Novel Device for Endoluminal Esophageal Atresia Repair: First-in-Human Experience

Abstract

Thoracoscopic esophageal atresia (EA) repair affords many benefits to the patient; however, intracorporeal suturing of the anastomosis is technically challenging. Esophageal magnetic compression anastomosis (EMCA) is a compelling option for endoluminal EA repair, but available EMCA devices have prohibitive rates of recalcitrant stricture. Connect-EA is a new endoluminal EMCA device system that employs 2 magnetic anchors with a unique mating geometry designed to reliably create a robust anastomosis and decrease rates of leak and stricture. We describe our first-in-human experience with this novel endoluminal device for staged EA repair in 3 patients (Gross type A, B, and C) at high risk for conventional surgical repair. First, the esophageal pouches were approximated thoracoscopically. After acute tension subsided, the device anchors were endoscopically placed in the esophageal pouches and mated. Anchors were spontaneously excreted in 2 cases. Endoscopic repositioning and retrieval of the anchors were required in 1 patient because of narrowed esophageal anatomy. There were no perioperative complications. Patients were managed for 14 to 18 months. The strictures that developed in the patients were membranous and responded well to dilation alone, resolving after 4 to 5 outpatient dilations. Gastrostomies were closed between 6 and 11 months and all patients are tolerating full oral nutrition. Early experience with this new endoluminal EMCA device system is highly favorable. The device offers considerable benefit over conventional handsewn esophageal anastomosis and anastomotic outcomes are superior to available EMCA devices.

Esophageal Magnetic Compression Anastomosis in Esophageal Atresia Repair: A PRISMA-Compliant Systematic Review and Comparison with a Novel Approach

“…The main advantage of endoluminal magnetic compression anastomosis is an endoscopic approach with shorter operative times [ 15 ]. With regard to the negative side effects of anesthesia in neonates and the discussed impaired neurodevelopmental outcomes, shorter operative times are especially beneficial in patients with comorbidities [ 27 ].…”

“…Eligible studies were divided into two subgroups: a historic group (HG) and patients treated with our novel, specially designed magnets (novel group, NG). In addition to 3 previously published cases [ 15 ], another case was added and described in the case report section.…”

“…Our research has focused on magnet size and geometry, with the aim of optimizing the devices to create a robust anastomosis and reduce post-interventional stricture rates [ 14 , 15 , 16 ]. The newly designed magnets were validated in an experimental animal model, which demonstrated highly favorable short- and long-term outcomes [ 14 , 16 ].…”

“…The newly designed magnets were validated in an experimental animal model, which demonstrated highly favorable short- and long-term outcomes [ 14 , 16 ]. Furthermore, the first in-human experience was published in 2021 with promising results [ 15 ].…”

Tips and Tricks—3 Use Cases of Interdisciplinary Knowledge Transfer in Minimally Invasive Pediatric Surgery

“…Even though magnets have recently been used successfully as therapeutic agents in pediatric surgery for neonates with high-risk complex esophageal atresia [ 8 , 9 ], they cause great concern in the infant after swallowing because, in combination with a second magnet or a metallic object, they can lead to intestinal perforation with fistula formation and a correspondingly severe course of disease.…”