Esophageal Magnetic Anastomosis Device (EMAD) to Simplify and Improve Outcome of Thoracoscopic Repair for Esophageal Atresia with Tracheoesophageal Fistula: A Proof of Concept Study.

BACKGROUND: We designed a new Esophageal Magnetic Anastomosis Device (EMAD) for thoracoscopic repair of esophageal atresia (EA) with tracheoesophageal fistula (TEF) without the need of handheld suturing or additional gastrostomy. METHODS: Synthetic EA-TEF model: Spherical and tubular shaped rubber balloons and a term infant sized plastic doll were used. Medical students (n = 10) and surgical trainees (n = 10) were asked to perform thoracoscopic repair of an "EA" with a hand sutured anastomosis (HA) and with the EMAD. Euthanized animal model: The esophagus in 5 piglets (3-4 kg) was dissected and a thoracoscopic esophageal magnetic anastomosis (EMA) was performed. Bursting pressure (BP) and pulling force (PF): HA and EMA were created on ex vivo New Zealand white rabbit (2.5-3 kg) esophagi (n = 25 in each test series). BP and PF were measured and compared against each other. RESULTS: Medical students were unable to complete HA, but were successful with the EMAD in 11.1 ± 2.78 min. Surgical trainees completed EMA in 4.6 ± 2.06 min vs. HA 30.8 ± 4.29 min (p<0.001). The BP following a HA (14.1 ± 3.32 cmH2O) was close to the physiological intraluminal pressure reported in a neonatal esophagus (around 20 cmH2O), whereas the BP with the EMAD was extremely high (>90 cmH2O) (p<0.001). The PF of an EMA (1.8 ± 0.30 N) was closer to the safety limits of anastomotic tension reported in the literature (i.e. 0.75 N) compared with the HA (3.6 ± 0.43 N) (p<0.0001). CONCLUSION: The EMAD could simplify, shorten, and potentially improve the outcome of thoracoscopic repair for EA with TEF in the future. A high BS and a relative low PF following EMAD application may lower the risk of postoperative complications such as esophageal leakage and stricture formation.