New Device in OSAS Relevant to the ENT – Surgeon.

Magne Tvinnereim, MD.,Ph.D. Specialist in Otolaryngology Head - & Neck surgery

International Accredited Sleep Specialist CEO, Spiro Medical AS & EuroSleep AS

Disclosure: Company Interests

The Philippines

• How many are the patients ?

• Population – 100 Million

• > 15 % of Population affected from SRBD

• Gives ; > 15 million sufferers

Why an ENT - Matter ? Because the main problems come from

Narrowing of the Throat.

Who is ill ?

Demands (AASM; 2007 / 2013):

OSA = RERA + AHI = oRDI RERA = Respiratory Effort Related Arousals

= Arousals during increased Lung work. OSA = Obstructive Sleep Apnea = AHI + RERA.

(Apnoeas, Hypopneas, Asleep/Awake.) oRDI = Obstructive Respiratory Distress Index.

These parameters give the Complete Diagnosis.

Diagnosing OSAS

Diagnostic Upgrade – 2013, American Academy of Sleep Medicine

Upper Airway narrowing generates increased Respiratory Effort for the Lungs to supply blood oxygen.

In 2013 (AASM) : Respiratory Effort is the most important parameter, measured by the Gold Reference Standard the Oesophageal Pressure

Obstructive Apnoea

Upper airway narrowing during sleep Inspiratory Snoring RERA OSAS resistance Hypersomnia

SRBD ;A Continuum

NormalPhenomenon

PathologicalConsequences

Diagnosis Established

OSAS = AHI + RERA = RDI.

5 < RDI < 15 ; Mild.15 < RDI < 30 ; Moderate.30 < RDI ; Serious.

Which TREATMENT to choose ?

Non Surgical Approaches Nasal / Oral Appliances POSA – Treatment.

CPAP

Surgical Approaches

Site of Phase I Phase II Obstruction ? Upper Lower

Phase III Nose

Multi- Soft Tissue

Level Skeletal Bariatric Surgery

Indications for SRBD Surgery1. Defined disease verified by

whole night recordings (WSDA) : PolySomnoGraphy (PSG)CardioRespiratory recordings

2. Ineffective conservative therapy (CPAP)

3. Treatable airway pathology

Where is the Stenosis?

Upper Airway Passage

Drug Induced Sleep Endoscopy, DISE.

• 1990, Pringle and Croft.• Short, not whole night.• Artificial Sleep• Most occlusion types:

Incorrect distribution.• Can miss Lower and

Multilevel occlusions.

Respiratory Effort

Open Closed

Upper Obstruction

Phase I :Upper obstruction

• The highest pressure gradient is above the soft palate

P2, below soft palate

P0, in oesophagus

Level Diagnosis

The pressure recordings will Always Identify The Lowest Limit of the occlusion. If the pressure recordings say predominantly upper narrowing we can be sure that the problems are above the upper pressure sensor in the pharynx.

Always measures the Lower Limit

Upper Lower Multilevel

Sequential Pharyngeal Multilevel Collapse Worlds First Multple-sensor Pressure Recording.

Level and Snoring

Upper Occlusions at Night - is The Surgeons Delight!

Factors increasing Surgical outcome :

Defining Site of Pharyngeal narrowing.Diagnosing Upper Pharyngeal obstruction.«Light sufferers» :OSAS patients with RDI < 20 – 30.OSAS patients with predominantly RERAs.Patients with BMI < 32Patients without Comorbidities Patients without Comorbidities

Surgical Level Strategy.

Upper: Nasal Surgery Soft tissue Pharyngeal surgery

Lower: Soft tissue Pharyngeal / BOT surgery, Implants.Multilevel: Lateral collapse – mostly Oropharyngeal

To be excluded by ENT-exam or DISE.Then consider;Multilevel Soft Tissue Surgery/BOT-excision.Implants ; ReVent, InspireSkeletal, max/mandib. – genioglossus etc. …

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Spiro Medical Innovation are directed and solved along three development lines:

Exceptional high-tech Catheter development for 2013 required Data Acquisition. World exclusive rights for advanced, newly patented Micro-Pressure-Transducer recording technique and signal processing : Gold Reference Standard diagnostics.

Revolutionary diagnostic Paradigm shift by innovative Algorithm development for demanded Awakening Parameter : ElectroEncephaloGraphy (EEG) are Replaced by a unique Spiro invented awakening parameter – the Spiro Respiratory Effort Related Arousal, sRERA.Patented!

Automated Reproducible SW-Interpretation: Digital numbers.Clinical Treatment application Advisory: Treatment recommendations. Preoperative site of throat obstruction, increasing surgical outcome.

Innovative ENT - Device Solution

Innovation : ApneaGraph® Spiro

OSA : Complete Automated Diagnosis - Level of Obstruction

- Level of Snoring - Gold Reference Standard

Safe – Tolerable – Cost Effective – Covers all AASM - 2013 Criteria.

Changing Habits

Questions?