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Vladimir S Kozlov M. D., Ph.D.#, Wolf J. Mann M. D. Ph.D. FACS*
* Department of Otolaryngology, Head and Neck Surgery
University of Mainz, School of Medicine, Mainz, Germany
# Department of Otolaryngology, Head and Neck Surgery
Yaroslavl Regional Hospital, Yaroslavl, Russia
Corresponding author:
Jan Gosepath M. D.
Universitaets-HNO-Klinik
Langenbeckstrasse 1
55101 Mainz
Tel.: +49-6131/177361
Fax.: +49-6131/176637
E-mail:gosepath@hno.klinik.uni-mainz.de
Presented in part at the Fall Meeting of the American Rhinologic Society in Denver, CO., Sept. 8th, 2001
Abstract
BACKGROUND: The «YAMIKâ «sinus catheter was designed as a new device for the topical treatment of rhinosinusitis. It creates intermittent positive and negative intranasal pressure after sealing the ipsilateral nostril and choana with two inflatable cuffs. Affecting the nasal cavity and all paranasal sinuses of one side at a time it is used to evacuate mucous and secretions as well as and to introduce antiseptic, antibacterial or antifungal solutions. DESIGN: This study was designed to evaluate the effectiveness of the «YAMIKâ «catheter in cases of prolonged episodes of acute purulent rhinosinusitis in patients who previously underwent endonasal sinus surgery for chronic rhinosinusitis. 20 patients were treated at repeated visits to the outpatient clinic of our institution. At each visit, their clinical symptoms as well as findings on anterior rhinoscopy, nasal endoscopy and A-mode ultrasound were evaluated. RESULTS: Acute disease resolved completely within 10 days of treatment in 17 of the 20 patients. Two patients discontinued after repeated treatments, showing only mild improvement. One patient felt uncomfortable during the application of the «YAMIKâ «catheter and did not continue after the initial treatment. CONCLUSION: Our results suggest that the «YAMIKâ «catheter is a helpful device in the topical treatment of acute rhinosinusitis, especially in patients who suffer from prolonged episodes of acute purulent infection after previous sinus surgery.
Key Words: «YAMIKâ «sinus catheter, rhinosinusitis, topical treatment
Introduction
Acute episodes of purulent rhinosinusitis can sometimes show a prolonged course despite therapeutical efforts, including culture guided antibiotic treatment. Especially patients, who underwent previous sinus surgery for chronic rhinosinusitis are sometimes difficult to treat effectively enough to minimize the risk of recurrent disease. However, in order to reduce the incidence of such postoperative sinonasal infections, many surgeons encourage patients to apply topical nasal washes or douches. A common problem with most topical applications of various solutions to the nose is that the respective agent is primarily instilled into the nasal cavity, but does not reach the mucosa of the paranasal sinuses in effective amounts. The «Yamikâ «sinus catheter was introduced as a new device to introduce antiseptic, antibacterial or antifungal solutions into the nasal cavity and all paranasal sinuses through the natural or surgical ostia. At the same time the catheter offers the possibility to evacuate mucous or discharge from both the nasal cavity and all paranasal sinuses also along their natural way of drainage (1,2). The effectiveness of the device has been reported in patients with acute purulent sinusitis with or without cooexisting nasal allergies as a procedure well applicable in an outpatient clinic (3,4). This investigation was designed to evaluate the effectiveness of the «Yamikâ «procedure in patients suffering from prolonged episodes of acute, purulent rhinosinusitis, who had previously undergone endonasal sinus surgery for chronic rhinosinusitis. The focus was to show whether or not this way of topical treatment would be suitable to effectively treat the inflammatory disease of nasal and paranasal mucosa in this particular group of patients.
Patients and Methods
Patient evaluation
20 patients, 12 male and 8 female at an average age of 46.3 years, ranging from 31 to 64 years, who presented to our outpatient clinic between October 2000 and May 2001 were included in this study. They had all undergone previous endonasal sinus surgery for chronic rhinosinusitis at our institution or elsewhere. In all cases surgery had included bilateral maxillary antrostomies as well as bilateral frontal sinus surgery. They presented with typical complaints of acute rhinosinusitis such as nasal congestion, headache, facial pain or pressure and purulent discharge. A thorough clinical exam including anterior rhinoscopy and nasal endoscopy was performed at the time of the initial and all follow up visits. A-mode ultrasound examination (Rhinoscope, Atmos, Germany) was also performed at all visits to evaluate the status of the maxillary and the frontal sinuses. Diagnosis was hence established using a) patients history, b) clinical findings on nasal endoscopy and c) ultrasound findings. These same criteria were applied to evaluate the individual course during follow up.
Use of the «Yamikâ «sinus catheter
The 20 Patients then all underwent between one and seven bilateral treatments with the «Yamikâ «sinus catheter (fig. 1), after informed consent was obtained. This device is designed to create alternating positive and negative pressure in the nasal cavity and the paranasal sinuses of one side at a time. It is thus meant to evacuate mucus, pathological secretions and discharge from the sinuses by negative pressure on the one hand and to introduce topical medical solutions by positive pressure on the other hand. The catheter (fig. 2) is made of natural latex (RevultexÔ) and consists of a body, supported by a flexible wire, with two inflatable cuffs, one at the distal end to seal the patients choana, the other, meant to seal the ipsilateral nostril, being mobile in respect to the catheters body, allowing for an individual fit to the patients nose. Valves are used to inflate the two cuffs or to adjust the necessary pressure for a tight fit. The working-channel has an adapter for a syringe on the external end and an opening between the two cuffs on the other, so that this opening is located within the nasal cavity near the middle meatus when the device is introduced into the patients nose (fig. 3). Before the catheter is inserted, the two cuffs are checked for air-tightness by inflating 6-7 ml of air into both cuffs, gently compressing them between two fingers.
Possible allergy to latex was ruled out in all patients before initiating the «Yamikâ «treatment. We always applied a topical decongestant (Naphazoline 0.1%) as well as a topical anaesthetic (Tetracain 1%) to the nasal cavity before the use of the catheter. After insertion of the catheter the posterior cuff, sealing the choana, was inflated with 8 — 12 ml of air. The anterior cuff, was then adapted to a perfect fit in the nasal vestibulum and inflated under visual control to seal off the respective nostril. A large syringe was then adapted to the working channel and used to apply alternating controlled negative pressure in order to evacuate secretions from the nose and the paranasal sinuses, collecting the discharge in the syringe. In a second step 10 ml of the respective topical solution were applied from the syringe to either side of the nasal cavity and paranasal sinuses in a similar fashion by alternating controlled positive pressure. To increase the effectiveness of this step the patient was asked to bend the head towards the shoulder of the side being treated. The two steps were performed separately for the right and the left side of the nose.
Betadine (5%) and hydrogen peroxide (H2O2, 1%) were used as topical antiseptic solutions for irrigation of the nasal cavity and the paranasal sinuses. Each of the two substances was used in 10 cases to check for possible differences in their respective effectiveness. For each case the choice between the two solutions was made randomly and not based on diagnostic criteria.
During the time «Yamikâ «was applied it was the only modality of therapy, although 12 patients had had a course of antibiotics prior to starting the catheter treatment. A control group was not included, since it would have required no treatment at all for this period of time. However, several studies have evaluated spontaneous courses of acute sinusitis as opposed to antibiotic treatment (5-7) and overall the spontaneous resolution rate is estimated at a range between 55 and 70%.
Individual follow up
After the initial treatment all patients were asked for follow up two days later for a repeated treatment. Only if the symptoms had not improved in a significant way or if the amount of evacuated purulent discharge was similar to the first treatment, they were asked to continue to return every two days. Only one patient did not wish to come back for a second treatment after she had felt uncomfortable during the initial therapy. 17 patients had a total of two treatments, one had five and one had seven treatments. The 17 patients, who had two treatments were seen again one week after their last «Yamikâ «procedure for re-evaluation. At each visit anterior rhinoscopy and nasal endoscopy were repeated as well as A-mode ultrasound of the sinuses.
Investigators performing the treatment in this group of patients had no financial ties to the manufacture, production, sale or proceeds from the «Yamikâ «catheter at any time neither did they consult for the company in any way.
Results
Initial evaluation
At the time of their initial visit to our department (day 0), clinical exam including nasal endoscopy revealed various degrees of edematous mucosal swelling and purulent secretions from the middle meatus in all 20 patients. Polypoid changes within the middle meatus and/or the ethmoid region and/or the frontal recess were seen in nine patients and recurrent nasal polyposis in two. On nasal endoscopy the previously surgically enlarged ostia in the middle meatus were narrowed by mucosal swelling and/or mucosal swelling in 11 cases. The ethmoid region was open but narrowed by various degrees of mucosal swelling in all but the two patients with recurrent polyposis, where the ethmoid region was blocked by polyps. According to the A-mode ultrasound exam 16 patients had signs of mucosal swelling, and/or secretions within the maxillary and 9 patients within the frontal sinuses uni- or bilaterally. 12 Patients had already been on a course of oral antibiotics without significant improvement prior to their first «Yamikâ «catheter treatment. 5 of these had received amoxicillin without prior culturing, the other seven had been treated with a choice of an oral antibiotic based on nasal cultures.
Evaluations in follow up
10 out of the 19 patients seen two days after this first treatment (day 2) reported an improvement of their symtoms, especially of facial pressure and headache. Clinical exam showed a decrease of purulent secretions visible in the middle meatus and the nasal cavity in these 10 patients. However, 17 out of the 19 patients felt a significant relief after the following second treatment and were then asked to come back to the office 1 week later for re-evaluation or earlier in case of a relapse of symptoms. After this one week all 17 patients reported to be free of facial pressure and headache and at this point these17 patients had no more significant pathologic findings on ultrasound exam in both the maxillary and the frontal sinus. Clinical exam showed marked reduction of edematous mucosal reaction with some residual swelling in four cases. However the remaining two patients, who had not improved at the time of the second visit, were treated a third time another 2 days later (day 4). At that point, both still showed some mucosal swelling and some purulent discharge in the middle meatus and the ethmoid region on nasal endoscopy as well as signs of mucosal swelling within both maxillary sinuses on ultrasound exam. One patient had recurrent panpolyposis, which did not show any change on clinical exam or ultrasound. Both patients were seen repeatedly, one discontinued the treatment after the fifth visit (day 8) with mild amelioration of his symptoms, the other patient with panpolyposis did not show any effect after the seventh visit (day 12) and was finally scheduled for revision surgery, according to a repeated CT-scan. This patient also had symptomatic relief after each treatment, not lasting longer than several hours. The clinical course of all 20 patients is detailed in a table.
Based on the effects of the treatment on the course of clinical symptoms and those seen on nasal endoscopy, no differences could be observed between patients treated with betadine and those treated with H2O2.
Discussion
Since the „Yamikâ„ sinus catheter was first introduced in Russia (1), it has been repeatedly modified in slight details, resulting in an updated „YAMIK-3“ (8) and the most recent «Yamik-5“ (9). Slight modifications have been applied to the valves for inflating the anterior and the posterior cuff as well as to the channels used for extracting secretions or introducing solutions. «Yamik-5“ allows for simultaneous irrigation of the mucosa and evacuation of secretions. However, the principle of this device, which is basically to apply a suction/irrigation system to the nose, that affects both the nasal cavity as well as all paranasal sinuses of one side at the same time, remained unchanged since it was first introduced. Although a variety of indications for the use of this sinus catheter have been described (10-13), the main indication in our hands appears to be the topical treatment of acute episodes of sinusitis especially in patients who previously underwent surgery of chronic rhinosinusitis. Basically all medical solutions used in topical nasal treatment can be applied. The role of topical treatment of the nasal cavity and the paranasal sinuses has been widely discussed in the literature with a variety of studies validating the benefit of saline solution for improved sinonasal clearance in acute or chronic rhinosinusitis as well as topical corticosteroids and decongestants for improved drainage and better control of nasal polyps in chronic rhinosinusitis (14-20). It was shown, that topical application of nasal steroids does not have any statistically significant effect on intranasal bacterial growth, verified by cultures (21). Treatment with topical nasal antimicrobial agents has also been reported to be successful (22).
As far as the alternating positive and negative pressure is concerned, that is generated intranasally during the «Yamikâ «treatment, two studies were conducted to evaluate possible effects on the mucociliary transport system. Measuring saccharin transport time before and after the treatment revealed that there is a temporary decrease in ciliary activity, followed by complete recovery within three hours (23,24). However, the positive effect, that endonasal sinus surgery is known to have on mucociliary clearance (25) is not disturbed but rather enhanced by the resulting hyperemia and the reduction of mucosal edema (24). The mucociliary system is known to be susceptible to deteriorational effects of high concentrations of topically applied solutions. In a recent study we investigated the effects of different topical solutions on ciliary activity of nasal respiratory cells (26). Antiseptic, antibiotic and antifungal solutions were evaluated in various concentrations, clearly showing dose dependant effects on ciliary activity. Following the results of this study, all tested substances can deteriorate ciliary activity in high concentrations, but can be safely used for topical intranasal if their concentration is carefully selected.
The present study was designed to evaluate the use of the «Yamikâ «sinus catheter in patients presenting with an acute episode of rhinosinusitis after previously having undergone endonasal sinus surgery for chronic sinus disease. 17 of the 20 individuals enrolled in the study were free of symptoms one week after performing two treatments. 12 of the 20 patients had already been on a 1 week course of oral antibiotics without any significant effect prior to the first «Yamikâ «procedure. The goal being evacuation and unspecific irrigation of the nasal cavity and the paranasal sinuses, the topical treatment in these 20 cases was performed with antiseptic solutions of betadine 5% and H2O2 1%, each in 10 cases. No difference was seen in the effectiveness of these two solutions. However, due to the small sample size of 10 patients in each group, this observation was made without the power of statistical significance. One patient elected to discontinue the treatment after the pressure originating from the posterior cuff, sealing the choana, had caused a certain degree of discomfort during the initial procedure. This discomfort was most likely due to a momentary obstruction of the eutachian tube. However, in no case did any persistent obstruction of the eustachian tube occur after the traetment was finished. All other patients tolerated the procedure without any discomfort or pain. One patient had only mildly improved after 8 days and five treatments. In this case, endoscopy revealed a decrease of mucosal edema after that time, but a persisting occlusion of the paranasal sinuses due to a high degree of scarring in the ethmoid region and the middle meatus on both sides. In the remaining patient, who did not display any positive effect on his recurrent polipoid disease, revision surgery was scheduled after a repeated coronal CT-scan showed complete opacification of all sinuses bilaterally. This patient reported a temporary improvement for several hours after each visit, which was probably mainly related to the topical decongestant that was routinely applied before the catheter was inserted.
In conclusion we found the use of the «Yamikâ «sinus catheter particularly helpful in this group of patients, where in the event of recurrence of acute onsets of sinonasal disease after previous surgery, it is desirable to resolve the acute inflammation quickly and to reduce the degree of mucosal thickening and thereby minimize the risk of sequelant surgical revisions. In our hands this unique device is used only in carefully selected indications such as the ones reported in this study, since it appears considerably time consuming to be performed as a standard procedure in the outpatient clinic as catheterization of both sides of the nose takes approximately 10-15 minutes. It therefore does not appear as an alternative or an enhancement for regular washing with saline as it is widely used in standard postoperative care. Also it is -although not painful — associated with some mild discomfort for some patients, which is reported in a variable fashion. For the latter reason we have not used it in our pediatric in- and outpatient clinic so far, although previous reports have been encouraging regarding its effects in children with purulent sinusitis (12,13). The results of this investigation validate the usefulness of the «Yamikâ «catheter as it, unlike most nasal washes or douches, allows for a topical application of any chosen solution not only to the nasal cavity, but to all paranasal sinuses of one side at the same time, as long as the natural or surgical ostia are patent.
References:
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Figures
Fig 1: Photograph of a patient undergoing treatment of the left nose with the «Yamikâ «sinus catheter, using betadine 5% solution for irrigation.
Fig 2: Components of the «Yamikâ «sinus catheter: The body of the catheter (1), the two cuffs (2 + 3), the working passage with syringe-adapter (5 + 6), the two valves for inflating the cuffs (7), and the flexible rod for better adaptation of the Catheter`s body to the individual nasal cavity (4 + 8).
Fig 3: Correct position of the catheter within the nasal cavity with the two cuffs sealing the choana posteriorly and the vestibulum anteriorly.