Balloon Sinuplasty: Our Experience

Abstract

Chronic rhino sinusitis (CRS) is a common disease. Maxillary sinusitis not cured by the medicines was addressed by the open surgical procedure namely Caldwell Luc operation. Thereafter introduction of nasal endoscopes in 1970’s led to the minimally invasive surgery FESS which preserved the physiology of the nose and sinuses. In the year 2002 balloon sinuplasty was introduced in the western world and subsequently in India. Due to various logistics it was not performed and reintroduced in the year 2015 in India. It can be termed as micro minimally invasive surgery wherein anatomy as well as physiology of the nose and sinuses were preserved in cases of medically non responsive mild to moderate sinusitis. 20 cases were selected for exclusive balloon sinuplasty of maxillary sinus. Balloon sinuplasty is a relatively new procedure which can be termed as micro minimally invasive surgery addressing the CRS without the traditional forms for surgery like incision, cutting or microdebriding. The principle is causing microfractures by inflating the sinus opening and thus facilitating the drainage of the sinus contents. No immediate or late post operative complications were noted. Sinus patency 6 months later was present in 90% of the cases. Balloon sinuplasty is an excellent procedure for medically nonresponsive CRS without polyposis. The success rate is spectacular matching the FESS with almost no immediate post operative and late complication. The recurrence rate of sinusitis is low. We conclude that balloon sinuplasty is a micro invasive procedure which saves operating time, time of hospital stay of the patient and delivers excellent result with almost no complications. We hope it could be incorporated as a routine surgery for mild to moderate sinusitis not responding to medicines.

Introduction

Chronic rhino sinusitis is a common disease. It is characterized by at least two symptoms presenting at the same time lasting for at least 12 consecutive weeks, such as the feeling of nasal blockage, nasal discharge, pain in the face and reduction or loss of smell.

Nose and sinuses have complex anatomy and physiology. The epicenter of paranasal sinus drainage is osteo meatal unit which is the common drainage pathway for the maxillary, ethmoidal and frontal sinusitis. Opening of the sinus by the instruments with the aid of endoscopes formed the basis of FESS.

In the further advancement instead of cutting by instruments or microdebriding, balloon sinuplasty was introduced which by inflation near the sinus opening caused sinuses to open by microfracture. No trauma was inflicted on the nasal mucosa [1].Patients presenting with a positive computed tomography (CT) scan, who do not improve after pharmacological treatment, should be consider for FESS [1].

When a patient presents with chronic rhino sinusitis initially treated by pharmacological therapy. Unresponsive patients are addressed by conventional functional endoscopic sinus surgery. Whereas balloon sinuplasty is a technique which just remodels the opening of the sinuses thus facilitating the drainage of the sinus contents [2, 3].

FESS as well as balloon sinuplasty improves the quality of life as indicated by the SNOT scale but balloon sinuplasty renders the advantage of being safe and effective in adults as well as in children [4–10].

In fact since balloon sinuplasty causes minimal trauma, lesser operating time and minimal exposure to the anaesthesia; it is probably the safest option for the critically ill paritnts and children suffering from the CRS [11].

Some studies have indicated that balloon sinuplasty technique is as effective as ESS [5] in improving the symptoms of the patients and the CT scan results.

Aims and Objectives

Aim

The aim of this study is to share our experience of balloon sinuplasty.

Objectives

Study of clinical improvement after the balloon sinuplasty.

Study Methodology

Balloon sinuplasty was started at our institution, 2021. Till date 20 patients have successfully undergone this procedure at our institution. In totality 32 sinuses have been addressed.

This prospective study was conducted over a period of 24 months from January 2021 to 2023. The patients were meticulously followed for 6 months after the procedure.

The principal aim of our study was to observe the intra operative, immediate post operative and late complications of the balloon sinuplasty and overall success rate of the procedure. We wanted to analyse the overall feasibility to perforn this surgery considering success rate, complications and financial consideration.

We performed balloon sinuplasty on 20 cases and 32 sinuses were addressed.

All these patients were selected based upon the inclusion and exclusion criteria for the study, as formulated below.

A diagnosis of chronic rhino-sinusitis was arrived at as per the Lund–Kennedy criteria (1995) i.e., patients having 8 weeks or more of persistent symptoms and signs of sinusitis, not resolving with 3 weeks of pharmacological therapy or 4 episodes per year or more of recurrent acute sinusitis, each lasting for 10 days, in association with persistent changes noted on CT-PNS scans, done 4 weeks after completion of medical treatment [1–3].

Inclusion criteria, was the presence of unilateral or bilateral maxillary chronic rhino-sinusitis, which had been unresponsive to 3 weeks of trial with medical management. The disease should be mild to moderate maxillary sinusitis without nasal polyposis.

Exclusion criteria were severe CRS with nasal polyposis,history of trauma to the nose or face, congenital anomaly of the nose or face, congenital diseases like ciliary dyskinesia, distorted anatomy of the osteo meatal unit or patients not compliant for 6 months follow up.

All the patients were operated under general anaesthesia. Nasal packing was done by lignocaine adrenalin 1:100000 concentration for 30 min. No local anaesthesia was injected.

The patient laid supine with head up 15 degree on head ring.

Guide wire was introduced in the nose after removing the pack and entered in the maxillary sinus to be addressed. Lights were put off and maxillary glow was noted (Fig. 1). After delineating the maxillary sinus opening balloon was railroaded to the opening and inflated at 12 atmosphere for 10 s (Fig. 2).

Fig. 1.

Maxillary glow

Fig. 2.

Balloon being introduced in the maxillary sinus opening

Results

20 cases were selected for balloon sinuplasty in which 32 maxillary sinuses were addressed.

No immediate post operative complications were noted. No nasal bleeding was observed. No CSF leak was observed.

No orbital complications were seen.

The patients were discharged the same day or the day after.

The patients were meticulously followed for 6 months. Endoscopic evaluation was done at the end of the 6 months and 29 out of 32 maxillary sinuses were patent (91%).

Discussions

Balloon sinulasty was introduced in the western world first in the year 2002. Subsequently it was introduced in India. Hirherto few cases were performed and few studies pertaining to the indian subcontinent were performed but balloon sinuplasty was mostly had a temporary stop in India when the company supplying the balloon withdrew from the Indian market. Subsequently in the year 2015 Merill reintroduced the Balloon sinus catheter in India and new era of this procedure started. It was brought with safe option of illuminant wire rather than flouroscopic dye used earlier.

Here we did prospective study of 20 cases where 32 sinuses were addressed in a tertiary care institute. The study holds the importance that despite introduction of this procedure almost 2 decades back not a conclusive evidence of its success has been documented specially in the Indian subcontinent.

Maxillary sinusitis was addressed by Caldwell Luc operation tradionally which was subsequently replaced by the functional endoscopic sinus surgery in the 1990’s. It is a minimally invasive surgery which preserves the functions of the nose and the sinuses and hence the name.

Since the introduction of the balloon sinuplasty the preservation of anatomy and the functions of the nose and sinuses have gone a notch higher. It works on the principles of balloon catheter used in the angioplasty wherein dilatation of the sinuses are done by inflating the balloon at 12 atmosphere for 10 s like the dilatation of the blocked arteries by the angioplasty catheter.

The cost of the one time disposable balloon sinus catheter maybe the limiting factor as it costs 510 USD in India. But if we consider the stay in the hospital (as it is a day care surgery), the minimal operating time and thus less use of the operating room and anaesthesia the high cost of the consumable may be partially nullified.

We used merill sinus balloon dilatation catheter system (7 mm) for the maxillary sinus opening (Fig. 3).

Fig. 3.

Sinus Balloon dilatation catheter system

The limitation of this study was we exclusively chose maxillary sinusitis so can’t comment on the prognosis and complication of frontal and/or sphenoidal sinusitis. Also balloon sinuplasty can be used in adjunct with the Fess which is also known as hybrid fess with balloon sinuplasty. This procedure can be used in severe cases of CRS with/without nasal polyposis. We stuck to exclusive balloon sinuplasty in Maxillary Sinusitis to see its results in the mild to moderate sinusitis. Since it’s a very expensive procedure even in the government set up as the catheter is one time disposable we limited the study to 20 cases.

More precise results could be obtained by larger number of subjects.

Conclusions

Balloon sinuplasty is an excellent procedure which is safe and highly effective for medically nonresponsive CRS without polyposis. The success rate is spectacular matching the FESS with almost no immediate post operative and late complication. The recurrence rate of sinusitis is low after the procedure.

We conclude that balloon sinuplasty is a micro invasive procedure which saves operating time, time of hospital stay of the patient and delivers excellent result with almost no complications.

We hope it could be incorporated as a routine surgery for mild to moderate sinusitis not responding to pharmacological therapy.

Author Contributions

RG: manuscript writing.

Funding

None.

Declarations

Conflict of interest

None.

Research Involving Human Participants and/or Animals

No.

Informed Consent

Taken from the participant.