Winston C. Vaughan

Safety and outcomes of balloon catheter sinusotomy: A multicenter 24-week analysis in 115 patients

OBJECTIVE: The aim of this study was to further evaluate the safety and effectiveness of balloon catheter devices to dilate obstructed sinus ostia/perform sinusotomy. METHODS: Through a prospective, multicenter evaluation, safety was assessed by rate of adverse events, patency was determined by endoscopic examination, and sinus symptoms were determined by the Sino-Nasal Outcome Test (SNOT 20). RESULTS: At the conclusion of the 24-week analysis, endoscopy determined that the sinusotomy was patent in 80.5% (247 of 307) sinuses and nonpatent in 1.6% (5 of 307), and could not determine ostial patency status in 17.9% (55 of 307). Of the ostia visualized on endoscopy, 98% were patent (247 of 252), while 2% (5 of 252) were considered nonpatent. SNOT 20 scores showed consistent symptomatic improvement over baseline. Revision treatment was required in 3 sinuses (3 of 307 sinuses, 0.98%) in 3 patients (3 of 109 patients, 2.75%). CONCLUSION: Balloon catheter technology appears safe and effective in relieving ostial obstruction. Patients were pleased and indicated that they experienced symptomatic improvement.

Use of nebulized antibiotics for acute infections in chronic sinusitis.

OBJECTIVE: Infections in patients with chronic sinusitis after surgery can be difficult to treat. Nebulized antimicrobial therapy was studied as a treatment option. STUDY DESIGN: Patients with chronic sinusitis, previous sinus surgery, and an acute infection were offered nebulized antibiotics or standard therapy. Cultures were taken and sensitivity testing was performed. Retrospective chart reviews were also performed. RESULTS: Forty-two patients were included. The most common side effects were sore throat and cough. Symptomatic and endoscopic data before and after nebulized therapy showed a longer infection-free period (average, 17 weeks) compared with standard therapy (average, 6 weeks). Improvements in posterior nasal discharge, facial pain/pressure, and emotional consequences were noted. CONCLUSION: Nebulized therapy was safe and effective in this cohort. Endoscopy and outcome measure changes showed consistent improvements. SIGNIFICANCE: A novel therapy for acute sinus infections in patients with chronic sinusitis and previous endoscopic sinus surgery is presented.

Long-term outcome analysis of balloon catheter sinusotomy: Two-year follow-up

Objective Assess two-year postoperative clinical outcomes for patients receiving balloon catheter sinusotomy. Methods Patients who had sinus ostia dilated with balloon catheters were prospectively evaluated two years after surgery by Sinonasal Outcome Test (SNOT-20) and computed tomographic (CT) scan. Results Sixty-five patients (195 ballooned sinuses) were followed for two years after surgery, including 34 “balloon-only” patients and 31 “hybrid” patients. SNOT-20 symptom scores were significantly improved from baseline (0.87 vs 2.17 baseline, P < 0.001) and stable compared to six months and one year; this was the case for both balloon-only (1.09 vs 2.09, P < 0.001) and hybrid (0.64 vs 2.26, P < 0.001) patients. Lund-MacKay CT scores were significantly improved from baseline (2.69 vs 9.66, P < 0.001) and stable compared to one year, confirmed for both balloon-only (1.75 vs 5.67, P < 0.015) and hybrid (3.25 vs 12.05, P < 0.001) subsets of patients. A total of 85% of patients reported improvement of their sinus symptoms, with 15% same and 0% worsened. Revision treatment was required in seven of 195 sinuses (3.6%) in six of 65 patients (9.2%). Conclusion Patients who receive balloon catheter sinusotomy in endoscopic sinus surgery have significant improvement in symptoms two years after surgery. Radiographic evidence also confirms resolution of disease after two years. This demonstrates durability of clinical results previously reported at 24 weeks and one year after surgery.

Catheter-Based Dilation of the Sinus Ostia: Initial Safety and Feasibility Analysis in a Cadaver Model:

Background Over the past 20 years, many patients have benefited from endoscopic sinus surgery and its ability to relieve sinus obstruction. However, problems still occur with surgery, thereby leaving room for innovation. Recently, catheter-based technology has provided new options for treating cardiac, vascular, and urologic diseases. We speculated that catheter technology also might offer new treatment options for sinusitis patients. The purpose of this investigation was to explore the feasibility and safety of catheter-based technology to relieve sinus ostial obstruction. Methods Anatomic models and human cadaver specimens were used initially to design and iterate catheters to open sinus ostial drainage pathways. Thereafter, the safety of balloon-catheter dilation was evaluated in six human cadaver heads. CT scan obtained before and after catheter ostial dilation was analyzed for evidence of catheter-induced trauma. Dilated ostia also were examined by endoscopy and gross anatomic dissection for unwanted catheter-induced trauma. Results Catheters successfully dilated 31 of 31 ostia, including 9 maxillary, 11 sphenoid, and 11 frontal ostia/recesses. CT scan, endoscopy, and gross anatomic dissection revealed that such dilation did not cause trauma to surrounding structures such as the orbit or skull base. Mucosal trauma imparted by catheter dilation appeared to be less than that normally seen with standard endoscopic instruments. Conclusion This initial study suggests that catheter technology can be used to dilate sinus ostia safely. Mucosal preservation and ease of use make catheters an attractive minimally invasive treatment strategy. Additional testing in patients is indicated to gain additional safety information and to explore the usefulness of catheter-based technology.

Balloon catheter sinusotomy: one-year follow-up--outcomes and role in functional endoscopic sinus surgery.

Objective The primary objective was to assess the long-term effectiveness of balloon catheter sinusotomy. Methods Patients who had sinus ostia dilated with balloon catheters were prospectively evaluated 1 year after surgery with nasal endoscopy, a CT scan, and the Sino-Nasal Outcome Test (SNOT-20). Results Sixty-six patients (202 sinuses) were examined. One hundred seventy-two of 202 sinus ostia (85%) were endoscopically patent, 1 percent (2/202) were nonpatent, and ostial patency could not be determined by endoscopy in 28 of 202 (14%). In these “indeterminate” sinuses, the CT scans were normal in 13, implying functional patency in 91.6 percent of sinuses (185/202). Sinus CT scan scores were 1.95 at 1 year versus 8.89 at baseline (P < 0.001), and 1-year SNOT-20 scores (0.91) were significantly improved from baseline (2.14, P < 0.0001). Conclusion Balloon catheter sinusotomy results were durable over the study period, showing long-term effectiveness.

Revision Endoscopic Frontal Sinus Surgery with Surgical Navigation

BACKGROUND: Revision surgery of the frontal sinus remains one of the most difficult operations for the endoscopic surgeon. Most agree that knowledge and recognition of its complex anatomy and sparing of frontal recess mucosa are keys to a successful operation. The use of surgical navigation systems may allow for more precise dissections and greater rates of frontal recess patency. METHODS: Retrospective review of all patients undergoing revision endoscopic frontal sinus surgery with surgical navigation was performed with a minimum 24-month follow-up. RESULTS: Sixty-seven patients underwent revision endoscopic frontal sinus surgery with surgical navigation. The average follow-up was 32 months. Fifty-eight (86.6%) had a patent frontal recess and significant subjective improvement in symptoms. No patient underwent external frontal sinus obliteration, and there were no major complications. CONCLUSIONS: Endoscopic techniques with surgical navigation are effective in revision frontal sinus cases. The dissection of remnant agger nasi, obstructing frontal and supraorbital cells are necessary to widen the anterior-posterior as well as the medial-lateral dimensions of the recess. Computer navigational systems appear to serve as a valuable adjunct in preoperative planning and safe intraoperative dissection. (Otolaryngol Head Neck Surg 2004;130:312–8.)

Nationwide survey on the use of image-guided functional endoscopic sinus surgery.

OBJECTIVE: To evaluate impressions and usage of sinus surgery image-guided surgical (IGS) systems by ENT surgeons in the United States. STUDY DESIGN AND SETTING: A survey was mailed to selected practicing ENT physicians, investigating regional information, practice type, IGS usage patterns, perceived benefits and limitations, and usage of the 61795 surgery code. RESULTS: Seventy-three percent of respondents use IGS. Nonusers respond that it provides no benefit or is too expensive. Eighty percent of respondents replied that IGS may allow for increased safety in certain procedures. Most users attempt reimbursement with the 61795 code. CONCLUSION: IGS usage is increasing but appears to be perceived as expensive and nonbeneficial in certain situations. Most respondents, however, felt that IGS may lead to safer surgery in certain situations, including revision and frontal procedures. Several factors appear to limit routine use including ease of use, technical setup, code reimbursement, and initial purchase costs. SIGNIFICANCE: IGS use appears to be increasing. The most frequent users appear to agree with the previously issued AAO-HNS guidelines regarding appropriate indications. Expanded use may depend on ease of use, reimbursement, and affordability. EBM rating: D-5

Management of the lateral frontal sinus lesion and the supraorbital cell mucocele.

Background Masses that radiographically appear in the lateral aspect of the frontal sinus can be difficult to access and often are approached through external approaches. Supraorbital ethmoid cells pneumatize the orbital plate of the ethmoid bone to lie posterior and lateral to the frontal sinus. Opacification of a supraorbital cell may radiographically give the appearance of a laterally based frontal sinus lesion. Often, these represent mucoceles, in which their drainage can be achieved through endoscopic techniques and without the need for an external approach. Methods Retrospective review of patients treated for lateral frontal sinus lesions at a tertiary sinus center was performed. Radiology, endoscopic findings, operative reports, and patient symptoms were reviewed. Results Ten patients were identified with lateral frontal sinus lesions based on radiography of the paranasal sinuses and nasal endoscopy. All patients were determined to be supraorbital mucoceles. These patients underwent surgical drainage using computer-aided endoscopic techniques. Initially, endoscopic drainage of the mucocele was successful in all patients. One patient was lost to follow-up after 3 months and one patient underwent a revision endoscopic surgery with trephination 5 months after the initial drainage. The remaining eight patients remain free of disease by nasal endoscopy and postoperative computed tomography scans (median follow-up of 25 months; range, 8–38 months). Conclusion Knowledge of the anatomy of the ethmoid complex and presence of various cells within the frontal recess such as supraorbital cells are important in the management of the laterally based frontal sinus lesion. Often, these lesions may represent supraorbital cell mucoceles amenable to endoscopic drainage. Given the nature of mucoceles, long-term follow-up is needed before endoscopic drainage of these lesions can be validated. However, preliminary data suggest that an endoscopic approach provides for adequate drainage and helps avoid external approaches.

Informed Consent in Functional Endoscopic Sinus Surgery: The Patient's Perspective

OBJECTIVE: Informed consent is essential prior to functional endoscopic sinus surgery (FESS). The content of this discussion is often determined by each surgeon. Many doctors discuss all potential complications. This may provoke anxiety or deter from beneficial surgery. Our goal was to examine the process from the patients perspective. STUDY DESIGN: A list of potential complications was reviewed with FESS patients. Patients were asked questions concerning their consent and the potential complications before and after FESS. RESULTS: Both before and after surgery, patients felt that discussion of most potential complications was important. Vision changes and cerebrospinal fluid leak (CSF) received the highest scores. No significant differences were found between primary and revision cases. CONCLUSION: Patients wanted most potential FESS complications to be discussed. Even though this triggered anxiety, they felt it was important to have a thorough disclosure. Findings presented may impact how surgeons counsel patients prior to FESS.

Endoscopic repair of large skull base defects after powered sinus surgery

OBJECTIVES: To evaluate the management of patients with large skull base defects (> 2 cm) and intracranial injury caused by powered endoscopic sinus surgery. STUDY DESIGN AND SETTING: All patients treated for postendoscopic sinus surgery skull base injury over a 4-year period were reviewed. RESULTS: Three patients with skull base defects greater than 2 cm in size and associated intracranial injury from powered ESS were identified. All patients presented with active cerebrospinal fluid leaks. CT scans showed intracranial injury and pathology reports revealed brain tissue removal. Using image-guided endoscopic techniques, all defects were addressed with multilayer repair. Closure was achieved in all patients on the first attempt, with an average follow-up of 27 months. CONCLUSIONS: The use of powered instrumentation along the skull base can be dangerous and can result in extensive skull base defects with associated loss of dura and gray matter. Large ethmoid roof defects and significant intracranial injury, however, are not absolute contraindications to endoscopic repair.