Sillers, Michael J.a; Melroy, Christopher T.b
Chronic rhinosinusitis (CRS) remains one of the most common chronic illnesses in the United States with approximately 14% of the population affected . CRS has also been recognized to have a significant negative impact on the quality of life, worse in some respects than heart disease, chronic obstructive pulmonary disease, and back pain . For these reasons, effective treatments have been sought and largely have focused on the medical therapies to eradicate, reduce, or simply control symptoms. Approximately, 500 000 individuals undergo functional endoscopic sinus surgery (FESS) annually when medical therapy fails .
With the introduction and advancement of FESS nearly 3 decades ago by Stammberger and Kennedy, it has become the accepted methodology employed in treating medically refractory CRS. As the principles of FESS have matured over time, instrumentation has also evolved. Smaller forceps, mucosal-sparing cutting instruments, and powered instrumentation have become better suited for a more delicate, structural preservation approach to the surgical treatment of sinus disease. Introduced in 2005, balloon catheter dilation (BCD) is the newest technology in sinus surgery instrumentation and has been shown to result in the durable dilation of peripheral sinus outflow tracts. This has been associated with the reduction in CRS symptoms and improvement in patients’ assessed quality of life [4–7,8▪,9]. BCD differentiates itself from other sinus instruments by focusing on dilating natural drainage pathways without removing tissue when used as a sole means of treating maxillary, frontal, and sphenoid sinus outflow obstruction. Because of its mucosal-sparing nature, BCD typically results in less bleeding, more rapid healing, fewer postoperative debridements, and earlier return to work. BCD is not indicated as a direct intervention for ethmoid sinus disease.
It is important to state from the onset that the choice of surgical instrumentation does not change the indications for sinus surgery. Rather, patients should be considered a surgical candidate based on persistent, demonstrable disease in spite of appropriate medical therapy. Once this determination has been made, the surgical setting and instrumentation are chosen. In general, patients are diagnosed with CRS based upon symptom duration of at least 12 weeks, endoscopic findings, and demonstrable sinus disease by computed tomography (CT). Much debate continues among practitioners regarding the surgical treatment of recurrent acute rhinosinusitis (RARS), defined by at least four acute events per year separated by symptom-free intervals. At present, there are not sufficient data that would support performing sinus surgery in these patients without CT evidence of disease. Therefore, this review will focus on the surgical treatment of medically refractory CRS patients utilizing BCD tools.
Unique to the performance of FESS in-office using BCD technology is the consideration of accessing the involved sinus. Anatomic variations such as middle turbinate concha bullosa, paradoxical curvature of the middle turbinate, and nasal septal deviation are not contraindications but may make sinus access difficult and uncomfortable for the patient even with appropriate anesthesia. Patients should demonstrate tolerability to rigid diagnostic nasal endoscopy before embarking on an attempt to perform in-office surgery. As an alternative to a transnasal approach, patients may undergo transantral maxillary and ethmoid infundibular dilation in the setting of unfavorable nasal anatomy on the involved side.
In general, the ideal patient for BCD in an office setting demonstrates mucosal disease involving the maxillary, frontal, and sphenoid sinuses, either in isolation or combination. Patients with extensive disease involving the ethmoid sinuses with or without nasal polyps may not be suited for in-office surgery, but may still benefit from BCD as part of a ‘hybrid’ procedure in which ethmoid disease is formally addressed with traditional FESS techniques in an operating room setting.
Anesthetic options for in-office surgery can be categorized as local topical, local infiltrative, and systemic. Regardless of the method chosen, adequate anesthesia is the goal and this varies among physicians. Local topical therapies may include aerosolized 4% lidocaine or 2% pontocaine, typically in combination with a topical decongestant. Oxymetazoline, phenylephrine HCl (1.0%), or adrenaline (1 : 1000) have all been reportedly used. These can be applied in an aerosolized solution or to a cotton pledget and placed in the nasal cavity, middle meatus, and sphenoethmoidal recess depending on the sinuses requiring treatment. The key to local topical anesthesia is patience, and an adequate level is often indicated when the patient reports dental numbness. At this time, local infiltrative anesthesia may be utilized but may not be necessary. Typically, 1–2% lidocaine with 1 : 100 000–200 000 adrenaline is injected into the middle turbinate vertical lamella and the lateral nasal wall.
Systemic anesthesia by way of oral sedation may be considered based on patient and physician preference. Vital sign monitoring is dictated by patient comorbidity and local standards.
When multiple sinuses are being treated, many surgeons proceed from posterior to anterior to keep bleeding posterior to the area of dissection. It is common to proceed with the sphenoid followed by the frontal and maxillary sinuses. It is crucial to have a full complement of scopes and standard endoscopic instruments available in addition to an assistant who is familiar with the procedure and instruments.
Although the basic principles of BCD are the same regardless of the device used, there are specific technical differences based on the sinus targeted for treatment. Currently, Acclarent (Menlo Park, CA, USA) and Entellus Medical (Maple Grove, MN, USA) offer FDA-approved systems for BCD of the sphenoid, frontal, and maxillary sinus outflow tracts. The primary difference is that the Acclarent system (Fig. 1) relies on a guide wire to access and confirm sinus entry, while the Entellus system (Fig. 2) relies on tactile feedback.
Sphenoid sinus technique
Nasal endoscopy is performed with a 0° endoscope and a straight introducing cannula or ‘sinus guide’ is passed medial to the middle turbinate with its final position just medial to the anterior tip of the superior turbinate. The endoscope is then removed from the nasal cavity and reinserted inferior to the instrument. A lighted guide wire is passed through the sinus guide and advanced until it successfully traverses the sphenoid ostium. With the endoscope positioned below the sinus guide, inadvertent superior or inferior guide wire advancement can be easily detected. With successful access of the sphenoid sinus achieved through the sphenoid ostium, there is a lack of resistance on the guide wire until it begins to curl within the sphenoid sinus. The lighted guide wire transilluminates the sinus and results in a diffuse ‘glow’ of the sphenoid sinus, best seen when the light source to the endoscope is momentarily turned off. Cross-table fluoroscopy can also confirm correct placement of the guide wire for any of the peripheral sinuses.
A balloon dilating catheter is passed over the guide wire under endoscopic visualization until the distal aspect of the balloon just enters the sinus. The balloon is expanded using the inflation device under endoscopic visualization to the recommended pressure for approximately 5 s. The balloon is deflated and withdrawn. With all sinuses, irrigation can be performed and the dilated sinus can be visualized with the appropriately angled endoscope.
Frontal sinus technique
A 0° endoscope is typically used for the procedure, although the internal frontal ostium itself is best visualized with more angled endoscopes. Access to the frontal sinus is best achieved if the tip of the 70° sinus guide is insinuated between the uncinate process and the face of the ethmoid bulla in the parasagittal plane. The distal tip should be visible near the upper third of the ethmoid bulla and not passed into the frontal recess in order to allow the guide wire a broader area to search. The lighted guide wire is passed under endoscopic visualization until it finds entry into the frontal sinus. This is confirmed with the transillumination of the forehead skin with the focal bright light coming from within the sinus. If the guide wire does not pass into the frontal sinus, it is retracted back into the sinus guide, the sinus guide is repositioned, and attempted cannulation is repeated. Once the frontal sinus is successfully accessed, balloon advancement and dilation are performed and may be repeated more proximally or distally within the frontal sinus outflow tract depending on the anatomy and length of balloon chosen.
Maxillary sinus technique
The maxillary sinus can be the most challenging sinus to treat with balloon dilation because the uncinate process remains in place as the maxillary sinus is treated. Under visualization with a 0° or 30° endoscope, a 110° or 90° sinus guide is passed into the middle meatus with the tip pointing inferiorly. It is passed posteriorly and inferiorly within the middle meatus before being rotated laterally to insinuate the tip between the uncinate process and ethmoid bulla. The uncinate process is gently retracted anteriorly using the tip of the sinus guide. The tip of the sinus guide is then again rotated until it is anatomically in line with the position of the natural maxillary sinus ostium. This approximates the 8 o’clock position on the patient's right side and the 4 o’clock on the left side. This correlates with a CT analysis by Sikand [10▪▪], in which the angle of the natural ostium averaged 17.5° from the horizontal plane. It is important to keep the tip of the sinus guide visible, so it does not inadvertently penetrate the posterior or anterior fontanelle.
The lighted guide wire is passed into the sinus; transillumination of the lateral and inferior maxilla confirms the guide wire is within the maxillary sinus. It is important to insure that the tip is not confined to the medial aspect of the maxilla, which could be the case if the tip were incorrectly positioned in a Haller cell or in the submucosal plane. It is important to conceptually note that transillumination simply confirms that the tip of the guide wire is in the maxillary sinus. Transillumination anteriorly and inferiorly can also occur if the guide wire is passed into the maxillary sinus inappropriately via an accessory ostium or any procedurally created antrostomy. This is the importance of endoscopic visualization during positioning of the sinus guide – it must be passed to the correct position and used to retract the uncinate process anteriorly without itself penetrating the medial maxillary sinus wall. Incorrectly placed antrostomies have been described in a cadaver series with resident surgeons [11▪]. However, the technique described above should lead to successful cannulation of the natural ostium. If there is doubt, the uncinate process can be partially removed to confirm proper guide wire and subsequent balloon catheter placement.
The balloon catheter is passed over the guide wire fully into the sinus, then partially withdrawn so that it spans the entire outflow tract of the maxillary sinus. This is achieved by rotating and repositioning the entire unit (sinus guide and balloon catheter) medially and posteriorly. Dilation is performed as detailed above.
All of the above-mentioned techniques employ a transnasal endoscopic approach; Entellus manufactures an additional system that utilizes a sublabial, transantral technique. The procedure begins with a sublabial approach under local anesthesia by making an incision within the canine fossa. A trocar with a cutting tip penetrates the anterior maxillary wall to access the antrum. Through the trocar, a small flexible or rigid endoscope can be passed into the maxillary sinus for visualization. A balloon dilating catheter is passed through the trocar, into the maxillary sinus, across the maxillary ostium, and into the ethmoid infundibulum. The balloon is expanded, deflated, and the system is removed. Irrigation is performed as indicated.
As with any new device, safety and feasibility are initial concerns. Patient tolerability is an additional concern specific to the consideration of in-office surgery. BCD tools have been proven from the beginning to be well tolerated and effective in dilating peripheral sinus outflow tracts in patients undergoing surgery in the operating room [4–7,8▪,9]. Complication rates associated with BCD compare favorably with those reported in the literature for traditional FESS [4–7,8▪,9,12–16,17▪▪–19▪▪] (Table 1).
More recent studies have also shown that similar safety, feasibility, tolerability, and technical success can be achieved in the office setting with these tools utilized under local anesthesia. Albritton et al.[17▪▪] reported on 37 patients, in whom a total of 59 sinuses were dilated in-office for medically refractory CRS. There was a single nonserious adverse event reported when a patient inadvertently swallowed a pledget used for local topical anesthesia. Ninety-one percent of attempted sinus dilations were successfully achieved. Only 3.4% of patients felt the procedure was intolerable and only 5.6% of patients reported intense pain during the procedure, specifically associated with balloon inflation. In a multicenter study, Karanfilov et al.[18▪▪] reported 552 sinus dilations in 203 patients (mean 2.7 sinuses/patient) again with only a single adverse event reported. One patient experienced periorbital swelling that resolved without sequelae within 1 week after the procedure. Technical success in dilating sinuses was achieved in 93.3% of maxillary, 90.5% of sphenoid, and 93.7% of frontal sinuses. Only 3% found the procedure intolerable with local anesthesia and nearly 70% resumed normal activities within 48 h after the procedure. Finally, Cutler et al. reported on 71 patients who underwent transantral dilation of the maxillary and ethmoid infundibulum, 19 of whom underwent the procedure in the office setting under local anesthesia. They achieved 100% technical success with only one adverse event. A patient developed subcutaneous emphysema after using continuous positive airway pressure following the procedure. This resolved spontaneously without consequence. Procedures were well tolerated with a patient reported mean pain score of 2.7/10 and 88% resumed normal activities within 48 h [17▪▪–19▪▪]. The majority of patients report that the most significant pain during BCD is associated with the inflation of the balloon. Educating patients in advance and communicating with them throughout the procedure may help minimize this. A summary of pain and tolerability is seen in Table 2.
In each of these studies, anesthesia was not standardized and was based on physician preference. In addition, each of the above three studies reported statistically significant and clinically meaningful improvement in quality-of-life measures similar to prior studies performed in an operating room setting. This suggests that outcomes are not dependent on the site of service but depend on the appropriate application of the technology to carefully selected patients with CRS.
Although there are numerous reports of safe and successful outcomes related to BCD technology utilized in CRS patients, the large majority of them are not randomized and blinded trials and therefore fall short of the ideal clinical design. Batra et al. and Burton et al. have criticized the current data largely based on study design and the lack of randomized, prospective trials [21,22]. Plaza et al.[20▪] published a randomized, blinded, prospective study reporting an increase in frontal sinus outflow tract patency in patients in whom BCD was used to treat the frontal sinus in a ‘hybrid’ fashion compared to traditional FESS techniques.
In the current healthcare environment, cost considerations become paramount. Physicians and patients alike seek new avenues for cost reduction and containment, however, not at the expense of sacrificing outcomes. Prickett et al.[23▪▪] presented a cost analysis of office-based vs. operating room rhinologic procedures in 29 matched pairs. Current Procedural Terminology (CPT) codes included in the comparison were 31231, 31237, 31254, 31255, 31256, 31267, 31276, and 31287. Using direct total charges, allowed charges, and scaled charges, they found that office procedures could be performed for $3300–$5000 less than matched procedures performed in the operating room. There is still opportunity for significant cost savings when performing BCD in-office even when factoring in the cost of the disposable tools. The authors also reported that all 29 in-office procedures, which included primary and revision surgery, were performed without complications.
In-office surgery has numerous potentially attractive features – avoidance of general anesthesia, rapid recovery and return to normal activities, and significant potential cost savings. However, if procedures in this setting carry higher risk, are unacceptably painful, and are less effective, then offering this option to patients would seem unethical. From the current body of evidence, it appears that in-office FESS utilizing balloon sinus dilation tools is safe, well tolerated, and with outcomes similar to those achieved in an operating room setting.
Conflicts of interest
Disclosures: C.T. Melroy: Acclarent, Inc. – Consultant and speaker; Olympus – Consultant.
Michael J. Sillers: Acclarent – Scientific Advisory Board; GE Navigation – Scientific Advisory Board; Xoran Technologies – Speakers Bureau.
REFERENCES AND RECOMMENDED READING
Papers of particular interest, published within the annual period of review, have been highlighted as:
▪ of special interest
▪▪ of outstanding interest
Additional references related to this topic can also be found in the Current World Literature section in this issue (pp. 87–88).
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This article reports the safety, technical success, and clinically significant improvement in patients with CRS undergoing frontal, maxillary, and sphenoid sinus surgery with BCD tools. The technical success in accessing the target sinus was greater than 90%.
18▪▪. Karanfilov B, Silvers S, Pasha R, et al.
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This is a large, multicenter, prospective study further reporting the safety, tolerability, and clinically significant improvement in QOL in patients with CRS undergoing in-office surgery with BCD tools under local anesthesia. It is a ‘real world’ experience using varied anesthetic techniques with similar patient acceptance. These results should be reproducible.
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Patients can be successfully treated by transantral dilation with high patient acceptance. A total of 88% of patients return to normal activities within 48 h of the procedure.
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This is the first, randomized, blinded, prospective study utilizing BCD tools. Frontal recess patency is durable and may be superior to patency seen with traditional FESS.
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Office-based nasal endoscopy with and without debridement has been performed safely in the office for decades. Other rhinologic procedures can also be safely performed and with substantial cost savings compared to similar procedures in the operating room. There is potential for significant cost saving using BCD tools in the office even when disposable costs are considered.
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