Minimally invasive nerve treatment improves chronic rhinitis outcomes

Temperature-controlled radiofrequency neurolysis of the posterior nasal nerve improved the symptom burden and quality of life of patients with chronic rhinitis through 24 months, according to a study published in Allergy & Rhinology.

“This study was an extension of an earlier study exploring the impact of RhinAer on rhinitis symptom burden through 12 months,” Dale R. Ehmer Jr., MD, FACS, of Ear, Nose & Throat Associates of Texas in McKinney, Texas, told Healio.

The RhinAer System (Aerin Medical Inc.) generates and sends 4 W of 60°C temperature-controlled bipolar radiofrequency energy to a single-use, disposable handheld stylus that is applied to one to three nonoverlapping positions in the posterior nasal nerve (PNN) region for 12 seconds in each position.

According to the researchers, PNN and Vidian nerve neurectomies are believed to block parasympathetic stimulation. Blocking parasympathetic innervation can reduce submucosal glands secretion, blood flow in the submucosa and stromal edema.

Dale R. Ehmer Jr.

“With this extension, we wanted to examine long-term follow-up at 24 months, in addition to patient quality of life (QoL) and satisfaction with the procedure,” Ehmer said.

Noting that the RhinAer has been commercially available since 2020, Ehmer said that many patients ask how long its results last.

“It was important for us to do this study to ensure the results were durable,” Ehmer said. “We were pleasantly surprised to confirm that not only do the results last, but they continue to improve through the 2-year mark.”

The study’s design and results

Patients were treated between October 2018 and June 2019, with 24-month data from 34 patients (21 women; average age, 58.7 ± 12.6 years) collected through May 2021.

These patients also completed surveys asking the same series of questions at baseline before the procedure and at 3, 12 and 24 months after the procedure.

No adverse events, serious or otherwise, related to the device or procedure were reported.

There was a mean change in reflective total nasal symptom scores (rTNSS) of –5.5 (95% CI, –6.4 to –4.6) at 24 months, which the researchers called a significant 65.5% improvement.

Also at 24 months, 97.1% (95% CI, 85.1%-99.5%) of patients reported a minimal clinically important difference (MCID) of one point or greater improvement in rTNSS. Based on a more stringent MCID, the researchers continued, 88.2% of patients (95% CI, 73.4%-95.3%) reported at least 30% improvement at 24 months.

The researchers additionally found that significant improvements in rhinorrhea, nasal congestion, nasal itching and sneezing rTNSS subscores were maintained through all time points in the study (P < .001).

“Another significant finding was that there was significant improvement in rTNSS regardless of rhinitis subtype,” Ehmer said.

The 13 patients with allergic rhinitis experienced a –4.8 (95% CI, –6.1 to –3.5) improvement in mean rTNSS. The 10 nonallergic patients also experienced an improvement of –6.1 (95% CI, –8.5 to –3.7), and the 11 patients with unknown rhinitis reported an improvement of –5.8 (95% CI, –7.4 to –4.3).

“I think one of the most important findings of this study was that RhinAer can be used in patients with both allergic and nonallergic rhinitis,” Ehmer said. “Also, both populations show similar improvement in symptoms through 24 months.”

Compared with baseline responses, significantly more patients also reported:

• never or rarely having trouble falling asleep (P < .001);
• very frequently or frequently having good sleep through the night (P = .045);
• never or rarely feeling fatigued during the day (P = .018);
• never or rarely feeling frustration, restlessness or irritability (P < .001);
• never or rarely feeling embarrassment or self-consciousness about their chronic rhinitis (P = .002);
• very frequently or frequently having a good sense of well-being (P = .009); and
• rarely or never using nasal sprays (P = .008).

The researchers further classified patient satisfaction with the procedure and results as high and consistent from 3 to 24 months.

“Additionally, we found sustained positive results in multiple QoL measures with other common symptoms such as post-nasal drip and chronic cough also showing continued improvement,” Ehmer said.

On a six-point scale, post-nasal drip improved from a mean of 4.1 to 2.1 and chronic cough improved from 3.2 to 0.9 (both, P < .001). Plus, 24% of patients reported an overall decrease in the number of medication classes taken for their rhinitis, whereas 15% reported an overall increase.

The study’s implications

“Usually in clinical studies, the intervention has the highest benefit right after the procedure and then can decrease in effectiveness over time. In this study, our results persisted, as we saw continued improvement from 3 months through 12 months, and now the 24 month results. The interesting follow-up question is why,” Ehmer said.

Ehmer said that the researchers are not certain, but they hypothesize that the continued improvement is due to the treatment effect of reducing the hyperactivity of the PNN, which then potentially downregulates inflammation and chronic rhinitis symptoms over time.

“There are a vast number of patients in our practices who suffer from rhinitis symptoms, despite medical therapy, and this treatment allows us to address their symptoms in a safe, effective, durable, minimally invasive manner under local anesthesia in the office,” Ehmer said.

“Also, the wide swath of symptoms that showed sustained, significant improvement gives ENT physicians the ability to discuss this therapy with a multitude of patients. Patients that suffer from postnasal drip and cough can be particularly challenging to treat, and we showed that RhinAer improved those symptoms as well,” he continued.

Other studies are now evaluating the RhinAer System, Ehmer said, including a randomized control trial with positive results that will follow patients through 3 years and generate even longer-term data.

Reference:

• Aerin Medical’s RhinAer demonstrates long-term safety and efficacy for treatment of chronic rhinitis in newly published two-year study. https://aerinmedical.com/company-news/aerin-medical-rhinaer-demonstrates-long-term-safety-and-efficacy-for-treatment-of-chronic-rhinitis-in-newly-published-two-year-study/. Posted June 7, 2022. Accessed June 13, 2022.