DOZ047.47: Flourish device for treatment of esophageal atresia

Abstract Esophageal atresia (EA) is usually repaired soon after birth. However, there are conditions in which early repair is not possible including prematurity, a large distance between the ends, failed attempt at primary anastomosis, and postoperative complications. Cases in which the ends of the esophagus are not able to be brought together without significant tension, or long-gap esophageal atresia (LGEA), remain a challenge to manage. A variety of techniques have been used to establish esophageal continuity consisting of extensive mobilization, myotomies, esophageal flaps, and traction of the segments. The use of magnets is a nonsurgical alternative for esophageal anastomosis. There have been a few series demonstrating initial success and accomplishment of magnamosis in EA patients. A prospective, single-arm, observational study is currently enrolling patients to evaluate the safety and benefit of the Flourish Device (Cook Medical), a catheter-based, magnetic device used to lengthen the atretic esophageal ends and create an anastomosis. The primary outcomes include stricture requiring dilation or surgery, anastomotic leaks or other adverse events with follow-up for two years. The distance of the esophageal gap is measured with metal probes. All patients require a mature gastrostomy and atretic segments < 4 cm apart. The proximal catheter has a suction port and the distal portion has a channel for feeds. Placement is done under fluoroscopy with anesthesia or sedation. Daily chest radiographs are obtained until union of the magnets occur. Successful anastomosis is identified by saliva in the gastrostomy catheter, feeds in the esophageal catheter, or with a contrast study. One day after confirmation, the magnets may be removed. When the catheters are aligned, the magnets attract. Once the magnets have connected, the tissue between them sloughs off while the outer rim heals establishing the anastomosis. The Flourish device may be particularly useful in patients in whom additional operations are not ideal such as those with congenital anomalies or who have undergone previous operations or complications.