Clinical Trial Results Show Active Chest Tube Clearance as Part of an ERAS Program Significantly Improves Outcomes in Cardiac Surgery

Significant Reductions in Chest Tube Clogging, Complications, and Resource Use Demonstrated in Prospective Study

IRVINE, Calif.--(BUSINESS WIRE)--ClearFlow, Inc., a medical device company based in Irvine, California, announced positive results from a clinical trial published in the peer-reviewed journal Innovations: Technology and Techniques in Cardiothoracic and Vascular Surgery. The study, conducted by cardiac surgeons at Franciscan Health Indianapolis, is detailed in the article, “Active Chest Tube Clearance Added to an Enhanced Recovery After Cardiac Surgery (ERAS) Program Improves Outcomes and Reduces Resource Utilization.”

The prospective trial evaluated ClearFlow’s PleuraFlow Active Clearance Technology (ACT) System, which significantly reduced retained blood complications in heart surgery patients. The system minimized chest tube clogging, lowered the incidence of retained blood syndrome (RBS) and postoperative atrial fibrillation (POAF), as well as reduced median ICU hours during recovery.

The PleuraFlow System, used at the bedside in the ICU, enables clinicians to maintain chest tube patency without compromising the sterile field. By ensuring effective evacuation of blood and fluid from the surgical site postoperatively, PleuraFlow reduces retained blood, a known contributor to complications such as POAF, pleural effusions, and pericardial effusions.

Conducted from January 2020 to August 2023 at Franciscan Health Indianapolis, this pragmatic, prospective observational study included 1,334 adult cardiac surgery patients. The control group (650 patients) received standard drainage, while the intervention group (684 patients) received PleuraFlow’s Active Tube Clearance. Key findings demonstrated for the patients receiving Active Tube Clearance include:

• 41% reduction in RBS (8.2% vs. 4.8%, p=0.014)
• 17% decrease in POAF (33.8% vs. 28.1%, p=0.049)
• 30% reduction in median ICU hours (51.6 vs. 36.3 hours, p<0.001)
• 64% reduction in ICU readmissions (3.2% vs. 1.17%, p=0.013)
• 23% decrease in total chest drainage (p<0.001), enabling earlier chest tube removal and faster recovery

Principal investigator Marc Gerdisch, MD, Chief of Cardiovascular and Thoracic Surgery and Co-Director of the Heart Valve Center at Franciscan Health, stated, “We studied the clinical outcomes and financial implications of PleuraFlow chest drains when added to our established ERAS Cardiac program protocols. The unequivocal positive results have led to significantly fewer complications, and hospital days. More recently, we have leveraged our confidence the chest is well drained to achieve a median time to extubation of zero hours. Perhaps most importantly, the bedside nurse is able to ensure the chest drain is patent.”

Louis Perrault, MD, PhD, a study coauthor and cardiac surgeon at the Montreal Heart Institute, added, “Conventional chest tubes are prone to clogging, which can hinder recovery. This study, alongside prior research, strongly supports incorporating PleuraFlow’s active clearance into ERAS Cardiac Surgery programs to reduce RBS, POAF, and ICU time.”

“This study strengthens the evidence for PleuraFlow’s role in improving patient outcomes,” said Hannah Beathard, CEO of ClearFlow. “By maintaining chest tube patency, PleuraFlow reduces retained blood and related complications, aligning with the ERAS Cardiac Society’s Class I, Level B-NR recommendation for active chest tube maintenance as a critical component of optimal cardiac surgery recovery.”

About ClearFlow, Inc.

ClearFlow, Inc. is an Irvine, 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 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 and Active Clearance Technology are registered trademarks of ClearFlow, Inc.