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.

 

Empty Nose Syndrome as an Iatrogenic Condition from Surgery

Comprehensive Summary of the Study on Empty Nose Syndrome as an Iatrogenic Condition from Surgery

**Overview**

The study, titled "Empty Nose Syndrome as an Iatrogenic Condition from Surgery," published in *Current Otorhinolaryngology Reports* (2023), provides an in-depth review of Empty Nose Syndrome (ENS), focusing on its sjukdomsutveckling, diagnosis, and management. The researchers examine the role of surgical interventions, particularly turbinate surgery, in the development of ENS, highlighting recent advancements in computational fluid dynamics (CFD) that have shed light on the condition's underlying mechanisms.

**Introduction**

ENS, first described in 1994, is a rare and often debilitating condition that occurs primarily after partial or total resection of the nasal turbinates, structures responsible for regulating airflow and humidifying inhaled air. Despite having a patent nasal airway, patients with ENS experience paradoxical nasal obstruction and a range of other distressing symptoms. Historically, the condition was controversial and often dismissed as a psychological issue due to its rarity and elusive pathophysiology. However, recent studies, particularly those using CFD, have provided a more scientific understanding of ENS, reinforcing the notion that it is an iatrogenic (medically induced) condition.

**Key Findings**

1. **Pathogenesis and Nasal Airflow Alterations**

   - ENS is associated with significant changes in nasal airflow dynamics. Normally, nasal airflow is turbulent and distributed across the nasal cavity, allowing for proper air conditioning and stimulation of thermoreceptors that signal nasal patency.

   - After turbinate surgery, the airflow becomes laminar and more concentrated in the middle meatus, bypassing the inferior and superior parts of the nasal cavity. This change reduces the effectiveness of air conditioning and impairs the sensation of airflow, contributing to ENS symptoms.

   - CFD studies have shown that patients with ENS experience increased airflow velocity and decreased nasal resistance, yet paradoxically suffer from a sensation of nasal obstruction. This is because the airflow is no longer distributed evenly across the nasal cavity, leading to inadequate stimulation of the mucosal receptors responsible for detecting airflow.

2. **Sensorineural Dysfunction**

   - ENS also involves neurosensory abnormalities, particularly involving the trigeminal nerve, which plays a critical role in sensing nasal airflow. Damage to this nerve, either during surgery or as a result of altered airflow patterns post-surgery, can impair the sensation of nasal patency.

   - Histopathological studies have shown decreased expression of thermoreceptors (TRPM8) in the nasal mucosa of ENS patients, further supporting the role of sensorineural dysfunction in the disease.

3. **Psychological Impact**

   - ENS has a profound psychological impact, with a significant proportion of patients experiencing anxiety, depression, and sleep disturbances. Studies have shown that ENS patients have much higher rates of moderate to severe depression compared to those with other nasal conditions, such as chronic rhinosinusitis.

   - Suicidal ideation has been reported in a notable percentage of ENS patients, underscoring the severe psychological burden of the condition. 

4. **Diagnosis**

   - The diagnosis of ENS involves a combination of clinical assessment and specialized tools. The Empty Nose Score 6-Questionnaire (ENS6Q) is a validated tool that helps differentiate ENS from other nasal conditions based on symptoms like nasal dryness, a sensation of diminished airflow, and the feeling that the nose is "too open."

   - The cotton wool test, where a small piece of cotton is placed in the nasal cavity to temporarily restore turbinate bulk, can provide diagnostic insight by significantly reducing symptoms in ENS patients.

5. **Management and Treatment**

   - Management of ENS is challenging, as the condition often requires a multifaceted approach. Medical treatments focus on symptom relief through nasal moisturization and psychological support, including cognitive-behavioral therapy and pharmacotherapy for anxiety and depression.

   - Surgical interventions are considered for patients who do not respond to medical therapy. These include inferior meatal augmentation procedures (IMAP) to restore nasal airflow dynamics and submucosal filler injections to temporarily alleviate symptoms by increasing tissue bulk in the nasal cavity.

   - The success of surgical treatments supports the notion that ENS is indeed an iatrogenic condition, as these procedures aim to reverse the changes caused by the initial surgery.

**Conclusions**

The study concludes that ENS is a complex, multifactorial condition primarily resulting from surgical alterations to the nasal turbinates. The insights provided by CFD have improved the understanding of ENS, highlighting the critical role of nasal airflow dynamics and sensorineural function in its pathogenesis. Despite advances in diagnosis and management, ENS remains a challenging condition, with a need for further research to identify patients at risk and optimize treatment strategies. The study emphasizes the importance of a careful pre-operative assessment to prevent the occurrence of ENS and the need for ongoing research to refine surgical techniques and therapeutic approaches.

**Empty Nose Syndrome in Focus**

The study confirms that ENS is a genuine, physically based condition, not merely a psychological phenomenon, though it has significant psychological ramifications. The findings also highlight the importance of recognizing ENS as a potential risk when considering turbinate surgery and suggest that preventive measures and patient education are crucial in managing expectations and outcomes.

**Final Thoughts**

This comprehensive review underscores the importance of understanding ENS as both a physiological and psychological condition. The recognition of its iatrogenic origins calls for greater caution in nasal surgeries and a more holistic approach to patient care, incorporating both physical and mental health support to manage this debilitating condition effectively.

Distinguishing computed tomography findings in patients with empty nose syndrome

This study, conducted by Andrew Thamboo and colleagues, addresses the challenge of diagnosing Empty Nose Syndrome (ENS), a controversial condition often arising after nasal surgeries such as inferior turbinate reduction (ITR). ENS is characterized by a range of debilitating symptoms, including a paradoxical sensation of nasal obstruction despite a clear nasal passage, dryness, pain, and even psychological distress. However, due to the lack of standardized diagnostic criteria, identifying ENS has been challenging for clinicians.

The researchers aimed to determine whether specific radiographic features, particularly those visible on computed tomography (CT) scans, could be used to objectively differentiate ENS patients from those who had undergone ITR but did not develop ENS, as well as from healthy individuals with no history of sinonasal procedures. The study involved analyzing CT scans from three groups: 65 patients diagnosed with ENS, patients with a history of ITR without ENS symptoms, and control patients with no sinonasal disease history.

Key measurements were taken at the level of the nasolacrimal duct, including the thickness of the mucosa in the nasal septum, inferior turbinate, nasal floor, and lateral nasal wall, across different segments of the nasal cavity (anterior, central, and posterior). The study found that the mucosal thickness in the central and posterior segments of the septum was significantly greater in ENS patients compared to both ITR without ENS patients and controls. Specifically, a septal mucosal thickness greater than 2.64 mm in the central nasal region and greater than 1.32 mm in the posterior nasal region were identified as potential markers for ENS, offering high sensitivity and specificity.

The findings support the notion that ENS is a distinct pathophysiological entity with measurable differences in nasal mucosa that can be identified through CT imaging. The study also suggested that the nasal septum, particularly in the central and posterior regions, exhibits dynamic hypertrophy in ENS patients, potentially contributing to their symptoms.

However, the study acknowledges limitations, including the retrospective design and the small sample size, particularly in the ENS group. Moreover, the role of excessive nasal hygiene practices in contributing to mucosal swelling in ENS patients was speculated but not proven. Despite these limitations, the study provides valuable insights into the potential for developing objective diagnostic criteria for ENS, which could greatly benefit patients suffering from this underrecognized condition.

The study did discuss Empty Nose Syndrome (ENS) extensively, highlighting the difficulties in diagnosing the condition and the need for objective criteria. The conclusions emphasize that specific CT findings, particularly related to mucosal thickness in the central and posterior nasal septum, could serve as important diagnostic markers for ENS. This could lead to better recognition and management of the condition, offering hope for patients who suffer from its often debilitating symptoms.

Pathophysiology of Empty Nose Syndrome

This research study, titled "Pathophysiology of Empty Nose Syndrome," conducted by Jeanie Sozansky and Steven M. Houser, delves into the complexities of Empty Nose Syndrome (ENS), a rare but debilitating condition often arising as a complication of turbinate surgery. ENS occurs when the nasal turbinates are partially or completely removed, disrupting normal airflow patterns and impairing the neurosensory mechanisms responsible for detecting nasal airflow. The study aimed to understand the underlying pathophysiology of ENS by reviewing current literature on nasal airflow sensation, nasal patency, and the mechanisms of sensory perception.

**Background:**

ENS was first described in 1994 by Kern and Stenkvist, who identified patients with extensive turbinate resections suffering from paradoxical nasal obstruction—where the nasal passages appear wide open, yet the patient feels congested. The exact cause of this paradoxical sensation remained unclear for many years. Over time, ENS was recognized as a complication of various turbinate surgeries, including total turbinectomy and less invasive procedures like submucosal resection and laser therapy, especially when performed aggressively.

**Key Findings:**

1. **Subjective vs. Objective Nasal Patency:**

Traditional methods for assessing nasal obstruction, such as rhinomanometry and acoustic rhinometry, focus on anatomical measurements and airflow resistance. However, these methods do not correlate well with the subjective sensation of nasal patency. ENS patients often report a blocked sensation despite having wide nasal cavities, which cannot be explained by objective tests alone.

2. **Neurosensory Mechanisms:**

The study highlights the importance of the trigeminal nerve, specifically the TRPM8 receptor, in sensing nasal airflow. TRPM8 is activated by cool air, which is crucial for the sensation of nasal patency. In ENS, the altered airflow patterns reduce the cooling of nasal mucosa, leading to inadequate activation of these receptors. This results in the brain perceiving the nose as obstructed despite the absence of physical blockage.

3. **Airflow Pattern Alterations:**

ENS patients have a disproportionate nasal cavity volume relative to the mucosal surface area, leading to a laminar airflow pattern instead of the necessary turbulent flow. This disruption hinders the air's ability to cool the mucosa, diminishing the activation of cool thermoreceptors and thereby reducing the sensation of nasal patency.

4. **Dyspnea and Respiratory Distress:**

Many ENS patients experience a sensation of breathlessness or dyspnea, which is thought to be linked to the disrupted neurosensory feedback between the nasal passages and the brain. The study found that ENS patients have abnormal brain activation patterns when assessing nasal patency, indicating that the condition affects not just the nose but also the respiratory centers in the brain, contributing to the sensation of suffocation or difficulty breathing.

5. **Neurosensory System Aberrations:**

Beyond the physical alterations in airflow, the study discusses how nerve damage during turbinate surgery can lead to lasting sensory deficits. These deficits might be responsible for the ongoing abnormal sensations in ENS patients. Even if the surgery is technically successful, improper nerve healing can result in the permanent loss of normal nasal sensation, exacerbating ENS symptoms.

**Conclusions:**

The study concludes that ENS is not solely a result of anatomical changes but is heavily influenced by neurosensory dysfunction. The researchers propose that ENS develops due to a combination of impaired airflow patterns and neurosensory system aberrations, which together alter the perception of nasal patency. ENS patients suffer from genuine physiological changes, not just psychological symptoms, and these changes significantly impact their quality of life. The study calls for a more nuanced approach to diagnosing and treating ENS, emphasizing the need for a better understanding of the neurosensory components involved.

**Learnings and Implications:**

The research underscores the complexity of ENS and the importance of preserving nasal structure and function during turbinate surgeries. It suggests that careful surgical planning and consideration of the neurosensory impacts are crucial in preventing ENS. Moreover, the study opens avenues for further research into treatments that could restore normal sensory function or compensate for the loss of turbinate tissue, potentially improving outcomes for ENS patients.

This study is significant in that it shifts the focus from purely anatomical considerations to a more comprehensive understanding of how the nose functions as a sensory organ, particularly in the context of ENS. By doing so, it offers a new perspective on how to approach both the diagnosis and management of this challenging condition.

 

Surgery of the turbinates and “empty nose” syndrome

The research study titled "Surgery of the Turbinates and Empty Nose Syndrome" provides a comprehensive examination of the surgical interventions performed on the nasal turbinates, which are structures within the nasal cavity that play a crucial role in regulating airflow, humidifying, and warming the air we breathe. The study highlights the complexities and challenges associated with turbinate surgery, particularly focusing on the phenomenon known as Empty Nose Syndrome (ENS).

Overview of Turbinate Surgery

Turbinate surgery is often performed to alleviate nasal obstruction caused by conditions such as chronic rhinitis or hypertrophy of the turbinates. The primary goal of these surgical procedures is to improve nasal airflow while preserving the mucosal function of the nasal cavity. However, the study notes that there is no universally accepted surgical technique for turbinate reduction, leading to variability in outcomes and patient experiences.

Empty Nose Syndrome (ENS)

One of the significant concerns raised in the study is the risk of developing Empty Nose Syndrome, a condition that can occur after the resection of turbinates. ENS is characterized by a paradoxical sensation of nasal obstruction despite the nasal passages being physically wide open. Patients with ENS often report a dry nose, crusting, and a feeling of inadequate airflow, which can be distressing and difficult to treat. The study emphasizes that ENS is a surgically irreversible condition, making it crucial for surgeons to carefully consider the extent of turbinate removal during surgery.

Findings from Clinical Studies

The research includes findings from a clinical study conducted at the ENT University Clinic in Ulm, which investigated the airflow dynamics in patients with ENS. Using MRI-based numerical flow simulations, the study found that patients with ENS had significantly higher temperatures of inhaled air at certain points in the nasal cavity compared to healthy individuals. Additionally, the absolute humidity of the air was lower in ENS patients, contributing to the sensation of dryness and increased crust formation. These findings underscore the importance of the nasal turbinates in conditioning inhaled air and maintaining mucosal health.

Conclusions and Lessons Learned

The study concludes that while turbinate surgery can provide relief for many patients suffering from nasal obstruction, it carries the risk of complications such as ENS. The authors stress the need for careful patient selection and thorough preoperative counseling to ensure that patients are aware of the potential risks and benefits of the procedure. Furthermore, the study highlights the importance of preserving as much mucosal tissue as possible during surgery to maintain the natural functions of the nasal cavity.

In summary, the research emphasizes the delicate balance that surgeons must strike between achieving adequate airflow and preserving the integrity of the nasal mucosa. The findings serve as a reminder of the complexities involved in nasal surgery and the need for ongoing research to better understand the long-term effects of turbinate reduction procedures. The study advocates for a more conservative approach to turbinate surgery, prioritizing patient safety and quality of life over aggressive surgical interventions.