Smith, Lyn A3; Stanley, Adrian J4; Bergman, Jacques J4; Kiesslich, Ralf4; Hoffman, Arthur4; Tjwa, Eric T4; Kuipers, Ernst J4; von Holstein, Christer Stael4; Oberg, Stefan4; Brullet, Enric4; Schmidt, Palle N1; Iqbal, Tariq4; Mangiavillano, Benedetto4; Masci, Enzo4; Prat, Frederic4; Morris, Allan J4
1 Gastrounit, Medical Division, Gastrounit, Amager and Hvidovre Hospital, The Capital Region of Denmark2 Gastrounit, Amager and Hvidovre Hospital, The Capital Region of Denmark3 *Department of Gastroenterology, Glasgow Royal Infirmary, Glasgow **Department of Gastroenterology, Queen Elizabeth Hospital, Birmingham, United Kingdom †Department of Gastroenterology and Hepatology, Academic Medical Centre, Amsterdam §Department of Gastroenterology and Hepatology, Erasmus University Medical Centre, Rotterdam, The Netherlands ‡Department of Gastroenterology, St. Mary's Hospital, Frankfurt, Germany ∥Department of Surgery, Lund University Hospital, Lund, Sweden ¶Department of Gastroenterology, Hospital Parc Tauli, Sabadell, Spain #Department of Gastroenterology and Gastroenterologic Surgery, Copenhagen University Hospital, Hvidovre, Denmark ††Department of Gastroenterology and Gastrointestinal Endoscopy, San Paolo University Hospital, Milan, Italy ‡‡Department of Gastroenterology, Cochin Hospital, Paris, France.4 unknown
results of the Survey to Evaluate the Application of Hemospray in the Luminal Tract
BACKGROUND: Hemospray TM (TC-325) is a novel hemostatic agent licensed for use in nonvariceal upper gastrointestinal bleeding (NVUGIB) in Europe. GOALS: We present the operating characteristics and performance of TC-325 in the largest registry to date of patients presenting with NVUGIB in everyday clinical practice. METHODS: Prospective anonymized data of device performance and clinical outcomes were collected from 10 European centers using the multicentre SEAL survey (Survey to Evaluate the Application of Hemospray in the Luminal tract). TC-325 was used as a monotherapy or as second-line therapy in combination with other hemostatic modalities at the endoscopists' discretion. RESULTS: Sixty-three patients (44 men, 19 women), median age 69 (range, 21 to 98) years with NVUGIB requiring endoscopic hemostasis were treated with TC-325. There were 30 patients with bleeding ulcers and 33 with other NVUGIB pathology. Fifty-five (87%) were treated with TC-325 as monotherapy; 47 [85%; 95% confidence interval (CI), 76%-94%] of them achieved primary hemostasis, and rebleeding rate at 7 days was 15% (95% CI, 5%-25%). Primary hemostasis rate for TC-325 in patients with ulcer bleeds was 76% (95% CI, 59%-93%). Eight patients, who otherwise may have required either surgery or interventional radiology, were treated with TC-325 as second-line therapy after failure of other endoscopic treatments, all of whom achieved hemostasis following the adjunct of TC-325. CONCLUSIONS: This multicentre registry identifies potentially useful characteristics of Hemospray (TC-325) when used either as monotherapy or as a rescue therapy in a wide variety of ulcer and nonulcer NVUGIB.
Journal of Clinical Gastroenterology, 2013, Vol 48, Issue 10
Adult; Aged; Aged, 80 and over; Combined Modality Therapy; Europe; Female; Gastrointestinal Hemorrhage; Health Care Surveys; Hemostasis, Endoscopic; Hemostatic Techniques; Hemostatics; Humans; Male; Middle Aged; Minerals; Prospective Studies; Recurrence; Registries; Time Factors; Treatment Outcome; Young Adult; Journal Article; Multicenter Study