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. Balloon technology was initially cleared by the U.S. Food and Drug Administration in 2005 and is an endoscopic, catheter-based system for chronic sinusitis. It uses a balloon over a wire catheter to dilate sinus passageways. When the balloon is inflated, it is hoped that the sinus openings will dilate and widen the walls of the sinus passageway, with the goal of restoring normal drainage.
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 and it is hoped that the sinus will remain open after the balloon is then deflated and removed.
The balloon technique is touted as a "less invasive" treatment than traditional functional endoscopic sinus surgery because tissue is not removed, only dilated. This point is emphasized in direct-to-consumer advertising campaigns hoping that patients will be less frightened and more likely to consent to surgery, and may have a speedier recovery.
Limitations of Balloon Procedures
The supposed benefit of balloon surgery in not removing tissue is also its greatest limitation. In fact, endoscopic sinus surgery (ESS) has always been minimally invasive. It began that way many years ago, and the 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. The risks for balloon sinuplasty are vastly different than with 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 ESS. While balloon sinuplasty serves a population of patients with favorable anatomy, the traditional ESS still remains the gold standard for treatment of sinus disease in the specialty.
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. During a balloon procedure, there is little to no ability to biopsy tissue however cultures are easily obtained and flushing or irrigating infected sinuses are easily performed once the sinus is dilated.
The patients who most need sinus intervention, patients with polyps in their nose, cannot be adequately treated with balloons.
The ethmoid sinuses, which are the frequently diseased areas between the eyes, cannot be treated with balloons since there is not a single ostea 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.
The ability of a balloon to enter a truly blocked sinus (i.e. a patient who actually needs surgery) is dependent on the skill, experience and expertise of the surgeon. Like any task, once the learning curve has been mastered, 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? 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.
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. 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.
I agree that this is indeed a wonderful new technology and the references listed below shares these results. While the balloon technology has become a well established tool for cardiovascular surgeons worldwide, this same approach now is helping those suffering with severe unrelenting sinus disease. As we speak, lengthy multiclinic scientific outcomes studies are being performed to further confirm this applicable technology. Changes in how we have viewed sinus disease is evolving into a more complete pathway that yields favorable results in groups who have been over operated in the past. As we continue to challenge ourselves to reach for new therapeutic options, it is duely important to apply this technology appropriately in a cost efficient comprehensive pathway.
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
- 1. Hamilos, D.,J.; Chronic sinusitis. Allergy Clin Immunol 2000; 106: 213-227
- Stankiewicz, J. et al; Cost Analysis in the Diagnosis of Chronic Rhinosinusitis, Am J Rhinol 2003; 17(3): 139-142
- 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
- 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