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The first real-world evidence analysis on the impact of the PROPEL family of implants in CRS patients
CMR Publication

The use of PROPEL following sinus surgery may result in payer savings from reduced healthcare resource utilization.

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Patients with chronic rhinosinusitis (CRS) may benefit from postoperative care that reduces inflammation, in order to achieve improved sinus surgery outcomes

CRS is an inflammatory disease with often chronic and debilitating
sinonasal symptoms such as1:

  • Congestion

  • Nasal discharge

  • Facial pain or pressure

  • Loss of smell

Consider the impact. CRS attacks patients from within, causing substantial damage. Patients with CRS report greater bodily pain and impaired social functioning than do those with angina, congestive heart failure, back pain, and chronic obstructive pulmonary disease.2

Ultimately, CRS exacts a tremendous economic impact that burdens healthcare systems and patients3

Direct costs related to CRS:
$10-$13 billion per year in the USA
are primarily driven by outpatient doctor visits, prescription medical therapy, and sinus surgery

Indirect costs related to CRS:
>$20 billion per year in the USA are primarily driven by lost work capabilities

Challenges may hold your patients from
realizing optimal sinus surgery outcomes

Although some patients may achieve symptom control by medical management, others may benefit from endoscopic sinus surgery (ESS).1,4 However, despite optimal surgical technique, postoperative challenges can limit sinus surgery outcomes. Common challenges include5,6:

  • Scarring or stenosis of surgical opening

  • Recurrent inflammation and polyposis

  • Inadequate delivery of topical therapy

MAY PREVENT YOUR PATIENTS FROM ACHIEVING OPTIMAL SINUS SURGERY OUTCOMES11,12

Each sinus has unique challenges during sinus surgery

  • FRONTAL

  • Restenosis is a common challenge, partly due to the anatomically narrow boundaries of the frontal sinus, leading to limited sinusotomy size7
38

reduction in
FSO diameter

Restenosis is observed following frontal sinus surgery independent of polyps. The average diameter of the frontal sinus ostia (FSO) decreased by 38% (3.5 mm vs 5.6 mm) after 13 months, in patients who underwent traditional ESS8

  • ETHMOID

  • A common complication is middle turbinate lateralization (MTL), which may be associated with an increased risk of revision surgery9
25

frequency
of MTL

MTL may occur in as many as 25% of patients who had ESS at ≥6 months follow-up9

more likely to need
revision surgery

21% of patients with MTL required revision surgery vs 9% in patients without MTL9

  • MAXILLARY

  • The causes of sinus surgery failure can be attributed to 3 main reasons. Overall, nearly 1 in 5 patients will require revision surgery10

frequency
of MTL

In a retrospective study conducted over a 5-year period, the top 3 causes for maxillary ESS failure were10:

  1. obstructed natural ostia
  2. disease in the anterior ethmoid or frontal sinus
  3. resistant organisms
Up to
18

more likely to need
revision surgery

It is estimated that between 2% and 18% of maxillary cases require revision surgery10

Overall, postoperative inflammation related to surgery and the underlying disease is hard to predict and can hinder the benefits of surgery. So, safe and effective postoperative care options are needed that effectively deliver corticosteroids to the sinus and minimize reliance on patient compliance

Reducing postoperative inflammation and scarring is essential to help improve long-term patient outcomes and reduce the need for additional interventions11,12

POSTOPERATIVE CARE IMPACTS LONG-TERM OUTCOMES: improvements in quality of life after ESS at 6 months are indicative of results seen at 1.6 years.13

Elevate your postoperative care regimen beyond traditional options

In order to maintain the benefits achieved with surgery, postoperative care regimens are needed that ensure that newly opened sinuses remain open and inflammation is controlled from both the underlying disease and the procedure.4 Common postoperative regimens include4,14:

  • Topical steroid sprays
  • Oral steroids
  • Mechanical spacers ± steroids

Although these regimens have an established role in postoperative care, they do not provide an optimal solution for all patients.

  • Topical steroid sprays15,16

  • Poor penetration into the sinus
  • ~60% of active drug in a metered dose of nasal steroid spray is removed by mucociliary clearance within 15 minutes
  • Poor patient compliance
  • Only 40% patients use intranasal corticosteroids as directed

  • Oral steroids17,18

  • Effective in addressing inflammation but carry systemic risks, such as
  • Hyperglycemia
  • Infections
  • Bone loss
  • Adrenal suppression
  • Ophthalmic complication
  • Gastrointestinal symptoms
  • Psychiatric symptoms

  • Mechanical spacers ± steroids14

  • Obstruction impairs drainage
  • Notable variability in steroid dose
  • Unknown release duration of steroid
  • Painful removal
  • Absence of efficacy/safety data from clinical trials

Historically, there was an unmet need for postoperative care options proven in randomized controlled trials to significantly improve sinus surgery outcomes

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References

  1. Rosenfeld RM, Piccirillo JF, Chandrasekhar SS, et al. Clinical practice guideline (update): adult sinusitis. Otolaryngol Head Neck Surg. 2015; 152(2 suppl):S1-S39.
  2. Gliklich RE, Metson R. The health impact of chronic sinusitis in patients seeking otolaryngologic care. Otolaryngol Head Neck Surg. 1995;113(1):104-109.
  3. Rudmik L. Economics of Chronic Rhinosinusitis. Curr Allergy Asthma Rep. 2017;17(4):20.
  4. Sedaghat AR. Chronic Rhinosinusitis. Am Fam Physician. 2017;96(8):500-506.
  5. Ramadan HH. Surgical causes of failure in endoscopic sinus surgery. Laryngoscope. 1999;109(1):27-29
  6. Otto KJ, DelGaudio JM. Operative findings in the frontal recess at time of revision surgery. Am J Otolaryngol. 2010;31(3):175-180.
  7. Luong A, Ow RA, Singh A, et al. Safety and effectiveness of a bioabsorbable steroid-releasing implant for the paranasal sinus ostia: a randomized clinical trial [published online ahead of print]. JAMA Otolaryngol Head Neck Surg. 2017. doi:10.1001/jamaoto.2017.1859.
  8. Hosemann W, Kühnel T, Held P, et al. Endonasal frontal sinusotomy in surgical management of chronic sinusitis: a critical evaluation. Am J Rhinol. 1997;11(1):1-9.
  9. Bassiouni A, Chen PG, Naidoo Y, Wormald PJ. Clinical significance of middle turbinate lateralization after endoscopic sinus surgery. Laryngoscope. 2015;125(1):36-41.
  10. Richtsmeier WJ. Top 10 reasons for endoscopic maxillary sinus surgery failure. Laryngoscope. 2001;111(11 Pt 1):1952-1956.
  11. Kennedy DW, Wright ED, Goldberg AN. Objective and subjective outcomes in surgery for chronic sinusitis. Laryngoscope. 2000;110(3 Pt 3):29-31.
  12. Kennedy DW. The PROPEL™ steroid-releasing bioabsorbable implant to improve outcomes of sinus surgery. Expert Rev Respir Med. 2012;6(5):493-498.
  13. Soler ZM, Smith TL. Quality-of-life outcomes after endoscopic sinus surgery: how long is long enough? Otolaryngol Head Neck Surg. 2010;143(5):621-625.
  14. Han JK, Marple BF, Smith TL, et al. Effect of steroid-releasing sinus implants on postoperative medical and surgical interventions: an efficacy meta-analysis. Int Forum Allergy Rhinol. 2012;2(4):271-279.
  15. Shah SA, Berger RL, McDermott J, et al. Regional deposition of mometasone furoate nasal spray suspension in humans. Allergy Asthma Proc. 2015;36(1):48-57.
  16. Nabi S, Rotenberg BW, Vukin I, et al. Nasal spray adherence after sinus surgery: problems and predictors. J Otolaryngol Head Neck Surg. 2012;41(suppl 1): S49-S55.
  17. Cope D, Bova R. Steroids in otolaryngology. Laryngoscope. 2008;118(9):1556-1560.
  18. Shen J, Welch K, Kern R. Mometasone furoate sinus implant - a new targeted approach to treating recurrent nasal polyp disease. Expert Rev Clin Pharmacol. 2018;11(12):1163-1170.

The PROPEL sinus implants are intended to maintain patency and locally deliver steroid to the sinus mucosa in patients ≥18 years of age following sinus surgery: PROPEL for the ethmoid sinus, PROPEL Mini for the ethmoid sinus/frontal sinus opening, and PROPEL Contour for the frontal/maxillary sinus ostia. Contraindications include patients with confirmed hypersensitivity or intolerance to mometasone furoate (MF) or hypersensitivity to bioabsorbable polymers. Safety and effectiveness of the implant in pregnant or nursing females have not been studied. Risks may include, but are not limited to, pain/pressure, displacement of the implant, possible side effects of intranasal MF, sinusitis, epistaxis, and infection. For full prescribing information see IFU at www.IntersectENT.com/technologies/. Rx only.

©2022 Intersect ENT, Inc. All rights reserved. Intersect ENT and PROPEL are registered trademarks of Intersect ENT, Inc. in the United States and other countries. MPM-11549 Rev 7.0

The above-identified implants, delivery systems, and/or the use of the above-identified implants/delivery systems in a method may be covered by one or more U.S. and/foreign patents, found at intersectent.com/patents.