Chronic Rhinosinusitis

SINUSITIS SYMPTOMS

Sinus Cavity

Sinusitis occurs when the sinus cavities are unable to properly drain mucus, which results in an inflammation of the sinus cavity. The disease is primarily classified into three types: acute, recurrent and chronic.

  • Acute sinusitis lasts less than four weeks and is often caused by excess or thick mucus. In general, acute sinusitis is treated with medical management.
  • Recurrent acute sinusitis is characterized by more than four episodes of acute sinusitis per year.
  • Chronic sinusitis is the most severe form of sinusitis and lasts more than 12 weeks per year. Otolaryngologists further classify their chronic sinusitis patients into those with nasal polyps and those without nasal polyps.

In addition, there are additional sinus conditions, including:

  • Barosinusitis: a swelling or inflammation of the lining of one or more of the sinuses due to a change in air pressure.
  • Sinogenic headache (also known as sinus headache): persistent or recurring headaches as a result of mucosal contact points within the nasal cavity.

PATIENT POPULATION

Highly Prevalent Disease

Chronic sinusitis is one of the most prevalent chronic conditions among adults in the U.S. The prevalence rates vary by source from approximately 5%-15% of the adult population. The Centers for Disease Control (CDC) estimates that chronic sinusitis occurs in approximately 12% of the U.S. adult (18 years and older) population. In 2015, there were an estimated 29 million adult chronic sinusitis patients in the U.S.

There were approximately six million pediatric chronic sinusitis patients in the U.S. in 2015. While some clinicians believe pediatric chronic sinusitis patients should be left untreated, clinical studies have shown that pediatric patients with chronic sinusitis have a significantly reduced quality of life as compared to selected other diseases.

TREATMENT OPTIONS

The Treatment Continuum

Many chronic sinusitis patients progress slowly through the treatment continuum. When symptoms first present, patients often seek care from their primary care physician or PCP. These physicians typically prescribe or recommend over the counter (OTC) medications, such as decongestants, nasal and systemic steroids, mucolytics and irrigation.

As symptoms persist and possibly worsen, patients are often referred to more specialized physicians, such as otolaryngologists and/or allergists, who are then able to diagnose chronic sinusitis via endoscopic imaging.

Flow Chart

Following multiple rounds of medication, it is estimated that approximately 60% of patients remain symptomatic and may be optimal candidates for a more invasive treatment option.

Functional Endoscopic Sinus Surgery (FESS) – The Standard of Surgical Care

Functional endoscopic sinus surgery (FESS) is the preferred surgical treatment option for chronic sinusitis patients. FESS is traditionally performed in a hospital operating room and involves the removal of the inflamed sinus tissue, as well as the underlying bone to open the nasal pathway and enlarge the sinus ostia. The surgeon can also perform additional procedures if needed to treat nasal deformities or to gain access to the sinuses.

 The three most common sinus surgery procedures include ethmoidectomy, maxillary antrostomy and powered septoplasty with turbinoplasty.

  • Ethmoidectomy: aids in clearing the ethmoid sinuses.
  • Maxillary antrostomy: enables the maxillary sinuses to drain more efficiently and effectively.
  • Powered septoplasty with turbinoplasty: involves the clearing of breathing difficulties caused by a deviated or displaced nasal septum that causes one nasal passage to be smaller than the other or enlarged turbinates, which clean and humidify the air as it transitions from the nose to the lungs.

When the surgical procedure is complete, the surgeon fills the nasal cavity with packing materials that aid in preventing surgical adhesions and controlling bleeding. In addition, patients often require at least one (if not multiple) follow-up visits for debridement, whereby the surgeon removes damaged tissue from the body.

Some Drawbacks to Surgery Remain

While FESS is the standard of care in the surgical treatment of chronic sinusitis, it does carry a host of risks and selected drawbacks.

Selected Drawbacks, Traditional Sinus Surgery (FESS)
  • Irreversible changes to the patient’s underlying anatomy.
  • Post-operative pain and discomfort, including that of follow-up debridement procedures.
  • Recovery time of approximately 2-3 days.
  • General anesthesia risks, such as excessive bleeding and intraorbital complications.
  • Surgical complications, including eye swelling or blindness (though quite rare, occurring in approximately 1% of all FESS procedures).

 

Source: Company Data, Deutsche Bank

In addition, while sinus surgery is effective in the majority of patients, it is estimated that approximately 10% of FESS patients will require revision surgery with more than 60% of patients experiencing recurrent symptoms within the first year of the FESS procedure.

Balloon Sinus Dilation (BSD) - A Minimally Invasive Approach

Balloon sinus dilation was introduced in 2005 as a minimally invasive alternative to functional endoscopic sinus surgery (FESS) in patients with chronic sinusitis.

Balloon sinus dilation can be used to treat the maxillary, frontal and sphenoid sinuses but not the ethmoid sinuses. The procedure uses a balloon catheter to remodel and widen the sinus passageway and generally takes approximately one hour.

Procedure Chart

The Hybrid Surgical Treatment Option (HYBRID) – A Customized Approach

“The primary goal of endoscopic sinus surgery is relieving obstruction and re-establishing sinus ventilation and drainage. This is a generally accepted surgical principle that applies to all of the paranasal sinuses regardless of what instrumentation is utilized.”

From: The American Academy of Otolaryngology (AAO) - http://www.entnet.org/content/practice-management-tool

 

The Hybrid Surgical Treatment Option involves both Functional Endoscopic Sinus Surgery (FESS) and Balloon Sinus Dilation (BSD) procedures. This surgical approach is utilized to achieve optimum outcomes for many chronic rhinosinusitis patients. Some extensive sinus conditions cannot be fully managed by either FESS or BSD procedures exclusively making a hybrid approach more beneficial. By using both modalities, a customized surgical intervention for each affected sinus can be utilized.

chart

The SinusleeveTM Balloon for Hybrid Procedures

The Sinusleeve Balloon with other manual ENT surgical instruments

The SinusleeveTM Balloon is intended to be used with commonly used ENT instruments to dilate the sinus ostia and spaces within the maxillary, frontal and sphenoid paranasal sinus cavities. The SinusleeveTM Balloon is compatible with commonly used suction instruments, including instruments with the latest image guided navigation capability.

There are many advantages to using the SinusleeveTM Balloon during hybrid procedures.

  • Adapts common surgical instruments for balloon dilation
  • Performs dual functions simultaneously
  • Provides surgeon with surgical options
  • Provides adequate reach for optimum positioning
  • Versatile to use as situation demands

The Sinusleeve Baloon Placed on a suction instrument for balloon dilation

Source Below: The American Academy of Otolaryngology (AAO)

Sinus ostial dilation (e.g. balloon ostial dilation) is a therapeutic option for selected patients with chronic rhinosinusitis (CRS) and recurrent acute rhinosinusitis (RARS) who have failed appropriate medical therapy. Clinical diagnosis of CRS and RARS should be based on symptoms of sinusitis and supported by nasal endoscopy documenting sinonasal abnormality or mucosal thickening on computed tomography of the paranasal sinuses. This approach may be used alone to dilate an obstructed sinus ostium (frontal, maxillary, or sphenoid) or in conjunction with other instruments (eg, microdebrider, forceps). The final decision regarding use of techniques or instrumentation for sinus surgery is the responsibility of the attending surgeon.

References

  1. Achar P., Duvvi S. & Kumar B.N. Endoscopic dilatation sinus surgery (FEDS) versus functional endoscopic sinus surgery (FESS) for treatment of chronic rhinosinusitis: a pilot study. Acta Otorhinolaryngol Ital. 2012; 32, 314-319. 
  2. Atkins J, Truitt T. In-office balloon dilation of the ethmoid infundibulum. Operative Techniques in Otolaryngology. 2010; 21:102-106.
  3. 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 All. 2014;28:323-9. 
  4. Bolger  WE, Brown CL, Church CA, et al. Safety and outcomes of balloon catheter sinusotomy: a multicenter 24-week analysis in 115 patients. Otolaryngol Head Neck Surg. 2007; 137(1):10-20. 
  5. Brodner D, Nachlas N, Mock P, et al. Safety and outcomes following hybrid balloon and balloon-only procedures using a multifunction, multisinus balloon dilation tool. Int Forum Allergy Rhinol. 2013 Aug;3(8):652-8. 
  6. Brown CL, Bolger WE.  Safety and feasibility of balloon catheter dilation of paranasal sinus ostia: a preliminary investigation. Ann Otol Rhinol Laryngol. 2006; 115(4):293-299. Sep;27(5):416-22. doi: 10.2500/ajra.2013.27.3970. Epub 2013 Aug 5.
  7. Chandra, RK, Kern, RC, Cutler, JL, Welch, KC and Russell, PT (2015). REMODEL larger cohort with long-term outcomes and meta-analysis of standalone balloon dilation studies. The Laryngoscope. doi: 10.1002/lary.25507
  8. Christmas DA, Mirante JP, Yanagisawa E.  Endoscopic view of balloon catheter dilation of sinus ostia (balloon sinuplasty). Ear Nose Throat J. 2006; 85(11): 698, 700. 
  9. Cutler J., Bikhazi N., Light J., Truitt T., Schwartz M. & Investigators A.T. Standalone balloon dilation versus sinus surgery for chronic rhinosinusitis: A prospective, multicenter, randomized, controlled trial. Am J Rhinol Allergy. 2013. Sep;27(5):416-22. doi: 10.2500/ajra.2013.27.3970. Epub 2013 Aug 5.
  10. Fokkens W et al. European Position Paper on Rhinosinusitis and Nasal Polyps 2012   
  11. Friedman M, Schalch P, Lin HC, et al. Functional endoscopic dilatation of the sinuses: patient satisfaction, postoperative pain, and cost. Am J Rhinol. 2008; 22(2):204-209.
  12. Gould J et al. In-office, multisinus balloon dilation: 1-Year outcomes from a prospective, multicenter, open label trial. Am J Rhinol All. 2014;2:156-63.
  13. Hathorn et al. Randomized controlled trial: hybrid technique using balloon dilation of the frontal sinus drainage pathway. Int Forum Allergy Rhinol. 2015;5:167-73. 
  14. Karanfilov B, Silvers S, Pasha R, et al. Office-based balloon sinus dilation: a prospective, multicenter study of 203 patients. Int Forum Allergy Rhinol. 2013; 3(5):404-411. 
  15. Kuhn FA, Church CA, Goldberg AN, et al. Balloon catheter sinusotomy: one-year follow-up--outcomes and role in functional endoscopic sinus surgery. Otolaryngol Head Neck Surg. 2008; 139(3 Suppl 3):S27-37. 
  16. Levine HL, Sertich AP 2nd, Hoisington DR, et al.; PatiENT Registry Study Group. Multicenter registry of balloon catheter sinusotomy outcomes for 1,036 patients. Ann Otol Rhinol Laryngol. 2008; 117(4):263-270. 
  17. Levine SB, Truitt T, Schwartz M, Atkins J. 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. Ann Otol Rhinol Laryngol 2013;122:665-671.
  18. Levy et al. Paranasal Sinus Balloon Catheter Dilation for Treatment of Chronic Rhinosinusitis: A Systematic Review and Meta-analysis. Otolaryngol Head Neck Surg. 2016;154:33-40.
  19. Orlandi R et al. International Consensus Statement of Rhinosinusitis. Int For Allergy Rhinology
  20. Payne SC et al. Medical therapy versus sinus surgery by using balloon sinus dilation technology: A prospective multicenter study. Am J Rhinol All. 2016;30:279-86. 
  21. Plaza G, Eisenberg G, Montojo J, Onrubia T, Urbasos M, O'Connor C. Balloon dilation of the frontal recess: a randomized clinical trial. Ann Otol Rhinol Laryngol. 2011. Aug;120 (8):511-8.
  22. Prince A and Bhattacharyya N. An Analysis of Adverse Event Reporting in Balloon Sinus Procedures. Otolaryngol Head Neck Surg. 2016;154:748-53
  23. Ramadan HH, McLaughlin K, Josephson G, et al. Balloon catheter sinuplasty in young children. Am J Rhinol Allergy. 2010; 24(1):e54-56.
  24. Rudmik L et al. Defining appropriateness criteria for endoscopic sinus surgery during management of uncomplicated adult chronic rhinosinusitis: a RAND/UCLA appropriateness study. Int For Allergy Rhinology
  25. Sikand et al. Office-Based Balloon Sinus Dilation: 1-Year Follow-up of a Prospective, Multicenter Study. Ann Otol Rhinol Laryngol. 2015;124:630-7.
  26. Sillers MJ et al. In-office balloon catheter dilation: analysis of 628 patients from an administrative claims database. Laryngoscope. 2015;125:42-8 
  27. Soler ZM, Smith TL. Quality-of-life outcomes after endoscopic sinus surgery: how long is long enough? Otolaryngol Head Neck Surg. 2010; 143:621-5. 
  28. Stankiewicz J, Tami T, Truitt T, et al. Impact of chronic rhinosinusitis on work productivity through one-year follow-up after balloon dilation of the ethmoid infundibulum. Int Forum Allergy Rhinol. 2011 Jan-Feb; 1 (1): 38-45. 
  29. Stankiewicz J, Tami Y, Truitt T. et al. Transantral, endoscopically guided balloon dilatation of the ostiomeatal complex for chronic rhinosinusitis under local anesthesia. Am J Rhinol Allergy. 2009; 23(3):321-327. 
  30. Stankiewicz J, Truitt T, Atkins J, et al. Two-year results: transantral balloon dilation of the ethmoid infundibulum. Int Forum Allergy Rhinol. 2012; 2:199-206. 
  31. Tomazic PV, Stammberger H, Braun H, et al. Feasibility of balloon sinuplasty in patients with chronic rhinosinusitis: the Graz experience. Rhinology. 2013; Jun;51(2):120-7. 
  32. Vaughn WC. Review of balloon sinuplasty. Curr Opin Otolaryngol Head Neck Surg. 2008; 16:2-9.
  33. Wang et al. Sinus balloon catheter dilation in pediatric chronic rhinosinusitis resistant to medical therapy. JAMA Otolaryngol Head Neck Surg. 2015; 141:526-31. 
  34. Weiss RL, Church CA, Kuhn FA, et al. Long-term outcome analysis of balloon catheter sinusotomy: two-year follow-up. Otolaryngol Head Neck Surg. 2008; 139(3 Suppl 3):S38-46. 
  35. Wittkopf ML. Becker SS. Duncavage JA. Russell PT. Balloon sinuplasty for the surgical management of immunocompromised and critically ill patients with acute rhinosinusitis. Oto – Head & Neck Surg. 2009 Apr; 140(4); 596-598.

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