Original Research
An Analysis of Adverse Event Reporting in Balloon Sinus Procedures Anthony Prince, MD1 and Neil Bhattacharyya, MD1
Otolaryngology– Head and Neck Surgery 1–6 Ó American Academy of Otolaryngology—Head and Neck Surgery Foundation 2016 Reprints and permission: sagepub.com/journalsPermissions.nav DOI: 10.1177/0194599815627779 http://otojournal.org
Sponsorships or competing interests that may be relevant to content are disclosed at the end of this article.
Received September 17, 2015; revised December 16, 2015; accepted December 30, 2015.
Abstract Objective. (1) Become familiar with reported adverse events related to balloon dilation of the paranasal sinus ostia. (2) Understand the sequelae occurring with these events.
C
Study Design. Retrospective analysis of a prospective database. Setting. OpenFDA database. Subjects and Methods. The OpenFDA program website of the Food and Drug Administration was queried with the Application Program Interface query system for medical device adverse events involving balloon devices for the dilation of paranasal sinus ostia from January 2006 through December 2014. The raw data were then tabulated, with adverse events codified by event type, sinus involved, injury type, device malfunction, surgeon error, and qualitative data. Sequelae were also quantified. Results. In sum, 114 adverse events were identified. Patient injury was the most frequently reported adverse event (n = 72), followed by 36 device malfunctions, 4 deaths, and 2 unclassified. The most common injury involved orbital complications, including 23 (20.2%) orbital wall fractures and 22 (19.3%) postseptal and 22 (19.3%) preseptal orbital injuries. In addition, there were 17 (14.9%) skull base injuries and 7 (6.1%) cases of severe epistaxis observed; 11 (9.6%) cases mentioned surgeon error. Cerebrospinal fluid leak was significantly associated with frontal surgery (P = .002) and sphenoid surgery (P = .001), whereas post- and preseptal orbital injury was associated with maxillary surgery (P = .017 and P = .002). Epistaxis was associated with sphenoid surgery (P = .032). Conclusions. Based on the number of balloon sinus procedures performed, Food and Drug Administration–reported adverse events are uncommon, although a select portion can be severe. Surgeons should be aware of different complications reported with specific sinuses addressed with balloon techniques. Keywords balloon sinus dilation, adverse events, paranasal sinuses, sinus surgery, chronic rhinosinusitis
hronic rhinosinusitis affects approximately 4.9% of the US adult population, and .600,000 ambulatory sinonasal operations are conducted each year with a low perioperative complication rate.1-3 The use of balloon devices for the dilation of paranasal sinus ostia represents a relatively new tool in the surgical management of chronic rhinosinusitis. First introduced into clinical practice in 2006, this technology relies on catheter-based dilation of the paranasal sinuses to relieve ostial obstruction associated with chronic sinonasal inflammatory disease. Several studies have investigated this technology and provided justification for its clinical use in functional endoscopic sinus surgery candidates.4-10 Bolger and Vaughan performed a human cadaver study in 2006 and concluded that catheter-based dilation of the paranasal sinus ostia is both feasible and safe with respect to avoiding surrounding critical structures, including the skull base and orbit.4 This seminal investigation was later followed by a small prospective cohort study in which balloon dilation was performed on the frontal, maxillary, and sphenoid sinuses without any reported adverse events.5 The success of this preliminary clinical study prompted a larger, multi-institutional, prospective analysis in which balloon dilation was employed either alone or as an adjunct to a standard functional endoscopic sinus surgery procedure. While nonrandomized, this study demonstrated high ostial-patency rates, improved patient symptoms, and no adverse complications over a 2-year period.6-8 Despite these positive results and the now widespread use of this technology, relatively little is known about the rate and nature of adverse events reported with balloon catheter dilation. Melroy examined the topic in 2008 by surveying the Food and Drug Administration’s (FDA’s)
1 Department of Otology and Laryngology, Harvard Medical School, Boston, Massachusetts, USA
This article was presented at the 2015 AAO-HNSF Annual Meeting & OTO EXPO; September 27-30, 2015; Dallas, Texas. Corresponding Author: Anthony Prince, MD, Division of Otolaryngology, Harvard Medical School, 45 Francis Street, Boston, MA 02115, USA. Email: [email protected]
Downloaded from oto.sagepub.com at Middle East Technical Univ on February 18, 2016
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Manufacturer and User Facility Device Experience database for adverse events associated with the procedure.11 He found only 3 reported complications and concluded that the complication rate associated with this innovative catheterbased technique was exceedingly low.11 Since this publication, there have been only sporadic case reports highlighting complications associated with balloon dilation of the paranasal sinus ostia.12,13 Yet, to date, no systematic analysis of adverse events associated with balloon dilation has been performed despite the technology’s widespread use. Utilizing the OpenFDA website for medical device adverse event reporting, this study sought to evaluate the types and distribution of adverse events associated with balloon dilation procedures and to understand the specific sequelae arising from complications related to balloon dilation of the paranasal sinus ostia.
Methods The OpenFDA website maintained by the FDA was queried via the Application Program Interface query system (accessed January 2015) for medical device adverse event reports pertaining to balloon devices for dilation of paranasal sinuses from January 2006 through December 2014. The extracted data were scrutinized for balloon devices being used in the paranasal region and by common manufacturers of balloon sinus dilation devices. The type of reporter disclosing the adverse event was also recorded. Cases were excluded in which a balloon device was used for nonsinus purposes (eg, tracheal dilatation or eustachian tube dilatation). The raw data for adverse events were tabulated in Microsoft Excel and then codified into the following categories: type of adverse event, specific paranasal sinus or sinuses involved, type of injuries sustained, whether or not a device malfunction occurred, whether or not surgeon error was ascribed, along with qualitative data in the free-form text field of the adverse event report. Cases were also noted in which a balloon-only procedure was performed as compared with a hybrid procedure employing rigid instrumentation. Adverse events were further classified as death, injury, device malfunction, or other. Patient complications and associated sequelae, when occurring, were also tabulated according to type: skull base injury, cerebrospinal fluid (CSF) leak, meningitis, pneumocephalus, intracranial abscess, orbital wall fracture, postseptal orbital injury, preseptal orbital injury, visual sequela, and severe epistaxis. Device malfunctions were classified as device retention, device fracture, device rupture, and device impaction. Device retention denoted those cases in which a portion of the device was retained as a foreign body and may have required an unintended procedure for extraction. By comparison, device impaction referred to those cases in which a portion of the device became lodged at the intended site of ostial dilation. Associations were analyzed between specific sequelae and the paranasal sinuses involved in the balloon adverse event with chi-square testing in SPSS 22.0 (IBM, Chicago,
Illinois). Significance was set at P = .05. Similar analyses were conducted for the type of device-related adverse event, surgeon error, and the occurrence of individual sequelae. As the data analyzed for the purposes of this study are in the public domain, this study was reviewed by our hospital’s committee on clinical investigations and deemed exempt from review.
Results From 2006 to 2014, a total of 114 adverse events were reported and recorded in the FDA database with respect to balloon sinus complications. The majority of cases were reported by health care professionals, including physicians (n = 79), non-MD health care professionals (n = 3), and risk managers (n = 3). One undisclosed voluntary reporter was also noted. Company representatives disclosed 26 cases, including 3 events discovered through a literature search. Among the events, 53.5% involved the maxillary sinus; 11.2%, the sphenoid sinus; and 44.7%, the frontal sinus. Forty-seven adverse events involved a balloon-only procedure, while 22 adverse events were in the setting of a hybrid procedure. In 45 cases, this particular information was unknown. In total, there were 36 (31.6%) cases of device malfunction, 72 (63.2%) cases of patient injury, 4 (3.5%) deaths, and 2 (1.8%) unclassified events. In 11 cases (9.6%), there was discrete text indicating surgeon error with the balloon device. In the majority of cases, there was insufficient information to ascertain whether the adverse event occurred in the setting of an initial or revision surgery. Table 1 lists the overall distribution of injuries that were noted among the adverse balloon dilation events. In total, 17 cases resulted in a skull base injury, with the majority (n = 15) developing a CSF leak noted either intraoperatively or in the immediate postoperative period. In 4 of these cases, there was a concern that a skull base defect may have been present preoperatively (2 patients with prior head trauma, 1 with a history of extensive sinus surgery for hemangiopericytoma, and 1 with multiple prior sinus operations in the setting of cystic fibrosis). Among other intracranial injuries, 1 case of postoperative meningitis with a subsequent death was observed in a hybrid procedure that involved an endoscopic ethmoidectomy. The exact sinus dilated during this case was not specified. Last, 1 case of an intracranial abscess was observed following a hybrid procedure that involved both frontal and maxillary balloon dilations. This case necessitated neurosurgical intervention with a resultant craniotomy and drainage of a frontal lobe abscess; long-term sequela to the patient was not reported. The most common injury related to balloon sinus dilation involved the orbit (Table 1). Among these, 13 cases required a lateral canthotomy; 3, a medial orbital decompression; and 1, a subciliary incision following preseptal edema. In addition, 7 cases noted visual complications as a result of an orbital injury, including pain with medial gaze and blurry vision. These visual complications for the most part were transitory; however, 1 case did specifically note a long-term visual deficit following a postseptal orbital injury.
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Table 1. Distribution of Injuries Reported in Balloon Dilation Procedures of the Paranasal Sinus Ostia. Injury Type Skull base Skull base injury with CSF leak Skull base injury without CSF leak Meningitis Pneumocephalus Intracranial abscess Orbital Orbital wall fracture Preseptal orbital injury Postseptal orbital injury Permanent visual sequelae Severe epistaxis
n
%a
15 2 1 1 1
13.2 1.8 0.9 0.9 0.9
23 22 22 1 7
20.2 19.3 19.3 0.9 6.1
Abbreviation: CSF, cerebrospinal fluid. a Percentage among reported complications.
Table 3 presents the associations between the sinus involved with the balloon procedure and the type of complication or sequela observed. CSF leak was significantly associated with frontal surgery (P = .002) and sphenoid surgery (P = .001), whereas post- and preseptal orbital injury was significantly associated with maxillary surgery (P = .017 and P = .002, respectively). Severe epistaxis was significantly associated with sphenoid surgery (P = .032). Table 4 outlines the associations among device malfunction, surgeon error, and type of complication or sequela observed. No device malfunction was reported in the majority of cases, with patient-related complications including severe epistaxis, skull base, and orbital injuries. With the exception of severe epistaxis, these findings were statistically significant. Surgeon error was not significantly associated with any of the complications or sequelae enumerated in the database.
Discussion
Table 2. Type of Device Malfunctions Reported in Balloon Dilation Procedures of the Paranasal Sinus Ostia. Malfunction Type
n
%a
Fracture Rupture Retention Other Impaction
27 9 4 4 1
23.7 7.9 3.5 3.5 0.9
a
Percentage among reported cases.
Table 2 describes the various types of device malfunctions occurring during balloon dilation procedures associated with an adverse event in the FDA database. The most common malfunction was device fracture, with a total of 27 cases enumerated in the database. In 21 of these cases, the distal tip of the guide wire fractured during the dilation procedure. The causes reported for this varied and included inappropriate bending of the nonmalleable tip, using excessive force, or using a damaged guide wire. There were 4 cases of device retention, 1 of which required additional surgical intervention for extraction. Among the ‘‘other’’ category, there were 2 failures of balloon inflation, 1 failure of balloon deflation, and 1 failure of instrument tracking. As previously mentioned, there were 4 deaths reported in the database. The first was previously discussed and involved an uncomplicated hybrid procedure that was followed by postoperative meningitis. The second death was attributed to surgeon error following an off-label use of a balloon device used through a frontal sinus trephination that resulted in a postoperative seizure and death. The remaining 2 deaths were thought to be unrelated to the actual dilation procedure (1 sudden cardiac arrest and 1 massive postoperative intracranial bleed following uncomplicated maxillary balloon sinus dilatation).
Based on data submitted to the FDA over a 9-year period following the introduction of balloon dilation technology, the current results indicate a wide distribution of adverse events. The FDA database captures mandatory reporters (including manufacturers and device-user facilities) as well as voluntary reporters (including health care professionals and consumers). In total, there were 114 adverse events that specifically involved balloon catheter ostial dilation. The distribution of these events varied widely in terms of severity. Device malfunction was the most common reason for an adverse event that did not involve a patient injury. While device malfunction accounted for nearly one-third of adverse events, it did not appear to be associated with patient complications. Severe adverse events were also noted and included patient injury and death. The majority of adverse events involved maxillary sinus balloon dilation (53.5%), followed closely by frontal sinus dilation (44.7%). The results of this analysis also indicate that balloon dilation complications vary according to the sinus dilated, a finding that is of particular importance to the operating surgeon. Balloon dilation of the maxillary sinus was significantly associated with a range of orbital injuries, including orbital wall fractures and pre- and postseptal orbital complications. Likewise, balloon dilation of the frontal and sphenoid sinuses was found to be significantly associated with skull base injuries, including CSF leak. In addition, sphenoid sinus ostial dilation was significantly associated with severe epistaxis. While each sinus was associated with a different set of complications, surgeon error was not associated with any of the reported adverse events. The findings of the study are salient in that they are among the first in the literature to show the risk associated with balloon dilation of each paranasal sinus. Prior studies have reported minimal to no adverse events associated with balloon dilation technology. Bolger and Vaughan performed a human cadaveric study in 2006 to examine the safety of balloon sinus dilation and did not report any damage to the lamina papyracea or the lateral lamella of the cribriform
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Table 3. Association between Specific Complication or Sequela Observed and Sinus Involved in Balloon Dilation.a Complication/Sequela Skull base injury No Yes CSF leak No Yes Orbital wall fracture No Yes Postseptal orbital injury No Yes Preseptal orbital injury No Yes Severe epistaxis No Yes
Maxillary Sinus Dilation, %
P Value
Frontal Sinus Dilation, %
P Value
Sphenoid Sinus Dilation, %
P Value
58.9 29.4
.034
36.8 82.4
.001
7.4 35.3
.005
56.8 33.3
.103
36.8 80.0
.002
6.3 40.0
.001
43.9 82.6
.002
51.2 30.4
.099
13.4 8.7
.729
48.3 77.3
.017
48.3 36.4
.349
13.5 4.5
.304
45.6 86.4
.001
48.9 31.8
.162
12.2 9.1
.741
55.7 28.6
.245
43.4 71.4
.241
9.4 42.9
.032
Abbreviation: CSF, cerebrospinal fluid. a Bold P value indicates statistical significance (P \.05).
Table 4. Association between Complication or Sequela Observed and Device Malfunction and Surgeon Error. Complication/Sequela
Device Malfunction, %
P Value
Surgeon Error, %
P Value
37.9 6.3
.019
8.4 20.0
.352
37.9 7.1
.032
8.4 21.4
.155
42.7 8.7
.003
9.7 15.8
.682
39.3 9.1
.010
11.8 9.5
1.000
41.1 0.0
.000
12.5 5.3
.463
34.9 0.0
.094
12.0 0.0
.600
Skull base injury No Yes CSF leak No Yes Orbital wall fracture No Yes Postseptal orbital injury No Yes Preseptal orbital injury No Yes Severe epistaxis No Yes Abbreviation: CSF, cerebrospinal fluid. a Bold P value indicates statistical significance (P \.05).
plate in their study.4 A nonrandomized prospective cohort study of 10 endoscopic sinus surgery patients who successfully underwent balloon catheter–based dilation of the frontal, maxillary, and sphenoid sinuses corroborated this finding and showed that the technology is safe without any
reported adverse events.5 A multicenter prospective nonrandomized study dubbed the CLEAR trial enrolled 115 patients who underwent balloon-only and hybrid procedures, and it found a high level of ostial patency over a 2-year period and improved patient symptoms. In this study, the
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only adverse event reported was device malfunction, which was noted in 12 of 358 dilated sinuses. This included balloon rupture, tip malfunction, and failure of timely deflation; however, there were no cases of CSF leak, orbital injury, or severe epistaxis observed in this multicenter trial.6-8 In addition, a similarly designed multi-institutional prospective study that involved 203 patients examined the efficacy and safety of office-based balloon sinus dilation, and it also concluded that the procedure is safe and effective, noting only 1 adverse event reported—namely, transient periorbital swelling.14 One reason for the difference observed in the degree of adverse events between this study and prior studies may involve patient selection. Prior clinical studies used strict exclusion criteria to optimize safety and reduce the potential for adverse events. Patients in the CLEAR trial, for example, were systemically excluded if there was a history of extensive sinonasal inflammatory polyps, prior extensive sinonasal surgery, severe osteoneogenesis, sinonasal malignancy, a history of facial trauma with distorted sinus anatomy, and cystic fibrosis. Unlike these clinical trials, the cases in this analysis reporting an adverse event to the OpenFDA database contained patients with many of these particular conditions, including prior head trauma, extensive prior sinonasal surgery, cystic fibrosis, and sinonasal malignancy. In several of these cases reported in the database, the reporter was concerned that a preoperative bony dehiscence as well as altered sinus anatomy could have contributed to the development of patient injury. This difference in patient characteristics may speak then to both the importance of patient selection and the surgeon’s experience in mitigating the potential for adverse events associated with balloon sinus procedures. The strength of this study includes the fact that it draws on a large database designed to monitor device performance and detect device-related adverse events. This characteristic of the study enables an examination on how balloon dilation technology operates in the real-world environment, outside of clinical trials with strict inclusion and exclusion criteria. However, this study also contains weaknesses, which may limit the generalizability of its findings. First, the data obtained from the OpenFDA website cannot be used to determine rates of adverse events, which would help to compare safety with that of functional endoscopic sinus surgery employing rigid instrumentation. Second, while the database invites reporting from device manufactures, health care professionals, user facilities, and consumers alike, it leads to a fair degree of variability in the depth of adverse events reporting, which can result in inconsistent results and also possible underreporting of events. That said, the level of voluntary reporting in our study was exceedingly robust, with approximately 86 of 114 adverse events being voluntarily reported to the FDA website. Additionally, the fact that significant associations were noted between the sinus dilated and the complications observed, despite the shortcomings of a voluntary reporting system, strengthens our conclusions rather than weakens them.
The findings from this study should prompt surgeons to consider the complications associated with balloon sinus dilation of each sinus. Future studies will need to better elucidate the factors that might predispose to particular injuries based on the sinus dilated. For example, does a certain Keros skull base classification correlate with an increased risk of a skull base injury with frontal sinus dilation? Moreover, does the use of irrigation of the maxillary sinus after submucosal microfracture of the lamina papyracea increase the risk of periorbital complications? Answering these questions will require a thorough understanding of not only patient anatomic factors but also differences in dilation techniques and the level of surgeon expertise in performing the procedure. Future researchers may also want to consider evaluating the rate of complications associated with balloon catheter sinus dilation by not only relying on queries from centralized databases but also utilizing the current CPT codes specific to balloon dilation procedures to better compare the safety profile of balloon dilation technology with that of standard rigid functional endoscopic surgery.
Conclusion Based on the large number of balloon sinus procedures performed annually, FDA-reported adverse events are uncommon, although a select fraction can be severe. Surgeons should be aware of different complications reported with specific sinuses addressed with balloon techniques, as well as the potential for device failure and associated complications. Author Contributions Anthony Prince, responsible for the acquisition, analysis and interpretation of data for the project, as well as drafting, critically revising, and providing final approval of the work; ensured the accuracy and integrity of the submitted work; Neil Bhattacharyya, responsible for the conception, analysis and interpretation of data for the project, as well as drafting, critically revising, and providing final approval of the work; ensured the accuracy and integrity of the submitted work.
Disclosures Competing interests: Anthony Prince, consultant for Knopp Biosciences, LLC; Neil Bhattacharyya, consultant for IntersectENT, Entellus, Inc and Sanofi, Inc. Sponsorships: None. Funding source: None.
References 1. Bhattacharyya N. Ambulatory sinus and nasal surgery in the United States: demographics and perioperative outcomes. Laryngoscope. 2010;120:635-638. 2. Bhattacharyya N. Incremental health care utilization and expenditures for chronic rhinosinusitis in the United States. Ann Otol Rhinol Laryngol. 2011;120:423-427. 3. Bhattacharyya N. Unplanned revisits and readmissions after ambulatory sinonasal surgery. Laryngoscope. 2014;124: 1983-1987.
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4. Bolger WE, Vaughan WC. Catheter-based dilation of the sinus ostia: initial safety and feasibility analysis in a cadaver model. Am J Rhinol. 2006;20:290-294. 5. Brown CL, Bolger WE. Safety and feasibility of balloon catheter dilation of paranasal sinus ostia: a preliminary investigation. Ann Otol Rhinol Laryngol. 2006;115:293-299. 6. 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. 7. Kuhn FA, Church CA, Goldberg AN, et al. Balloon catheter sinusotomy: one-year follow-up—outcomes and role in functional endoscopic sinus surgery. Otolaryngol Head Neck Surg. 2008;139(3)(suppl 3):S27-S37. 8. Weiss RL, Church CA, Kuhn FA, Levine HL, Sillers MJ, Vaughan WC. Long-term outcome analysis of balloon catheter sinusotomy: two-year follow-up. Otolaryngol Head Neck Surg. 2008;139(3)(suppl 3):S38-S46. 9. Plaza G, Eisenberg G, Montojo J, Onrubia T, Urbasos M, O’Connor C. Balloon dilation of the frontal recess: a
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randomized clinical trial. Ann Otol Rhinol Laryngol. 2011;120: 511-518. Levine HL, Sertich AP 2nd, Hoisington DR, Weiss RL, Pritikin J; PatiENT Registry Study Group. Multicenter registry of balloon catheter sinusotomy outcomes for 1,036 patients. Ann Otol Rhinol Laryngol. 2008;117:263-270. Melroy CT. The balloon dilating catheter as an instrument in sinus surgery. Otolaryngol Head Neck Surg. 2008;139(3) (suppl 3):S23-S26. Tomazic PV, Stammberger H, Koele W, Gerstenberger C. Ethmoid roof CSF-leak following frontal sinus balloon sinuplasty. Rhinology. 2010;48:247-250. Ozkiris M, Akin I, Ozkiris A, Aydin R, Saydam L. Orbital complication of balloon sinuplasty. J Craniofac Surg. 2014;25: 499-501. Karanfilov B, Silvers S, Pasha R, et al. Office-based balloon sinus dilation: a prospective, multicenter study of 203 patients. Int Forum Allergy Rhinol. 2013;3:404-411.
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An Analysis of Adverse Event Reporting in Balloon Sinus Procedures Anthony Prince, MD1 and Neil Bhattacharyya, MD1
Otolaryngology– Head and Neck Surgery 1–6 Ó American Academy of Otolaryngology—Head and Neck Surgery Foundation 2016 Reprints and permission: sagepub.com/journalsPermissions.nav DOI: 10.1177/0194599815627779 http://otojournal.org
Sponsorships or competing interests that may be relevant to content are disclosed at the end of this article.
Received September 17, 2015; revised December 16, 2015; accepted December 30, 2015.
Abstract Objective. (1) Become familiar with reported adverse events related to balloon dilation of the paranasal sinus ostia. (2) Understand the sequelae occurring with these events.
C
Study Design. Retrospective analysis of a prospective database. Setting. OpenFDA database. Subjects and Methods. The OpenFDA program website of the Food and Drug Administration was queried with the Application Program Interface query system for medical device adverse events involving balloon devices for the dilation of paranasal sinus ostia from January 2006 through December 2014. The raw data were then tabulated, with adverse events codified by event type, sinus involved, injury type, device malfunction, surgeon error, and qualitative data. Sequelae were also quantified. Results. In sum, 114 adverse events were identified. Patient injury was the most frequently reported adverse event (n = 72), followed by 36 device malfunctions, 4 deaths, and 2 unclassified. The most common injury involved orbital complications, including 23 (20.2%) orbital wall fractures and 22 (19.3%) postseptal and 22 (19.3%) preseptal orbital injuries. In addition, there were 17 (14.9%) skull base injuries and 7 (6.1%) cases of severe epistaxis observed; 11 (9.6%) cases mentioned surgeon error. Cerebrospinal fluid leak was significantly associated with frontal surgery (P = .002) and sphenoid surgery (P = .001), whereas post- and preseptal orbital injury was associated with maxillary surgery (P = .017 and P = .002). Epistaxis was associated with sphenoid surgery (P = .032). Conclusions. Based on the number of balloon sinus procedures performed, Food and Drug Administration–reported adverse events are uncommon, although a select portion can be severe. Surgeons should be aware of different complications reported with specific sinuses addressed with balloon techniques. Keywords balloon sinus dilation, adverse events, paranasal sinuses, sinus surgery, chronic rhinosinusitis
hronic rhinosinusitis affects approximately 4.9% of the US adult population, and .600,000 ambulatory sinonasal operations are conducted each year with a low perioperative complication rate.1-3 The use of balloon devices for the dilation of paranasal sinus ostia represents a relatively new tool in the surgical management of chronic rhinosinusitis. First introduced into clinical practice in 2006, this technology relies on catheter-based dilation of the paranasal sinuses to relieve ostial obstruction associated with chronic sinonasal inflammatory disease. Several studies have investigated this technology and provided justification for its clinical use in functional endoscopic sinus surgery candidates.4-10 Bolger and Vaughan performed a human cadaver study in 2006 and concluded that catheter-based dilation of the paranasal sinus ostia is both feasible and safe with respect to avoiding surrounding critical structures, including the skull base and orbit.4 This seminal investigation was later followed by a small prospective cohort study in which balloon dilation was performed on the frontal, maxillary, and sphenoid sinuses without any reported adverse events.5 The success of this preliminary clinical study prompted a larger, multi-institutional, prospective analysis in which balloon dilation was employed either alone or as an adjunct to a standard functional endoscopic sinus surgery procedure. While nonrandomized, this study demonstrated high ostial-patency rates, improved patient symptoms, and no adverse complications over a 2-year period.6-8 Despite these positive results and the now widespread use of this technology, relatively little is known about the rate and nature of adverse events reported with balloon catheter dilation. Melroy examined the topic in 2008 by surveying the Food and Drug Administration’s (FDA’s)
1 Department of Otology and Laryngology, Harvard Medical School, Boston, Massachusetts, USA
This article was presented at the 2015 AAO-HNSF Annual Meeting & OTO EXPO; September 27-30, 2015; Dallas, Texas. Corresponding Author: Anthony Prince, MD, Division of Otolaryngology, Harvard Medical School, 45 Francis Street, Boston, MA 02115, USA. Email: [email protected]
Downloaded from oto.sagepub.com at Middle East Technical Univ on February 18, 2016
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Manufacturer and User Facility Device Experience database for adverse events associated with the procedure.11 He found only 3 reported complications and concluded that the complication rate associated with this innovative catheterbased technique was exceedingly low.11 Since this publication, there have been only sporadic case reports highlighting complications associated with balloon dilation of the paranasal sinus ostia.12,13 Yet, to date, no systematic analysis of adverse events associated with balloon dilation has been performed despite the technology’s widespread use. Utilizing the OpenFDA website for medical device adverse event reporting, this study sought to evaluate the types and distribution of adverse events associated with balloon dilation procedures and to understand the specific sequelae arising from complications related to balloon dilation of the paranasal sinus ostia.
Methods The OpenFDA website maintained by the FDA was queried via the Application Program Interface query system (accessed January 2015) for medical device adverse event reports pertaining to balloon devices for dilation of paranasal sinuses from January 2006 through December 2014. The extracted data were scrutinized for balloon devices being used in the paranasal region and by common manufacturers of balloon sinus dilation devices. The type of reporter disclosing the adverse event was also recorded. Cases were excluded in which a balloon device was used for nonsinus purposes (eg, tracheal dilatation or eustachian tube dilatation). The raw data for adverse events were tabulated in Microsoft Excel and then codified into the following categories: type of adverse event, specific paranasal sinus or sinuses involved, type of injuries sustained, whether or not a device malfunction occurred, whether or not surgeon error was ascribed, along with qualitative data in the free-form text field of the adverse event report. Cases were also noted in which a balloon-only procedure was performed as compared with a hybrid procedure employing rigid instrumentation. Adverse events were further classified as death, injury, device malfunction, or other. Patient complications and associated sequelae, when occurring, were also tabulated according to type: skull base injury, cerebrospinal fluid (CSF) leak, meningitis, pneumocephalus, intracranial abscess, orbital wall fracture, postseptal orbital injury, preseptal orbital injury, visual sequela, and severe epistaxis. Device malfunctions were classified as device retention, device fracture, device rupture, and device impaction. Device retention denoted those cases in which a portion of the device was retained as a foreign body and may have required an unintended procedure for extraction. By comparison, device impaction referred to those cases in which a portion of the device became lodged at the intended site of ostial dilation. Associations were analyzed between specific sequelae and the paranasal sinuses involved in the balloon adverse event with chi-square testing in SPSS 22.0 (IBM, Chicago,
Illinois). Significance was set at P = .05. Similar analyses were conducted for the type of device-related adverse event, surgeon error, and the occurrence of individual sequelae. As the data analyzed for the purposes of this study are in the public domain, this study was reviewed by our hospital’s committee on clinical investigations and deemed exempt from review.
Results From 2006 to 2014, a total of 114 adverse events were reported and recorded in the FDA database with respect to balloon sinus complications. The majority of cases were reported by health care professionals, including physicians (n = 79), non-MD health care professionals (n = 3), and risk managers (n = 3). One undisclosed voluntary reporter was also noted. Company representatives disclosed 26 cases, including 3 events discovered through a literature search. Among the events, 53.5% involved the maxillary sinus; 11.2%, the sphenoid sinus; and 44.7%, the frontal sinus. Forty-seven adverse events involved a balloon-only procedure, while 22 adverse events were in the setting of a hybrid procedure. In 45 cases, this particular information was unknown. In total, there were 36 (31.6%) cases of device malfunction, 72 (63.2%) cases of patient injury, 4 (3.5%) deaths, and 2 (1.8%) unclassified events. In 11 cases (9.6%), there was discrete text indicating surgeon error with the balloon device. In the majority of cases, there was insufficient information to ascertain whether the adverse event occurred in the setting of an initial or revision surgery. Table 1 lists the overall distribution of injuries that were noted among the adverse balloon dilation events. In total, 17 cases resulted in a skull base injury, with the majority (n = 15) developing a CSF leak noted either intraoperatively or in the immediate postoperative period. In 4 of these cases, there was a concern that a skull base defect may have been present preoperatively (2 patients with prior head trauma, 1 with a history of extensive sinus surgery for hemangiopericytoma, and 1 with multiple prior sinus operations in the setting of cystic fibrosis). Among other intracranial injuries, 1 case of postoperative meningitis with a subsequent death was observed in a hybrid procedure that involved an endoscopic ethmoidectomy. The exact sinus dilated during this case was not specified. Last, 1 case of an intracranial abscess was observed following a hybrid procedure that involved both frontal and maxillary balloon dilations. This case necessitated neurosurgical intervention with a resultant craniotomy and drainage of a frontal lobe abscess; long-term sequela to the patient was not reported. The most common injury related to balloon sinus dilation involved the orbit (Table 1). Among these, 13 cases required a lateral canthotomy; 3, a medial orbital decompression; and 1, a subciliary incision following preseptal edema. In addition, 7 cases noted visual complications as a result of an orbital injury, including pain with medial gaze and blurry vision. These visual complications for the most part were transitory; however, 1 case did specifically note a long-term visual deficit following a postseptal orbital injury.
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Table 1. Distribution of Injuries Reported in Balloon Dilation Procedures of the Paranasal Sinus Ostia. Injury Type Skull base Skull base injury with CSF leak Skull base injury without CSF leak Meningitis Pneumocephalus Intracranial abscess Orbital Orbital wall fracture Preseptal orbital injury Postseptal orbital injury Permanent visual sequelae Severe epistaxis
n
%a
15 2 1 1 1
13.2 1.8 0.9 0.9 0.9
23 22 22 1 7
20.2 19.3 19.3 0.9 6.1
Abbreviation: CSF, cerebrospinal fluid. a Percentage among reported complications.
Table 3 presents the associations between the sinus involved with the balloon procedure and the type of complication or sequela observed. CSF leak was significantly associated with frontal surgery (P = .002) and sphenoid surgery (P = .001), whereas post- and preseptal orbital injury was significantly associated with maxillary surgery (P = .017 and P = .002, respectively). Severe epistaxis was significantly associated with sphenoid surgery (P = .032). Table 4 outlines the associations among device malfunction, surgeon error, and type of complication or sequela observed. No device malfunction was reported in the majority of cases, with patient-related complications including severe epistaxis, skull base, and orbital injuries. With the exception of severe epistaxis, these findings were statistically significant. Surgeon error was not significantly associated with any of the complications or sequelae enumerated in the database.
Discussion
Table 2. Type of Device Malfunctions Reported in Balloon Dilation Procedures of the Paranasal Sinus Ostia. Malfunction Type
n
%a
Fracture Rupture Retention Other Impaction
27 9 4 4 1
23.7 7.9 3.5 3.5 0.9
a
Percentage among reported cases.
Table 2 describes the various types of device malfunctions occurring during balloon dilation procedures associated with an adverse event in the FDA database. The most common malfunction was device fracture, with a total of 27 cases enumerated in the database. In 21 of these cases, the distal tip of the guide wire fractured during the dilation procedure. The causes reported for this varied and included inappropriate bending of the nonmalleable tip, using excessive force, or using a damaged guide wire. There were 4 cases of device retention, 1 of which required additional surgical intervention for extraction. Among the ‘‘other’’ category, there were 2 failures of balloon inflation, 1 failure of balloon deflation, and 1 failure of instrument tracking. As previously mentioned, there were 4 deaths reported in the database. The first was previously discussed and involved an uncomplicated hybrid procedure that was followed by postoperative meningitis. The second death was attributed to surgeon error following an off-label use of a balloon device used through a frontal sinus trephination that resulted in a postoperative seizure and death. The remaining 2 deaths were thought to be unrelated to the actual dilation procedure (1 sudden cardiac arrest and 1 massive postoperative intracranial bleed following uncomplicated maxillary balloon sinus dilatation).
Based on data submitted to the FDA over a 9-year period following the introduction of balloon dilation technology, the current results indicate a wide distribution of adverse events. The FDA database captures mandatory reporters (including manufacturers and device-user facilities) as well as voluntary reporters (including health care professionals and consumers). In total, there were 114 adverse events that specifically involved balloon catheter ostial dilation. The distribution of these events varied widely in terms of severity. Device malfunction was the most common reason for an adverse event that did not involve a patient injury. While device malfunction accounted for nearly one-third of adverse events, it did not appear to be associated with patient complications. Severe adverse events were also noted and included patient injury and death. The majority of adverse events involved maxillary sinus balloon dilation (53.5%), followed closely by frontal sinus dilation (44.7%). The results of this analysis also indicate that balloon dilation complications vary according to the sinus dilated, a finding that is of particular importance to the operating surgeon. Balloon dilation of the maxillary sinus was significantly associated with a range of orbital injuries, including orbital wall fractures and pre- and postseptal orbital complications. Likewise, balloon dilation of the frontal and sphenoid sinuses was found to be significantly associated with skull base injuries, including CSF leak. In addition, sphenoid sinus ostial dilation was significantly associated with severe epistaxis. While each sinus was associated with a different set of complications, surgeon error was not associated with any of the reported adverse events. The findings of the study are salient in that they are among the first in the literature to show the risk associated with balloon dilation of each paranasal sinus. Prior studies have reported minimal to no adverse events associated with balloon dilation technology. Bolger and Vaughan performed a human cadaveric study in 2006 to examine the safety of balloon sinus dilation and did not report any damage to the lamina papyracea or the lateral lamella of the cribriform
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Table 3. Association between Specific Complication or Sequela Observed and Sinus Involved in Balloon Dilation.a Complication/Sequela Skull base injury No Yes CSF leak No Yes Orbital wall fracture No Yes Postseptal orbital injury No Yes Preseptal orbital injury No Yes Severe epistaxis No Yes
Maxillary Sinus Dilation, %
P Value
Frontal Sinus Dilation, %
P Value
Sphenoid Sinus Dilation, %
P Value
58.9 29.4
.034
36.8 82.4
.001
7.4 35.3
.005
56.8 33.3
.103
36.8 80.0
.002
6.3 40.0
.001
43.9 82.6
.002
51.2 30.4
.099
13.4 8.7
.729
48.3 77.3
.017
48.3 36.4
.349
13.5 4.5
.304
45.6 86.4
.001
48.9 31.8
.162
12.2 9.1
.741
55.7 28.6
.245
43.4 71.4
.241
9.4 42.9
.032
Abbreviation: CSF, cerebrospinal fluid. a Bold P value indicates statistical significance (P \.05).
Table 4. Association between Complication or Sequela Observed and Device Malfunction and Surgeon Error. Complication/Sequela
Device Malfunction, %
P Value
Surgeon Error, %
P Value
37.9 6.3
.019
8.4 20.0
.352
37.9 7.1
.032
8.4 21.4
.155
42.7 8.7
.003
9.7 15.8
.682
39.3 9.1
.010
11.8 9.5
1.000
41.1 0.0
.000
12.5 5.3
.463
34.9 0.0
.094
12.0 0.0
.600
Skull base injury No Yes CSF leak No Yes Orbital wall fracture No Yes Postseptal orbital injury No Yes Preseptal orbital injury No Yes Severe epistaxis No Yes Abbreviation: CSF, cerebrospinal fluid. a Bold P value indicates statistical significance (P \.05).
plate in their study.4 A nonrandomized prospective cohort study of 10 endoscopic sinus surgery patients who successfully underwent balloon catheter–based dilation of the frontal, maxillary, and sphenoid sinuses corroborated this finding and showed that the technology is safe without any
reported adverse events.5 A multicenter prospective nonrandomized study dubbed the CLEAR trial enrolled 115 patients who underwent balloon-only and hybrid procedures, and it found a high level of ostial patency over a 2-year period and improved patient symptoms. In this study, the
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only adverse event reported was device malfunction, which was noted in 12 of 358 dilated sinuses. This included balloon rupture, tip malfunction, and failure of timely deflation; however, there were no cases of CSF leak, orbital injury, or severe epistaxis observed in this multicenter trial.6-8 In addition, a similarly designed multi-institutional prospective study that involved 203 patients examined the efficacy and safety of office-based balloon sinus dilation, and it also concluded that the procedure is safe and effective, noting only 1 adverse event reported—namely, transient periorbital swelling.14 One reason for the difference observed in the degree of adverse events between this study and prior studies may involve patient selection. Prior clinical studies used strict exclusion criteria to optimize safety and reduce the potential for adverse events. Patients in the CLEAR trial, for example, were systemically excluded if there was a history of extensive sinonasal inflammatory polyps, prior extensive sinonasal surgery, severe osteoneogenesis, sinonasal malignancy, a history of facial trauma with distorted sinus anatomy, and cystic fibrosis. Unlike these clinical trials, the cases in this analysis reporting an adverse event to the OpenFDA database contained patients with many of these particular conditions, including prior head trauma, extensive prior sinonasal surgery, cystic fibrosis, and sinonasal malignancy. In several of these cases reported in the database, the reporter was concerned that a preoperative bony dehiscence as well as altered sinus anatomy could have contributed to the development of patient injury. This difference in patient characteristics may speak then to both the importance of patient selection and the surgeon’s experience in mitigating the potential for adverse events associated with balloon sinus procedures. The strength of this study includes the fact that it draws on a large database designed to monitor device performance and detect device-related adverse events. This characteristic of the study enables an examination on how balloon dilation technology operates in the real-world environment, outside of clinical trials with strict inclusion and exclusion criteria. However, this study also contains weaknesses, which may limit the generalizability of its findings. First, the data obtained from the OpenFDA website cannot be used to determine rates of adverse events, which would help to compare safety with that of functional endoscopic sinus surgery employing rigid instrumentation. Second, while the database invites reporting from device manufactures, health care professionals, user facilities, and consumers alike, it leads to a fair degree of variability in the depth of adverse events reporting, which can result in inconsistent results and also possible underreporting of events. That said, the level of voluntary reporting in our study was exceedingly robust, with approximately 86 of 114 adverse events being voluntarily reported to the FDA website. Additionally, the fact that significant associations were noted between the sinus dilated and the complications observed, despite the shortcomings of a voluntary reporting system, strengthens our conclusions rather than weakens them.
The findings from this study should prompt surgeons to consider the complications associated with balloon sinus dilation of each sinus. Future studies will need to better elucidate the factors that might predispose to particular injuries based on the sinus dilated. For example, does a certain Keros skull base classification correlate with an increased risk of a skull base injury with frontal sinus dilation? Moreover, does the use of irrigation of the maxillary sinus after submucosal microfracture of the lamina papyracea increase the risk of periorbital complications? Answering these questions will require a thorough understanding of not only patient anatomic factors but also differences in dilation techniques and the level of surgeon expertise in performing the procedure. Future researchers may also want to consider evaluating the rate of complications associated with balloon catheter sinus dilation by not only relying on queries from centralized databases but also utilizing the current CPT codes specific to balloon dilation procedures to better compare the safety profile of balloon dilation technology with that of standard rigid functional endoscopic surgery.
Conclusion Based on the large number of balloon sinus procedures performed annually, FDA-reported adverse events are uncommon, although a select fraction can be severe. Surgeons should be aware of different complications reported with specific sinuses addressed with balloon techniques, as well as the potential for device failure and associated complications. Author Contributions Anthony Prince, responsible for the acquisition, analysis and interpretation of data for the project, as well as drafting, critically revising, and providing final approval of the work; ensured the accuracy and integrity of the submitted work; Neil Bhattacharyya, responsible for the conception, analysis and interpretation of data for the project, as well as drafting, critically revising, and providing final approval of the work; ensured the accuracy and integrity of the submitted work.
Disclosures Competing interests: Anthony Prince, consultant for Knopp Biosciences, LLC; Neil Bhattacharyya, consultant for IntersectENT, Entellus, Inc and Sanofi, Inc. Sponsorships: None. Funding source: None.
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