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Practical techniques in office-based balloon sinus dilation

Published:February 24, 2014DOI:https://doi.org/10.1016/j.otot.2014.02.012
      Balloon dilation instruments allow surgeons to restore sinus drainage pathways in properly selected patients with chronic rhinosinusitis using minimally invasive methods. For patients who are unable or reluctant to undergo surgery in an operating room, balloon dilation in the physician׳s office offers another option. Patient benefits of office-based treatment include no fasting period, convenient scheduling, avoidance of general anesthesia, rapid return to normal activities, and potentially lower out-of-pocket costs. For physicians and staff, office-based treatment offers the opportunity to provide safe, effective, and efficient care while improving patient comfort and convenience. The objective of this article is to provide current, practical information to surgeons who are beginning or enhancing their use of office-based transnasal balloon sinus dilation.

      Keywords

      Introduction

      Rhinosinusitis is one of the most common health conditions in the United States, affecting approximately 13.6% of the population each year.
      • Pleis J.R.
      • Ward B.W.
      • Lucas J.W.
      Summary health statistics for U.S. adults: National Health Interview Survey, 2009. National Center for Health Statistics.
      For patients with chronic rhinosinusitis (CRS) that is refractory to medical management, sinus surgery is often considered, and each year, approximately 500,000 patients undergo surgical treatment.
      Since 2005, balloon sinus dilation (BSD) systems have been used as stand-alone or adjunctive tools in functional endoscopic sinus surgery (FESS) to dilate peripheral sinus ostia and transition spaces, and they have been shown to be safe and effective in the treatment of selected patients with CRS.
      • Weiss R.L.
      • Church C.A.
      • Kuhn F.A.
      • et al.
      Long-term outcome analysis of balloon catheter sinusotomy: Two-year follow-up.
      • Levine H.L.
      • Sertich 2nd, A.P.
      • Hoisington D.R.
      • et al.
      Multicenter registry of balloon catheter sinusotomy outcomes for 1036 patients.
      • Plaza G.
      • Eisenberg G.
      • Montojo J.
      • et al.
      Balloon dilation of the frontal recess: A randomized clinical trial.
      • 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.
      BSD tools allow surgeons to restore normal sinus drainage and function with minimal disruption to the nasal tissue, thereby facilitating a procedure that can be performed in an office setting, under local anesthesia. From a patient perspective, potential advantages of office-based BSD over hospital-based procedures include convenient scheduling around work or school hours, less-burdensome preparation, familiar surroundings, avoidance of general anesthesia, and rapid return to work or equivalent activities.
      • Sikand A.
      Introduction to an office-based sinus surgery technique.
      • Albritton 4th, F.D.
      • Casiano R.R.
      • Sillers M.J.
      Feasibility of in-office endoscopic sinus surgery with balloon sinus dilation.
      • Sillers M.J.
      • Melroy C.T.
      In-office functional endoscopic sinus surgery for chronic rhinosinusitis utilizing balloon catheter dilation technology.
      • Karanfilov B.
      • Silvers S.
      • Pasha R.
      • et al.
      Office-based balloon sinus dilation: A prospective, multicenter study of 203 patients.
      New evidence of safety and efficacy of BSD in an office setting has recently been published.
      • Karanfilov B.
      • Silvers S.
      • Pasha R.
      • et al.
      Office-based balloon sinus dilation: A prospective, multicenter study of 203 patients.
      • Cutler J.
      • Bikhazi N.
      • Light J.
      • et al.
      Standalone balloon dilation versus sinus surgery for chronic rhinosinusitis: A prospective, multicenter, randomized controlled trial.
      For physicians, making the transition to office-based BSD requires proficiency in hospital-based BSD procedures, good communication skills, capable staff, and appropriate office infrastructure. Surgeons who may be unaccustomed to operating on conscious patients must refine their skills and establish procedures that are effective in an office setting. This article provides practical information and techniques that may be useful for physicians and their staff in initiating or refining office-based BSD procedures.

      Patient selection

      Appropriate patient selection is critical for achieving successful outcomes with office-based BSD. The primary indications for BSD are the same as those for FESS, including a diagnosis of CRS with persistent evidence of disease (≥12 weeks) despite appropriate medical treatment. As investigators in a recently completed clinical study,
      • Karanfilov B.
      • Silvers S.
      • Pasha R.
      • et al.
      Office-based balloon sinus dilation: A prospective, multicenter study of 203 patients.
      our patient selection procedures were initially defined by the eligibility criteria for the study. Participants were adult patients diagnosed with CRS who had failed at least 3 weeks of maximal medical therapy. Maximal medical therapy consisted of 3 weeks of culture-directed or broad-spectrum antibiotics, >6 weeks of intranasal steroids, oral steroids (if polyps or severe inflammation is present), >6 weeks of nasal irrigation, and, in some cases, 4 weeks of antihistamines. As described in the published report, all candidates had planned endoscopic sinus surgery and were offered the option of office-based BSD. Patients with cystic fibrosis, ciliary dysfunction, sinonasal tumors, severe polyposis (grade 3), obstructive lesions limiting access, or a history of facial trauma were excluded.
      Following the clinical study, our patient selection process has evolved to include patients with more challenging anatomy and greater disease burden but remains driven by the individual patient׳s medical history, findings of nasal endoscopic examination, computed tomographic (CT) findings, and anticipated procedural tolerance. Failing maximal medical therapy remains as a stringent criterion, and our current BSD candidates have failed multiple rounds of extensive medical treatment. Many candidates have symptoms for CRS for years before referral to our office. Patients frequently present with facial or forehead pressure and chronic daily symptoms. If an allergic source for CRS is suspected, patients are evaluated and managed by an allergy specialist before they are referred to us. Approximately 30% of our cases are revision procedures—primarily for patients who have previously undergone extensive FESS.
      Computed tomography and thorough nasal endoscopic examinations are used to determine the extent of pathology and to assess surgical access to the region to be treated. As our experience with BSD tools has grown, we have been able to successfully treat patients with more complex anatomy. A detailed analysis of the CT scan is always performed to reveal not only the extent and location of the sinus disease but also the anatomical variants that may help in making informed decisions on the appropriateness of office-based BSD. Patients showing significant ethmoid disease may not be candidates for office-based surgery and may require FESS treatment in an operating room.
      In addition to nasal and sinus pathology, nasal endoscopy can reveal anatomical limitations to an office-based procedure. The position of the middle turbinate is a key factor. If it is paradoxic and cannot be medialized, then space constraints could prevent easy access, and the procedure may be uncomfortable for the patient. Patients presenting with mild-to-moderate septal deviations are candidates for office-based BSD; however, those with severe deviations are not. Patients with thick turbinate bones, wide concha bullosa, floppy uncinate processes, or restrictive superior ethmoid cells may also be unsuitable. Polyposis is only a deterrent in severe (eg, pansinusitis) cases, and in rare situations, an office-based polypectomy may be performed. Figure 1 shows a preoperative, coronal CT image of a 33-year-old patient with maxillary ostial stenosis and concha bullosa whose bilateral frontal and maxillary sinuses were successfully dilated despite having complex anatomy. The Lund-Mackay
      • Lund V.J.
      • Mackay I.S.
      Staging in rhinosinusitis.
      sinus grading for the patient׳s CT scan indicated bilateral, partial opacification of the maxillary and anterior ethmoid sinuses and total opacification of the ostial meatal complex (the total Lund-Mackay CT score was 8). His preoperative and 52-week postoperative symptom scores were 2.2 and 1.3, respectively (20-item Sino-Nasal Outcome Test
      • Piccirillo J.F.
      • Merritt M.G.
      • Richards M.I.
      Psychometric and clinimetric validity of the 20-item Sino-Nasal Outcome Test (SNOT-20).
      ). No adjunctive procedures were performed during treatment.
      Figure thumbnail gr1
      Figure 1Coronal CT image of a patient with complex nasal anatomy that was successfully treated with office-based balloon sinus dilation.
      Once candidacy for in-office BSD is established based on the medical and anatomical criteria, selection depends on the patient׳s motivation and anticipated tolerance for a procedure under local anesthesia. In our experience, patient tolerance for diagnostic nasal endoscopy is a good indicator of anticipated tolerance for office-based BSD. In addition, physicians must clearly explain all treatment options and their associated risks and benefits. We find that patient satisfaction with office-based BSD is heavily influenced by the surgeon׳s approach and communication style. In-office BSD is described to the patient as a minimally invasive treatment step beyond medication that may allow them to avoid or postpone FESS using rigid instrumentation under general anesthesia in an operating room setting.
      To appropriately set expectations, we let patients know that office-based BSD may alleviate all or only some of their symptoms and that in some cases, access to all sinuses may not be possible. Differences between general and local anesthesia are explained, and patients are told that during a BSD procedure, they would feel pressure associated with no pain or some brief pain (10-15 seconds). They are reassured in knowing that perioperative and postoperative pain is monitored and managed. We tell them that the duration of the dilation procedure is generally short and the duration of in-office recovery is quick. Lack of required fasting, ability to wear normal clothing, and flexible scheduling are discussed as benefits during the consultation. For those who are interested, showing the candidate a video that explains the BSD procedure can be very helpful in describing the process and facilitating the decision.

      Patient preparation

      As may be expected, conscious patients require more perioperative preparation and coaching than those undergoing general anesthesia. Patients must know what to expect throughout the procedure. During the briefing, we tell patients that similar to office-based dental procedures, the topical medication makes their teeth numb and that although the local injections are usually painless, some of the anesthesia medication may drip down their throat and may make them feel like they have a lump in their throat. We also tell patients that their heart rate may rise for 30-60 seconds after the medication is given and reassure them that their heart rate and blood pressure will be closely monitored during the procedure.
      Having a caring, proficient, and stable office staff increases procedural efficiency, reduces stress, and enhances the patient׳s overall experience. All of our office staff members are involved in some aspect of the procedure and play an important role in scheduling, welcoming, preparing, and monitoring the patient. To prepare patients for the procedure room environment and BSD process, they are told that the lights in the room go off during the procedure to allow clear visualization of the illuminated wire that is used to confirm access to the sinuses. We also let them know that during the procedure, they may hear popping and cracking sounds as the sinus opens and this is normal. In our practice, patients are advised to bring reading materials, a personal music player, or something similar to entertain themselves while they wait. Patients are instructed to arrive 60 minutes before the procedure is performed to allow sufficient time for paperwork, briefing, and administration of local anesthesia. We offer a gown to patients to absorb any perspiration; however, typically they remain partially dressed during the procedure. Generally, we ask patients to complete a standard questionnaire to record preprocedure symptoms and to also complete a second survey approximately 8 weeks later. This allows us to share and review results with patients after the treatment.

      Local anesthesia

      Providing safe, effective pain management is a key component in enhancing the patient׳s experience with office-based BSD. Selection and use of medications are tailored to meet the needs of the individual patient and take into account the anticipated complexity of the procedure. Various agents and protocols for effective nasal anesthesia have been described in the literature based on physician preferences.
      • Sikand A.
      Introduction to an office-based sinus surgery technique.
      • Sillers M.J.
      • Melroy C.T.
      In-office functional endoscopic sinus surgery for chronic rhinosinusitis utilizing balloon catheter dilation technology.
      • Atkins J.
      • Truitt T.
      In-office balloon dilation of the ethmoid infundibulum.
      • Goyal P.
      • Hwang P.H.
      In-office surgical treatment of sinus disease: Office-based surgical procedures in rhinology.
      • Noorily A.D.
      • Noorily S.H.
      • Otto R.A.
      Cocaine, lidocaine, tetracaine: Which is best for topical nasal anesthesia?.
      • Bourolias C.
      • Gkotsis A.
      • Kontaxakis A.
      • et al.
      Lidocaine spray vs tetracaine solution for transnasal fiber-optic laryngoscopy.
      Our standard protocol (Table) was established during our clinical research and has not been changed. It should be emphasized that the local anesthesia protocol and techniques described in this article represent only one of many options for office-based treatment.
      TableAnesthesia protocol for office-based balloon sinus dilation
      Oral anxiolytics
       TypeLorazepam
       Dose1-2 mg
       Waiting time30-45 min
      Topical
       Type4% tetracaine with oxymetazoline (50/50 mixture)
       LocationFrontal or maxillary: place presoaked cotton pledgets in the middle meatus (around middle turbinate) and the medial side of the inferior turbinate. Sphenoid: place pledgets between the septum and the middle turbinate above the choana.
       Waiting time20-40 min
       Additional notesVerify positioning of the pledgets and reposition them as needed. Check for numbness in teeth and upper palate.
      Infiltration
       Type1% or 2% lidocaine with epinephrine mixed with sodium bicarbonate solution (2.5 mL lidocaine with epinephrine with 0.5 mL bicarbonate)—not more than 2 mL per side
       LocationFrontal or maxillary: inject using a superior-to-inferior pattern—directly along the uncinate plate, the middle turbinate (especially lateral side), and the neck of the middle turbinate. Sphenoid: focus injections on the medial wall of the middle turbinate and the septum (Figure 2).
       Waiting time5 min
       Additional notesCheck for blanching around injection sites. Additional injections may be necessary during the procedure at the physician׳s discretion.
      Following the patient׳s consent, an oral anxiolytic (lorazepam: 1-2 mg) may be offered to the patient 30-45 minutes before the BSD procedure. The use of spray anesthesia with nasal decongestant is described in some published protocols; however, we avoid using it to spare patients the discomfort of having liquid drip down their throat. Topical anesthesia is initiated using cotton pledgets (1 large and 1 small) infused with a 50-50 mixture of 4% tetracaine and oxymetazoline placed in each side of the nose according to sinuses requiring treatment. In our experience, tetracaine has shown to be effective in providing topical anesthesia, and published reports support its use over lidocaine for intranasal procedures.
      • Noorily A.D.
      • Noorily S.H.
      • Otto R.A.
      Cocaine, lidocaine, tetracaine: Which is best for topical nasal anesthesia?.
      • Bourolias C.
      • Gkotsis A.
      • Kontaxakis A.
      • et al.
      Lidocaine spray vs tetracaine solution for transnasal fiber-optic laryngoscopy.
      For frontal or maxillary sinus treatment, cotton pledgets are placed in the middle meatus (around the middle turbinate) and on the medial side of the inferior turbinate. For patients with tortuous anatomy, inserting the cotton pledgets can be the most uncomfortable part of the BSD procedure. Patient discomfort, if encountered, is brief and proactively managed through frequent encouragement and support. The cotton pledgets are repositioned as needed until the patient׳s teeth and upper palate are numb—typically 20-40 minutes. For sphenoid treatments, a cotton pledget is placed between the septum and the middle turbinate in a very posterior orientation (above the choana).
      Following topical anesthesia, the patient is moved to the procedure room where infiltrative anesthesia is administered by injection using a 1%-2% lidocaine with epinephrine solution (1:100,000-1:200,000 dilution). More recently, we started adding sodium bicarbonate to the anesthesia solution (approximately 0.5 mL bicarbonate per 2.5 mL lidocaine or epinephrine) not more than 1 hour before the procedure to neutralize its acidity. To prepare the sites, 2 cotton pledgets are removed with a small one left in the middle meatus to absorb any excess liquid from the anesthesia. In our experience, getting the middle turbinate adequately anesthetized is very important. For frontal or maxillary sinus dilations or both, injections of local anesthesia begin at the superior portion of the uncinate plate, followed by the neck of the middle turbinate, the remaining middle turbinate, and the remaining uncinate plate (Figure 2A). For sphenoid procedures, injections are focused on the medial wall of the middle turbinate and the septum (Figure 2B). With good topical anesthesia, injections in the mucosa above the choana (performed with a spinal needle) are not needed. To avoid having excess anesthesia drip into the patient׳s throat and causing numbing or gagging, our goal is to inject no more than 2 mL on each side of the nose. After approximately 5 minutes, we check for numbness as indicated by good blanching around the injection sites. During the dilation procedure, additional injections may be required based on the patient׳s response.
      Figure thumbnail gr2
      Figure 2Target sites for injection of infiltrative local anesthesia for left frontal or maxillary (A) and sphenoid (B) sinus dilations. Nasal anatomy shown includes the middle turbinate (MT), uncinate process (UP), septum, and superior turbinate (ST). (Color version of figure is available online.)

      Sphenoid sinus dilation

      Although less common than frontal or maxillary procedures, sphenoid sinus dilations are readily performed in the office setting. If multiple sinuses are being dilated, we follow a posterior-to-anterior approach by dilating the sphenoid before the frontal and the maxillary sinuses. Based on a preoperative review of the patient׳s CT scan, an appropriate balloon catheter is selected for the targeted sinus anatomy. In most cases, we find that a 7-mm × 16-mm balloon catheter works well for sphenoid as well as frontal and maxillary dilations. Under endoscopic visualization, the middle turbinate is lateralized and a straight sinus guide catheter is placed posteriorly at the inferior border of the superior turbinate and is positioned at a 30° angle up from the floor of the nose. A 0° or 30° endoscope is used for visualization. A guidewire with an illuminated tip is advanced through the catheter and rotated carefully to locate the ostium. As noted by others,
      • Sillers M.J.
      • Melroy C.T.
      In-office functional endoscopic sinus surgery for chronic rhinosinusitis utilizing balloon catheter dilation technology.
      we find that repositioning the endoscope below the guide catheter can facilitate the search process. Once the ostium is found, the guidewire is advanced and transillumination may be used to visually confirm wire placement in the sinus. If the wire tip is near the anterior face, it is possible to see light reflecting inside of the sphenoid sinus when the endoscope light is turned off. If the wire has advanced further and the tip has prolapsed on itself, the front wall, sphenoid ostium, and superior turbinate may be illuminated. Following confirmation, the balloon catheter is advanced over the wire until the proximal end is positioned in the ostium. Under endoscopic visualization, the balloon is inflated to 12 atm and then deflated after approximately 5 seconds.

      Frontal sinus dilation

      As mentioned, unless a sphenoid dilation is planned, the frontal sinuses are the first to be dilated. The CT scan is always reviewed before treatment begins as, in our experience, approximately 20% of patients have poorly formed or no frontal sinuses. A Freer elevator is used to medialize the middle turbinate, and if a concha bullosa is present, it may be compressed to widen the middle meatus. To further evaluate the access space and facilitate positioning of the guide catheter, the frontal sinus recess may be gently palpated using a frontal sinus seeker. Access to the sinus is gained by placing a frontal guide catheter just behind the uncinate plate superiorly, anterior to the ethmoidal bulla, and initiating a systematic medial-to-lateral search pattern to locate the ostium using the illuminated wire (Figure 3A). Experience and patient feedback are very useful in knowing when the wire placement is correct; a focal pinpoint of light on the patient׳s forehead confirms proper positioning. Following confirmation of sinus entry, the balloon is advanced and inflated (Figure 3B). If the balloon does not pass initially or only passes partially, the frontal recess may be predilated. Predilation of the lower portion of the frontal recess widens this region, permitting easier access into the superior portion of the recess and subsequently the frontal sinus. As mentioned before, we try to use a single large balloon (eg, 7-mm diameter × 16-mm length) for dilation. The 16-mm balloon frequently requires 2 dilations, 1 superior and 1 more inferior to cover the entire frontal recess. In some cases, bubbles appear at or near the proximal end of the balloon when dilation is successful.
      Figure thumbnail gr3
      Figure 3Left frontal sinus wiring (A) and balloon inflation (B) positions. (Color version of figure is available online.)

      Maxillary sinus dilation

      Before endoscopic visualization, the patient׳s CT scan is reviewed to assist in locating the position of the natural ostium. A seeker is used to palpate the lateral aspect of the uncinate plate and retract it slightly forward. This tissue can be very soft if the patient has had a large concha bullosa or paradoxical middle turbinate compressing the uncinate. We find that gentle medialization of the turbinate can help gain access to the steeply angled infundibulum and avoid cannulating an accessory ostium or inadvertently penetrating the posterior fontanel. Guide catheter entry is easiest at the inferior border of the uncinate (Figure 4A). If space permits, sliding the elbow of the guide up allows the illuminated wire to be introduced from a superior orientation that is aligned with the trajectory of the infundibulum (Figure 4B). If space is restricted, the wire may be introduced from the entry position, but care is needed to avoid introduction via the posterior fontanel. Gentle palpation of the wire tip in the infundibulum and an appreciation of the tactile sensation of natural ostium passage based on the surgeon׳s operating room experience are important. There should be no forcing of the wire and no “popping through,” which could indicate fontanel breach. Once the guide catheter position is visually confirmed, the wire is advanced; intense illumination of the patient׳s cheek confirms good positioning. It should be noted that cheek illumination typically is not as focal as the forehead illumination observed in frontal sinus procedures. The illumination can disappear quickly as the wire is advanced into the maxillary sinus and the wire tip deflects posteriorly. To enhance patient comfort, the wire is partially retracted after the balloon is advanced so that it does not rest or rotate on the floor of the sinus near the teeth. Balloon inflation may be initiated with the guide catheter in the superior or inferior orientation (Figure 5). When inflated, the balloon causes the uncinate process to bulge anteriorly and medially, providing visual confirmation of dilation. Following dilation, the balloon must be completely deflated and retracted before removing the guide catheter to protect the uncinate and the surrounding tissue. Typically, the same balloon that is used for frontal dilation is used for the maxillary procedure, and to ensure ostial patency, we generally perform 2 dilations when treating the maxillary sinus.
      Figure thumbnail gr4
      Figure 4Left maxillary sinus guide catheter placement (A) and wiring (B) positions. In (B), the uncinate process (UP) is shown as a semitransparent structure for illustrative purposes. (Color version of figure is available online.)
      Figure thumbnail gr5
      Figure 5Left maxillary sinus balloon inflation at superior (A) and inferior (B) positions. In (A), the uncinate process (UP) is shown as a semitransparent structure for illustrative purposes. (Color version of figure is available online.)

      Discussion

      The procedures described in this article highlight several practical techniques that may be useful for physicians and their staff in optimizing the patient׳s experience with office-based BSD. Many of the techniques are refinements to procedures that were introduced through our clinical research experience. With proper training, experience, and attention to detail, sinus dilation under local anesthesia has been shown to be a safe and effective method for treating selected patients with CRS. Having experience with BSD tools and procedures in an operating room setting is critical before making the transition to office-based care. Because the uncinate process is left intact during office-based BSD, endoscopic viewing of the infundibulum and the maxillary ostium may not be possible, and physicians must have a good understanding of the spatial anatomy to successfully access and treat maxillary disease. Experience and confidence in handling the instruments and managing conscious patients have allowed us to become comfortable in treating more complex cases of CRS. Most of our revision procedures follow not from BSD but from prior FESS surgery that did not alleviate symptoms or caused scarring and ostial reblockage. In these cases, we have found that patients are motivated to try office-based BSD rather than go back to the operating room.
      When medical management has failed and surgery is recommended, office-based BSD may be considered as a minimally invasive surgical approach offering another treatment option to selected patients with CRS. For surgeons and their staff, office-based BSD offers new opportunities to expand their professional skills. To date, published reports on BSD have focused appropriately on safety and efficacy results, but they offer little practical information to new adopters. By sharing the suggestions and techniques found in this article, we hope to assist other physicians who may be interested in offering or enhancing office-based BSD.

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