A prospective, non-randomized evaluation of a novel low energy radiofrequency treatment for nasal obstruction and snoring

Brehmer, D.; Bodlaj, Robert; Gerhards, Friedemann

doi:10.1007/s00405-018-05270-y

Cited by 16 publications

(29 citation statements)

References 36 publications

(48 reference statements)

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“…Treatment was effective in patients who had previous surgeries. Previous reports using treatment with the same device yielded similar results at three months after treatment: Total NOSE scale score reduction of 54% in 31 patients [12] and 66% in 50 patients [10]. In this report, the procedure was generally well-tolerated, and patients were satisfied with their outcomes.…”

Section: Follow-up and Clinical Measuressupporting

confidence: 73%

“…Temperature-controlled radiofrequency (RF) treatment of the nasal valve has previously been reported as means to achieve symptomatic improvement [10][11][12]. This study's objective was to evaluate the effectiveness of temperature-controlled RF treatment of the nasal valve in an observational cohort of patients diagnosed with nasal airway obstruction due to nasal valve collapse.…”

Section: Device and Proceduresmentioning

confidence: 99%

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Temperature-Controlled Radiofrequency Treatment of the Nasal Valve and Nasal Airway Obstruction: Early Results of a Prospective, Multi-Center Study

C.¹,

A.²,

P.³

2021

J Otolaryngol Rhinol

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Background: Nasal valve collapse is a primary cause of nasal obstruction. Patients with nasal airway obstruction suffer from a variety of symptoms that affect quality of life including congestion, headache, sleep problems, daytime sleepiness, and snoring.Objective: To evaluate the effectiveness of a low-power temperature-controlled radiofrequency procedure to treat the nasal valve and measure symptomatic improvement in patients diagnosed with nasal airway obstruction due to nasal valve collapse. Methods:A prospective, single-arm, multi-institutional study at 12 otolaryngology centers across the United States in adults > 18 years suffering from nasal airway obstruction that responded to temporary nasal valve dilation, and with a baseline Nasal Obstruction Symptom Evaluation (NOSE) scale score ≥ 60. Patients were treated in the nasal valve region with temperature-controlled radiofrequency energy and followed up at 3 months.Results: 122 adult patients underwent the procedure and 3 patients were lost to follow-up at the 3 months visit. NOSE scale total scores at three months post-procedure were significantly improved relative to baseline, from 80.3 (± 12.6; range: 60-100) to 32.9 (± 24.2; range: 0-100), P < 0.001. At baseline, 100% of patients' total NOSE scale scores were in the 'extreme' (score of 80-100) or 'severe' (55-75) categories; at three months post-procedure this decreased to 18.5%. At the three-month visit, 91.6% of the patients had either a 20% improvement in NOSE scale total score relative to baseline or at least one severity category improvement. Conclusion:Minimally-invasive temperature-controlled radiofrequency treatment of the internal nasal valve led to significant improvement in NOSE scale scores at three months. This treatment is safe and efficacious to treat nasal airway obstruction due to valve collapse.

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Section: Follow-up and Clinical Measuressupporting

confidence: 73%

Section: Device and Proceduresmentioning

confidence: 99%

Temperature-Controlled Radiofrequency Treatment of the Nasal Valve and Nasal Airway Obstruction: Early Results of a Prospective, Multi-Center Study

C.¹,

A.²,

P.³

2021

J Otolaryngol Rhinol

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“…Device settings to be used are: Temperature = 60°C, Power = 4 Watts, Treatment Time = 18 seconds, Cooling Time = 12 seconds. The temperature of 60°C was maintained automatically by the device throughout the treatment time 21 …”

Section: Methodsmentioning

confidence: 99%

Regional Peak Mucosal Cooling Predicts Radiofrequency Treatment Outcomes of Nasal Valve Obstruction

Krebs

Spector

et al. 2020

The Laryngoscope

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Objectives/Hypothesis: Low energy radiofrequency may offer effective treatment for narrow or obstructed nasal valve, yet its precise mechanism is not fully understood.Study Design: Prospective, nonrandomized, case series. Methods: Twenty prospective patients with internal nasal valve obstruction underwent office-based Vivaer treatment (Aerin Medical, Inc) under local anesthesia. Computational fluid dynamics (CFD) models were constructed based on the preand 90 days post-procedure computed tomography (CT) scans to identify salient changes in nasal airflow parameters.Results: Patients' Nasal Obstruction Symptom Evaluation score (NOSE: pre-treatment 78.89 ± 11.57; post-treatment 31.39 ± 18.30, P = 5e-7) and Visual Analog Scale of nasal obstruction (VAS: pre-treatment 6.01 ± 1.83; post-treatment 3.44 ± 2.11, P = 1e-4) improved significantly at 90 days after the minimally invasive approach. Nasal airway volume in the treatment area increased $7% 90 days post-treatment (pre-treatment 5.97 ± 1.20, post-treatment 6.38 ± 1.50 cm 3 , P = .018), yet there were no statistically significant changes in the measured peak nasal inspiratory flowrate (PNIF, pre-treatment: 60.

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“…(i) Clinical trial: EQ-5D was employed as a primary or secondary outcome in an investigation, where two groups of patients were compared, and one of the groups received an experimental treatment. This trial could be randomized [8][9][10], or not randomized [11,12], where the control group received care-as-usual. (ii) Burden of illness study: EQ-5D was used to express the severity of the disease and/or the relationship between the severity of the disease and the different medical and background variables that were examined [13,14].…”

Section: Resultsmentioning

confidence: 99%

The remarkably frequent use of EQ-5D in non-economic research

et al. 2021

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Introduction EQ-5D is an instrument which has been utilized for a variety of purposes, including in health-economic appraisals as an input into quality-adjusted life year (QALY) calculations. Indeed, it is the most-widely applied instrument for health-economic appraisal worldwide, and is recommended for use in QALY calculations by many national Health Technology Assessment (HTA) agencies. There is also a growing body of evidence for its usefulness in a variety of settings other than economic appraisals, but such use has not been well-documented. This study addresses this issue and documents how EQ-5D has been applied in both the non-economic and economic contexts. Methods The PubMed database was searched using the terms ‘EQ-5D’, ‘EQ-5D AND cost’, and ‘EQ-5D AND cost AND QALY’ from 1 January 1980 to 31 December 2019. We concentrated on 2019 publications for more detailed analyses. All the data collected for 2019 were downloaded and collected in EndNote. For 2019 only, we classified economic and non-economic use based on the inclusion of ‘cost’. We also checked by manual inspection whether the search terms were suitable in correctly identifying economic and non-economic use. Variants of the non-economic use of EQ-5D were classified as follows: (a) as a quality of life outcome measure; (b) as a tool for methodological research; (c) methodological issues of EQ-5D itself; (d) comparisons with other quality of life questionnaires; (e) mapping studies; (f) value sets; (g) alongside costs but no QALY calculated; and (h) other. Results The first publication found was from 1990. Up to and including 2019, 10,817 publications were identified, of which more than two in three did not contain any reference to costs or QALYs. In 2019, a total of 1409 manuscripts were identified, of which 239 were specifically for EQ-5D-5L. Four hundred and seven (28.9%) included some form of ‘costs’ and 157 (11.1%) both ‘costs’ AND ‘QALYs’ terms. For EQ-5D-5L, the corresponding numbers were 104 (43.5%) and 29 (12.1%), respectively. After manually checking all the 1409 papers, three were duplicated records, which were omitted. In the remaining 1406 papers, only 40 (2.8%) contained the term ‘cost’, but not ‘cost per QALY’, and only 117 (8.3%) were identifiable as economic evaluations using the term ‘cost per QALY’. Most non-economic use of EQ-5D was as a quality-of-life outcome measure (72.8%). Other applications were: as a tool for methodological research (6.7%); comparison studies (3.7%); EQ-5D methodological issues (3.5%); containing costs but not QALYs (2.8%); mapping (1.3%); value sets (0.4%); and other papers (0.4%). Conclusions The majority of the studies retrieved, covering a wide variety of research areas, reported upon the non-economic use of EQ-5D. Despite being the most-used instrument worldwide for QALY calculations, economic appraisal accounted for only a small, but important, part of published use.

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A prospective, non-randomized evaluation of a novel low energy radiofrequency treatment for nasal obstruction and snoring

Cited by 16 publications

References 36 publications

Temperature-Controlled Radiofrequency Treatment of the Nasal Valve and Nasal Airway Obstruction: Early Results of a Prospective, Multi-Center Study

Temperature-Controlled Radiofrequency Treatment of the Nasal Valve and Nasal Airway Obstruction: Early Results of a Prospective, Multi-Center Study

Regional Peak Mucosal Cooling Predicts Radiofrequency Treatment Outcomes of Nasal Valve Obstruction

The remarkably frequent use of EQ-5D in non-economic research

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