What are the adverse events related to balloon sinuplasty (BSP)?
Bottom line: The most common adverse events associated with balloon sinuplasty include balloon malfunction, guide catheter malfunction, cerebrospinal fluid leak, and significant eye swelling.
Explore This IssueApril 2020
Background: While functional endoscopic sinus surgery for chronic rhinosinusitis has largely replaced open procedures, it still requires resection of bone and mucosa, and severe complications can occur. BSP use increased steadily from 2012 to 2016, and direct-to-patient marketing surrounding catheter dilations is likely contributing to interest in and frequency of BSP.
Study design: Retrospective cross-sectional analysis of 211 adverse events from 208 reports between January 1, 2008, and January 1, 2019, involving BSP devices from Acclarent, Entellus, and Medtronic.
Setting: FDA MAUDE database.
Synopsis: The highest numbers of adverse events were reported in 2012 and 2014. When stratified by category, 48.3% of adverse events were patient complications, 47.9% were device related, and 3.8% were package related. The most common patient-related complications were cerebrospinal fluid (CSF) leak (frontal, sphenoid sinuses), eye swelling (maxillary, frontal sinuses; 30 patients required a lateral canthotomy), and epistaxis (frontal, sphenoid sinuses). The most common device-related adverse events were balloon malfunctions (balloon rupture during inflation, balloon detachment from the device, balloon not inflating) and catheter malfunctions (catheter guide wire tip detachment from the device). No patient deaths have reportedly been associated with BSP since 2014, but four reported peri-procedural deaths were not clearly associated with technical complications from the surgeon or device. These included one each from bacterial meningitis (with no associated CSF leak), cardiopulmonary arrest, intracranial bleed, and seizure. Limitations included the database’s reliance on mandatory and voluntary reporters to submit adverse event reports, lack of the total number of BSP devices used without complications, and lack of patient information for context.
Citation: Hur K, Ge M, Kim J, Ference EH. Adverse events associated with balloon sinuplasty: a MAUDE database analysis. Otolaryngol Head Neck Surg. 2020;162:137–141.