First Clinical Consensus Statement on Balloon Dilation Aims to Ensure Patient Safety

by Jennifer L.W. Fink •

This clinical consensus statement “provides a foundation that patients, providers, and insurers can lean on to cover an important problem that is fairly prevalent in our society,” Dr. Denneny said. “It will be adjusted as further research and clinical experience warrant.”

Jennifer Fink is a freelance medical writer based in Wisconsin.

Key Points

  • The FDA approved the first balloon catheter for intranasal use in 2005.
  • This is the first clinical consensus statement on balloon dilation of the sinuses, and it indicates that the procedure is appropriate for patients with sinonasal symptoms and positive findings on CT scan. It can also be used as an adjunct to FESS.

2018 Clinical Consensus Statement: Balloon Dilation of the Sinuses

1. Balloon dilation is not appropriate for:

  • patients who are without both sinonasal symptoms and positive findings on CT;
  • the management of headache in patients who do not otherwise meet the criteria of CRS or recurrent acute sinusitis;
  • the management of sleep apnea in patients who do not otherwise meet the criteria of CRS or recurrent acute sinusitis; or
  • patients with sinonasal symptoms and a CT that does not show evidence of sinonasal disease.

2. CT scanning of the sinuses is a requirement before balloon dilation can be performed.

3. Balloon dilation can be appropriate as an adjunct procedure to FESS in patients with chronic sinusitis without nasal polyps.

4. There can be a role for balloon dilation:

  • in patients with persistent sinus disease who have had previous sinus surgery; and
  • in managing patients with recurrent acute sinusitis as defined in the AAO-HNSF guidelines based on symptoms and CT evidence of ostial occlusions and mucosal thickening.

5. Balloon dilation can:

  • be performed under any setting as long as proper precautions are taken and appropriate monitoring is performed;
  • be performed under local anesthesia with or without sedation;
  • improve short-term quality-of-life outcomes in patients with limited CRS without polyposis; and
  • be effective in frontal sinusitis.

6. Surgeons who consider reusing devices intended for dilation of the sinuses should understand the regulations set forth by the FDA for reprocessing such devices and ensure that they are followed.

Source: Otolaryngol Head Neck Surg. 2018;158:203–214