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International Surgical Sleep Society

Notes from Eric Kezirian, Ed Weaver, Stuart MacKay, Jolie Chang

2022 Research Day

  • I. Objective Sleep Study Metrics
    • a. Recommended Primary Metrics:
      • i.AHI
      • ii.Apnea Index
      • iii.ODI (4%)
    • iv.%TST90: % of sleep time spent < 90% Sat
    • b. Secondary Metrics (encouraged):
      • i.Supine AHI
      • ii.Non-Supine AHI
      • iii.Central apnea % of total events
    • c.Removed:
      • i.O2 Sat Nadir (LSAT)
  • II. Patient Reported Outcome Measures
    • a.Primary measures (committed to use):
      • i.Snoring Bother: How bothersome is your snoring currently? (Likert Scale: 0=None to 10=Severe)
      • ii.ESS
      • iii.Global OSA-related quality of life change
    • b.Secondary measures (encouraged):
      • i.FOSQ
      • ii.SNORE-25

Permissions:
SNORE-25: Stacey Ishman, Eric Kezirian, and Ed Waver obtained permissions for use from Jay Piccirillo.

FOSQ-10: approved from Terri Weaver for research (circulated but not to be shared online); letter of agreement needed to send and receive scoring instructions.

Cardiovascular Outcome Measures

  • a.Proposed measures (optional):
    • i.Blood pressure (night of and morning after PSG)
    • ii.De-escalation or change in blood pressure medication(s) or dosing

The ISSS Research Workshop considered a list of loosely defined “real life”, “actual” and “surrogate” cardiovascular outcome metrics in OSA treatment.

Surrogate Markers

Actual Markers

Real Life Markers
24-hour blood pressure Carotid artery stenosis percentage Incidence of acute myocardial infarction
Systolic blood pressure Carotid intima-media thickness Incidence of coronary artery bypass graft

  • number of surgeries
  • number of vessels bypassed
Diastolic blood pressure Ejection fraction Incidence of non-fatal cardiac events needing percutaneous coronary interventions(PCI)
Diurnal blood pressure Pulmonary artery pressure Incidence of stroke
Nocturnal blood pressure Atrial dilatation Incidence of atrial fibrillation/cardiac arrhythmia
Baroreceptor sensitivity Left ventricular hypertrophy Deaths from AMI/stroke
Total cholesterol (lipid profiles) Electrophysiological studies – atrial conduction abnormalities Hospitalisations for transient ischaemia attack
Triglycerides Hospitalisations for unstable angina
High-density lipoprotein Incidence of congestive cardiac failure
Low-density lipoprotein Incidence of pulmonary arterial hypertension
Markers for sympathetic activity:

  • Plasma normetanephrine
  • Plasma metanephrine
  • Urine normetanephrine
  • Urine normetanephrine
 Incidence of systemic hypertension event
Autonomic dysfunction measures De-escalation or cessation of antihypertensive agents
Markers for oxidative stress:

  • 8-isoprostane
  • Plasma thioredoxin
 De-escalation or cessation of statins

ISSS 2022 Recommended Metrics for Studies on Sleep Surgery Outcomes

1. How bothersome is your snoring currently (0 = None, 10 = Severe)?

2. Epworth Sleepiness Scale (attached)

3. Global OSA-related quality of life change:

In terms of your sleep apnea and your health,has there been any change in your quality of life since the first time you came to Sleep Surgery Clinic?


If better:
 If worse:

Figure. Global Sleep Apnea Quality of Life Change instrument: 15-item (range —7 to +7)

4. Apnea-hypopnea index (AHI)

5.Apnea index

6. Oxygen desaturation index 4%

7. Percent of total sleep time with oxygen saturation <90%

Secondary (optional):

1. Functional Outcomes of Sleep Questionnaire – 10 (attached)

Note: Per Dr. Terri Weaver (owner of FOSQ and FOSQ-10), this questionnaire is OK to send out to ISSS members but should not be placed into the public domain, whether online or in any publication. If any members would like to use the FOSQ-10, they should complete the attached Letter of Agreement and return to Dr. Weaver at [email protected]. She will then send the scoring instructions for the FOSQ-10.

2. SNORE-25 (attached, including scoring instructions)

Note: Jay Piccirillo (owner of SNORE-25) has authorized sharing the instrument and scoring instructions with ISSS members.

3. Supine AHI

4. Non-supine AHI

5. Central apnea % of total events

Philadelphia 2022 ISSS: Drug Induced Sleep Endoscopy Research Group Meeting

ISSS Research Group participants recognize the benefit of drug induced sleep endoscopy (DISE) in the evaluation of sleep apnea. There is strong group interest in standardization of DISE, utility in patient selection, and prediction of surgical outcomes. Summaries of each presentation and discussion can be found below.

Pediatric Drug Induced Sleep Endoscopy (Dr. Erin M. Kirkham, University of Michigan)

Summary: There is no consensus or standardization in pediatrics- more research is needed

Issue Raised

Discussion Points/Future Directions

Anesthetic choice
  • Difficulties: Pediatric patients usually require pre-sedation and induction with inhalational agents
  • Dexmedetomidine felt to be “asleep brain, awake pharynx”
  • Participants expressed opinions ranging from equipoise between agents to strong preference for dexmedetomidine to DISE with inhalational agents
  • Current studies: Kirkham: RCT Propofol vs Dexmedetomidine (ClinicalTrials.gov Identifier: NCT05303987)
Scoring Pediatric DISE
  • 7 published scoring protocols
  • No scoring system correlates with OSA severity on PSG
  • Consensus coming!
Indication: What is role of DISE prior to T&A?
  • DISE can change surgical decision-making in children. Up to 58% underwent other surgery after DISE

(Kirkham et al, 2020. doi: 10.1007/s11325-019-02006-y)

Pharyngeal Opening Pressure (Dr. Raj C. Dedhia, University of Pennsylvania)

Summary: DISE with administration of PAP (DISE-PAP) combines endoscopic evaluation with physiologic measures of upper airway collapsibility. Pharyngeal opening pressure (PhOP) is the pressure at which inspiratory flow limitation is completely abolished and is a novel, objective measure of global airway collapsibility. There was consensus that there is a need for a measure to help predict surgical outcomes and that this should be a focus of future research on physiologic measures of airway collapse, such as PhOP

Issue Raised

Discussion Points/Future Directions

Standardization and Implementation
  • DISE-PhOP standardization is necessary to have useable aggregate data: maneuvers like mouth closure, head of bed position can all change PhOP
  • Practical implementation of Sleep Endoscopy with Positive Airway Pressure in Clinical Practice: 5 minutes and $19 (Hutz et al, 2022. doi:10.1002/lary.30272)
Correlations
  • Is there a correlation with autoPAP settings? It can be challenging to get therapeutic PAP on all patients
  • Correlation with VOTE score
Does PhOP predict surgical outcomes?
  • PhOP may provide gestalt that you need to be more aggressive. Can it help determine which procedure to perform?
  • What is the change in PhOP post-procedure?

Drug Induced Sleep Endoscopy and Surgical Outcomes (Dr. Olivier M. Vanderveken, Antwerp University Hospital)

Summary: DISE is viewed as a standard of care for decision making for the surgical treatment of OSA. National reimbursement and some guidelines require DISE for surgical treatment. How can we increase the evidence

Issue Raised

Discussion Points/Future Directions

Standardization Sedation

  • Lack of uniformity: multiple protocols for sedation are used across different institutions. This is hurdle to aggregating data
  • Depth of sedation: What is oversedation? Largely based on surgeon gestalt. Should BIS routinely be used?
  • What degree of oversedation changes degree/site/pattern of collapse?

Lidocaine

  • Is lidocaine important? Is one method of application better than another? Conflicting opinions

Position

  • Is position important? Consensus for supine position with neutral neck position
Level of collapse There is high interest in more research regarding:
Palate collapse

  • Do certain patterns of palatal collapse +/- lateral wall collapse and degree of contribution dictate which version of pharyngoplasty should be performed?

Epiglottic collapse

  • Is DISE epiglottic collapse indicative of natural sleep epiglottic collapse?
  • Should interventions be catered to epiglottic collapse seen on DISE?

Cardiovascular : The ISSS Research Workshop considered a list of loosely defined “real life”, “actual” and “surrogate” cardiovascular outcome metrics in OSA treatment. A detailed sample of this list is shown in FIGURE X

24-hour blood pressure

Actual Markers

Real Life Markers
Surrogate markers Carotid artery stenosis percentage Incidence of acute myocardial infarction
Systolic blood pressure carotid intima-media thickness Incidence of coronary artery bypass graft -number of surgeries -number of vessels bypassed
Diastolic blood pressure Ejection fraction Incidence of non-fatal cardiac events needing percutaneous coronary interventions(PCI)
Diurnal blood pressure Pulmonary artery pressure Incidence of stroke
nocturnal blood pressure Atrial dilatation Incidence of atrial fibrillation/cardiac arrythmia
Baroreceptor sensititvity Left ventricular hypertrophy Deaths from AMI/stroke
Total cholesterol (lipid profiles) Electrophysiological studies-atrial conduction abnormalities Hospitalisations for transient ischaemia attack
Triglycerides Hospitalisations for unstable angina
High-density lipoprotein Incidence of congestive cardiac failure
Low-density lipoprotein Incidence of pulmonary arterial hypertension
Markers for sympathetic activity

  • Plasma normetanephrine
  • Plasma metanephrine
  • Urine normetanephrine
  • Urine normetanephrine
 Incidence of systemic hypertension event
Autonomic dysfunction measures De-escalation or cessation of antihypertensive agents
Markers for oxidative stress:

  • 8-isoprostane
  • Plasma thioredoxin
 De-escalation or cessation of statins

FIGURE X

Workshop participants considered components of the list as collectable metrics. Whilst it was recognized smaller surgical studies have shown 24 hour blood pressure improvements (Lateral pharyngoplasty reduces nocturnal blood pressure in patients with obstructive sleep apnea Laryngoscope, 124:311–316, 2014 De Paula Soares et al) or trends to change (SAMS trial), and others have demonstrated surgery reduces single measures in blood pressure (Alternations of Blood Pressure Before and After OSA Surgery Otolaryngology-Head & Neck surgery, Vol 163, Issue 4, 2020,Redefining the Timing of Surgery for Obstructive Sleep Apnea in Anatomically Favorable Patients Laryngoscope, 124:S1–S9, 2014 Rotenberg et al,Blood pressure after Modified Uvulopalatopharyngoplasty: results from the SKUP3 randomized controlled trial. Sleep Medicine Vol 34 June 2017, p156-161, Fehrm et al), the workshop committee felt it best that such studies were performed as single or multi-center trials, rather than ISSS database collection analyses.

​In terms of “real life” metrics of cardiovascular outcomes following OSA surgery, the workshop recognized excellent large database study publications (for example Ibrahim et al JAMAOtolaryngolHeadNeckSurg.doi:10.1001/jamaoto.2020.5179) and single center long term observational studies (Peker Y et al doi:10.1164/rccm.2105124). It was deemed appropriate that such studies are confined to larger database sets and interested institutions, rather than ISSS member collectives.

​“Actual” metrics, such as the degree of carotid intimal thickening, could also be utilized in units with the investment, interest and ability to study such markers. Future pathways may also involve select sites evaluating hypoxic burden (Azarbarzin et al European Heart Journal 2019 40 1149-1157).

​Despite the above, interested members were encouraged to collect “night of and morning after” in laboratory polysomnography blood pressure readings, but recent direction towards level II studies may restrict the

Issue Raised

Specific Parameters

Challenges

Committee Consensus
Body Mass Index 32 Uncertain effect of HGNS implantation in this group More Research recommended re: Implantation in this range
Apnea Hypopnea 65 Uncertain effect of HGNS implantation in this group More Research recommended re: Implantation in this range
Titration Polysomnography following HGNS Implatation Titration AHI (+other) Vs Whole-night Average AHI (+other) Uncertain benefit in reporting AHI and other outcomes based on Titration Polysomnography; Titration algorithms are currently lacking Utilize Titration Polysomnography in select circumstances only; report Whole- night average AHI in research (within 12 months); practical clinician consideration recommended
Current Registries inadequate Timing of Outcome Measures Timing of collection of Outcome Measures is non-uniform/broad Genuine Registry with time specific data collection required
Pre-Implantation Clinician Counselling Assessment, Discussion and Decision Making Some clinicians and centers are inadequately describing other primary, alternative and salvage OSA treatment options Consider patient co- morbidities, anatomy, physiology and clinician expertise prior to implantation. Discussion requires realistic goals and expectations
Adherence to Therapy post- implantation Compliance + Compliance in the setting of subjective and objective improvement Documentation of symptomatic/subjectiv e improvement, bed partner input; Residual disease may not be relevant in the setting of symptomatic improvement and reduction in disease burden Clinicians need to consider compliance with therapy, symptomatic improvement, and reduction in disease burden in determining outcomes