A trial of ClearFlow’s PleuraFlow Active Clearance Technology (ACT) has demonstrated the value in adding the system into Enhanced Recovery After Cardiac Surgery (ERAS) cardiac programme protocols.
Securing US Food and Drug Administration (FDA) clearance in 2010, PleuraFlow ensures that chest tubes are unobstructed in adult cardiac surgery patients and that blood or fluid has been effectively evacuated from surgical sites post-operatively.
The system also functions to reduce retained blood, a known contributor to postoperative complications, including pleural effusions and post-operative atrial fibrillation (POAF).
Conducted at Franciscan Health in Indianapolis, US, ClearFlow’s prospective observational study included 1,334 adult cardiac surgery patients. The 650-patient control group received standard drainage while the 684-patient intervention group received PleuraFlow.
In the intervention group, respective reductions of 41%, 30%, and 64% were achieved in the incidence of retained blood syndrome (RBS), median ICU hours, and ICU readmissions.
PleuraFlow also demonstrated a 17% reduction in POAF and a 23% decrease in total chest drainage.
The study findings were published in the journal Innovations: Technology and Techniques in Cardiothoracic and Vascular Surgery.
Dr Marc Gerdisch, chief of cardiovascular and thoracic surgery, co-director of the Heart Valve Center at Franciscan Health and principal investigator of the study, commented: “We studied the clinical outcomes and financial implications of PleuraFlow chest drains when added to our established ERAS cardiac program protocols.”
Research suggests that ERAS protocols result in faster hospital discharge and potentially reductions in surgical complications. The protocol aims to improve recovery and reduce complications following surgery by taking steps to optimise a patient’s health before, during, and after the procedure.
Dr Gerdisch continued: “The unequivocal positive results have led to significantly fewer complications and hospital days. More recently, we have leveraged our confidence that the chest is well drained to achieve a median time to extubation of zero hours. Perhaps most importantly, the bedside nurse can ensure the chest drain is patent.”
In 2016, ClearFlow received an expanded indication clearance from the FDA for PleuraFlow’s use in the treatment of paediatric cardiothoracic surgery patients. PleuraFlow ACT remains the only FDA-cleared device indicated to prevent or minimise retained blood in patients recovering from heart surgery.
