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Balloon sinuplasty

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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][better source needed] 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

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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. The entire procedure takes around 31 minutes and if the procedure is successful, the sinus will remain open after the balloon is deflated and removed for up to 24 months.[6]

Research

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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[7][8][9][10][11][12][13][14][15][16]
  • delivers consistent, significant, lasting symptom improvement[7][8][9][10][11][12][14][16]
  • 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[7][8][9][10]
  • can be performed comfortably and effectively under local anesthesia in an office setting[9][10][11][14]

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.[7][8] 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

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The balloon technique is an alternative, less invasive treatment than the traditional functional endoscopic sinus surgery (FESS). 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 fewer 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

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Balloon sinuplasty may not be appropriate for all chronic and recurrent sinusitis patients.[17] Clinical studies have typically excluded patients with:[18]

References

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  1. ^ Hamilos D (2000). "Chronic sinusitis". Journal of Allergy and Clinical Immunology. 106 (2): 213–227. doi:10.1067/mai.2000.109269. PMID 10932063.
  2. ^ Stankiewicz J, et al. (2003). "Cost Analysis in the Diagnosis of Chronic Rhinosinusitis". Am J Rhinol. 17 (3): 139–142. doi:10.1177/194589240301700305. PMID 12862401. S2CID 29456505.
  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. doi:10.1177/194589240201600605. PMID 12512904. S2CID 25271116.
  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. PMID 17283554. S2CID 19376286.
  5. ^ "510(k) Premarket Notification".
  6. ^ Levine, Howard; Rabago, David (March 2011). "Balloon sinuplasty: a minimally invasive option for patients with chronic rhinosinusitis". Postgraduate Medicine. 123 (2): 112–118. doi:10.3810/pgm.2011.03.2269. ISSN 1941-9260. PMID 21474899. S2CID 24841283.
  7. ^ a b c d 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]
  8. ^ a b c d Cutler, Jeffrey; Bikhazi, Nadim; Light, Joshua; Truitt, Theodore; Schwartz, Michael; Armstrong, Michael; Bikhazi, Nadim; Chandler, Stephen; Cutler, Jeffrey; Ferouz-Colborn, Aliya; Gould, James; Light, Joshua; Marvel, Jeffrey; Schwartz, Michael; Truitt, Theodore (2013). "Standalone Balloon Dilation versus Sinus Surgery for Chronic Rhinosinusitis: A Prospective, Multicenter, Randomized, Controlled Trial". American Journal of Rhinology & Allergy. 27 (5): 416–422. doi:10.2500/ajra.2013.27.3970. PMID 23920419. S2CID 7983949.
  9. ^ a b c d Gould, James; Alexander, Ian; Tomkin, Edward; Brodner, David (2014). "In-Office, Multisinus Balloon Dilation: 1-Year Outcomes from a Prospective, Multicenter, Open Label Trial". American Journal of Rhinology & Allergy. 28 (2): 156–163. doi:10.2500/ajra.2014.28.4043. PMID 24598043. S2CID 18054290.
  10. ^ a b c d Levine, Steven B.; Truitt, Theodore; Schwartz, Michael; Atkins, James (2013). "In-Office Stand-Alone Balloon Dilation of Maxillary Sinus Ostia and Ethmoid Infundibula in Adults with Chronic or Recurrent Acute Rhinosinusitis: A Prospective, Multi-Institutional Study with 1-Year Follow-up". Annals of Otology, Rhinology & Laryngology. 122 (11): 665–671. doi:10.1177/000348941312201101. PMID 24358625. S2CID 22717319.
  11. ^ a b c Karanfilov, Boris; Silvers, Stacey; Pasha, Raza; Sikand, Ashley; Shikani, Alan; Sillers, Michael; ORIOS2 Study Investigators (2013). "Office-based balloon sinus dilation: A prospective, multicenter study of 203 patients". International Forum of Allergy & Rhinology. 3 (5): 404–411. doi:10.1002/alr.21112. PMID 23136057. S2CID 25806185.{{cite journal}}: CS1 maint: numeric names: authors list (link)
  12. ^ a b Albritton, Ford D.; Casiano, Roy R.; Sillers, Michael J. (2012). "Feasibility of in-office endoscopic sinus surgery with balloon sinus dilation". American Journal of Rhinology & Allergy. 26 (3): 243–248. doi:10.2500/ajra.2012.26.3763. PMC 3906511. PMID 22449614.
  13. ^ Cutler, Jeffrey; Truitt, Theodore; Atkins, James; Winegar, Bradford; Lanier, Brent; Schaeffer, B. Todd; Raviv, Joseph; Henderson, Diana; Duncavage, James; Stankiewicz, James; Tami, Thomas (2011). "First clinic experience: Patient selection and outcomes for ostial dilation for chronic rhinosinusitis". International Forum of Allergy & Rhinology. 1 (6): 460–465. doi:10.1002/alr.20069. PMID 22144055. S2CID 205337426.
  14. ^ a b c Stankiewicz, James; Truitt, Theodore; Atkins, James; Winegar, Bradford; Cink, Paul; Raviv, Joseph; Henderson, Diana; Tami, Thomas (2012). "Two-year results: Transantral balloon dilation of the ethmoid infundibulum". International Forum of Allergy & Rhinology. 2 (3): 199–206. doi:10.1002/alr.21024. PMID 22337530. S2CID 43539083.
  15. ^ Brodner, David; Nachlas, Nathan; Mock, Presley; Truitt, Theodore; Armstrong, Michael; Pasha, Raza; Jung, Christopher; Atkins, James (2013). "Safety and outcomes following hybrid balloon and balloon-only procedures using a multifunction, multisinus balloon dilation tool". International Forum of Allergy & Rhinology. 3 (8): 652–658. doi:10.1002/alr.21156. PMID 23424023. S2CID 205338004.
  16. ^ a b Weiss, Raymond L.; Church, Christopher A.; Kuhn, Frederick A.; Levine, Howard L.; Sillers, Michael J.; Vaughan, Winston C. (2008). "Long-term outcome analysis of balloon catheter sinusotomy: Two-year follow-up". Otolaryngology–Head and Neck Surgery. 139 (3_suppl_1): S38–S46. doi:10.1016/j.otohns.2008.06.008. PMID 18707993. S2CID 35150946.
  17. ^ Cohen, Alen N. (24 February 2014). "Suitability for Balloon Sinuplasty Procedure". Los Angeles Sinus Surgeon. Archived from the original on 2015-04-14. Retrieved 13 April 2015.
  18. ^ "Safety and Efficacy of Balloon Sinuplasty in Pediatric Sinusitis (INTACT)". ClinicalTrials.gov. 10 July 2012. Retrieved 13 April 2015.

Further reading

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