Balloon sinus ostial dilation (BSD) was introduced in 2005 as a less invasive alternative to endoscopic sinus surgery in the treatment of recurrent acute (RARS) and chronic rhinosinusitis (CRS). The technique involves placement of a balloon catheter under transillumination or navigation into the sinus ostium, with inflation resulting in dilation of the sinus opening and subsequent relief of obstruction. Since its development, extensive research has been conducted regarding its safety and efficacy. The purpose of this article is to review the current indications and contraindications for BSD as well as the pertinent evidence on its safety and efficacy.
Acclarent (based at Menlo Park, California, USA) was the first to obtain US FDA approval to introduce the balloon sinuplasty system as a catheter-dependent device for enlarging the paranasal ostia in 2005. The new device was similar to other apparatus in medical use for relieving obstruction in other organ systems while being minimally invasive. It is currently most appropriate to describe the equipment as a device, tool or instrument in the surgical toolkit rather than as a different, innovative way per se of performing surgical procedures [1–5].
Inflation of the balloon within the ostium increases the diameter of the opening by creating tiny breakages in the bone and displacing the bone to one side of the obstruction, while still preserving the epithelial mucosal lining surrounding the entrance. Among other advantages, balloon sinuplasty does not disrupt the normal anatomy of the ostiomeatal region, allowing the surgeon to concentrate on the obstruction itself and the sinus [6,7].
Lanza  was the first to report on dilatation of the paranasal sinuses in 1993. However, BSD was not officially approved by the US FDA until April 2005 [9,10]. Bolger and Vaughan initially demonstrated feasibility of the procedure in a cadaveric study . Subsequently, Brown and Bolger showed the safety and feasibility of BSD in 10 patients undergoing functional endoscopic surgery . The CLEAR (Clinical Evaluation to Confirm Safety and Efficacy of Sinuplasty in the Paranasal Sinuses) study then followed, which was a trial, a multicenter prospective trial involving 115 CRS patients who were treated with BSD . Where patency of the sinus could be assessed endoscopically, this reached 98%. No adverse events were reported and significant improvement in SNOT-20 (Sinonasal Outcome Test) and Lund McKay scores were observed upon follow-up at 1 and 2 years [12,13]. In the latter study, there was a reevaluation of 65 cases, representing 195 ostia opened via balloon sinuplasty. Of these, 85% had improved and the remaining 15% had remained the same. None were worse. Only six out of 65 cases went on to have revision procedures (i.e., 9.5%). Since then, further trial data have been published confirming that balloon sinuplasty is well tolerated and efficacious. These data have led to a better understanding of how it should be used and in which cases [14–19].
Balloon catheter dilation has clear advantages for sufferers from CRS, as it can be done within a clinic, does not necessitate a general anesthetic, and results in a shorter recover time than conventional surgery [20▪,21,22]. Multiple studies have demonstrated its successful implementation of BSD in the office setting. In a prospective, multicenter trial, Gould et al. described the 1-year outcomes of in-office multisinus (maxillary, with our without frontal/sphenoid) dilation in 81 patients with chronic or recurrent acute sinusitis. Of 317 attempts, 303 (98%) ostial dilations were successfully completed with no adverse events. Significant improvement in clinical symptoms (as determined by the 20-item Sinonasal Outcome Test and Rhinosinusitis Symptom Inventory scores) was observed. In addition, a reduction in healthcare utilization was also found, with fewer antibiotic courses and sinus-related physician visits seen following the procedure in comparison to the previous 1-year period. Similar findings were also demonstrated when analyzing data from the same cohort for in-office dilation of the maxillary sinus alone. In another multi-institutional randomized controlled trial, CRS patients treated with stand-alone dilation of maxillary ostia in the clinic had comparable outcomes to those managed with surgical antrostomy. Likewise, office-based balloon catheter dilation has also been effectively utilized to treat frontal sinus mucoceles, stenosed frontal ostia, and recalcitrant frontal sinusitis [20▪,21,22,23▪▪,24–26].
Endoscopic sinus surgery (ESS) and balloon dilation technology (BDT) share similar indications, a reflection of the fact that BDT is more of a tool than a separate technique per se . Both ESS and BDT aim to permit an enduring access and ventilation point to the blocked sinuses, facilitating a return to physiological function and improving the efficacy of maintenance treatments . BDT plays a special role in the management of recurrent acute sinusitis (RARS) and CRSsNP in which removal of tissue within the sinus may not be necessary in comparison to CRSwNP. At present, BDT in the clinic is primarily used for these indications. On the other hand, where some excision of diseased tissue is typical, such as in CRSwNP, AERD, allergic fungal sinusitis or hyperplastic sinusitis, BDT cannot be successfully employed as a monotherapy. It can, however, be used adjunctively with traditional surgical methods, so that the ethmoid sinuses are treated with ESS, whilst BDT used in the frontal, maxillary, and sphenoid sinuses to provide access for tissue removal. Given that sinusitis due to RARS and CRSw/oNP is more common than the other phenotypes, BDT can offer relief to many patients with sinusitis .
However, currently there is a paucity of RCTs comparing ESS and BSD, such that only grade C evidence exists to recommend balloon catheter dilation in sinusitis of the paranasal sinuses . The principal indications for balloon sinuplasty are outlined below :
- Chronic rhinosinusitis unresponsive to other treatment
- Recurrent acute rhinosinusitis
- Patients in intensive care with a fever centered on a sinus infection
- Frontal sinus recess cases where general anesthesia carries unacceptable risks
- Bleeding diathesis
Whilst much less frequently undertaken, the indications for children to receive FESS match those of adults, as detailed above. The main difference lies in the greater emphasis on pharmacological management of CRS is children, which encompasses recognizing and addressing underlying problems that can lead to CRS such as atopy, immunodeficiency and gastroesophageal reflux disease. Since BSD is both minimally invasive and permits irrigating the sinuses, it is an option in pediatric patients when appropriate pharmacological treatment has failed to alleviate the problem .
BSD is not recommended as the primary treatment modality for ethmoid disease, patients with extensive CRSwNP, widespread fungal sinusitis, underlying connective tissue disorders, or possible malignancy. It should also not be utilized in cases where disease is sufficiently advanced that either the bone has thickened or the margin of the orbit or the base of the skull are dehiscent. Unless pharmacological options including antimicrobials, steroids, generous doses of topical nasal agents and nasal hygiene measures have been attempted, surgical intervention should not be contemplated . A recent expert clinical consensus statement from the American Academy of Otolaryngology-Head & Neck Surgery also concluded that BSD is not appropriate for treatment of patients with headache that do not meet the diagnostic criteria for CRS or RARS or patients who do not have both positive findings of sinus disease on computed tomography and sinonasal symptoms [32▪].
The main contraindications to BSD as a sole treatment modality are as follows :
- Advanced ethmoidal disease
- Chronic sinusitis with nasal polyposis
- Allergic mycological rhinosinusitis
- Indications of new bone formation
- Cystic fibrosis
BALLOON SİNUPLASTY TECHNİQUE
The technique, which may occur under local or general anesthesia, is performed under endoscopic visualization (Figs 1–3). Guide catheters with heads variously angled are used to position the catheters with balloons at the edge of the ostia to be dilated. In its original iteration, inflation of the balloon was accomplished using iodine-containing contrast dissolved in either water or sterile saline at a concentration of approximately 150–180 mg/ml. This then allowed fluoroscopic evaluation of the position of the balloon . Under endoscopic guidance, the guide catheter is introduced to the vicinity of the sinusal ostium and a guide wire is then fed, using the catheter, into the sinus. The guide thread allows the balloon catheter to enter the sinusal ostium. Once the position is confirmed fluoroscopically, the dilated contrast medium is used for inflation to a pressure of 12 atmospheres followed by slow deflation and removal of the catheter . Use of fluoroscopy for localization of balloon catheters has now been largely supplanted by transillumination. However, more recently, advances in surgical navigation have enabled tracking of malleable instrumentation, including guidewires and catheters used in BSD (Fiagon, Fiagon GmbH, Germany). Another novel tool that has been developed is the electromagnetic balloon sinus dilation device (Nuvent, Medtronic, Minneapolis, Minnesota, USA). It consists of a rigid sinus seeker with built-in calibration which enables surgical navigation using an electromagnetic image guidance system (Fusion, Medtronic, Minneapolis, Minnesota, USA). With such devices, sinus surgeons now have additional tools in their armamentarium to ensure adequate placement of the balloon catheters. This may be particularly important when accessing the frontal sinus in patients with distorted anatomy or history of prior surgery.
The ostia of the sphenoid and maxillary sinuses can usually be rendered patent by a single inflation, whereas the ostial anatomy of the frontal sinus is lengthier and may require further inflation after moving the balloon. The aim is to render greater patency to the outflow by dilating the ostium, thereby reshaping the area without excising bone or mucosa, Such minimally invasive techniques may facilitate healing, reduce the need for postop debridements, and allow the mucosa and cilia to retain their physiological function .
The remodeling that occurs with BSD has been observed to affect the lateral part of the sphenoidal sinusal ostia the most, with the posteroinferior section of the upper infundibulum moved laterally. In the frontal recess, however, most of the patency was achieved on the medial portion, with the agger nasi cell affected posteromedially and the lateral, anterior and lower portions moved laterally. Dilation adjacent to the orbital lamina causes lateralization of the superior aspect of the uncinate process. Dilating the maxillary sinusal ostium causes the lower third of the uncinate process to be displaced anteriorly .
CLINICAL STUDIES FOR BALLOON SINUPLASTY
Levy et al. [33▪▪] reported that BSD resulted in significant improvement in quality of life (P = 0.04) as assessed by SNOT-20 scores, and decrease in paranasal sinus opacification (P < 0.001). Two studies have looked at SNOT-20 scores obtained following BSD or FESS, finding no significant difference (P = 0.07) in outcome. However, BSD was found to improve SNOT-20 scores to a greater degree when performed in the surgical theater versus the clinic (P = 0.004).
Ramadan  investigated the safety and feasibility of BSD in 30 pediatric cases of CRS. The sinuses that were treated included the maxillary (48 cases), sphenoid (six cases). and frontal sinuses (two cases). There were no complications. This same cohort was used in a subsequent study to compare the efficacy of BSD plus saline irrigation and adenoidectomy versus adenoidectomy alone . In 48 patients, 80% of those undergoing BSD had a moderate or significant increase in quality of life, but only 52% of those undergoing adenoidectomy alone reported the similar improvements .
Thirty-one cases who were immunocompromised and in critical condition underwent successful BSD for acute rhinosinusitis in Wittkopf et al.'s series . The immunocompromised status was associated with thrombocytopenia, neutropenia, or anemia. Wittkopf et al. stated that the reason for performing BSD as opposed to more conventional treatments (i.e., ESS) was to reduce the risk of bleeding. In all cases, BSD proved effective and safe. Other uses of BSD have been reported in the literature. Hueman and Eller  employed BSD in the reduction of a fracture within the frontal sinus considered to affect the ostium, while Wexler  wrote about revision surgery done using BSD to open up a blockage in the supraorbital ethmoid cell. A mini-trephine was used in the vicinity of the eyebrow.
Clinical Evaluation to Confirm Safety and Efficacy of Sinuplasty in the Paranasal Sinuses (CLEAR) was a well designed, multi-center study using a prospective methodology in which 109 cases of CRS with inadequate response to pharmacological management of the condition were registered. BSD was utilized for 358 blocked sinuses, of which 347 were successfully treated, a total of 96.9%. Scar tissue resulting from previous operations meant six cases could not be cannulated and four cases had anatomical features precluding the approach. One case had mucosal edema associated with polyposis. When followed up 24 weeks later, on average, the patients’ symptom scores had improved by 50.1%. A questionnaire designated ‘global change in sinusitis symptoms’ indicated that the patients quickly felt better: 83% did so by 1 week, 96% by 12 weeks, and 84% after 24 weeks .
BCS mainly achieves better functioning of the paransal sinuses by keeping the tissues intact and opening up the ostia with less tissue trauma . Thottam et al. found  that undergoing BSD led to 73.3% of cases using fewer antibiotics, while only 37.5% of those undergoing FESS had a similar reduction.
Since the CLEAR study, multiple trials have demonstrated positive clinical outcomes with use of BSD in the office setting to treat CRSsNP and RARS . In a prospective, multicenter trial, Gould et al. described the 1-year outcomes of in-office multisinus (maxillary, with our without frontal/sphenoid) dilation in 81 patients with chronic or recurrent acute sinusitis. Ninety-eight percent of ostial dilations were successfully completed with no adverse events. Significant improvement in SNOT-20 and RDSI scores were observed as well as reduced healthcare utilization. In another multi-institutional randomized controlled trial, CRS patients treated with stand-alone dilation of maxillary ostia in the clinic had similar outcomes to those managed with surgical antrostomy .
Melroy reviewed the US FDA database in 2008 to find a ‘major’ complication rate associated with BSD. The complication rate was reported as extremely low, 0.0035% per sinus or 0.01% per patient . Orbital penetration was reported in two cases but resolved spontaneously without further complications. In one case, CSF leakage occurred during ‘hybrid’ surgery, although the leakage could not be definitively linked to the balloon catheter .
Sillers et al.  looked at what healthcare resources were utilized by 628 cases of CRS. They found BSD used on the maxillary sinus in 88.9%, the frontal in 74.5%, and the sphenoid in 33.8%. Complications involving the orbit occurred in two cases, with seven patients sustaining bleeding possibly linked to BSD. CSF leakage did not occur postoperatively. There were no reports of blood transfusion, a need for lateral canthotomy, or canthoplasty.
Bolger et al. reported their experience of 109 cases where BSD was undertaken. There were no major adverse events, CSF leaks, damage to the orbit or epistaxis necessitating packing. Bacterial sinusitis did occur postoperatively in nine cases, but was successfully treated with oral antibiotics. In the CLEAR study (described above), no adverse events were reported.
Six out of nine centers involved in the CLEAR study reported on follow-up at 2 years from a clinical and radiological (CT) perspective. Sixty-five cases were followed up. Eight-five percent of these had improved symptomatically from their preoperative condition, 15% had symptoms at the same level, and 0% had experienced worsening. Comparing follow-up outcomes at 1 and 2 years, no additional adverse events had taken place [13,39]. Likewise, Abreu et al. researched BSD , judging it to be a safe and highly successful procedure that led to ostial patency that was maintained at follow-up and not associated with severe side-effects (e.g., CSF leakage, damage to the orbit or major hemorrhage).
BSD led to a relief of obstruction in the ostia for 91% (51 out of 56) of the sinuses in a cohort of 30 children with CRS who had failed medical treatment [17,39]. FESS and BSD performed in combination led to decreased severity of facial pain, congested sinuses, postnasal rhinorrhea, nasal discharge, and headache .
A case report by Tomazic et al.  presented the case of a 36-year-old woman who suffered right-sided CSF rhinorrhea following BSD for the right frontal sinus, which pierced the ethmoidal roof.
BSD has been shown to be a safe and effective treatment option for patients with CRSsNP and RARS. Evidence is best for addressing disorder of the frontal, sphenoid, and maxillary sinuses with limited disease severity. The occurrence of serious complications is rare. However, BSD has not been recommended in patients without the presence of concurrent sinonasal symptoms and imaging findings consistent with sinus disease.
We would like to thank Continuous Education and Scientific Research Association for scientific assistance with this paper. There is no financial support.
Author contribution and responsibilities: Cemal Cingi – planning, literature survey, writing the manuscript, submission. Nuray Bayar Muluk – planning, literature survey, writing the manuscript. Jivianne Lee – planning, literature survey, writing the manuscript.
IRB approval: waived as this paper is a review article.
Informed consent: not applicable as this paper is a review article.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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Papers of particular interest, published within the annual period of review, have been highlighted as:
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