Hemospray for Refractory Gastrointestinal Bleeding: Initial United States Experience

Abstract

Introduction: Endoscopic interventions including injection of epinephrine, bipoloar coagulation, clipping and argon plasma coagulation have revolutionized the endoscopic breadths of managing acute gastrointestinal bleeds(GIB). Hemospray, a novel technology used for the management of acute GIB allows for further capabilities in achieving endoscopic hemostasis. The aim of this study is to show the initial United States (U.S.) experience of hemospray for intractable GIB. Methods: Hemospray is a hemostatic spray (Cook Medical) used for the management of upper GIB (non-variceal) in Canada and Europe. Hemospray is not currently approved in the U.S., unless it is being utilized for compassionate use. A powder spray is spread evenly over the bleeding surface via a catheter passed through the endoscope and combines with water, creating a barrier which allows for hemostasis. We performed a 10 center retrospective study evaluating the use of hemospray for control of acute GIB. Results: A total of 10 cases were included, dating from February 2012 to March 2014. The mean age of subjects in our study was 59 (range 13-77). Indications for the use of hemospray included bleeding from peptic ulcer, ulcers at previous polypectomy site, ulcerated kaposi’s sarcoma, herpes virus infection causing mucosal damage, metastatic rhabdomyosarcoma, pancreatic cancer invasion into the stomach, neuroendocrine tumor invading the jejunum, ulcerated gastrointestinal stromal tumor and renal cell carcinoma invasion of the duodenum. Location of bleeding included the esophagus, gastric antrum, gastric cardia, gastric body, duodenum (2nd portion) and jejunum (at the level of previous choledochojejunostomy from previous Roux-en-y whipple resection of pancreas). All cases were evaluated endoscopically after the clinical presentation revealed sequelae of acute blood loss from the gastrointestinal tract. The endoscopic evaluations revealed active oozing in the majority of the cases (80%), presence of fibrin plug (10%) and presence of multiple vessels without active bleeding (10%). All cases had previous attempts with alternative hemostasis techniques which included APC, embolization, clipping, bipolar coagulation and epinephrine without success. Hemospray was used alone in 80% of the cases and used in conjunction with epinephrine injection in one case and an over the scope clip in another. Acute hemostasis was achieved in all cases. Acute rebleed occurred in three of the ten cases within 7 days post-procedure. No adverse events were reported. Conclusion: Hemospray is a safe and effective mechanism used to achieve acute hemostasis for the management of GIB not controlled by traditional methods. This is the largest US study evaluating this novel technology to treat acute, life threatening GIB. Disclosure - Seth A. Gross, MD - Consultant: Cook Medical. *Our study has been reviewed by the Conflict of Interest Committee at NYU in order to obtain IRB approval. We are happy to share the letter written by this committee which was required for IRB approval.