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Balloon sinuplasty for the treatment of chronic rhinosinusitis (CRS) refractory to conservative medical therapy has greatly risen over the last decade. With refinements in technique and the ability to perform the procedure outside of an operating room, an increasing number of patients elect to undergo this procedure based on its lower complication rates, quicker recovery time, and minimally invasive nature. This activity reviews the history, indications, contraindications, equipment, technique, complications, and other key elements of balloon sinuplasty in an operative and an in-office setting, and the role of an interprofessional team will be discussed regarding procedural assistance and education on proper operative technique. Objectives: Identify the indications and contraindications of balloon sinuplasty. Describe the equipment, personnel, preparation, and technique in regard to balloon sinuplasty. Review the potential complications of balloon sinuplasty. Summarize interprofessional team strategies for improving care coordination and communication to advance balloon sinuplasty and improve outcomes. Access free multiple choice questions on this topic.

Since the Federal Drug Administration's (FDA) approval for nasal sinus use in 2005, balloon sinuplasty (BSP) has continued to grow in popularity among otolaryngologists as a minimally invasive way to treat patients suffering from chronic rhinosinusitis (CRS).[1][2][3] The idea of using balloon dilation to open an anatomic structure is not a new concept, as cardiac surgeons have used similar techniques in coronary arteries since the late 1970s. In the late 1990s, some otolaryngologists attempted to use 5-7 French Fogarty catheters to preserve the patency of nasal ostia.[4] This technique allows dilation of sinus ostia and outflow tracts via local microfracture - without destroying the overlying mucosa and maintaining physiologic function.[3][5] The goal of BSP is to allow for improved mucociliary clearance by minimizing obstruction of the outflow tracts, thus causing symptomatic improvement in patients suffering from CRS. The description of chronic rhinosinusitis in the literature is the inflammation of nasal mucosa and the surrounding sinuses lasting more than 12 weeks.[1][6][7] Patients describe a myriad of symptoms, including congestion, rhinorrhea, facial pressure, hyposmia, and, most commonly, nasal obstruction.[1][5][6] This condition's etiology is not fully understood, and multiple studies point to various causes, including biofilms, bacterial antigens, fungal infections, and immune dysfunction.[3][7] The disease is currently broken down into two distinct subgroups: CRS with nasal polyposis (CRSwNP) and CRS without nasal polyposis (CRSsNP). Approximations are that over 31 million people suffer from CRS, and although medical management is the mainstay treatment for these patients, the literature notes an increasing number of surgical cases.[1][6] From 2006 to 2011, estimates were that 1 in 3.7 patients with CRS underwent sinus surgery for treatment. Upwards of 300000 patients elect for sinus surgery annually, which includes BSP, functional endoscopic sinus surgery (FESS), or a mix of both, called a "hybrid" procedure.[1][3][5][6]

The description of chronic rhinosinusitis in the literature is the inflammation of nasal mucosa and the surrounding sinuses lasting more than 12 weeks.[1][6][7] Patients describe a myriad of symptoms, including congestion, rhinorrhea, facial pressure, hyposmia, and, most commonly, nasal obstruction.[1][5][6] This condition's etiology is not fully understood, and multiple studies point to various causes, including biofilms, bacterial antigens, fungal infections, and immune dysfunction.[3][7] The disease is currently broken down into two distinct subgroups: CRS with nasal polyposis (CRSwNP) and CRS without nasal polyposis (CRSsNP). Approximations are that over 31 million people suffer from CRS, and although medical management is the mainstay treatment for these patients, the literature notes an increasing number of surgical cases.[1][6] From 2006 to 2011, estimates were that 1 in 3.7 patients with CRS underwent sinus surgery for treatment. Upwards of 300000 patients elect for sinus surgery annually, which includes BSP, functional endoscopic sinus surgery (FESS), or a mix of both, called a "hybrid" procedure.[1][3][5][6] Recently, there has been a push to perform BSP under local sedation in an in-office setting, which avoids the use of general anesthesia in patients with concomitant comorbidities and provides cost savings to the patient and the physician.[8] Holy et al. described that the ratio of sinus surgery per 100,000 patients had remained constant between 2006 and 2011. However, they did note a 7% increase in BSP-only procedures during that time frame.[9] One study, which used the Center for Medicare and Medicaid Database, looked at billing codes to compare the number of specific sinus procedures performed from 2012 to 2016. The number of balloon-only procedures jumped from 5603 to 25640 in that timeframe. This study found that in-office BSP served as the major reason for this jump in treatment numbers.[10] With the application of in-office BSP, concerns exist regarding the possibility of overutilizing the procedure due to its variety of proposed indications, which this activity will discuss later. In one retrospective cohort study, the authors used one of the largest commercial health insurance program's database. They noted that 86.53% of BSP procedures were studied in an in-office setting.[1] With the recent increase in popularity of BSP procedures and the ease of availability in an in-office setting, the authors of this paper hope to provide a general overview of balloon sinuplasty for physicians, healthcare providers, and patients alike.

Since its inception, balloon sinuplasty has had a reputation as a safe yet effective minimally invasive procedure. The first large-scale study by Bolger et al., the CLEAR study, looked at adverse events within a 24-week follow-up period after balloon sinuplasty. Out of the 115 patients included in the study, there were no serious adverse effects, defined as cerebrospinal fluid leaks (CSF), diplopia, significant intraoperative bleeding, or vision loss. There were a reported nine patients diagnosed with acute bacterial sinusitis during the immediate follow-up period, which researchers attributed to the procedure.[13] This same study population was then followed by Weiss et al. for two more years after the initial time frame. Sixty-five of the original 115 patients were enrolled due to two of the original surgical hospitals not participating. They noted no adverse events in the remaining participants in this study two years after the initial surgery.[17] A recent retrospective cohort study from 2018 explored the complication rates of 2851 patients who underwent BSP from 2011 to 2014. They noted an overall complication rate of 5.26%, which is subdivided into the following three categories: orbital (2.95%), bleeding (2.03%), and skull base injury (0.35%). The orbital complications category included the following: fractures, hemorrhage, orbital cellulitis, epiphora, pain, erythema around the eye, ophthalmoplegia, diplopia, and orbital disorder. Skull base complications consisted of CSF leak, pneumocephalus, skull base injury, and central nervous system complications. They also noted that the complication rates dropped from 2012 to 2014.[1] It is of interest to the authors that only one case report of a postoperative CSF leak has been noted in the literature directly after a BSP-only procedure, even though 0.35% of procedures have resulted in skull base injury per one of the largest insurance databases in the United States.[18]

A recent retrospective cohort study from 2018 explored the complication rates of 2851 patients who underwent BSP from 2011 to 2014. They noted an overall complication rate of 5.26%, which is subdivided into the following three categories: orbital (2.95%), bleeding (2.03%), and skull base injury (0.35%). The orbital complications category included the following: fractures, hemorrhage, orbital cellulitis, epiphora, pain, erythema around the eye, ophthalmoplegia, diplopia, and orbital disorder. Skull base complications consisted of CSF leak, pneumocephalus, skull base injury, and central nervous system complications. They also noted that the complication rates dropped from 2012 to 2014.[1] It is of interest to the authors that only one case report of a postoperative CSF leak has been noted in the literature directly after a BSP-only procedure, even though 0.35% of procedures have resulted in skull base injury per one of the largest insurance databases in the United States.[18] Other reported complications noted in the literature include acute bacterial sinusitis and tooth/facial numbness.[8][13] Interestingly, there was one case report of an acute myocardial infarction during a BSP procedure noted by Hughes et al. in a patient without cardiac history. The group hypothesized that excessive vagal stimulation occurred from instrumentation within the maxillary mucosa or the orbit, which was accidentally breached when trying to balloon the right frontal sinus ostia.[19]

Balloon sinuplasty is a minimally invasive process with a low complication rate and side effect profile. Although rare, complications of balloon sinuplasty may require intervention by other physician providers if deemed necessary by the procedural physician and team. Episodes of acute bacterial sinusitis may require the use of a pharmacist for appropriate antibiotic dosing in patients with concomitant comorbidities reducing renal or hepatic clearance.[8] Damage to the orbital wall and herniation of orbital contents into the nasal cavity may require consultation from ophthalmology in particular cases. Damage to the skull base could require a consultation with neurosurgery if not able to be controlled by otolaryngology.[1] As seen in one case report in this article, cardiology or emergency medicine may be needed if a patient develops an acute myocardial infarction intraoperatively.[19] [Level 5] As mentioned earlier in the article, other health professionals need to be aware of the equipment and necessary steps, especially if they plan to assist in the procedure itself. In many offices, medical assistants, nursing staff, residents, or medical students can support the operating physician in setting up the device, preparing the patient, inflating the balloon, and providing irrigation. The assistants need to have an adequate understanding of the parts and controls of the device in cases of defective instrumentation or if the operator requests assistance. If these assistants have in-depth knowledge of the procedural steps and instrumentation, they could also act as sentinels to prevent mistakes or errors made by the operating physician and prevent complications for the patient. Otolaryngologist nurses will provide post-procedural care and can coordinate again with the pharmacist if pain medications are needed and request the treating physician to prescribe as needed. Additionally, the pharmacist can verify dosing and administration for post-operative meds such as nasal rinses, etc. Only with an interprofessional team approach involving physicians, nurses, surgical assistants, and pharmacists to balloon sinuplasty can the likelihood of positive patient outcomes be increased. [Level V]

Educate the patient and family about the disease Ensure consent has been signed Ensure that the correct nostril is to be operated upon Ease patient anxiety Monitor vital signs during and after the procedure Assist the surgeon during the procedure

While sinuplasty is done by the surgeon, a nurse is often needed to assist during the procedure. First, the nurse has to confirm which side of the nose is being treated and document it. If any sedation is to be used, the nurse must regularly monitor the vital signs. The patient's pain level has to be monitored. After the procedure, the patient must be monitored for 1 to 2 hours before discharge.