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1.
Laryngoscope ; 134(1): 471-479, 2024 Jan.
Article in English | MEDLINE | ID: mdl-37560883

ABSTRACT

OBJECTIVE: We aimed to determine the preoperative prevalence of insomnia in the Adherence and Outcomes of Upper Airway Stimulation for OSA International Registry (ADHERE) and to examine serial sleep-related data longitudinally, in particular the Insomnia Severity Index (ISI), to compare outcomes between patients with no/subthreshold insomnia (ISI < 15) and moderate/severe insomnia (ISI ≥ 15) at baseline. METHODS: We analyzed observational data from ADHERE between March 2020 and September 2022. Baseline demographic and mental health (MH) data, apnea hypopnea index (AHI), ISI, and ESS (Epworth Sleepiness Scale) were recorded. At post-titration (PT) and final visits, AHI, ISI, ESS and nightly usage were compared between baseline ISI < 15 and ISI ≥ 15 subgroups. RESULTS: A baseline ISI was obtained in 928 patients (62% with ISI ≥ 15). Of the 578 and 141 patients reaching the 12- and 24-month time periods to complete PT and final visits, 292 (50.5%) and 91 (64.5%) completed the ISI, respectively. Baseline MH conditions were higher with ISI ≥ 15 than ISI < 15 (p < 0.001). AHI reduction and adherence did not differ between patients with baseline ISI ≥ 15 and ISI < 15. Patients with ISI ≥ 15 experienced greater improvement in ESS than ISI < 15 at post-titration and final visits (p = 0.014, 0.025). All patients had improved nocturnal, daytime, and overall ISI scores at follow-up visits (p < 0.001), especially for those with baseline ISI ≥ 15 compared with ISI < 15 (p < 0.05). CONCLUSION: HGNS therapy efficacy and adherence were similar between ISI severity subgroups at follow-up visits. Insomnia and sleepiness scores improved in all patients with HGNS therapy and to a greater degree in patients with baseline moderate/severe insomnia. LEVEL OF EVIDENCE: 4 Laryngoscope, 134:471-479, 2024.


Subject(s)
Electric Stimulation Therapy , Sleep Apnea, Obstructive , Sleep Initiation and Maintenance Disorders , Humans , Hypoglossal Nerve , Registries , Sleep Apnea, Obstructive/surgery , Sleep Initiation and Maintenance Disorders/epidemiology , Sleep Initiation and Maintenance Disorders/etiology , Sleep Initiation and Maintenance Disorders/therapy , Sleepiness , Treatment Outcome
2.
J Clin Sleep Med ; 17(12): 2477-2487, 2021 12 01.
Article in English | MEDLINE | ID: mdl-34279214

ABSTRACT

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.


Subject(s)
Electric Stimulation Therapy , Sleep Apnea, Obstructive , Humans , Hypoglossal Nerve , Polysomnography , Sleep , Sleep Apnea, Obstructive/therapy
3.
Otolaryngol Head Neck Surg ; 164(6): 1345-1353, 2021 06.
Article in English | MEDLINE | ID: mdl-33399502

ABSTRACT

OBJECTIVE: Insomnia and sleep apnea frequently co-occur, with additive effects of both disorders presenting clinicians with unique treatment challenges compared to one disorder alone. The hypoglossal nerve stimulator (HNS) is a promising treatment for patients with comorbid insomnia and sleep apnea (COMISA), many of whom have positive airway pressure (PAP) intolerance. Our aim was to determine adherence to and efficacy of HNS in veterans with COMISA refractory to PAP therapy compared to those with obstructive sleep apnea alone (OSA only). STUDY DESIGN: Retrospective case series. SETTING: A single, academic Veterans Affairs medical center. METHODS: Review of clinical records, pre- and postoperative polysomnography, and clinical measures of obstructive sleep apnea (OSA), sleepiness, and insomnia was conducted in 53 consecutive cases of veterans with OSA undergoing HNS implantation. HNS adherence was obtained at postoperative visits. HNS adherence and efficacy were compared between individuals with COMISA and OSA only. RESULTS: COMISA was noted in 30 of 53 (56.6%) veterans studied. There was no significant difference between HNS adherence in patients with COMISA and OSA only (5.6 vs 6.4 h/night, P = .17). HNS implantation improved polysomnographic and clinical measures of OSA and sleepiness in both COMISA and OSA only, and 56.5% (13/23) of patients with COMISA self-reported improvement in insomnia after surgery. CONCLUSION: HNS was successful in treating a complex veteran population with COMISA refractory to PAP when examining measures of treatment adherence and efficacy. Future studies of patients with COMISA undergoing HNS will examine effective combination therapy targeting insomnia and a multidisciplinary effort to optimize treatment adherence.


Subject(s)
Electric Stimulation Therapy , Hypoglossal Nerve , Sleep Apnea, Obstructive/therapy , Sleep Initiation and Maintenance Disorders/therapy , Aged , Female , Humans , Male , Middle Aged , Retrospective Studies , Sleep Apnea, Obstructive/complications , Sleep Initiation and Maintenance Disorders/complications , United States , Veterans Health Services
4.
Laryngoscope ; 131(7): 1663-1669, 2021 07.
Article in English | MEDLINE | ID: mdl-33264427

ABSTRACT

OBJECTIVES/HYPOTHESIS: Patients with Down syndrome have a high incidence of obstructive sleep apnea (OSA) and limited treatment options. Hypoglossal stimulation has shown efficacy but has not yet been approved for pediatric populations. Our objective is to characterize the therapy response of adolescent patients with down syndrome and severe OSA who underwent hypoglossal stimulation. STUDY DESIGN: Prospective longitudinal trial. METHODS: We are conducting a multicenter single-arm trial of hypoglossal stimulation for adolescent patients with Down syndrome and severe OSA. Interim analysis was performed to compare objective sleep and quality of life outcomes at 12 months postoperatively for the first 20 patients. RESULTS: The mean age was 15.5 and baseline AHI 24.2. Of the 20 patients, two patients (10.0%) had an AHI under 1.5 at 12 months; nine patients of 20 (45.0%) under five; and 15 patients of 20 (75.0%) under 10. The mean decrease in AHI was 15.1 (P < .001). Patients with postoperative AHI over five had an average baseline OSA-18 survey score of 3.5 with an average improvement of 1.7 (P = .002); in addition, six of these patients had a relative decrease of apneas compared to hypopneas and seven had an improvement in percentage of time with oxygen saturation below 90%. CONCLUSIONS: Patients with persistently elevated AHI 12 months after hypoglossal implantation experienced improvement in polysomnographic and quality of life outcomes. These results suggest the need for a closer look at physiologic markers for success beyond reporting AHI as the gold standard. LEVEL OF EVIDENCE: 4 Laryngoscope, 131:1663-1669, 2021.


Subject(s)
Down Syndrome/complications , Electric Stimulation Therapy/adverse effects , Hypoglossal Nerve , Quality of Life , Sleep Apnea, Obstructive/therapy , Adolescent , Child , Electric Stimulation Therapy/instrumentation , Electric Stimulation Therapy/statistics & numerical data , Female , Humans , Implantable Neurostimulators , Longitudinal Studies , Male , Prospective Studies , Severity of Illness Index , Sleep Apnea, Obstructive/diagnosis , Sleep Apnea, Obstructive/etiology , Treatment Failure , Young Adult
5.
Laryngoscope ; 131 Suppl 3: S1-S11, 2021 03.
Article in English | MEDLINE | ID: mdl-33295673

ABSTRACT

OBJECTIVES/HYPOTHESIS: Veterans have an increasing prevalence of obstructive sleep apnea (OSA) and high levels of intolerance to positive airway pressure (PAP). The hypoglossal nerve stimulator (HNS) is a promising alternative surgical treatment for OSA in these patients, many of whom suffer from mental health conditions such as post-traumatic stress disorder (PTSD) that may negatively affect their ability to use PAP. Our aims were: 1) to assess postoperative changes in OSA severity and sleepiness in a veteran only population after HNS; 2) to compare postoperative changes in OSA severity, sleepiness and HNS adherence between veterans with and without PTSD; and 3) to compare HNS adherence in our population to HNS adherence in the current literature as well as published PAP adherence data. STUDY DESIGN: Retrospective and prospective case series. METHODS: Clinical data on consecutive patients undergoing HNS in a Veterans Affairs hospital were examined for demographic data as well as medical, sleep, and mental health comorbidities. The overall cohort as well as subsets of patients with and without PTSD were examined for postoperative changes in OSA severity (apnea hypopnea index [AHI], lowest oxygen saturation (LSAT]), and sleepiness (Epworth sleepiness scale [ESS]), as well as for device adherence. PTSD and depression symptomatology were measured using the PTSD Checklist 5 (PCL-5) and Patient Health Questionnaire 9 (PHQ-9). RESULTS: Forty-six veterans were included. Forty-four patients were male (95.6%), 45 were white (97.8%), and the mean age was 61.3 years. Twenty-six patients met PCL-5 criteria for PTSD and 17 did not. OSA severity and sleepiness improved significantly in the overall cohort after HNS; median (IQR) AHI decreased from 39.2 (24.0, 63.0) to 7.4 (1.2, 20.8) events/hour (P < .0001), mean LSAT increased from 81% to 88% (P < .0001) and mean ESS decreased from 10.9 to 6.7 (P < .0001). These improvements were similar between patients with and without PTSD (P = .434-.918). Overall device adherence was 6.1 hours/night for the overall cohort and was not significantly different between patients with and without PTSD (P = .992). CONCLUSIONS: HNS is an efficacious therapy in a veteran population, providing patients with significant improvements in OSA severity and sleepiness. Veterans with and without PTSD benefited similarly from HNS when comparing improvements in sleep apnea severity and sleepiness as well as device usage. Adherence was similar to previously published HNS adherence data and better than PAP adherence reported in the literature. LEVEL OF EVIDENCE: 4 Laryngoscope, 131:S1-S11, 2021.


Subject(s)
Electric Stimulation Therapy/instrumentation , Hypoglossal Nerve/surgery , Sleep Apnea, Obstructive/therapy , Stress Disorders, Post-Traumatic/epidemiology , Veterans/statistics & numerical data , Aged , Comorbidity , Continuous Positive Airway Pressure/psychology , Electrodes, Implanted , Female , Humans , Male , Middle Aged , Patient Compliance/statistics & numerical data , Polysomnography , Postoperative Period , Prevalence , Prospective Studies , Retrospective Studies , Severity of Illness Index , Sleep Apnea, Obstructive/diagnosis , Sleep Apnea, Obstructive/epidemiology , Sleepiness , Stress Disorders, Post-Traumatic/psychology , Treatment Outcome , Veterans/psychology
6.
Otolaryngol Head Neck Surg ; 162(1_suppl): S1-S38, 2020 01.
Article in English | MEDLINE | ID: mdl-31910111

ABSTRACT

OBJECTIVE: Nosebleed, also known as epistaxis, is a common problem that occurs at some point in at least 60% of people in the United States. While the majority of nosebleeds are limited in severity and duration, about 6% of people who experience nosebleeds will seek medical attention. For the purposes of this guideline, we define the target patient with a nosebleed as a patient with bleeding from the nostril, nasal cavity, or nasopharynx that is sufficient to warrant medical advice or care. This includes bleeding that is severe, persistent, and/or recurrent, as well as bleeding that impacts a patient's quality of life. Interventions for nosebleeds range from self-treatment and home remedies to more intensive procedural interventions in medical offices, emergency departments, hospitals, and operating rooms. Epistaxis has been estimated to account for 0.5% of all emergency department visits and up to one-third of all otolaryngology-related emergency department encounters. Inpatient hospitalization for aggressive treatment of severe nosebleeds has been reported in 0.2% of patients with nosebleeds. PURPOSE: The primary purpose of this multidisciplinary guideline is to identify quality improvement opportunities in the management of nosebleeds and to create clear and actionable recommendations to implement these opportunities in clinical practice. Specific goals of this guideline are to promote best practices, reduce unjustified variations in care of patients with nosebleeds, improve health outcomes, and minimize the potential harms of nosebleeds or interventions to treat nosebleeds. The target patient for the guideline is any individual aged ≥3 years with a nosebleed or history of nosebleed who needs medical treatment or seeks medical advice. The target audience of this guideline is clinicians who evaluate and treat patients with nosebleed. This includes primary care providers such as family medicine physicians, internists, pediatricians, physician assistants, and nurse practitioners. It also includes specialists such as emergency medicine providers, otolaryngologists, interventional radiologists/neuroradiologists and neurointerventionalists, hematologists, and cardiologists. The setting for this guideline includes any site of evaluation and treatment for a patient with nosebleed, including ambulatory medical sites, the emergency department, the inpatient hospital, and even remote outpatient encounters with phone calls and telemedicine. Outcomes to be considered for patients with nosebleed include control of acute bleeding, prevention of recurrent episodes of nasal bleeding, complications of treatment modalities, and accuracy of diagnostic measures. This guideline addresses the diagnosis, treatment, and prevention of nosebleed. It focuses on nosebleeds that commonly present to clinicians via phone calls, office visits, and emergency room encounters. This guideline discusses first-line treatments such as nasal compression, application of vasoconstrictors, nasal packing, and nasal cautery. It also addresses more complex epistaxis management, which includes the use of endoscopic arterial ligation and interventional radiology procedures. Management options for 2 special groups of patients-patients with hereditary hemorrhagic telangiectasia syndrome and patients taking medications that inhibit coagulation and/or platelet function-are included in this guideline. This guideline is intended to focus on evidence-based quality improvement opportunities judged most important by the guideline development group. It is not intended to be a comprehensive, general guide for managing patients with nosebleed. In this context, the purpose is to define useful actions for clinicians, generalists, and specialists from a variety of disciplines to improve quality of care. Conversely, the statements in this guideline are not intended to limit or restrict care provided by clinicians based on their experience and assessment of individual patients. ACTION STATEMENTS: The guideline development group made recommendations for the following key action statements: (1) At the time of initial contact, the clinician should distinguish the nosebleed patient who requires prompt management from the patient who does not. (2) The clinician should treat active bleeding for patients in need of prompt management with firm sustained compression to the lower third of the nose, with or without the assistance of the patient or caregiver, for 5 minutes or longer. (3a) For patients in whom bleeding precludes identification of a bleeding site despite nasal compression, the clinician should treat ongoing active bleeding with nasal packing. (3b) The clinician should use resorbable packing for patients with a suspected bleeding disorder or for patients who are using anticoagulation or antiplatelet medications. (4) The clinician should educate the patient who undergoes nasal packing about the type of packing placed, timing of and plan for removal of packing (if not resorbable), postprocedure care, and any signs or symptoms that would warrant prompt reassessment. (5) The clinician should document factors that increase the frequency or severity of bleeding for any patient with a nosebleed, including personal or family history of bleeding disorders, use of anticoagulant or antiplatelet medications, or intranasal drug use. (6) The clinician should perform anterior rhinoscopy to identify a source of bleeding after removal of any blood clot (if present) for patients with nosebleeds. (7a) The clinician should perform, or should refer to a clinician who can perform, nasal endoscopy to identify the site of bleeding and guide further management in patients with recurrent nasal bleeding, despite prior treatment with packing or cautery, or with recurrent unilateral nasal bleeding. (8) The clinician should treat patients with an identified site of bleeding with an appropriate intervention, which may include one or more of the following: topical vasoconstrictors, nasal cautery, and moisturizing or lubricating agents. (9) When nasal cautery is chosen for treatment, the clinician should anesthetize the bleeding site and restrict application of cautery only to the active or suspected site(s) of bleeding. (10) The clinician should evaluate, or refer to a clinician who can evaluate, candidacy for surgical arterial ligation or endovascular embolization for patients with persistent or recurrent bleeding not controlled by packing or nasal cauterization. (11) In the absence of life-threatening bleeding, the clinician should initiate first-line treatments prior to transfusion, reversal of anticoagulation, or withdrawal of anticoagulation/antiplatelet medications for patients using these medications. (12) The clinician should assess, or refer to a specialist who can assess, the presence of nasal telangiectasias and/or oral mucosal telangiectasias in patients who have a history of recurrent bilateral nosebleeds or a family history of recurrent nosebleeds to diagnose hereditary hemorrhagic telangiectasia syndrome. (13) The clinician should educate patients with nosebleeds and their caregivers about preventive measures for nosebleeds, home treatment for nosebleeds, and indications to seek additional medical care. (14) The clinician or designee should document the outcome of intervention within 30 days or document transition of care in patients who had a nosebleed treated with nonresorbable packing, surgery, or arterial ligation/embolization. The policy level for the following recommendation, about examination of the nasal cavity and nasopharynx using nasal endoscopy, was an option: (7b) The clinician may perform, or may refer to a clinician who can perform, nasal endoscopy to examine the nasal cavity and nasopharynx in patients with epistaxis that is difficult to control or when there is concern for unrecognized pathology contributing to epistaxis.


Subject(s)
Cautery , Endoscopy/methods , Epistaxis/therapy , Ligation , Quality Improvement , Vasoconstrictor Agents/therapeutic use , Epistaxis/diagnosis , Epistaxis/prevention & control , Hemostatics/therapeutic use , Humans , Nasal Surgical Procedures/methods , Patient Acuity , Patient Education as Topic/methods , Risk Factors , Tampons, Surgical , Telangiectasia, Hereditary Hemorrhagic/diagnosis
7.
Otolaryngol Head Neck Surg ; 162(1): 8-25, 2020 01.
Article in English | MEDLINE | ID: mdl-31910122

ABSTRACT

OBJECTIVE: Nosebleed, also known as epistaxis, is a common problem that occurs at some point in at least 60% of people in the United States. While the great majority of nosebleeds are limited in severity and duration, about 6% of people who experience nosebleeds will seek medical attention. For the purposes of this guideline, we define the target patient with a nosebleed as a patient with bleeding from the nostril, nasal cavity, or nasopharynx that is sufficient to warrant medical advice or care. This includes bleeding that is severe, persistent, and/or recurrent, as well as bleeding that impacts a patient's quality of life. Interventions for nosebleeds range from self-treatment and home remedies to more intensive procedural interventions in medical offices, emergency departments, hospitals, and operating rooms. Epistaxis has been estimated to account for 0.5% of all emergency department visits and up to one-third of all otolaryngology-related emergency department encounters. Inpatient hospitalization for aggressive treatment of severe nosebleeds has been reported in 0.2% of patients with nosebleeds. PURPOSE: The primary purpose of this multidisciplinary guideline is to identify quality improvement opportunities in the management of nosebleeds and to create clear and actionable recommendations to implement these opportunities in clinical practice. Specific goals of this guideline are to promote best practices, reduce unjustified variations in care of patients with nosebleeds, improve health outcomes, and minimize the potential harms of nosebleeds or interventions to treat nosebleeds. The target patient for the guideline is any individual aged ≥3 years with a nosebleed or history of nosebleed who needs medical treatment or seeks medical advice. The target audience of this guideline is clinicians who evaluate and treat patients with nosebleed. This includes primary care providers such as family medicine physicians, internists, pediatricians, physician assistants, and nurse practitioners. It also includes specialists such as emergency medicine providers, otolaryngologists, interventional radiologists/neuroradiologists and neurointerventionalists, hematologists, and cardiologists. The setting for this guideline includes any site of evaluation and treatment for a patient with nosebleed, including ambulatory medical sites, the emergency department, the inpatient hospital, and even remote outpatient encounters with phone calls and telemedicine. Outcomes to be considered for patients with nosebleed include control of acute bleeding, prevention of recurrent episodes of nasal bleeding, complications of treatment modalities, and accuracy of diagnostic measures. This guideline addresses the diagnosis, treatment, and prevention of nosebleed. It will focus on nosebleeds that commonly present to clinicians with phone calls, office visits, and emergency room encounters. This guideline discusses first-line treatments such as nasal compression, application of vasoconstrictors, nasal packing, and nasal cautery. It also addresses more complex epistaxis management, which includes the use of endoscopic arterial ligation and interventional radiology procedures. Management options for 2 special groups of patients, patients with hemorrhagic telangiectasia syndrome (HHT) and patients taking medications that inhibit coagulation and/or platelet function, are included in this guideline. This guideline is intended to focus on evidence-based quality improvement opportunities judged most important by the working group. It is not intended to be a comprehensive, general guide for managing patients with nosebleed. In this context, the purpose is to define useful actions for clinicians, generalists, and specialists from a variety of disciplines to improve quality of care. Conversely, the statements in this guideline are not intended to limit or restrict care provided by clinicians based upon their experience and assessment of individual patients. ACTION STATEMENTS: The guideline development group made recommendations for the following key action statements: (1) At the time of initial contact, the clinician should distinguish the nosebleed patient who requires prompt management from the patient who does not. (2) The clinician should treat active bleeding for patients in need of prompt management with firm sustained compression to the lower third of the nose, with or without the assistance of the patient or caregiver, for 5 minutes or longer. (3a) For patients in whom bleeding precludes identification of a bleeding site despite nasal compression, the clinician should treat ongoing active bleeding with nasal packing. (3b) The clinician should use resorbable packing for patients with a suspected bleeding disorder or for patients who are using anticoagulation or antiplatelet medications. (4) The clinician should educate the patient who undergoes nasal packing about the type of packing placed, timing of and plan for removal of packing (if not resorbable), postprocedure care, and any signs or symptoms that would warrant prompt reassessment. (5) The clinician should document factors that increase the frequency or severity of bleeding for any patient with a nosebleed, including personal or family history of bleeding disorders, use of anticoagulant or antiplatelet medications, or intranasal drug use. (6) The clinician should perform anterior rhinoscopy to identify a source of bleeding after removal of any blood clot (if present) for patients with nosebleeds. (7a) The clinician should perform, or should refer to a clinician who can perform, nasal endoscopy to identify the site of bleeding and guide further management in patients with recurrent nasal bleeding, despite prior treatment with packing or cautery, or with recurrent unilateral nasal bleeding. (8) The clinician should treat patients with an identified site of bleeding with an appropriate intervention, which may include 1 or more of the following: topical vasoconstrictors, nasal cautery, and moisturizing or lubricating agents. (9) When nasal cautery is chosen for treatment, the clinician should anesthetize the bleeding site and restrict application of cautery only to the active or suspected site(s) of bleeding. (10) The clinician should evaluate, or refer to a clinician who can evaluate, candidacy for surgical arterial ligation or endovascular embolization for patients with persistent or recurrent bleeding not controlled by packing or nasal cauterization. (11) In the absence of life-threatening bleeding, the clinician should initiate first-line treatments prior to transfusion, reversal of anticoagulation, or withdrawal of anticoagulation/antiplatelet medications for patients using these medications. (12) The clinician should assess, or refer to a specialist who can assess, the presence of nasal telangiectasias and/or oral mucosal telangiectasias in patients who have a history of recurrent bilateral nosebleeds or a family history of recurrent nosebleeds to diagnose hereditary hemorrhagic telangiectasia syndrome (HHT). (13) The clinician should educate patients with nosebleeds and their caregivers about preventive measures for nosebleeds, home treatment for nosebleeds, and indications to seek additional medical care. (14) The clinician or designee should document the outcome of intervention within 30 days or document transition of care in patients who had a nosebleed treated with nonresorbable packing, surgery, or arterial ligation/embolization. The policy level for the following recommendation about examination of the nasal cavity and nasopharynx using nasal endoscopy was an option: (7b) The clinician may perform, or may refer to a clinician who can perform, nasal endoscopy to examine the nasal cavity and nasopharynx in patients with epistaxis that is difficult to control or when there is concern for unrecognized pathology contributing to epistaxis.


Subject(s)
Epistaxis/epidemiology , Epistaxis/therapy , Nasal Surgical Procedures/methods , Practice Guidelines as Topic , Quality Improvement , Conservative Treatment/methods , Epistaxis/diagnosis , Evidence-Based Medicine , Guideline Adherence , Humans , Incidence , Ligation/methods , Quality of Life , Recurrence , Risk Assessment , Severity of Illness Index , Treatment Outcome
8.
Laryngoscope ; 130(4): 866-872, 2020 04.
Article in English | MEDLINE | ID: mdl-31291013

ABSTRACT

OBJECTIVES: The hypoglossal nerve stimulator (HGNS) is currently approved for the treatment of obstructive sleep apnea (OSA) in patients with an apnea-hypopnea index (AHI) of >15 to ≤65 events/hour, and a central apnea index (CAI) <25% of the AHI, no complete concentric collapse on drug-induced sleep endoscopy, and a recommended body mass index (BMI) <32 kg/m2 . We present 18 patients implanted as a salvage procedure despite being outside these guidelines. METHODS: We included all patients who underwent HGNS but who did not meet all FDA guidelines. Demographic data, previous OSA treatments, polysomnographic (PSG) parameters from baseline and HGNS titration PSG, Epworth sleepiness score (ESS), and BMI were compared before and after surgery. RESULTS: Eighteen patients were identified: 94.4% male, median age 63 years. Seven underwent previous sleep surgery. Four had an AHI <15 (mean 10.5 events/hour), four had an AHI >65 (mean 86.9 events/hour), two had an elevated CAI (mean 31.3% of AHI), and 12 had a BMI >32 kg/m2 (range 32.1-39.1). Median AHI decreased from 25.3 to 3.75 events/hour on titration polysomnography (P = .0006), oxyhemoglobin saturation nadir increased from 82% to 88.5% (P = .0001) and median ESS dropped from 11 to 7.5 (P = .0016). Fifteen (83.3%) patients achieved surgical success (decrease in AHI >50% and AHI <20 events/hour) and 12 (66.7%) had an AHI <5 events/hour. Neither patient with CAI >25% was successfully treated. Median adherence = 33.5 hours/week. CONCLUSION: Our success rate for patients outside the Food and Drug Administration guidelines for HGNS (67%) was similar to the 1-year STAR trial results (66%). Future studies are necessary to consider expansion of these guidelines. LEVEL OF EVIDENCE: 4 Laryngoscope, 130:866-872, 2020.


Subject(s)
Electric Stimulation Therapy/methods , Hypoglossal Nerve , Sleep Apnea, Obstructive/therapy , Adult , Aged , Aged, 80 and over , Female , Humans , Male , Middle Aged , Ohio , Polysomnography , Practice Guidelines as Topic , Salvage Therapy , United States , United States Food and Drug Administration
9.
Laryngoscope ; 130(9): 2275-2280, 2020 09.
Article in English | MEDLINE | ID: mdl-31837150

ABSTRACT

OBJECTIVES: The hypoglossal nerve stimulator (HNS) is an effective treatment for obstructive sleep apnea (OSA) in a relatively healthy subset of the population. Our aim was to determine the efficacy of HNS in a veteran population with a high incidence of chronic disease and mental health disorders. Our secondary aim was to compare subjective outcomes and adherence between veterans with and without mental health disorders. METHODS: We included all patients who underwent HNS at our institution to date. Veterans were divided into two groups based on whether or not they carried a diagnosis of anxiety, depression, and/or post-traumatic stress disorder. Demographics, comorbidities, previous OSA treatments, adverse events, and adherence to therapy were recorded. Baseline and treatment outcome data were collected and analyzed including polysomnographic parameters, Epworth sleepiness scale score (ESS), and body mass index. RESULTS: Thirty-one patients were identified: 93.5% male, median age = 63.0 years. Median apnea hypopnea index (AHI) decreased from 30.0 to 3.0 events/hour (P < .001) and median ESS dropped from 11.0 to 6.5 (P < .001). There was no difference between groups with regard to change in AHI or ESS (P = .31 and .61). Twenty-six (89.7%) patients achieved surgical success (decrease in AHI > 50% and AHI < 20 events/hour) and 21 (72.4%) had AHI < 5 events/hour. The mean device usage was 5.4 hours/night which was not significantly different between groups (P = .55). CONCLUSION: Our cohort exhibited similar declines in AHI and ESS compared to published studies with adequate adherence to HNS. There were no significant differences in ESS or adherence to therapy between veterans with and without mental health disorders. LEVEL OF EVIDENCE: 4 Laryngoscope, 130:2275-2280, 2020.


Subject(s)
Electric Stimulation Therapy/methods , Patient Compliance/statistics & numerical data , Sleep Apnea, Obstructive/therapy , Veterans/psychology , Anxiety/complications , Depression/complications , Electric Stimulation Therapy/psychology , Female , Humans , Hypoglossal Nerve , Male , Middle Aged , Patient Compliance/psychology , Retrospective Studies , Severity of Illness Index , Sleep Apnea, Obstructive/psychology , Stress Disorders, Post-Traumatic/complications , Treatment Outcome
11.
Laryngoscope ; 129(11): E402-E406, 2019 Nov.
Article in English | MEDLINE | ID: mdl-30549045

ABSTRACT

We present three adults with Down syndrome and obstructive sleep apnea (OSA) treated with hypoglossal nerve stimulation. The average age of these three males was 37.3 years. All patients had severe OSA on polysomnography. Postimplantation titration sleep studies exhibited residual OSA according to average total apnea-hypopnea index (AHI), but there were significant reductions (86%-100%) in the titrated AHI at the ideal device setting. Morbidity of the surgery was low, and there was excellent device adherence, with an average of 57.3 hours/week. All patients reported subjective improvements in symptoms, and one patient experienced improved blood sugar control. Laryngoscope, 129:E402-E406, 2019.


Subject(s)
Down Syndrome/complications , Electric Stimulation Therapy/methods , Implantable Neurostimulators , Sleep Apnea, Obstructive/surgery , Adult , Electric Stimulation Therapy/instrumentation , Humans , Hypoglossal Nerve/surgery , Male , Middle Aged , Polysomnography , Sleep Apnea, Obstructive/congenital , Treatment Outcome
13.
Chest ; 147(6): 1681-1690, 2015 Jun.
Article in English | MEDLINE | ID: mdl-26033129

ABSTRACT

OSA is a common, often chronic, condition requiring long-term therapy. Given the prevalence of OSA, as well as its significant health-related sequelae, a range of medical and surgical treatments have been developed and used with varying success depending on individual anatomy and patient compliance. Although CPAP is the primary treatment, many patients cannot tolerate this treatment and require alternative therapies. In this clinical scenario, surgery is often warranted and useful. Surgical management is aimed at addressing obstruction in the nasal, retropalatal, and retroglossal/hypopharyngeal regions, and many patients have multiple levels of obstruction. This review presents a comprehensive overview of research findings on a wide spectrum of surgical approaches currently used by sleep clinicians when other therapeutic modalities fail to achieve positive outcomes.


Subject(s)
Sleep Apnea, Obstructive/surgery , Continuous Positive Airway Pressure , Humans , Otorhinolaryngologic Surgical Procedures , Sleep Apnea, Obstructive/therapy
14.
Otolaryngol Head Neck Surg ; 152(1 Suppl): S1-43, 2015 Feb.
Article in English | MEDLINE | ID: mdl-25644617

ABSTRACT

OBJECTIVE: Allergic rhinitis (AR) is one of the most common diseases affecting adults. It is the most common chronic disease in children in the United States today and the fifth most common chronic disease in the United States overall. AR is estimated to affect nearly 1 in every 6 Americans and generates $2 to $5 billion in direct health expenditures annually. It can impair quality of life and, through loss of work and school attendance, is responsible for as much as $2 to $4 billion in lost productivity annually. Not surprisingly, myriad diagnostic tests and treatments are used in managing this disorder, yet there is considerable variation in their use. This clinical practice guideline was undertaken to optimize the care of patients with AR by addressing quality improvement opportunities through an evaluation of the available evidence and an assessment of the harm-benefit balance of various diagnostic and management options. PURPOSE: The primary purpose of this guideline is to address quality improvement opportunities for all clinicians, in any setting, who are likely to manage patients with AR as well as to optimize patient care, promote effective diagnosis and therapy, and reduce harmful or unnecessary variations in care. The guideline is intended to be applicable for both pediatric and adult patients with AR. Children under the age of 2 years were excluded from the clinical practice guideline because rhinitis in this population may be different than in older patients and is not informed by the same evidence base. The guideline is intended to focus on a limited number of quality improvement opportunities deemed most important by the working group and is not intended to be a comprehensive reference for diagnosing and managing AR. The recommendations outlined in the guideline are not intended to represent the standard of care for patient management, nor are the recommendations intended to limit treatment or care provided to individual patients. ACTION STATEMENTS: The development group made a strong recommendation that clinicians recommend intranasal steroids for patients with a clinical diagnosis of AR whose symptoms affect their quality of life. The development group also made a strong recommendation that clinicians recommend oral second-generation/less sedating antihistamines for patients with AR and primary complaints of sneezing and itching. The panel made the following recommendations: (1) Clinicians should make the clinical diagnosis of AR when patients present with a history and physical examination consistent with an allergic cause and 1 or more of the following symptoms: nasal congestion, runny nose, itchy nose, or sneezing. Findings of AR consistent with an allergic cause include, but are not limited to, clear rhinorrhea, nasal congestion, pale discoloration of the nasal mucosa, and red and watery eyes. (2) Clinicians should perform and interpret, or refer to a clinician who can perform and interpret, specific IgE (skin or blood) allergy testing for patients with a clinical diagnosis of AR who do not respond to empiric treatment, or when the diagnosis is uncertain, or when knowledge of the specific causative allergen is needed to target therapy. (3) Clinicians should assess patients with a clinical diagnosis of AR for, and document in the medical record, the presence of associated conditions such as asthma, atopic dermatitis, sleep-disordered breathing, conjunctivitis, rhinosinusitis, and otitis media. (4) Clinicians should offer, or refer to a clinician who can offer, immunotherapy (sublingual or subcutaneous) for patients with AR who have inadequate response to symptoms with pharmacologic therapy with or without environmental controls. The panel recommended against (1) clinicians routinely performing sinonasal imaging in patients presenting with symptoms consistent with a diagnosis of AR and (2) clinicians offering oral leukotriene receptor antagonists as primary therapy for patients with AR. The panel group made the following options: (1) Clinicians may advise avoidance of known allergens or may advise environmental controls (ie, removal of pets; the use of air filtration systems, bed covers, and acaricides [chemical agents formulated to kill dust mites]) in patients with AR who have identified allergens that correlate with clinical symptoms. (2) Clinicians may offer intranasal antihistamines for patients with seasonal, perennial, or episodic AR. (3) Clinicians may offer combination pharmacologic therapy in patients with AR who have inadequate response to pharmacologic monotherapy. (4) Clinicians may offer, or refer to a surgeon who can offer, inferior turbinate reduction in patients with AR with nasal airway obstruction and enlarged inferior turbinates who have failed medical management. (5) Clinicians may offer acupuncture, or refer to a clinician who can offer acupuncture, for patients with AR who are interested in nonpharmacologic therapy. The development group provided no recommendation regarding the use of herbal therapy for patients with AR.


Subject(s)
Anti-Allergic Agents/therapeutic use , Complementary Therapies/methods , Rhinitis, Allergic/diagnosis , Rhinitis, Allergic/therapy , Acupuncture Therapy/methods , Administration, Intranasal , Adolescent , Adult , Child , Child, Preschool , Chronic Disease , Comorbidity , Cost of Illness , Cost-Benefit Analysis , Diagnosis, Differential , Drug Therapy, Combination , Evidence-Based Medicine , Female , Glucocorticoids/administration & dosage , Histamine Antagonists/therapeutic use , Humans , Immunoglobulin E/analysis , Immunotherapy/methods , Interdisciplinary Communication , Leukotriene Antagonists/therapeutic use , Male , Nasal Surgical Procedures/methods , Phytotherapy/methods , Prevalence , Quality of Life , Referral and Consultation , Rhinitis, Allergic/drug therapy , Rhinitis, Allergic/economics , Rhinitis, Allergic/epidemiology , Rhinitis, Allergic/immunology , Turbinates/surgery , United States/epidemiology
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