Inferior meatus augmentation procedure IMAP normalizes nasal airflow patterns in empty nose syndrome patients via computational fluid dynamics CFD modeling

 ### Summary of the Research Study on Empty Nose Syndrome and Inferior Meatus Augmentation Procedure

#### Background

Empty Nose Syndrome (ENS) is a controversial and often debilitating condition that arises from significant tissue loss in the nasal cavity, particularly affecting the inferior turbinates. Patients with ENS experience distressing symptoms such as nasal dryness, obstruction, burning, and crusting, which often occur after surgical procedures intended to widen the nasal passages by removing or reducing the inferior turbinates. Despite the apparent physical openness of the nasal passages post-surgery, patients with ENS report a paradoxical sense of nasal obstruction and discomfort.

The study in question investigates the efficacy of the Inferior Meatus Augmentation Procedure (IMAP) in alleviating ENS symptoms. IMAP involves the implantation of submucosal rib cartilage to restore the volume and contour of the nasal cavity, particularly in the inferior meatus. This study sought to understand the mechanisms behind the symptom relief provided by IMAP using advanced computational fluid dynamics (CFD) modeling.

#### Methods

The study involved five patients diagnosed with ENS who had undergone bilateral IMAP surgery. The procedure entailed the insertion of rib cartilage implants into the inferior meatus. Pre-operative and post-operative computed tomography (CT) scans were analyzed using CFD modeling to assess changes in nasal airflow patterns. The patients’ symptoms were evaluated using the Empty Nose Syndrome 6-Item Questionnaire (ENS6Q) both before and after surgery.

#### Results

1. **Symptom Improvement**: There was a significant reduction in ENS symptoms following IMAP surgery. The ENS6Q scores improved from a mean of 14.00 (indicating severe symptoms) to 4.80 (indicating mild symptoms), with a Cohen’s d value of 2.64 (p = 0.02), reflecting a substantial effect size.

2. **Airflow Dynamics**: CFD modeling revealed a notable shift in airflow patterns post-IMAP. Airflow distribution changed significantly, with a reduction in airflow through the middle meatus and an increase in airflow through the inferior meatus. This shift was observed across different slices of the nasal cavity:

   - **Anterior to the Implant**: Airflow through the middle meatus decreased from 67.13% to 46.18%, while airflow through the inferior meatus increased from 30.55% to 42.59% (p < 0.05).

   - **At the Implant**: A decrease in middle meatus airflow was noted (from 52.42% to 38.45%), although this was not statistically significant (p = 0.08).

   - **Posterior to the Implant**: No significant changes in airflow distribution were observed.

3. **Nasal Resistance**: There were no significant changes in nasal resistance pre- and post-IMAP, indicating that the improvement in symptoms was not due to changes in airflow resistance.

4. **Correlation with Symptom Relief**: A significant correlation was found between reduced airflow through the middle meatus and improved ENS6Q scores, suggesting that the shift in airflow patterns contributed to symptom relief.

#### Conclusions

The study supports the hypothesis that the symptoms of ENS are not solely related to nasal resistance but are significantly influenced by the abnormal distribution of nasal airflow. IMAP surgery effectively alters the airflow dynamics in the nasal cavity by redistributing airflow away from the middle meatus and enhancing airflow through the inferior meatus. This improvement in airflow patterns is associated with a reduction in ENS symptoms.

#### Key Findings and Implications

- **Mechanisms of Symptom Relief**: The symptom relief experienced by patients following IMAP surgery appears to be linked to the normalization of airflow patterns rather than changes in nasal resistance. The Coandă effect, where airflow adheres to the curvature of surfaces, may play a role in redistributing airflow towards the inferior meatus. 

- **Restoration of Nasal Function**: The augmentation of the inferior meatus via IMAP restores a more natural airflow pattern, providing patients with a more satisfying sensation of airflow and potentially addressing the root causes of ENS symptoms.

- **Future Directions**: While this study provides valuable insights into the benefits of IMAP, further research is needed to explore the exact mechanisms behind the observed airflow changes and to validate these findings in larger patient populations.

In summary, the research demonstrates that IMAP is a promising surgical intervention for ENS, providing significant symptomatic relief through the restoration of normal nasal airflow patterns.

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.