Significant Reductions in Costly Pulmonary Complications with Use of Drug-Free Device

Plattsburgh, NY, USA — 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 stays and lower costs compared with patients using standard of care alone.

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.

Monaghan’s Drug-Free Aerobika® Device Helps Reduce the Real-World Impact of Exacerbations in Chronic Obstructive Pulmonary Disease

This study provides the first real-world evidence for the benefits of using the Aerobika® device in reducing exacerbation-related emergency department visits and hospital readmissions.

monaghan-medical-corporation-logo

Syracuse, NY, USA — Monaghan Medical Corporation (MMC) (http://www.monaghanmed.com), today announced the publication of a study in Pulmonary Therapy showing that treatment with Monaghan’s Aerobika® device can significantly reduce the recurrence of exacerbations of chronic obstructive pulmonary disease (COPD) in the crucial 30-day period following hospitalization or emergency room visits.(1) The study also showed that per-patient cost of exacerbations was significantly lower in the group using the Aerobika® Oscillating Positive Expiratory Pressure (OPEP) device. This study provides the first real-world evidence for the benefits of using the Aerobika® device in reducing exacerbation-related emergency department visits and hospital readmissions.

COPD is a major (and growing) source of morbidity, mortality and healthcare utilization, with hospitalization for acute exacerbations being the biggest cost driver. Once a patient experiences an exacerbation, the risk of further exacerbation is increased two- to four-fold(2), and many patients experience two or three exacerbations every year.(3-5) As many as one in five patients discharged from hospital following an exacerbation are re-admitted within 30 days.(6)

This retrospective study analyzed hospital database records for 810 COPD Chronic Bronchitis patients who were hospitalized or visited the emergency room, and showed significantly fewer patients given the Aerobika® device experienced moderate-to-severe exacerbations or severe exacerbations compared with matched controls within the critical 30-day follow-up period. The study also showed a statistically significant savings in exacerbation-related costs in the Aerobika® device group compared with the control group for moderate-to-severe and severe exacerbations. The Aerobika® device was given in addition to the patients’ regular COPD treatments.

“This is the first study to evaluate the benefits of any OPEP in a real-world setting. It provides encouraging evidence that the Aerobika® device can help reduce recurrence of exacerbations in high-risk patients over the crucial early 30-day period,” noted Dr. Michael Bauer, Pulmonary Physician, Cooperstown, New York.

Dominic Coppolo, MBA, RRT, FAARC, Vice President Clinical Strategy and Development at Monaghan Medical, explained how the Aerobika® device may provide these benefits: “During an exacerbation, airways are compromised by (among other factors) inflammation and mucus build-up. This can continue to disrupt ventilation mechanics and lung function after the event, and lead to prolonged respiratory impairment. The Aerobika® device, with its proprietary mechanism of action, helps stent open and clear excess mucus from the upper airways, and may also aid drug deposition, providing a potential mechanism of protection from exacerbations.”

The internationally-recognized GOLD guidelines(7) for COPD treatment stress the importance of exacerbation management, stating that a major treatment goal is to ‘minimize the negative impact of the current exacerbation and to prevent subsequent events.’ A recent analysis(2) predicts that the absolute number of COPD cases could increase by between 150% and 220% in the period from 2010 to 2030, with the burden of inpatient care (total annual inpatient days) growing by around 185%. This further underlines this need to address the burden of COPD exacerbations.

About the Aerobika® device study
A retrospective cohort study utilizing patient data from the U.S. hospital Charge Detail Master (CDM) claims database (data selection period between 1 September 2013 and 31 August 2015). This real-word study involved 810 COPD patients with a diagnosis of chronic bronchitis, 405 receiving treatment with the Aerobika® device and 405 matched controls, (propensity matched to reduce bias and mimic randomization). The data showed significantly fewer patients given the Aerobika® device experienced moderate-to-severe exacerbations (18.5% vs 25.7%, p=0.014) or severe exacerbations (13.5% vs 19.0%; p < 0.046) compared with matched controls over the 30-day follow-up period, with consequent reductions in costs.

About the Aerobika® Device
The Aerobika® device is hand-held, robust, easy-to-use, and drug-free with a proprietary mode of action. 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, and may also aid in improved drug deposition. The Aerobika® 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® 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® device is available in the U.S. from Monaghan Medical Corporation, and in Canada, Mexico, and select European countries including the UK and Germany through Trudell Medical International. (http://www.monaghanmed.com/Aerobika-OPEP)

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® 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)

References:

1. Burudpakdee C et al. Pulm Ther 2017 DOI 10.1007/s41030-017-0027-5. Pub online 6 February 2017.

2. Khakban A, et al. Am J Respir Crit Care Med 2017 Feb 1;195(3):287-291.

3. Balter MS, et al. Can Respir J 2003; 10 (Suppl B):3B-32B.

4. Perera PN, et al. COPD J Chron Obst Pulm Dis 2012;9(2):131-41.

5. Puhan MA, et al. Respir Res 2005;6 (1): 1.

6. Shah T, et al. Chest. 2016 Oct;150(4):916-926.

7. The Global Strategy for the Diagnosis, Management and Prevention of COPD, Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2017. Available from: http://goldcopd.org (Last accessed 2 Feb 2017).

8. Svenningsen S, et al. COPD 2016;13(1):66-74.

For clinical inquiries, please contact:
Dominic P. Coppolo, MBA, RRT, FAARC
Vice President of Clinical Strategy and Development
Monaghan Medical Corporation
1-800-343-9071