Balloon sinuplasty

Balloon sinuplasty is a procedure that ear, nose and throat surgeons may use for the treatment of blocked sinuses. Patients diagnosed with sinusitis but not responding to medications may be candidates for sinus surgery.^[1][2][3][4] Balloon technology was initially cleared by the U.S. Food and Drug Administration^[5] in 2005 and is an endoscopic, catheter-based system for chronic sinusitis. It uses a balloon over a wire catheter to dilate sinus passageways. The balloon is inflated with the goal of dilating the sinus openings, widening the walls of the sinus passageway and restoring normal drainage.

Overview

Sinus surgery with balloons may be performed in a hospital, outpatient surgery setting or in the physician’s office under local anesthesia. The physician inserts a guide catheter through the nostril and near the sinus opening under endoscopic visualization. A flexible guide wire is then introduced into the targeted sinus to confirm access. Most guide wires have a light on the tip which may produce light transmission seen through the skin to help the physician with correct placement of the guide wire. Once access to a blocked sinus is confirmed, a balloon catheter is advanced over the guide wire and positioned in the blocked sinus opening for inflation. The balloon is inflated. If the procedure is successful, the sinus will remain open after the balloon is deflated and removed as the bone surrounding the sinus is permanently remodeled.

Research

Since the initial introduction of sinus dilation, a number of clinical studies have explored its safety, effectiveness, durability, and patient benefits. Data from these studies show that, for appropriate patients, sinus dilation:

• is extraordinarily safe—0.1% complication rate across 8 studies representing approximately 900 patients^{[6][7][8][9][10][11][12][13][14][15]}
• delivers consistent, significant, lasting symptom improvement^{[16][17][18][19][20][21][22][23]}
• is effective for treatment of patients with chronic or recurrent sinusitis, patients with frontal, maxillary and sphenoid disease, and patients with or without allergies, asthma, septal deviations, and previous surgery^{[24][25][26][27]}
• can be performed comfortably and effectively under local anesthesia in an office setting^{[28][29][30][31]}

To better understand sinus dilation’s role in treatment, many physicians sought a direct comparison of balloon sinus dilation to the current standard of care, functional endoscopic sinus surgery. Outcomes from the first prospective, multi-center, randomized controlled trial with sufficient statistical power to compare sinus dilation to functional endoscopic sinus surgery were published in the American Journal of Rhinology & Allergy in 2013 and 2014. Data from the study shows that balloon sinus dilation is as effective as functional sinus surgery, and delivers a better patient recovery experience.^[32][33] Balloon and surgical patients experienced a similar, significant level of:

• symptom improvement
• decline in number of rhinosinusitis episodes requiring medication in year after treatment
• improvements in work productivity and activity level

Patients who had balloon sinus dilation experienced a much quicker recovery, less bleeding, and less need for prescription pain medication. Overall, data from these studies address key clinical questions, and affirm sinus dilation’s role as an alternative to traditional surgery.

Benefits

The balloon technique is an alternative, less invasive treatment than the traditional Functional Endoscopic Sinus Surgery. The sinuses are dilated with a balloon instead of using metal instruments to cut and remove tissue to increase the openings. Because of less risk and less complications, balloon sinuplasty can be performed in the office under local anesthesia. This opens up an avenue of treatment for patients with sinus disease who otherwise would not be candidates for surgery secondary to age, health conditions, previous reactions to general anesthesia, or fear of "going under". For the right patient, this procedure can have the same degree of impact on reduction of symptoms as the formal surgery.

Limitations

Balloon sinuplasty may not be appropriate for all chronic and recurrent sinusitis patients.^[34] Clinical studies have typically excluded patients with:^[35]

• Eosinophilic disease
• severe polyposis or fungal sinusitis
• severe septal deviation
• cystic fibrosis
• Samter's triad
• facial trauma

References

1. Hamilos D (2000). "Chronic sinusitis". Allergy Clin Immunol 106: 213–227. doi:10.1067/mai.2000.109269.
2. Stankiewicz J, et al. (2003). "Cost Analysis in the Diagnosis of Chronic Rhinosinusitis". Am J Rhinol 17 (3): 139–142.
3. Subramnanian H, et al. (2002). "A Retrospective Analysis of Treatment Outcomes and Time to Relapse after Intensive Medical Treatment for Chronic Sinusitis". Am J Rhinol 16 (6): 303–312.
4. Hessler J, et al. (2007). "Clinical outcomes of chronic rhinosinusitis in response to medical therapy: Results of a prospective study". Am J Rhinol 21 (1): 10–18. doi:10.2500/ajr.2007.21.2960.
5. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm
6. Bikhazi, N. et al; Standalone balloon dilation versus sinus surgery for chronic rhinosinusitis: A prospective, multicenter, randomized, controlled trial with 1-year follow-up, Am J Rhinol Allergy 2014; May 20 [Epub ahead of print]
7. Cutler, J. et al; Standalone balloon dilation versus sinus surgery for chronic rhinosinusitis: A prospective, multicenter, randomized, controlled trial, Am J Rhinol Allergy 2013; 27(5): 416-422
8. Gould, J. et al; In-office, multisinus balloon dilation: 1-Year outcomes from a prospective, multicenter, open label trial, Am J Rhinol Allergy 2014; 28(2): 156-163
9. Levin, S. et al; In-office stand-alone balloon dilation of maxillary sinus ostia ethmoid infundibula in adults with chronic or recurrent acute rhinosinusitis: A prospective, multi-institutional study with 1-year follow-up, Ann Otol Rhinol Laryngol 2013; 122(11): 665-671
10. Karanfilov, B. et al; Office-based balloon sinus dilation: a prospective, multicenter study of 203 patients, Int Forum Allergy Rhinol 2013; 3(5): 404-411
11. Albritton, FD. Et al; Feasibility of in-office endoscopic sinus surgery with balloon sinus dilation, Am J Rhinol Allergy 2012; 26(3): 243-8
12. Cutler, J. et al; First clinic experience: patient selection and outcomes for ostial dilation for chronic rhinosinusitis, Intl Forum Allergy Rhinol 2011; 1(6): 460-465
13. Stankiewicz, J. et al; Two-year results: transantral balloon dilation of the ethmoid infundibulum, Intl Forum Allergy Rhinol 2012; 2(3): 199-206
14. Brodner, D. et al; Safety and outcomes following hybrid balloon and balloon-only procedures using a multifunctional, multisinus balloon dilation tool, Intl Forum Allergy & Rhinol 2013; 3(8): 652-658
15. Weiss, RL. et al; Long term outcome analysis of balloon catheter sinusotomy: two-year follow-up, Oto-Head and Neck Surg 2008; 139(3 Suppl 3); S38-S46
16. Bikhazi, N. et al; Standalone balloon dilation versus sinus surgery for chronic rhinosinusitis: A prospective, multicenter, randomized, controlled trial with 1-year follow-up, Am J Rhinol Allergy 2014; May 20 [Epub ahead of print]
17. Cutler, J. et al; Standalone balloon dilation versus sinus surgery for chronic rhinosinusitis: A prospective, multicenter, randomized, controlled trial, Am J Rhinol Allergy 2013; 27(5): 416-422
18. Gould, J. et al; In-office, multisinus balloon dilation: 1-Year outcomes from a prospective, multicenter, open label trial, Am J Rhinol Allergy 2014; 28(2): 156-163
19. Levin, S. et al; In-office stand-alone balloon dilation of maxillary sinus ostia ethmoid infundibula in adults with chronic or recurrent acute rhinosinusitis: A prospective, multi-institutional study with 1-year follow-up, Ann Otol Rhinol Laryngol 2013; 122(11): 665-671
20. Karanfilov, B. et al; Office-based balloon sinus dilation: a prospective, multicenter study of 203 patients, Int Forum Allergy Rhinol 2013; 3(5): 404-411
21. Albritton, FD. Et al; Feasibility of in-office endoscopic sinus surgery with balloon sinus dilation, Am J Rhinol Allergy 2012; 26(3): 243-8
22. Stankiewicz, J. et al; Two-year results: transantral balloon dilation of the ethmoid infundibulum, Intl Forum Allergy Rhinol 2012; 2(3): 199-206
23. Weiss, RL. et al; Long term outcome analysis of balloon catheter sinusotomy: two-year follow-up, Oto-Head and Neck Surg 2008; 139(3 Suppl 3); S38-S46
24. Bikhazi, N. et al; Standalone balloon dilation versus sinus surgery for chronic rhinosinusitis: A prospective, multicenter, randomized, controlled trial with 1-year follow-up, Am J Rhinol Allergy 2014; May 20 [Epub ahead of print]
25. Cutler, J. et al; Standalone balloon dilation versus sinus surgery for chronic rhinosinusitis: A prospective, multicenter, randomized, controlled trial, Am J Rhinol Allergy 2013; 27(5): 416-422
26. Gould, J. et al; In-office, multisinus balloon dilation: 1-Year outcomes from a prospective, multicenter, open label trial, Am J Rhinol Allergy 2014; 28(2): 156-163
27. Levin, S. et al; In-office stand-alone balloon dilation of maxillary sinus ostia ethmoid infundibula in adults with chronic or recurrent acute rhinosinusitis: A prospective, multi-institutional study with 1-year follow-up, Ann Otol Rhinol Laryngol 2013; 122(11): 665-671
28. Gould, J. et al; In-office, multisinus balloon dilation: 1-Year outcomes from a prospective, multicenter, open label trial, Am J Rhinol Allergy 2014; 28(2): 156-163
29. Levin, S. et al; In-office stand-alone balloon dilation of maxillary sinus ostia ethmoid infundibula in adults with chronic or recurrent acute rhinosinusitis: A prospective, multi-institutional study with 1-year follow-up, Ann Otol Rhinol Laryngol 2013; 122(11): 665-671
30. Karanfilov, B. et al; Office-based balloon sinus dilation: a prospective, multicenter study of 203 patients, Int Forum Allergy Rhinol 2013; 3(5): 404-411
31. Stankiewicz, J. et al; Two-year results: transantral balloon dilation of the ethmoid infundibulum, Intl Forum Allergy Rhinol 2012; 2(3): 199-206
32. Bikhazi, N. et al; Standalone balloon dilation versus sinus surgery for chronic rhinosinusitis: A prospective, multicenter, randomized, controlled trial with 1-year follow-up, Am J Rhinol Allergy 2014; May 20 [Epub ahead of print]
33. Cutler, J. et al; Standalone balloon dilation versus sinus surgery for chronic rhinosinusitis: A prospective, multicenter, randomized, controlled trial, Am J Rhinol Allergy 2013; 27(5): 416-422
34. Cohen, Alen N. (24 February 2014). "Suitability for Balloon Sinuplasty Procedure". Los Angeles Sinus Surgeon. Retrieved 13 April 2015.
35. "Safety and Efficacy of Balloon Sinuplasty in Pediatric Sinusitis (INTACT)". ClinicalTrials.gov. 10 July 2012. Retrieved 13 April 2015.

Further reading

• Brown CL, et al. (2006). "Safety and Feasibility of Balloon Catheter Dilation of Paranasal Sinus Ostia: A Preliminary Investigation;". Annals of Otology, Rhinology & Laryngology 115 (4): 293–299. doi:10.1177/000348940611500407.
• Bolger WE, et al. (2006). "Catheter Based Dilation of the Sinus Ostia: Initial Safety and Feasibility Analysis in a Cadaver Model;". American Journal of Rhinology 20 (3): 290–294. doi:10.2500/ajr.2006.20.2868.
• Karanfilov B, et al. (2013). "Office-based balloon sinus dilation: a prospective, multicenter study of 203 patients". Int Forum Allergy Rhinol 3: 404–411. doi:10.1002/alr.21112.