Atrial fibrillation (AF) is the most common arrhythmia that increases the risk of a stroke while impairing the patientÂ’s quality of life and costing US around $6.65 billion per year 6. Despite advances in the field, the current treatments have limited success rate especially in patients with longstanding AF with enlarged atria that requires multiple procedures with higher costs, inconvenience, and separate recovery of 2 time-consuming procedures that do not guarantee fully transmural lesions (arrhythmia treatment through the tissue thickness) since the epicardial (outside surface of the heart) and endocardial (inside surface of the heart) lesions are performed at 2 separate sittings and not well-aligned. Our proposed approach uses a self-aligning bipolar ablation system that includes a thoracoscopically guided epicardial delivery system and a flexible endocardial catheter following it across myocardium. This allows for simultaneous epicardial and endocardial tissue contact for the purpose of continuous bipolar ablation in a single procedure in a shorter time and higher treatment success rate. Therefore, we have developed a self-aligning technology which allows epicardial and endocardial ablation to be performed simultaneously in a single procedure, increasing transmurality, and decreasing the time and expense of the 2 procedures. Thus far, we have demonstrated 1- smooth catheter movement across the tissue. 2- successful transmural lesion sets in our ex vivo and in vivo open chest studies across the porcine atrial wall experiments. Phase I funding will enable us to optimize and prototype this paired endo- and epi- catheter system that is inserted via a conventional transseptal and thoracoscopic approach, respectively. This minimally invasive system will be capable of smooth movement, consistent contact force with tissue along the ablation path independent of tissue thickness, and transmural ablation along the atrial wall.
Public Health Relevance Statement: Narrative Over five million people in the U.S. suffer from abnormal heart rhythms that increases their risk of stroke (5 fold) while impairing their quality of life and costing US around $6.65 billion per year. At present, only a small fraction of people are offered curable ablation therapy because of recurrence after initial treatment. The EpiEndoAF device provides a minimally invasive solution to treat such patients with high success and play a major role in improving outcomes in these patients.
Project Terms: Ablation; Affect; American; Arrhythmia; Atrial Fibrillation; base; Cardiac ablation; Cardiac Surgery procedures; Catheters; Chest; Clinical; clinical investigation; Clinical Research; Consumption; cost; Couples; Custom; design; Devices; Electrodes; Elements; Engineering; Ensure; experimental study; Family suidae; FDA approved; first-in-human; flexibility; Funding; Future; Generations; Goals; Health Care Costs; Heart; Heart Abnormalities; Heart Atrium; Heart failure; heart rhythm; human study; Hybrids; Impairment; improved; improved outcome; in vivo; Legal patent; Lesion; Magnetism; Manufacturer Name; Marketing; miniaturize; minimally invasive; Modeling; Morbidity - disease rate; mortality; Movement; Myocardium; nitinol; Operative Surgical Procedures; Outcome; Patient-Focused Outcomes; Patients; Pharmacology; Phase; phase 2 study; Physiological; Play; pre-clinical; Procedures; prototype; Pulmonary veins; Quality of life; radio frequency; Recovery; Recurrence; Risk; Role; Side; Site; Small Business Innovation Research Grant; Spottings; Stroke; stroke risk; success; Surface; Surgical incisions; System; Techniques; Technology; Testing; Thick; Thoracoscopy; Time; Tissues; tool; Travel; Tube; Vacuum; Variant; Work
