OVERSTITCH^TM ENDOSCOPIC SUTURING SYSTEM FOR GASTROINTESTINAL APPLICATIONS: INITIAL RESULTS FROM A PROSPECTIVE MULTICENTER EUROPEAN REGISTRY

Aims OverStitch Endoscopic suturing devices are currently used for a wide range of applications.Recently a new single-channel version has been introduced,OverStitch-Sx^TM.A European registry was created to prospectively collect technical and clinical data regarding both OverStitch^TMand OverStitch-Sx^TM Systems,in order to provide procedural outcomes and find correlation between procedural characteristics and outcomes.

Methods Patients who underwent endoscopic OverStitch^TMorOverStitch-Sx^TMsuturing from January2018 to December2020 at9 European-Centers were enrolled in the registry.Data regarding type of disease treated,suturing pattern,and outcomes were registered.The technical feasibility(the success to introduce the device and reach the target area),technical success(the success to correctly place sutures in the target area)and clinical success(the complete resolution of the clinical issue)were analyzed.Gender,age,defect size(<1cm or≥1cm),defect location,type of suture,number of sutures applied were analyzed by Person-correlation coefficient.

Results In the study period137patients(M/F79/58;mean age 59.8)were enrolled.There were no cases of failure in the device introduction(100%technical feasibility).Endoscopic suturing was successfully performed in 136cases(of which16.3% involved the OverStitch-Sx^TM)obtaining a technical success rate of 99.3%.No adverse events were recorded.Overall clinical success was89%.Mucosal defects were sutured in 32patients with100%clinical success.Endoscopic suturing was used 23times to treat leaks/fistulas,with a clinical success rate of64.7%,85%for stent fixations(n=38),94.4%for perforations(n=22),80% in postoperative leaks(n=7).No significant correlation between location,suture pattern,sutures number,and procedure success was found,apart from<1cm size fistulas treated by a continuous suture,more likely to achieve clinical success during follow-up.

Conclusions Overstitch-based suturing is technically feasible regardless of treatment site and suturing method,with no cases of failure.The overall technical success rate(99.3%)and the clinical outcome success rate(89%)demonstrate the Overstitch suturing technology provides reliable suturing with clinical advantages especially with fistulas<1 cm in size.

Publication History

Article published online:
14 April 2022