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Peter Baptista

Dept. ORL, University Clinic of Navarra

Email: pmbaptista@unav.es

Phone:

Website: www.cun.es

Objectives Patients with chronic rinosinusitis resistant to systemic treatment have as an alternative endoscopic nasal surgery. Recently, two independent new surgical tools have been introduced into clinical practice as an option for minimally invasive treatment of mild to moderate chronic ethmoidal mucosal disease with involvement of the frontal recess. The Relieva Stratus TM MicroFlow Spacer (Acclarent, Inc.) for the ethmoidal complex (RStE) and the Relieva Stratus TM MicroFlow Spacer (Acclarent, Inc.) for the frontal recess (RStF). Currently, per the Food and Drug Administration (U.S.) both temporary implantable spacers are approved for use in patients with saline only, however, the RStE is approved for use with triamcinolone acetonide (40mg/ml) and is CE marked for use in the European Union. Any use of the device beyond these approved indications is considered “off-label” and is the discretion of the surgeon. The following is our experience with both devices in 16 patients. Methods Sixteen patients were enrolled, six patients had Ethmoidal Microflow Spacer inserted and 10 patients had the frontal MicroFlow spacer, among this latest group three were bilateral insertions. The Stratus catheter was implanted endoscopicaly under general anesthesia in combination with balloon sinuplasty technique for either the maxillary or the frontal sinus. Triamcinolone was the drug used for local delivery. The Stratus was removed in office 4 week later. The overall follow-up rate was of 3 months postoperative. Results No maJor complications were observed. For those patients that had RStE, mild or moderate disease was seen in the implanted site, the catheter was implanted in the ethmoid bulla and removed in office under local anesthesia. Frontal Stratus was inserted after a complete opening of the frontal sinus ostium either by sinuplasty or by conventional FESS accompanied by surgery of the anterior and posterior sinus, sphenoidectomy. The intraoperaory bleeding was significantly less, compared with traditional surgery. Patients did not described foreign object sensation after surgery. We observed good evolution in all patients but one, in which Stratus® relieva was performed. This patient persisted with chronic inflammation of the maxilary and ethmoid sinus due to oralantral fistula and functional endoscopy surgery was performed as an alternative for definitive treatment.

Conclusion

Our study describes preliminary results of the use of drug eluting stents (Microflow Stratus) in its two sites, ethmoid and frontal sinus. Early results support the reduction of postoperative edema which may prevent frontal sinus ostial stenosis. Appropriate selection of patients is necessary for a good outcome.

RELIEVA STRATUS®, TREATMENT FOR CHRONIC RHINOSINUSITIS

Baptista PM, de Abajo J, Barona L

Department of ENT. University Clinic of Navarra. University of Navarra.Pamplona (Spain)

Device description The drug eluting spacer system consists of two main components in both the ethmoid and frontal spacer: i.) the microflow spacer ii.) deployment guide. The microflow spacer is formed by a catheter shaft at one end surrounded by a distal membrane reservoir (approximately 24 mm) containing hundreds of micropores that allow for the seepage of triamcinolone acetonide and a pair of laterally opposed retention wings for maintaining the deployed position. The proximal end contains a one-way valve that prevents the backflow of the instilled fluid and a suture, which aids in retrieval in the postoperative period. b) The deployment guide consists of an access trocar and delivery sheath in the case of the ethmoidal type and only a curved deployment sheath for the frontal spacer. The deployment guide functions to properly position the spacer prior to deployment. Study design A prospective, clinical trial approved by the hospital institutional review board was performed in the Department of Otolaryngology of the University Clinic of Navarra, in chronic rhinosinusitis patients who failed maximal medical therapy and where undergoing functional endoscopic sinus surgery. Six adult patients received implantation of RStE with mild or moderate disease of the ethmoidal area without massive polyposis. RStF was performed in ten adult patients that had radiographic obstruction/inflammation of the frontal sinus, with obstruction of the FSOT. These patients also presented with disease of the ethmoids, maxillary and sphenoid sinuses. CRS was defined as symptomatic inflammation for a period of at least 12 weeks of duration and confirmed with a Computed Tomography (CT) scan. No ethmoid surgery was performed on patients in whom RStE was to be placed, however, some patients underwent maxillary and/or frontal surgery. RStF placement required either a balloon dilation frontal sinuplasty or anterior ethmoidectomy and traditional endoscopic frontal recess dissection. Patients also underwent concurrent procedures including maxillary antrostomy, posterior ethmoidectomy, sphenoidectomy or septoplasty. The micro flow spacer was deployed per manufacturers recommendations and filled with 0.3 ml of Triamcinolone acetonide 40 RStE patients did not receive any oral or intravenous steroids before or after the procedure. Intranasal steroids were prescribed twice daily for a period of at least 3 weeks postoperatively. In patients undergoing RStF oral steroids were prescribed for polypoid changes in the preoperative period and postoperatively for only 10 days. The steroid dose was also lower at 0.5mg/Kg/day instead of 1mg/Kg/day in a tapering pattern Follow-up visits occurred at postoperative days 2, 8, 14, 21, 60 and 90. Ethmoid patients also underwent postoperative CT scanning and graded according to the Lund-MacKay scoring system2. RStF patients were graded according to visual endoscopic permeability of the frontal os, using a modification of Murr et al3 endoscopic grading form.

Our study describes preliminary results of the use of drug eluting stents (Microflow Stratus) in its two sites, ethmoid and frontal sinus. Early results support the reduction of postoperative edema which may prevent frontal sinus ostial stenosis.

Patients diagnosed with chronic rhinosinusitis who have underwent maximum medical therapy and have failed to improve are considered candidates for surgical intervention. While the tentants of traditional FESS surgery are well established and effective, recently, two new drug eluting implantable spacers are available as a minimally invasive procedure and post procedure option, repectively. The first option for minimally invasive treatment of mild to moderate chronic ethmoidal mucosal disease with involvement of the frontal recess is the the Relieva Stratus TM MicroFlow Spacer (Acclarent, Inc.) for the ethmoidal complex (RStE. The second option, is a temporary implantable spacer for the frontal sinus by the same name, Relieva Stratus TM MicroFlow Spacer (Acclarent, Inc.) (RStF), it is similar in design and concept to the aforementioned device. Currently, per the Food and Drug Administration (U.S.) both temporary implantable spacers are approved for use in patients with saline only, however, the RStE is CE marked use with triamcinolone acetonide (40mg/ml) in the European Union. Any use of the device beyond these approved indications is considered “off-label” and is the discretion of the surgeon. The following is our experience with both devices in 16 patients.

INTRODUCTION METHODS AND MATERIALS

1. Stankiewicz JA, Lal D, Connor M, Welch K Complications in endoscopic sinus surgery for chronic rhinosinusitis: a 25-year experience. Laryngoscope. 2011 Dec;121(12):2684-701.

2. Hopkins C, Browne JP, Slack R, Lund V, Brown P. The Lund-Mackay staging system for chronic rhinosinusitis: how is it used and what does it predict? Otolaryngol Head Neck Surg. 2007 Oct;137(4):555-61

3. Murr AH, Smith TL, Hwang PH, et al. Safety and efficacy of a novel bioabsorbable, steroid-eluting sinus stent. Int Forum Allergy Rhinol. 2011; Jan-Feb;1(1):23-32

4. Melroy CT, Kuhn FA. Safety of ethmoid sinus drug-eluting catheter insertion. Ann Otol Rhinol Laryngol. 2009 Oct;118(10):708-13

5. Catalano PJ, Thong M, Weiss R, Rimash T. The MicroFlow Spacer: A Drug-Eluting Stent for the Ethmoid Sinus.Indian J Otolaryngol Head Neck Surg. 2011; Jul;63(3):279-84.

6. Villari CR, Wojno TJ, Delgaudio JM. Case report of orbital violation with placement of ethmoid drug-eluting stent. Int Forum Allergy Rhinol. 2012 Jan-Feb;2(1):89-92

7.Forwith KD, Chandra RK, Yun PT, Miller SK, Jampel HD ADVANCE: a multisite trial of bioabsorbable steroid-eluting sinus implants. Laryngoscope. 2011; Nov;121(11):2473-80

DISCLOSURE:

Dr. Baptista is part of a board of speakers per contract for Acclarent (Johnson & Johnson)

This study has not been funded or sponsored by any organization

CONCLUSIONS

DISCUSSION

RESULTS

REFERENCES

Table 2: Patients implanted with Ethmoid Stratus containing 0.31 mL Triamcinolone acetonide (40 mg/ml) MEAN [AGE 54.5 YEARS DURATION OF IMPLANT: 23.6 DAYS] F:Female, M:Male, FR: Frontal Recess, M:Maxillectomy, ET:Ethmoidectomy SP:Sphenoidectomy, BI:Bilateral, RT:Right, LT:Left, LM: Lund MacKay Staging, Pre: Pre operatively, Post: Post operatively

Table 1: Patients implanted with Frontal Stratus containing 0.31 mL Triamcinolone acetonide (40 mg/ml) MEAN [AGE 55.2 YEARS DURATION OF IMPLANT: 18.3 DAYS] F:Female, M:Male, FR: Frontal Recess, M:Maxillectomy, ET:Ethmoidectomy SP:Sphenoidectomy, BI:Bilateral RT: Right LT:Left BI: Bilateral

Figure 3: Frontal Stratus: A) Left Frontal Sinusotomy B) Left frontal Relieva Stratus placed stem of catheter has been cut-off after 3ml Triamcinolone was placed. C) Aspect of ostium of frontal sinus after 90 days of the procedure

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ABSTRACT

CONTACT

Figure 2: Ethmoidal Stratus. Above CT scans: Patient with bilateral chronic ethmoidal inflammation. A right ethmoidectomy with conventional FESS, a left ethmoidal Stratus Relieva was placed, and septoplasty. Below: 3 months postoperative. CT scans demonstrate an important improvement, Left side has less inflammation.

There has been limited literature reporting on the use of steroid eluting implantable spacers for use in the ethmoid or frontal sinuses as these are not approved for use in the U.S. Steroids can potentially avoid scaring and closure of the frontal sinuses in those patients with frontal sinus disease with or without polyps. Local delivery of steroids may allow for decreased dosing and may obviate the need for systemic treatment. Although these devices have excellent safety profiles4,5, displacement of one RStE has been previously described in literature. Orbital wall violation was seen, with the stent abutting the lateral orbital wall. The patient underwent medial orbital decompression and successful stent removal, but continued to have a dilated pupil in the affected eye6. Therefore, we believe, that RStE, may be a good alternative for patients with mild or moderate ethmoid CRS, in whom maximal medical therapy has not been successful as an alternative to a conventional FESS ethmoidectomy. Concerns regarding corticosteroids affecting the hypothalamic-pituitary-adrenal axis (HPA) or ocular disturbances are a paramount issue. In the U.S., an FDA approved implantable spacer coated in mometasone furoate has been introduced that functions mechanically to maintain medialization of the middle turbinate after complete ethmoidectomy and elute steroid over a 3-week period. This product has been extensively studied for ocular adverse effects and has proven safe7. CRS inflammatory polyp disease is a challenging problem that has a high recurrence rate. Drug eluting stents will play a significant role in the future management of sinus disease where local therapies will deliver a variety of drugs. Further studies of these devices and drug therapies will be necessary in the future with longer follow-up and proven safety profiles.

Sixteen patients were enrolled between October 2011 and April 2012. 19 sinuses were treated. Six patients had RStE inserted and 10 patients had the RStF, among this latest group three were bilateral insertions. Patient baseline demographics are provided in Tables 1 and 2. Mean age of implantation in both groups was 55.6 years old. The most frequent symptoms reported prior to sinus surgery were obstruction, fatigue, headache and postnasal drainage. Only one of the patients had previous surgery, consisting of previous maxilo-ethmoidectomy for nasal polyp disease For those patients that had RStE, mild or moderate disease was diagnosed for the implanted site. In one of the patients a conventional FESS ethmoidectomy was performed on one side and on the contralateral side placement of the MicroFlow Spacer was inserted. The remainder of these patients underwent septoplasty and maxillary sinuplasty. In all patients in whom RStF was performed, a complete opening of the frontal sinus ostium was achieved either by sinuplasty (4cases) or by conventional FESS accompanied by surgery of the anterior and posterior sinuses, sphenoidectomy and septoplasty (6 cases). Three patients were implanted bilaterally; one of these had a history of previous surgery with stenosis. The stent placement was performed under direct endoscopic visualization in all patients successfully, without any peri- or postoperative complications. All patients had the device removed after approximately 21 days, in the office. All ethmoidal stratus patients had significant reduction of edema measured by endoscopy, postoperative CT scan and in quality of life scores, but one patient. This patient did not improve from his maxillary inflammatory, and was found later to have an oral-antral fistula contributing to the maxillary pathology. All patients implanted with RStF showed a complete patent frontal ostium at post removal day 0. In six patients the ostium continued to be patent after 3 months. In two cases narrowing of the os was seen at 3 months and in the remaining two cases stenosis of the os due to polypoid tissue.

A B C

Figure 1: Ethmoid Relieva MicroFlow Spacer Stratus (RStE): A) Catheter B) Tip of the catheter with Microflow Spacer C) Ethmoid deployment guide trocar with sheath D) Frontal deployment guide

A

B

C

D

Gender Age Durationof

Implant indays

Side Additional procedures

Balloon Sinuplasty®

Endoscopicevaluation (Postop90days)

M 63 16 RT BI-M,ET,SP NO Partialopacification,stenotictissuedevelopment F 53 15 BI NONE BI-FR Patentostium M 78 16 RT BI-M,ET,SP NO Patentostia M 36 19 LT BI-M,ET,SP LT-FR Patentostia,Polypoidtissuegrowth M 33 13 LT BI-M,ET,SP NO Patientostium F 67 17 RT BI-M,ET NO Patientostium F 57 20 BI BI-M,ET,SP NO Opacifiedostia,Polypoidtissuegrowth F 67 22 BI BI-M,ET,SP BI-FR Patentostia F 43 31 RT BI-M,ET,SP RT-FR Patentostium

M 65 20 RT BI-M,ET,SP NO Partialopacification,Stenotictissuedevelopment

Gender Age DurationofImplantindays

Side Additionalprocedures

BalloonSinuplasty®

RTPreLM

LTPreLM

RTPostLM

LTPostLM

F 40 36 RT - RT–M 4 0 0 0

M 71 31 LT - LT–M 1 7 1 7

F 53 20 LT RT-ET LT–F,

RT-M

3 4 0 0

F 55 15 LT - - 1 3 0 0

F 52 20 LT - - 3 4 2 0

F 56 20 RT - RT-M 5 0 1 0