Ear, Nose & Throat Journal2023, Vol. 102(4) 239–243© The Author(s) 2021Article reuse guidelines:sagepub.com/journals-permissionsDOI: 10.1177/0145561320983942journals.sagepub.com/home/ear
Objectives: Nasal saline irrigation is the corner stone of postoperative care after functional endoscopic sinus surgery (FESS) for chronic rhinosinusitis (CRS). However, intrasinus penetration of the saline solution can be challenging and may require difficult head position, particularly for the frontal sinus. Our aim was to evaluate a novel device for direct intrasinus self-irrigation, usable at home for both maxillary and frontal sinus. Methods: Thirty devices were implemented in 23 patients: in the maxillary sinus for 18 patients and in the frontal sinus for 5 patients. The device was removed after 7 days on average (5-10 days), and nasal saline irrigation was carried on with a squeeze bottle for 6 weeks. Retrospective evaluation of the device included: device-related complication, patient satisfaction, and ostial or middle turbinate synechiae at 3 months. Results: No device-related complication (obstruction, displacement, infection, bleeding) occurred. Twenty-one (91.3%) patients were satisfied with the device. Two patients required the help of a nurse for irrigation. No ostial of middle turbinate synechiae was visualized at 3 months. This new endonasal device enables direct intrasinus self-irrigation after FESS for CRS. Conclusion: This preliminary study showed that this device is safe and easy to use. However, further investigations are required to assess its potential role to reduce the risk of synechiae and revision surgery.
Keywordssinus surgery, postoperative care, sinus irrigation, chronic rhinosinusitis, frontal sinus, maxillary sinus
Chronic rhinosinusitis (CRS) is a common disease characterized by inflammation of the sinonasal mucosa resulting in nasal congestion, nasal discharge, facial pressure or pain, and olfactory dysfunction.1 In case of medically refractory disease, functional endoscopic sinus surgery (FESS) is recommended.2 In the past 25 years, FESS techniques had widespread among ENT surgeons with more than 500 000 procedures being performed yearly in the United States.3 Nevertheless, postoperative complications are not uncommon, particularly postoperative synechiae, which can lead to poorer outcome and revision surgery.3 Synechia formation can arise in the immediate postoperative period and is responsible of nasal obstruction, ostial stenosis, and disease recurrence.4 Therefore, there is an increasing effort to prevent postoperative endonasal adhesions and many experts have suggested that early postoperative care is a critical determinant of surgical success and maybe long-term quality of life (QoL).5 Postoperative care after FESS is not currently standardized among sinus surgeons but 2 recent evidence-based reviews have been performed in the last decade.5,6 Nasal irrigation remains the only unanimously recommended care after any kind of sinus surgery.6 There is a lack of consensus regarding the best delivery method for postoperative nasal saline irrigation.5,7 However, high-volume nasal irrigation (240 mL at least once a day) has been recommended by most experts.7,8 The theoretical benefits of high-volume irrigation are (1) more effective debris, clots, and crusts removal and (2) intrasinus penetration which may lead to improved sinus cleansing and earlier mucociliary clearance recovery.6,7 Intrasinus penetration depends on 3 important factors: (1) ostium size, (2) presence and position of the middle turbinate, and (3) head position.7,8 However, frontal sinus irrigation remains challenging even in the recommended head-down and forward position (also called vertex-down position) which is not acceptable for many patients.9 Maxillary sinus irrigation is also reduced in the presence of the middle turbinate, particularly if it is lateralized.10-12 Therefore, the aim of our study was to make a preliminary evaluation of the Sinusplint, a new device for direct frontal or maxillary sinus irrigation after endoscopic sinus surgery.
The Sinusplint is a silicone made device (Invotec International) which combines a flexible catheter with a nasal splint (Figure 1). The catheter has an external diameter of 3 mm (9F) and internal diameter of 2 mm. The splint has 2 main purposes: (1) it stabilizes the catheter in 2 segments: a horizontal one for easier cannulation and a vertical one for easier insertion into the frontal sinus or the maxillary sinus, (2) it facilitates the attachment of the catheter to the nasal septum. A syringe connector is provided for hospital-based irrigation and can be replaced at any length of the extranasal part of the catheter (Figure 2). If the extranasal part of the catheter is trimmed just behind the columella for more discretion during home care, cannulas can be used for irrigation in front of a mirror, usable sizes ranging from 20G (1.1 mm) to 16G (1.6 mm; Figure 3).
A cadaveric model was developed at the Fer à Moulin School of Surgery to validate the concept. Four fresh cadavers were dissected in a staged manner (maxillary antrostomy, posterior ethmoidectomy, anterior ethmoidectomy, and Draf 1 procedure, Draf 2a procedure) on one side (2 right sides and 2 left sides). The device was initially inserted with a Politzer forceps, and the catheter was placed within the maxillary sinus with a 45° Blakesley forceps and within the frontal sinus with a Cottle septum elevator (Figure 4). After maxillary sinus catheter insertion, irrigation was successful in all cases. After frontal sinus insertion, irrigation was successful except in one case of narrow ostium (3 mm), which required a Draf 2a procedure sinusotomy to achieve successful irrigation. Using probing measurement, we determined that 5 mm was the minimal ostium size to allow easy saline exit from the sinus during irrigation.
From January 2018 to January 2020, 23 patients (13 males and 10 females) underwent FESS for CRS. The mean age was 51.65 (standard deviation: 15.14), ranging from 27 to 77 years old. Thirty devices were implemented (Figure 5): (1) in the maxillary sinus for 18 patients (bilateral in 4 cases of nasal polyposis), (2) in the frontal sinus for 5 patients (bilateral in 3 cases of nasal polyposis). After removal of the device during postoperative consultation, 2 questions were asked to the patient to assess the satisfaction rate: (1) “was the irrigation easy to perform?” and (2) “did any discomfort or complication occurred during irrigation?.” Nasal endoscopy was performed after removal to assess the need of debridement. Nasal saline irrigation was carried on with a squeeze bottle for 6 weeks, using the nose-to-sink position. At 3 months, ostial patency was checked through endoscopic visualization without probing.
No technical difficulty was encountered during placement of the device. For the first 5 patients (3 maxillary sinus placements and 2 frontal sinus placements), only hospital-based irrigation (Figure 2) was performed for 48 hours (240 mL twice per day). The device was removed before hospital discharge. No complication occurred during saline irrigation. For the 18 other patients (15 maxillary sinus placement and 3 frontal sinus placement), home-based irrigation (Figure 3) was performed at day one after surgery. Patients were discharged the same day after maxillary sinus surgery or after an overnight stay after ethmoidectomy of frontal sinus surgery. Home-based saline irrigation consisted on 3 syringes of 20 mL 3 times a day with an 18G cannula. No complication occurred during saline irrigation. The device was removed after a mean period of 7 days (5-10 days).
No patient required nasal debridement. Twenty-one (91.3%) patients were satisfied with the device and reported ease of use and no adverse event. Two patients had difficulties to cannulate the catheter: one patient was visually impaired and one patient had an overtrimmed catheter which could not be seen in front of the mirror. They required a nurse at home for irrigation. No ostial stenosis or middle turbinate synechiae were observed at 3 months.
Ostial or turbinal synechia increases the risk of revision surgery an impacts long-term QoL after FESS.3,13 Therefore, the primary aim of early postoperative care is to avoid early ostial closure and middle turbinate lateralization.4 Nasal irrigation is the cornerstone of this care.6 It requires a high volume (>200 mL) of saline to ensure intrasinus penetration which may help to maintain ostial patency and promote early mucociliary recovery. Optimal sinonasal lavage may also reduce the need for postoperative nasal debridement.6,7
Historically, invasive procedures such as maxillary sinus puncture and frontal sinus minitrephination have been developed to achieve direct sinus irrigation, usually for a very short period of time (2-4 days after surgery).14-16 Nowadays, maxillary sinus puncture is no longer used for postoperative care but frontal sinus minitrephination is still used for perioperative spotting of the ostium and few rhinologists use it in the immediate postoperative period.15,16 Indeed, it has been hypothesized that early removal of clots and stagnant secretions combined with regular irrigation flow through the sinus ostium should help to prevent early ostial stenosis and should decrease the need of postoperative debridement in the frontal recess, which is a difficult to clean area.5,6,8 Nevertheless, these invasive methods are hardly tolerated for longer duration than few days and carry a risk of orbital trauma and orbital compartment syndrome after sinus puncture and irrigation.17-20
Recently, direct postoperative sinus irrigation has been evaluated for longer durations and through the natural ostium.21,22 Regarding maxillary sinus irrigation, a prospective controlled study by Kim et al showed that direct maxillary sinus irrigation with an irrigator may be effective to prevent poor prognostic factors such as persistent purulent discharge and to improve endoscopic score, at 3 months after surgery.21 However, this method required several appointments (8 sessions in 2 months) and was time-consuming (500 mL in each sinus). Regarding frontal sinus irrigation, Rotenberg et al also evaluated the use of a biliary T-tube stent to achieve direct frontal sinus irrigation after Draf 3 procedure, for 4 weeks.22 After 1 to 2 days of saline irrigation at hospital, the T-tube was shortened to remove the extranasal segment, and patients were able to irrigate their own sinuses without any uncomfortable position. The study reported a 96.7% patency rate at 6 months, with a high compliance with rinsing regimens.22 However, because of its shape, this catheter was not primarily designed for smaller frontal sinusotomy or other sinus irrigation. On the other hand, our study showed that the Sinusplint is usable for both maxillary and frontal sinus and its catheter allows effective sinus irrigation (if ostium size is sufficient and sinus walls intact).
Aside sinus irrigation protocols, stents have been widely used after frontal sinusotomy to avoid early ostial closure but there is no conclusive evidence regarding their long-term benefit.4-6 Spacers, splints, and nasal packings have also been widely used to avoid middle turbinate lateralization.23,24 Floppy middle turbinate can also be sutured to the nasal septum have to avoid such early complication.25 In our opinion, the use of a transostial catheter prevents ostial synechia in the immediate postoperative period and may also help to prevent early middle turbinate lateralization period as the catheter acts as a spacer. However, long-term comparative study of the Sinusplint is required to validate this assumption.
At last, our study showed that easy home-based sinus irrigation was achieved in most patients without the need of any difficult head position. Most patients were satisfied with the device. Interestingly, such intrasinus catheter could also be used to easily distribute topical agents (steroids, antibiotics, surfactants, etc) to the paranasal sinuses in the postoperative period or in case of recalcitrant sinusitis.9,26,27
Nevertheless, any endonasal device can lead to complications as any foreign body carries a risk of infection, inflammation, granulation, and biofilm.22,28,29 In consequence, it should not be maintained for a longer period than few weeks.22,30 In addition, this preliminary study had several limitations: retrospective analysis of data, no control group, limited number of patients, and short follow-up. Therefore, its usefulness remains to be proved by carrying a prospective and comparative study with blind evaluation of the Lund-Kennedy endoscopic score and the Lund-MacKay scannographic score, in addition to the Sino-nasal Outcome Test and a QoL questionnaire.
The Sinusplint is a simple silicone-made device specifically designed for early postoperative care after FESS. Its main feature is to enable direct sinus irrigation through an ostium of at least 5 mm. It is usable at home for maxillary or frontal sinus irrigation. Our first clinical experience with the device was very encouraging and demands further investigation on its potential role to reduce the risk of early synechia and revision surgery which impact long-term QoL after FESS for CRS.
The authors give special thanks to Alexis Pouret, François Pouret, and Baptiste Grenier.
The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: The device was developed by HB in partnership with Invotec1 without any financial retribution.
The author(s) received no financial support for the research, authorship, and/or publication of this article.
Mohammad Al Omani https://orcid.org/0000-0001-7267-0829
Hakim Benkhatar https://orcid.org/0000-0002-8623-8882
1 Centre Hospitalier de Versailles, Service d’ORL et chirurgie cervico-faciale, Le Chesnay, France
Received: September 15, 2020; revised: October 09, 2020; accepted: December 07, 2020
Corresponding Author:Hakim Benkhatar, MD, ENT-Head and Neck Surgery, Centre Hospitalier de Versailles, 177 rue de Versailles, 78150 Le Chesnay, France.Email: hbenkhatar@ch-versailles.fr
