Hypoglossal Nerve Stimulator Surgery for treatment of OSA. Disclosures. Hypoglossal Nerve Stimulation 11/9/2016

Transcription

1 Hypoglossal Nerve Stimulator Surgery for treatment of OSA olando Molina MD South Florida ENT Associates A Disclosures I do not have any relevant financial disclosures at this time. Hypoglossal Nerve Stimulation A new, clinically proven, treatment for patients unable to use CA Selection criteria Moderate to Severe Apnea (AHI 20-65) BMI <33 Age >18 Sleep endoscopy evidence of velopharynxand oropharynx anterior-posterior collaspe 1

2 Airway Obstruction Sites of Airway Obstruction Nasal alate Tongue base Epiglottis Inspire Medical Systems, Inc All ights eserved Intraoperative Examination Examination 2

3 Drug Induced Sleep Endoscopy Hypoglossal Nerve Stimulation Stimulation Timed With Breathing espiratory Cycle Timing Stimulation delivered during inspiration 1. Gentle stimulation of HGN 3. Computer & Battery 2. Sense Breathing 3

4 The Distal Hypoglossal Nerve Styloglossus Hyoglossus Hypoglossal Nerve (CN XII) Gentle stimulation Genioglossus Geniohyoid Clinical Evidence 126 patients were recently studied in the STA trial 22 centers across both the US and Europe eduction in Sleep Apnea Improvement in Quality of ife Source: STA Trial data published in the New England Journal of Medicine (N Eng J Med. 2014;370(2): ) Serious event rate 2% 11 eduction in Snoring Source: Inspire STA pivotal trial 12 4

5 Hypoglossal Nerve Stimulation rocess Assessment Implant Follow Up outine Follow-ups Sleep profile Anatomy check Typically outpatient Therapy activation Therapy optimization outine annual follow up Surgery Hypoglossal Nerve Stimulation Surgery Therapy affects the airway at multiplelevels Tx OFF - alate osterior oropharyngeal wall Tx ON - alate osterior Uvula alate Tongue- Base OFF Tongue Base ON Tongue Base Epiglottis ingual Tonsils 15 5

6 Inspire Therapy: Sleep Study Illustration Airflow, breathing and normal oxygen levels restored Inspire therapy turned on Airflow SpO2 Severe OSA Events OSA Events esolved Inspire Therapy rocedure Overview Typically an Outpatient rocedure General anesthesia ain Management Mild discomfort and swelling at the incision sites for a few days after the procedure, usually managed with over-the-counter pain medication ecovery eturn to regular diet and most activities of daily living immediately after the procedure Avoid strenuous activities for a few weeks Incisions After Healing is Complete Incision on neck for stimulation lead Incision and device under collarbone Incision on chest for sensor lead *hotos used with patient consent 6

7 What Does Inspire Therapy Feel ike? atients describe feeling a tingling sensation or mild muscle contraction when first activating Inspire therapy Inspire therapy is adjustable for patient comfort Most patients acclimate well to Inspire therapy within the first month of use In the STA Trial at 1 year: 86% of patients reported using Inspire therapy every night 93% of patients reported using Inspire therapy five or more night per week iving with Inspire Therapy With the sleep remote, patients can: - Start therapy - Stop therapy - ause therapy - Increase or decrease energy Inspire Therapy Contraindications* Screening sleep study shows > 25% central+mixed apneas Anatomical assessment findings that could compromise the performance of Inspire such as complete concentric collapse (CCC) at the palate re-existing conditions that have compromised neurological control of the upper airway atients who are unable or do not have the necessary assistance to operate Inspire therapy atients who are pregnant or plan to become pregnant atients who will require MI atients with another implantable device (i.e. pacemaker) should consult the device manufacturer to assess possibility of interaction *Indications approved by the United States Food & Drug Administration, April