Enrique Rodríguez de Santiago1, Diego Burgos-Santamaría2, Leticia Pérez-Carazo3, Enric Brullet4, Lucía Ciriano5, Faust Riu Pons6, Miguel Ángel de Jorge Turrión7, Susana Prados8, Daniel Pérez-Corte9, Irene Becerro-Gonzalez10, Emma Martinez-Moneo11, Angel Barturen12, Ignacio Fernández-Urién13, Antonio López-Serrano14, Carlos Ferre-Aracil15, María Lopez-Ibañez3, Carlos Carbonell3, Oscar Nogales3, Eva Martínez-Bauer4, Álvaro Terán Lantarón5, Giulia Pagano6, Enrique Vázquez-Sequeiros2, Agustín Albillos2. 1. Department of Gastroenterology and Hepatology, Hospital Universitario Ramón y Cajal, Universidad de Alcalá, Madrid, Spain; Instituto Ramón y Cajal de Investigación Sanitaria (IRYCIS), Madrid, Spain. 2. Department of Gastroenterology and Hepatology, Hospital Universitario Ramón y Cajal, Universidad de Alcalá, Madrid, Spain; Instituto Ramón y Cajal de Investigación Sanitaria (IRYCIS), Madrid, Spain; Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Instituto de Salud Carlos III, Madrid, Spain. 3. Department of Gastroenterology and Hepatology, Endoscopy Unit, Hospital General Universitario Gregorio Marañón, Universidad Complutense de Madrid, Madrid, Spain. 4. Endoscopy Unit, Hospital Universitario Parc Taulí, Sabadell, Barcelona, Spain. 5. Department of Gastroenterology and Hepatology, Hospital Universitario Marqués de Valdecilla, Santander, Cantabria, Spain. 6. Department of Gastroenterology, Endoscopy Unit, Hospital del Mar, Barcelona, Spain; IMIM (Hospital del Mar Medical Research Institute), Barcelona, Spain. 7. Digestive Service, Hospital de Cabueñes, Gijón, Spain. 8. Department of Endoscopy, Hospital Universitario HM Sanchinarro, Madrid, Spain. 9. Department of Gastroenterology, Hospital de Avilés, Asturias, Spain. 10. Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Instituto de Salud Carlos III, Madrid, Spain; Department of Gastroenterology and Hepatology, Hospital Universitario de La Princesa, Madrid, Spain; Instituto de Investigación Sanitaria Princesa (IIS-IP), Madrid, Spain. 11. Gastroenterology Service, Hospital Universitario de Cruces, Baracaldo-Vizcaya, Spain. 12. Gastroenterology Service, Hospital Universitario de Cruces, Baracaldo-Vizcaya, Spain; Department of Gastroenterology, Clínica IMQ Zorrotzaurre, Bilbao, Spain. 13. Department of Gastroenterology and Hepatology, Complejo Hospitalario de Navarra, Pamplona, Spain. 14. Department of Gastroenterology, Hospital Universitari Doctor Peset, Universidat de Valencia, Valencia, Spain. 15. Department of Gastroenterology and Hepatology, Hospital Universitario Puerta de Hierro, Majadahonda, Madrid, Spain.
Abstract
BACKGROUND AND AIMS: TC-325 (Hemospray, Cook Medical, Winston-Salem, NC) is an inorganic hemostatic powder recently approved by the U.S. Food and Drug Administration. This study aimed to examine the effectiveness, safety, and predictors of TC-325 failure in a large real-life cohort. METHODS: This was a retrospective study conducted at 21 Spanish centers. All patients treated with TC-325 until September 2018 were included. The primary outcome was treatment failure, defined as failed intraprocedural hemostasis or recurrent bleeding within the first 30 postprocedural days. Secondary outcomes included safety and survival. Risk and predictors of failure were assessed via competing-risk models. RESULTS: The cohort comprised 261 patients, of whom 219 (83.9%) presented with upper gastrointestinal bleeding (GIB). The most common causes were peptic ulcer (28%), malignancy (18.4%), and therapeutic endoscopy-related GIB (17.6%). TC-325 was used as rescue therapy in 191 (73.2%) patients. The rate of intraprocedural hemostasis was 93.5% (95% confidence interval [CI], 90%-96%). Risks of TC-325 failure at postprocedural days 3, 7, and 30 were 21.1%, 24.6%, and 27.4%, respectively. On multivariate analysis, spurting bleeding (P = .004), use of vasoactive drugs (P = .02), and hypotension (P = .008) were independent predictors of failure. Overall 30-day survival was 81.9% (95% CI, 76%-86%) and intraprocedural hemostasis was associated with a better prognosis (adjusted hazard ratio, 0.29; P = .006). Two severe adverse events were noted. CONCLUSION: TC-325 was safe and effective for intraprocedural hemostasis in more than 90% of patients, regardless of the cause or site of bleeding and its use as rescue therapy. In this high-risk cohort treated with TC-325, the 30-day failure rate exceeded 25% and was highest with spurting bleeding or hemodynamic instability.
BACKGROUND AND AIMS: TC-325 (Hemospray, Cook Medical, Winston-Salem, NC) is an inorganic hemostatic powder recently approved by the U.S. Food and Drug Administration. This study aimed to examine the effectiveness, safety, and predictors of TC-325 failure in a large real-life cohort. METHODS: This was a retrospective study conducted at 21 Spanish centers. All patients treated with TC-325 until September 2018 were included. The primary outcome was treatment failure, defined as failed intraprocedural hemostasis or recurrent bleeding within the first 30 postprocedural days. Secondary outcomes included safety and survival. Risk and predictors of failure were assessed via competing-risk models. RESULTS: The cohort comprised 261 patients, of whom 219 (83.9%) presented with upper gastrointestinal bleeding (GIB). The most common causes were peptic ulcer (28%), malignancy (18.4%), and therapeutic endoscopy-related GIB (17.6%). TC-325 was used as rescue therapy in 191 (73.2%) patients. The rate of intraprocedural hemostasis was 93.5% (95% confidence interval [CI], 90%-96%). Risks of TC-325 failure at postprocedural days 3, 7, and 30 were 21.1%, 24.6%, and 27.4%, respectively. On multivariate analysis, spurting bleeding (P = .004), use of vasoactive drugs (P = .02), and hypotension (P = .008) were independent predictors of failure. Overall 30-day survival was 81.9% (95% CI, 76%-86%) and intraprocedural hemostasis was associated with a better prognosis (adjusted hazard ratio, 0.29; P = .006). Two severe adverse events were noted. CONCLUSION:TC-325 was safe and effective for intraprocedural hemostasis in more than 90% of patients, regardless of the cause or site of bleeding and its use as rescue therapy. In this high-risk cohort treated with TC-325, the 30-day failure rate exceeded 25% and was highest with spurting bleeding or hemodynamic instability.
Authors: Armin Kuellmer; Juliane Behn; Benjamin Meier; Andreas Wannhoff; Dominik Bettinger; Robert Thimme; Karel Caca; Arthur Schmidt Journal: United European Gastroenterol J Date: 2019-09-25 Impact factor: 4.623
Authors: Muhammad Aziz; Simcha Weissman; Tej I Mehta; Shafae Hassan; Zubair Khan; Rawish Fatima; Yuriy Tsirlin; Ammar Hassan; Michael Sciarra; Ali Nawras; Amit Rastogi Journal: Ann Gastroenterol Date: 2020-01-20
Authors: Nabil Ali-Mohamad; Massimo Cau; James Baylis; Veronika Zenova; Hugh Semple; Andrew Beckett; Andrew McFadden; Fergal Donnellan; Christian Kastrup Journal: Endosc Int Open Date: 2021-04-22