Complications of Novel Radiofrequency Device Use in Rhinology: A MAUDE Analysis

This study, titled "Complications of Novel Radiofrequency Device Use in Rhinology: A MAUDE Analysis," investigates the adverse events (AEs) associated with the use of intranasal radiofrequency (RF) devices. These devices have gained popularity in otolaryngology, particularly for procedures related to the nasal airways, such as turbinate reduction and treatment of chronic rhinitis. The study primarily draws from the U.S. Food and Drug Administration's (FDA) Manufacturer and User Facility Device Experience (MAUDE) database to identify and analyze complications reported by physicians, patients, and manufacturers.

### Background and Objectives

Intranasal RF devices, including Celon® (Olympus), VivAer® (Aerin Medical), RhinAer® (Aerin Medical), and NeuroMark® (Neurent Medical), have been increasingly adopted in clinical practice. While these devices are marketed as minimally invasive options for nasal procedures, concerns have emerged regarding their safety, particularly the risk of tissue damage and other complications. The study aims to assess the safety profile of these devices by reviewing adverse events reported in the MAUDE database, thereby providing insights that could guide safer clinical use.

### Methods

The researchers queried the MAUDE database for adverse events related to the four mentioned RF devices. The data collected spanned from the inception of the database to February 2, 2023. Three reviewers independently analyzed the data, resolved discrepancies through discussion, and categorized the adverse events. The study did not undergo Institutional Review Board (IRB) approval as the data used is publicly available.

### Results

A total of 24 adverse events related to the use of RF devices were identified:

- **Celon® (11 events, 45.8%)**: The most common complication was tissue necrosis, accounting for 63.6% of Celon®-related events, often attributed to user error (e.g., high power settings). A notable case involved pediatric ocular palsy.

- **VivAer® (3 events, 12.5%)**: Complications included synechiae formation, mucosal perforation due to tissue necrosis, and a case of Empty Nose Syndrome (ENS).

- **RhinAer® (8 events, 33.3%)**: The majority of events (87.5%) were severe cases of epistaxis (nosebleeds), with many requiring surgical intervention, such as sphenopalatine artery ligation or blood transfusions.

- **NeuroMark® (2 events, 8.3%)**: Both events involved severe epistaxis, with one case necessitating septoplasty and cautery.

### Discussion

The study reveals that while RF devices are generally considered safe, they are not without risks. The low number of reported adverse events might suggest overall safety in trained hands, but certain severe complications underscore the need for caution. Specifically:

- **Tissue Necrosis**: The most common issue with Celon® was tissue necrosis, often linked to operator error. This suggests that RF energy settings need to be carefully managed to avoid damaging the surrounding tissues.

- **Epistaxis**: The frequent occurrence of severe nosebleeds, particularly with RhinAer® and NeuroMark®, indicates that the posterior nasal nerve ablation these devices perform can provoke significant bleeding, sometimes weeks after the procedure. This necessitates thorough patient counseling and preparedness for potential complications.

The study also highlights a unique case of Empty Nose Syndrome (ENS) reported with VivAer®, a debilitating condition where the nasal passages feel too open, leading to a sensation of suffocation and other symptoms despite normal airflow.

### Conclusions and Lessons Learned

The findings suggest that while RF devices offer innovative treatment options in rhinology, they carry risks that must be carefully managed. Surgeons should be vigilant in adjusting device settings to avoid tissue damage, particularly in sensitive areas. The study calls for more extensive long-term data and suggests that early adopters of such technologies should closely monitor patient outcomes to ensure safety.

The occurrence of severe epistaxis, tissue necrosis, and rare but severe complications like ocular palsy or ENS underscores the need for cautious and informed use of these devices. The researchers advocate for better training, careful patient selection, and thorough postoperative follow-up to mitigate these risks. Additionally, as the MAUDE database relies on voluntary reporting, the actual incidence of complications may be underreported, indicating a need for more rigorous safety monitoring in clinical practice.