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The Continuum of Products

and Solutions for the

COPD Patient

1 AARC CEU credit

Objectives

• Review COPD

• Discuss current practices for treatment – components

of care

• Review COPD staging

• Identify the Philips Respironics Incorporated (PRI)

products and solutions as they relate to the

progression of COPD

• Present tools which will help your DME to grow and

thrive in today’s market

2

Objectives

• Understand how home NIV may contribute to

reduction of readmissions for patients may have

chronic respiratory failure.

• Review patient identification for home NIV Tx

• Understand new options for home NIV

– AVAPS-AE mode of ventilation

– Mouthpiece Ventilation

3

COPD and Home NIV

COPD: An overview

4

5

COPD and Respiratory Insufficiency

• Often (but not always) caused by smoking or long term exposure to

irritants. Over time this irritation creates obstruction of the lower airway

that interferes with gas exchange, can’t get air in or out.

• Patients with OSA have obstruction issues in the upper airway, COPD

creates obstruction in the lower airways.

• Lungs lose normal elasticity like an overstretched rubber band. Patients

with advanced/very severe COPD often experience respiratory fatigue

leading to respiratory failure. Respiratory Failure in COPD is

sometimes referred to as hypercapnia meaning elevated levels of CO2.

COPD – fast facts

• leading cause of death

• Million afflicted

• Million diagnosed

• Million moderate to severe

COPD worldwide

• 3rd

• 24

• 12

• 65

6

COPD Characteristics

• Chronic Bronchitis & Emphysema

• Persistent, Non-Reversible Airflow Limitation

• Loss of Tissue Elasticity

• Paranchymal Destruction

• Airway Inflammation

8

Long-Term NIV for COPD with Chronic

Respiratory Failure Nava EMJ Oct 2013;1;54-62

1.) COPD During Sleep: Nocturnal Hypoventilation noted in REM sleep*

• 42% COPD Pts.= PaCO2 ↑ >10mmhg at night – ↑ tolerance for ↑ PaCO2

• Low Central Respiratory Drive

*REM sleep = Impaired upper airway tone and accessory muscle

activity. 1

Quality of Life Impact of Severe COPD

Long-Term NIV for COPD with Chronic Respiratory Failure

– Nava, Ergan EMJ 2013; 1:54-62

“Symptom burden comparable

to that of cancer”

“Greater negative impact

on health status than

cardiovascular disease

or diabetes”

9

Change in COPD Mortality compared with

other major causes from 1970-2002

COPD Heart disease Cancer Stroke Accidents Diabetes

Death rate (% change) 102.8% -52.1% -2.7% -63.1% -41.0% 3.2%

-80.0%

-60.0%

-40.0%

-20.0%

0.0%

20.0%

40.0%

60.0%

80.0%

100.0%

120.0%

Death rate (% change)

U.S. Leading Causes of Death; JAMA, September 14, 2005 – Vol. 294, No. 10 10

Published guidelines

GOLD

• Global initiative for Chronic Obstructive Lung Disease

NICE

• The National clinical guidelines on management of COPD in adults in primary and secondary care

ATS – ERS

• American Thoracic Society – European Respiratory Society

SEPAR – ALAT

• Spanish Society of Pulmonary and Thoracic Surgery – The Latin American Thoracic Association

HOT TOPICS IN RESPIRATORY MEDICINE: Issue 5, 2007 ... Guidelines for the treatment of COPD. Javier de Miguel Díez, Myriam Calle Rubio, ..... Aalbers R, Ayres J, Backer V, et al. 11

COPD stages

Severity classified by spirometry (PFT’s)

Stage 1 Stage 2

Stage 3 Stage 4

12

COPD stages

Severity classified by spirometry

Stage 1

GOLD Pocket Guide to COPD Diagnosis, Management, and Prevention. A guide for Health Care Professionals Updated 2010. See also www.goldcopd.org 13

COPD stages

MILD

FEV1 / FVC < 70%

FEV1 ≥ 80% predicted

With or without symptoms

Stage 1 80% normal lung function


COPD treatment considerations

Stage 1

Mild

• Avoid risk factors

• Influenza vaccination



Stage 1

Mild


• Add SABA

OptiChamber Diamond, valved holding chamber



Stage 1

Mild


• Add SABA

Holding chamber

SVN - MicroElite



Stage 1

Mild


• Add SABA

• Spirometry



Stage 1

Mild


• Add SABA

• Spirometry

Oximetry screening – WristOx


COPD stages


Stage 1 Stage 2

20

COPD stages

MODERATE

FEV1 / FVC < 70%

50% ≤ FEV1 < 80%

predicted

Stage 2 50 – 80% normal lung function



Stage 2

Moderate

• Stage 1 plus

LABA

SVN – SideStream Plus



Stage 2

Moderate

• Stage 1 plus

LABA

• Pulmonary rehab



Stage 2

Moderate

• Stage 1 plus

LABA

Pulmonary rehab

Threshold IMT / PEP • Inspiratory muscle

training

• Secretion clearance



Stage 2

Moderate

• Stage 1 plus

LABA

Pulmonary rehab

Supplemental O2

HomeLox / GoLox



Stage 2

Moderate

• Stage 1 plus

LABA

Pulmonary rehab

Supplemental O2

UltraFill



Stage 2

Moderate

• Stage 1 plus

LABA

Pulmonary rehab

Supplemental O2

EverGo



Stage 2

Moderate

• Stage 1 plus

LABA

Pulmonary rehab

Supplemental O2

PAP consideration for overlap – BiPAP S/T


COPD stages


Stage 1 Stage 2

Stage 3

29

COPD stages

SEVERE

FEV1 / FVC < 70%

30% ≤ FEV1 < 50%

predicted

Stage 3 30 – 50% normal lung function

Modified from GOLD Pocket Guide to COPD Diagnosis, Management, and Prevention. A guide for Health Care Professionals Updated 2010. See also www.goldcopd.org 30


Stage 3

Severe

• Stage 1 & 2 plus

ICS



Stage 3

Severe


ICS

NIV – BiPAP AVAPS



Stage 3

Severe


ICS

NIV

Patient interface


COPD stages


Stage 1 Stage 2

Stage 3 Stage 4

34

COPD stages Severity classified by spirometry

VERY SEVERE

FEV1 / FVC <70%

FEV1 <30% predicted

Stage 4 Less than 30% normal lung function



Stage 4

Very severe

• Stages 1-3 plus

• Surgical options

• LVRS



Stage 4

Very severe

• Stages 1-3 plus


Mechanical Ventilation – Trilogy PIV

http://piv.respironics.com


http://piv.respironics.com/


Stage 4

Very severe

• Stages 1-3 plus


Mechanical Ventilation

Lifeline

24/7

Auto-alert


Putting it all together

39

I Mild

II Moderate

III Severe

IV Very severe

The Right Fit Oxygen Advisor

39

40

• COPD is preventable and treatable

• Current practices for COPD treatment continue to

evolve

• COPD staging – GOLD revisions were changed in

2013

Conclusion – wrap up

41

CEU certificate

• To obtain your CEU certificate log on to the Philips Respironics’

Partners in Training website at: http://pit.respironics.com

• Log in to the website

• Click on “CEU Online Management System” on the left side

COPD stages Severity classified by spirometry

VERY SEVERE

FEV1 / FVC <70%

FEV1 <30% predicted

or FEV1 <50% predicted plus

chronic respiratory failure

Stage 4 Less than 30% normal lung function



Stage 4

Very severe

• Stages 1-3 plus


• LVRS (remove 20 to 35% of the poorly functioning lung tissue)

• Airway stents?



Stage 4

Very severe

• Tx for Stages 1-3 plus


Mechanical Ventilation – Trilogy Nocturnal NIV

Secondary mode: MPV


COPD and Home NIV

Healthcare costs related to COPD

readmissions

46

The costs of readmissions

• In the US, hospital

readmissions for COPD

within 30 days occur in 15-

25% of cases. ¹

• The estimated costs of

these admissions to US

Health Care is over $49

billion dollars. ³

² Plant P, Owen J, Parrott S, Elliott M. Cost effectiveness of ward based non-invasive ventilation for acute exacerbations of COPD; economic analysis of randomized

controlled trial. BMJ 2003; 326 1-5. 3Keenan S. Gregor, Sibbald W. Cook D, Gafni A. Noninvasive positive pressure ventilation in the setting of severe, acute exacerbations of COPD: More effective and

less expensive. Crit Care Med 2000; Vol. 28, No. 6 (2094-2102)

¹ Jencks Sl, Williams M, Coleman E.. Rehospitalizations among Patients in the Medicare Fee –for –Service Program. NE Journal of Med 2009; 360: 1418-28³

47

48

New Medicare focus on readmissions

Pt. Protection and Affordable Care Act

– The Hospital Readmissions Reduction Program (HRRP), part of the

Affordable Care Act, took effect on October 1, 2012

– Medicare targeting the diagnoses accounting for highest numbers of

readmissions

-

RT for Decision Makers March 2013

49


•Hospital is accountable for

readmission within 30 days.

- RT for Decision Makers March 2013

50

Medicare is targeting 7 Diagnoses that are

responsible for 30% of all readmissions

2012

• CHF

• Acute MI

• Pneumonia

2015

• COPD

• Angioplasty

• Coronary Artery

Bypass Graft

• Vascular Disease

51


•COPD and the other new Dx’s

kicked in Oct. 1 of 2014.


52


Hospital payment penalties:

Medicare payment penalties

1% in 2013

2 % in 2014

3% in 2015


Hospital Compare

• CMS website/database:

– Quality of care

– Hospital 30 day readmission rates

– Data for 4000 Medicare certified hospitals across the country

– http://www.medicare.gov/hospitalcompare/search.html

– Number of COPD discharges reported

– How compares with national average

http://www.medicare.gov/hospitalcompare/search.html

http://www.medicare.gov/hospitalcompare/search.html

Home Non-Invasive Ventilation

Where we came from and

where we are today

Perceptions of home ventilation

• Past: 24/7 vent dependency, trach/INV only,

complex devices, high risk/cost service.

• Present: Option for patients needing INV or NIV

treatment of neuromuscular, thoracic restrictive

and chronic respiratory failure associated with

chronic obstructive pulmonary disease*.

(*Medicare NCD)

55

Hospital NIV Ventilator

Home NIV Ventilator

• Present: Nocturnal NIV

57

Home NIV Advantages

• Ease of use

• Reduced need for skilled caregivers

• Elimination of tracheostomy-related

complications

• Improved patient comfort

• Allows speech, improved communication

• Lower overall cost of care

58

Goals of Home NIV

• Relieve symptoms

• Reduce work of breathing

• Improve or stabilize gas exchange

• Improve duration and quality of sleep

• Maximize quality of life

• Prolong survival

• Nicholas Hill, Noninvasive Positive Pressure Ventilation: Principles and

Applications

59

60

Diagnoses that may be appropriate for Home NIV?

• Muscular Dystrophies

• ALS

• Higher Spinal Cord Injuries

• Other myopathies: Acid maltase deficiency, polymyositis,

mitochondrial disorders.

• Neurological disorders: Spinal muscular atrophies (SMA l,ll,lll)

Neuropathies: Guillain-Barre syndrome, Multiple Sclerosis

• Skeletal pathologies such as kyphoscoliosis

• COPD with respiratory insufficiency/chronic respiratory failure

COPD and Home NIV

Clinical References

(pubmed.gov)

61

Barnes Healthcare Non-Invasive Management Program

• The Barnes Healthcare Services (AL, FL, GA) Non-Invasive Ventilation

Management Program.

• Published June 2015 in Journal of Clinical Sleep Medicine.

”Retrospective Assessment of Home Ventilation to Reduce

Rehospitalization in Chronic Obstructive Pulmonary Disease. 663-670. “

Steven Coughlin, PhD1; Wei E. Liang, PhD2; Sairam Parthasarathy, MD3

• Retrospective study of a QI program preformed at a single center.

Intervention included nocturnal NIV with AVAPS-AE. Medication

reconciliation by a pharmacist, adequate provision of O2 and ongoing

RT follow-up.

http://www.aasmnet.org/jcsm/ViewAbstract.aspx?pid=30059







Barnes COPD Home Management data presented at the

AARC (Published in Journal of Clinical Sleep)

• 397 COPD Chronic Respiratory Failure patients 1 year pre home NIV

and 1 year post

• Inclusion criteria included 2 (or more) admissions within the previous

year due to acute COPD exacerbations . Trilogy with AVAPS-AE mode

used on all patients in 1 yr post

• Tidal Volume based on Ideal Body Weight with Min and Max pressures

to meet patients demands/needs

• Only 9 of 397 required readmission for COPD exacerbation the year

following initiating Trilogy/AVAPS-AE vs 100% the year prior.

• One year survival rate increased to 82%

64

High-Intensity non-invasive positive pressure ventilation

for stable hypercapnic COPD

Wolfram Windisch et al. International Journal of Med Sciences, 2009; 6 (2)

72-76

• Describe outcome of high-intensity NIV aimed at decreasing

PaCO2 as an alternative to conventional NIV with lower

settings in stable hypercapnic COPD patients.

• High Intensity = Ave I Pressure is 28 cm H20

• Low Intensity = IPAP 12 to 18cm H20




72-76

• Physiological parameters, exacerbation rates and long-term

survival were assessed in 73 COPD patients (mean FEV1

30 % predicted) who were placed on high-intensity NIV due

to chronic hypercapnic respiratory failure between March

1997 and May 2006.

• Results: Controlled NIV with RR of 21 breaths/min and

positive airway pressures of 28 (+5/-5) cm H20 led to

significant improvements in ABG’s and lung function

65



After two months of NIV:

• TLC remained unchanged

• FVC on average went from 49% to 55% of predicted

• FEV1 30 to 35%

PC02 51 to 47

Wolfram Windisch et al. International Journal of Med

Sciences, 2009; 6 (2) 72-76

66




72-76

• Readmissions:

67

Only 16 of the 73 patients (22%)

required hospitalization due to a

COPD exacerbation during the first

year.

Decrease in EMG activity with Long Term Ventilation in

COPD

• Respiratory Muscle strength

– Electrical activity of Respiratory Muscles. Three Respiratory

Muscles,

– Intercostal

– Diaghram

– Scalenes

– Chronic NIV may be beneficial for the electrical activity of the

respiratory muscles

Deiverman et al. ERS Abstract in 2009.

68

Rationale for NIV in COPD Treatment

Improved Sleep

• Improved Sleep (Total time of sleep, efficiency of sleep

– Patients had COPD and were hypercapnic. Patients were using

either O2 or O2 and NIV during the night.

– TST % 202 – 260 min w O2, 339 min with O2 and NIV

,

Efficiency % Total number of hours asleep as opposed to total

number of hours in bed. Average 50%, up to 70% with O2 and

80% with O2 and NIV

– Awake % 40, 30 with O2 20% with O2 and NIV

Meecham Jones. Et al 1995 AJRCCM

69

Rationale – Improved Ventilation

• Improved Ventilation

• Nocturnal NIV in addition to Rehab in hypercapnic pateints with

COPD (2008)

– Author looked at tidal volume, minute volume and RR

– Found significant Increases in ventilation during the

daytime when patients are using NIV at night.

Deiverman et al.2008

70

Long-term home noninvasive mechanical ventilation

increases systemic inflammatory response in chronic

obstructive pulmonary disease:

RESULTS:

• Ninety-three patients were included (48 NIV, 45 oxygen), with analogous

baseline features. Sputum analysis showed similar HNP, IL-6, IL-10, and TNF-

alpha levels (P > 0.5). Conversely, NIV group exhibited higher HNP and IL-6

systemic levels (P < 0.001) and lower IL-10 concentrations (P < 0.001).

Subjects undergoing NIV had a significant reduction of rehospitalizations

during follow-up compared to oxygen group (P = 0.005). These findings were

confirmed after propensity matching and pH stratification.

Paone G, et al Abstract 2014 71

Long-term home NIV increases systemic inflammatory

response in chronic obstructive pulmonary disease

RESULTS:

These findings challenge prior paradigms based on the assumption that

pulmonary inflammation is per se detrimental.

NIV beneficial impact on lung mechanics may overcome the potential

unfavorable effects of an increased inflammatory state.

Paone G, et al Abstract 2014

72

Rational for NIV

• Respiratory Muscle strength

– . Decrease in EMG activity with Long Term Ventilation in COPD

– Electrical activity of Respiratory Muscles. Three Respiratory

Muscles,

– Intercostal

– Diaghram

– Scalenes

– Chronic NIV may be beneficial for the electrical activity of the

respiratory muscles

Deiverman et al. ERS Abstract in 2009

73

How may home NIV help the COPD patient?

• Rest and unload the respiratory muscles

• Improved sleep efficiency

• Improvements in PFTs and ventilation,

• Improvements in inflammation response

• Reduction in readmissions for chronic

respiratory failure

75

• AVAPS-AE Mode

– Auto backup rate

– Adjustable AVAPS rate

Mouthpiece Ventilation

Pressure Support up to 50 cmH2O

New NIV updates and expanded versatility

AVAPS Review

• AVAPS acts primarily as a bi-level pressure support device but is able

to provide a constant tidal volume with the AVAPS feature enabled

– Can be used with S, S/T, PC or T modes

• Automatically adjusts the pressure support level to maintain a

consistent tidal volume

– IPAP will automatically increase or decrease to maintain set tidal

volume

76

• Automatically titrates pressure support

– Changes in body position

– Sleep stage

– Changes in respiratory mechanics

• Delivers average tidal volume

– Within the night

– Long-term progression

• AVAPS produces results comparable to sleep lab titration of PS1

– CO2 reduction

– Health-related quality of life

– Sleep quality

1Murphy, PBThorax thoraxjnl-2011-201081: Published Online First: 1 March 2012 doi:10.1136/thoraxjnl-2011-201081

AVAPS: proven effective

77

Performance Capabilities

AVAPS

With AVAPS

78

AVAPS- AE

AVAPS-AE is a auto-titration mode of noninvasive ventilation designed to

better treat respiratory insufficiency patients (OHS, COPD and NMD) in

the hospital and homecare environments

Achieving a targeted volume is now completely automatic

• Proven performance of AVAPS

• Auto EPAP

• Auto backup rate

• Can be used together or in various combinations

79

AVAPS-AE

Auto EPAP maintains patent upper airway

at a comfortable pressure

• Auto adjusting EPAP to meet changing patient needs

• Maintains a patent airway

80

Current PRI Auto EPAP/CPAP

Flatness Roundness Peak Shape

AVAPS-AE

Flo

w

Pre

ssu

re

Forced oscillation technique (FOT) at 5 Hz, 1

cm amplitude during EPAP

Comparison of Auto EPAP methods

81

AVAPS-AE

Auto backup rate provides

comfortable assistance when needed

• Auto backup rate is near resting rate

• No manual adjustments

(auto-default setting)

82

EPAP

Target Vt

IPAP PS min

PS max

AVAPS-AE: Maintaining tidal volume and airway

patency

EPAP min

EPAP max

Resistance

83

AVAPS-AE: Auto EPAP

• Auto EPAP provides airway patency

– Designed for NIV use only

– Patient benefit: lower, more comfortable

EPAP pressure

• AVAPS-AE and patient overlap

– 29% to 40% of COPD patients have OSA1

– 90% of OHS patients have OSA2

• AVAPS-AE: 1st NIV therapy with Auto EPAP

designed for respiratory insufficiency and

respiratory failure patients

1Jelic International Journal of COPD 2008:3(2)269-275 2Mokhlesi. Chest 2007:131;1624-1626

84

Expanding Ventilatory Support

Mouthpiece ventilation (MPV)

MPV is a form of volume ventilation whereby the patient’s normal state is

disconnected from the ventilator and the patient initiates a breath, as

needed, through an oral interface.

85

Kiss Trigger and MPV Support System

• A new ‘kiss’ trigger with signal flow technology detects when the patient

engages and disengages from the mouthpiece to deliver on-demand

ventilation

• This feature combines with a mouthpiece ventilation (MPV) support

system to enhance ease of use

86

BiPAP vs Trilogy NIV Vent for Respiratory Failure/COPD

(General Overview – See CMS NCD/LCD’s)

Trilogy NIV Vent (E0464)

• Chronic Respiratory Failure

• NCD currently (no LCD)

• Physician documentation of Chronic

Respiratory Failure and why an NIV

Vent is being ordered for patient.

• Documentation considerations:

May include PCO2 and/or PFT’s (Stage

4 COPD)

Readmissions for Resp Failure

Higher pressures (up to 40cmH20)

Auto Pressure Support and EPAP

Mouthpiece Ventilation available

AVAPS-AE Mode

Protection from breath-stacking

Auto Rate

More time to exhale

BiPAP (E0470/E0471)

May be adequate if device meets

patients needs

• Lower pressures are adequate

• Patient meets RAD Guidelines:

1, ABG PaCO2, done while awake and breathing the

patient’s usual prescribed Fi02 ≥ 52mmhg

and

2. Sleep oximetry SaO2 less than or equal to 88% for at

least five continuous minutes, done while breathing oxygen

at 2 LPM or the patient’s usual FIO2 (whichever is higher)

and

3. Prior to initiating therapy, Obstructive Sleep Apnea (OSA)

and treatment with a continuous positive airway pressure

device (CPAP) has been considered and ruled out

88

Questions???

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The Continuum of Products and Solutions for the COPD …c.ymcdn.com/sites/€¦ · The Continuum of Products and Solutions for the COPD Patient ... COPD During Sleep: ... GOLD Pocket