CLINICAL STUDY
Orbital Complication of Balloon Sinuplasty Mahmut Özkiriş, MD,* İbrahim Akin, MD,* Asuman Özkiriş, MD,† Reha Aydin, MD,* and Levent Saydam, MD* Abstract: Balloon sinuplasty (BS) is a relatively new conservative approach, first licensed for the treatment of chronic rhinosinusitis in 2006. The philosophy of the technique is to improve impaired sinus drainage by enlarging stenosed or obstructed natural sinus ostiums. The recent improvements in balloon sinuplasty made virtually all paranasal sinus ostiums to be safely accessible with this technique. Compared to classical endoscopic technique, the main advantage of balloon sinuplasty is the low complication rate reported. It is very seldom to encounter major complications related to critical structures such as orbits and skull base. Since its first description, very few severe complications directly attributable to the technique have been reported in literature as of today. In this article, we report a case of medial orbital wall fracture developed due to the pressure of the inflated balloon in a balloon sinuplasty procedure. Key Words: Balloon sinuplasty, orbita, complication (J Craniofac Surg 2014;25: 499–501)
C
hronic rhinosinusitis (CRS) is a common disease resulting from inflammation of the sinonasal mucosa. The underlying cause of the inflammation is multifactorial, including genetic and environmental contributions.1 Rhinosinusitis is defined as a sudden onset of 2 or more symptoms, one of which should be either nasal blockage or nasal discharge (anterior or posterior nasal drip). Other symptoms are facial pain or pressure, and impairment or loss of smell. The American Academy of Otolaryngology—Head and Neck Surgery published a clinical practice guideline in 2007 defining CRS by symptoms, clinical signs, and objective findings.1 In the clinical practice, CRS is described by having for 12 weeks or longer duration of 2 or more of the following signs and symptoms1: 1. Mucopurulent discharge 2. Nasal obstruction 3. Pressure, facial pain, or fullness or decreased sense of smell. In addition, objective findings of nasal inflammation are needed for the diagnosis. These are 1 or more of the following: 1. Purulent (not clear) mucus or edema in the middle meatus or ethmoid region From the *Department of Otolaryngology, Head and Neck Surgery, Bozok University School of Medicine, Yozgat, and †Department of Ophthalmology, Kayseri Training and Research Hospital, Kayseri, Turkey. Received December 10, 2013. Accepted for publication December 26, 2013. Address correspondence reprint requests to Mahmut Özkiriş, MD, Department of Otolaryngology, Bozok University School of Medicine, Adnan Menderes Bulvari No. 42, Yozgat, Turkey; E-mail: [email protected] The authors report no conflicts of interest. Copyright © 2014 by Mutaz B. Habal, MD ISSN: 1049-2275 DOI: 10.1097/SCS.0000000000000658
2. Polyps in the nasal cavity or the middle meatus 3. Radiographic imaging showing inflammation of the paranasal sinuses.
In an office setting, the first 2 findings can be evaluated by nasal endoscopy. CRS is best considered as a group of heterogeneous disorders from a multitude of causes that result in mild to severe symptomatic inflammation of the sinonasal mucosa.2 While CRS is defined as a chronic disease, there are concerns related to the use of systemic agents over prolonged periods. Longterm use of antibiotics and corticosteroids may lead to some adverse effects, antimicrobial resistance, and drug interactions. The development of topical therapy delivered directly to the sinonasal cavity has created an alternative treatment strategy to help potentiate these concerns.3 Rhinosinusitis (RS) poses a major health problem, substantially affecting the quality of life, productivity, and finances. According to a recent analysis of US National Health Interview Survey data, RS affects approximately 1 in 7 adults.4 The number of workdays missed annually due to RS was similar to that reported for asthma (5.67 days vs. 5.79 days, respectively), and patients with RS were more likely to spend more than $500 per year on health care than were people with chronic bronchitis.5 Endoscopic sinus surgery (ESS) is the current standard method of choice for the surgical treatment of patients with a broad spectrum of sinonasal inflammatory or non-inflammatory diseases.6,7 In CRS, the goal of ESS is to correct the impaired drainage and ventilation of the involved paranasal sinuses (PNS) enabling the proper of mucociliary function thus facilitating the drainage of these cavities and enabling the penetration of medication and solutions for nasal flushing.6,8 Despite numerous benefits compared to the conventional open procedures, ESS still has some inherent challenges and limitations, especially because it ends up with removing bone tissue and nasal mucosa fragments, which may cause bleeding; temporary physiological changes to the nasosinusal mucosa, especially the paradoxal reduction of mucociliary movements in the postoperative period; and local scar fibrosis, which leads to re-obstruction of the treated PNS. Additionally, the emerging weak points of ESS through the years like severe complications related with critical structures surrounding paranasal sinuses provoked many researchers to describe less invasive treatment options. One of the latest techniques, so-called balloon sinuplasty, was first described in 2006.7 This technique as in a similar fashion to balloon angioplasty simply consists of insertion of an inflatable balloon through the nose into the natural openings of paranasal sinuses which, when inflated, widens the ostium and facilitating the drainage of sinus cavities. A fiberoptic illumination system and nasal endoscopes are used to confirm the correct placement of balloon to the targeted sinus ostium. The absence of need for excision of any bony or mucosal structures for instrumentation prevents development of scar and synechia formation which results in uninterrupted mucociliary transportation without disturbing the natural landmarks.6–9
The Journal of Craniofacial Surgery • Volume 25, Number 2, March 2014
Copyright © 2014 Mutaz B. Habal, MD. Unauthorized reproduction of this article is prohibited.
499
The Journal of Craniofacial Surgery • Volume 25, Number 2, March 2014
Özkiriş et al
FIGURE 1. Transillumination of left frontal sinus.
FIGURE 3. Preoperative CT.
The Technical Description
were 2/3 resected and a wide synechia of right middle concha with septum were noted which was thought to be resulted also from the previous surgery. The synechia was released by radiofrequency technique (Ellman International Inc., USA). After adequate endoscopic visualization of the landmark points, the Relieva Sinus Balloon Catheter System (Acclarent Inc., Menlo Park, CA, USA) was used with a transillumination technique under endoscopic guidance. At first step, a guidewire was advanced into the right maxillary sinus ostium through the catheter, and its position was confirmed by transillumination of the sinus externally. A 5-mm balloon was then introduced and inflated up to 12 atm of pressure with a saline solution into the right maxillary sinus ostium. After routine irrigation of sinus cavity with saline solution, the instrumentation was transferred to the left nasal cavity. During endoscopic examination of the left nasal cavity, a sudden swelling of the entire right periorbital area including upper and lower eyelids was noted. Due to swollen eyelids, the eyes were not examinable. With a prediagnosis of acute periorbital collection of blood or irrigation fluid, an immediate subciliary incision of the lower orbital rim periosteum was performed. Clear fluid leaking from subcutaneous level was noted and the swelling was released immediately. An emergency ophthalmology consultation was called that revealed bilaterally normal intraocular pressures with no visible damage to orbital contents. The surgery was abandoned after this complication, and the incision was closed subdermally (Fig. 4). The early postoperative course was uneventful. The postoperative eye findings including visual acuity and eye movements bilaterally were all within normal limits. A paranasal sinus CT was taken which revealed a small fracture area on the right inferomedial orbital wall which was not present in preoperative CT (Fig. 5). The rest of the CT findings of orbital contents did not show any abnormality.
The principle is similar to that used effectively for many years in balloon angioplasty and uses a Seldinger technique. A catheter tailored to each sinus is delivered into the nose endoscopically. A guide wire is advanced into the sinus through the catheter and its position confirmed by transillumination of the sinus, visible externally (Figs. 1 and 2). Following this, the balloon is delivered over the guide wire to span the ostium. The balloon is dilated with the balloon inflation device (a screw-handle pump) that gently enlarges the ostium by creating tiny fractures of the surrounding bone and compressing soft tissue such that no mucosa is removed. The balloon is then deflated and removed. In some recently published papers, it is believed that these devices may cause benefits, when compared to conventional EES, in reducing surgery time, hospital stay, and the use of other materials, such as nasal packing.6,8,10 Whereas clinical indications still remain controversial, a few specific complications have been published to date.3,5 The case presented here is the first documentation of an inferior orbital bony wall fracture with balloon sinuplasty equipment alone.
CLINICAL REPORT A 46-year-old female patient presented to our clinic with a long-lasting history of chronic maxillary and frontal headache and postnasal drip complaints. Before admittance, she gave a 3-week history of upper respiratory tract infection, associated with disabling maxillary sinus pain due to partial response to a 7-day course of amoxicillin. The patient was re-treated with co-amoxiclav, topical oxymetazoline drops, and saline solutions combination for 3 weeks resulting in complete resolution of symptoms. A paranasal sinus CT was taken which showed an appearance of previous bilateral inferior turbinectomies and bilateral opacification of maxillary and ethmoid sinuses (Fig. 3). Upon these findings, the patient was scheduled for balloon sinuplasty under endoscopic guidance. Before hospitalization, the patient was fully informed about the procedure. Following administration of general anesthesia, the procedure was started with a thorough endoscopic examination of both nasal cavity and related structures. Bilateral inferior turbinates
FIGURE 2. Semi-flexible guide catheters of several angulations and device to inflate balloon.
500
DISCUSSION Management of chronic rhinosinusitis still continues to challenge patients and otorhinolaryngologists. CRS is a complex
FIGURE 4. The postoperative appearance at seventh day.
© 2014 Mutaz B. Habal, MD
Copyright © 2014 Mutaz B. Habal, MD. Unauthorized reproduction of this article is prohibited.
The Journal of Craniofacial Surgery • Volume 25, Number 2, March 2014
FIGURE 5. Postoperative CT.
condition with profound effects on quality of life and health care expenditure. There is now a preponderance of evidence supporting the concept that inflammation, as opposed to infection, is the dominant etiologic factor in CRS. While systemic antibiotics and steroids were a mainstay of treatment in the past, the focus is now shifting toward topical therapy, improved nasal delivery systems, and novel anti-inflammatory therapies.11 Despite recent improvements in medical treatment approaches, surgery still continues to play an important role in the management of recalcitrant disease. Introduction of state-of-the art endoscopic systems provided increased visual acuity resulting in better treatment results and lower morbidity rate. However, despite its many proven advantages, this technique may still result in serious and even fatal complications in some cases especially in unexperienced hands. In a nationwide study on 62,823 ESS cases in the United States, the overall major complication rate was 1%, of which orbital injury comprised 0.07%.11 To overcome these bothersome complications, a novel technique called balloon sinuplasty was introduced in 2006.7 The main principle of this approach is to use an inflatable balloon to enlarge the natural sinus ostiums. The pressure of the inflated balloon eventually causes submucosal microfractures in the bony canal, which results in re-formation of wider communications between the sinus cavity and nasal passages with preservation of the normal mucociliary activity.4,12 The most important advantage over the classical functional endoscopic sinus surgery approaches is achievement of ostium widening with preservation of natural landmarks that can be necessary to use in further and possibly much more extensive surgical interventions. Sinuplasty offers some other advantages compared to traditional nasal endoscopic surgery, such as decreased surgical time, shorter hospital stays, and, more importantly, lesser need for postoperative care.7,10,13 Additionally, FESS still can be reserved as an option in unsuccessful balloon cases. Owing to its conservative nature, this procedure seems to be safe with only a few complications reported, mostly insignificant.12,13 Theoretically, the following complications might occur with balloon sinuplasty: • Creation of a false passage with catheter, guide wire, or balloon into the orbital cavity or cranium. • In the sphenoid sinus, dehiscent internal carotid arteries and optic nerves might be at risk of injury, especially when the latter travel freely through the sinus—the guide wire might “wrap around” the nerve resulting in potential damage when followed by the balloon to be inflated. • Tiny bone fragments resulting from fractures induced deliberately by balloon dilatation may pierce or tear dura. • Finally, balloons may rupture when inflated at higher-thanrecommended pressure or damaged by sharp bony edges.
Complication of Balloon Sinuplasty
None of the above-listed theoretical possibilities has been reported in the literature to date, underlining the good safety profile of the technology. As of today, only 5 major complications have been reported including 1 cerebrospinal fluid (CSF) leak inferior and anterior to the sella turcica, 1 ethmoid roof CSF leak following frontal sinus balloon sinuplasty, and 1 intraoperative cardiac arrest after attempt of sinus balloon dilatation14,15 The presented appears to be the first reported case of intraoperative orbital complication directly related to the balloon sinuplasty technique in the literature. Based on the reports in the literature and our own experience, balloon sinuplasty technology has a relatively good safety profile. Whereas clinical indications still remain controversial, a few specific complications have been published to date. However, as documented in our case, the potential for complication exists both theoretically and practically. Preoperative meticulous radiological evaluation of ostial and periostial structures should always be an integral part of the procedure. Balloons must never be inflated without absolute certainty of their exact positioning confirmed by fluoroscopy or transillumination.
REFERENCES 1. Rosenfeld RM, Andes D, Bhattacharyya N, et al. Clinical practice guideline: adult sinusitis. Otolaryngol Head Neck Surg 2007;137:S1–S31 2. Benninger MS, Ferguson BJ, Hadley JA, et al. Adult chronic rhinosinusitis: definitions, diagnosis, epidemiology, and pathophysiology. Otolaryngol Head Neck Surg 2003;129:1–32 3. Cain RB, Lal D. Update on the management of chronic rhinosinusitis. Infect Drug Resist 2013;6:1–14 4. Pleis JR, Lucas JW, Ward BW. Summary health statistics for U.S. adults: National Health Interview Survey, 2008. National Center for Health Statistics. Vital Health Stat 10 2009;1–157. Available at: http://www.cdc.gov/nchs/data/series/sr_10/sr10_242.pdf. Accessed February 16, 2011 5. Bhattacharyya N. Contemporary assessment of the disease burden of sinusitis. Am J Rhinol Allergy 2009;23:392–395 6. Nogueira Júnior JF, Silva MLS, Santos FP, et al. Sinuplastia com balão: um novo conceito na cirurgia endoscópica nasal. Arq Int Otorrinolaringol 2008;12:538–545 7. Friedman M, Schalch P. Functional endoscopic dilatation of the sinuses (FEDS): patient selection and surgical technique. Op Tech Otolaryngol Head Neck Surg 2006;17:126–134 8. Bolger WE, Brown CL, Church CA, et al. Safety and outcomes of balloon catheter sinusotomy: a multicenter 24-week analysis in 115 patients. Otolaryngol Head Neck Surg 2007;137:10–20 9. Brown CL, Bolger WC. Safety and feasibility of balloon catheter dilation of paranasal sinus ostia: a preliminary investigation. Ann Otol Rhinol Laryngol 2006;115:293–299 10. Friedman M, Schalch P, Lin HC, et al. Functional endoscopic dilation of the sinuses: patient satisfaction, postoperative pain, and cost. Am J Rhinol 2008;22:204–209 11. Ramakrishnan VR, Kingdom TT, Nayak JV, et al. Nationwide incidence of major complications in endoscopic sinus surgery. Int Forum Allergy Rhinol 2012;2:34–39 12. Anon JB, Jacobs MR, Poole MD, et al. Antimicrobial treatment guidelines for acute bacterial rhinosinusitis. Otolaryngol Head Neck Surg 2004;130:1–45 13. Stamm A, Nogueira JF, Lyra M. Feasibility of balloon dilatation in endoscopic sinus surgery simulator. Otolaryngol Head Neck Surg 2009;140:320–323 14. Tomazic PV, Stammberger H, Koele W, et al. Ethmoid roof CSF leak following frontal sinus balloon sinuplasty. Rhinology 2010; 48:247–250 15. Hughes N, Bewick J, Van Der Most R, et al. A previously unreported serious adverse event during balloon sinuplasty. BMJ Case Rep 2013. 2013 pii:bcr2012007879. doi: 10.1136/bcr-2012-007879
© 2014 Mutaz B. Habal, MD
Copyright © 2014 Mutaz B. Habal, MD. Unauthorized reproduction of this article is prohibited.
501
Orbital Complication of Balloon Sinuplasty Mahmut Özkiriş, MD,* İbrahim Akin, MD,* Asuman Özkiriş, MD,† Reha Aydin, MD,* and Levent Saydam, MD* Abstract: Balloon sinuplasty (BS) is a relatively new conservative approach, first licensed for the treatment of chronic rhinosinusitis in 2006. The philosophy of the technique is to improve impaired sinus drainage by enlarging stenosed or obstructed natural sinus ostiums. The recent improvements in balloon sinuplasty made virtually all paranasal sinus ostiums to be safely accessible with this technique. Compared to classical endoscopic technique, the main advantage of balloon sinuplasty is the low complication rate reported. It is very seldom to encounter major complications related to critical structures such as orbits and skull base. Since its first description, very few severe complications directly attributable to the technique have been reported in literature as of today. In this article, we report a case of medial orbital wall fracture developed due to the pressure of the inflated balloon in a balloon sinuplasty procedure. Key Words: Balloon sinuplasty, orbita, complication (J Craniofac Surg 2014;25: 499–501)
C
hronic rhinosinusitis (CRS) is a common disease resulting from inflammation of the sinonasal mucosa. The underlying cause of the inflammation is multifactorial, including genetic and environmental contributions.1 Rhinosinusitis is defined as a sudden onset of 2 or more symptoms, one of which should be either nasal blockage or nasal discharge (anterior or posterior nasal drip). Other symptoms are facial pain or pressure, and impairment or loss of smell. The American Academy of Otolaryngology—Head and Neck Surgery published a clinical practice guideline in 2007 defining CRS by symptoms, clinical signs, and objective findings.1 In the clinical practice, CRS is described by having for 12 weeks or longer duration of 2 or more of the following signs and symptoms1: 1. Mucopurulent discharge 2. Nasal obstruction 3. Pressure, facial pain, or fullness or decreased sense of smell. In addition, objective findings of nasal inflammation are needed for the diagnosis. These are 1 or more of the following: 1. Purulent (not clear) mucus or edema in the middle meatus or ethmoid region From the *Department of Otolaryngology, Head and Neck Surgery, Bozok University School of Medicine, Yozgat, and †Department of Ophthalmology, Kayseri Training and Research Hospital, Kayseri, Turkey. Received December 10, 2013. Accepted for publication December 26, 2013. Address correspondence reprint requests to Mahmut Özkiriş, MD, Department of Otolaryngology, Bozok University School of Medicine, Adnan Menderes Bulvari No. 42, Yozgat, Turkey; E-mail: [email protected] The authors report no conflicts of interest. Copyright © 2014 by Mutaz B. Habal, MD ISSN: 1049-2275 DOI: 10.1097/SCS.0000000000000658
2. Polyps in the nasal cavity or the middle meatus 3. Radiographic imaging showing inflammation of the paranasal sinuses.
In an office setting, the first 2 findings can be evaluated by nasal endoscopy. CRS is best considered as a group of heterogeneous disorders from a multitude of causes that result in mild to severe symptomatic inflammation of the sinonasal mucosa.2 While CRS is defined as a chronic disease, there are concerns related to the use of systemic agents over prolonged periods. Longterm use of antibiotics and corticosteroids may lead to some adverse effects, antimicrobial resistance, and drug interactions. The development of topical therapy delivered directly to the sinonasal cavity has created an alternative treatment strategy to help potentiate these concerns.3 Rhinosinusitis (RS) poses a major health problem, substantially affecting the quality of life, productivity, and finances. According to a recent analysis of US National Health Interview Survey data, RS affects approximately 1 in 7 adults.4 The number of workdays missed annually due to RS was similar to that reported for asthma (5.67 days vs. 5.79 days, respectively), and patients with RS were more likely to spend more than $500 per year on health care than were people with chronic bronchitis.5 Endoscopic sinus surgery (ESS) is the current standard method of choice for the surgical treatment of patients with a broad spectrum of sinonasal inflammatory or non-inflammatory diseases.6,7 In CRS, the goal of ESS is to correct the impaired drainage and ventilation of the involved paranasal sinuses (PNS) enabling the proper of mucociliary function thus facilitating the drainage of these cavities and enabling the penetration of medication and solutions for nasal flushing.6,8 Despite numerous benefits compared to the conventional open procedures, ESS still has some inherent challenges and limitations, especially because it ends up with removing bone tissue and nasal mucosa fragments, which may cause bleeding; temporary physiological changes to the nasosinusal mucosa, especially the paradoxal reduction of mucociliary movements in the postoperative period; and local scar fibrosis, which leads to re-obstruction of the treated PNS. Additionally, the emerging weak points of ESS through the years like severe complications related with critical structures surrounding paranasal sinuses provoked many researchers to describe less invasive treatment options. One of the latest techniques, so-called balloon sinuplasty, was first described in 2006.7 This technique as in a similar fashion to balloon angioplasty simply consists of insertion of an inflatable balloon through the nose into the natural openings of paranasal sinuses which, when inflated, widens the ostium and facilitating the drainage of sinus cavities. A fiberoptic illumination system and nasal endoscopes are used to confirm the correct placement of balloon to the targeted sinus ostium. The absence of need for excision of any bony or mucosal structures for instrumentation prevents development of scar and synechia formation which results in uninterrupted mucociliary transportation without disturbing the natural landmarks.6–9
The Journal of Craniofacial Surgery • Volume 25, Number 2, March 2014
Copyright © 2014 Mutaz B. Habal, MD. Unauthorized reproduction of this article is prohibited.
499
The Journal of Craniofacial Surgery • Volume 25, Number 2, March 2014
Özkiriş et al
FIGURE 1. Transillumination of left frontal sinus.
FIGURE 3. Preoperative CT.
The Technical Description
were 2/3 resected and a wide synechia of right middle concha with septum were noted which was thought to be resulted also from the previous surgery. The synechia was released by radiofrequency technique (Ellman International Inc., USA). After adequate endoscopic visualization of the landmark points, the Relieva Sinus Balloon Catheter System (Acclarent Inc., Menlo Park, CA, USA) was used with a transillumination technique under endoscopic guidance. At first step, a guidewire was advanced into the right maxillary sinus ostium through the catheter, and its position was confirmed by transillumination of the sinus externally. A 5-mm balloon was then introduced and inflated up to 12 atm of pressure with a saline solution into the right maxillary sinus ostium. After routine irrigation of sinus cavity with saline solution, the instrumentation was transferred to the left nasal cavity. During endoscopic examination of the left nasal cavity, a sudden swelling of the entire right periorbital area including upper and lower eyelids was noted. Due to swollen eyelids, the eyes were not examinable. With a prediagnosis of acute periorbital collection of blood or irrigation fluid, an immediate subciliary incision of the lower orbital rim periosteum was performed. Clear fluid leaking from subcutaneous level was noted and the swelling was released immediately. An emergency ophthalmology consultation was called that revealed bilaterally normal intraocular pressures with no visible damage to orbital contents. The surgery was abandoned after this complication, and the incision was closed subdermally (Fig. 4). The early postoperative course was uneventful. The postoperative eye findings including visual acuity and eye movements bilaterally were all within normal limits. A paranasal sinus CT was taken which revealed a small fracture area on the right inferomedial orbital wall which was not present in preoperative CT (Fig. 5). The rest of the CT findings of orbital contents did not show any abnormality.
The principle is similar to that used effectively for many years in balloon angioplasty and uses a Seldinger technique. A catheter tailored to each sinus is delivered into the nose endoscopically. A guide wire is advanced into the sinus through the catheter and its position confirmed by transillumination of the sinus, visible externally (Figs. 1 and 2). Following this, the balloon is delivered over the guide wire to span the ostium. The balloon is dilated with the balloon inflation device (a screw-handle pump) that gently enlarges the ostium by creating tiny fractures of the surrounding bone and compressing soft tissue such that no mucosa is removed. The balloon is then deflated and removed. In some recently published papers, it is believed that these devices may cause benefits, when compared to conventional EES, in reducing surgery time, hospital stay, and the use of other materials, such as nasal packing.6,8,10 Whereas clinical indications still remain controversial, a few specific complications have been published to date.3,5 The case presented here is the first documentation of an inferior orbital bony wall fracture with balloon sinuplasty equipment alone.
CLINICAL REPORT A 46-year-old female patient presented to our clinic with a long-lasting history of chronic maxillary and frontal headache and postnasal drip complaints. Before admittance, she gave a 3-week history of upper respiratory tract infection, associated with disabling maxillary sinus pain due to partial response to a 7-day course of amoxicillin. The patient was re-treated with co-amoxiclav, topical oxymetazoline drops, and saline solutions combination for 3 weeks resulting in complete resolution of symptoms. A paranasal sinus CT was taken which showed an appearance of previous bilateral inferior turbinectomies and bilateral opacification of maxillary and ethmoid sinuses (Fig. 3). Upon these findings, the patient was scheduled for balloon sinuplasty under endoscopic guidance. Before hospitalization, the patient was fully informed about the procedure. Following administration of general anesthesia, the procedure was started with a thorough endoscopic examination of both nasal cavity and related structures. Bilateral inferior turbinates
FIGURE 2. Semi-flexible guide catheters of several angulations and device to inflate balloon.
500
DISCUSSION Management of chronic rhinosinusitis still continues to challenge patients and otorhinolaryngologists. CRS is a complex
FIGURE 4. The postoperative appearance at seventh day.
© 2014 Mutaz B. Habal, MD
Copyright © 2014 Mutaz B. Habal, MD. Unauthorized reproduction of this article is prohibited.
The Journal of Craniofacial Surgery • Volume 25, Number 2, March 2014
FIGURE 5. Postoperative CT.
condition with profound effects on quality of life and health care expenditure. There is now a preponderance of evidence supporting the concept that inflammation, as opposed to infection, is the dominant etiologic factor in CRS. While systemic antibiotics and steroids were a mainstay of treatment in the past, the focus is now shifting toward topical therapy, improved nasal delivery systems, and novel anti-inflammatory therapies.11 Despite recent improvements in medical treatment approaches, surgery still continues to play an important role in the management of recalcitrant disease. Introduction of state-of-the art endoscopic systems provided increased visual acuity resulting in better treatment results and lower morbidity rate. However, despite its many proven advantages, this technique may still result in serious and even fatal complications in some cases especially in unexperienced hands. In a nationwide study on 62,823 ESS cases in the United States, the overall major complication rate was 1%, of which orbital injury comprised 0.07%.11 To overcome these bothersome complications, a novel technique called balloon sinuplasty was introduced in 2006.7 The main principle of this approach is to use an inflatable balloon to enlarge the natural sinus ostiums. The pressure of the inflated balloon eventually causes submucosal microfractures in the bony canal, which results in re-formation of wider communications between the sinus cavity and nasal passages with preservation of the normal mucociliary activity.4,12 The most important advantage over the classical functional endoscopic sinus surgery approaches is achievement of ostium widening with preservation of natural landmarks that can be necessary to use in further and possibly much more extensive surgical interventions. Sinuplasty offers some other advantages compared to traditional nasal endoscopic surgery, such as decreased surgical time, shorter hospital stays, and, more importantly, lesser need for postoperative care.7,10,13 Additionally, FESS still can be reserved as an option in unsuccessful balloon cases. Owing to its conservative nature, this procedure seems to be safe with only a few complications reported, mostly insignificant.12,13 Theoretically, the following complications might occur with balloon sinuplasty: • Creation of a false passage with catheter, guide wire, or balloon into the orbital cavity or cranium. • In the sphenoid sinus, dehiscent internal carotid arteries and optic nerves might be at risk of injury, especially when the latter travel freely through the sinus—the guide wire might “wrap around” the nerve resulting in potential damage when followed by the balloon to be inflated. • Tiny bone fragments resulting from fractures induced deliberately by balloon dilatation may pierce or tear dura. • Finally, balloons may rupture when inflated at higher-thanrecommended pressure or damaged by sharp bony edges.
Complication of Balloon Sinuplasty
None of the above-listed theoretical possibilities has been reported in the literature to date, underlining the good safety profile of the technology. As of today, only 5 major complications have been reported including 1 cerebrospinal fluid (CSF) leak inferior and anterior to the sella turcica, 1 ethmoid roof CSF leak following frontal sinus balloon sinuplasty, and 1 intraoperative cardiac arrest after attempt of sinus balloon dilatation14,15 The presented appears to be the first reported case of intraoperative orbital complication directly related to the balloon sinuplasty technique in the literature. Based on the reports in the literature and our own experience, balloon sinuplasty technology has a relatively good safety profile. Whereas clinical indications still remain controversial, a few specific complications have been published to date. However, as documented in our case, the potential for complication exists both theoretically and practically. Preoperative meticulous radiological evaluation of ostial and periostial structures should always be an integral part of the procedure. Balloons must never be inflated without absolute certainty of their exact positioning confirmed by fluoroscopy or transillumination.
REFERENCES 1. Rosenfeld RM, Andes D, Bhattacharyya N, et al. Clinical practice guideline: adult sinusitis. Otolaryngol Head Neck Surg 2007;137:S1–S31 2. Benninger MS, Ferguson BJ, Hadley JA, et al. Adult chronic rhinosinusitis: definitions, diagnosis, epidemiology, and pathophysiology. Otolaryngol Head Neck Surg 2003;129:1–32 3. Cain RB, Lal D. Update on the management of chronic rhinosinusitis. Infect Drug Resist 2013;6:1–14 4. Pleis JR, Lucas JW, Ward BW. Summary health statistics for U.S. adults: National Health Interview Survey, 2008. National Center for Health Statistics. Vital Health Stat 10 2009;1–157. Available at: http://www.cdc.gov/nchs/data/series/sr_10/sr10_242.pdf. Accessed February 16, 2011 5. Bhattacharyya N. Contemporary assessment of the disease burden of sinusitis. Am J Rhinol Allergy 2009;23:392–395 6. Nogueira Júnior JF, Silva MLS, Santos FP, et al. Sinuplastia com balão: um novo conceito na cirurgia endoscópica nasal. Arq Int Otorrinolaringol 2008;12:538–545 7. Friedman M, Schalch P. Functional endoscopic dilatation of the sinuses (FEDS): patient selection and surgical technique. Op Tech Otolaryngol Head Neck Surg 2006;17:126–134 8. Bolger WE, Brown CL, Church CA, et al. Safety and outcomes of balloon catheter sinusotomy: a multicenter 24-week analysis in 115 patients. Otolaryngol Head Neck Surg 2007;137:10–20 9. Brown CL, Bolger WC. Safety and feasibility of balloon catheter dilation of paranasal sinus ostia: a preliminary investigation. Ann Otol Rhinol Laryngol 2006;115:293–299 10. Friedman M, Schalch P, Lin HC, et al. Functional endoscopic dilation of the sinuses: patient satisfaction, postoperative pain, and cost. Am J Rhinol 2008;22:204–209 11. Ramakrishnan VR, Kingdom TT, Nayak JV, et al. Nationwide incidence of major complications in endoscopic sinus surgery. Int Forum Allergy Rhinol 2012;2:34–39 12. Anon JB, Jacobs MR, Poole MD, et al. Antimicrobial treatment guidelines for acute bacterial rhinosinusitis. Otolaryngol Head Neck Surg 2004;130:1–45 13. Stamm A, Nogueira JF, Lyra M. Feasibility of balloon dilatation in endoscopic sinus surgery simulator. Otolaryngol Head Neck Surg 2009;140:320–323 14. Tomazic PV, Stammberger H, Koele W, et al. Ethmoid roof CSF leak following frontal sinus balloon sinuplasty. Rhinology 2010; 48:247–250 15. Hughes N, Bewick J, Van Der Most R, et al. A previously unreported serious adverse event during balloon sinuplasty. BMJ Case Rep 2013. 2013 pii:bcr2012007879. doi: 10.1136/bcr-2012-007879
© 2014 Mutaz B. Habal, MD
Copyright © 2014 Mutaz B. Habal, MD. Unauthorized reproduction of this article is prohibited.
501
