Endoscopic suturing for GI applications: initial results from a prospective multicenter European registry.


Journal

Gastrointestinal endoscopy
ISSN: 1097-6779
Titre abrégé: Gastrointest Endosc
Pays: United States
ID NLM: 0010505

Informations de publication

Date de publication:
11 2022
Historique:
received: 06 03 2022
revised: 28 05 2022
accepted: 01 06 2022
pubmed: 12 6 2022
medline: 26 10 2022
entrez: 11 6 2022
Statut: ppublish

Résumé

OverStitch devices (OverStitch and OverStitch Sx; Apollo Endosurgery, Inc, Austin, Tex, USA) are used for a wide range of applications. A European registry was created to prospectively collect technical and clinical data regarding both systems to provide procedural outcomes and to find correlation between procedural characteristics and outcomes. This study shows the initial results of the first 3 years of the registry. Patients who underwent endoscopic suturing from January 2018 to January 2021 at 9 centers were enrolled. Data regarding the disease treated,suturing pattern and outcomes were registered. Technical feasibility (success reaching the target area), technical success (success placing sutures), and clinical success (complete resolution of the clinical issue) were recorded and analyzed. During the study period, 137 patients (57.7% men) were enrolled with 100% technical feasibility rate. Endoscopic suturing was successfully performed in 136 cases (16.7% with OverStitch Sx), obtaining a technical success rate of 99.3%. No adverse events were recorded. Overall clinical success was 89%. Mucosal defects were sutured in 32 patients (100% clinical success). Leaks/fistulas were treated in 23 patients (64.7% clinical success). The clinical success of stent fixations (n = 38) was 85%. Perforations (n = 22) were repaired with a clinical success of 94.7%. No significant correlation between location, suture pattern or number, and the success was found, except in case of fistulas where fistulas <1 cm treated by a continuous suture were more likely to achieve clinical success in the follow-up (P < .001). OverStitch-based suturing is technically feasible regardless of site and method of suturing, with no cases of failure. The overall technical success rate of 99.3% and the clinical outcome success rate of 89% demonstrate that OverStitch technology provides reliable suturing with clinical advantages, especially with fistulas <1 cm.

Sections du résumé

BACKGROUND AND AIMS
OverStitch devices (OverStitch and OverStitch Sx; Apollo Endosurgery, Inc, Austin, Tex, USA) are used for a wide range of applications. A European registry was created to prospectively collect technical and clinical data regarding both systems to provide procedural outcomes and to find correlation between procedural characteristics and outcomes. This study shows the initial results of the first 3 years of the registry.
METHODS
Patients who underwent endoscopic suturing from January 2018 to January 2021 at 9 centers were enrolled. Data regarding the disease treated,suturing pattern and outcomes were registered. Technical feasibility (success reaching the target area), technical success (success placing sutures), and clinical success (complete resolution of the clinical issue) were recorded and analyzed.
RESULTS
During the study period, 137 patients (57.7% men) were enrolled with 100% technical feasibility rate. Endoscopic suturing was successfully performed in 136 cases (16.7% with OverStitch Sx), obtaining a technical success rate of 99.3%. No adverse events were recorded. Overall clinical success was 89%. Mucosal defects were sutured in 32 patients (100% clinical success). Leaks/fistulas were treated in 23 patients (64.7% clinical success). The clinical success of stent fixations (n = 38) was 85%. Perforations (n = 22) were repaired with a clinical success of 94.7%. No significant correlation between location, suture pattern or number, and the success was found, except in case of fistulas where fistulas <1 cm treated by a continuous suture were more likely to achieve clinical success in the follow-up (P < .001).
CONCLUSIONS
OverStitch-based suturing is technically feasible regardless of site and method of suturing, with no cases of failure. The overall technical success rate of 99.3% and the clinical outcome success rate of 89% demonstrate that OverStitch technology provides reliable suturing with clinical advantages, especially with fistulas <1 cm.

Identifiants

pubmed: 35690150
pii: S0016-5107(22)01740-0
doi: 10.1016/j.gie.2022.06.004
pii:
doi:

Types de publication

Multicenter Study Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

780-786

Informations de copyright

Copyright © 2022 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.

Auteurs

Roberta Maselli (R)

Endoscopic Unit, Department of Gastroenterology, IRCCS Humanitas Research Hospital, Milan, Italy; Department of Biomedical Sciences, Humanitas University, Milan, Italy.

Rossella Palma (R)

Endoscopic Unit, Department of Gastroenterology, IRCCS Humanitas Research Hospital, Milan, Italy.

Mario Traina (M)

ISMETT - IRCCS - UPMC ITAY, Palermo, Italy.

Antonino Granata (A)

ISMETT - IRCCS - UPMC ITAY, Palermo, Italy.

Diego Juzgado (D)

Endoscopy, Quirón Salud, Madrid, Spain.

Marco Bisello (M)

Padova University Hospital, Padova, Italy.

Horst Neuhaus (H)

Evangelisches Krankenhaus Düsseldorf, Dusseldorf, Germany.

Torsten Beyna (T)

Evangelisches Krankenhaus Düsseldorf, Dusseldorf, Germany.

Davinder Bansi (D)

Imperial College London, London, UK.

Laura Flor (L)

Imperial College London, London, UK.

Pradeep Bhandari (P)

Portsmouth University Hospital, Portsmouth, UK.

Mo Abdelrahim (M)

Portsmouth University Hospital, Portsmouth, UK.

Amyn Haji (A)

King's College, London, UK.

Rehan Haidry (R)

University College London Hospital, London, UK.

Alessandro Repici (A)

Endoscopic Unit, Department of Gastroenterology, IRCCS Humanitas Research Hospital, Milan, Italy; Department of Biomedical Sciences, Humanitas University, Milan, Italy.

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