ANAHEIM, Calif.--(BUSINESS WIRE)--ClearFlow, Inc., a medical device company based in Anaheim, CA., has announced that the cover of the January 2018 issue of The Annals of Thoracic Surgery features a review article that elucidates the biological mechanisms by which retained shed mediastinal blood can trigger postoperative atrial fibrillation (POAF) in susceptible individuals as well as how this could represent a new target for prevention of POAF.
The article can be viewed online here: http://www.annalsthoracicsurgery.org/article/S0003-4975(17)31095-0/fulltext.
The article’s author group is comprised of key opinion leaders on the subject, including Samuel St-Onge, MD (Montreal Heart Institute (MHI); Louis P. Perrault, MD, (MHI); Philippe Demers, MD, (MHI), Edward M. Boyle, MD, (St. Charles Medical Center, Bend, OR); A. Marc Gillinov, MD, (Cleveland Clinic); James Cox, MD, (Washington University, St. Louis) and Spencer Melby, MD, (Washington University, St. Louis). The authors cited the latest clinical articles that demonstrate the contribution of retained pericardial blood in the development of intrapericardial oxidative stress and inflammation that contributes to the triggering of POAF.
All patients having heart surgery are required to have drainage catheters to remove shed blood from around the heart and lungs in the early hours of recovery following surgery.
Approximately 1 in 5 patients suffer enough retained blood to require a drainage intervention, and that results in worse outcomes, including a significantly higher incidence of POAF.
In recent years, clinical evidence has shown that these drainage catheters have a high failure rate due to clogging, potentially leading to retained blood that can slow recovery, contribute to postoperative complications and increase total cost of care.
“POAF is one of the most common complications following heart surgery and is associated with significantly worse outcomes which include longer hospital stays, increased readmission rates, and deaths during the recovery period,” said Edward Boyle, MD, a co-author on the study. “Growing evidence exists demonstrating that by reducing the exposure of the pericardium to retained blood, POAF is significantly and consistently reduced.”
According to the conclusion of the review article, these studies provide a strong rationale for further efforts to identify practical ways to reduce pericardial blood during the early recovery period after cardiac surgery as a strategy to prevent POAF.
It’s important to note that attempts at maintaining chest tube patency via stripping, squeezing, milking, and open suction have long been made to prevent retained shed mediastinal blood, but these techniques have been found to be ineffective, and even potentially harmful, and therefore are not generally recommended.
“One approach to limiting retained pericardial blood is for surgeons to insert our PleuraFlow® ACT® System, which is the only device of its kind designed to actively prevent clot formation in the chest-tube and keep drainage lumens clear during the immediate post-surgery period while maintaining the sterile environment,” said Paul Molloy, CEO of ClearFlow, Inc. “The PleuraFlow® ACT® System provides a simple, easy to adopt approach to not only remove an inflammatory trigger that contributes to POAF, but also reduce the need for reinterventions for pericardial and pleural effusions as well.”
As described in this review article by St-Onge et al, “Studies where retained blood is minimized have shown promising reductions in POAF.” A study recently published in the Journal of Thoracic and Cardiovascular Surgery (JTCVS), for example, showed that patients treated with the PleuraFlow® ACT® System experienced a statistically significant 43% reduction in retained blood complications such as bloody pleural and pericardial effusions as well as a statistically significant 33% reduction in POAF. http://www.jtcvsonline.org/article/S0022-5223(17)30556-1/abstract
Additionally, a study by St. Onge and colleagues in the December 2017 Journal of Thoracic and Cardiovascular Surgery demonstrated a similar reduction in POAF by utilizing the PleuraFlow® ACT® System. (http://www.clearflow.com/press/newly-published-peer-reviewed-study-reveals-benefits-clearflows-pleuraflow-act-system/)
“Given that POAF is so common in patients recovering from heart surgery, a novel approach to improving treatment options is needed,” said Paul Molloy. “Currently there are no preventative drug regimens that can reliably prevent POAF in large cross-sections of patients, and there is no other device technology that can make such a meaningful reduction in this common complication by simply addressing a known shortcoming of commonly used chest drainage catheters."
The PleuraFlow® Active Clearance Technology® System is approved for use in the U.S., Europe, Australia, Brazil, Canada, Mexico and other countries in Asia and the Middle East.
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 2017 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, Active Clearance Technology, and FlowGlide are registered trademarks of ClearFlow, Inc.