Office-Based Balloon Sinus Dilation: 1-Year Follow-up of a Prospective, Multicenter Study.

OBJECTIVE: Balloon sinus dilation (BSD) instruments afford the opportunity for office-based sinus procedures in properly selected patients with chronic rhinosinusitis (CRS). This study evaluated patient-reported outcomes 1 year after office-based BSD. METHODS: Adult patients with medically refractory CRS were prospectively enrolled into a multicenter, single-arm study and treated with office-based BSD under local anesthesia. Follow-up on 203 patients was conducted at 2, 8, and 24 weeks postsurgery using validated outcome measures for quality of life (SNOT-20) and computed tomography imaging (Lund-Mackay score). After 24 weeks, patients were re-enrolled for 1-year follow-up to evaluate changes in SNOT-20 scores and revisions. RESULTS: All patients who re-enrolled (n = 122) completed the study, with an average follow-up of 1.4 years. Neither preoperative SNOT-20 nor Lund-Mackay CT scores were predictive of re-enrollment and return for follow-up. Compared to baseline, improvements in SNOT-20 scores remained statistically significant (P < .001) and clinically meaningful (mean decrease ≥ 0.8). In patients followed to 1.4 years, 9 of 122 (7.4%) had revision surgery. CONCLUSION: Following office-based BSD, significant improvements in quality of life observed at 24 weeks were maintained 1 year postsurgery. These extended results provide further evidence of office-based BSD as an effective, minimally invasive procedure for appropriately selected patients with CRS.

Long-term outcomes following impedance-controlled radiofrequency ablation for the treatment of chronic rhinitis.

Objective: To assess long-term safety and effectiveness of a multipoint, impedance-controlled, RF ablation device for treatment of chronic rhinitis through 12-month follow-up. Methods: A prospective, multicenter study. Bilateral posterior nasal nerve (PNN) ablation was performed on all participants. Assessments at 6-, 9-, and 12-month visits included Visual Analog Scale Nasal Symptom Score (VAS NSS), reflective Total Nasal Symptom Score (rTNSS), mini-Rhinoconjunctivitis Quality of Life Questionnaire (mini RQLQ), and adverse events. Results: Thirty-six participants were enrolled and 35 completed the 12-month follow-up. All 5 VAS NSS items demonstrated statistically significant improvement (p < .0001) over baseline at all 3 time points. The total rTNSS improved from 7.9 ± 1.8 at baseline to 4.3 ± 2.1 at 6-months, 3.8 ± 2.4 at 9-months, and 4.0 ± 2.1 at 12-months (all p < .0001). At 12-months, 91% (31/35) of participants had achieved the minimum clinically important difference (MCID) of a reduction from baseline of ≥1 point and 80% (28/35) of the participants met the responder criteria of ≥30% reduction from baseline. The total mean mini RQLQ was reduced from 3.0 ± 1.0 at baseline to 1.4 ± 0.8 at 6-months, 1.4 ± 1.0 at 9-months, and 1.3 ± 0.8 at 12-months (all p < .0001). At 12-months, 86% (30/35) of participants achieved the MCID of a reduction from baseline of ≥0.4 points for the mini RQLQ. No related serious adverse events occurred during the study. Conclusions: Impedance-controlled RF ablation of the PNN is safe and resulted in durable, significant improvement in rhinitis symptoms and quality of life through 12-month follow-up. Trial Registration: The study is registered at www.clinicaltrials.gov with the unique identifier of NCT05324397. Level of Evidence: 4.

Two-year outcomes of temperature-controlled radiofrequency device treatment of the nasal valve for patients with nasal airway obstruction.

Background: The objective of this study was to evaluate long-term symptom improvements in patients with nasal airway obstruction (NAO) secondary to nasal valve collapse (NVC) following minimally invasive temperature-controlled radiofrequency (TCRF) treatment. Methods: A prospective, single-arm, multicenter study in patients >18 years with NAO due to NVC. Inclusion criteria were response to nasal valve dilation (e.g., modified Cottle maneuver) and baseline Nasal Obstruction Symptom Evaluation (NOSE) Scale score ≥60. Patients were treated in the nasal valve region with a TCRF device and followed through 2 years. A responder was ≥20% reduction NOSE Scale score or ≥1 reduction in severity class. Results: A total of 122 patients were treated and 91 reached 2 years. The mean baseline NOSE Scale score was 80.3 (95% CI, 78.1-82.6). The adjusted mean change in score at 2 years was -45.8 (95% CI, -53.5 to -38.1), p < 0.001; a 57.0% improvement. The 2-year responder rate was 90.1% (95% CI, 82.3%-94.7%). Significant and sustained symptom improvement was achieved in subpopulations based on sex, age, body mass index, baseline NAO severity, nasal surgery history, NVC mechanism, septal deviation, and other anatomic contributors of NAO. No serious adverse events with a relationship to the study device and/or procedure were reported. Conclusions: Minimally invasive TCRF device treatment of the internal nasal valve for NAO is well tolerated and leads to significant and sustained improvement in NAO symptom severity through 2 years, including in patients with both static and dynamic NVC, septal deviation, turbinate enlargement, or prior nasal surgery. Level of Evidence: 2b.

Clinical evaluation of a novel multipoint radiofrequency ablation device to treat chronic rhinitis.

Objective: Safety and efficacy of the NEUROMARK® system for treating chronic rhinitis. Methods: A prospective, single-arm, multicenter study was performed on adults with chronic rhinitis who underwent radiofrequency ablation to the posterior nasal nerves. Primary endpoints were device-related serious adverse events (SAEs) at 1 month and change from baseline in visual analog scale nasal symptom scale (VAS NSS) for rhinorrhea and nasal congestion at 3 months. Total nasal symptom score (rTNSS) and mini Rhinoconjunctivitis Quality of Life Questionnaire (mini RQLQ) score were also evaluated. Results: Thirty-six participants were enrolled and completed follow-up at 1 and 3 months. Mean VAS NSS scores for rhinorrhea and nasal congestion demonstrated significant improvement at 3 months (both p < .0001). The mean percent changes from baseline in VAS rhinorrhea and nasal congestion were 53% and 55%, respectively. Total scores and all individual rTNSS items significantly improved (all p < .001) over the measured interval. Percent responder rate (≥30% reduction from baseline in total rTNSS) at 3 months was 78%. The total mean mini RQLQ scores, as well as all subdomains, improved significantly (all p < .0001). At 3 months, 89% of participants reported a minimal clinically important difference of ≥0.4 point improvement in the mini RQLQ score. No SAEs occurred during the study. Conclusions: The NEUROMARK System is a novel radiofrequency ablation device that provides safe and effective treatment to the posterior nasal nerves for patients with chronic rhinitis. Study participants experienced statistically significant and clinically meaningful improvement in symptoms and quality of life assessments at 3 months post-procedure. Trial Registration: The study is registered at www.clinicaltrials.gov with the unique identifier of NCT05324397. Level of Evidence: 4.

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.

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.

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.

Expandable tracheal stenting for benign disease: worth the complications?

OBJECTIVES: To characterize the limitations of self-expandable stents in the management of benign tracheal stenosis, we performed a retrospective review at a tertiary care medical center. METHODS: Patients who underwent tracheal stenting were assessed for the cause and severity of tracheal stenosis, comorbidities, stent-related complications, and follow-up airway procedures. RESULTS: Sixteen adults (12 women, 4 men; mean age, 47 years) had a total of 26 stents placed for benign disease. Intubation-related stenoses were most frequent (81%). The average follow-up time was 20 months (range, 1 to 40 months). Each stent remained functional for an average of 12.4 months. In the study group, 87% had a complication that required surgical intervention to maintain a patent airway. The most common problem was granulation tissue formation at the ends of the stent causing airway restenosis (81%), and 5 patients (31%) required tracheotomy as a result of restenosis around the stent. Fourteen of the stents (56%) were removed or expelled from the patients. CONCLUSIONS: The implantation of self-expandable stents is a minimally invasive method of managing benign tracheal stenosis. Although a small subset of patients may benefit from placement, the majority of patients have complications that require intervention to maintain a patent airway. Thoughtful discretion is critical in selecting patients for this intervention.

Common fibro-osseous lesions of the paranasal sinuses.

Within in the broad spectrum of disease that can affect the paranasal sinuses is a class of benign bony abnormalities known collectively as fibro-osseous lesions. Fibrous dysplasia, ossifying fibroma, and osteoma are three distinct entities that lie along a continuum from the least to the most bony content. They have similar appearance and makeup; however, their clinical implications vary. This article focuses primarily on sinonasal osteomas, with less emphasis on fibrous dysplasia and ossifying fibroma.

Balloon Catheter Dilation of the Frontal Sinus Ostium.

The decision to operate on the frontal sinus is based on persistent symptoms that have been refractory to appropriate medical therapy with associated radiographic evidence of disease by computed tomography. There is currently no evidence to support operating on radiographically negative frontal sinuses, regardless of the availability of technology or site of service options. There are many surgical procedures as well as a variety of different technologies available for the treatment of symptomatic, medically refractory frontal sinus disease. Balloon catheter dilation can be performed safely in an office setting with outcomes comparable to those in traditional operating room settings.

In-office balloon catheter dilation: analysis of 628 patients from an administrative claims database.

OBJECTIVES/HYPOTHESIS: Balloon catheter dilation (BCD) of the paranasal sinuses is increasingly described as a standalone procedure in the office for minimally invasive treatment of patients with chronic rhinosinusitis (CRS). This study evaluates CRS-related healthcare utilization before and after in-office treatment as performed by otolaryngologists within the United States in an all-comer population. STUDY DESIGN: Retrospective claims database analysis. METHODS: The MarketScan database was queried for patients undergoing BCD (Current Procedural Terminology [CPT] 31295-31297) for CRS (International Classification of Diseases Ninth Edition [ICD-9] 473.x) since 2011 in the office (place of service: 11). Exclusion criteria included < 1 year preoperative enrollment, < 6 months postoperative history, and concurrent (± 30 days) endoscopic sinus surgery (CPT 31254-31288). A cohort of 628 patients was identified. Analyses included preoperative comorbidities and CRS-related healthcare use. RESULTS: Preoperative comorbidities included asthma (29.0%), polyps (11.5%), and aspirin sensitivity (9.9%). An average of 3.0 sinuses (95% confidence interval: 2.91-3.17) were dilated at index. Maxillary, frontal, and sphenoid dilations were performed in 88.9%, 74.5%, and 33.8% of cases, respectively. There were two orbital complications and seven cases of hemorrhage potentially associated with the procedure, but no postoperative cerebrospinal fluid leaks. No blood transfusion, lateral canthotomy, or canthoplasty were reported. CRS-related postoperative healthcare use declined rapidly from the immediate preoperative state. Twenty-one patients underwent revisions, with one patient undergoing two surgeries for a total of 22 reoperations (3.5%). CONCLUSIONS: In-office BCD is associated with low risks of complications and revisions. Whereas not significant for patients with polyps, decreases in healthcare utilization pre- to postsurgery were significant for patients without polyps.

Minimally invasive approaches to the sphenoid sinus.

OBJECTIVE: We sought to develop an algorithm for surgical approaches to the sphenoid sinus. STUDY DESIGN AND SETTING: Retrospective review was conducted of all patients who underwent a sphenoid sinusotomy by the senior author between July 1994 and August 2001. RESULTS: The study population consisted of 141 patients, in whom 5 different surgical approaches were used: transseptal (47 [33.3%]), transnasal (19 [13.5%]), transethmoid (72 [51.1%]), transmaxillary (2 [1.42%]), and external (1 [0.7%]). Of the 47 transseptal approaches, 43 (91.5%) were for extirpation of a neoplasm. In contrast, 60 of 72 (83.3%) transethmoid procedures were for infectious/inflammatory disorders. An endoscopic approach was used for 7 of 8 (87.5%) skull base repairs. Four transsphenoid optic nerve decompressions were performed. The minor and major complication rates were 2.1% and 0.71%, respectively. CONCLUSIONS: The anatomic location of the pathologic process can guide the surgeon in selecting the most appropriate technique. SIGNIFICANCE: Surgical treatment of sphenoid pathology can be safely and successfully performed through a variety of approaches.

In-office functional endoscopic sinus surgery for chronic rhinosinusitis utilizing balloon catheter dilation technology.

PURPOSE OF REVIEW: Balloon catheter dilation (BCD) technology was introduced in 2005 as a device employed to dilate maxillary, sphenoid, and frontal sinus outflow tracts in patients with chronic sinus disease. With the evolution of the technology, BCD has been utilized in the office setting. The purpose of this review is to discuss the safety, tolerability, and technical success of this change of venue and to consider the possible significant cost savings in the current healthcare environment. RECENT FINDINGS: Recent studies have shown that BCD technology can be safely and successfully used in the office setting with high patient satisfaction and symptom improvement similar to that achieved in the operating room. SUMMARY: In select patients with chronic sinus disease, BCD can be safely and effectively utilized to open compromised outflow tracts from the peripheral sinuses including the maxillary, sphenoid, and frontal sinuses. This has the potential to reduce the overall costs related to the surgical treatment of medically refractory sinus disease.

Office-based balloon sinus dilation: a prospective, multicenter study of 203 patients.

BACKGROUND: Balloon sinus dilation (BSD) is an increasingly used tool in endoscopic sinus surgery (ESS). The tissue-sparing nature of the instrumentation allows for properly selected patients to undergo office-based procedures under local anesthesia. METHODS: This was an Institutional Review Board (IRB)-approved, prospective, 14-center trial. Patients (n = 203) requiring ESS for medically refractory chronic sinusitis underwent transnasal BSD treatment in an office setting under local anesthesia. Safety, tolerability, technical success, clinical efficacy (20-item Sino-Nasal Outcome Test [SNOT-20]), and radiographic outcome (Lund-Mackay [LMK] score) of ESS with BSD in the office setting were assessed. Subjects were followed at 2, 8, and 24 weeks. RESULTS: A total of 552 sinuses were dilated in 203 patients: 47.6% maxillaries, 45.5% frontals, and 6.9% sphenoids. Seventy-seven patients were revisions of prior ESS. The mean number of sinuses dilated per subject was 2.7. Technical dilation success was 93.3%, 90.5%, and 93.7% for maxillary, sphenoid, and frontal sinuses, respectively. SNOT-20 and LMK computed tomography (CT) scoring showed statistically significant improvement at 24 weeks (p < 0.0001) and clinically significant improvement in quality of life. The procedure was reported as tolerable or highly tolerable by 82.3% of patients. There were 0.15 postoperative debridements per patient and the majority returned to normal activity within 48 hours. One (0.5%) procedure-related adverse event related to periorbital swelling was reported, which spontaneously resolved shortly after the procedure without further sequelae. CONCLUSION: Performance of ESS with BSD in the office under local anesthesia is feasible, well-tolerated, safe, and effective. Twenty-four week follow-up demonstrates clinical and statistical improvement in patient quality of life and radiographic outcomes.

Feasibility of in-office endoscopic sinus surgery with balloon sinus dilation.

BACKGROUND: Balloon sinus dilation (BSD) tools are increasingly used in endoscopic sinus surgery (ESS) and post maximal may cause less tissue trauma/bleeding, potentially enabling office-based ESS. We evaluate the feasibility of ESS performed in-office using BSD instrumentation. METHODS: All patients had a diagnosis with chronic rhinosinusitis. Because of symptom resolution failure postmaximal medical therapy (prolonged antibiotics, corticosteroids, and other adjuvant therapies), all patients were candidates for ESS. In-office ESS using BSD tools was performed on 37 subjects at nine sites. Procedure feasibility was assessed prospectively through technical success rate, procedure tolerability, quality of life, and radiographic outcomes. Subjects were followed at 1, 4, 24, and 52 weeks. RESULTS: In-office technical success by subject was 89% (33/37). There was one nonserious adverse event. In-office BSD was tolerable, with 93% (27/29) of patients reporting the procedure as tolerable or highly tolerable. Two in-office subjects (7%) indicated poor procedure tolerability. Intraprocedure pain was also well managed during in-office BSD, with 66% (24/36) of patients reporting no pain or pain of low intensity. While 33% (12/36) reported higher-scale pain, usually during balloon inflation, only 2 patients experienced intense pain. At 52 weeks, 95% of the subjects stated they would have procedure again. Sino-Nasal Outcome Test-20 scores revealed clinically and statistically significant treatment effects at all time points, comparable to previous balloon dilation studies conducted in an operating room setting. Lund-Mackay scores revealed a statistically significant reduction at 24 weeks. CONCLUSION: Office-based ESS with BSD is feasible with demonstration of high technical success rate, meaningful patient symptom improvement, and high patient satisfaction.

Revision septoplasty.

This article addresses the challenge of persistent nasal airway obstruction following septoplasty, specifically as it relates to revision septoplasty. Emphasis is on the importance of and the steps to be taken in making a complete and correct diagnosis of the problem before any surgery is performed. The authors present two categories of revision surgery: surgery involving the cartilaginous septum and surgery involving the bony septum, because they believe the evaluation and management of these areas are distinct. This article presents a discussion of airflow dynamics, options to objectively assess nasal volume and patency, examination of the septum, and surgical approaches and techniques.

The use of portable intraoperative computed tomography scanning for real-time image guidance: a pilot cadaver study.

BACKGROUND: This study was performed to assess the feasibility of using intraoperative computed tomography (CT) to provide real-time updates to image guidance systems (IGSs) during surgery. METHODS: The xCAT ENT portable intraoperative CT scanner (Xoran Technologies, Ann Arbor, MI) was used to acquire scans before, midway, and at the end of six cadaver dissections during the Southern States Rhinology Course, Augusta, GA, in October 2006. These scans were used to recalibrate three different IGSs used during the dissection. Time measurements were recorded and dosimetry was obtained from the cornea, sphenoid sinus (near the optic chiasm), and from the operative field during acquisition of the images. IGS accuracy was determined at the skull base and lamina papyracea. Surgeons were interviewed on benefits of real-time updates to the IGS after completion of dissections. RESULTS: The xCAT ENT scanner was compatible with all three IGS platforms. The average time to update the IGS was 13 minutes. Radiation doses to the cornea were 620 mrad per scan, and optic chiasm was 800 mrad/scan. The accuracy at the anterior skull base improved from 1.58 to 0.62 mm (p=0.026). The accuracy at the posterior skull base improved from 1.46 to 0.71 mm (p=0.014). The accuracy at the lamina was not significantly changed. CONCLUSION: Intraoperative portable CT scanning with real-time IGS updates is feasible and likely would add little additional time. Accuracy is improved at the skull base. Prospective studies on actual patients are warranted.

A 2-phase screening process for patients with Wegener's granulomatosis: a pilot study.

A 2-phase screening process for patients with persistent upper respiratory tract manifestations for the detection of Wegener's granulomatosis (WG) was tested in 28 patients in this pilot study. One patient with WG was identified. A larger study is warranted.