MRO Magazine

Unmet Need for Chest Tube Patency Standards an Area of Focus at Cardiovascular-Thoracic (CVT) Critical Care Conference


October 6, 2015
By Business Wire News

WASHINGTON

ClearFlow Inc., a medical device company based in Anaheim, CA, participated in a series of panel presentations related to the subject of chest tube patency standards to prevent Retained Blood Syndrome (RBS) following cardiothoracic surgery last Friday at the Cardiovascular-Thoracic (CVT) Critical Care Conference in Washington DC. Clinical cardiac surgery intensive care leaders from around the world gathered at the conference, organized by the Foundation for the Advancement of CardioThoracic Surgical Care (FACTS-Care) in Washington, DC. CVT Critical Care Conference is one of the premier settings for cardiac critical care exchange of ideas. Specialists meet at the CVT Critical Care Conference each year to discuss the latest concepts, technology, and protocols and formulate new approaches and clinical practice standards for the care of patients recovering from heart surgery in their hospitals.

Presentations given by Felix Balzer, MD of Charité University in Berlin and Spencer Melby, MD of Washington University and Barnes Jewish Hospital in St. Louis were followed by a panel discussion.

A common issue for these patients and their clinicians is chest tube clogging, known to occur in over one-third of heart surgery patients. Chest tubes are used for all patients recovering after heart surgery to drain shed blood during early recovery. When this occurs, nearly one in five patients can suffer from a range of complications, including the need to perform subsequent re-operations or interventions to remove blood, blood clots or bloody fluid from the pericardial or pleural spaces after cardiac surgery. These complications are referred to as Retained Blood Syndrome (RBS) and result in a longer length of stay, higher mortality and a higher rate of readmissions.

At the 2014 CVT Critical Care Conference, results of clinical studies demonstrating a marked reduction in interventions required for complications for RBS with the PleuraFlow System were presented. The results showed a statistically significant reduction of interventions for RBS by 42% in the treatment group. In addition, the trial revealed a statistically significant reduction of postoperative atrial fibrillation (POAF). Patients treated with PleuraFlow System also had a statistically significant reduction in bleeding, suggesting that the Active Clearance Technology may help reduce the amount of bleeding after heart surgery.

The PleuraFlow System enables caregivers to actively keep chest drainage tubes clear of clot in the early hours after heart surgery. PleuraFlow is the first FDA cleared device indicated to maintain chest drain patency and to reduce chest tube clogging and retained blood.

At this year’s meeting, Dr. Balzer presented data detailing the high costs of RBS, not only in terms of the resulting complications and delayed recovery for patients, but also the added financial burden for hospitals and health care systems caring for them.

Chest tube clogging and RBS are suspected to contribute to the development of Post Operative Atrial Fibrillation (POAF), one of the most common complications in patients recovering from heart surgery. Dr. Melby, a noted authority of atrial fibrillation, spoke about how blood retained around the heart contributes to inflammation that contributes to the development of POAF in patients after cardiac surgery.

“With a known failure rate of over one third of chest tubes due to clogging, it is surprising that there are not national standards for methods to routinely prevent this problem,” said Paul Molloy, ClearFlow’s President & CEO, who also served as panel moderator. “With growing research that allows us to better understand this issue, and how preventing chest tube clogging with active clearance reduces the complications of RBS, more standardized approaches are being developed, adopted and shared by medical facilities and clinicians to improve quality while reducing complications and costs. We’re proud that our pioneering PleuraFlow technology can play a key role in these solutions.”

The PleuraFlow Active Clearance Technology System is approved for use in the U.S., Europe, Australia, Brazil, and Canada, and has either cleared or is pending clearance in over a dozen more countries.

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 SurgeonsTechno-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.

for ClearFlow Inc.
Paul Williams, 310/569-0023
paul@medialinecommunications.com