–Study Supports Previously Published Data on Reduction of Postoperative Atrial Fibrillation After Heart Surgery Among Patients Treated with PleuraFlow Active Clearance Technology–
Anaheim, CA – September 27, 2017—ClearFlow Inc., a medical device company based in Anaheim, California, has announced the publication of significantly positive results in a study evaluating the company’s PleuraFlow® Active Clearance Technology® System.
Data from a peer-reviewed clinical study indicating a marked reduction in Postoperative Atrial Fibrillation (POAF) among patients with active clearance of chest tubes after heart surgery was published in the August edition of the Journal of Thoracic and Cardiovascular Surgery. The study is titled “Examining the impact of active clearance of chest drainage catheters on postoperative atrial fibrillation” and was written by Samuel St-Onge, MD, Walid B Ali, MD, Ismail Bouhout, MD, Denis Bouchard, MD, Yoan Lamarche, MD, Louis P Perrault, MD and Philippe Demers, MD (http://www.jtcvsonline.org/article/S0022-5223(17)30556-1/abstract).
All patients having heart surgery are required to have drainage catheters to remove shed blood from around the heart and lungs in the early hours of recovery following surgery. In recent years, clinical evidence has shown that these drainage catheters have a high failure rate due to clogging, potentially leading to retained blood that can slow recovery, contribute to postoperative complications and increase total cost of care. ClearFlow developed the world’s first Active Clearance Technology® that allows care providers to prevent chest tube clogging during early recovery of heart surgery patients. This innovative technology was developed by surgeons seeking a solution to an unmet need for their patients and is now being utilized in a number of leading centers of excellence around the world.
In this newly published study by independent investigators from the Montreal Heart Institute in Montreal, Canada, a statistically significant reduction in Postoperative Atrial Fibrillation (POAF) from 35% to 23% (a 34% reduction) was documented among patients treated with the PleuraFlow System. In addition, results demonstrated a trend toward shorter postoperative length of stay in the hospital among patients treated with the PleuraFlow System’s chest drainage protocol.
In an accompanying editorial by the same authors from the Montreal Heart Institute, titled “Posterior pericardial drainage: Could improving chest tube patency provide the same benefits?” (http://www.jtcvsonline.org/article/S0022-5223(17)30609-8/abstract), the authors discussed the link between retained blood in the pericardium and the development of POAF, and the role that active clearance of chest tubes can play in reducing this problem.
In this editorial, Dr. St-Onge and his colleagues refer to a recently published meta-analysis of 19 randomized, controlled trials by Gozdek et al., (http://www.jtcvsonline.org/article/S0022-5223(16)31682-8/pdf). The authors assessed whether efforts to reduce pooling of blood around the heart with posterior pericardial drainage after cardiac procedures among 3,425 patients might be valuable to patients’ recovery. St-Onge stated, “…it clearly establishes the evidence that keeping the blood away from the pericardial space where it can promote effusions and supraventricular tachyarrhythmias is important to outcomes but also shows that conventional chest drainage does not get the job done.”
“This latest study provides an additional layer of peer-reviewed, published evidence that retained blood plays an important role in the development of POAF, said Paul Molloy, CEO of ClearFlow, “and that by reducing retained blood by preventing chest tube occlusion, POAF can therefore be reduced with a medical device. This kind of real world data is particularly helpful for hospitals looking to reduce costs and complications as hospitals move to comply with MACRA value healthcare regulations and provide better quality healthcare at lower costs.”
“POAF is a common complication that prolongs hospitalization and contributes to readmissions in nearly 1 in 3 patients after heart surgery,” said Edward Boyle, MD, Co-Founder and Chairman of ClearFlow. “Currently there are no preventative drug regimens that can reliably prevent POAF in large cross-sections of patients, and there is no other device technology that can make such a meaningful reduction in this common complication by simply addressing a known shortcoming of commonly used chest drainage catheters.”
The PleuraFlow® Active Clearance Technology® System is approved for use in the U.S., Europe, Australia, Brazil, Canada, Mexico and other countries in Asia and the Middle East.
About ClearFlow, Inc.
ClearFlow, Inc. is an Anaheim, CA based medical device company that has developed a patented active blood and fluid evacuation system to speed recovery, reduce complications and lower healthcare costs related to medical tube obstruction. The company has been awarded several prestigious awards, including the 2017 Global Frost & Sullivan Award for New Product Innovation, the European Association of Cardiothoracic Surgeons Techno-College Innovation Award for worldwide innovation that has the potential to change the standard of care in heart and lung surgery, and the Innovations in Cardiovascular Interventions Award, among others.
PleuraFlow, Active Clearance Technology, and FlowGlide are registered trademarks of ClearFlow, Inc.