ClearFlow's PleuraFlow System Reduces Cardiac Surgery Complications by 41% in Large Clinical Trial
Key Insights
A prospective study of 1,334 cardiac surgery patients demonstrated that ClearFlow's PleuraFlow Active Clearance Technology (search) significantly reduced retained blood syndrome (search) by 41% and postoperative atrial fibrillation (search) by 17%.
The system achieved a 30% reduction in median ICU hours and 64% decrease in ICU readmissions, enabling faster recovery and earlier chest tube removal in cardiac surgery patients.
Published in Innovations: Technology and Techniques in Cardiothoracic and Vascular Surgery, the trial results support incorporating active chest tube clearance into Enhanced Recovery After Cardiac Surgery protocols.
ClearFlow, Inc. (search) has announced positive results from a large-scale clinical trial demonstrating that its PleuraFlow Active Clearance Technology (search) (ACT) System significantly reduces complications and resource utilization in cardiac surgery patients. The prospective study, conducted at Franciscan Health Indianapolis (search) and published in the peer-reviewed journal Innovations: Technology and Techniques in Cardiothoracic and Vascular Surgery, provides compelling evidence for incorporating active chest tube clearance into Enhanced Recovery After Cardiac Surgery (ERAS) programs.
Study Design and Patient Population
The pragmatic, prospective observational study was conducted from January 2020 to August 2023, enrolling 1,334 adult cardiac surgery patients. The control group of 650 patients received standard drainage protocols, while the intervention group of 684 patients received treatment with PleuraFlow's Active Tube Clearance system. The study was designed to evaluate both clinical outcomes and financial implications when the technology was added to established ERAS cardiac program protocols.
Significant Reduction in Key Complications
The trial demonstrated substantial improvements across multiple clinical endpoints for patients receiving active tube clearance. Most notably, the intervention group experienced a 41% reduction in retained blood syndrome (search) (RBS), with incidence dropping from 8.2% in the control group to 4.8% in the treatment group (p=0.014). Additionally, postoperative atrial fibrillation (search) (POAF) was reduced by 17%, occurring in 28.1% of intervention patients compared to 33.8% of controls (p=0.049).
The PleuraFlow system also achieved a 30% reduction in median ICU hours, decreasing from 51.6 hours in the control group to 36.3 hours in the intervention group (p<0.001). ICU readmissions were dramatically reduced by 64%, falling from 3.2% to 1.17% (p=0.013). The system further demonstrated a 23% decrease in total chest drainage (p<0.001), enabling earlier chest tube removal and faster overall recovery.
Clinical Mechanism and Benefits
The PleuraFlow System operates at the bedside in the ICU, enabling clinicians to maintain chest tube patency without compromising the sterile field. By ensuring effective evacuation of blood and fluid from the surgical site postoperatively, the technology addresses retained blood, a known contributor to complications including POAF, pleural effusions (search), and pericardial effusions (search). Conventional chest tubes are prone to clogging, which can hinder recovery and lead to these complications.
Expert Perspectives
Principal investigator Marc Gerdisch, MD, Chief of Cardiovascular and Thoracic Surgery and Co-Director of the Heart Valve Center at Franciscan Health, emphasized the clinical impact: "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."
Study coauthor Louis Perrault, MD, PhD, a cardiac surgeon at the Montreal Heart Institute (search), 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."
Regulatory Status and Clinical Adoption
PleuraFlow ACT secured FDA clearance in 2010 and remains the only FDA-cleared device indicated to prevent or minimize retained blood in patients recovering from heart surgery. In 2016, ClearFlow received expanded indication clearance for the system's use in pediatric cardiothoracic surgery patients. The technology aligns 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.
Hannah Beathard, CEO of ClearFlow, stated: "This study strengthens the evidence for PleuraFlow's role in improving patient outcomes. 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."