE scores from baseline at 3, 6, and 12 months, respectively. Subgroup analysis also demonstrated that the mechanism of nasal valve collapse (static vs. dynamic) and prior nasal surgery did not affect the extent of improvement throughout the 12-month follow-up.