Introduction to balloon sinus dilation

Chronic and recurrent sinusitis is a highly symptomatic condition caused by inflammation and sinus infections secondary to obstructed sinus drainage.  Following medical management, a patient who continues to be symptomatic and has a nasal endoscopy of the middle meatus or a CT scan showing evidence of significant inflammation and heavy purulent drainage may be considered as a candidate for Functional Endoscopic Sinus Surgery (FESS).  This surgery is designed to open narrowed sinus drainage paths, improve mucus transport, and relieve symptoms.

The introduction of balloon sinus dilation of sinus ostia has provided new options to physicians and their patients. Like standard endoscopic sinus surgery, balloon sinus dilation durably opens the narrowed drainage pathways. Balloon sinus dilation is sometime used in conjunction with FESS (a “hybrid” procedure), but is also employed as the sole therapeutic tool to open sinus drainage paths (balloon only).

Balloon sinus dilation clinical study highlights

Since 2005, over 30 studies have been published regarding the use of balloon sinus dilation to treat sinustis. This growing body of evidence has examined the clinical safety, efficacy, and tolerability of balloons when used as standalone procedures or as tools as part of hybrid procedures with traditional sinus surgery.

To view a more complete bibliography of balloon sinus dilation literature, visit our Clinical Library page.

Symptoms improvement

Patient symptoms improved significantly after balloon sinus dilation. SNOT-20 quality of life scores were better than pre-treatment at 3M, 6M, 12M and 24M. This is true for both hybrid and balloon only studies.^1,2

To review sample BREATHE I case studies, click here.

Productivity improvement 

Balloon only sinus treatment significantly reduced absenteeism, presenteeism, activity impairment, and work limitations at 3M, 6M, and 12M following treatment. At 12M follow-up, lost productivity at work as measured by two surveys was reduced by 73% and 76% compared to pre-treatment.³

Durability

The durability of outcomes seen with balloon dilation is consistent with sinus surgery literature that showed quality of life scores at 5 months post procedure and are predictive of long term outcomes to 20 months.⁴

Sinus ostial patency 12 months after treatment was 99% in 174 sinus ostia observable by endoscope. For sinus ostia not observable by endoscope, CT scans were used to determine functional patency resulting in 92% of 202 sinus ostia that were functionally patent.⁵ Although ostial patency is not correlated to symptoms, these data demonstrate the durability of balloon dilation at opening sinus drainage paths.

The durability of sinus ostial dilation is demonstrated by SNOT-20 quality of life scores and surgical revision rates.

• SNOT-20 scores at 24M follow-up remained significantly improved from pre-treatment and not different than scores at 6M and 12M.²

• Surgical revision rates for endoscopic sinus surgery range from 7% to 12%. Revision rates following balloon sinus dilation were 2.4%, 4.2% and 9.2% in the Registry, BREATH I, and CLEAR studies.^1,2,6

Complication rates

No serious adverse events attributed to balloon dilation have been reported in the five clinical studies involving 1,200 patients. Two CSF leaks associated with hybrid procedures and standard surgical cutting tools were reported.^6-10 

Summary 

Balloon sinus dilation has been proven in numerous multi-center studies and comparative studies to be highly safe, consistently efficacious out to two year follow-up, and to have low rates of repeat surgery.

Society policy statements for the role of balloon sinus dilation in the treament of sinusitis

Both the American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNS) and the American Rhinologic Society (ARS) have released policy statements affirming the role of balloon sinus dilation in the treatment of select patients with sinusitis.

Click here to view the AAO-HNS balloon dilation policy statement.

Click here to view the ARS balloon dilation policy statement.

References

¹ One-year results: Transantral balloon dilation of the ethmoid infundibulum.
Stankiewicz J, Truitt T, Atkins J. Ear Nose and Throat J. 2010 Feb; 72-77. View abstract.

² Long term outcome analysis of balloon catheter sinusotomy: two-year follow-up
Weiss RL, Church CA, Kuhn FA, Levine HL, Sillers MJ, Vaughan WC. Oto-Head and Neck Surg. 2008 Sep; 139(3 Suppl 3); S38-S46. View Abstract.

³ Impact of chronic rhinosinusitis on work productivity through one-year follow-up after balloon dilation of the ethmoid infundibulum.
Stankiewicz, J, Tami, T, Truitt, T, Atkins, J, Winegar, B, Cink, P, Schaeffer, B T, Raviv, J, Henderson, D, Duncavage, J and Hagaman, D. International Forum of Allergy & Rhinology, 2011 1: 38–45. View abstract.

⁴ Quality of life outcomes after endoscopic sinus surgery: How long is enough?
Soler, ZM, Smith, TL. Otolaryngol Head Neck Surg 2010; 143; 621-625. View abstract.

⁵ Balloon catheter sinusotomy: one-year follow-up—outcomes and role in functional endoscopic sinus surgery
Kuhn FA, Church CA, Goldberg AN, Levine HL, Sillers MJ, Vaughan WC, Weiss RL. Oto-Head & Neck Surg. 2008Sep; 139(3 Suppl #); S27-S37. View Abstract.

⁶ Multicenter registry of balloon catheter sinusotomy outcomes for 1,036 patients.
Levine HL, Sretich II AP, Hoisington DR, Weiss RL, Pritikin J. Ann Otol Rhinol Laryngol. 2009 Apr; 117(4); 263-270. View Abstract.

⁷ Safety and outcomes of balloon catheter sinusotomy: a multicenter 24-week analysis in 115 patients.
Bolger WE, Brown CL, Church CA, Goldberg AN, Karanfilov B, Kuhn FA, Levine HL, Sillers MJ, Vaughan WC, Weiss RL. Oto-Hean & Neck Surg. 2007 Jul; 137(1); 10-20. View Abstract.

⁸ First clinic experience--Patient selection and outcomes for ostial dilation for CRS.
Cutler, J, Truitt T, Atkins J, Winegar B, Lanier B, Schaeffer BT, Raviv J, Henderson D, Duncavage J, Stankiewicz J, Tami T. Submitted and under review for publication in Int Forum Allergy Rhinol.

⁹ Functional endoscopic dilation of the sinuses: patient satisfaction, postoperative pain, and cost.
Freidman M, Schlach P, Lin HC, Mazloom N, Neidrich M, Joseph NJ. Am J of Rhinology. 2008 Mar-Apr; 22(2); 204-209. View Abstract.

¹⁰ Balloon dilation of the frontal recesses: A randomized study.
Plaza, G. Poster 2010 AAO OTO & Expo (SP503).