Indications

Post-Operative Atrial Fibrillation
Post-operative atrial fibrillation (POAF) is the most common, significant and currently unresolved complication of more than 1 million annual cardiothoracic surgery procedures such as coronary bypass grafting and aortic heart valve repairs. POAF is an abnormal irregular heart rhythm that occurs within a week following surgery, whereby electrical signals are randomly generated throughout the upper chambers (atria) of the heart. While the precise mechanisms of this process are not well-defined, it is believed that the surgical procedure triggers an initial imbalance in the cardiac autonomic nerve system. This initial imbalance causes different areas of the atrial tissue to become uncoordinated in their conductivity. The resulting disturbance then leads to post-operative atrial fibrillation which requires immediate intervention that includes anti-arrhythmic drugs such as amiodarone and/or external cardioversion.

POAF occurs in up to 40 percent of coronary bypass and approximately 60  percent of heart valve repair patients. Its occurrence is associated with higher morbidity and longer intensive-care hospitalization. According to numerous published studies, the hospitalization time of bypass patients who experience post-operative atrial fibrillation post operatively is increased by an average of 2-4 days. This additional length of stay cost is typically not reimbursed to the hospital. According to various studies, the additional cost per open heart surgery patient in the U.S. amounts to $2,366 to $3,783. The economic impact resulting from this prolongation of hospitalization exceeds $900 million per year in the United States alone. Aside from the economic impact, patients with persistent POAF have significantly higher risk of post-operative stroke and other cardiovascular complications. In particular, those patients leaving the hospital with an unresolved POAF are highly likely to develop a chronic post-operative atrial fibrillation that persists over the long term.

POAF is considered a vexing problem and the last major unresolved complication of cardiothoracic surgeries. The onset of clinically relevant post-operative atrial fibrillation cannot be predicted in individual patients; advanced age is the only generally accepted predictor.

To prevent the onset of POAF in cardiac surgery patients, CardioPolymers is developing Plexisyl-AF, a biopolymer-based device that promises to provide a significant but temporary isolation of strategic nerve relays of the heart that are implicated in the generation of POAF during the patient’s recovery phase from surgery. The market potential of Plexisyl-AF exceeds $400 million per year in the U.S. alone.

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