VivAer (Aerin Medical Inc.) is a device used in a noninvasive office-based procedure that is an alternative to invasive surgical intervention. VivAer is intended to modify the soft tissue of the nasal airway using low-dose nonablative radiofrequency (RF) energy. The RF energy can be used to remodel nasal cartilage and soft tissue throughout the nasal valve, including the septum, the inferior turbinate, and the nasal valve itself.
CLINICAL STUDIES
In 2024, Han et al. published a systematic review and meta-analyses with the aim of showing comparable temperature controlled radiofrequency (TCRF) treatment of nasal valve collapse (NVC) outcomes using historical evidence of the following three established procedures: 1) rhinoplasty surgery focused on the nasal valve (RNV), 2) rhinoplasty surgery without concomitant turbinate treatment (RWOT), and 3) all rhinoplasty surgery procedures (All RS). Although TCRF is indicated for treating turbinate hypertrophy, current peer-review literature does not address the turbinate region and only internal nasal valve was reviewed. An average NOSE score was set at 45 or greater (moderate to extreme problem) and follow-up occurred at 3, 6, and 12 months post procedure. Efficacy outcomes were measured using weighted mean difference (WMD) in NOSE score from baseline to follow-up timepoint reported as a negative integer, where the greatest improvement is seen in greater negative integers. Pooled efficacy results of TCRF compared to RNV, RWOT, and All RS exhibited comparable results at all timepoints (TCRF at 3 and 12 months: -43.3 and -48.8; RNV at 3 and 12 months: -41.9 and -48.8; RWOT at 3 and 12 months: -44.4 and -45.3; All RS at 3 and 12 months: -47.1 and -47.7). Limitations to consider include significant statistical heterogeneity (I2 > 60%) of all cohorts at the 12-month timepoint precluding the ability to determine clinical utility. Further, the TCRF study inclusion criteria excluded physiological manifestations that typically warrant the need for surgical intervention (e.g., turbinate hypertrophy, severe septal deviation, etc.), potentially resulting in favorable outcomes in the TCRF cohort. Nasal valve collapse is generally treated with spacer grafts, however, a limited number of comparator studies utilized this method. Although the authors appear to show comparable outcomes among TCRF and alternative nasal procedures, the limitations warrant further analysis. Future studies with an expanded study population and appropriate comparator are needed to substantiate TCRF as a suitable alternative to the established standard of care.
In 2024, Silvers and colleagues performed a two-year follow-up from a prospective, multicenter, single-blinded, randomized controlled trial (see Silvers et al. 2021 and Han et al. 2022). After primary end-point evaluation at 3 months, eligible individuals in the sham control crossed over to the active treatment group. The aim of this follow-up was to determine whether the temperature controlled radiofrequency (TCRF) treatment showed sustained improvements of nasal airway obstruction (NAO) through two years via measurement of an individual-reported outcome (NOSE) improvement from baseline. Responders were defined as ≥ 20% decrease in NOSE score from baseline. The responder rate in the treatment cohort (n=73) after two years was sustained (90.4% [95% Confidence Interval, 81.5% to 95.3%]) from the three month timepoint (86.0% [95% CI, 78.2% to 91.3%]). They also showed sustained NOSE score treatment effect through two years (-41.7 [95% CI -48.8 to -34.6]) from the three month timepoint (adjusted mean, -40.9 [95% CI -46.9 to -35.0]). Medication and nasal dilator use—though not dictated by the trial protocol—was also assessed through two years where an overall trend in medication reduction or discontinuation was documented. Of the 56 individuals on medication and/or nasal dialtors, 10.5% continued use, 5.3% increased use, 33.3% discontinued medication entirely, and 45.6% had discontinued/decreased use in ≥1 medication/nasal dilator. While concomitant medication reflects real-world clinical outcomes, the treatment's effictiveness may be overestimated. Additional limitations including high attrition rate (39%; 73/119), exclusion of severe NAO populations typically indicated for surgical intervention, and the inherent bias of self-reported outcomes limit the confidence of reported results. Despite the demonstrated sustained efficacy of up to two years, future studies investigating more severe medical characteristics supported by objective outcome measurements dictating medication regimen are needed to determine clinical meaningful impact in the NAO population.
In 2023, Yao et al conducted a prospective, single-arm, multicenter study in varying subpopulations (n=122) experiencing nasal airway collapse with severe to extreme NOSE scores (≥ 55). Mean baseline NOSE score was 80.3 (95% CI, 78.1 to 82.6). Primary outcome includes procedure responders as defined by patients with ≥ 20% improvement in NOSE Scale score or ≥ 1 severity-class improvement from baseline with five total timepoint measurements (i.e., Baseline, 3-month, 6-month, 1 year, 2 years). Secondary outcome includes medication/nasal breathing aid use from baseline to follow up, reported as a binary grouping of "much less frequently/less frequently" or "same/more frequently/much more frequently." Unlike previously reported populations in TCRF trials, the authors include and provide analysis for subpopulations such as septal deviation/turbinate, turbinate hypertrophy, nasal polyps, and nasal vestibular stenosis. At two-years, 90.1% (95% CI, 82.3% to 94.7%) were sustained responders, with an adjusted mean change of -45.8 (95% CI, -53.5 to -38.1; p < 0.001). Medication frequency was reduced in 49.2% (34/63) of patients taking oral medications and in 72.2% (26/36) using nasal breathing strips. A subpopulation exploratory analysis was also conducted that demonstrated significant improvements among all subpopulations when comparing each timepoint to baseline NOSE score (all p-values > 0.001). Further, NOSE score differences between subpopulations were comparable (i.e., nasal vestibular stenosis vs. no nasal vestibular stenosis, etc). Only one group (Severe NOSE class vs. Extreme NOSE class) showed significant score differences which is to be expected as the baseline scores are intrinsically separate classifications. The authors appear to demonstrate safety and durability of TCRF for treating nasal airway obstruction up to two years in various subpopulations. The exploratory analysis of subpopulations contributes to the understanding of populations typically indicated for surgery. Though the overall reduction in medication, nasal sprays, and breathing strips were substantial, they were not dictated by the protocol potentially introducing favorable outcomes that is difficult to ascertain without a control group. Limitations include a lack of 1) control arm, 2) objective clinical outcomes, and 3) medication standardization that precludes determining the clinical utility of TCRF for the treatment of nasal airway obstruction.
In 2022, Jacobowitz et al. published the 4-year results of the prospective, nonrandomized, multicenter case series described in Ephrat et al. (2021) and Jacobowitz et al (2019). Individuals with prior nasal valve surgery or other surgical nasal procedures within the past 12 months were excluded. Medication use was not controlled during the study but individuals were medically treated before surgery. Individuals underwent bilateral treatment with a VivAer device. Extended follow-up assessments included use of the validated Nasal Obstruction Symptom Evaluation (NOSE) scale score, completed in person, by telephone, or through mail at 36 and 48 months postprocedure. Of the 49 individuals in the initial study, 39 agreed to participate in follow-up through 24 months. Of these, 29 individuals agreed to extended follow-up through 48 months (five declined participation, three did not respond to the invitation, and two had a surgical procedure for nasal airway obstruction and were ineligible to continue). The baseline mean NOSE score was 81.0 (± 9.9), and at 6 months it was 21.6 (± 18.6), with 93% responders. Except for mean age, participants versus nonparticipants had no significant differences in characteristics. The proportion of 6-month responders among the nonenrolled group was 95%, confirming that early treatment response was unlikely to be associated with participation in extended follow-up. Compared with baseline, mean total NOSE scores significantly improved after treatment and were maintained throughout the 48 months. Mean NOSE domain scores showed sustained improvement through 48 months, including individuals with NOSE scores in the “extreme” (score of 80–100) or “severe” (score of 55–75) categories at baseline. Limitations of this study include 1) single-arm design without randomized control, 2) no control of medication usage, and 3) significant attrition relative to the primary study.
In 2022, Han et al. published the 12-month results of a prospective, multicenter, single-blinded, randomized controlled trial (RCT), in which individuals were assigned to temperature-controlled radiofrequency (TCRF) device treatment of the nasal valve or a sham control procedure (no RF energy) (see Silvers et al. 2021). Individuals had a baseline NOSE scale score of 55 or greater with nasal valve collapse as the primary or substantial contributor to nasal airway obstruction (NAO). After primary end point evaluation at 3 months, eligible individuals in the sham control arm crossed over to active treatment. The objective of the study was to determine if active treatment of the nasal valve with a TCRF device, previously demonstrated superior to a sham procedure at 3 months, was safe and associated with sustained improvements in symptoms of NAO through 12 months. The primary end point measure was responder rate, defined as 20% or greater reduction in NOSE scale score or 1 or greater reduction in NOSE scale clinical severity category. A total of 108 individuals received active treatment (77 as index active treatment, 31 after crossover). The combined group of individuals receiving active treatment had a mean baseline NOSE scale score of 76.3 (95% confidence interval [CI], 73.6–79.1). At 12 months (n=88), the responder rate was 89.8% (95% CI, 81.7%–94.5%). The NOSE scale score improved from baseline (mean change, −44.9 [95% CI, −52.1 to −37.7]). No device/procedure-related serious adverse events were reported. The authors concluded that "[i]n this follow-up of a cohort from a randomized clinical trial, the minimally invasive TCRF device, previously demonstrated to be superior to a sham procedure, was safe and associated with improvement in symptoms of NAO through 12 months postprocedure." Limitations of this study include 1) medication use was not dictated by the protocol and could potentially have had some confounding effect on symptom relief; 2) the results reported are through 12 months, and continued follow-up is needed to determine the longer-term durability of effect; 3) the eligibility criteria, particularly exclusion criteria, should be taken into account when considering the results of this trial and individual selection in clinical practice; and 4) the majority of the trial population were White, potentially limiting the generalizability of the results to individuals of different races and ethnicities who may have meaningful differences in nasal anatomy.
In 2021, Silvers et al. published the results of a prospective, multicenter, single-blinded RCT, in which individuals were assigned to bilateral temperature-controlled RF treatment of the nasal valve (n=77) or a sham procedure (n=41), in which no RF energy was transferred to the device/treatment area. The objective of the study was to compare active device treatment against a sham procedure (control). The primary end point was responder rate at 3 months, defined as a 20% or greater reduction in NOSE scale score or 1 or greater reduction in clinical severity category. At baseline, individuals had a mean NOSE scale score of 76.7 (95% CI, 73.8–79.5) and 78.8 (95% CI, 74.2–83.3) (P=0.424) in the active treatment and sham-control arms, respectively. At 3 months, the responder rate was significantly higher in the active treatment arm (88.3% [95% CI, 79.2%–93.7%] vs 42.5% [95% CI, 28.5%–57.8%]; P<0.001). The active treatment arm had a significantly greater decrease in NOSE scale score (mean, −42.3 [95% CI, −47.6 to −37.1] versus −16.8 [95% CI, −26.3 to −7.2]; P<0.001). Three adverse events at least possibly related to the device and/or procedure were reported, and all resolved. The authors concluded that "temperature-controlled RF treatment of the nasal valve is safe and effective in reducing symptoms of nasal airway obstruction (NAO) in short-term follow-up." Limitations of this study include 1) physicians were not blinded to treatment-arm assignment, which may have been a source of bias; 2) medication use was not dictated by the protocol and could potentially have had some confounding effect on symptom relief; and 3) the results reported are through 3 months, and longer-term follow-up is needed to confirm the results.
In 2021, Wu et al. published the results from a prospective, nonrandomized case series, in which 20 individuals with internal nasal valve obstruction underwent office-based VivAer treatment under local anesthesia. The individuals' NOSE score (pretreatment 78.89 ± 11.57; posttreatment 31.39 ± 18.30, P=5e-7) and Visual Analog Scale of nasal obstruction (VAS: pretreatment, 6.01 ± 1.83; posttreatment, 3.44 ± 2.11, P=1e-4) improved significantly at 90 days after the minimally invasive approach. Nasal airway volume in the treatment area increased approximately 7% 90 days posttreatment (pretreatment 5.97 ± 1.20; posttreatment 6.38 ± 1.50 cm3; P=0.018), yet there were no statistically significant changes in the measured peak nasal inspiratory flowrate (PNIF; pre-reatment, 60.16 ± 34.49; posttreatment, 72.38 ± 43.66 mL/s; P=0.13) and CFD computed nasal resistance (pretreatment, 0.096 ± 0.065; posttreatment, 0.075 ± 0.026 Pa/(mL/s); P=0.063). As validation, PNIF correlated significantly with nasal resistance (r=0.47, P=0.004). Among all the variables, only the peak mucosal cooling posterior to the nasal vestibule significantly correlated with the NOSE score at baseline (r=−0.531, P=0.023) and with posttreatment improvement (r=0.659, P=0.003). Limitations of the study include 1) the single‐arm, nonrandomized design and lack of a control group; 2) the study was limited to 20 individuals; and 3) short follow-up period (90 days).
In 2021, Ephrat et al. published the 2-year results of the prospective, nonrandomized, multicenter case series described in Jacobowitz et al. (2019). Thirty‐nine adult patients from an original cohort of 49 individuals with severe to extreme NOSE scale scores and dynamic or static internal nasal valve obstruction as the primary or significant contributor to obstruction were studied. Individuals received intranasal bilateral radiofrequency treatment in a clinical study with a follow‐up to 6 months, and were prospectively evaluated at 12, 18, and 24 months. The patient‐reported NOSE scale score and 21 Quality of Life (QoL) questions were assessed. Clinically significant improvement from baseline in NOSE scale score change demonstrated at 6 months (mean, 55.9; standard deviation [SD], 23.6; P< 0.0001) was maintained through 24 months (mean, 53.5; SD, 24.6; P<0.0001). Responders (≥15‐point improvement) consisted of 92.3% of participants at 6 months and 97.2% at 24 months. Responses to the QoL questions also showed improvement in patients’ QoL. Limitations of this study include 1) the single‐arm, nonrandomized design and lack of a control group; 2) based on the study design utilized, the observed association of treatment and NOSE score could be caused by a placebo effect; 3) the lack of objective measures of nasal obstruction and nasal airflow; and 4) the extended follow‐up study enrolled 39 of the 50 original participants in the original 6‐month clinical study (participants with less improvement or satisfaction with the procedure may have chosen not to enroll).
In 2019, Jacobowitz et al. published the results of a prospective, nonrandomized, multicenter case series that was designed to assess the safety and effectiveness of in‐office bipolar radiofrequency treatment of nasal valve obstruction. Adult individuals with a NOSE score of 60 and greater were selected. The individuals were clinically diagnosed with dynamic or static internal nasal valve obstruction as primary or significant contributor to obstruction and were required to have a positive response to nasal mechanical dilators or lateralization maneuvers. Bilateral RF treatment was applied intranasally using a novel device, under local anesthesia in a single session. Safety and tolerance were assessed by event reporting, inspection, and Visual Analogue Scale (VAS) for pain. Efficacy was determined using the NOSE score and patient‐reported satisfaction survey at 26 weeks. Fifty patients were treated. No device or procedure‐related serious adverse events occurred. The mean baseline NOSE score was 79.9 (SD, 10.8; range, 60–100), and all individuals had severe or extreme obstruction. At 26 weeks, mean NOSE score was 69% lower at 24.7 (P<0.0001) with 95% two‐sided CIs 48.5 to 61.1 for decrease. The decrease in NOSE score did not differ significantly between individuals who did or did not have prior nasal surgery. Patient satisfaction mean by survey was 8.2 of 10. Limitations of this study include 1) its uncontrolled, nonrandomized, unblinded design, which can be prone to selection bias; 2) a placebo effect cannot be excluded; 3) the cohort was almost entirely White, and limited to 50 subjects (a placebo‐controlled study with a larger and more diverse population is needed); and 4) the endpoint analysis was performed at 26 weeks postprocedure, thus relatively short term (follow‐up for outcome over several years is needed to assess longevity of the individuals’ outcome).
In 2019, Brehmer et al. published the results of a prospective case series evaluating the safety and efficacy of the VivAer system for the treatment of narrowed nasal valves and to measure changes in the symptoms of nasal obstruction and snoring. The study involved 31 individuals presenting with symptoms of nasal obstruction and snoring. In all individuals, an improvement was observed in nasal breathing measured by NOSE score, sleep quality by Snore Outcomes Survey (SOS) questionnaire and QoL as measured by EQ-5D and Sino-Nasal Outcome Test (SNOT)-22. Limitations of this study include absence of a placebo group (nontreatment group) and the short follow-up period (average of 3 months).
