ClearFlow medical device company has announced positive clinical trial results for its PleuraFlow device, presented at the American Association for Thoracic Surgery (AATS) 99th Annual Meeting on (4–7 May, Toronto, Canada). The company also announced inclusion in the new Enhanced Recovery After Surgery (ERAS) cardiac surgery perioperative guidelines.
PleuraFlow is a medical device used at the bedside in the intensive care unit to actively maintain chest tube patency following cardiac surgery. A patent chest tube enables evacuation of blood and fluid from the operative site after closure of the surgical wound and reduces retained blood. Retained blood is accepted as contributing to many common complications after surgery, including post-operative atrial fibrillation (POAF), pleural effusions, and pericardial effusions.
According to a press release from the company, the new data stems from a prospective randomised controlled clinical trial evaluating the use of PleuraFlow’s active clearance technology (ACT) system in heart surgery patients at the Montreal Heart Institute. It demonstrated a statistically significant reduction in chest tube clogging and emergency reoperations for retained blood, and a directional reduction in POAF.
Edward Boyle, a cardiothoracic surgeon, and ClearFlow founder says: “This positive randomised clinical trial comes on the heels of five prior studies demonstrating that active maintenance of chest tube patency after cardiac surgery reduces complications related to retained blood. This study shows once again that the PleuraFlow system achieves a more efficient evacuation of shed mediastinal blood, which is critical in recovery after cardiac surgery.”
The first “Guidelines for Perioperative Care: Enhanced Recovery After Surgery Society Recommendations” were also published at AATS 2019, as well as in the current edition of JAMA Surgery. ERAS Cardiac Surgery recommends maintaining chest tube patency without breaking the sterile field to prevent retained blood complications as a Class I, Level B-NR classification.
The PleuraFlow active clearance technology system is approved for use in the USA, Europe, Australia, Brazil, Canada, Mexico and other countries in Asia and the Middle East.