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endoscope and a combination of surgical tools (e.g., curettes, forceps, powered micro-debriders, powered shavers, and/or sinus balloon catheters), surgeons enlarge the patient’s sinus openings to clear passageways in order to restore normal sinus ventilation and drainage. The goal of surgery is to improve sinus ventilation and drainage by enlarging the openings of the sinuses, removing any polyps and correcting significant structural problems that may be hindering drainage. The maxillary sinus creates a unique challenge. The maxillary ostia, located within the ethmoid infundibulum, often cannot be accessed transnasally without excising a portion of the uncinate process. An alternative approach to the maxillary ostia is through the sinus, via the canine fossa. A guidewire can be advanced from within the maxillary sinus to the nasal fossa. The dilating balloon can enlarge the ostia while deflecting the uncinate process. 4 Approximately 350,000 FESS procedures are done each year in the United States for CRS. Balloon Ostial Dilation A newer procedure, balloon ostial dilatation can be used as an alternative or as an adjunct to FESS for those with CRS or RARS. The goal of this technique, when used as an alternative to FESS, is to improve sinus drainage using a less invasive approach. The procedure involves placing a guidewire in the sinus ostium, advancing a balloon over the guidewire, and then stretching the opening by inflating the balloon. The guidewire location is confirmed with fluoroscopy or with direct transillumination of the targeted sinus cavity. General anesthesia may be needed for this procedure to minimize patient movement. According to the manufacturer, the RELIEVA SPINPLUS® Balloon Sinuplasty System is intended to: provide a means to access the sinus space and illuminate within and transilluminate across nasal and sinus structures; dilate the sinus ostia and spaces associated with the paranasal sinus cavities for diagnostic and therapeutic procedures; and irrigate from within a target sinus for therapeutic procedures and to facilitate diagnostic procedures. system This evidence review is limited to BOD when used as a standalone procedure. BOD may also be used in combination with FESS.2,3, When used as an adjunct to FESS, it is intended to facilitate and/or increase access to the sinuses. BOD may also be used on 1 sinus and FESS on another sinus in the same patient during the same operation. Summary Balloon ostial dilation (BOD, also known as balloon sinuplasty) is proposed as an alternative to functional endoscopic sinus surgery (FESS) for patients with chronic rhinosinusitis (CRS) or recurrent acute rhinosinusitis (RARS) who fail medical management. The procedure involves placing a balloon in the sinus ostium and inflating the balloon to stretch the opening. It can be performed as a stand-alone procedure or as an adjunctive procedure to FESS. This evidence review addresses BOD as a standalone procedure. For individuals with CRS who receive BOD as a stand-alone procedure, the evidence includes RCTs, observational studies, and systematic reviews. Relevant outcomes are symptoms, change in disease status, quality of life, and treatment-related morbidity. In the REMODEL RCT, balloon ostial dilation was non-inferior to FESS for patients with chronic rhinosinusitis. Durability of effect was demonstrated in uncontrolled studies that followed patients who received balloon dilation for up to 24 months. Evidence from RCTs is supported by multiple observational studies and a systematic review showing improved quality of life following BOD. In a retrospective cohort study that used data from a large commercial insurance database to examine adverse events reported in patients who underwent balloon dilation (n=2851), FESS (n=11,955), or a hybrid procedure (n=1234), the overall complication rate was 7.35% with FESS and 5.26% with balloon dilation. The evidence is sufficient to determine the effects that the technology results in an improvement in the net health outcome. For individuals with RARS who receive BOD as a stand-alone procedure, the evidence includes RCTs. Relevant outcomes are symptoms, change in disease status, quality of life, and treatment-related morbidity. In the REMODEL study of BOD compared to FESS, 32% of patients were diagnosed with recurrent acute rhinosinusitis (N=29). Balloon ostial dilation was non-inferior to FESS on measures of quality of life at 6 months and 12 months post-procedure. One RCT comparing balloon ostial dilation plus medical care to medical care alone in patients with RARS found significantly improved quality of life and lower mean number of sinus infections after 24 months in the balloon dilation group. A third RCT included a mix of patients with chronic and RARS and found improved quality of life compared to FESS,
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