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1.
Cleve Clin J Med ; 90(12): 755-765, 2023 Dec 01.
Artículo en Inglés | MEDLINE | ID: mdl-38040437

RESUMEN

Treatment options for obstructive sleep apnea include positive airway pressure and alternatives such as behavioral interventions, oral appliances, nasal expiratory positive airway pressure, negative pressure interventions, and surgical procedures. Certain drugs are also promising. An important aspect of the treatment includes troubleshooting the reasons for poor adherence to positive airway pressure treatment, discussing alternatives based either on individual preference or on phenotypic characterization of the sleep apnea, and managing expectations.


Asunto(s)
Presión de las Vías Aéreas Positiva Contínua , Apnea Obstructiva del Sueño , Humanos , Presión de las Vías Aéreas Positiva Contínua/métodos , Apnea Obstructiva del Sueño/terapia
2.
Laryngoscope ; 132(11): 2270-2274, 2022 11.
Artículo en Inglés | MEDLINE | ID: mdl-35352830

RESUMEN

OBJECTIVE: In 2021 the U.S. FDA issued a Class 1 safety recall notice for specific devices due to a risk of carcinogen exposure. The objective of this study was to evaluate reports of cancer linked to CPAP devices to understand implications for the field of sleep medicine. METHODS: Cases of cancer involving CPAP devices were retrieved from the MAUDE database from 2014 to 2021 and analyzed with descriptive statistics. RESULTS: A total of 2571 patient injuries were associated with CPAP. Reports of cancer (n = 209; 4.62%) were the second most commonly documented patient problem associated with CPAP, although 1950 (43.13%) patients had a device problem without an associated injury. Of the 209 cancer cases associated with CPAP, 200 (95.7%) of the adverse event reports were received by the FDA in 2021. There were 174 (9.15%) descriptions of the CPAP polyurethane sound abatement foam degrading in association with a cancer diagnosis, but degradation was more commonly not associated with malignancy (n = 1728; 90.85%). Other frequently documented CPAP device problems included broken devices (n = 279; 6.92%), fire (n = 182; 4.51%), and patient-device incompatibility (n = 144; 3.57%). CONCLUSION: Malignancy associated with CPAP devices has been reported; however, future studies are required to establish causation. Given 95.7% of those documented cases were reported in 2021, otolaryngologists should be prepared to discuss the risks of carcinogenesis associated with CPAP. The otolaryngology community should also be aware of the potential bandwagon effect and the implications for CPAP compliance. LEVEL OF EVIDENCE: 4 Laryngoscope, 132:2270-2274, 2022.


Asunto(s)
Neoplasias , Apnea Obstructiva del Sueño , Carcinógenos , Presión de las Vías Aéreas Positiva Contínua/efectos adversos , Humanos , Neoplasias/epidemiología , Poliuretanos , Apnea Obstructiva del Sueño/diagnóstico
3.
JAMA Otolaryngol Head Neck Surg ; 148(1): 61-69, 2022 01 01.
Artículo en Inglés | MEDLINE | ID: mdl-34762105

RESUMEN

Importance: Hypoglossal nerve stimulation (HNS) and positive airway pressure (PAP) have been shown to improve patient-reported outcomes (PROs) in obstructive sleep apnea (OSA). However, to our knowledge, there are no data that compare change in PROs between HNS and PAP or that indicate whether HNS improves comorbid insomnia or depression in the long term. Objectives: To determine whether HNS is associated with improvements in patient-reported sleepiness, insomnia, and depression in the long term and to compare the respective associations of HNS and PAP with improved PROs. Design, Setting, and Participants: This retrospective cohort study used data from patients treated at the Cleveland Clinic for OSA. Participants received either HNS (referred sample) from November 1, 2015, to September 31, 2018, or PAP (previous cohort) from January 1, 2010, to December 31, 2014, for OSA. Patients were matched 3:1 for PAP:HNS based on age, body mass index (BMI; calculated as weight in kilograms divided by height in meters squared), sex, and apnea hypopnea index (AHI). Data were collected at baseline and at prespecified follow-up points. Data were analyzed from March 26, 2020, to September 9, 2021. Exposures: Treatment with HNS vs PAP. Main Outcomes and Measures: Data collected included AHI and Epworth Sleepiness Scale (ESS), Functional Outcomes of Sleep Questionnaire (FOSQ), Insomnia Severity Index (ISI), and Patient Health Questionnaire-9 (PHQ-9; depression) scores. Results: Among 85 patients receiving HNS (mean [SD] age, 62.8 [9.5] years; 59 men [69.4%]; 77 White patients [90.6%]; mean [SD] BMI, 28.8 [3.1]), compared with 217 matched patients receiving PAP (mean [SD] age, 62.1 [9.9] years; 157 men [72.4%]; 173 White patients [81.2%]; mean [SD] BMI, 29.5 [3.1]) included in the analysis, significant improvements were seen in PHQ-9 scores for HNS vs PAP (least square means, -4.06 [95% CI, -5.34 to -2.79] vs -2.58 [95% CI, -3.35 to -1.82]; mean difference, -1.48 [95% CI, -2.78 to -0.19]) with comparable improvements in ESS, FOSQ, and ISI scores. Clinically meaningful differences were observed in 42 of 65 HNS group patients (64.6%) vs 118 PAP group patients (54.5%) for ESS scores, 29 of 49 HNS group patients (59.2%) vs 67 of 217 PAP group patients (30.9%) for FOSQ scores, 14 of 48 HNS group patients (29.2%) vs 53 of 217 PAP group patients (24.4%) for PHQ-9 scores, and 23 of 49 HNS group patients (46.9%) vs 79 of 217 PAP group patients (36.4%) for ISI scores. At the 1-year post-HNS assessment, meaningful improvements were seen in 17 of 28 patients (60.7%) for ESS scores, 11 of 20 patients (55.0%) for FOSQ scores, 7 of 23 patients (30.4%) for PHQ-9 scores, and 11 of 25 patients (44.0%) for ISI scores. Conclusions and Relevance: In this cohort study of patients with OSA, sustained improvements in PROs were observed 1 year after HNS and were comparable to those for PAP at 3 months. These findings suggest that HNS is a viable treatment for improving insomnia and depression in patients with OSA.


Asunto(s)
Presión de las Vías Aéreas Positiva Contínua/métodos , Terapia por Estimulación Eléctrica/métodos , Nervio Hipogloso/fisiopatología , Medición de Resultados Informados por el Paciente , Apnea Obstructiva del Sueño/terapia , Anciano , Estudios de Cohortes , Femenino , Humanos , Masculino , Persona de Mediana Edad , Estudios Retrospectivos
4.
J Clin Sleep Med ; 17(12): 2477-2487, 2021 12 01.
Artículo en Inglés | MEDLINE | ID: mdl-34279214

RESUMEN

Hypoglossal nerve stimulation (HGNS) has evolved as a novel and effective therapy for patients with moderate-to-severe obstructive sleep apnea. Despite positive published outcomes of HGNS, there exist uncertainties regarding proper patient selection, surgical technique, and the reporting of outcomes and individual factors that impact therapy effectiveness. According to current guidelines, this therapy is indicated for select patients, and recommendations are based on the Stimulation Therapy for Apnea Reduction or STAR trial. Ongoing research and physician experiences continuously improve methods to optimize the therapy. An understanding of the way in which airway anatomy, obstructive sleep apnea phenotypes, individual health status, psychological conditions, and comorbid sleep disorders influence the effectiveness of HGNS is essential to improve outcomes and expand therapy indications. This article presents discussions on current evidence, future directions, and research gaps for HGNS therapy from the 10th International Surgical Sleep Society expert research panel. CITATION: Suurna MV, Jacobowitz O, Chang J, et al. Improving outcomes of hypoglossal nerve stimulation therapy: current practice, future directions and research gaps. Proceedings of the 2019 International Sleep Surgery Society Research Forum. J Clin Sleep Med. 2021;17(12):2477-2487.


Asunto(s)
Terapia por Estimulación Eléctrica , Apnea Obstructiva del Sueño , Humanos , Nervio Hipogloso , Polisomnografía , Sueño , Apnea Obstructiva del Sueño/terapia
5.
Am J Otolaryngol ; 42(5): 103036, 2021.
Artículo en Inglés | MEDLINE | ID: mdl-33873050

RESUMEN

Non-traumatic laryngeal fracture is uncommon but should be suspected whenever patients present with dysphonia, odynophagia, dysphagia, neck crepitus, or hemoptysis following a sneeze or coughing episode. Physical examination coupled with computed tomography is essential for making the diagnosis. Management can vary depending on the severity of the case, but the general approach is similar to any trauma. In this report, we describe a non-traumatic laryngeal fracture that occurred following a forceful sneeze. The case was notable for the presence of pneumomediastinum, independent mobility of the thyroid ala, and operative intervention was pursued to repair the fracture.


Asunto(s)
Fracturas Espontáneas/etiología , Fracturas Espontáneas/cirugía , Laringe/lesiones , Estornudo/fisiología , Adulto , Disfonía/etiología , Fracturas Espontáneas/complicaciones , Fracturas Espontáneas/diagnóstico por imagen , Humanos , Masculino , Enfisema Mediastínico/etiología , Tomografía Computarizada por Rayos X
6.
Ann Otol Rhinol Laryngol ; 130(4): 370-376, 2021 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-32862654

RESUMEN

OBJECTIVE: To compare patients with moderate-severe obstructive sleep apnea (OSA) undergoing traditional single and multilevel sleep surgery to those undergoing upper airway stimulation (UAS). STUDY DESIGN: Case control study comparing retrospective cohort of patients undergoing traditional sleep surgery to patients undergoing UAS enrolled in the ADHERE registry. SETTING: 8 multinational academic medical centers. SUBJECTS AND METHODS: 233 patients undergoing prior single or multilevel traditional sleep surgery and meeting study inclusion criteria were compared to 465 patients from the ADHERE registry who underwent UAS. We compared preoperative and postoperative demographic, quality of life, and polysomnographic data. We also evaluated treatment response rates. RESULTS: The pre and postoperative apnea hypopnea index (AHI) was 33.5 and 15 in the traditional sleep surgery group and 32 and 10 in the UAS group. The postoperative AHI in the UAS group was significantly lower. The pre and postoperative Epworth sleepiness scores (ESS) were 12 and 6 in both the traditional sleep surgery and UAS groups. Subgroup analysis evaluated those patients undergoing single level palate and multilevel palate and tongue base traditional sleep surgeries. The UAS group had a significantly lower postoperive AHI than both traditional sleep surgery subgroups. The UAS group had a higher percentage of patients reaching surgical success, defined as a postoperative AHI <20 with a 50% reduction from preoperative severity. CONCLUSION: UAS offers significantly better control of AHI severity than traditional sleep surgery. Quality life improvements were similar between groups.


Asunto(s)
Terapia por Estimulación Eléctrica , Procedimientos Quirúrgicos Otorrinolaringológicos , Complicaciones Posoperatorias , Calidad de Vida , Apnea Obstructiva del Sueño , Manejo de la Vía Aérea/métodos , Estudios de Casos y Controles , Investigación sobre la Eficacia Comparativa , Terapia por Estimulación Eléctrica/efectos adversos , Terapia por Estimulación Eléctrica/métodos , Femenino , Humanos , Masculino , Persona de Mediana Edad , Procedimientos Quirúrgicos Otorrinolaringológicos/efectos adversos , Procedimientos Quirúrgicos Otorrinolaringológicos/métodos , Evaluación de Procesos y Resultados en Atención de Salud/estadística & datos numéricos , Hueso Paladar/cirugía , Polisomnografía/métodos , Polisomnografía/estadística & datos numéricos , Complicaciones Posoperatorias/diagnóstico , Complicaciones Posoperatorias/epidemiología , Apnea Obstructiva del Sueño/diagnóstico , Apnea Obstructiva del Sueño/fisiopatología , Apnea Obstructiva del Sueño/terapia , Lengua/cirugía
7.
Ann Otol Rhinol Laryngol ; 130(5): 467-474, 2021 May.
Artículo en Inglés | MEDLINE | ID: mdl-32924533

RESUMEN

OBJECTIVE: An increasing number of facilities offer Upper Airway Stimulation (UAS) with varying levels of experience. The goal was to quantify whether a surgical learning curve exists in operative or sleep outcomes in UAS. METHODS: International multi-center retrospective review of the ADHERE registry, a prospective international multi-center study collecting UAS outcomes. ADHERE registry centers with at least 20 implants and outcomes data through at least 6-month follow-up were reviewed. Cases were divided into two groups based on implant order (the first 10 or second 10 consecutive implants at a given site). Group differences were assessed using Mann-Whitney U-tests, Chi-squared tests, or Fisher's Exact tests, as appropriate. A Mann-Kendall trend test was used to detect if there was a monotonic trend in operative time. Sleep outcome equivalence between experience groups was assessed using the two one-sided tests approach. RESULTS: Thirteen facilities met inclusion criteria, contributing 260 patients. Complication rates did not significantly differ between groups (P = .808). Operative time exhibited a significant downward trend (P < .001), with the median operative time dropping from 150 minutes for the first 10 implants to 134 minutes for the subsequent 10 implants. The decrease in AHI from baseline to 12-month follow-up was equivalent between the first and second ten (22.8 vs 21.2 events/hour, respectively, P < .001). Similarly, the first and second ten groups had equivalent ESS decreases at 6 months (2.0 vs 2.0, respectively, P < .001). ESS outcomes remained equivalent for those with data through 12-months. CONCLUSIONS: Across the centers' first 20 implants, an approximately 11% reduction operative time was identified, however, no learning curve effect was seen for 6-month or 12-month AHI or ESS over the first twenty implants. Ongoing monitoring through the ADHERE registry will help measure the impact of evolving provider and patient specific characteristics as the number of implant centers increases.


Asunto(s)
Terapia por Estimulación Eléctrica/instrumentación , Electrodos Implantados , Laringe/cirugía , Curva de Aprendizaje , Procedimientos Quirúrgicos Otorrinolaringológicos , Apnea Obstructiva del Sueño , Femenino , Humanos , Cooperación Internacional , Laringe/fisiopatología , Masculino , Persona de Mediana Edad , Tempo Operativo , Procedimientos Quirúrgicos Otorrinolaringológicos/métodos , Procedimientos Quirúrgicos Otorrinolaringológicos/normas , Procedimientos Quirúrgicos Otorrinolaringológicos/estadística & datos numéricos , Evaluación de Resultado en la Atención de Salud , Polisomnografía/métodos , Polisomnografía/estadística & datos numéricos , Sistema de Registros/estadística & datos numéricos , Estudios Retrospectivos , Apnea Obstructiva del Sueño/diagnóstico , Apnea Obstructiva del Sueño/fisiopatología , Apnea Obstructiva del Sueño/cirugía
8.
Ann Am Thorac Soc ; 17(12): 1610-1619, 2020 12.
Artículo en Inglés | MEDLINE | ID: mdl-32663043

RESUMEN

Rationale: Understand the impact of insurance coverage on sleep apnea outcomes for patients awaiting upper airway stimulation.Objectives: Examine the natural history of impact of upper airway stimulation treatment versus insurance denial (comparators) on sleep apnea outcomes.Methods: A parallel-arm experimental study design was used to compare objective sleep apnea measures and patient-reported outcomes in those who received upper airway stimulation approval versus denial in a multinational prospective study (NCT02907398). Wilcoxon rank-sum test and logistic regression models were used to assess for differences of objective and subjective outcome changes in those who underwent upper airway stimulation versus no treatment comparators.Results: A greater reduction in apnea-hypopnea index was observed in those who underwent upper airway stimulation (n = 230, follow-up: 360 ± 171 d) versus no treatment (n = 100, follow-up: 272 ± 278 d), that is, -19.1 ± 15.8 versus -8.1 ± 20.9, respectively, P < 0.001, with consistent findings observed with nocturnal hypoxia measures. Concordantly, a greater improvement noted with subjective measures of dozing propensity was observed in patients undergoing upper airway stimulation versus comparators (Epworth Score, -5.1 ± 5.5 vs. 1.8 ± 3.7, respectively, P < 0.001) and overall sleep-related patient-reported outcomes. Women and those with previous oral appliance use had a lower odds of insurance approval (odds ratio [OR], 0.40; 95% confidence interval [95% CI], 0.22-0.71 and OR, 0.35; 95% CI, 0.18-0.69, respectively).Conclusions: Objective and subjective sleep apnea burden was more improved in those receiving upper airway stimulation versus not. Results underscore the need to optimize clinical care pathways focused on effective treatment of patients with obstructive sleep apnea who are not upper airway stimulation-insurance eligible and prioritize public health policy initiatives to address insurance-based sex-specific disparities.


Asunto(s)
Apnea Obstructiva del Sueño , Presión de las Vías Aéreas Positiva Contínua , Femenino , Humanos , Masculino , Medición de Resultados Informados por el Paciente , Estudios Prospectivos , Apnea Obstructiva del Sueño/terapia , Resultado del Tratamiento
9.
Am J Otolaryngol ; 41(5): 102585, 2020.
Artículo en Inglés | MEDLINE | ID: mdl-32521300

RESUMEN

INTRODUCTION: Determine the feasibility of a two-incision surgical approach to hypoglossal nerve stimulator implantation based on anatomic considerations. METHODS: Upper airway stimulation (UAS) using the Inspire system uses three implanted devices-the implantable pulse generator (IPG), stimulation lead and sensing chest wall lead. The traditional surgical approach requires three skin incisions located on the submandibular neck, anterosuperior chest wall and inferolateral chest wall. Our surgical team sought to determine the anatomic considerations of combining the two chest wall incisions into one. In order to minimize morbidity and reduce operative time, the chest wall sensing lead was placed posterolateral to the IPG site via the same incision. RESULTS: Using an adult cadaver for anatomical analysis, access to the third and fourth intercostal spaces was made more difficult by the pectoralis major humeral head and upper arm. The intercostal space was narrower, the musculature along the anterior axillary line and anterior chest wall was devoid of the innermost intercostal muscle group found more laterally. Furthermore, there were much thinner external and internal intercostal muscle components as they transitioned to a membranous layer anteriorly in comparison to the inferolateral chest wall. CONCLUSION: Lack of the innermost intercostal muscle and thinning of the external and internal intercostal muscles lateral to the IPG site leaves little barrier between the thoracic musculature and parietal pleural increasing the risk of complications such as pleurisy and pneumothorax. Given the anatomical findings, a two-incision surgical approach for UAS therapy is at higher risk for complications.


Asunto(s)
Terapia por Estimulación Eléctrica/instrumentación , Terapia por Estimulación Eléctrica/métodos , Electrodos Implantados , Nervio Hipogloso , Implantación de Prótesis/métodos , Toracotomía/métodos , Cadáver , Estudios de Factibilidad , Humanos , Pared Torácica/anatomía & histología , Pared Torácica/cirugía
10.
Otolaryngol Head Neck Surg ; 163(4): 707-709, 2020 10.
Artículo en Inglés | MEDLINE | ID: mdl-32515642

RESUMEN

During the coronavirus 2019 pandemic, there has been a surge in production of remote learning materials for continued otolaryngology resident education. Medical students traditionally rely on elective and away subinternship experiences for exposure to the specialty. Delays and cancellation of clinical rotations have forced medical students to pursue opportunities outside of the traditional learning paradigm. In this commentary, we discuss the multi-institutional development of a robust syllabus for medical students using a multimodal collection of resources. Medical students collaborated with faculty and residents from 2 major academic centers to identify essential otolaryngology topics. High-quality, publicly available, and open-access content from multiple sources were incorporated into a curriculum that appeals to a variety of learners. Multimodal remote education strategies can be used as a foundation for further innovation aimed at developing tomorrow's otolaryngologists.


Asunto(s)
Betacoronavirus , Infecciones por Coronavirus/epidemiología , Curriculum , Educación de Pregrado en Medicina/métodos , Internado y Residencia/métodos , Otolaringología/educación , Neumonía Viral/epidemiología , COVID-19 , Humanos , Pandemias , SARS-CoV-2 , Encuestas y Cuestionarios
11.
Laryngoscope ; 130(10): 2494-2498, 2020 10.
Artículo en Inglés | MEDLINE | ID: mdl-32096882

RESUMEN

OBJECTIVES: Determine the rates of, reasons for, and effectiveness of device reprogramming utilizing in-office awake endoscopy (AE) in subjects who underwent upper airway stimulation (UAS) surgery. STUDY DESIGN: Retrospective chart review. METHODS: Retrospective chart review at a tertiary care center on patients implanted with UAS devices from November 2015 to July 2018. RESULTS: Sixty patients were implanted with UAS devices. Average pre- and postsurgical total apnea-hypopnea index (AHI) was 40.6 and 4.2 with a 36.4 total AHI reduction. Treatment success based on Sher criteria was observed in 88% of patients. Postoperative titration polysomnography revealed an average functional threshold (FT) and minimum therapeutic amplitude (MTA) of 1.6 and 2.1 V, respectively. A total of 24 AEs were performed in 19 (32%) patients. The most common complaints and reasons for AE were perceived stimulus discomfort (42%), frequent awakenings (32%), and persistent fatigue or non-normalized AHI (21%). After first AE, there was a 0.87 (53%) and 0.93 (45%) V reduction in FT and MTA, respectively. CONCLUSION: Patients with obstructive sleep apnea continue to succeed with UAS. Fewer than one-third of patients had postsurgical complaints requiring device reconfiguration utilizing AE to assess the pharyngeal airway and optimize device settings. Reduction in the FT and MTA after AE may improve compliance by reducing discomfort and frequent awakenings. Periodic monitoring of patients with implanted UAS devices is necessary to optimize efficacy and maintain patient compliance. LEVEL OF EVIDENCE: 4 Laryngoscope, 130:2494-2498, 2020.


Asunto(s)
Terapia por Estimulación Eléctrica/instrumentación , Endoscopía , Apnea Obstructiva del Sueño/cirugía , Adulto , Anciano , Anciano de 80 o más Años , Femenino , Humanos , Masculino , Persona de Mediana Edad , Estudios Retrospectivos , Vigilia
12.
Otolaryngol Head Neck Surg ; 162(3): 400-407, 2020 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-31959054

RESUMEN

OBJECTIVE: Hypoglossal nerve stimulation (HGNS) is an effective treatment for patients with obstructive sleep apnea (OSA) who fail continuous positive airway pressure (CPAP). We assessed the relationship between patient characteristics and response to HGNS. STUDY DESIGN: Retrospective cohort study. SETTING: Single tertiary care institution. SUBJECTS AND METHODS: This study included CPAP-intolerant patients with moderate to severe OSA after HGNS system implantation from November 2015 to December 2017. Patient measures, drug-induced sleep endoscopy (DISE) findings, and apnea-hypopnea indices (AHIs) were recorded. RESULTS: Forty-eight patients underwent implantation with the following median measures: age, 66 years; body mass index, 28.6; and neck circumference, 41.0 cm. Patients were classified by Friedman tongue position (II, 27%; III, 56%; IV, 17%) and Mallampati grade (I, 25%; II, 50%; III, 23%; IV, 2%). By DISE, 71% had anterior-posterior palatal collapse. Additionally, 38% had lateral oropharynx collapse; 50%, tongue base collapse; and 27%, epiglottis collapse. Following implantation, median AHI improved from 38.5 to 2.7 (P < .001), and 92% of patients had no worse than mild OSA (8% moderate). Patients with Friedman tongue position grade II/III experienced greater change in AHI as compared with grade IV (94.2% vs 73.8%, P < .001). Patients with Mallampati score I/II experienced greater improvement versus score III/IV (94.7% vs 66.5%, P < .001). No DISE findings, including any obstruction or collapse, were associated with change in AHI. CONCLUSION: This study further confirms HGNS as an effective treatment of CPAP-intolerant OSA. Office measures such as Friedman tongue position IV and Mallampati III/IV were associated with mildly decreased response. DISE findings were not associated with patient response.


Asunto(s)
Terapia por Estimulación Eléctrica , Nervio Hipogloso , Apnea Obstructiva del Sueño/terapia , Anciano , Femenino , Humanos , Masculino , Persona de Mediana Edad , Polisomnografía , Estudios Retrospectivos , Apnea Obstructiva del Sueño/fisiopatología , Lengua/inervación
13.
Chest ; 157(1): 173-183, 2020 01.
Artículo en Inglés | MEDLINE | ID: mdl-31299245

RESUMEN

BACKGROUND: Positive airway pressure (PAP) and upper airway stimulation (UAS) are approved OSA treatment options. Although the effect of PAP on improvement in BP and daytime sleepiness (defined according to the Epworth Sleepiness Scale [ESS]) has been established, the impact of UAS on BP remains unclear. This study hypothesized that PAP and UAS will confer improvements in BP and daytime sleepiness. METHODS: Clinic-based BP and ESS scores were compared between 517 patients with OSA (apnea-hypopnea index, 15-65) and BMI ≤ 35 kg/m2 initiating PAP therapy (2010-2014) at the Cleveland Clinic and 320 patients with UAS implantation (2015-2017) via an international registry with 2- to 6-month follow-up. Mixed effect models were used to compare outcomes in 201 patients in each arm following propensity matching. RESULTS: PAP showed greater improvement in diastolic BP (mean difference of change between groups, 3.7 mm Hg; P < .001) and mean arterial pressure (mean difference of change between groups, 2.8 mm Hg; P = .008) compared with UAS. UAS showed greater improvement in ESS scores vs PAP (mean difference of change between PAP and UAS groups, -0.8; P = .046). UAS therapy usage was 6.2 h/week greater than PAP-treated patients (95% CI, 3.3-9.0). Results were consistent following adjustment for therapy adherence. CONCLUSIONS: PAP showed greater improvement in BP, potentially reflecting an enhanced ability of PAP to exert beneficial mechanical intrathoracic cardiac and vascular influences. BP measurement error in the UAS group may also have accounted for findings. Greater improvement in sleepiness symptoms was noted with UAS compared with PAP.


Asunto(s)
Presión Sanguínea/fisiología , Presión de las Vías Aéreas Positiva Contínua/métodos , Terapia por Estimulación Eléctrica , Apnea Obstructiva del Sueño/terapia , Somnolencia , Índice de Masa Corporal , Femenino , Estudios de Seguimiento , Humanos , Masculino , Persona de Mediana Edad , Puntaje de Propensión , Calidad de Vida , Sistema de Registros , Apnea Obstructiva del Sueño/fisiopatología , Encuestas y Cuestionarios
14.
Laryngoscope ; 130(5): 1333-1338, 2020 05.
Artículo en Inglés | MEDLINE | ID: mdl-31520484

RESUMEN

OBJECTIVE/HYPOTHESIS: The ADHERE Registry is a multicenter prospective observational study following outcomes of upper airway stimulation (UAS) therapy in patients who have failed continuous positive airway pressure therapy for obstructive sleep apnea (OSA). The aim of this registry and purpose of this article were to examine the outcomes of patients receiving UAS for treatment of OSA. STUDY DESIGN: Cohort Study. METHODS: Demographic and sleep study data collection occurred at baseline, implantation visit, post-titration (6 months), and final visit (12 months). Patient and physician reported outcomes were also collected. Post hoc univariate and multivariate analysis was used to identify predictors of therapy response, defined as ≥50% decrease in Apnea-Hypopnea Index (AHI) and AHI ≤20 at the 12-month visit. RESULTS: The registry has enrolled 1,017 patients from October 2016 through February 2019. Thus far, 640 patients have completed their 6-month follow-up and 382 have completed the 12-month follow-up. After 12 months, median AHI was reduced from 32.8 (interquartile range [IQR], 23.6-45.0) to 9.5 (IQR, 4.0-18.5); mean, 35.8 ± 15.4 to 14.2 ± 15.0, P < .0001. Epworth Sleepiness Scale was similarly improved from 11.0 (IQR, 7-16) to 7.0 (IQR, 4-11); mean, 11.4 ± 5.6 to 7.2 ± 4.8, P < .0001. Therapy usage was 5.6 ± 2.1 hours per night after 12 months. In a multivariate model, only female sex and lower baseline body mass index remained as significant predictors of therapy response. CONCLUSIONS: Across a multi-institutional study, UAS therapy continues to show significant improvement in subjective and objective OSA outcomes. This analysis shows that the therapy effect is durable and adherence is high. LEVEL OF EVIDENCE: 2 Laryngoscope, 130:1333-1338, 2020.


Asunto(s)
Terapia por Estimulación Eléctrica , Neuroestimuladores Implantables , Apnea Obstructiva del Sueño/terapia , Anciano , Estudios de Cohortes , Terapia por Estimulación Eléctrica/instrumentación , Femenino , Humanos , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Sistema de Registros , Factores de Tiempo , Resultado del Tratamiento
15.
Otolaryngol Head Neck Surg ; 161(5): 897-903, 2019 11.
Artículo en Inglés | MEDLINE | ID: mdl-31234734

RESUMEN

OBJECTIVE: To examine whether previous palate or hypopharyngeal surgery was associated with efficacy of treatment of obstructive sleep apnea with hypoglossal nerve stimulation. STUDY DESIGN: Cohort (retrospective and prospective). SETTING: Eleven academic medical centers. SUBJECTS AND METHODS: Adults treated with hypoglossal nerve stimulation were enrolled in the ADHERE Registry. Outcomes were defined by the apnea-hypopnea index (AHI), in 3 ways: change in the AHI and 2 definitions of therapy response requiring ≥50% reduction in the AHI to a level <20 events/h (Response20) or 15 events/h (Response15). Previous palate and hypopharyngeal (tongue, epiglottis, or maxillofacial) procedures were documented. Linear and logistic regression examined the association between previous palate or hypopharyngeal surgery and outcomes, with adjustment for age, sex, and body mass index. RESULTS: The majority (73%, 217 of 299) had no previous palate or hypopharyngeal surgery, while 25% and 9% had previous palate or hypopharyngeal surgery, respectively, including 6% with previous palate and hypopharyngeal surgery. Baseline AHI (36.0 ± 15.6 events/h) decreased to 12.0 ± 13.3 at therapy titration (P < .001) and 11.4 ± 12.6 at final follow-up (P < .001). Any previous surgery, previous palate surgery, and previous hypopharyngeal surgery were not clearly associated with treatment response; for example, any previous surgery was associated with a 0.69 (95% CI: 0.37, 1.27) odds of response (Response20 measure) at therapy titration and a 0.55 (95% CI: 0.22, 1.34) odds of response (Response20 measure) at final follow-up. CONCLUSION: Previous upper airway surgery was not clearly associated with efficacy of hypoglossal nerve stimulation.


Asunto(s)
Terapia por Estimulación Eléctrica , Nervio Hipogloso , Hipofaringe/cirugía , Hueso Paladar/cirugía , Apnea Obstructiva del Sueño/terapia , Adulto , Anciano , Estudios de Cohortes , Femenino , Humanos , Masculino , Persona de Mediana Edad , Retratamiento , Resultado del Tratamiento
16.
Eur Respir J ; 53(1)2019 01.
Artículo en Inglés | MEDLINE | ID: mdl-30487205

RESUMEN

Upper airway stimulation (UAS) has been shown to reduce severity of obstructive sleep apnoea. The aim of this study was to identify predictors of UAS therapy response in an international multicentre registry.Patients who underwent UAS implantation in the United States and Germany were enrolled in an observational registry. Data collected included patient characteristics, apnoea/hypopnoea index (AHI), Epworth sleepiness scale (ESS), objective adherence, adverse events and patient satisfaction measures. Post hoc univariate and multiple logistic regression were performed to evaluate factors associated with treatment success.Between October 2016 and January 2018, 508 participants were enrolled from 14 centres. Median AHI was reduced from 34 to 7 events·h-1, median ESS reduced from 12 to 7 from baseline to final visit at 12-month post-implant. In post hoc analyses, for each 1-year increase in age, there was a 4% increase in odds of treatment success. For each 1-unit increase in body mass index (BMI), there was 9% reduced odds of treatment success. In the multivariable model, age persisted in serving as statistically significant predictor of treatment success.In a large multicentre international registry, UAS is an effective treatment option with high patient satisfaction and low adverse events. Increasing age and reduced BMI are predictors of treatment response.


Asunto(s)
Terapia por Estimulación Eléctrica/instrumentación , Neuroestimuladores Implantables , Satisfacción del Paciente , Vigilancia de Productos Comercializados , Apnea Obstructiva del Sueño/terapia , Anciano , Femenino , Alemania , Humanos , Modelos Logísticos , Masculino , Persona de Mediana Edad , Sistema de Registros , Factores de Tiempo , Resultado del Tratamiento , Estados Unidos
17.
Am J Otolaryngol ; 39(4): 462-463, 2018.
Artículo en Inglés | MEDLINE | ID: mdl-29703415

RESUMEN

OUTCOME OBJECTIVES: METHODS: This is a case report of a patient who underwent placement and initiation of a hypoglossal nerve stimulator device in the context of receiving electroconvulsive therapy for bipolar depression between February and September 2016. To our knowledge, this has not yet been reported in the literature. Outcome measurements included successful device activation and successful device use throughout electroconvulsive therapy. RESULTS: The patient underwent successful device implantation, activation, and use without disruption throughout electroconvulsive therapy sessions. No special device deactivation was required during electroconvulsive therapy sessions. CONCLUSION: Obstructive sleep apnea is a common disorder that causes significant reduction in quality of life and is an independent risk factor for multiple comorbidities. Electroconvulsive therapy is an established treatment for medication-refractory depression with minimal risk in most patient populations. This is the first report in the literature of a patient undergoing ECT for bipolar depression with recent activation of Inspire hypoglossal nerve stimulator who had no disruption in the function of his implanted device.


Asunto(s)
Trastorno Depresivo/terapia , Terapia por Estimulación Eléctrica/instrumentación , Terapia Electroconvulsiva/instrumentación , Nervio Hipogloso , Apnea Obstructiva del Sueño/complicaciones , Anciano , Trastorno Depresivo/diagnóstico , Trastorno Depresivo/etiología , Humanos , Masculino , Apnea Obstructiva del Sueño/diagnóstico , Apnea Obstructiva del Sueño/terapia
18.
Am J Otolaryngol ; 39(3): 266-270, 2018.
Artículo en Inglés | MEDLINE | ID: mdl-29540289

RESUMEN

OBJECTIVES: Hypoglossal nerve stimulation (HNS) therapy is an emerging surgical treatment for select patients with obstructive sleep apnea (OSA). This study aims to compare outcomes in patients with moderate to severe OSA who underwent HNS surgery (Inspire Medical Systems) and those who underwent traditional airway reconstructive surgery, specifically uvulopalatopharyngoplasty (UPPP). METHODS: Patients who underwent HNS implantation (n = 20), all with moderate to severe OSA, inability to adhere to positive pressure therapy, and compliant with previously published inclusion criteria, were compared to a historical cohort that were intolerant of CPAP with similar inclusion criteria who all underwent UPPP (n = 20) with some also undergoing additional procedures such as septoplasty/turbinate reduction. Data including body mass index (BMI), pre- and post-implant apnea-hypopnea index (AHI) were assessed. RESULTS: For patients who underwent HNS, mean preoperative BMI was 28.0. Mean AHI decreased significantly from 38.9 ±â€¯12.5 to 4.5 ±â€¯4.8. All patients achieved an AHI < 20 post implant with 65% (13/20) with an AHI ≤ 5. For patients who underwent traditional airway surgery, mean preoperative BMI was 27.5; mean AHI decreased from 40.3 ±â€¯12.4 to 28.8 ±â€¯25.4. CONCLUSION: While both traditional surgery and HNS are effective treatments for patients with moderate to severe OSA with CPAP intolerance, our study demonstrates that HNS is "curative" in normalizing the AHI to <5 in the majority of patients. For select patients, HNS therapy provides excellent objective improvement in outcome measures.


Asunto(s)
Terapia por Estimulación Eléctrica/métodos , Nervio Hipogloso , Procedimientos Quirúrgicos Otorrinolaringológicos/métodos , Apnea Obstructiva del Sueño/terapia , Adulto , Anciano , Índice de Masa Corporal , Estudios de Cohortes , Femenino , Estudios de Seguimiento , Humanos , Masculino , Persona de Mediana Edad , Hueso Paladar/cirugía , Polisomnografía/métodos , Estudios Retrospectivos , Medición de Riesgo , Índice de Severidad de la Enfermedad , Apnea Obstructiva del Sueño/diagnóstico , Resultado del Tratamiento , Úvula/cirugía
19.
Am J Otolaryngol ; 39(2): 122-126, 2018.
Artículo en Inglés | MEDLINE | ID: mdl-29277289

RESUMEN

OBJECTIVE: Hypoglossal nerve stimulation is an effective treatment for a subset of patients with Obstructive Sleep Apnea (OSA). Although multiple clinical trials demonstrate its efficacy, no previous literature explores the potential impact the stimulator has on swallowing and voice. Our primary objective is to evaluate patient reported post-operative changes in voice or swallowing following hypoglossal nerve stimulator placement. STUDY DESIGN: Prospective cohort study. SETTING: Tertiary care hospital. SUBJECT AND METHODS: Patients scheduled to receive a hypoglossal stimulator were enrolled. Participants completed baseline Voice Handicap Index-10 (VHI-10) and Eating Assessment Tool-10 (EAT-10) questionnaires preoperatively and again at 1week, 3months, and 6months post-operatively following placement of a hypoglossal nerve stimulator. RESULTS: 9 males and 5 females completed the study. The mean pre-operative VHI-10 and EAT-10 score was 3 and 0.8 respectively. Using linear mixed models, a clinically and statistically significant increase in the mean EAT-10 score was observed post-operatively at 1week (p=0.007), which was not observed at the time points the stimulator was active. A clinically and statistically significant decrease in VHI-10 score was observed following 2months of active stimulator use (p=0.02), which was not observed at any other time point. CONCLUSION: The implantation and use of the hypoglossal nerve stimulator over 5months did not demonstrate any sustained, patient reported changes in voice handicap and swallowing function. While larger studies are warranted, our findings can be used to provide further informed consent for hypoglossal nerve stimulator implantation.


Asunto(s)
Deglución/fisiología , Terapia por Estimulación Eléctrica/métodos , Nervio Hipogloso/fisiopatología , Apnea Obstructiva del Sueño/cirugía , Voz/fisiología , Adulto , Anciano , Femenino , Estudios de Seguimiento , Humanos , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Apnea Obstructiva del Sueño/fisiopatología , Encuestas y Cuestionarios , Resultado del Tratamiento
20.
Am J Otolaryngol ; 38(2): 193-197, 2017.
Artículo en Inglés | MEDLINE | ID: mdl-28139321

RESUMEN

OUTCOME OBJECTIVES: 1) Analyze differences in healthcare usage between subjects receiving different perioperative analgesic medications after uvulopalatopharyngoplasty (UPPP) surgery. 2) Comment on the impact of perioperative analgesic medication on length of hospital stay and complications after UPPP. METHODS: A retrospective cohort study of 120 UPPPs conducted by a single surgeon in the past 5years was conducted. Subjects were grouped based on perioperative pain medication regimen into three groups; narcotics alone (n=83), narcotics with gabapentin (n=27), or narcotics with ketorolac tromethamine (n=10). The primary outcome variable was total number of clinic/emergency room and/or telephone encounters related to post-UPPP pain. Secondary outcomes included length of post-operative hospital stay, number of telephone and/or clinical encounters in which the patient complained specifically of pain or requested a refill for analgesics, and post-operative complications. RESULTS: No significant difference was found between the three analgesic regimens in post-operative hospital stay length (p=0.28, median stay 23.5h), number of clinic or telephone encounters related to pain (p=0.26, mean value 0.71 encounters), or post-operative complication rate (p=0.82, 5.9% complication rate). CONCLUSION: This study shows no significant difference in post-operative healthcare usage between patients with peri-operative analgesic regimens including narcotics alone, gabapentin with narcotics, or ketorolac with narcotics. Post-operative complication rate and length of stay did not differ between groups. These data suggest that these three medication regimens have similar impact on post-operative course for UPPP patients. Therefore, the most affordable or simplest options have equivalent effects on post-operative healthcare usage.


Asunto(s)
Analgésicos/uso terapéutico , Revisión de la Utilización de Medicamentos , Procedimientos Quirúrgicos Otorrinolaringológicos/métodos , Manejo del Dolor/métodos , Dolor Postoperatorio/tratamiento farmacológico , Apnea Obstructiva del Sueño/cirugía , Adulto , Femenino , Humanos , Tiempo de Internación/estadística & datos numéricos , Masculino , Persona de Mediana Edad , Paladar Blando/cirugía , Faringe/cirugía , Estudios Retrospectivos , Resultado del Tratamiento , Úvula/cirugía
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