The Flourish Pediatric Esophageal Atresia Device uses magnets to join both ends of the esophagus.
Imagine being handed a newborn baby who appears to be entirely healthy, but shortly after birth drools excessively and coughs and suddenly turns blue as its first feeding returns back to you through the nose and mouth. This is what happens when the esophagus does not connect to the stomach but instead dead ends into a pouch or connects to the trachea. The child cannot eat until this problem is corrected because any attempts to swallow will be followed by the liquid being regurgitated or aspirated into the lungs, where pneumonia is a sure result.
The condition is called esophageal atresia (EA) and is described as “a developmental defect of the upper gastrointestinal tract in which the continuity between the upper and lower esophagus is lost.” EA has been associated with numerous environmental and heritable conditions, including trisomy 21,18, and 13. In most cases, it is impossible to pinpoint the specific cause. EA can occur with or without a fistula, or connection, between the trachea and the esophagus. A tracheoesophageal fistula (TEF), as it is called, occurs in about 1 of 3,000 to 5,000 newborns.
The anatomical abnormalities of EA are varied, but the most common is distal TEF, which accounts for more than 80% of cases. Isolated EA, when the esophagus ends in a pouch, accounts for about 8% of all cases.
Initial emergent treatment is to place a tube into the stomach through the abdominal skin to feed the infant. Open-chest surgery has long been the main option for these infants, although thoracoscopic repair is also used by some physicians. Surgery aims to correct the fistulas—there may be more than one—between the esophagus and the trachea and to reconnect the esophagus so food goes into the stomach.
Surgical procedures (and sometimes many are needed) are fraught with danger because they involve opening and entering the chest either with incisions or with a thoracoscope. Short term, there is a risk of infection. Long term, the adverse events include shoulder weakness, winged scapula, and thoracic scoliosis.
If there is a long gap between the esophageal ends, the Foker technique, named for John Foker, MD, at Boston Children’s Hospital, allows surgeons to place “traction sutures” in the esophageal ends, where tension on the sutures is increased daily until the two parts stretch and grow long enough to connect. Then a second surgical procedure is done to reconnect the tubes.
Although the Foker technique leads to significantly shorter time to definitive anastomosis and lower risk of complication compared with traditional surgery, it is controversial, partly because outcomes at some centers have not been good.
But the traction sutures gave scientists an idea: What if you could create “tension” between the two ends of the esophagus so the two ends of the esophagus would stretch to meet without a surgical procedure? You would still need to “open” the pouch on each end and reconnect them surgically—or would you? How could this be done? How about using magnetic force!
Over the past four decades, numerous iterations have used magnets, but no commercially sold device was available in this country until this year. Recently a small company named Wilson-Cook Medical, located in Winston-Salem, N.C., finally received FDA approval for a device that does all of the work.
The Flourish Pediatric Esophageal Atresia Device is indicated for lengthening atretic esophageal ends and creating an anastomosis with a nonsurgical procedure. It was approved for use in patients up to one year old with esophageal atresia without tracheoesophageal fistula (TEF) or patients for whom a concurrent TEF has been closed as a result of a prior procedure. The device is indicated for atretic segments less than four centimeters apart.
Basically, the device consists of a magnet that goes into the top pouch and another into the lower pouch. It is a complex device because of the need to perform imaging and suctioning of secretions. It has two parts, an oral-esophageal catheter and a gastric catheter, both with two openings. The oral-esophageal catheter has an attached magnet and uses one opening for suction of saliva and the other for injection of contrast to confirm anastomosis. The gastric catheter uses one opening for balloon inflation and deflation and the second for placement of the magnet and for flushing as well as feeding.
After assessing suitability for use of the Flourish device, the top catheter is inserted through the mouth and the lower one by an incision through the abdominal wall into the stomach. The oral-esophageal catheter is inserted orally and advanced until the magnet is located at the distal end of the upper pouch. The gastric catheter is inserted over a wire guide with fluoroscopy through a gastric stoma (which is typically created for tube feedings) until the magnet is at the distal end of the lower pouch. Both catheters are secured and the waiting begins.
During the clinical trial, after 3 to 13 days, the traction caused by the magnets pulled the ends of the esophagus together. Eventually, surrounding tissues grew together and the tissue between the magnets started to die.
Once the anastomosis is confirmed with fluoroscopy, the upper catheter is cut, leaving the magnet behind. Then both magnets and the lower catheter are removed via the gastrostomy lumen. A new orogastric tube or nasogastric tube is placed for a few days to promote healing.
No procedure or device is free of adverse events, and the Flourish device is no exception. But the results are pretty impressive. The clinical trial leading to approval was limited to 16 patients, but all experienced successful anastomosis. No patient experienced an anastomotic leak. Most (81%) needed endoscopic dilation, which is about double the rate seen with standard surgical care. Many also had residual issues with gastroesophageal reflux disease, tracheomalacia, dysmotility of the esophagus requiring treatment, asthma, and recurrent pulmonary infections, problems that also can occur in patients treated with traditional surgical techniques.
The device is contraindicated for patients with teeth (which could damage the oral catheter), those with existing (uncorrected) TEF, for creating an anastomosis other than in the esophagus, for patients without an appropriately sized tract, and for patients with signs of significant infection at the gastrostomy site.
As a condition of approval, the FDA required a postapproval study consisting of a prospective, single-arm, new observational study with a minimum of 20 subjects followed for two years.
EA, although uncommon, is a complex and dangerous newborn birth defect with, until now, only chest surgical approaches. The Flourish Pediatric Esophageal Atresia Device is a remarkable alternative to traditional chest surgical procedures.