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] 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.

The Procedure[edit]

Sinus surgery with balloons may be performed in a hospital, outpatient surgery setting or in the physician’s office under local anesthesia. The surgeon and patient will determine the ideal site and anesthesia type for the procedure based on the patient's medical history, surgical need and preferences. 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.

Research[edit]

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.

Patients Not Best Suited for Standalone Balloon Sinuplasty[edit]

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

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

Proposed Benefits[edit]

The balloon technique is touted[citation needed] as a "less invasive" treatment than the traditional Functional Endoscopic Sinus Surgery because tissue is not removed, only dilated. This point is emphasized in direct-to-consumer advertising campaigns[citation needed] hoping that patients will be less frightened and more likely to consent to surgery, and may have a speedier recovery.[citation needed]

Limitations of Balloon Procedures[edit]

The supposed benefit of balloon surgery in not removing tissue is also its greatest limitation.[citation needed] In fact, functional endoscopic sinus surgery (FESS) has always been minimally invasive.[citation needed] Patient discomfort associated with "sinus surgery" is most often due to other procedures performed simultaneously with surgery on the sinuses such as straightening the inside of the nose.[relevant? ] The risks for balloon sinuplasty are vastly different from traditional endoscopic sinus surgery. Since there is no cutting involved with the balloon sinuplasty, serious risks to the eye and brain are not seen. The risks are published at less than 0.01% for the balloon sinuplasty vs 3.4% via a traditional FESS. While balloon sinuplasty serves a population of patients with favorable anatomy, the traditional FESS still remains the gold standard for treatment of sinus disease in the specialty.[citation needed]

Biopsy of pathological material (examining the diseased tissue under the microscope)and culture for possible disease-causing microorganisms (attempting to isolate organisms in an incubator)are hallmarks of the diagnostic and treatment process for any patient with a significant problem that requires intervention.[citation needed] During a balloon procedure, there is little to no ability to biopsy tissue however cultures are easily obtained and flushing or irrigating infected sinuses can easily be performed once the sinus is dilated.[clarification needed]

The patients who most need sinus intervention, patients with polyps in their nose, cannot be adequately treated with balloons.[citation needed]

The ethmoid sinuses, which are the frequently diseased areas between the eyes, cannot be treated with balloons since there is not a single osteon to easily target. Studies have shown that 85% of patients who suffer with ethmoid disease will improve when the diseased frontal and maxillary sinuses are dilated.[citation needed]

Controversy[edit]

The ability of a balloon to enter a truly blocked sinus (i.e. a patient who actually needs surgery)[citation needed] is dependent on the skill, experience and expertise of the surgeon. Once past the learning curve, the balloon sinuplasty is routinely performed in minutes. If a sinus balloon will enter the sinus without removing tissue, did the patient truly need sinus surgery?.[citation needed] This is a decision made by the patient and the doctor in a cooperative fashion. The diagnosis of chronic or recurrent acute sinusitis needs to be established by following well established criteria and the patient needs to be treated with maximal medical therapy. If the patient fails treatment then he/she becomes a candidate if their anatomy shows the need for outflow tract dilation.

The ability to confirm localization of the flexible guide wire in a sinus that is diseased may be challenging but since the insertion devices have easy means of adjustment, the entry is usually accomplished quickly. Some balloon procedures use fluoroscopic guidance that results in significant X-ray exposure to the patient however this technology is now considered obsolete with the transillumination technique so radiation exposure now is eliminated.

The ability of any third party payer to confirm that an effective dilation was performed is nil, but the SNOT-20 outcomes data routinely shows significant patient improvement and satisfaction well after the procedure has been performed. Since Medicare establishes the CPT fees for each surgical procedure, billing the codes accurately remains at the discretion of the surgeon.

Since no tissue is removed, the potential for bleeding and scarring is much less than with true endoscopic sinus surgery.

Hybrid procedures: so-called "hybrid procedures" use traditional techniques in the operating room in addition to a balloon catheter. This has been encouraged by the manufacturers of the equipment (presumably to increase unit sales) but is controversial because there is little to nothing that could potentially be accomplished with a balloon that cannot be accomplished without one. A hybrid procedure is believed by many surgeons to increase operating time and expense without providing additional benefit. Another opinion, Hybrid procedures allow the surgeon to assure that any supra orbital sinus cells have been adequately treated in the frontal area without added risk to injure the eyes or violate the delicate bone separating the brain from the nose. It is another tool in the toolbox. Carpenters use different saws and mechanics use different screw drivers but each accomplishes similar tasks. Surgeons happily accept another tool to fix the problem.

Reimbursement: Manufacturers of balloon products have successfully lobbied third party payers to pay significantly more for balloon procedures than for traditional endoscopic sinus surgery even though traditional surgery is 1) more demanding of the surgeon, 2) is capable of treating a wider range of pathology, and 3) remains the gold standard for sinus intervention. This is true especially if the surgeon can convince the patient to have the procedure performed in the office under a local anesthetic. In fact, reimbursement for surgeons is much, much higher if the procedure is done in the physician office rather than under anesthesia in an operating room, even though much less can be accomplished in the office than can be accomplished in the O.R. Increasing reimbursement for surgeons to perform surgery in a particular way obviously has the potential to increase unit sales for the manufacturers, but also provides a conflict of interest to surgeons who are tempted to provide a procedure that is not in the best interest of the patient.

CPT (current procedure terminology)code for maxillary sinus balloon sinusplasty is 31295, average medicare payment to physician for this 15 minutes procedure is around $2,000.00 to 2,500.00, and medicare payments will be additional 50% higher if it is performed to both sinuses. Readers can check medicare payment at their state from American Medical Association website, (https://ocm.ama-assn.org/OCM/CPTRelativeValueSearch.do?submitbutton=accept). The cost of balloon is average $700.00 and one device can be used in both sinuses. For comparison, an average medicare payment to surgeon for much more complicated surgeries such as for cochlear implants surgery, or a many other major ear surgery is around $1,2000.00. Such a high reimbursement rate persuades some ENT clinics to heavily advertise on about this procedure. This issue was also discussed at 2012 American Rhinology Meeting, and potential possibility of abuse in indications was a great concern.

Another opinion, while the reimbursement for the physician performing the procedure in the office is higher, the expense to perform this procedure isn't absorbed by a surgery center or hospital. The physician needs to purchase this disposable equipment, provide the tools, medication and assistance for the procedure to be performed in the office setting.[citation needed] The effective treatment in the office has been shown to significantly reduce the expense for surgical treatment for sinus disease since there is no facility fee or anesthesia fee as seen in a hospital or surgery center. This translates to a significant cost savings. Medicare is trying to encourage ENT doctors to embrace this technology to save medical dollars. Once again, the balloon does not replace traditional ESS, it provides another tool like that seen in the evolution of invasive cardiac therapy. Some patients require open heart multiple-vessel bypass surgery while other patients may benefit from an intravascular balloon catheterization for dilation of occluded arteries. Finally, this procedure is routinely performed on a Saturday AM and patients return to their normal schedule including returning to work without restrictions on that following Monday AM. This enables a patient to have an option for sinus relief without a loss of employment or using up valuable vacation time for recovery.

Inappropriately Expanding the Indications for Surgery: Early years of office sinus balloon procedures have resulted in a proliferation of ENT surgeons' radio advertising and websites promoting this supposed wonderful new technology. Anecdotal reports of the first few years of office sinus dilation procedures indicates many unnecessary procedures with dubious indications and dilation of sinuses that are not diseased on preoperative imaging.

Additional reading[edit]

1. Brown, CL, et al.; Safety and Feasibility of Balloon Catheter Dilation of Paranasal Sinus Ostia: A Preliminary Investigation; Annals of Otology, Rhinology & Laryngology April 2006, Vol. 115(4): 293-299

2. Bolger, WE, et al.; Catheter Based Dilation of the Sinus Ostia: Initial Safety and Feasibility Analysis in a Cadaver Model; American Journal of Rhinology May–June 2006, Vol. 20, No. 3, P. 290-294

3. Karanfilov B, et al. Office-based balloon sinus dilation: a prospective, multicenter study of 203 patients.Int Forum Allergy Rhinol, 2013; 3:404–411

References[edit]

  1. ^ 1. Hamilos, D.,J.; Chronic sinusitis. Allergy Clin Immunol 2000; 106: 213-227
  2. ^ Stankiewicz, J. et al; Cost Analysis in the Diagnosis of Chronic Rhinosinusitis, Am J Rhinol 2003; 17(3): 139-142
  3. ^ Subramnanian, H., et al; A Retrospective Analysis of Treatment Outcomes and Time to Relapse after Intensive Medical Treatment for Chronic Sinusitis. Am J Rhinol 2002; 16(6): 303:312
  4. ^ Hessler, J., et al; Clinical outcomes of chronic rhinosinusitis in response to medical therapy: Results of a prospective study. Am J Rhinol 2007; 21(1): 10-18
  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