Benedetto Mangiavillano1, Jong Ho Moon2, Stefano Francesco Crinò3, Alberto Larghi4, Khanh Do-Cong Pham5, Anthony Yuen Bun Teoh6, Danilo Paduano7, Yun Nah Lee2, Hae Won Yoo2, Il Sang Shin2, Gianenrico Rizzatti3, Carlos Robles-Medranda8, Roberto Oleas8, Maria Cristina Conti Bellocchi4, Francesco Auriemma7, Laura Lamonaca7, Federica Spatola7, Rita Conigliaro9, Antonio Facciorusso10, Armando Gabbrielli4, Alessandro Repici11. 1. Gastrointestinal Endoscopy Unit, Humanitas Mater Domini, Castellanza, Italy; Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Milan, Italy. 2. Digestive Disease Center and Research Institute, Department of Internal Medicine, SoonChunHyang University School of Medicine, Bucheon, Korea. 3. Gastroenterology and Digestive Endoscopy Unit, The Pancreas Institute, G.B. Rossi University Hospital, Verona, Italy. 4. Digestive Endoscopy Unit, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy. 5. Department of Medicine, Haukeland University Hospital, Bergen, Norway. 6. Department of Surgery, Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong SAR, China. 7. Gastrointestinal Endoscopy Unit, Humanitas Mater Domini, Castellanza, Italy. 8. Instituto Ecuatoriano de Enfermedades Digestivas (IECED), Guayaquil, Ecuador. 9. Gastroenterology and Digestive Endoscopy Unit, Azienda Ospedaliero-Universitaria di Modena, Baggiovara, Modena, Italy. 10. Gastroenterology Unit, Department of Medical and Surgical Sciences, University of Foggia, Foggia, Italy. 11. Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Milan, Italy; Humanitas Clinical and Research Center, IRCCS, Rozzano, Italy.
Abstract
BACKGROUND AND AIMS: Electrocautery-tip lumen-apposing metal stents (EC-LAMSs) have extended the indications of therapeutic EUS. We aimed to retrospectively evaluate safety and technical and clinical success of a newly developed EC-LAMS, the Hot-Spaxus (Taewoong Medical Co, Gimpo, Korea), for various EUS-guided procedures. METHODS: We included and retrospectively analyzed consecutive patients at 8 tertiary care referral centers who had undergone EUS interventional procedures using the Hot-Spaxus between October 2018 and February 2021. RESULTS: Of 58 included patients (male-to-female, 36:22; mean age, 63.5 ± 14.9 years), 29 had undergone pancreatic fluid collection drainage (50%), 22 (37.9%) biliary drainage for malignant distal obstruction, 3 (5.1%) gallbladder drainage for acute cholecystitis, 3 gastroenteroanastomoses, and 1 (1.7%) pelvic collection drainage. Technical success was achieved in 54 of 58 patients (93.1%) and clinical success in all 58. Adverse events occurred in 6 patients (11.1%): 2 early (3.7%), 1 late (1.8%), and 3 long term (5.6%). The outcomes were similar to those observed in a control group of patients treated with the Hot-Axios (Boston Scientific, Marlborough, Mass, USA), the other available EC-LAMS. CONCLUSIONS: Our study showed that the novel EC-LAMS has high technical and clinical success rates for various interventional EUS indications. Future multicenter prospective studies will better clarify the role of this new EC-LAMS for different indications.
BACKGROUND AND AIMS: Electrocautery-tip lumen-apposing metal stents (EC-LAMSs) have extended the indications of therapeutic EUS. We aimed to retrospectively evaluate safety and technical and clinical success of a newly developed EC-LAMS, the Hot-Spaxus (Taewoong Medical Co, Gimpo, Korea), for various EUS-guided procedures. METHODS: We included and retrospectively analyzed consecutive patients at 8 tertiary care referral centers who had undergone EUS interventional procedures using the Hot-Spaxus between October 2018 and February 2021. RESULTS: Of 58 included patients (male-to-female, 36:22; mean age, 63.5 ± 14.9 years), 29 had undergone pancreatic fluid collection drainage (50%), 22 (37.9%) biliary drainage for malignant distal obstruction, 3 (5.1%) gallbladder drainage for acute cholecystitis, 3 gastroenteroanastomoses, and 1 (1.7%) pelvic collection drainage. Technical success was achieved in 54 of 58 patients (93.1%) and clinical success in all 58. Adverse events occurred in 6 patients (11.1%): 2 early (3.7%), 1 late (1.8%), and 3 long term (5.6%). The outcomes were similar to those observed in a control group of patients treated with the Hot-Axios (Boston Scientific, Marlborough, Mass, USA), the other available EC-LAMS. CONCLUSIONS: Our study showed that the novel EC-LAMS has high technical and clinical success rates for various interventional EUS indications. Future multicenter prospective studies will better clarify the role of this new EC-LAMS for different indications.
Authors: Benedetto Mangiavillano; Jong Ho Moon; Antonio Facciorusso; Francesco Di Matteo; Danilo Paduano; Milutin Bulajic; Andrew Ofosu; Francesco Auriemma; Laura Lamonaca; Hae Won Yoo; Roberta Rea; Marco Massidda; Alessandro Repici Journal: Endosc Int Open Date: 2022-07-15