At
30 days post-discharge, significantly fewer patients in the AEROBIKA®
OPEP device cohort were re-hospitalized (13.9 vs. 22.9%; p=0.042),
and mean length of hospital stay was significantly shorter (1.25±4.04
days vs. 2.60±8.24 days; p=0.047) compared with the IS cohort. Costs
due to hospitalizations were 80% lower in the AEROBIKA®
OPEP device group (p=0.001).
The
burden of PPCs, especially in patients undergoing abdominal, thoracic
or cardiac surgery, is substantial:
• death
rate is higher compared with patients who don't have PPCs (at 30 days
mortality is up to 10 times higher, and at 90 days up to 20 times
higher)
• resource
use and costs are significantly increased (mainly due to longer
length of hospital stay); a US database study of over 700,000
patients predicted that PPCs could lead to an additional 9,500
deaths, 92,000 extra ICU admissions and overall added costs to the US
of US$3.42 billion.(2)
The
causes of PPCs may be related to, among other things, shallow
breathing and reduced airway clearance, therefore physical therapy
techniques that increase lung volume and clearance have been
recommended to reduce the risk and severity of PPCs. One such
technique is incentive spirometry (IS), which encourages the patient
to take long, slow breaths by inhaling through a device to raise a
ball or piston.(3) The use of IS is common in clinical practice
although there appears to be little evidence to support its
value.(3,4) Another commonly used intervention to prevent and treat
PPCs is positive expiratory pressure (PEP) therapy, which involves
breathing against expiratory resistance.
The
AEROBIKA® OPEP device is an easy-to-use, drug-free oscillating
positive expiratory pressure (OPEP) device; when the patient exhales
through the device, intermittent resistance creates a unique
pressure-oscillation dynamic, which expands the airways and helps
expel mucus to the upper airways where it can be coughed out.
Clinical trial and real-world data have shown that the AEROBIKA®
OPEP device increases lung volume, reduces hyperinflation and
improves airway clearance in patients with COPD(5) or
bronchiectasis,(6) as well as reducing exacerbations in patients with
COPD.(7) These observations suggested a potential value for the
device in preventing PPCs, leading the authors to conduct this
retrospective real-world database study.
Co-author
Dominic Coppolo, MBA, RRT, FAARC, Vice President Clinical Strategy
and Development, commented that "based on the study findings,
and taking into consideration both the low cost and low risk safety
profile of the AEROBIKA® OPEP device, I would suggest
that it could be beneficial to include as standard of care in all
such post-operative patients", noting that future studies are
warranted to further define the benefits. He went on to add "The
fact that patients in the AEROBIKA® OPEP device group
in our study incurred lower healthcare costs in the 30-day period
following discharge (mainly as a result of fewer complications
requiring readmission) is particularly relevant as providers and
insurers look to reduce early rehospitalization."
About
Monaghan Medical Corporation (MMC, USA)
MMC
offers leading aerosol drug delivery devices and respiratory
management products including AEROECLIPSE® II BAN,
AEROCHAMBER PLUS® aVHC and the AEROBIKA®
OPEP device exclusively in the United States. MMC's strength lies in
product development around core capabilities in mechanical design
complimented by collaboration with a state-of-the-art aerosol
research laboratory. MMC focuses on developing cost-efficient,
outcome-based solutions for its customers.
(http://www.monaghanmed.com)
About
the AEROBIKA® Device
The
AEROBIKA® OPEP device (http://www.monaghanmed.com/aerobika)
is a hand-held, robust, easy-to-use, drug-free oscillating positive
expiratory pressure (OPEP) device designed to help expel mucus from
the lungs, expand airways and enhance drug deposition. When the
patient exhales through the device, intermittent resistance creates a
unique pressure-oscillation dynamic, which expands the airways, helps
expel the mucus to the upper airways where it can be coughed out. The
AEROBIKA® OPEP device is designed to function
independent of angle of use or flow rate, and allows for a direct
aerosol pathway for patients using a nebulizer for medication
delivery. The AEROBIKA® OPEP device has been shown to
significantly improve forced vital capacity (FVC), 6-min walk
distance (6MWD), and St. George's Respiratory Questionnaire (SGRQ)
score in COPD patients.(8) The AEROBIKA® OPEP device is available in
the US via Monaghan Medical Corporation, and in Canada, Mexico, and
select European countries including the UK and Germany through
Trudell Medical International (http://www.trudellmed.com).
(http://www.monaghanmed.com/Aerobika-OPEP)
About
the study
This
retrospective database study utilized patient data stored in IQVIA's
proprietary Hospital Charge Detail Master (CDM) database. The CDM
database manages daily transactional patient charges from over 650
hospitals from 46 states in the USA, covering 7 million annual
inpatient stays and 60 million annual outpatient visits. A total of
887 cardiac, thoracic or upper abdominal surgery patients
hospitalized between 1 September 2013 and 30 April 2017 were
identified to have used the AEROBIKA® OPEP device (in
addition to standard of care, incentive spirometry), of whom 144
matched the selection criteria. The comparison cohort was 144
propensity-score matched subjects who had used IS alone.
For
clinical inquiries, please contact:
Dominic
P. Coppolo, MBA, RRT, FAARC
Vice
President Clinical Strategy and Development
Monaghan
Medical Corporation
1-800-343-9071
Words
or phrases accompanied by ® are trademarks and registered trademarks
of Monaghan Medical Corporation or an affiliate of Monaghan Medical
Corporation. © 2018 Monaghan Medical Corporation.
1.
Burudpakdee C, Near AM, Huang H, Coppolo D, Kushnarev V, Suggett J. A
Real-World Evidence Study Assessing the Impact of Adding the
Aerobika® Oscillating Positive Expiratory Pressure
Device to Standard of Care Upon Healthcare Resource Utilization and
Costs in Post-Operative Patients. Pulmonary Therapy. 2018.
2.
Linde-Zwirble W, Bloom J, Mecca R, Hansell D. Postoperative pulmonary
complications in adult elective surgery patients in the US: severity,
outcomes and resources use. Critical Care. 2010;14 (Suppl 1):P210.
3.
Restrepo RD, Wettstein R, Wittnebel L, Tracy M. Incentive spirometry:
2011. Respiratory care. 2011;56(10):1600-1604.
4.
Carvalho CR, Paisani DM, Lunardi AC. Incentive spirometry in major
surgeries: a systematic review. Revista brasileira de fisioterapia
(Sao Carlos (Sao Paulo, Brazil)). 2011;15(5):343-350.
5.
Svenningsen S, Paulin GA, Sheikh K, et al. Oscillatory Positive
Expiratory Pressure in Chronic Obstructive Pulmonary Disease. COPD.
2016;13(1):66-74.
6.
Svenningsen S, Guo F, McCormack DG, Parraga G. Noncystic Fibrosis
Bronchiectasis: Regional Abnormalities and Response to Airway
Clearance Therapy Using Pulmonary Functional Magnetic Resonance
Imaging. Academic radiology. 2017;24(1):4-12.
7.
Burudpakdee C, Seetasith A, Dunne P, et al. A real-world study of
30-day exacerbation outcomes in chronic obstructive pulmonary disease
(COPD) patient managed with Aerobika® OPEP. Pulmonary
Therapeutics. 2017.
8.
Khoudigian-Sinani S, Kowal S, Suggett JA, Coppolo DP.
Cost-effectiveness of the Aerobika® oscillating
positive expiratory pressure device in the management of COPD
exacerbations. International journal of chronic obstructive pulmonary
disease. 2017;12:3065-3073.
