Significant reductions in costly pulmonary complications with use of drug-free device

LONDON, ON, June 20, 2018 /CNW/ - Post-operative pulmonary complications (PPCs) are a major burden to the healthcare system. A new real-world study published in Pulmonary Therapy, indicates significant reductions in costs when using  the Aerobika* oscillating positive expiratory pressure (OPEP) device in the postoperative care setting.¹ The retrospective database analysis including 288 patients undergoing cardiac, thoracic or upper abdominal surgery suggests that use of the Aerobika* OPEP device in addition to standard of care (incentive spirometry, IS) was associated with fewer re-hospitalizations, shorter hospital stay and lower costs compared with patients using standard of care alone.

The Aerobika* OPEP device (CNW Group/Trudell Medical International)

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 COPD⁵ 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 Dr. Jason Suggett 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 Trudell Medical International (TMI)

Trudell Medical International designs, develops, manufactures, and distributes a wide range of medical devices and is home to a global Aerosol Lab and Research Center. From the flagship AeroChamber^* Brand of Valved Holding Chamber and the latest award-winning Aerobika* OPEP device, to custom designed products and systems, our best-in-class respiratory management products have been sold in over 110 countries. Their efficacy has been validated in hundreds of peer-reviewed articles from various medical journals.  www.trudellmed.com. 

About the Aerobika^* OPEP device  

The Aerobika* device 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.⁵ Real-world evidence has shown that the Aerobika* OPEP device can significantly reduce the recurrence of exacerbations of COPD in the crucial 30-day period following hospitalization or emergency room visits,⁷ with associated cost reductions.⁸ The Aerobika* OPEP device is available in Canada, Mexico, and select European countries including the UK and Germany through Trudell Medical International and in the US via Monaghan Medical Corporation.

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 was144 propensity-score matched subjects who had used IS alone.

* trade-marks and registered trade-marks of Trudell Medical International © TMI 2018. All rights reserved. 

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.

SOURCE Trudell Medical International

For clinical inquiries, please contact: Jason Suggett PhD, BPharm, MBA, MRPharmS, Group Director of Global Science and Technology, 1- 519-455-7060

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