New Clinical Consensus Statement on Balloon Dilation of the Sinuses

February 2018 – Vol. 37, No. 1

The AAO-HNSF’s Otolaryngology–Head and Neck Surgery journal recently published the Clinical Consensus Statement (CCS) on Balloon Dilation of the Sinuses (BDS) that was previewed at our Annual Meeting in Chicago last year. I would like to thank and congratulate the participants on the panel that produced the statements of agreement related to this evolving tool for treating disorders of the sinonasal tract.

The use of this technology as it continues to evolve has proven to be a valuable addition to the armamentarium of the otolaryngologist treating sinus-related diseases. The Academy felt that it would be beneficial to produce a CCS that describes best practices and current management paradigms based on existing scientific literature and a panel of experts in the field of rhinology. This document would provide guidance to practitioners treating sinus-related disease, patients affected by these diseases, and the payers covering  these treatments.

I feel this CCS accomplishes that goal, based on our current knowledge. As the field progresses and further advancements are made, evidence may accumulate that warrants future updates to all or part of this document. As is the case with all our CCS and CPG products, the CCS on BSD will be reviewed on a regular basis and updated based on the most current literature and experience.

The following organizations have endorsed the CCS: American Academy of Allergy, Asthma & Immunology; American Academy of Otolaryngic Allergy; American Rhinologic Society; and the Triological Society.

— James C. Denneny III, MD

 

Patient criteria

  1. Balloon dilation is not appropriate for patients who are without both sinonasal symptoms and positive findings on CT.
  2. Balloon dilation is not appropriate for the management of headache in patients who do not otherwise meet the criteria for chronic sinusitis or recurrent acute sinusitis.
  3. Balloon dilation is not appropriate for the management of sleep apnea in patients who do not otherwise meet the criteria for chronic sinusitis or recurrent acute sinusitis.
  4. CT scanning of the sinuses is a requirement before balloon dilation can be performed.
  5. Balloon dilation is not appropriate for patients with sinonasal symptoms and a CT that does not show evidence of sinonasal disease.
  6. Balloon dilation can be appropriate as an adjunct procedure to FESS in patients with chronic sinusitis without nasal polyps.
  7. There can be a role for balloon dilation in patients with persistent sinus disease who have had previous sinus surgery.
  8. There is a role for balloon sinus dilation in managing patients with recurrent acute sinusitis as defined in the AAO-HNSF guideline based on symptoms and the CT evidence of ostial occlusion and mucosal thickening.
  9.  

    Perioperative considerations

  10. 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.
  11. Balloon dilation can be performed under any setting as long as proper precautions are taken and appropriate monitoring is performed.
  12. Balloon dilation can be performed under local anesthesia with or without sedation.
  13.  

    Outcomes

  14. Balloon dilation can improve short-term quality-of-life outcomes in patients with limited CRS without polyposis.
  15. Balloon dilation can be effective in frontal sinusitis.

Clinical consensus statements vs. clinical practice guidelines

The AAO-HNS Foundation produces two primary quality products, clinical consensus statements (CCSs) and clinical practice guidelines (CPGs), that are used to define best practices, create performance measures, and educate clinicians and the public about current management of common problems. Both products are evidence-based, using the best available evidence to address perceived gaps in care and opportunities for quality improvement. 

A CCS is defined as statements of fact developed by a group of content experts, for which consensus is sought using an explicit, a priori methodology to identify areas of agreement and disagreement. The statements that reach consensus are intended to improve patient care and clinical outcomes, but are not explicit recommendations for action. Instead, their impact on clinical care requires interpretation and value judgments by clinicians and policy makers. The core of a CCS is a series of statements for which a level of agreement (consensus, near consensus, no consensus) is sought using a modified Delphi method, a systematic iterative approach that does not require face-to-face interaction. The current AAO-HNS methodology for CCS development was published in 2015 (Rosenfeld RM, Nnacheta LC, Corrigan MD).

A CPG is defined as recommendations intended to optimize patient care that are informed by a systematic review of the evidence and an assessment of benefit and harms of alternative care options. In contrast to a CCS, the key statements in a CPG call for explicit action by clinicians, with associated levels of obligation (strong recommendation, recommendation, option), an action statement profile, and supporting text. An algorithm is included to show the interrelationship of the key action statements, and secondary products are developed, including an executive summary, plain language summary, and patient decision aids. The current AAO-HNS methodology for CPG development was published in 2013 (Rosenfeld RM, Shiffman RN, Robertson P).

Whether a specific topic is best suited for a CCS or a CPG depends primarily on the level of underlying evidence and the intended target audience. A CPG is most applicable to a multidisciplinary audience with a robust evidence base that includes randomized trials, systematic reviews, and other guidelines. A CCS is most applicable to situations where the evidence base is insufficient for a clinical practice guideline but for which significant practice variations and quality improvement opportunities exist, primarily for an audience of otolaryngologists. A more detailed comparison of characteristics of guidelines versus consensus statements is shown in the table.

References

  1. Rosenfeld RM, Nnacheta LC, Corrigan MD. Clinical consensus statement development manual. Otolaryngol Head Neck Surg; 2015; 153(Suppl 2S):S1-S14.
  2. Rosenfeld RM, Shiffman RN, Robertson P. Clinical practice guideline development manual, 3rd edition: a quality-driven approach for translating evidence into action. Otolaryngol Head Neck Surg 2013; 148(Suppl 1):S1-S55.