|Year : 2013 | Volume
| Issue : 4 | Page : 301-305
Balloon dilatation sinuplasty: concept, procedure, and debate
Department of Otolaryngology, Head and Neck Surgery, Tanta University, Tanta, Egypt
|Date of Submission||01-Jun-2013|
|Date of Acceptance||30-Jun-2013|
|Date of Web Publication||1-Feb-2014|
MD, PO Box 527, Tanta 31211
Chronic rhinosinusitis affects millions of people every year. When medical treatment by antibiotics and steroids is not effective, then functional endoscopic sinus surgery is indicated.
The aim of this article is to define the concept of balloon dilatation sinuplasty (BDS), to describe its technique and to review the current literature for the indications, contraindications, complications, outcomes and follow-ups of patients submitted to this procedure.
The review showed that Balloon Dilatation Sinuplasty is a feasible, safe and effective procedure. It can be used an alternative in the treatment of CRS patients as a stand-alone medical procedure or as a hybrid surgical one with conventional instruments and/or with microdebriders
Keywords: Balloon, dilatation, sinusitis
|How to cite this article:|
Elguindy A. Balloon dilatation sinuplasty: concept, procedure, and debate. Tanta Med J 2013;41:301-5
| Background|| |
Chronic rhinosinusitis (CRS) affects millions of people every year. When medical treatment by antibiotics and steroids is not effective, surgery is indicated and functional endoscopic sinus surgery (FESS) has been proven to be the minimally invasive procedure of choice  .
However, is FESS really a minimally invasive procedure? A minimally invasive procedure should offer (a) minimal normal tissue removal, (b) reduced surgical time, (c) fewer complications, (d) faster healing, (e) short postoperative care, and (f) fewer medication use. In FESS, however, there is (a) removal of too much normal tissue to securely access hidden pathology  , (b) bleeding, pain, adhesions, and cicatricial stenosis especially in the most 'unforgiving' area, which is the frontal recess, and (c) adverse effect in nasal airflow and aerodynamics, resulting in increased airflow distribution to sinuses leading to washout of local nitric oxide (NO) gas and unexposed areas becoming exposed to environment and bacteria, viruses, and fungi ,, [Figure 1]. Paranasal sinuses (PNSs) generate large amounts of NO, which enhances local host defense mechanisms through direct inhibition of pathogen growth and stimulation of mucociliary activity  . We know that large openings of the sinus ostia can significantly reduce the concentration of NO inside these cavities  . Recurrent or persistent disease occurs in 10-20% of cases  . Not only this, but also FESS has been reported with orbital and skull base complications.
Recent advances in CRS continue to entail clearer definitions, potential roles of fungi, superantigens and biofilms, newer medications, delicate tools such as thrucut, silcut, and microdebriders, navigation systems, and balloon dilatation sinuplasty (BDS)  .
| Objectives|| |
The aim of this article was to define the concept of BDS, to describe its technique, and to review the current literature for the indications, contraindications, complications, outcomes, and follow-ups of patients submitted to this procedure.
Theory of balloon dilatation sinuplasty
The rationale of FESS is widely accepted, as widening of sinus ostia would improve drainage and aeration leading to restoration of mucociliary clearance  .
On the basis of the success of catheterization and balloon dilatation in cardiology, the Bioengineers of California started, in 2002, a project of adapting balloon catheters to dilate sinus ostia, hypothesizing that it is less traumatic and it reaches inaccessible areas without the need of removal of normal tissues  . In May 2005, Acclarent (Menlo Park, California, USA) received FDA approval for its Relieva Balloon Sinuplasty technology as a minimally invasive treatment alternative for CRS.
Research on balloon dilatation sinuplasty
Research on BDS has passed through the following steps:
- Preclinical Safety and Feasibility Study  .
- Pioneer Clinical Safety and Feasibility Study  .
- Initial Multicentric Clinical Safety and Feasibility Study (CLEAR Study)  .
- Comparative Satisfaction, Pain, and Cost Study  .
- PatiENT Registry Study the Balloon Sinuplasty in a 'real-world' setting  .
Safety was assessed by the rate of adverse events, feasibility was tested by the rate the ostium was successfully located, cannulated, and dilated, efficacy was investigated by endoscopic examination of dural patency, and sinus symptoms improvement was determined using the Sino-Nasal Outcome Test (SNOT-20).
Initial preclinical study
The study was conducted on cadavers with 31 ostia and revealed that the balloon catheters dilated all ostia successfully. The dissections did not show lesion in any noble structure adjacent to the ostia, and the mucosa within the ostium was flattened, stretched, and torn to release and allow the dilation but remained attached to the surrounding structures and hence was preserved. Observation of the ostia after dilation showed that sphenoidal sinus ostia dilation is more significant in its lateral portion, with lateralization of the posterior and lower portion of the superior turbinate. In the frontal recess, the dilation prevailed medially with displacement of the agger nasi cells. In the maxillary sinus ostium, the dilation prevailed anteriorly with anteriorization of the lower third of the uncinated process. The easiest sinus to cannulate was the sphenoidal one followed by the frontal and the most difficult was the maxillary sinus  .
First human study 
The surgeon was able to successfully dilate all planned ostia (10 maxillary, five sphenoidal, and three frontal recesses). No adverse effects were recorded. The devices were found to be easy to use and well tolerated  .
First multicenter study 
A prospective, nonrandomized trial by 10 experienced rhinologists was conducted on 115 patients and followed up for 6 months. At 6 months, overall patency was 80.5%, the nonpatency rate was 1.6%, and patency was 'indeterminate' in 17.9%. Successful dilation was performed in 96.9% of visualized ostia. Dilated ostia decreased in size, initially because of edema; this was reversed by time. By the end of the study, the dilated ostia stabilized in ~75% patients. Patient symptom (SNOT-20) showed significant improvement over baseline measures. No serious adverse effects were noted. In three sinuses, a revision procedure was required (2.75%)  .
Comparative satisfaction, pain, and cost study 
Friedman et al.  compared retrospectively a group of patients treated with balloon sinuplasty with a group submitted for FESS. A total of 70 adult patients were evaluated. All patients were submitted to the SNOT-20 test. The results showed a significant improvement in the SNOT-20 in both procedures. As for the patients satisfaction with the interventions, 91.4% answered 'yes, they would undergo the procedure again' for sinuplasty against 48.6% of the patients submitted for FESS.
PatiENT registry study the balloon sinuplasty in a 'real-world' setting 
Of the 1036 patients in this study, sinus balloon catheters were used in 3276 peripheral sinuses at an average of 3.2 sinuses treated per patient. The average follow-up was 40.2 weeks. With respect to safety, no major adverse events attributed to the use of sinus balloon catheters; it is comparable favorably to 1.1% incidence of serious adverse events in published FESS literature. With respect to effectiveness, 2.4% of patients required a revision surgery. A total of 1.3% of sinuses treated using Balloon Sinuplasty instruments (Menlo Park, California, USA) required a revision surgery. Concerning patient outcomes, sinus symptoms improved in 95.2% of patients. A total of 73.8% of patients were completely free of sinus infections postsurgery. Therefore, use of Balloon Sinuplasty instruments in sinus surgery was concluded to be safe and effective and improves patients' quality of life  .
The two leading societies (ASR and AAOHNS), who once had position statements that contradicted each other, now consider these devices as a FESS tool  .
Case selection is an important consideration. Candidates were patients who failed medical therapy and who were recommended for endoscopic sinus surgery.
- Chronic sinusitis limited mostly to ostial obstruction of the sinuses.
- Pediatric sinusitis due to risk of facial growth retardation and higher incidence of complications  .
- ICU patients.
- Patients with bleeding disorder or high anesthetic risk.
- Silent sinus syndrome.
- In combination with FESS (hybrid procedure).
Frontal sinus disease management
The management of frontal sinus disease is the best example of the advantages, disadvantages, advancements, and challenges that we now face with FESS. Management requires expertise with drills, angled scopes, frontal recess anatomy, and the management of potential complications. The frontal recess area is not forgiving. Mucosal removal, edema, infection, incomplete surgery, and scar tissue formation may lead to failure. The first thing that attracts most of the surgeons to balloon sinuplasty devices is their potential in frontal sinus surgery by providing a more minimally invasive procedure .
- Significant ethmoidal disease.
- Diffuse sinonasal polyposis.
- Allergic fungal rhinosinusitis.
- Osseous neoformation.
- Cystic fibrosis.
Endoscopes sets of 0, 30, 45, or 70° may be used. In addition, a set of guide catheters, flexible guide threads, flexible balloon catheters, washing catheters, and pump for the balloon insufflation with manometer are necessary. The guide catheters are available in several angulations: frontal with 70° angulations; maxillary with 90-110° angulations; and sphenoidal with 0-30° angulations [Figure 2]. The insufflation pump consists of a high pressure syringe with piston and manometer used for the balloon pressure monitoring at the tip of the catheter [Figure 3]. The solution used for balloon insufflation may be physiologic saline of 0.9%. A luminous catheter is used, which allows the identification of the PNS through transillumination [Figure 4] and [Figure 5]. The balloons are coupled in catheters [Figure 6]. The balloon's standard size is 5 mm, although there are balloons of 7 and 3 mm. The pump must be free from air bubbles for correct functioning. The balloon insufflation maximal pressure recommended by the manufacturer is 16 atm. Generally, pressures ranging from 8 to 12 atm are used with good results. The inflated balloon produces local microfractures that end up remodeling the anatomy, dilates the ostia, and allows a PNS normal aeration without, however, the removal of the tissues and damage to the nasal mucosa [Figure 7],[Figure 8],[Figure 9] and [Figure 10]. The balloon is then deflated and withdrawn from the sinus ostium. The same balloon may be used and dilated in several PNSs in the same session of the same patient  .
Debate and controversy
Progress maker or progress consumer? Individual response to innovation varies because innovation has the potential to replace an existing paradigm and hence evokes resistance to change. The introduction of balloon sinuplasty appears to be very similar to surgical navigation. There are early adopters, several 'mid-stream' users, and even some severe critics. Navigation systems were initially met with resistance because of changes in technique, technology, and cost. Most of them now agree that they have led to significant improvements in management of various skull base and periorbital diseases  .
Nick Jones said that BDS is 'A technology looking for a disease', whereas Rice  stated that 'BDS does not deal with the ethmoid sinus which is the key to chronic sinusitis'. We agree that relieving ostial obstruction is a time-tested pathophysiologic principle and widely accepted treatment practice. We disagree that the ethmoids are necessarily the key to sinusitis. As our knowledge develops, we may learn that ethmoid disease is an effect, not a cause of sinusitis.
Innovation of new medical devices is an expensive process leading to the need to recover development costs. A recent investigation found the overall costs of traditional endoscopic sinus surgery and BDS to be similar in USA. Expenses should be balanced by tangible benefits such as microinvasive intervention, reduced surgery time, short hospital stay, no nasal packs or splints, reduced recovery time, decreased postoperative debridements, few postoperative medications, few office follow-up visits, increased patient satisfaction, and decreased revision rate  .
New treatments or devices (such as BDS) will face challenges, concerns, and criticisms and surgeons should review, test, and improve upon them  . Investigations that offer evidence level 1 (randomized controlled trial) or 2 (prospective cohort study with an internal control group) are rare.
| Conclusion|| |
BDS is a feasible, safe, and an effective procedure that can be used as an alternative in the treatment of CRS patients. It may be used as a stand-alone medical procedure or as a hybrid surgical one with conventional instruments and/or with microdebriders.
| Acknowledgements|| |
Conflicts of interest
There are no conflicts of interest.
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[Figure 1], [Figure 2], [Figure 3], [Figure 4], [Figure 5], [Figure 6], [Figure 7], [Figure 8], [Figure 9], [Figure 10]