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1.
Laryngoscope ; 134(5): 2077-2084, 2024 May.
Artigo em Inglês | MEDLINE | ID: mdl-37916848

RESUMO

OBJECTIVE: To assess the long-term safety and effectiveness of temperature-controlled radiofrequency (TCRF) neurolysis of the posterior nasal nerve (PNN), a minimally invasive treatment for chronic rhinitis. METHODS: A prospective, single-arm study of 129 patients at 16 centers (United States, Germany) was conducted. Patient-reported outcome measures were the 24-h reflective total nasal symptom score (rTNSS) and mini rhinoconjunctivitis quality of life questionnaire (MiniRQLQ). Postnasal drip and cough symptoms were assessed using a 4-point scale. RESULTS: The mean pretreatment rTNSS was 7.8 (95% CI, 7.5-8.1). The significant rTNSS treatment effect at 3 months (-4.2 [95% CI, -4.6 to -3.8]; p < 0.001) was sustained through 2 years (-4.5 [95% CI, -5.0 to -3.9]; p < 0.001), a 57.7% improvement. At 2 years, the proportion of patients with a minimal clinically important difference (MCID) of ≥30% improvement in rTNSS from baseline was 80.0% (95% CI, 71.4%-86.5%). Individual postnasal drip and cough symptom scores were significantly improved from baseline through 2 years. The proportion of patients who reached the MCID for the MiniRQLQ (≥0.4-point improvement) at 2 years was 77.4% (95% CI, 68.5%-84.3%). Of 81 patients using chronic rhinitis medications at baseline, 61.7% either stopped all medication use (28.4%) or stopped or decreased (33.3%) use of ≥1 medication class at 2 years. No device/procedure-related serious adverse events were reported throughout 2 years. CONCLUSION: TCRF neurolysis of the PNN resulted in sustained improvements in chronic rhinitis symptom burden and quality of life through 2 years, accompanied by a substantial decrease in medication burden. LEVEL OF EVIDENCE: 4 Laryngoscope, 134:2077-2084, 2024.


Assuntos
Qualidade de Vida , Rinite , Humanos , Estudos Prospectivos , Rinite/cirurgia , Rinite/tratamento farmacológico , Nariz , Tosse , Resultado do Tratamento
2.
Am J Rhinol Allergy ; 36(6): 747-754, 2022 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-35818709

RESUMO

BACKGROUND: Temperature-controlled radiofrequency (TCRF) neurolysis of the posterior nasal nerve (PNN; RhinAer) is a minimally invasive treatment option for patients with chronic rhinitis. OBJECTIVE: To determine clinical outcomes and quality of life (QoL) following TCRF neurolysis of the PNN. METHODS: A prospective single-arm study of 129 patients with chronic rhinitis at 16 medical centers in the United States and Germany. RESULTS: The mean 24-h reflective total nasal symptom score (rTNSS) improved from 7.8 (95% CI, 7.5-8.1) at baseline to 3.6 (95% CI, 3.2-4.0) at 3 months and continued to improve to 2.9 (95% CI, 2.5-3.3) at 6 months (p < .001 comparing follow-up to baseline and p = .002 comparing 3 and 6 months). This represents 53.8% improvement over baseline at 3 months and 62.8% improvement at 6 months. Rhinorrhea, congestion, sneezing, and itching subscores and postnasal drip and cough scores were all significantly improved over baseline at both timepoints. At 3 months, 76.2% (95% CI, 68.1%-82.8%) of patients achieved a minimal clinically important difference of ≥30% improvement in rTNSS over baseline and the percentage was higher at 6 months (83.5% [95% CI, 75.8%-89.0%]). At 3 months, 80.3% (95% CI, 72.6%-86.3%) reported a minimal clinically important difference of ≥0.4-point improvement in the mini rhinoconjunctivitis quality of life questionnaire score, and the percentage was higher at 6 months; 87.7% (95% CI, 80.7%-92.4%). There were no serious adverse events with a relationship to the device/procedure reported through 6 months. CONCLUSION: In this large, multicenter study, TCRF neurolysis of the PNN was safe and resulted in a significant reduction in rhinitis symptom burden at 3 months that was sustained/improved through 6 months. The majority of patients reported a clinically relevant improvement in QoL at 3 and 6 months postprocedure.


Assuntos
Rinite , Humanos , Estudos Prospectivos , Qualidade de Vida , Rinite/tratamento farmacológico , Rinite/cirurgia , Inquéritos e Questionários , Temperatura , Resultado do Tratamento
3.
Allergy Rhinol (Providence) ; 13: 21526575221096045, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-35663498

RESUMO

Background: Temperature-controlled radiofrequency neurolysis of the posterior nasal nerve has been shown to reduce the symptom burden of patients with chronic rhinitis. Objectives: To evaluate the long-term safety and effectiveness of temperature-controlled radiofrequency neurolysis of the posterior nasal nerve for the treatment of chronic rhinitis. Methods: A prospective extension of a 12-month single-arm study, where reflective total nasal symptom score (rTNSS) and the responses to a study-specific quality of life questionnaire and patient satisfaction survey were collected at 24 months. Results: Forty-seven patients completed initial 12-month follow-up after treatment with the study device, of which 34 patients were reconsented and completed 24-month follow-up. The mean rTNSS of the long-term follow-up patients improved from 8.4 (95% confidence interval (CI), 7.7 to 9.0) at baseline to 2.9 (95% CI, 2.1 to 3.6), P < .001 at 24 months, a 65.5% improvement. On a 6-point scale (0-5), postnasal drip improved from a mean of 4.1 (95% CI, 3.6 to 4.6) to 2.1 (95% CI, 1.7 to 2.5) and chronic cough improved from 3.2 (95% CI, 2.7 to 3.6) to 0.9 (95% CI, 0.5 to 1.3) from baseline through 24 months; P < .001 for both measures. The proportion of patients achieving a minimal clinically important difference of 30% improvement from baseline at 24 months was 88.2% (95% CI, 73.4%-95.3%). At 24 months, 24% of patients were taking overall fewer and 15% taking overall more rhinitis medication classes than at baseline. Patients reported a higher quality of life in terms of sleep, well-being, and lower oral medication/nasal spray use at 24 months. There were no serious adverse events considered related to the procedure in the 12-24-month period. Conclusion: Temperature-controlled radiofrequency neurolysis results in a significant and durable reduction in the symptom burden of chronic rhinitis and patients reported improved quality of life through 24 months postprocedure.

4.
Am J Rhinol Allergy ; 36(1): 149-156, 2022 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-34382444

RESUMO

BACKGROUND: Chronic rhinitis is a prevalent condition with a significant impact on quality of life. Posterior nasal nerve and vidian neurectomy are surgical options for treating the symptoms of chronic rhinitis but are invasive procedures. OBJECTIVE: To determine the outcomes of patients diagnosed with refractory chronic rhinitis and treated with temperature-controlled radiofrequency neurolysis of the posterior nasal nerve area in a minimally invasive procedure. METHODS: A prospective, single-arm multicenter study with follow-up through 52 weeks. Eligible adult patients had chronic rhinitis symptoms of at least 6 months duration with inadequate response to at least 4 weeks usage of intranasal steroids and an overall 12-h reflective total nasal symptom score (rTNSS) ≥ 6 with subscores 2 to 3 for rhinorrhea, 1 to 3 for nasal congestion, and 0 to 3 for each of nasal itching and sneezing. Temperature-controlled radiofrequency energy was delivered to the nasal cavity mucosa overlying the posterior nasal nerve region with a novel single-use, disposable, handheld device. RESULTS: A total of 50 patients were treated (42.0% male; mean age 57.9 ± 11.9 years), and 47 completed the study through 52 weeks. Mean rTNSS significantly improved from 8.5 (95% CI 8.0, 9.0) at baseline to 3.6 (95% CI 3.0, 4.3) at 52 weeks (P < .001), a 57.6% improvement. Similar trends in improvement were noted for rTNSS subscores (rhinorrhea, nasal congestion, itching, sneezing), postnasal drip scores, and chronic cough scores. Subgroup analysis demonstrated the treatment was effective regardless of rhinitis classification (allergic or nonallergic). No serious adverse events with a relationship to the device/procedure occurred. CONCLUSIONS: Temperature-controlled radiofrequency neurolysis of the posterior nasal nerve area for the treatment of chronic rhinitis is safe and resulted in a durable improvement in the symptoms of chronic rhinitis through a 52-week follow-up. Data suggest that this novel device could be considered a minimally invasive option in the otolaryngologist's armamentarium for the treatment of chronic rhinitis.


Assuntos
Rinite , Administração Intranasal , Adulto , Idoso , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Qualidade de Vida , Rinite/cirurgia , Temperatura , Resultado do Tratamento
5.
Head Neck ; 33(5): 615-9, 2011 May.
Artigo em Inglês | MEDLINE | ID: mdl-21484915

RESUMO

BACKGROUND: Shoulder function can be negatively affected during treatment of upper aerodigestive tract carcinoma. The purpose of this study was to investigate the impact of selective neck dissection alone or in combination with radiotherapy and/or chemotherapy. METHODS: We conducted an observational study in adults who underwent selective neck dissection for the treatment of upper aerodigestive tract cancer who were >6 months from completion of their therapy. Recurrent disease and use of flap reconstruction were part of the exclusion criteria. A modified Constant's score was used to evaluate shoulder function. RESULTS: Thirty-four patients (42 selective neck dissections) met the inclusion criterion. Operated shoulder function was significantly (p < .001) decreased as compared to the nonoperated shoulder. There was no statistical difference in the total Constant's score, in the subjective or objective scores among selective neck dissection only, in the selective neck dissection plus radiation therapy, or in the selective neck dissection plus chemoradiation therapy. CONCLUSION: Selective neck dissection can have a negative effect on shoulder function despite spinal accessory nerve preservation. Adjuvant therapy does not contribute additional detriment to shoulder function.


Assuntos
Esvaziamento Cervical/efeitos adversos , Dor de Ombro/fisiopatologia , Ombro/fisiopatologia , Quimioterapia Adjuvante/efeitos adversos , Estudos Transversais , Feminino , Neoplasias Gastrointestinais/patologia , Neoplasias Gastrointestinais/terapia , Humanos , Masculino , Pessoa de Meia-Idade , Exercícios de Alongamento Muscular , Radioterapia Adjuvante/efeitos adversos , Amplitude de Movimento Articular/fisiologia , Rotação , Dor de Ombro/reabilitação , Trato Gastrointestinal Superior/patologia
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