Newly Published Study in Journal of Thoracic and Cardiovascular Surgery Confirms Heavy Toll of Retained Blood Syndrome on Post-Surgery Outcomes and Hospital Resource Utilization
–ClearFlow Technology Offers Solution–
Anaheim, CA – June 28, 2016—ClearFlow Inc., a medical device company based in Anaheim, California, has announced the publication of another peer reviewed study in a leading cardiovascular surgery journal emphasizing the importance of preventing Retained Blood Syndrome (RBS).
The Journal of Thoracic and Cardiovascular Surgery has published a peer-reviewed study from cardiac anesthesia and surgical investigators in Berlin detailing the heavy toll unevacuated retained blood plays on patients recovering after heart surgery. The investigators from Charité – Universitätsmedizin Berlin’s Department of Anesthesiology and Intensive Care Medicine and Cardiac Surgery Department evaluated clinical data on nearly 7,000 patients who underwent heart surgery and examined the outcomes of patients who developed RBS, defined as the subsequent need for postoperative re-intervention to remove blood, blood clots, or bloodily fluid from around the heart and lungs after surgery.
In the study, 1 in 5 patients developed retained blood-related conditions postoperatively during early recovery, which was associated with a marked increase in in-hospital mortality, a postoperative length of stay more than 13 days in the hospital, greater than 5 days in the intensive care unit, and time of ventilation greater than 23 hours, all of which are quality indicators of worse outcomes and increased resource utilization.
In an accompanying invited editorial in the same journal entitled “Minor Postoperative Morbidity Should not be Neglected” by cardiac surgeons from Pontchaillou University Hospital, in Rennes, France, the authors commented that, “the current article ultimately underlines that much improvement can still be done in the prevention of early postoperative morbidity associated with the accumulation of shed blood into the chest and pericardial cavities after cardiac surgery, which leads to repeat or prolonged hospitalization, additional treatments, increased costs, and delayed recovery.”
“This data again emphasizes that what can start out as a seemingly minor postoperative complication, such as postoperative pleural or pericardial effusions or hemothorax as part of retained blood syndrome, can clearly have major implications in terms of patient recovery,” said Edward Boyle, MD, Co-Founder and Chairman of ClearFlow. “In the associated editorial, the authors state how important it is to seek to minimize every possible complication during recovery after heart surgery, especially at a time when heart surgery is being compared to less invasive new treatments.”
ClearFlow has developed and marketed the PleuraFlow® Active Clearance Technology® System, the world’s first approved device that allows care providers to proactively prevent chest tube clogging and retained blood during early recovery in heart surgery patients. This innovative technology was developed by surgeons seeking a solution to an unmet need for their patients and is now in use in a number of leading centers of excellence around the world in over 25,000 cases. In another recently published peer-reviewed study in this same journal in March, 2016, Active Clearance Technology was shown to reduce interventions for retained blood required after surgery from 20% to 11% (a 43% reduction) in all cardiac surgery patients when the PleuraFlow System was used, as well as a reduction in post-operative atrial fibrillation (POAF) from 30% to 20% (a 33% reduction) in propensity matched patients.
“The study again reinforces the importance of optimal blood evacuation through chest tubes after cardiac surgery to prevent retained blood is an important and measurable quality indicator that can have a big impact on patient outcomes and hospital costs,” said Paul Molloy, CEO of ClearFlow. “This data is particularly pertinent given the physician and hospital payment changes by CMS in the United States where care providers will be penalized for not minimizing preventable complications through the new Medicare Access and Children’s Health insurance Program Reauthorization Act of 2015. As such, we have been experiencing considerable interest from programs around the world that are seeking to reduce retained blood and associated complications such as post-operative atrial fibrillation (POAF) by adding PleuraFlow technology to their existing continuous quality improvement programs and institutional chest tube patency protocols.”
The PleuraFlow Active Clearance Technology System is approved for use in Europe, Australia, Brazil, the U.S. and Canada, and 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 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 and Active Clearance Technology are registered trademarks of ClearFlow, Inc.