Twelve-month outcomes following temperature-controlled radiofrequency treatment of the septal swell body for nasal airway obstruction.

BACKGROUND: Improved nasal airway obstruction (NAO) symptoms were reported at 3 months following temperature-controlled radiofrequency (TCRF) treatment of the septal swell body (SSB). This report provides results from assessments of the long-term safety and efficacy of TCRF treatment of SSB hypertrophy to treat NAO through 12 months posttreatment. METHODS: This prospective, multicenter, long-term, open-label study was conducted in nine centers within the United States and included patients with severe/extreme NAO attributed to SSB hypertrophy. Outcome measures included assessments of Nasal Obstruction Symptom Evaluation Score (NOSE), Numeric Rating Scale (NRS) ease-of-breathing, patient satisfaction, and adverse events at 6 and 12 months. RESULTS: Of the 70 patients treated, 65 and 62 patients completed the 6- and 12-month follow-up assessments. Compared to baseline, there was a 67.5% decrease in adjusted mean NOSE scores at 6 months (mean change -49.6, 95% confidence interval [CI] -54.8 to -44.4; p < 0.001) and a 65.4% decrease at 12 months (mean change -48.1, 95% CI -53.7 to -42.5); p < 0.001), which is consistent with previously published 3-month results. A 62.0% and 62.5% improvement compared to baseline was observed in the NRS ease-of-breathing score at 6 and 12 months, respectively (p < 0.001). No serious adverse were reported overall and no new device- or procedure-related adverse events were reported in the interval between 3 and 12 months posttreatment. CONCLUSION: TCRF treatment of SSB hypertrophy has a significant and durable effect on improving the symptoms of NAO and health-related quality of life in patients with symptoms of nasal obstruction and congestion through 12 months postprocedure.

Temperature-controlled radiofrequency device treatment of septal swell bodies for nasal airway obstruction: An open-label, single arm multicenter study.

BACKGROUND: Nasal airway obstruction (NAO) is a highly prevalent disorder. Septal swell body (SSB) hypertrophy is an often overlooked contributor to NAO. SSB treatment may relieve symptoms of NAO. The objective of this study was to assess the clinical use of a temperature-controlled radiofrequency (TCRF) device to treat SSBs to improve symptoms in adults with NAO. METHODS: In this prospective, multicenter, open-label, single arm study, patients with severe or extreme NAO related to SSB hypertrophy received bilateral TCRF treatment in the SSB area. The primary endpoint was improvement in Nasal Obstruction Symptom Evaluation (NOSE) Scale scores from baseline to 3 months postprocedure. A subset of study patients underwent computed tomography (CT) imaging to evaluate posttreatment changes in SSB size. RESULTS: Mean NOSE Scale scores significantly improved from 73.5 (SD 14.2) at baseline to 27.9 (SD 17.2) at 3 months postprocedure, a reduction of -45.3 (SD 21.4, 95% confidence interval [CI]: -50.4 to -40.1; p < 0.0001); the responder rate was 95.7% (95% CI: 0.88 to 0.99; p < 0.0001). CT evaluation at 3 months showed statistically significant reductions in the SSB with the greatest reduction in the middle thickness (mean change -3.4 [SD 1.8] mL, 95% CI: -4.0 to -2.8; p < 0.0001). Minimal adverse events with any relationship to the device or procedure were reported; none were serious in nature and no septal perforations occurred. CONCLUSIONS: This study demonstrates that TCRF treatment of SSB hypertrophy is well tolerated and effective at reducing both SSB size and symptoms of NAO at 3 months posttreatment.

Development of an optimized preoperative computed tomography imaging checklist for endoscopic sinus surgery utilizing a systematic review of the literature and the modified Delphi method.

BACKGROUND: Critical review of computed tomography (CT) imaging is essential in preoperative planning for endoscopic sinus surgery. In this study, we used a systematic review and a modified Delphi method to develop a comprehensive checklist that facilitates preoperative review of sinus CT imaging. METHODS: We performed a systematic review of PubMed, Embase, CINAHL, Cochrane, and Web of Science databases to identify existing checklists developed to evaluate sinus CT imaging. An inclusive list of items from these checklists was compiled and a modified Delphi methodology was used to assign ranked priority. The Delphi process involved 14 rhinologists and had three phases: an initial survey with Likert priority (scale of 1-9) and two rounds of live discussions followed by survey to confirm consensus. RESULTS: Ninety-seven possible checklist items were identified from a systematic review and panelist input. On initial survey, 63 items reached a consensus score of 7+, and 13 items had near consensus scores between 6 and 7; two of these 13 borderline items were retained after subsequent panelist discussion. The resulting items were consolidated into an 11-item disease checklist and a 24-item anatomical checklist; the anatomical checklist was further divided into six subsections: nasal cavity, maxillary, ethmoid, sphenoid, frontal, skull base, and orbit. Additionally, panelists identified six core aspects of patient history to consider prior to surgery. CONCLUSIONS: After establishing content validity through a systematic literature review and a modified Delphi method, we developed a comprehensive checklist for preoperative sinus CT imaging review; implementation and evaluation of validity among trainees will suggest overall utility.

Costs in Pituitary Surgery: Racial, Socioeconomic, and Hospital Factors.

Objective To investigate the influence of patient demographic factors and hospital factors on cost and length of stay in patients undergoing pituitary surgery. Design/Setting A retrospective cross-sectional study of the 2008 to 2012 Nationwide/National Inpatient Sample. Participants Patient demographics and hospital characteristics for patients undergoing pituitary surgery were compared between white, black, and Hispanic patients. Main Outcome Measures Variables associated with increased cost and increased length of hospital stay were ascertained and compared against each racial and ethnic group via multiple linear regression analysis. Results Of 8,812 patients who underwent pituitary surgery, 5,924 (67.2%) patients were white, 1,590 (18.0%) were black, and 1,296 (14.7%) were Hispanic. Patient variables found to be significantly different between racial groups via univariate analysis were age, chronic conditions, gender, income, and primary payer. Hospital variables found to be significantly different were location/teaching status, region, and ownership. Hospitalization cost was significantly lower for whites (-$3,082, 95% confidence interval [CI] -$3,961 to -$2,202) and significantly higher for both blacks ($1,889, 95% CI $842-$2,937) and Hispanics ($2,997, 95% CI $1,842-$4,152). Length of hospital stay was also significantly lower in whites (-1.01, 95% CI -1.31 to -0.72) and significantly higher for both blacks (0.65, 95% CI 0.30 to 1.00) and Hispanics (0.96, 95% CI 0.57-1.35). Conclusions Racial and ethnic factors contribute to differences in hospital utilization and cost for patients undergoing pituitary surgery. Further investigations are necessary to uncover the sources of these disparities in an effort to provide safer and more affordable care to all patients.

Primary intraosseous cavernous hemangioma of the clivus: case report and review of the literature.

Primary intraosseous hemangiomas are benign, vascular malformations that account for approximately 1% of all primary bone neoplasms. These tumors are mostly found in vertebral bodies and are rarely seen in the calvarium, where they represent 0.2% of bony neoplasms. When found in the skull, they tend to present with vague symptoms and do not have the typical radiological findings suggestive of hemangiomas. Because of this, these tumors can be missed in many cases or may be misinterpreted as more ominous lesions like multiple myeloma or osteosarcoma. Involvement of the skull base is exceedingly rare, and presentation with cranial nerve unilateral polyneuropathies has not been reported. We report a patient case with review of recent pertinent literature.